REGULATION OF TOBACCO PRODUCTS (Part 2) Y 4. EN 2/3; 103-153 Regulation of Tobacco Productsi (Pa... HEARINGS BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OP REPRESENTATIVES ONE HUNDRED THIRD CONGRESS SECOND SESSION APRIL 28, MAY 17 AND 26, 1994 Serial No. 103-153 Printed for the use of the Committee on Energy and Commerce REGUUTION OF TOBACCO PRODUCTS (Part 2) HEARINGS BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRD CONGRESS SECOND SESSION APRIL 28, MAY 17 AND 26, 1994 Serial No. 103-153 Printed for the use of the Committee on Energy and Commerce U.S. GOVERNMENT PRINTING OFFICE 84-528CC WASHINGTON : 1995 For sale by the U.S. Government Printing Office Superintendent of Documents. Congressional Sales Office, Washington, DC 20402 ISBN 0-16-046535-4 COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman HENRY A. WAXMAN, California PHILIP R. SHARP, Indiana EDWARD J. MARKEY, Massachusetts AL SWIFT, Washington CARDISS COLLINS, IlUnois MIKE SYNAR, Oklahoma W.J. "BILLY" TAUZIN, Louisiana RON WYDEN, Oregon RALPH M. HALL, Texas BILL RICHARDSON, New Mexico JIM SLATTERY, Kansas JOHN BRYANT, Texas RICK BOUCHER, Virginia JIM COOPER, Tennessee J. ROY ROWLAND, Georgia THOMAS J. MANTON, New York EDOLPHUS TOWNS, New York GERRY E. STUDDS, Massachusetts RICHARD H. LEHMAN, Cahfomia FRANK PALLONE, Jr., New Jersey CRAIG A. WASHINGTON, Texas LYNN SCHENK, California SHERROD BROWN, Ohio MIKE KREIDLER, Washington MARJORIE MARGOLIES-MEZVINSKY. Pennsylvania BLANCHE M. LAMBERT, Arkansas Alan J. Roth, Staff Director and Chief Counsel Dennis B. Fitzgibbons, Deputy Staff Director Margaret A. Durbin, Minority Chief Counsel and Staff Director CARLOS J. MOORHEAD, California THOMAS J. BLILEY, Jr., Virginia JACK FIELDS, Texas MICHAEL G. OXLEY, Ohio MICHAEL BILIRAKIS, Florida DAN SCHAEFER, Colorado JOE BARTON, Texas ALEX MCMILLAN, North CaroUna J. DENNIS HASTERT, Illinois FRED UPTON, Michigan CLIFF STEARNS, Florida BILL PAXON, New York PAUL E. GILLMOR, Ohio SCOTT KLUG, Wisconsin GARY A. FRANKS, Connecticut JAMES C. GREENWOOD, Pennsylvania MICHAEL D. CRAPO, Idaho Subcommittee on Health and the Environment HENRY A. WAXMAN, MIKE SYNAR, Oklahoma RON WYDEN, Oregon RALPH M. HALL, Texas BILL RICHARDSON, New Mexico JOHN BRYANT, Texas J. ROY ROWLAND, Georgia EDOLPHUS TOWNS, New York GERRY E. STUDDS, Massachusetts JIM SLATTERY, Kansas JIM COOPER, Tennessee FRANK PALLONE, Jr., New Jersey CRAIG A. WASHINGTON, Texas SHERROD BROWN, Ohio MIKE KREIDLER, Washington JOHN D. DINGELL, Michigan (Ex Officio) California, Chairman THOMAS J. BLILEY, Jr., Virginia MICHAEL BILIRAKIS, Florida ALEX MCMILLAN, North Carohna J. DENNIS HASTERT, UUnois FRED UPTON, Michigan BILL PAXON, New York SCOTT KLUG, Wisconsin GARY A. FRANKS, Connecticut JAMES C. GREENWOOD, Pennsylvania CARLOS J. MOORHEAD, California (Ex Officio) Karen Nelson, Staff Director WiLLL\M SCHULTZ, Counsel Phillip Barnett, Counsel Mary M. McGrane, Minority Counsel 01) CONTENTS Page Hearings held on: April 28, 1994 1 May 17, 1994 157 May 26, 1994 331 Testimony of: Califano, Joseph A., Jr., president. Center on Addiction and Substance Abuse at Columbia University 162 DeNoble, Victor John, senior behavior analyst, Delaware Community Mental Retardation Program 4 Glenn, James F., chairman, president, and CEO, Council for Tobacco Research, USA 340 Mele, Paul C, Armed Forces Radiobiology Research Institute 16 Material submitted for the record by: Coalition on Smoking OR Health: News release and statement 395 Council for Tobacco Research, USA: Letter dated September 27, 1994, additional clarification of questions asked Mr. Glenn at May 26, 1994 hearing 403 Health and the Environment Subcommittee, majority staff report: Hill and Knowlton Documents: How the Tobacco Industry Launched Its Disinformation Campaign 418 Health and the Environment Subcommittee: Additional questions for Dr. DeNoble from Hon. Thomas Bliley, Jr., and responses 151 List of documents which have been retained in committee files 155 (III) REGULATION OF TOBACCO PRODUCTS THURSDAY, APRIL 28, 1994 House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment, Washington DC. The subcommittee met, pursuant to notice, at 10 a.m., room 2123 Raybum House Office Building, Hon. Henry A. Waxman (chair- man) presiding. Mr. Waxman. The meeting of the subcommittee will come to order. This hearing is a continuation of the subcommittee's over- sight hearings on tobacco products. The witnesses this morning are Dr. Victor DeNoble and Dr. Paul Mele. Dr. DeNoble worked in Philip Morris's behavioral pharmacology laboratory from 1980 to 1984. During most of that time, he directed animal research on nicotine and substances that might be sub- stituted for nicotine. Dr. Mele worked with Dr. DeNoble in his lab- oratory. On March 31, I released a study that Dr. DeNoble had coau- thored with Dr. Mele and that demonstrated that nicotine has rein- forcing properties, which the National Institute of Drug Abuse has stated is a hallmark for addiction. The study was accepted for pub- lication in 1983, and again in 1986, but each time, Philip Morris directed Dr. DeNoble to withdraw it. As a consequence, it was never published. Today, Dr. DeNoble and Dr. Mele are here to testify about these incidents and others during their employment at Philip Morris. To my knowledge, they are the first scientists to be released from their confidentiality agreements by a tobacco company. On behalf of the subcommittee, I want to welcome Dr. DeNoble and Dr. Mele, and to say that we are pleased that they are willing to testify in the subcommittee's oversight hearings on tobacco prod- ucts. But before calling on the two of you, I want to recognize mem- bers for any opening statements they wish to make, and to recog- nize Mr. Bliley first. Mr. Bliley. Thank you, Mr. Chairman. Today we will hear in greater detail about an issue that was raised at the subcommittee's last two tobacco hearings, research on nicotine undertaken by former Philip Morris research scientists in the early 1980's. And, as with the other tobacco-related issues that this sub- committee has recently considered, this issue already has been aired in the press. It is therefore critically important that, once again, our deliberations attempt to separate fact from fiction, and that we opt for good policy rather than good headlines. I hope that (1) we approach the proceedings today from the benefit of a wisdom that can only be achieved through experience. In this case, the experience is very recent because we have been down this road before. Just a month ago, allegations were flying in the media about nicotine spiking. In response, top executives from the major tobacco companies came before us voluntarily and under oath to put these unfounded claims to rest and to set the record straight. Hopefully, the process will allow for a similar fair hearing for all concerned regarding this issue. In conclusion, I am here to listen. But because we have the bene- fit of hearing only one side of the issue here today, additionsd ques- tions surely will arise. Therefore, this hearing should be viewed as but part of a larger process that allows both sides of the issue to be properly aired. Mr. Waxman. Thank you, Mr. Bliley. I agree with your comments that this is one part of a series that will be available for us to get the information to the subcommittee. Mr. Synar? Mr. Synar. Thank you, Mr. Chairman. As early as 40 years ago, researchers informed Americans of the harmful effects of smoking. The industry continues to deny the deadliness of smoking. On April 14th of this year, the CEO's of the seven major U.S. tobacco compa- nies flatly denied, while under oath, that nicotine is addictive and that smoking causes cancer. Today, Dr. Victor DeNoble, the former associate senior scientist with Philip Morris, will tell us a different story. His testimony will directly contradict the tobacco executives' statements that nicotine is not addictive, and it will show that the companies have proof of nicotine's addictiveness. Now, why do our executives continue to deny it? Because to do anything else would subject them to expensive and immediate li- ability. This concealment, coupled with the industry's continued di- rect targeting of children, is criminal. Americans are beginning to demand some answers from tobacco companies, not to bring back the 8 million lives lost, but to prevent the next generation of children from taking up this addiction that will, in all likelihood, result in their deaths. I look forward to this important and revealing accumulation of information today in the continuing battle with the largest prevent- able cause of death in our society. [The opening statement of Mr. S3niar follows:] Statement of Hon. Mike Synar As early as 40 years ago, researchers informed Americans of the harmful effects of smoking. In the years since the 1964 Surgeon General's Report on Smoking, the tobacco industry has continuously denied the deadliness of smoking. On April 14, 1994, the CEO's of the seven major U.S. tobacco companies flatly denied, while under oath, that nicotine is addictive and that smoking causes cancer. Today, Dr. Victor DeNoble, former Associate Senior Scientist with Philip Morris, will testify concerning an article entitled, "Nicotine as a Positive Reinforcer in Rats: Effects of Infusion Dose and Fixed Ratio Size", which he submitted to Pyschopharmacology on May 16, 1983. His article, never published because he was forced to retract it by Philip Morris, concluded that "all the rats initiated and main- tained nicotine self-administration." This directly contradicts the tobacco executives' statements that nicotine is not addictive. It shows the companies had proof of nico- tine's addictiveness. This concealment, coupled with the industry's direct targeting of children, is criminal. American Tobacco Company, which sold off its tobacco products line this week, saw the writing on the wall. Americans are beginning to demand some an- swers from tobacco companies — not to bring back the 8 million lives lost — but to pre- vent the next generation of children from taking up the addiction that will, in all likelihood, result in their deaths. Mr. Waxman. Thank you very much, Mr. Synar. Mr. Wyden? Mr. Wyden. Thank you very much, Mr. Chairman. I too want to commend you for the painstaking approach you are taking on the health hazards of tobacco. I think of this series of hearings as an effort to get at the core of the onion by peeUng away the deceptive practices we have seen in this industry layer by layer. Today's Hearing is especially important because we have a respected re- searcher, a former tobacco industry scientist who, in effect, is brought in from the cold. Now, this is no spy novel. But the whole environment of the to- bacco industry and its relationship to tobacco consumers very often does read like a cloak-and-dagger thriller. This industry works with secret lists, confidential technologies, and veiled advertising mes- sages. And, in effect, through these practices, can orchestrate a world-class confidence game. Individuals like Dr. DeNoble who get in their way because of em- barrassing information they might have to offer are, in effect, pushed to the sidelines. And it seems to me the losers are consum- ers who each day by the tens of thousands decide to take up this deadly habit. Now, the corporate leaders who run this industry have told the subcommittee, in sworn testimony, that they have no proof that their products are addictive. Recently they came before us and said that they are making a safe product that millions of Americans enjoy. In effect, their message was that the United States Congress was the bad guy for trying to dampen enthusiasm for a harmless vice. But the fact of the matter is that all Americans ought to be trou- bled by what we are going to learn today, which is that when the tobacco industry does research and the results hurt them, the in- vestigators and their data are buttoned up tight. What we are learning is that tobacco science is politicized science. And it is espe- cially important that we have Dr. DeNoble's message today. Mr. Chairman, I look forward to pursuing this with you. You have taken, in my view, another important step by bringing Dr. DeNoble here, and I look forward to our questions. Mr. Waxman. Thank you very much, Mr. Wyden. Dr. DeNoble and Dr. Mele, we are pleased to welcome you both to our subcommittee hearing today. You were both employed as re- search scientists by Philip Morris during the early 1980's. I under- stand, Dr. DeNoble, that you are going to make a statement, but that Dr. Mele wishes simply to be available to answer questions. But before we get to your testimony, I want to inform you that the applicable rules of the House and the rules of the committee are in that blue and white pamphlet that is on the table before you. They will inform you of the limits on the power of this subcommit- tee and the extent of your rights during your appearance today. Do you desire to be represented by counsel, or advised by coun- sel, during your appearances today? Mr. DeNoble. Mr. Chairman, I do have counsel with me, and I would like the opportunity to talk with him, if necessary. Mr. Waxman. ok. Dr. Mele? Mr. Mele. Yes. I would likewise. Mr. Waxman. Do you object to appearing before the subcommit- tee under oath? Mr. DeNoble. No, sir, I do not. Mr. Mele. No. Mr. Waxman. OK. If you have no objections to appearing before us under oath, I'd like to ask you both to rise and raise your right hand. [Witnesses sworn.] Mr. Waxman. Please consider yourself to be under oath. I'd like to ask each of you to identify yourself for the record. Mr. DeNoble. I'm Dr. Victor John DeNoble. Mr. Mele. I am Dr. Paul C. Mele. Mr. Waxman. And would you introduce anyone who is with you today? Could you be sure the mike is turned on? There is a button that pushes forward. Mr. DeNoble. I have with me my wife. Chum DeNoble, and my counsel, Eric Snyder. Mr. Mele. Yes. I have my wife, Joy Mele; my son, Tristan Mele; my counsel, Dave Vladeck. Mr. Waxman. Thank you. Dr. DeNoble, I'd like to recognize you to make your comments. Mr. DeNoble. Thank you. Mr. Waxman. Would you pull the microphone close to you so that we can be sure to get all of this on the record? TESTIMONY OF VICTOR JOHN DENOBLE, SENIOR BEHAVIOR ANALYST, DELAWARE COMMUNITY MENTAL RETARDATION PROGRAM, ACCOMPANIED BY PAUL C. MELE, ARMED FORCES RADIOBIOLOGY RESEARCH INSTITUTE Mr. DeNoble. Mr. Chairman and members of the committee, I am Dr. Victor John DeNoble, and this is my colleague and friend. Dr. Paul Mele. We are grateful to have this opportunity to talk to you about our research. Mr. Waxman. Excuse me, Dr. DeNoble. I'm not sure your mike is on. Is your light on? Mr. DeNoble. The light is on, yes, sir. Mr. Waxman. Pull it closer to you then. Mr. DeNoble. My career began in 1976 when I received a Ph.D. in experimental psychology from Adelphi University in New York. After receiving my degree, I began post-doctoral research on the be- havioral and the electrophysiological effects of alcohol in non- human primates at Downstate Medical Center, in New York. Following this, I accepted a post-doctoral position sponsored by the National Institute of Drug Abuse at the University of Min- nesota. At Minnesota I studied the self-administration techniques in rodent, non-human primates. I am currently a senior behavioral analyst with the Community Mental Retardation Program for the State of Delaware. From April of 1980 to April of 1984, I was employed at the Philip Morris Research Center in Richmond, Va., as an associate scientist; 6> and then as an associate senior scientist, a position I was promoted to in 1983. During that time, I established and directed a behav- ioral pharmacology laboratory to study the behavioral and physio- logical effects of nicotine in rats. Our goal was to identify the effects of nicotine in the central nervous system, and to establish structure activity relationships among organically synthesized analogues of nicotine. The purpose of this nicotine analogue program was to develop an analogue that would retain the physiological effects of nicotine in the brain as well as the behavioral effects, but not have adverse effects on the cardiovascular system. Our program was successful in identifying a series of compounds which met this criteria. In order to behaviorally evaluate nicotine analogues, a character- ization of the behavioral effects of nicotine in rats using a variety of offered conditioning procedures needed to be developed. One of the earliest test procedures we used was a nicotine self-administra- tion test. In this procedure, an animal can press a lever and deliver a drug solution into its vein. If the solution has reinforcing prop- erties or qualities, the animal will continue to press the lever. We found that nicotine functioned as an intravenously delivered reinforcer in rats in the absence of any inducement conditions. In previous studies, inducement conditions made the analysis of nico- tine's reinforcing effects difficult to assess. Our result demonstrated for the first time that nicotine shared common characteristics with other drugs that are delivered intravenously. In other studies, we also found that rats would develop tolerance to repeated injections of nicotine, and this tolerance was in part be- havioral and in part physiological. Following tolerance develop- ment, higher doses of nicotine were required to produce the effects that were both quantitatively and qualitatively similar to before tolerance development. We also examined the potential of nicotine to produce a physical dependence in rats. In two separate experiments, we were not able to show that nicotine produced a withdrawal syndrome. There were several other studies performed in the laboratory with nicotine. And although none of these — ^very few of these stud- ies were published, almost all of this research has since been rep- licated, confirmed by other investigators around the world. In 1982, however, we began to investigate the behavioral effects of another smoke component. To the best of my knowledge, this re- search has never been replicated and therefore awaits scientific confirmation. In our search to identify molecules in cigarette smoke that may have reinforcing properties other than nicotine, we identi- fied a molecule called acetaldehyde. It was in high concentrations in cigarette smoke. Because acetaldehyde could be delivered to the brain in seconds, and is highly reactive with catecholamines, we hypothesized that, one, acetaldehyde functions as a reinforcer for rats; and, two, that possibly interactions with nicotine could be achieved. Our research confirmed that acetaldehyde was a reinforcer for rats, and the rein- forcing properties of acetaldehyde and nicotine combinations would interact producing additive effects in these animals. I would like to state that senior research management in Rich- mond, Va., as well as top officials of the Philip Morris Company in New York, continually reviewed our research and approved our re- search. Senior management also reviewed and made final decisions determining whether data could be published, presented at sci- entific meetings, or even discussed in the scientific community. With regard to the Philip Morris press release, dated March 31st, 1994, the statements made concerning my research and my assess- ment of the self-administration experiments are out of context and misleading. Further, during my employment with Philip Morris, three manuscripts were approved for publication. Two of these manuscripts were subsequently ordered to be withdrawn by the company after this approval. In addition, a 1983 scheduled presentation of the nicotine self-ad- ministration paper at the American Psychological Association meet- ing was also blocked by the company. Finally, without prior discus- sion or prior warning, the behavioral pharmacology laboratory was abruptly closed in April of 1984. Mr. Chairman, and members of the committee, I would like to thank you for reading our statement, and I welcome any questions. [The prepared statement of Dr. DeNoble follows:] Statement of Victor John DeNoble Mr. Chairman and members of the committee, I am Dr. Victor John DeNoble, a behavioral psychologist, and I am senior behavior analyst for the Community Men- ted Retardation Program for the State of Delaware. I am grateful to have this oppor- tunity to discuss my research at this hearing on tobacco. From 1980 to 1984, I was employed at the Philip Morris Research Center in Rich- mond, Virginia as an associate senior scientist. My responsibilities were to establish and direct a behavioral pharmacology laboratory to study the behavioral and physio- logical effects of nicotine and other smoke components in rats. Our initial goal was to identify the behavioral effects of nicotine on the central nervous system and to establish structure activity relationships among organically synthesized nicotine analogues. The purpose of the nicotine analogue program was to develop an ana- logue that would retain physiological and behavioral effects in the brain and be de- void of any pharmacological effects in other organs, specifically, the cardiovascular system. In order to accomplish this goal, a characterization of the behavioral effects of nicotine in rats using a variety of operant conditioning procedures needed to be developed. With regard to the nicotine analogue program, our primary behavioral test was a nicotine drug discrimination procedure. Rats were trained to identify whether they had been injected with nicotine or saline. Using nicotinic-cholinergic antagonists, we demonstrated that the rats ability to discriminate (identify) whether it was injected with nicotine or saline was mediated by nicotine's effect in the brain not by nico- tine's effect on the peripheral nicotinic receptors. This test procedure was used to identify nicotine analogues that would mimic the effects of nicotine in this discrimination procedure. This behavioral data was then combined with nicotinic receptor binding data, as well as peripheral pharmacology data generated outside Philip Morris Research Center to develop structure-activity relationships among these analogues. The goal of this program was to identity a nic- otine analogue that would have central nervous system effects without effects on the cardiovasciilar system. In our self-administration studies we demonstrated that: (1) nicotine functioned as an intravenously delivered reinforcer for rats; (2) that rats would press levers several times for a single injection; (3) that nicotine self-administration was con- trolled, at least in part, by nicotine levels in blood or tissue; (4) that the reinforcing effects were mediated by central nicotinic-cholinergic receptors; (5) that endogenous opioid receptors did not mediate nicotine's reinforcing effects and, finally; (6) that termination of chronic self-administration of nicotine over several weeks did not re- sult in observable behavioral signs of a physiological dependence. With regard to this last observation, we extended our findings by examining the effects of nicotine self-administration on concurrent lever pressing maintained by food. Concurrent nicotine self-administration was shown not to interfere with lever pressing for food and that discontinuing access to nicotine self-administration did not alter the rate or pattern of food intake. In a related experiment, we examined the effects of pharmacological antagonism of chronic nicotine administration on lever pressing maintained by food. The results showed that antagonism of chron- ically administered nicotine also did not result in a disruption of schedule-controlled behavior. Termination or antagonism of chronic nicotine administration did not result in a disruption of lever pressing for food suggesting that chronic administration of nico- tine ciid not result in a physiological dependence in these tests. Studies on the development and loss of tolerance to chronic nicotine exposure re- vealed that tolerance to the behavioral effects of nicotine developed following chronic administration of nicotine. The study design allowed us to demonstrate that both physiological and behavioral tolerance develops to chronic nicotine administration. Following tolerance development, higher doses of nicotine were required to produce effects that were both quantitatively and qualitatively similar to those observed be- fore tolerance had developed. Our laboratory also conducted a series of studies on the behavioral effects of nico- tine when injected directly into the ventricles of the brain, as well as, when nicotine is injected into different Drain sites. This research was directed at identifying the neuroanatomical substrates mediating the behavioral effects of nicotine. These test procedures also became a primary screening tool for the nicotine analogue program since the behavioral effects of nicotine were shown to be controlled by nicotine s ef- fect on the brain, not on peripheral systems. The above mentioned studies summarizes major research efforts with nicotine and nicotine analogues. There were several other experiments which provided support for these major research programs. Almost all of the research that occurred between 1980 and 1984 has subsequently been replicated, confirmed and extended by other investigators around the world. However, in 1982 we began to investigate the behavioral effects of another smoke component. To the best of my knowledge, this research has never been replicated, and therefore, awaits scientific conflmation. In our search to identity other molecules in tobacco smoke that may have reinforc- ing properties, we identified acetaldehyde as a major component of gas phase smoke. Tobacco itself does not contain acetaldehyde, but, as a product of pyrolysis, large amounts of acetaldehyde are formed and delivered in the gas phase of smoking. In- terest in this molecule began in the mid-1960's when it was demonstrated that an- other aldehyde, formaldehyde, was shown to condense with endogenous catecholamines to form compounds called tetrahydroisoquinolines (TIQ's). In the mid 1970's, it was demonstrated that acetaldehyde, a major metabolite of alcohol could also form TIQ's. TIQ's have been hypothesized to act as "false neurotransmitters" in catecholamine-containing neurons. The fact that acetaldehyde is in high concentration in smoke, is delivered to the brain in seconds, and is highly reactive with catecholamines led us to hypothesize that: (1) acetaldehyde may func- tion as an intravenously delivered reinforcer for rats; (2) that the reinforcing effect would be mediated by the formation of TIQ's; and that, (3) interactions with nico- tine's reinforcing effects would be possible. Our research confirmed that acetaldehyde was: (1) a reinforcer when delivered in- travenously; (2) that rats would press levers several times for a single injection; and (3) that termination of acetaldehyde access did not result in observable signs of a physiological dependence. In a related series of experiments, we further dem- onstrated that the reinforcing properties of nicotine ana acetaldehyde would interact behaviorally producing additive effects in rats. These results formed the basis for the hypothesis that both nicotine and acetal- dehyde are reinforcing agents in cigarette smoke and that their interaction would result in an enhanced reinforcing effect in humans. I would like to thank you for allowing me to place my statement in the record. Mr. Waxman. Thank you very much, Dr. DeNoble. If the mem- bers have no objection, we're going to recognize each one in turn for 10 minutes, but since these are our only witnesses for today, if someone is pursuing a line of questioning that might go a little beyond the 10 minutes, I hope we'll be willing to extend the cour- tesy to continue that line of questioning. Dr. DeNoble, I want the clerk to give you Exhibit 1, which is your resume. And I note that you've published more than 20 arti- cles, and that you have held teaching positions at 7 universities. [The document follows:] 8 CUHWicuiiin YITftF VICTOR J. DaNOBLE 1200 C«np Woods Court Newark. DE 19711 T»tophon«: Homt: (302) 234-1106 IDUCATIQNt BA Ptychotegy Adeiphi University, N.Y. 1971 M.S. Exp«rim«nt*l Psychotogy Ad«lphj UnivcfsHy, N.Y. 1874 Ph.O. R^lok>gieal Psyehoioay Adelphi University. N.Y. I07e Title of Dlsssrftioii! RMponse Acceleration and Suppression Produced t>y Response-independent Food Presentation in Rats with Septal Lesions. Presented at ttie FinHifn Pyvcholooical AMOClation. 1974. Published JCPP ai:1 07-11 7. 1977. (Advisor Or. M. A. Caplan) ^atlftnai instltlute ef Drun Abuae Poatdoetoral Pellow: University of Minnesota, Department of Pharmacology and Psychia^, MN 1978- 1080 (Sponsors: Or. Richard A. Meieeh. Or. Roy PIckans and Dr. Travis Thompson) currant Position; Senbr Behavwr Analyst, Department of Mental Retardation, Delaware State Mental HmWi Oapartmont PfiSf ARCH BXPlHIgNCE! 1091 - 1992 Manager, Oevek>pment and Trainir)g. R&D OperatioTM, Ou Pont Merck Pharmaceutical Company, Experimental Statkm, Wilmington, Delaware. 1 990 • 1991 Research Assodata, Central Nervous System Research, The OuPont Merck Pharmaceutical Company. Experimental SttMRI'' Wnmington. Delaware. ^ * 1987 • 1990 Research Associate, Central Nervous System Research, E. I. DuPont de Nemours & Co.. Inc., Experimental Statk)n, Wilmington, Delaware. 1984 • 1987 Research Associate, CNS Research, Ayerst (.atioratoriea Research, Inc., Princeton, New Jersey. 1983 • 1984 Associate Senior Scientist. Project Leader, Behavioral Pharmacology Laboratory, Philip Morris Research Center. Richmond, Virginia. 1980 • 1983 Project Leader, Behavioral Pharmacology Laboratory. Philip Morris Research Center. Richmond, Virginia. 9 2 - RESEARCH JXPiRliNCg (oont'd)! 1078 • 1080 R«March Associate, Psychiatry Research Unit. Univarsiiy of Mir^nesota. 1878 • 1877 Research Associate, Department of Biopsychotogy and Arwtomy, Oownstate Medical Center, Brooklyn, New York. 1874 • 1877 Senior Research Scientist, Electrophyaioiogy Laboralofy, Department of Psychiatry, Oownstate Medwal. BrooMyn, New York. TgACHING gXPERlENCl! 1888 • 1880 Adjunct Associate Professor, Department of P8ychok>gy, University of Delaware, Newark. Deiaware. 1886 - 1887 Adjunct Assistant Professor, Department of Psychology, Trenton State Colleoe, Trenton, New Jersey. 1883 • 1888 Adjunct Associate Profeseor, Department of Psychok>gy, Virginia Commonwealth University, Richmond, Virginia. 1877 • 1878 Adjunct Associate Professor, Department of Psychology. State University of New York. Farmingdale. New York. 1878 • 1878 Adjunct Assistant Professor, Department of Psychokjgy, City UnivertHy of New York, Brooklyn College, New York. 1873 • 1878 Adjurvst Lecturer, Department of Paycholofly. City University of New York, Brooklyn College, New York. 1876 - 1877 Adjunct Lecturer at State University of New York, Farmingdale. 1872 ■ 1876 AcQunot Lecturer at Adeiphi University. QUgftT REViEWER FOR; Neuropaytjhophannacotogy Sdtnce Pharmacology 6k>chemi8try and Behavk>r Physbk>glcal Psychology Physk}k}gy and Behavior LMeScJencee 1084 Division 28 • American Psychotogical Association 1885 Division 28 • Amerwan Psychotoglcal Association 10 - 3 PUBLICATIONS; DeNobte, VJ.. DeNobte, K.F., Spenoef. K.R.. Chiu. A.T.. Wong. P.C, Timmormans. P.B.M.W.M. Nonp«ptide Anglotdnwn II Receptof Antagonist and Angiotansin ConvfttUng Enzym« lnhft}itof: Effect on a Renln-lnducod Ooficit of a Pastiva Avoidance RespooM in Rati. Brain Roa. ^1, 230-235, 1991. DfiNobIa, VJ., OoNobta. K.F.. Sp«nc«r, K.R. Protaction against hypoxia induoed paaaiva avoidanoa doficite: interaction b«twaen DuP 996 and ketanserin. Rrain Rhs RuI 29 (8). 1M1. OaNobie, VJ., Schrack. L.M., Ralgal, A. and DeNobia, K.F. Visual recognition mamory in squirrel monkeyt: Effects of aarotonin antagonists on baseline and hypo)da>induc«d performance deficits. Ptiarmacol Blochem Befiav. 39, 991-996, 1991. DeNk)ble. V. J.. DeNoble, K. F., Spencer, K- R-, Johnson, L. C, Cook, L., Myera, M. J. wtd Scribner R. M. Comparison of OuP 996, an acetyk:hollne release enhancer, with Physoatigmine, Tetrahydroaminoacdrkflne and 3,4-diaminopyrkline on hypoxia- induced amnesia in rate, Pharm. Biochem. Behav.. 36, 957-981, 1990. Cook L, Nickoteon, V. J.. Steinfela, G. F,. Rohrbach, K. W. and DeNoble. V. J. Cognition enhancemen't by the acetylcholine releaser DuP 996. Drug Dev. Raa.. 19, 301-314, 1990. Jonea K. W., Bauerie L. M., DeNoble V. J. Differential effects of Phencyclkflne agonisto and aiffina receptor agonists on the rets Fur. J. Pharm.. 179, 97-102, 1990. and eiffina receptor agonists on the retentk>n of a passh^e avokjance reeponse in rMs. DeNcble, V. J., Jones, K. W., Schaeffer, C. L. and Bauerie. L M. 3-(2 Carboxyplperazin-4-yOpropyM*phosphonic ackl (CPP) and phencyclkSne produce a deficit of passive avokianc« retentk>n in rats. Eur. J. Pharm.. 176, 187- 202, 1900. Jones, K. W.. Schaeffer, C. L and DeNoble, V. J. SystemKally administered N-Methyl- 0-Aepartate interferes with acquisition of a pa$s^e avoidance response in rats. Phurm. Hiocham. Rahav.. 34. ISMdS, 1989. Strak, K. F., Spencer. K. R. and DeNoble. V. J. Serotonergic antagonists protect against an hypoxlS'lnduced defcit ct a passive avoidance response in rats. Pharm. Blocham. fiillA:^.. 33. 241-244, 1989. DeNoble, V. J., Hepler, 0. J. and Barto, R, A, Cysteamino-lnduced depleton o4 somatostatin produced differential cognitive deficits In rats. Prain Research. 482, 42-46. 1988. DeNoble, V. J. Vinpocetine enhances retrieval of a step-through passive avokJance response In rats. Ptiarm. Biochem und Rahav.. 26. 183-186, 1987. DeNobia, V. J. and Mete. P. C. Brain sites involved in the mediation of the behavteral effects of intraventricularly administered ^-Nicotine. PsychoDhafmacolo^v. 90, 166-159, 1986. 11 PU8LICATI0N8 fcont'dk D«Nobl«, V. J.. Rep«tti, S. J., Ge^kt. L W.. Wood, L M. and Kelm, K. L. Vmpoc«tio«: Nootropic •ff^d* on soopolamint-induced and hypoxia-inducad retriaval dafidia of a stap-throush paaaiva avokJanca rasponsa in rats, p^arm. Riochem. Behav.. 24, 1123-1126, 1986. DaNoble, V. J., Mala, P. C. ar>d Portar, J. H. Intravanous salf-adminlstratlon of pantobarbltal arxj athanoi in rats. Pharm. Bioeham. and Behav.. 23, 750-763, 1965. DeNobIa, V. J.. Dragan, Y. and Carron, L Bahavioral affacts of inlraventricularly admlnlaterad (-)-nicotind on fixad ratio achadutes of food prosentation in rats. PavchoDharmaeoleav.. 77, 316-321, 1082. DaNobia, V. J,. Svikia, D. arvd Maisch, R. A. OraJiy delivered pentobarbital a* a rainfofcar of rhasus monkeye with concurrent accesa to water, fij^^eiia Medtea. Book Series 620, 303-320, 1962. Ptekena, R., MucSow, D. and DeNoWa. V. J. Methohexital-reinforced responding in rats: Effects of fixed ratio size and injection dose. J. Pharmacol. Exp. Ther.. 216. 20i- 209, 1961. Begleltar, H., DeNoWe, V. J. and PorjeM, B. Protracted brain dysfunction after akxihol withdrawal In monkayt. RlQlogtcal Eft«*^tit of Air.nhoi Ptanum Preas. 231-251. 1960. OeNobIa, V. J. and Bagleiter, H. Impairment of acquisition of a DRL schedule foliowing protoriged ethanol oontumption. Pharm. Riochem and Rahav.. 10, 393-396, 1979. Deh4obla, V. J. and Ba^eitar, H. Salt>«dminlstration of aioohol In monkeya; the affecta of prior exposure. Pharm. Biochfm tkr>6 Bahav.. 6. 391-397, 1976. Def^oble, V. J. ind Beglerter, H. Fixed-ratto performance and blood alcohol levels in monkeys. Paytenain oonvarting enzyme inhi>ltor: effact on a renki'^nducdd dertcit of a paash^e avoidanca reaponaa In rati. Society for Nauroacience, 1991. Tarn, S., Stalnfela, G.. McElroy. J.. DaNoble, V., Johnson, A., and Cook, L DuP 734 la a novel aigma racaptor antagonlsl Society for Neuroscience. 1991. DeNoble, V. J., Schrack. L. M., Relgel. A. L, and DaNoble. K. F. Serotonergic antagonicta improve performance in two models of a delayed match to sample task in squirrel monkeys. FASE6, 1090. Tarn, S. W., Jonee, K. W.. Zeller, K. L, and DeNoble. V. J. Differential effects of PCP, (•»-)*SKF 10.047, neuroleptica, and BMY 14602 on rotation in rats with unilateral nlgroatn'ata! lesions. FASEB, 1990. Barto, R. A.. Strek, K. F., Jones, K. W., and DeNoble. V. J. (♦)-SKF 10.047 diacrimination: In aaafch of the interoceptive cue. FASEB. 1990. OaNoble. V. J., Jonaa, K. W.. Schaeffer, C. L and Bauerle. L M. CPP and PCP produca amnaaia of a paanva avoidanca response in rats. Society for Nauroacience, 1989. Jones, K. W., Bauerta, L. M. and DeNoble, V. J. Effects of PCP and eigma racaptof Eganda on acquisition of a paaaive avoManca (.^ponae in rata. Sodaty for Neuroadance, 1980. Confatene, P.N.. RA. Eari. A.L. Johnaon, M.J. Myera, C.Y. Cheng, V.R. GantI, R.M. Scribner. V. J. f^ckolaon, V.J. DeNoble, S.W. Tarn, L. Cook. Acetyteholine-ralaasing aganta as cognitk>n anhancars. Chemistry and atructure-activity relatlonshipa of 2,2onV6): Hepl»r, D. J., Tarn, S. W. and D«No6le. V. J. The sigma agontetg PCP and (+)-SKF 10,047 induce dopamine release in brain slices and rotation in rats with unilateraJ substantia nigra lesions. Society for Neuroscience, 1988. Jones, K. W., Schaeffer. C. Steinfels, G. F.. Albenci, G. P. and DeNoble. V. J. Selective effects of NMDA on acquisition of rat paasive avoidanca. Society for Neurosctence 1088. Mole, P. C. and DeNoble. V. J. Chronic mecamylamine does not produce behavioral supersensitivity to nicotine. Society for Neurosctence, 1986. DeNoble, V. J. Vinpocetine enhances retrieval of a step-through passive avoidance response in rats. Society for Neuroscienee, 1986. Repetti, S. J., DeNoble, V. J., King, G. A. arxi Simmonds, J. Lesions of the nucleus basatis magnoceliulafis (NBM) in rat* impair acquisition of a differential reinforcement of kjw rate (DRL) schedule: Attenuation by vinpocetine. Neuroscienee, 1988. DeNoble, V. J. and Mele, P. C. Brain sites involved in the behavioral effects of intraventricularly administered (-)*nicotine. American Psychological Association, e3rd Annual Meeting, 1986. DeNoble, V. J., Repetti, S. J. and Keim, K. L. Vinpocetine increases the rate of acquisition of repetitive differential reinforcement of low rate (DRL) schedules in ° rata. FASEB. 1886. Mole, P. C. and DeNobte, V. J. Development of behavioral tolerance following chronic nicotine administration. FASEB, 1986. DeMoble, V. J.. Gelpka. L W.. Repetti. S. J.. Wood, L M. and Kelm, K. L. Vinpocetine: Nootropic effects on cRsrupted memory retrieval h rats. Neuroscienee. 1986. Mele, P. C. and DeNoble, V. J. Rate-dependent effects of amphetamine and chlordiazepoxide on schedule-controlled responding in rats. American PsychologJcal Association, 92nd Anrujal Meeting, 1986. DeNoble, V. J., Mele, P. C and Porter, J. Intravenous self-administration of pentobarbital and ethanol in rats. American Psychological Association, 91st Annual Meeting, 1984. DeNoble, V. J., Mele, P. C. and Ryan, F. J. Reinforcing properties of nicotine In rats, American Psychological Association, 90th Annual Meeting, 1983. DeNoble, V. J., Ryan, F. J., Dragan. Y. P.. Mele, P. C, Naworal, J. and KomfeW. R. Antagonism (rf chronic nicotine administration: Effects on echedule-controlled behavior in rats. Society for Neuroscienee, 1982. DeNoble. V. J., Dragan. Y., Carron, L. and Mole, P. C. Intraventricular (-)-nicotine infusions disrupt fixed-ratio performance in rats. American Psychological Association, 69th Annual Meeting, 1982. DeNoble. V. J. and Carron, L. Studies on the effects of intraventricular infusions of (- )-nlcotine on behavior maintained under fixed-ratio schedules. Society for Neuroscienee, 1981. 14 PRESENTATIONS ^eonfdV DftNobla. V. J. and Meiach, R. A. Orally ddlivered pentobarbftal as a reintorcer tor rh««U8 monkBys: effects of concurrent water, side position. arxJ drug concentration. Committee on Problem* of Drug Dependence, 1980. Pickene, R., Muchow, D. and DeNobIa, V. J. Intravenous methohexitaJ eelf- adminiatrattoo by rats. Committee on Problem* of Drug Dependence, 1980. DeNobte, V. J. arxl Meiach, R. A. Pentobarbital aa a relnlorcer for monkeye wWi concurrent acceaa to water. American Psychoiogical Association, fiTtt^ Annual Meeting, 1060. INVITED PRESENTATIONS AND CHAIRMANSHIP?: DeNoble. V. J. Chairpereon. DuPont'a Cognition W(ykin<;i Croup. 1989-presenL DeNoble. V. J. Chairperson, DuPont'a Animal Welfare Committafl 1987-1989. DeNoble, V. J. and Repetti. S. J. Preclinical evaluation of druga that enhance learning and memory In rata. Canadian PevcholoQicai AssociatKjn. Symposium on the Psychopharmacotogy of Learning and Memory, Vancover, B. C, Canada, 1987, Invrtfld A(ittal as a relnforcer for rhesus monkeys with concun-ent access to water: Effects o* concentration, fixed ratio size, and fiquid positions. Eighth International Congress of PhafmacQk^gy■ Nogawa, Kawasaki. Japan, 1981. Invited Address. 15 - e - PATENTS: Jirkovsky. I., King, G., Reinhart. B. and DeNoble, V. J. 6, 7. 8, 9-letrahydro-10. methyl-pyrldo {1,2-Al indol-Q-aminet and derivatives ther*ot, useful fof tha treatmani of cognitive impairmenti. US Patent 4,624,954-11-25-86, 1986. De^kJb^e, V. J.. DeNoble, K. F., Earl, R. A. Use ot serotonin-two type receptor antagofiiats in combination with neurotransmitter release enhancers (e.g. DtiP 096) for treating cognition dyafunction. Caaa No. BP-6450, 1990. Chiu. A., DeNoble, V., Duncia, J.. Wong. P. Treatment of central nervoua eyetom diaofderi with imidazole angiotdnajn-ll receptor antagonists. Case No. BP-643S, 1990. Chiu, A.. DeNoble, V., Duncia, J,. Wong. P. Treatment of central nervous system . disorders with t>eruimida2ole angtotensin-il receptor antagonists. Case No. BP-6456, 1990. Chiu, A.. DeNoble, V., Duncia, J.. Wong, P. Treatment of central nervous system disorders with pyrazole, pyrrole and triazole angiotensin-ll receptor antagonisU. Case No. BP-6457, 1990. Chiu, A.. DeNoble, V„ Duncia, J.. Wong, P. Treatment of central nervous disorders with imidazole compound*. Case No. BP-6458, 1990. Johnson, A., Christos. T.. Schmidt, W.. Pottorf, R., Smyser, T., DeNoble. V., Stewart, J., Gilligan, P., Cain, G., Maduskuie, T., Arvanitis, A. Panlally pnstected C-terminal neurotervsin fragments and bond modified fragments as analgesics. Case No. 6P-6S43, iQdO. Boswell, G. A., DeNoble, V. J. 6icyclo[2:2:2}oct-l-y1 amines as therapeutic agents to treat cognibon dysfunction and Parkinsonism. Case No. BP-6515, 1991. DeNoble, V. J. The use of neurotransmitter release enhancers (eg DuP 921) in combination with monoamine oxidase B inhibitors for treating cognitive dysfunction. MOf submitted, 1991. Earl, R. A., DeNoble, V.J. 4.4'-(9H-f1uoren-9-ylidenebis (methylene)) •bispyrimidine for treating neurological disorders. Case No. BP-6444. 1992. 16 Mr. Waxman. Dr. Mele, we are also pleased that you are able to be here. And although you didn't present a formal statement, could you tell us about your training, education, and emplojrment back- ground? Mr. Mele. Yes. First, Mr. Chairman, let me thank you and the members of the committee for allowing me to be here today. I re- ceived my Ph.D. degree in experimental psychology in 1980 from Adelphi University, in the field of behavioral pharmacology. That work focused on the effects of amphetamine on complex behavior in rats. Following that work, I spent 2 years at the University of Wiscon- sin at Madison, funded under a National Institute of Health re- search service award, where I studied the behavioral toxicology of lead and polychlorinated biphenyls in non-human primates. Following that, I went to the Philip Morris Research Center, to work with Dr. DeNoble. That was in November of 1981, and I was there until its closing in April of 1984. Since leaving Philip Morris, I have been with the Department of Defense, at the Armed Forces Radiobiology Research Institute, in Bethesda, studying effects of ionizing radiation and radioprotectant compounds on the behavior of laboratory animals. Mr. Waxman. Thank you very much, Dr. Mele. Dr. DeNoble, I assume that you are aware that a month ago Dr. David Kessler, the Commissioner of the Food and Drug Adminis- tration, testified before this subcommittee about nicotine manipula- tion. He referred to your article on nicotine self-administration in rats and to the fact that Philip Morris ordered the article with- drawn after it had been accepted for publication. Subsequent to his testimony, I released your article. Then just 2 weeks ago, the executives from the largest tobacco companies appeared before this subcommittee and testified that nicotine is not addictive. For example, William Campbell, the presi- dent and CEO of Philip Morris, U.S.A., testified, and I quote, "Cig- arette smoking is not addictive. Nicotine contributes to the taste of cigarettes and the pleasure of smoking." Now, you ran a laboratory that was charged with identifying the essential characteristics of nicotine so that a S3Tithetic form of nico- tine could be developed, yet you didn't test for the taste of nicotine. Did you ever hear of any serious discussion to the effect that Philip Morris leaves nicotine in cigarettes for taste? Mr. DeNoble. No, sir, none at all. Mr. Waxman. As I understand it, you were charged with develop- ing a rat model to test nicotine analogues for the effects on the brain in an effort to develop a nicotine substitute. Did anyone at Philip Morris ever suggest to you during the course of your ana- logue work that you should develop an analogue that would dupli- cate the taste of nicotine? Mr. DeNoble. No, not at all. Mr. Waxman. Are you aware of anyone else doing work on this at Philip Morris? Mr. DeNoble. Our laboratory didn't do any work in taste. That could have been done in the other areas of the Research Center, but I don't have any knowledge of that. 17 Mr. Waxman. Prior to your employment at Philip Morris, what sort of scientific work had you done? Mr. DeNoble. I was working at the University of Minnesota, under a sponsorship of the National Institute of Drug Abuse. My work was with drug self-administration in non-human primates and rodents. Mr. Waxman. You were doing animal tests on alcohol and bar- biturates? Mr. DeNoble. That is correct, yes. Mr. Waxman. OK. You were previously doing work on drugs for which there is a concern about both dependence and abuse? Mr. DeNoble. That's correct. Mr. Waxman. And at Philip Morris you did similar types of ani- mal research on nicotine, is that correct? Mr. DeNoble. Very similar, yes. Mr. Waxman. Can you compare the tests you did on nicotine with the tests that the National Institute on Drug Abuse would do to determine if a drug has an abuse potential? Mr. DeNoble. Well, they are exactly the same tests. We did not do drug comparisons, but the test models are exactly the same. Mr. Waxman. As I understand it, in order to test nicotine ana- logues, you had to understand the brain effects of nicotine itself. How did you approach this task? Where did you start? Mr. DeNoble. When the lab existed, we already had one test which identified whether rats could tell us whether they were given an injection of nicotine peripherally in the — systemically. Our first model, to get to a direct effect of the pleasurable effects, if you will, of nicotine, was to look at a self-administration model. That was the primary screen. Mr. Waxman. I suppose that there are many brain effects that a substance might have, and many tests that could be done. It is my understanding that there are certain tests that qualify as hall- marks of potential drug abuse or addiction. Am I correct that in the early 1980's, the three animal tests that would be done to identify whether a substance was potentially ad- dictive would be self-administration, tolerance, and physical with- drawal? Mr. DeNoble. That is correct. Mr. Waxman. And isn't it true that you did all these tests and that they were a central part of your work at the laboratory? Mr. DeNoble. That is also correct. Mr. Waxman. Now, would you briefly describe for us how you tested for self-administration, tolerance, and physical dependence? Mr. DeNoble. Well, for self-administration, the animals were surgically prepared with a catheter that lodged itself just above the heart. The animals, after surgical recovery, could be hooked up to an infusion pump. If the animal pressed one of two levers, one lever didn't do anything, the other lever would deliver a nicotine solution into the vein. If nicotine is a reinforcing agent, then the pressing of the lever would increase, and that is what we found. We did several manipu- lations and several investigations to clearly show that the animal was pressing the lever to obtain nicotine. 18 In terms of tolerance, a study design that Paul put together was to repeatedly inject animals with nicotine over several days, and then test to determine whether or not the animal was tolerant to the disruptive effects of nicotine. When you inject nicotine in an animal and he is working on a lever for food, the performance of the animal becomes impaired. That performance impairment goes away as the animal has expo- sure to nicotine. We also demonstrated in that experiment that part of that tolerance was physiological and part of the tolerance was behavioral, that is, a learned tolerance. In physical dependence, we conducted two large experiments in which we chronically administered nicotine to rats over several days, if not weeks. We challenged the nicotine in the animals with an antagonist, mecamylamine. Or in another experiment we let the — simply the nicotine, took it away from the animal. We did not observe any withdrawal syndrome as evidenced by changes in food- motivated behavior. Mr. Waxman. So of the three hallmarks of dependence, you did find that there was self-administration and tolerance, but you did not find that there was a physical dependence? Mr. DeNoble. That is correct. Mr. Waxman. OK. And did the studies that you did also indicate that nicotine has a potential for drug liability? Mr. DeNoble. Yes. The self-administration study is a classical hallmark to indicate that a solution or drug substance has a poten- tial for abuse, yes. Mr. Waxman. And what does "drug liability" mean? Mr. DeNoble. It essentially means that if you find it in an ani- mal, it has the potential to be a drug of abuse in humans. You need to then go on to do other species, and other strains of animals, and also go into the human to determine the final factor. Mr. Waxman. Now, on March 31, I released a version of your self-administration study. On that same day Philip Morris issued a statement, which I'd like entered into the record, without objec- tion, as Exhibit 2, Response of Philip Morris U.S.A. to Congressman Waxman's Press Conference Dr. Victor DeNoble was employed by Philip Morris from April 1980 to March 1984 as a research scientist in the Research and Development Department. Dr. DeNoble conducted nicotine-related research and concluded that nicotine is a reinforcer in the class of nonaddictive chemical compounds such as saccharin, or water, and that he did not believe nicotine fit the accepted criteria for drug dependence. He also con- cluded that nicotine self-administration cannot be viewed as a form of drug "abuse" or as an "addiction." Contrary to the suggestions that Dr. DeNoble's research has been somehow with- held from the scientific community and the public, we find dozens of publications authored by him, including five based on his nicotine-related research conducted while at Philip Morris. At no time did Philip Morris seek an injunction, legal or otherwise, against the publication of any of Dr. DeNoble's research. As with virtually all industries, publi- cation of research done while an employee must be reviewed and approved prior to such publication. We are aware of one instance when Dr. DeNoble failed to go through the Philip Morris manuscript review process and thus was told not to pub- lish Philip Morris research until completing the process. An abstract based on that research was published. 19 Mr. Waxman. And they said, and I quote, "Dr. DeNoble con- cluded that nicotine self-administration cannot be viewed as a form of drug abuse." On the basis of your work at Philip Morris, did you reach such a conclusion? Mr. DeNoble. No, sir, I did not. Mr. Waxman. At this time, I'd like to show you Exhibit 3, which is a letter from Dr. Alan Leschner, director of the National Insti- tute on Drug Abuse. That letter states that the findings in your study, quote, "indicate that nicotine has reinforcing properties, one of the hallmark characteristics of an addictive drug." Do you agree with that characterization of your work? Mr. DeNoble. Yes, I do. [Exhibit No. 3 follows:] C4 20 Public Hiilth Servic* { ^y DEPARTMENT OF HEALTH & HUMAN SIRVICES Natioml Iniiituie* of HMrtV — ^ National Inatilule on Drug Atxjta SeOO Flthsri Lina 4PR18 8M Rockvilla, Maryland 20687 The Honorable Henry A. Waxman Chairman, Subcommittee on Health and the Environment Committee on Energy and Commerce House of Representative! Washington. D.C. 20515-6118 Dear Mr. Waxman: I am writing in response to your request of April 1 1 for the evaluation by the National Institute on Drug Abuse (NIDA) of the significance of the findings presented in Dr. Victor DeNoble's 1983 research paper, 'Nicotine as a Positive Rcinforcer in Rats: Effects of Infusion Dose and Fixed Ratio Size." The findings from Dr. DeNoble's study demonstrate that nicotine does act in a reinforcing manner when tested in an animal model. It is also important to note that the rate of nicotine self-administration varied with the dose of the drug. Furthermore, when the subject's baseline nicotine level was increased by the researcher, the rate of self-administration of nicotine by the subject in the study was decreased. These two findings support the contention that nicotine reinforcement was due to the pharmacologic effects of this substance. These findings from the DeNoble study indicate that nicotine has reinforcing properties, one of the hallmark characteristics of an addictive drug, and arc consistent with those of NIDA-Supported researchers who have studied the reinforcing effects of nicotine. You also requested my comments on the statement by the Phillip Moms Company that the DeNoble study shows that 'nicotine is a reinforcer in the class of nonaddictivc chemical compounds such as saccharin or water.' It Is true that saccharin and water can also serve as reinforcers; however, the reinforcing propwties of water depend upon the animals being deprived of water and the reinforcing pn^jcrties of saccharin are due to its taste. In the DeNoble study, the animals were neither food nor water deprived, and nicotine was administered intravenously, which avoids taste effects. Therefore, nicotine docs not have the same characteristics a.s water and saccharin. I hope you will find this information helpful. Sincerely, Alan 1. Leshner, Ph.D. Director 21 Mr. Waxman. You were not able to show there is physical de- pendence. Am I correct that later studies did show a withdrawal syndrome in rats on nicotine, meeting the third criteria for addic- tion? Mr. DeNoble. That is correct. Those studies were not performed in our laboratory. They have since been performed between 1984 and 1994. Mr. Waxman. Why did those studies reach a different result than yours? Mr. DeNoble. I have reviewed those studies, and the conclusion that I can come to is that those studies use very different measures than what we were using, much more sensitive measures than we were using. We modeled our dependence studies after work that I had done with alcohol and with barbiturates. So we didn't fmd it using those procedures, but other people have. Mr. Waxman. I'd like to ask you about your study on self-admin- istration. Prior to your work, had anyone ever shown that rats will self-administrate nicotine? Mr. DeNoble. There had been at least a half a dozen demonstra- tions that rats will self-administrate nicotine. The problem with most of those studies was that there was a confounding variable of inducement. It was not clear. You couldn't interpret clearly wheth- er nicotine was a true reinforcing agent, or whether it was coupled to another thing going on in the animal's life. Mr. Waxman. So your studies succeeded where others failed. Can you tell us why? Mr. DeNoble. I think the main difference between our study and previous studies was the infusion time. Back in the 1970's and 1980's, it was common to infuse a drug solution into the vein of an animal over a 13 to 15 second period. That's not what happens, if you observe a smoker. A smoker takes smoke into his lung and nicotine is immediately going to the lung, and immediately getting to the brain. So we basi- cally shortened our infusion times to less than 4 seconds, so that we were delivering a very quick, pulsed infusion. That seemed to be the critical factor in our success. Mr. Waxman. I'd like to show you some posters, if we can have those displayed? [Posters displayed.] Mr. Waxman. The first one. Exhibit 4, is entitled. Self-adminis- tration Methodology. Could you explain it for us? [Exhibit No. 4 follows:] 22 8 in I 8i 23 Mr. DeNoble. Yes. That is a poster, and this is a rat that would be inside of an experimental chamber and has a switch, what I refer to as a lever. The rat is also, you can see on his back he is surgically prepared with a catheter that lodges in his vein or the atrium of the heart. The rat has the option to go over and press the lever. When he does, it activates some programming circuitry, you record when the press occurred. It also activates an infusion pump, and that pump then will infuse nicotine, or whatever solution you have, into the animal's vein. Again, if that solution is a reinforcer, the rat will continue to press the lever at reasonably high rates. Mr. Waxman. We have another poster, which would be Exhibit 9. That shows the number of times the rats press the lever for nico- tine. Can you explain it for us? And let me indicate, by the way, that both of these posters are furnished to us from your slides that were given to us by you? Mr. DeNoble. That's correct. This is a grouped data shot. Primarily, after the rats are sur- gically prepared with the catheter, you put them in the box and they are hooked up to a pump which has saline in it. And the ani- mals don't press the lever very often for saline. If fact, they pressed it less than 12 times. If you now substitute nicotine at a dose of 32 micrograms per kilograms, you can see that after several days an animal will inject itself well over — almost 90 times per 24-hour session. If you now remove the drug solution, in this case nicotine, the animal stops pressing the lever in a series of days. So the nicotine self-adminis- tration falls back down to the original saline levels. Standard control is to reintroduce the nicotine. And that is the second large bar where you see it says "32." And that is, again, where the animals will resume pressing the lever, once nicotine is again made available intravenously. Mr. Waxman. How did you pick the dose of nicotine to give to the rats? Mr. DeNoble. Well, we looked through the literature at the time, in the early 1980's. And it was determined by us that about 1 to 2 milligrams of nicotine was coming through in a cigarette. I just simply divided that by a 70 kilogram individual and came up with 30 micrograms per kilogram. Mr. Waxman. And is that any relationship to what a human would get? Mr. DeNoble. It's basically — it's very difficult to answer that question. It's based upon what a single cigarette delivers to a human, but I don't know if it's any relationship to the physiological effects. I cannot answer that. Mr. Waxman. We have the next exhibit. Exhibit 10. It's a little bit more complicated. It's my understanding that it shows how hard the rats will work for nicotine. Can you explain that to us? [Exhibits 9 and 10 follow:] 0- 24 105 90 ^ 75 I 60 =*-45 CM CO CO I 30 CO Z 15 1 32 0 32 NICOTINE DOSE (>ig/kg) 25 O 300 • f 200 i 4 a LU csi OO CO LO , , ^ /^ a. Z O 100 LU <:£^ > ? - ''--4- „.*-X-.J 0 J \ L J L \ I 3 4 5 6 FIXED RATIO SIZE 7 8 26 Mr. DeNoble. Can I walk over there, or is that hard to do? Mr. Waxman. That's going to be a little difficult to get this on the microphone. Mr. DeNoble. That would be fine. If you look at what's called fixed ratio size, that is how many times a rat has to press a lever. And if you look at the unit number 1, he gets a single press, he gets a single injection. If you now say to the animal, I'm going to see how hard you'll work for it, I'm going to ask you to press the lever twice. The animal Mr. DeNoble. Thank you. This represents an animal pressing the lever twice for nicotine. What is interesting is this dotted line tells you how many infusions the animal is taking. Here he is tak- ing a stable level of infusions, if you ask him to double his work output. You can ask him to triple it, quadruple it, et cetera. The animals will continue to work and press the lever to get nicotine, up to about a fixed ratio of about 6 or 7, and then it begins to fall off. The cost is just too high. Two points about this slide. One is, animals will work for nico- tine; and second is, animals will maintain a constant level of nico- tine infusion over different work schedules. Mr. Waxman. At our April 14th hearing, Philip Morris' chief ex- ecutive officer testified that you had, quote, "Concluded that nico- tine is a reinforcer in the class of non-addictive chemical com- pounds such as saccharine and water." We asked Philip Morris for these and other relevant documents, but they were unable to pro- vide them prior to this hearing. Is Philip Morris correct that you concluded after you did this work, that nicotine is a reinforcer comparable to saccharine and water? Mr. DeNoble. No, not at all. Mr. Waxman. What would be the difference? Mr. DeNoble. Well, water is a reinforcer, but you need to be food-deprived or very nervous to drink it. Food is a reinforcing agent, but you need to be hungry, or it needs to taste good, it re- quires tongue. Nicotine was being injected directly into the vein. We went on to use a series of blocking agents to show that it was the brain activ- ity of nicotine, not its effect on the periphery, not its effect on taste systems, that would determine its reinforcing effects. An animal doesn't have to need nicotine for it to be a reinforcer. All it has to do is experience it. Mr. Waxman. Now, you said, "food." Would that also apply to saccharine, that you need the taste of the saccharine? Mr. DeNoble. Exactly. Yes, the reinforcing effects of saccharine are clearly mediated via its interactions with the taste system in the mouth. Mr. Waxman. Now, if you ran the kind of tests you did for nico- tine on saccharine, what would you find? Mr. DeNoble. Saccharine is not self-administrated intra- venously, to the best of my knowledge. Mr. Waxman. So you have an intravenous feeding of this nicotine that's going right to the brain. If you put saccharine intravenously, 27 there would be no taste, there would be no reason why they would want to go back to it? Mr. DeNoble. I don't know of any experiment that has ever demonstrated that, no. Mr. Waxman. Finally, I want to ask you about a statement in the 1983 version of your unpublished article on self-administration that doesn't appear in your 1986 version. In the 1983 version of the arti- cle, you state that nicotine "May be a weak reinforcing agent." What was the basis for this statement, and why did you take it out in the later version of the article? Mr. DeNoble. In the earlier version of the article, I was doing some literature comparisons between nicotine and other intra- venously delivered reinforcers, specifically, psychostimulants like cocaine and amphetamine. And if you look at just how hard an ani- mal will work for these substances, nicotine looks like a weak reinforcer. And I had made that statement that I thought that was a fair assessment at that time. As we began to think and know more about the reinforcing ef- fects of these drugs, we also found that rat models do not nec- essarily predict how reinforcing something will be in a human. For example, alcohol is not a very good intravenously delivered reinforcer in rats. But alcohol is a very powerful reinforcing agent in humans. So I did not put that in the second article, simply be- cause I didn't think my data was strong enough to make that state- ment. Mr. Waxman. Put this all in a historical context for us. Your work on nicotine at Philip Morris, what significance did it have at that time frame, and how should we view this research project? Mr. DeNoble. The work that we did with nicotine was clearly some years ahead of the external scientific community. It wasn't until 1989 that Bill Corgal demonstrated that nicotine would func- tion as an intravenously delivered reinforcer for rats using the same models that I used, that Paul and I used. Interestingly enough, he found the same dosing schedules to be effective. The work that we did on self-administration, on depend- ence, on tolerance, on frustration, clearly would have moved the scientific community much further than it had been moved by that work not getting out. Mr. Waxman. Dr. Mele, do you want to add anything to this? Mr. Mele. Just that this work, some of these studies were the first to be done with nicotine. I have no doubt that other people would have performed these studies subsequently, just as has been done recently in Toronto, but they weren't being done at the time. And to quote a recent review article in Science, a news story, it said that, basically, it took 6 or 7 years for the nicotine self-admin- istration model to be developed and come out, whereas, it would have been out much earlier had this work been allowed to go out and stay out. Mr. Waxman. So your work at Philip Morris indicated the rein- forcing nature of nicotine, information that didn't come out until years later and led to the Surgeon General's Report, I guess it was 1988 or 1989, where the public was finally informed by the chief medical officer of this country that nicotine is an addictive sub- stance in cigarettes. 28 Mr. DeNoble. That's correct. I think the significance of the self- administration is only — is in part because it was a rat model. And if you can understand the biochemistry of this system, if you can understand how drugs interact in the brain, you need to run doz- ens if not hundreds of animals. So the significance — other people had already been doing this from 1984 on, but the rat model wasn't developed until 1989. Mr. Waxman. Thank you very much. Mr. Bliley? Mr. Bliley. Thank you, Mr. Chairman. Dr. DeNoble, Dr. Henningfield and the Surgeon General have testified before this subcommittee that nicotine use creates a physiological dependence. They have testified that such dependence is important because it shows that nicotine use is addicting. Isn't it true that while you were working at Philip Morris, you told your superiors that your experiments showed that nicotine use does not create a physio- logical dependence? Mr. DeNoble. That's true. We demonstrated that in at least two separate experiments. Mr. Bliley. Thank you. Dr. Henningfield works at the National Institute on Drug Abuse. In 1979, NIDA published a report titled, "National Institute on Drug Abuse Technical Review on Cigarette Smoking As An Addiction." Isn't it true that while you were em- ployed at Philip Morris, you reported to your superiors that most of the evidence in this report was, quote, "Fancy", rather than fact? And that, in fact, NIDA had chosen the researchers used in this re- port in a biased way so that NIDA could claim publicly that ciga- rette smoking was an addiction? Mr. DeNoble. I don't know that I said that. If I could get a — it's very possible that I reviewed those documents, but I don't know that those are my words. Mr. Bliley. After this report by the NIDA came out, you did your experiments in which you carefully examined whether or not nicotine use created a physiological dependence, and you found that nicotine use did not create a physiological dependence? You then reported this to Philip Morris? Mr. DeNoble. That's correct. The models we used were at the time, in the 1980's, were excellent models. The animals are very highly motivated in these models. And the animals clearly would show a physical dependence to things like alcohol and barbiturates. But we did not find it with nicotine. Mr. Bliley. You also did experiments while at Philip Morris to determine if — and I'll try this word — acetaldehyde use caused phys- iological dependence, and you found that acetaldehyde use did not create a physiological dependence? Mr. DeNoble. Yes. We used the same experiments that we did with nicotine. Mr. Bliley. You also did experiments while at Philip Morris to determine whether injections of acetaldehyde and nicotine mixed together caused physiological dependence. And you found that acet- aldehyde and nicotine mixed together did not cause a physiological dependence? Mr. DeNoble. That is correct. Mr. Bliley. We have been told by other witnesses that because animals will self-administer nicotine, this is proof that nicotine is 29 addictive. Isn't it true that while you were working at PhiUp Mor- ris, you told your superiors that animals will self-administer sac- charine? Mr. DeNoble. No, sir. I never said that they will self-administer saccharine. They will work for saccharine. You can press the lever and get a food pellet or get saccharine, and that is a self-adminis- tration procedure. The difference between self-administration of saccharine and food and nicotine is that one is delivered intra- venously, the other one goes through the peripheral system. So, saccharine, yes, you can self-administer it but only through the oral route. It will not go intravenously. Mr. Bliley. Isn't it true that you conclude from your research at Philip Morris that behavioral factors are primarily responsible for tolerance of nicotine? Mr. DeNoble. No. I'd like to defer that to Dr. Mele. Paul was an expert, is an expert in tolerance and nicotine. Mr. Mele. Well, I ran the tolerance studies anyway. Yes, we did determine that under certain conditions behavioral factors contrib- uted heavily to the development of tolerance to nicotine. Behavioral factors were not the only component, at least back then, what was termed a physiological or metabolic component. There was a duel role in our studies, at least in the first studies we ran, the behav- ioral component was much larger. Mr. Bliley. And you reported this to your superiors at Philip Morris, both of you? Mr. Mele. Yes. Mr. DeNoble. Yes. Mr. Bliley. Isn't it true that you also concluded from your re- search at Philip Morris that if there is a physiological tolerance to nicotine, it is like that developed to that of saccharine or caffeine? Mr. Mele. I don't know that tolerance develops to saccharine. I do know that tolerance develops to caffeine, yes. Mr. Bliley. And you reported that to your superiors? Mr. Mele. Tolerance to saccharine — I'm sorry, tolerance to caf- feine, tolerance to nicotine, tolerance to alcohol, pentobarbital, it's pretty much the same. Different mechanisms perhaps, physio- logical mechanisms in the liver, but the general conditions are the same, yes. Mr. Bliley. This subcommittee had been told by some witnesses that the evidence is clear that nicotine alone is an addicting sub- stance, in part because ceasing the use of nicotine causes physio- logical withdrawal symptoms. Isn't it true that while you were em- ployed at Philip Morris, you told your superiors that your research showed that stopping nicotine use does not result in physiological withdrawal? Mr. Mele. In rats, yes. Mr. Bliley. While you were employed at Philip Morris, you also did experiments to determine if stopping acetaldehyde use caused physiological withdrawal symptoms. And while you were working at Philip Morris, you told your superiors that your experiments found no physiological withdrawal resulted from stopping the use of acetaldehyde, isn't that correct? Mr. Mele. Yes. In our experiments in rats. 30 Mr. Bliley. While you were working at Philip Morris, you also did experiments to determine if stopping the use of acetaldehyde and nicotine mixed together caused physiological withdrawal symp- toms. Again, while you were employed at Philip Morris, did you not tell your superiors that your experiments showed that stopping the use for acetaldehyde and nicotine mixed together did not cause physiological withdrawal? Mr. Mele. Yes, we did. Mr. Bliley. Am I correct that all of your experiments at Philip Morris were with rats, and that none of your experiments involved people? Mr. Mele. That is correct. Mr. Bliley. Doctor, 40 million Americans have quit smoking. Isn't it true that while you were working at Philip Morris, you ad- vised your superiors that the relative ease with which people can stop smoking without formal treatment identifies smoking behavior as fundamentally different from addictive behavior? Mr. Mele. It's not fundamentally different, but it clearly is dif- ferent than if you are an alcohol, or if you are a heroin abuser, that is correct. Mr. Bliley. Well, is that what you advised your superiors? Mr. Mele, Yes, that's true. Mr. Bliley. Am I correct that acetaldehyde is something that re- sults naturally from burning tobacco? Mr. Mele. That is, yes, correct. Mr. Bliley. Nicotine, of course, is also a natural part of tobacco, isn't it? Mr. Mele. Yes, it is. Mr. Bliley. Dr. DeNoble, I now want to ask you about your re- search paper on rats' self-administration of nicotine that was sub- mitted to Psychopharmacology and withdrawn. As I recall, the title of that paper was, quote, "Nicotine as a Positive Reinforcer in Rats, Effects of Infusion Dose and Fixed Ratio Size." According to both the abstract and the first page of your manu- script your research found that "even determination of prolonged access to nicotine, under which it functions as a positive reinforcer, does not result in physiological dependence," unquote. Is that right? Mr. DeNoble. That is a correct observation, yes. Mr. Bliley. The amount of nicotine injected directly into the rats' veins, in this experiment, were much higher than the amount of nicotine a smoker receives, isn't that true? Mr. DeNoble. The amount of nicotine injected at the 32 microgram dose is roughly the equivalent of one cigarette. But what we did was we did a spread of ranges of doses, so we showed a 32, 16, 8, and 4. Eight and four were not as reinforcing as 16. So we did branch the range. So it is roughly the equivalent of a single cigarette, or less, in a rat. I also might add, sir, that animals have been shown to be either more sensitive to drugs, depending upon the drug class. So it's very difficult to make a direct compari- son to the human. Mr. Bliley. You reported, I believe, in this paper, as you told your superiors all the time that you were employed at Philip Mor- 31 ris, that there was no evidence of physiological dependence to nico- tine in the experiment. Is that true? Mr. DeNoble. That is correct, yes. We were unable to find it using a model in which an animal is a highly motivated animal. The model is, you deprive the animal of food, and the animal has to work for food, and then you have it being administered nicotine. Pull the nicotine away, and the animal — your evidence of physio- logical dependence is that the food-directed behavior is changed in some way, is altered. We did not observe that. We did not see an animal sort of show a physical dependence withdrawal syndrome in that particular model. Mr. Bliley. This subcommittee has been told that the evidence has been clear for some time that nicotine itself is an addicting substance, that the use of nicotine alone creates a physiological de- pendence, and that stopping only the use of nicotine causes physio- logical withdrawal sjonptoms. Isn't it true that while you were em- ployed by Philip Morris, you told your superiors that your research at Philip Morris showed that nicotine does not create a physio- logical dependence, and that stopping the use of nicotine does not create physiological withdrawal? Mr. DeNoble. Yes, we did. In the same way we also said to them that self-administration in the rat does not necessarily predict the amount of self-administration in the human. Gentlemen, you have to be very careful about predicting from rats to humans. What the animal data shows you is that there is something to look at. And when you see self-administration, you need to go fur- ther. When you fail to find physical dependence, you need to go fur- ther to determine whether it's really going to be generalizable to the population. Mr. Bliley. Mr. Chairman, I assume I'll be allowed to go on? Doctor, isn't it true that to your knowledge Philip Morris never used any of your research to change the acetaldehyde or nicotine content in any commercial cigarette? Mr. DeNoble. Yes. I have no knowledge of that. Mr. Bliley. Isn't it true that to your knowledge, Philip Morris never used your research to create a new commercial cigarette Mr. DeNoble. That is correct. Mr. Bliley. Dr. Mele, if I might, isn't it true that while you were working at Philip Morris, you advised your superiors that your ex- periments showed that nicotine use does not create a physiological dependence? Mr. Mele. No, I don't recall that at all. Mr. Bliley. You didn't Mr. Mele. Only as part of, possibly, a co-author on Dr. DeNoble's — I know the tolerance work I was working on that in- volved chronic administration took — for over 100 days, we did not find a physiological dependence in that study. But I don't recall specifically discussing that with anybody at Philip Morris. It may be in the main script, it may not. I just don't recall that. Mr. Bliley. Isn't it true that while you were employed at Philip Morris, you advised your superiors that your experiments showed that acetaldehyde use does not create a physiological dependence? 32 Mr, Mele. Yes. Under the conditions which we ran the studies, which were very limited, we did not find a physiological depend- ence. Mr. Bliley. Isn't it true that while you were employed at Philip Morris, you also did experiments to determine if discontinuing the use of nicotine or acetaldehyde created physiological withdrawal symptoms, and that you told your superiors at Philip Morris that your research showed that discontinuation of nicotine or acetal- dehyde did not cause physiological withdrawal symptoms? Mr. Mele. Yes. Again, under the conditions of those experiments, we could not identify any physiological withdrawal. Mr. Bliley. And you did all of your experiments, of course with Dr. DeNoble, were with rats? Mr. Mele. Correct. Mr. Bliley. Isn't it true that some rats in your experiments at Philip Morris like nicotine more than other rats? Mr. Mele. Some rats may administer higher doses, or have dif- ferent dose response curves than other rats. That is very typical of any drug effect in any rat or any animal. There are individual dif- ferences. Mr. Bliley. Isn't it true that albino rats did not seem to like nic- otine as much as hooded rats? Mr. Mele. I didn't work with albino rats at all when I was at Philip Morris. Mr. Bliley. Though you didn't work with albino rats, isn't it gen- erally true that albino rats don't seem to like nicotine as much. Dr. DeNoble? Mr. Mele. I'm not sure. I can't answer that question. Mr. DeNoble. I can't answer that question either. I'm not sure where that data is coming from. Mr. Bliley. Well, isn't it true. Dr. DeNoble, that you decided to use hooded rats in your experiments because hooded rats were easier to get to self-administer? Mr. DeNoble. No. That's incorrect. There was a paper published in the early 1980's, I believe, around 1980 actually, which dem- onstrated that the albino rat was not a prototypical animal to do drug research because it had altered biochemistry, because it is an albino. The hooded rat has an intact, more generalizable biochemistry in the brain, so that a hooded rat's biochemistry is much closer to that of a monkey's, and it's closer to that of a human. So we elected to do all of our studies in hooded rats, whether it be self-administra- tion, tolerance, dependence, because their brain biochemistry rep- resented more what a normal animal is. Mr. Bliley. Thank you. Thank you, Dr. DeNoble. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bliley. Mr. Synar? Mr. Synar. Thank you, Mr. Chairman. First of all, believe it or not, I think Mr. Waxman, Mr. Wyden, and I understand why the executives of these seven major tobacco companies came in here a couple of weeks back, and in the face of overwhelming historical medical evidence, denied the addictiveness of nicotine. They have been counseled by their attorneys that an admission on their part would increase their chances of liability. 33 Dr. DeNoble, you don't have that same responsibility; you are a scientist. And I want to ask you, do you agree with the statement we heard from the executives under oath, that nicotine is not ad- dictive? Mr. DeNoble. I'll answer that in 1994, not 1984. I think there is an overwhelming body of evidence that nicotine does produce an addiction in the human. That overwhelming body of evidence does not come from my single rat study or Paul's study on tolerance. So my opinion in 1994 is, yes. I think in 1980, 1981, 1982, 1983, and 1984, I think there were some doubts in my mind because the data wasn't there. Mr. Synar. So what you are saying is that your study didn't de- finitively prove that nicotine was addictive. But it predicted that this was a serious problem, as you had seen, and therefore occa- sioned further study and review? Is that basically what you are saying today? Mr. DeNoble. It certainly did indicate that nicotine had an abuse liability and we needed to look further to determine other factors, yes. Mr. Synar. Mr. Johnson, the chairman of RJR, during his testi- mony a couple of weeks back, said that nicotine is comparable to saccharine and chocolate. Your study doesn't support that propo- sition, does it? Mr. DeNoble. No, sir, it does not. Mr. Synar. In fact, that's stretching the truth a little bit to say that we could compare nicotine to saccharine and chocolate? Mr. DeNoble. Experimentally, scientifically, I believe that to be correct, yes. Mr. Synar. You've testified this morning. Dr. DeNoble, that one purpose of the analogue research study was to find a synthetic form of nicotine with reduced cardiovascular effects. Why were your superiors at Philip Morris concerned about the cardiovascular effect of nicotine? Mr. DeNoble. That program actually was in existence before I got to Philip Morris. The nicotine analogue program I know was there before I got there because the analogues were there, and they also had some animal experiments ongoing. The discussions around nicotine in the 1980's — in the late 1970's, early 1980's was that there was a cardiovascular risk. Clearly, nico- tine has effects on the cardiovascular system. It was also clear that efibct on the cardiovascular system could be related to increased heart disease. So the objective of the program was to come up with a molecule that would mimic nicotine's effect in the brain, and would not af- fect the peripheral nervous system and therefore not have cardio- vascular liability. Mr. Synar. So beyond addictiveness, nicotine has other con- sequences with respect to the health of a person? Mr. DeNoble. Yes. Mr. Synar. Dr. DeNoble, could you outline the official policy at Philip Morris with respect to documentation of studies? What I'm interested in is how were the original papers that you worked on archived? How were the documents maintained? Where were they 34 kept? Was there periodic destruction of those documents? Is there a master index of those studies and working papers? Mr. DeNoble. The laboratory would write annual reports every year. They were fairly extensive. Paul and I would put them to- gether. All data, all original data would be archived in an annual report and sent to — would be distributed throughout the research center and then sent to central file. We kept all our original data in notebooks which would also go to a central filing unit. I know of no instance in which data had been destroyed, at least not while I was there, up until April of 1984. We also gave interim reports which would be considered pharmacology reports, or, were we to publish — ^trv to write a manuscript, that manuscript would also be distributed throughout the research center. Mr. Synar. Now, did any other researchers at Philip Morris con- duct research on humans while you were there? Mr. DeNoble. On humans? Mr. Synar. On humans. Mr. DeNoble. Yes. There was one laboratory that conducted electrophysiological studies in humans, looking at the effects of cig- arette smoke on electrical brain activity, and also looking at the ef- fect of flavorants added to the nasal cavity, and looking at the ef- fects on brain activity. Mr. Synar. OK. Let's talk about the article which has been really the focus of the controversy. Did Philip Morris orally request that you pull your article from the magazine, or did they send you cor- respondence requesting that? Mr. DeNoble. I never received a correspondence. I just was asked to remove it by our manager. We tried very hard to convince him that we shouldn't remove it from publication, but we lost that battle, so we were told to pull it from the journal. I immediately called Herb, Herb Barry, up and told him of the situation and sent him off a note, as an official record, that we needed to withdraw the paper. Mr. Synar. OK. Just for the record, Dr. DeNoble, once again, why did you leave Philip Morris? Mr. DeNoble. I left because the lab was closed down. It was abruptly closed down in April of 1984. Mr. Synar. Did they give you a reason that they couldn't find an- other position for you? Mr. DeNoble. Actually they never said that they couldn't. They just said that it would never be to the caliber of the position that we had, that clearly it would be a step down in pay as well as visi- bility. I think that clearly we needed to leave. Mr. Synar. Did you look for other jobs in the tobacco industry? Mr. DeNoble. No. We're not allowed to do that. Part of your con- tractual agreement with Philip Morris is that you cannot work for a competitor. And I don't remember the time frame, and I think it was 7 years or something like that. Mr. Synar. OK. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Synar. Mr. Greenwood? Mr. Greenwood. Thank you, Mr. Chairman. Back to the purpose of this study. Congressman Synar mentioned that in your testi- mony you referenced the goal of this program was to identify a nic- otine analogue that would have central nervous system effects 35 without effects on the cardiovascular system. We understand that now. First of all, let me ask you this. Has such an analogue ever been discovered, to your knowledge? Mr. DeNoble. We did discover a lead series of analogues which had met the criteria of reduced cardiovascular effect and main- tained the brain effects. So, yes, we were able to identify at least two analogues that would meet that criteria. Mr. Greenwood. So what are the practical implications of that and what uses have been made, if any, to your knowledge, of these analogues? Mr. DeNoble. I don't think any use has been made of it. In fact, it was basically put on the shelf. There was not, to my knowledge, any activity around these analogues. Mr. Greenwood. Are these analogues found in nature or are they synthetic? Mr. DeNoble. They are synthetic. They are organically syn- thesized. Mr. Greenwood. Was the goal to somehow remove the nicotine from tobacco and substitute this synthetic analogue? Mr. DeNoble. That was exactly the goal, to remove nicotine from the tobacco and have the analogue be a substitute so that you would produce a safer cigarette. Mr. Greenwood. Is the idea for the analogue that you were searching for and that you say has been found, to have the same habit-forming qualities of nicotine without the health risks? Mr. DeNoble. That's a very difficult question to answer, when you talk about habit forming. If you are asking me, would it main- tain self-administration, would it act as a reinforcing agent, would it maintain the brain receptor qualities, the answer to that is, yes, that is correct. Mr. Greenwood. Do you have any information as to why, if that synthetic analogue has been discovered, it hasn't been utilized in the production of tobacco products? Mr. DeNoble. No, I don't. But I would also mention that the analogue that I'm talking about, or the series of analogues, meets the criteria. But before you could actually use that, you would have to go through a whole series of other testing, and that was never done. Mr. Greenwood. Would it have to be approved by the FDA? Mr. DeNoble. I guess that would depend upon how you put it in tobacco. You could, theoretically, genetically engineer plants to grow it, if it's a simple molecule. But that's far beyond my exper- tise. Mr. Greenwood. Were you asked to devise the format of this re- search, or were you directed by superiors at Philip Morris as to how your research was to be conducted? Mr. DeNoble. No. The goals of the laboratory were pretty straightforward. It was an analogue program. We put together the screening procedures. With the exception of the drug discrimination procedure which was there, we determined the direction of the lab in collaboration with management. I met with my manager weekly to discuss research directions and data. So it was really a collabo- 36 rative arrangement. The people in Richmond are good scientists, and it was a good exchange of ideas. Mr. Greenwood. Now, if I understand your testimony, the rea- son that we've heard very different kinds of answers to different questions directed by different members of the panel is that when Chairman Waxman or Mr. Synar have asked you questions about the addictive quality or the reinforcing qualities of nicotine, you have really relied on the information that has been brought for- ward by other researchers in the past 10 years. When you've been asked to give information based your own study of 10 years ago, you had different information. So, on the one hand, you said, yes, my study didn't demonstrate that nicotine was addictive or reinforcing, however, we now know that it's the case. Does that correctly summarize what you said? Mr. DeNoble. Let me see if I can clarify it. The work that was done in 1981, 1982, and 1983, on nicotine self-administration clear- ly shows that nicotine is an intravenously driven reinforcer. That is a characteristic of a drug of abuse. When you talk about addiction, you are talking about a human condition. Rats — we can't predict that nicotine is addictive in hu- mans based upon that single observation in rats. So my study stands, our study stands, as this is a characteristic of the drug, it's definitely a substance that could have an abuse liability. That ends right there. From 1984 on, there have been numerous studies demonstrating in humans, as well as in monkeys, that nicotine has qualities that the committee calls addicting. Mr. Greenwood. Now, we talked about other substances throughout these hearings, everything from saccharine and caffeine to alcohol and amphetamines to heroin. Is it possible to place the qualities of nicotine on some sort of a spectrum? Is it more like caf- feine or is it more like heroin, in terms of its effect on either mice or humans? Mr. DeNoble. Well, in humans I think the data indicates that it's more like cocaine and amphetamine. Those are the studies that have been done back in the late 1980's. In the animal, you have to do direct comparisons, and very few of those studies have been done. In the rat, nicotine is probably like alcohol, if you want to talk about weak reinforcing effects. But in the human, I think the data indicates it's more like a stimulant. Mr. Greenwood. Caffeine is a stimulant, right? Mr. DeNoble. Caffeine, I think, is classified as a weak stimu- lant, yes. Mr. Greenwood. A weak stimulant. So you are saying it's more like cocaine than it is like caffeine? Mr. DeNoble. That would be the data, that is the research, yes. Mr. Greenwood. OK. There are lots of pleasurable responses that you can get both rats and humans to work for, to push pedals for, or whatever else they do. What is the difference between that and addictive behavior? Mr. DeNoble. Not much. The difference is that the animal is in a controlled experimental procedure, and you are controlling vari- ables. When a human self-administers a drug, it's the same situa- tion. The human has to go buy it, he has to work to get it. I mean, 37 the comparisons, the similarities are astounding, so they are very similar. Self-administration techniques predict what humans will do. Mr. Greenwood. There has been probably too much made about the food comparisons to cigarettes. But there are people with eating disorders who seem by a lot of measures to be as addicted to foods as people are to substances. Are we talking about the same range of human behavior? Mr. DeNoble. Not really, because things like bulimia or people who have food addictions, may, in fact, be driven by biochemical imbalances in the brain. That may, in fact, be a psychiatric dis- order. You don't have to have a psychiatric disorder to be addicted. The addiction or the self-administration is cued by the drug in the brain, so they are really very different things. Mr. Greenwood. OK. Finally, your testimony in this hearing has been fascinating in terms of science. It is interesting to learn about your experiments, the experiments that have followed, and the var- ious qualities that are found in nicotine. But we are here to make public policy. So I guess I have to ask you this: What are you here to tell us in terms of public policy? This is very interesting science, but what should we take from your testimony? What do you want us to do in response to your testimony, in terms of crafting public policy? Mr. DeNoble. Well, I'm not here to make public policy. I'm here to tell you of the science that was done between 1980 and 1984. I'm here to position that science as to its relevancy with reference to other science that's being done from 1984 on. I'm not going to be so bold as to tell you what to do with public policy. I can't do that. Mr. Greenwood. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Greenwood. Mr. Wyden? Mr. Wyden. Thank you, Mr. Chairman. Let me, if I could. Dr. DeNoble, go back to this point with Mr. Bliley, because Mr. Bliley was talking specifically about nicotine effects and showing with- drawal in rats. Now, you testified that subsequent studies show that nicotine does cause withdrawal in rats. What was it about these studies that made it possible to identify withdrawal symp- toms? Mr. DeNoble. Our study, as I mentioned, relied upon a very strongly motivated behavior. If the rat didn't press the lever, it didn't eat. And that is a very strong drive. These later studies used very subtle measures. Whereas a rat doesn't necessarily have to press the lever to eat, but maybe to deliver itself a glucose sweet- ened solution. So it's a reward, if you will, a candy. Under those conditions where the rat is not so strongly moti- vated, people have shown that nicotine will disrupt those meas- ures. So the difference was that ours was a very highly motivated animal. If you don't press, you don't eat. The other one is, if you don't press, well, maybe you don't get your glucose. Mr. Wyden. Let me turn now to an area that Chairman Wax- man, I think, has really focused on very correctly, and that is this matter of secrecy in the tobacco industry. I just look at the events of what went on in your situation, and many others, as just sort of like a spy novel, with all this cloak-and-dagger kind of activity. 38 I wanted to ask you about some of the details of your situation. When you were hired in 1980, did you discuss whether you would be able to publish the results of your research at Philip Morris? Mr. DeNoble. Yes, I did. And, as with most companies, it clearly depended upon the proprietary position. I do — when I went there it was clear to me that I would not be able to publish everything when I wanted to, but eventually we thought we'd be able to pub- lish everything. So, yes, they were very clear on that. Mr. Wyden. Did Philip Morris try to keep your work secret? Mr. DeNoble. During the first 2 years of the laboratory's exist- ence, the lab was really quite secretive. The animals would be brought in at night or in very early morning, under a cover so that — people knew that we had animals in the building. They couldn't not know, but they didn't know what we were doing with them. And we weren't permitted to discuss our research at any of the research meetings for the first 2 years or so. Mr. Wyden. So the animals were brought in and they were cov- ered up? Mr. DeNoble. Yes. That's correct. Mr. Wyden. And when the rats had died, were they taken out after hours, and that sort of thing? Mr. DeNoble. Usually they were incinerated, yes. Mr. Wyden. And nobody was allowed into the laboratory without management's permission? Mr. DeNoble. That is correct. Mr. Wyden. What would you say if another scientist working in the building asked you about your work? Mr. DeNoble. We used to tell them we were just doing some ex- periments in the nicotine analogue program. Everybody knew about the analogue program, but the animal research was not a very well-known commodity. Mr. Wyden. Who told you to follow all these secrecy procedures? Mr. DeNoble. They were laid out to us by our management when I was hired. Mr. Wyden. And that was Mr. Dunn and Mr. DeNoble. Dr. Dunn, Dr. Osdene. Mr. Wyden. Now, in the fall of 1982, as I understand it, you sub- mitted a manuscript to Philip Morris on the self-administration matter. You wanted permission to publish the paper. We can give you that exhibit. Who reviewed this paper and whether approval was given? 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Uni5«r PM4*- Kartiitil ai^ fc4t.U 1 T>M f«ve«av dtcTtiM La t^ OLMbcr o< it«re4 rIcocIm iafutlou »a4 Uie tvUl BU»b«r of laru«ioQi «• • f«ACtIe* 9/ the tat«rv*l <)•&■««« r«*poTi«« lso«p««d«fiv pcogrdMMd 8e«B (1 *taodir4 •rror) X I«M uui ufui9m (t dscTMte La t}u asal>cc of coavrol 90 's« (t 4.a) 11 (U.a) 4S 45 (* 5.0) 73 (14.3) 60 3« (i 3.4) 75 ua.i) 90 tl (i 1.5) 74 (n.4) 47 n^uet 1. X/(ec;i •f lo^ititMlIiv* iflt^c for olcoti«« »• iiwi aumbmr of ik/Ml»M (Ufc »«n*l). brh V*r r«pr«*«tt« « •*!■ *( 10 ••••icui (10 tmla i 1, 24 fe«ur ««tii«<««). Hm ««rtlc«l Hoc* «Xo« XMm at.«n4«(4 an^r. Tb» rltftt Ii4« •( Ite {L«ux« •*«« »b« •£«*« of varrina th« ^M •€ nVcotUe M both ttw m«ber of lafuilofl* (t»U4 ila*t) tad lAtaiM iaC4k« (r|/lt(/»e*il9a, 4&tW4 ILoii) w4tr an IK I ra»ia a^^ Llaa Carron far their ladaatcal a«altv-«»««. 48 !• no K) 60 40 20 -ia;s J. jt_ 0 38 I 16 32 64 tUcifi-l 49 Mr. DeNoble. This paper was reviewed by my immediate man- agement. I think it was Jim Charles at the time, although it might have been Dr. Dunn. I don't remember exactly when we changed. It was reviewed by them, then sent to the director of research, Dr. Osdene. From there it gets kind of fuzzy, I don't know where it goes. But it comes back about 2 weeks later with a yes or a no. Mr. Wyden. Approval was given to submit it to this Psychopharmacology Journal? Mr. DeNoble. To Psychopharmacology, as well as to the Amer- ican Psychological Association meeting in Anaheim, coming up in 1983. Mr. Wyden. All right. Let me ask you, if I might, about some later events at Philip Morris. You were promoted in 1983? Mr. DeNoble. Yes, I was. Mr. Wyden. And your supervisors evaluated your performance and gave you favorable marks over all? Mr. DeNoble. Yes. We were given evaluations each year that we were there. Mr. Wyden. Did you get raises? Mr. DeNoble. Yes, we did, every year that we were there. Mr. Wyden. How about your associate. Dr. Mele? Mr. Mele. Yes, the same thing. Mr. Wyden. All right. Now, we're also interested in some devel- opments in mid- 1983, where you and some researchers flew from Richmond, Va. to New York City, to brief the senior management on your work. Can you walk us through what happened in some of those key events that started back in Richmond? Mr. DeNoble. Sure. We were notified by our senior management that we were going to be going to New York corporate headquarters to give a presentation on the activities of the behavioral pharmacol- ogy laboratory. We were taken to the airport, put on a company jet, flown up to New York, and one of the PM-1 limousines met us and took us over to the corporate headquarters. At that point, we gave a presentation to several members of New York corporate staff, entertained questions, had lunch in corporate executive dining room, and then were flown back that evening on the company jet. Mr. Wyden. What kind of questions were you asked at the New York briefing? Mr. DeNoble. I was only asked one question. Mr. Wyden. What was that? Mr. DeNoble. I can't quote it but I'll paraphrase it. It's basically, "Why should I risk a billion dollar industry on rats pressing a lever to get nicotine?" Mr. Wyden. And this was a Philip Morris executive that asked you that question? Mr. DeNoble. Yes. Mr. Waxman. Could the gentleman yield to me? Mr. Wyden. I'd be happy to. Mr. Waxman. Could you tell us who was at this meeting? Mr. DeNoble. I've been wracking my brain and I can't. There is only one individual that I can remember who was there and that was a lady named Carolyn Levy, Dr. Levy. Mr. Waxman. Were these top management people? 50 Mr. DeNoble. Yes, they were. Mr. Waxman. Thank you, Mr. Wyden. Mr. Wyden. Would it be fair to say that the senior management people were troubled or worried about the work that you were doing? Mr. DeNoble. From that meeting, I didn't think so. In fact, on the way back in the plane, we all thought things went very, very well. However, subsequently after that meeting, we were told that our laboratory might be shut down, but they wanted to continue the research. And the possibility was that we would set up a lab- oratory in Lusanne, Switzerland, to continue the research. Mr. Wyden. Let me ask you specifically about a matter a couple of weeks after the meeting. Were you told a couple of weeks after the meeting, by several of the Philip Morris management, that your lab was generating information that the company did not want generated inside the company? Mr. DeNoble. That is correct. Apparently, at the time some liti- gation had come out, some lawsuits. And we were told that the data we were generating, and the types of studies that we doing, would not be favorable in that litigation. Mr. Wyden. Were you told then that the top management was looking at a couple of specific options, one of them was releasing you and your associate from employment, and possibly trying to look at some other arrangement? Mr. DeNoble. Yes. Two options were discussed. One was to re- lease us from employment but employ us as contract individuals somewhere in Richmond or somewhere close to the research center, because the scientists at Philip Morris down in Richmond, felt the research should continue. Then there was the idea, the discussion that really doesn't re- move it from the company as much as they would like it, so they talked about sending us to Lusanne, Switzerland, at a contract fa- cility. Mr. Waxman. Could the gentleman yield? Mr. Wyden. I'd be happy to yield, Mr. Chairman. Mr. Waxman. Could we get for the record, who was telling you these things? Mr. DeNoble. Dr. Jim Charles and Dr. Tom Osdene. Mr, Waxman. They were with you at Philip Morris in Richmond? Mr. DeNoble. Yes. Dr. Charles was our immediate supervisor. He was the manager of the biochemistry group. Dr. Osdene was the research director and reported to the vice president. Mr. Waxman. And both of those options were to have you do the work, but not in house? Mr. DeNoble. That is correct. Mr. Waxman. Did they give you a reason? Mr. DeNoble. They just said that if the work were removed from the company, connecting it back to the company would be, you know, more difficult to do than if it's being done right in the com- pany itself. Mr. Waxman. That's what we call deniability. Mr. DeNoble. I'm sorry, sir, I don't know. Mr. Waxman. Mr. Wyden? SI Mr. Wyden. Dr. Mele, can you confirm that these discussions took place? Mr. Mele. Yes, they did. Mr. Wyden. All right. Let's turn, if we could now, to August of 1983. The company was involved in the Cipollone case, sued. One of the claims, of course, was that cigarettes were dangerous be- cause they were addictive. Now, to begin with, the self-administration paper that you sub- mitted to pharmacology, I understand that in August of 1983, about the time of the lawsuit, this paper was accepted for publica- tion, but at essentially that time you were told that you could not publish it? Mr. DeNoble. That is correct. I was told to withdraw it. Mr. Wyden. And let us now make sure we understand the status of that paper because, you know, to me this is one of the kinds of key concerns I have, because right at a time when the company has some exposure, and there is independent science generated within the company, the company is still trying to push it aside; and I'm curious about the status of the paper. At that time, had the paper gone through peer review at this particular journal? Mr. DeNoble. Yes. It had been reviewed by Dr. Barry and two anonymous reviewers. Mr. Wyden. So it had been officially accepted for publication? Mr. DeNoble. Yes. Mr. Wyden. And were you told by management that you would have to withdraw it? Mr. DeNoble. Yes, I was. Mr. Wyden. Did management say that it could help plaintiffs in litigation, if it was published? Mr. DeNoble. I don't believe they said that. But they did say that if it — actually they said, if it were published, it wouldn't be good for litigation. Mr. Wyden. And you protested at that time? Mr. DeNoble. Oh, yeah, we both did, very much so. Mr. Wyden. You said that, in effect, you were a scientist and you had an obligation to let science go forward unfettered, and it would be embarrassing to retract the paper after acceptance? Mr. DeNoble. I would love to say I said it that way, but I basi- cally protested Mr. Wyden. Don't let me characterize it. You say it. Mr. DeNoble. I basically protested and felt that the paper was released. It had been approved, it should have been published, that there was no doubt about that. We protested both to our immediate manager, Jim Charles and also to the director of research. Dr. Osdene. Mr. Wyden. And you wrote in August of 1983 to the Journal withdrawing publication? You said you were withdrawing the manuscript due to factors beyond your control? Mr. DeNoble. That is correct. Mr. Wyden. All right. Mr. Chairman, I would like that letter in- troduced into the record as Exhibit 12, and note that my time has expired. Mr. Waxman. Without objection, it will be in the record as Ex- hibit 12. 52 [Exhibit 12 follows:] Philip Morris Research Center, P.O. Box 26583, Richmond, VA. August 30, 1983. Herbert Barry, III, Ph.D., University of Pittsburgh, School of Pharmacy, Pittsburgh, PA Dear Dr. Barry: I regret to inform you that due to factors beyond my control I must withdraw our manuscript #8381400 from consideration as a publication in Psychopharmacology. Please accept my sincerest apology. Sincerely, Victor J. DeNoble, Ph.D., Associate Senior Scientist. Mr. Waxman. Does the gentleman want additional time? Mr. Wyden, Yes, if that would be acceptable. Maybe a couple of more questions at this point would be helpful, Mr. Chairman. Now, Dr. DeNoble, you were scheduled to go to California to present your work before the American Psychological Association. This was supposed to be a process, a program of a poster presen- tation. What is that, and what happened to your presentation? Mr. DeNoble. Well, a poster presentation is very much like the posters you have over here. You would take an introduction of what the experiment was, a title, and you put all your results up, and you put your conclusions up. It's basically a 3-hour poster session in which you stand by the presentation for at least an hour, a mini- mum of an hour, and discuss your research with other scientists who are at the meeting. Mr. Wyden. Were you told by the top management at Philip Morris that you couldn't make a poster presentation? Mr. DeNoble. Yes, we were. I was. Mr. Wyden. And did they tell you why you couldn't make a post- er presentation? Mr. DeNoble. It had to do with the effects that — facts that this would not look good in the current litigation. Mr. Wyden. OK. At that time, did you get a visit from a small battalion of lawyers at Philip Morris, over at your lab? Mr. DeNoble. Well, a couple of them came, yes. We did get vis- ited by several attorneys. Mr. Wyden. Three or four, or how many? Mr. DeNoble. Give me a second, please. [The witness confers with Mr. Mele.] Mr. DeNoble. There were at least three attorneys. Mr. Wyden. OK. And they basically set up shop next to your lab and brought their xerox machine and started rummaging around your documents and files? Mr. DeNoble. They did go through my files; they went through Paul's files as well. They took documents and placed them in red folders. These red folders were then documents that they would photocopy. They did not remove anything from the lab, they just photocopied everything they thought was important. Mr. Waxman. Will the gentleman yield to me? For the record, do you recall the names of any of those attorneys? Mr. DeNoble. Yes. There was Fred Newman. I believe he was a corporate attorney from New York. Rhonda Fawcett, who was from an agency called Shook, Hardy, and Bacon, in Kansas City; and her two supervisors, and I do not remember their names. 53 Mr. Waxman. She was from a law firm? Mr. DeNoble. She was from a law firm in Kansas City. Mr. Waxman. And two of her supervisors from the law firm? Mr. DeNoble. Yes. Mr. Waxman. OK. Mr. Wyden. Let me, if I could possibly understate this, Dr. DeNoble. Isn't it a little bit unusual to have a paper like this, after it has been peer reviewed, accepted for a journal, suppressed, a poster presentation canceled, and then to have a visit by three or four lawyers, isn't that a little bit unusual? Mr. DeNoble. Yes, sir, it is. Mr. Wyden. OK. Mr. Chairman, thank you. Mr. Waxman. Thank you, Mr. Wyden. I'm going to recognize my- self for another round of questions. Let me just see if I understand the chronology here. You went to work in 1980. You were doing work in 1980, 1982. By June of 1983 you went to New York and you met with some of the top executives at Philip Morris. You are telling them what you were doing in your lab work, that was June 1983. In August, you wanted to publish your paper. You were told when you were hired that you could publish papers. And now you were being told you couldn't publish this paper or make a presen- tation to the American Psychological Association. That August 1983 is a significant time as well, because on Au- gust 1, 1983, the Cipollone case was filed. The Cipollone was a case of going against Philip Morris for liability for a death resulting from cigarette smoking. Now, as Mr. Wyden indicated, you started to get more concern expressed by people at Philip Morris. People were suggesting, your supervisors were suggesting, perhaps you ought to go outside of Philip Morris and do your work, go to Switzerland to an independ- ent lab from where you were. And you next had visits from these lawyers that came by, and they were looking very carefully at your work. I'd like to jump ahead 2 months to November of 1983. Your laboratory had a visit from Shep Pollack. According to Moody's Industrial Manual from 1983, Shep Pollack was an important person at Philip Morris. In fact, he was the president and chief operating officer of Philip Morris, U.S.A. He was also on the Board of Directors of the parent company, Philip Morris, Incorporated. Who visited the laboratory with Mr. Pollack? Mr. DeNoble. He was accompanied by Mr. Fred Newman, the attorney I mentioned previously. Mr. Waxman. And Mr. DeNoble. And also by, I'm sorry, also by Jim Charles, I be- lieve, or Dr. Osdene. But they didn't tour the lab, just Mr. Newman and Mr. Pollack. Mr. Waxman. And what happened at that meeting? Mr. DeNoble. We toured the laboratory facility. We set up a demonstration for Mr. Pollack, that he could actually see the ani- mals working for food, or/and pressing the lever for nicotine. Mr. Waxman. You had a demonstration of the rat actually self- administering? 54 Mr. DeNoble. Yes. It was easy to do. The lab was situated such that if we stood in the operating room, we could see the self-admin- istration room, and those doors could be left open. And we could also sit and look into the experimental room where the animals would work for food, and those doors — we had to train animals to actually work Mr. Waxman. Just so we can understand this. I think we have a photograph of what that cage looked like. That was Exhibit 8, earlier referred to but not shown to the committee. So what happened? Mr. DeNoble. That's a single experimental chamber in our self- administration room. As I indicated, there is a little lever or switch, and you can see levers in the boxes. The animal has access to water and food. There is a pump on top of the box, and there is a solution behind it, probably of either nicotine or acetaldehyde. The animal is hooked up to the tether that hangs down in the box, and can press the lever to deliver the solution into its vein. Mr. Waxman. So you are there with the president of Philip Mor- ris, showing him how these rats self-administer nicotine in their brain Mr. DeNoble. In their heart. Mr. Waxman. This was in their heart? Mr. DeNoble. Yes. Mr. Waxman. And that this is a reinforcing agent? I assume that you went through all of that information for Mr. DeNoble. Yes. The interesting thing was, I mean, the ques- tion brought out of course, was, you know, was this addiction? And Mr. Waxman. Who asked that question? Mr. DeNoble. Mr. Pollack. And I went into my routine. It's not addiction, it's a reinforcing agent and it predicts abuse liability. So it was an opportunity to do some educating. Mr. Waxman. What did Mr. Pollack say about that? Mr. DeNoble. He accepted the answer. We chatted about that and we moved forward. Mr. Waxman. What about Fred Newman, he was the lawyer, did he ask any questions? Mr. DeNoble. Mr. Newman asked if this test procedure was the same test procedure that a government agency would use to dem- onstrate addiction? After I corrected him about addiction, I did say it's the exact procedure that NIDA would use to demonstrate abuse liability, yes. Mr. Waxman. And NIDA is? Mr. DeNoble. The National Institute of Drug Abuse. Mr. Waxman. OK. And what was his reaction to that? Mr. DeNoble. He was not very happy with that reaction. He ba- sically shook his head and walked off. Mr. Waxman. Dr. Mele, can you confirm this report of this meet- ing with Shep Pollack, the president of Philip Morris in visiting the lab in November of 1983? Mr. Mele, Yes. He did visit, he toured the lab, and he did ask the question, and it was responded to just as Dr. DeNoble says. Mr. Waxman. Let me make an observation about the significance of what you are telling us, because to this day Philip Morris has 55 maintained that nicotine is not addictive, and it is in cigarettes only for its taste. Yet it is now clear that 10 years ago, the president of Philip Mor- ris, the president of the company, visited your lab and actually wit- nessed a rat injecting himself with nicotine. This rat was not doing that because of the taste of nicotine, and the rat wasn't pressing the lever to get more nicotine because of peer review. The rat was pressing this lever in order to self- administer nico- tine because this was something that rat physiologically wanted. And he was told by you that nicotine is a reinforcing drug that has an abuse liability? Is that a correct statement? Mr. DeNoble. [Nodding affirmatively.] Mr. Waxman. What was the immediate result of the visit by Shep Pollack? Were you told to continue your research? Mr. DeNoble. Actually, yes. Two weeks later we were given a green light to just go ahead. We actually hired another person in, a contract person. We were told that everything was fine and to just run full force, and we did. So we just kept doing experiments. Mr. Waxman. This was the end of the year beginning in 1984. And in April of 1984, Philip Morris made a decision to close down the laboratory. Could you please recount for us the closing of the lab? Mr. DeNoble. I believe it was the second Thursday. It was April 5th, the first Thursday, in 1984. It was at 3 in the afternoon, and Dr. Charles, Jim, called me to his office and was telling me what a great job we had done for the company. Quite frankly, I thought this was great and we were getting a lot of accolades. I was getting a lot of accolades, and Paul. And he said, "However, we are discontinuing animal research beginning now." I was told that Paul had to come up and talk to him. And I was basically to shut the equipment off; terminate the experiments, even if they were ongoing; to kill all the animals the following day; and that was the end. We were — our badges were discontinued ac- cess to the research center. By the following Monday, we couldn't get back in. We were provided offices, we were provided secretarial support, we were provided funds to look for other jobs. Quite frankly, the company was very gracious to us during that time, but the lab was literally shut down. Mr. Waxman. When you were told they were shutting down your lab, what was your reaction? What did you say to them? Mr. DeNoble. Why? I mean, you know, why? All of a sudden ev- erything was going down the tubes, and the response that I imme- diately got was that it was a business decision. I mean, that's the only thing they said to us during the first couple of weeks it was shut down. Mr. Waxman. Did you ask for, at least for a short period of time, to complete some of the work that was ongoing? Mr. DeNoble. To do anything. I mean, just to complete manu- scripts, and we were not able to do that. We weren't able to con- tinue. Mr. Waxman. Is it accurate that you asked for at least another day to get some more data? 56 Mr. DeNoble. We did. We were able to get that Friday to. Right, we went back the next day on Friday and we did kill all our rats. And at that point, the lab was over, it was ended. Mr. Mele. May I add something here? Mr. Waxman. Yes. Dr. Mele. Mr. Mele. Because I was going through this recently, we did — that Friday was a critical day to end one study. I don't remember what the study was, but it was a final manipulation of a long series of manipulations. And we did ask for permission to, at least, finish that study. And that was denied. Mr. Waxman. What do you mean, manipulations? Mr. Mele. It was a chronic dosing study, and this was the day where the animals would have been tested to see how they re- sponded. I don't remember, again, the details of the study, but we did try and get that one final data point, and they didn't even want us to continue that much. It wasn't of much interest to the com- pany, it was of interest to us. Mr. Waxman. Did you ever go back to the lab? Mr. DeNoble. I had the occasion to go back to the lab a few days later, the following week, because I had the combination to a safe where we kept some controlled substances, yes. Mr. Waxman. And what did you find? Mr. DeNoble. The lab was gone, everything was gone. The equipment was gone, the cages were gone, the animals were gone, all the data was gone. It was empty rooms. Mr. Waxman. Was it as if there had never been a lab there be- fore? Mr. DeNoble. You'd probably think there was, but there was no evidence there was any behavioral lab there. The only thing that was there was the safe. Everything was gone. It was just gone. Mr. Waxman. OK. Thank you. Mr. Bliley? Mr. Bliley. Dr. DeNoble, could you clarify one point for me? Ear- lier you mentioned lawyers from Philip Morris being in your lab in 1983. Isn't it correct that they were in your lab to collect docu- ments to be produced in a lawsuit, perhaps the Cipollone case? Mr. DeNoble. I believe that is correct, yes. Mr. Bliley. And, Mr. Chairman, could we keep the record open so that we can submit some questions in writing to these two gen- tlemen? Mr. Waxman. Without objection, we will keep the record open, and members of the subcommittee may have additional questions they'll want you to respond to in writing. For the record, we would ask you to make those responses. Mr. Bliley. Thank you, Mr. Chairman, I have no further ques- tions. Mr. Waxman. Thank you, Mr. Bliley. Mr. Synar? Mr. Synar. Thank you, Mr. Chairman. Doctor, let me move on to this issue of your termination of employment. After the lab closed, what career options did Philip Morris give you? Mr. DeNoble. There were three options that were offered to us. One was to stay with the company, the second one was to receive a cash pay-out, and the third was to continue us on the payroll until we located new positions elsewhere. 57 Mr. Synar. What option did you take? Mr. DeNoble. Well, originally we took the option of staying with the company. We figured times were tough in the 1980's, and jobs were very difficult to come by, so we said, we'll stay with the com- pany. And we were then informed that if we did do that, that sig- nificant reductions in salary, as well as positions — there was even discussions of, well, you may in fact have to go sweep the floor somewhere, if we stayed with the company. So it was clear that they didn't want us to be there. So the sec- ond option we both elected was to continue on salary until we lo- cated new positions. Mr. Synar. So, ultimately, what happened? Mr. DeNoble. Ultimately, we both found new jobs. Mr. Synar. OK. When you left Philip Morris, were you free to talk about your work, or were you covered by a secrecy agreement? Mr. DeNoble. I think we were — we were still covered by that agreement, so we kept it pretty low profile at the time. At least we thought it was low profile. We were pretty upset about this, so we didn't talk about it very freely. Mr. Synar. Let's move this story on beyond that. It didn't end after you left Philip Morris. In 1985 and 1986, you both made var- ious efforts to publish and present some of your work. And I'm told, for instance, and we have a letter and an article to this effect, you sent the Journal in December of 1985. That letter, I think, is Ex- hibit 13. I'd ask unanimous consent that it be made part of the record. Mr. Waxman. Without objection, that will be Mr. Synar. And the article is Exhibit Number 14. Mr. Waxman. And the same for that. [Testimony resumes on p. 92.1 [Exhibits 13 and 14 follow:] 58 AVGfStJ AYERSTLABORATORIES RESCAnCH, INC. CN 1000 / »r.-e9l9" V««» j„i ,t, 01-41 / T. . 1(11. J.» J300 / 'g 0 • t3'7tj Cece»b rats was initiated and maintained under an FR sc'"ed'jle ty iv infusions of nicotine. These results derronstrate that iv delivered "icotine can ircrease end maintain lever pressing that results in its delivery. The changes in the nicotine delivery prc- cedure shc-.ved that lever pressing was maintained by the nicotine cmtin- gency. T^-ere were four indications of the positive reinforcing effects Q-f nicotine: 1; a c'eate-- nunber of lever presses when nicotine was respcnse-ccnt ingent than v;hen saline was resporse-contircent ; 2) a greater n'^rber of responses on the nicotine lever tnan on the control lever; 3) a systeratic decrease in the number of contingent infusions when nicot'ne was delivered ncncontirgently; ^1 systematic changes in lever pressing as a function of the nicotine dose. '" ' • ' '' Several previous repcts have examined the maintenance of respond- ing by iv infusions of nicotine under an FR 1 schedule in rats (Clarke 1969; Lang et al. 1979; Singer et al . 1976; Hanson et al. 1979; Latiff et al. 1980). Although self-administration of nicotine was de«>on- strated in irost of these studies the 'ates of responding were gere'ally ■"ower than those maintained by othe-- rein'orcers jnder similar condi- tions (-ickens et al. 197£). In adcition, several previous studies 13 72 _.../ under conditions of reduced body weight and/or con- current fixed-time food presentations win nicotine maintain rates of responding above those maintained by saline (Lang et a1. 1977; Latiff et a1. 1S80). In the present study, however, several doses of nicotine maintained lever pressing above saline levels in the absence of weight reduction procedures or fixed-time 'ood presentations. One poss5.C irg/kg) cf the antagonist are used (Segal et al. 1979). Naloxone has also been shown to reduce the amount of cigarettes smoked during a 3 h test per- 17 76 iod (Karras and Kane 1980). In contrast, naloxone has not been shown to be an effective antagonist of nicotine- induced antinociception in rats (Sah!ey et a1. 1977; Tripathi et al. 1982). The present results are consistent with previous findings in rats in that naloxone across a range of doses was ineffective as an antagonist to the positive rein- forcing effects of iv nicotine in rats. To sunrarize, previous atteanpts to establish nicotine as ar iv deliv- e'-ed reinforcer for rats have shovirn that only under conditions of reduced body weight ard/or concurrent fixed-tine food presentation c following prograimed nicotine infusions will nicotine self- administratior, occur at rates above vehicle control levels (Lang et al. 1977; Hanson et a1 1979; Lang and Smith 1980). The present results show that nicotine can function as an intravenously delivered positive rein'orcer for rats in the abserce of such conditions, and th?t the lev- el of responding can be ir.aintaired across several ratio values. In this study the maintenance of leve-- pressing was uneoui vocally the result of consequent nicotine infusions. The fact that pretreatmert with irecamyl amine (a centrally-active nicotinic antagonist) but not hexatrethonium {a nicotinic antagonist that does not readily penetrate the central nervous system) blocked the positive reinforcing effects of nicotine suggests that this effect is centrally mediated. In addition, the failure of large doses (3.0 ng/kg) of naloxone to alter the rein- 'orcing effects of nicct'ne suggests that the erdocerous opioid system may net mediate the effects. Furthenrore, the behavicr was shewn to be sensitive to both dose and response contingency manipulations. 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(1982) N'ovel phenylpiperidine opio'd antagonists and partial aoonists: Effects on fluid consumption. Eur. J. Pharmacol 31: 185-192. Karqules, O.L., Moisset, B., Lewis, M.J., Shibuya.H. and Pert, C.B. (1978): 6-Endorphin is associated with overeating in genetically obese mice (ob/ob) and rats (sa/sa). Science. 202: 988-991. ("■e'tzer, L.T., Rosecrans, J. A., Aceto. M. 0. and Harris, L.S. [1980): Discriminative stimulus properties of the optical isomers of nicotine. Psyc^cp'-arTjcolcgy 68: 285-286. Mor'-ison, C.F., Goodyear, J.M. and Sellers C.K.: Antagonism by antimus- carlnic and ganglion-blocking drugs of some of the behavioral effects of nicotine. Psychopharmacologia (Berlin) 15: 341-350. Morrison, C.F. (1967): A comparison of the effects of nicotine and amphetamine on DRL performance in the rat. Psychophannacologia (Ber- lin) 12: 176-180. 23 81 Korrison, C.F. and Stephenson, J. A. (1969): Kicotlne Injections as the conditioned stimulus in discrimination learning. 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Comp. ?hj». o> c* LU 1 50 >^ < 0.75 16 32 64 8 16 32 64 NICOTINE DOSE {/i.g/kg/INFUSlON) 88 V 110 Oioo z o u u- 80 o ^ 60 UJ o. < ^ 40 o § 20 L- { ^-1-- 1 ---^-.^ CONTROL 30 45 60 90 INTERINFUSION INTERVAL ( mi n) 3 89 300 200 O 100 J I I I I I I I 1 2 3 4 5 6 7 8 FIXED RATIO SIZE r 90 120 z 105 o in 3 90 z *>» o -at 75 :t CM £2. to 60 z O (7) U- 45 Z UJ Z 30 H- o u 15 _ 1 i 1 rrn HEXAMETHONIUM ■^ MECAMYALAMINE 1, 0.75 COSE (mg/kg^c) 91 Z o C?5 30 CM CO vO Z g 20 _ 10 _ .— — NICOTINE ♦ SALINE . . NICOTINE ♦ 0 TSmgAo/sc MEC AMYLAMINE . . NICOTINE ♦ li mg/kgAc MECAMYLAMINE 0 0 NICOTINE ♦3.0mQ/k8/K MECAMYLAMINE - 0 — 0-3 3-6 6-9 9^2 12-15 HOURS 15-18 18-21 21-24 92 Mr. Synar. This article is a revised version of a self-administra- tion paper that Philip Morris suppressed in 1983. I understand that you sent that self-administration paper to the journal in De- cember of 1985, without first getting a consent from Philip Morris. Some might say that this was a violation of your secrecy agree- ment. Did you take that risk? Mr. DeNoble. Yes, I did. Mr. Synar. And why did you take that risk? Mr. DeNoble. It's one thing for industry to hold back scientific information because they are involved in the development of a product. It's another thing to say, we need to get the patents done. It's done all the time in the drug industry. Scientists aren't free to publish right away. Usually, you have to get the product out, or you have to get a position in the marketplace. There are valid rea- sons to do that for market reasons. This had nothing to do with the product. This information wasn't going out simply because the company didn't like what it said, and that was unacceptable. In 1986, people still weren't close to doing these kinds of research. They still hadn't picked up, so we took the risk. Mr. Synar. I understand that in April of 1986, you and Dr. Mele went to St. Louis to present a paper on tolerance to nicotine before the Federation of American Societies for Experimental Biology. What was the response by Philip Morris to that? Mr. DeNoble. They sent us a letter indicating that was a viola- tion of our agreement and that they would not tolerate that kind of conduct in the future. Mr. Synar. I'd like to enter into the record as Exhibit 15, a copy of that letter. Mr. Waxman. Without objection, it will made part of the record. [Exhibit 15 follows:] Philip Morris Companies, Inc., 120 Park Avenue. New York. NY. April 23. 1986. Dr. Paul C. Mele, 3205 Whispering Pines Drive. Silver Spring, MD Dear Dr. Mele: It has come to our attention that you presented a paper at the Federation of American Societies for Experimental Biology in St. Louis on "The De- velopment of Behavioral Tolerance Following Chronic Nicotine Administration." As you are aware, upon your employment at Philip Morris on November 16, 1981, you signed an agreement (a copy of which is enclosed) reauiring you to keep confidential, unless expressly permitted otherwise, research developed while an employee of the Company. The disclosure of such information as a result of your employment at Philip Morris without permission constitutes a breach of your agreement with the Company. In the future, you are expected to comply with the terms of the agree- ment. If you have any questions regarding this letter or the agreement, please address them to my attention. Very truly yours, Eric A. Taussig, Assistant General Counsel. Mr. Synar. Dr. DeNoble, I understand that in August of 1983, you and Dr. Mele spoke at a convention of the American Psycho- logical Association in Washington, DC about another aspect of your work for Philip Morris. What was Philip Morris' response to that appearance? Mr. DeNoble. That was quite interesting because they actually had somebody out there taking pictures of us. They sent one of their people out to take a picture, and they sent us another letter 93 indicating that — a little stronger this time — action would be taken against us. At that point, I called Mr. Taussig, who was, I think, the assist- ant general counsel, to discuss with him, to actually kind of let him know that we had submitted two manuscripts for review, and one was going to be published, and the other one was accepted and was going to be published. And that led to him telling me that if these articles were published, they would be suing us, and it would be very long and costly. Mr. Synar. So that was the action to be taken? They were going to sue you? Mr. DeNoble. That is correct. They also indicated that if they could, they would try to bring an injunction against the journal to prevent publication of the self-administration paper. But that did not occur because I was able to pull it out. Mr. Synar. Was this in writing? Mr. DeNoble. No, sir, it was not. It was in a phone conversation. Mr. Synar. OK. I have a copy of that letter sent to you and Dr. Mele, dated September 10th, Exhibit 16. I'd ask unanimous consent that it be made part of the record. Mr. Waxman. Without objection, that will be the order. [Exhibit 16 follows:] Philip Morris Companies, Inc., 120 Park Avenue, New York, NY, September 10, 1986. Dr. Victor J. DeNoble, 5603 Fox Run Drive, Plainsboro, NJ Dr. Paul C. Mele, 3205 Whispering Pines Drive, Silver Spring, MD Gentlemen: On April 23, 1986, I sent each of you a letter advising you of your obligations pursuant to the agreement which you signed with the Company at the commencement of your employment. In that letter, I indicated that the Company expected you to comply with the agreement. I also advised you that the Company considered your presentation of a paper at the Federation of American Societies for Experimental Biology in St. Louis in April 1986 based upon research performed at Philip Morris during the course of your employment to be a breach of the agreement since the consent of the Company had not been obtained. We have since learned that during the latter part of August, you attended an American Psychological Association meeting in Washington, DC at which time you disclosed information relating to research on a project entitled "Brain Sites Involved in the Mediation of the Behavioral Effects of Intraventricularly Administered Nico- tine." Management has determined that the research relating to this latest presen- tation was performed at Philip Morris. Again, the consent of the Company was not obtained. The Company cannot tolerate this kind of conduct. As I stated in my earlier letter, if you wish to publish or otherwise utilize research from Philip Morris, you must request and receive permission from the Company. Any further breach of your agreement will result in action being taken. Very tnily yours, Eric A. Taussig, Assistant General Counsel. Mr. Synar. Doctor, in this letter that you have before you, Philip Morris says, and I quote, "The company cannot tolerate this type of conduct. Any further breach of your agreement will result in ac- tion being taken." And that was signed by Eric Taussig, the assist- ant general counsel for Philip Morris. So what happened next was that he called you and then Mr. DeNoble. No, sir. I called him to let — ^because when I got this letter, we had already sent out two more publications. I called him to let him know that they had gone out. 94 Mr. Synar, And you got a harsh lecture, based upon that con- versation? Mr. DeNoble. Yes, sir. Mr. Synar. Based upon that conversation, did you contact the psychopharmacological magazine to see what you could do? Mr. DeNoble. Yes, I called Herb Barry up and asked him what the status of the two papers were. The first paper, which was a brain site paper, had already gone to press. It was out, there was nothing we could do. The self-administration paper, I believe your Exhibit 14, was in press but it had not gone to proof, so we were able to again, for the second time in 3 years, unfortunately, tell Herb that we had to pull the paper back. Mr. Synar. All right. I have a copy of the letter that you sent the journal editor, Herbert Barry. It's Exhibit 17. I'd ask unani- mous consent that it be made part of the record. Mr. Waxman. Without objection, that will be the order. [Exhibit 17 follows:] September 22, 1986. Victor J. DeNoble, Ph.D., Ayerat Laboratories Research, Inc., CW 8000, Princeton, NJ Dear Victor: The revised version of your MS 868-1666, received August 4, is sat- isfactorily improved and abbreviated. Thanks for your thorough, effective changes. My routine check for discrepancies between the reference list and citations in the text has revealed that Lang et al. (1977) cited on pages 3 and 11, is not in the ref- erence list. Since it was in the reference list in the prior version, this one of the 16 reference list items deleted apparently should have been retained. I share the distress you expressed in your phone conversation of September 18 that the Philip Morris Company has issued an injunction against publication of this paper. I am returning to you the typescript, including the glossy prints of the four figures. I will accept your paper for publication and send it to the Technical Editor only if I receive fi"om vou a corrected tjrpescript with the information that the in- junction has been lifted. When I return to the author a manuscript that I expect will be acceptable after revision, I keep it in a pending status for 6 months. At the end of that time, I send to the Joumafs Production Office a circulation slip specifying that the paper will not be published. I will follow this procedure unless I receive contrary instructions from you. Although it is disappointing both for you and for me that the efforts on this paper by you, by two expert reviewers, and to a lesser extent by me will apparently not result in publication, I believe that your effort and experience will be beneficially applied to yovu- future papers. You have my best wishes for success in your ongoing and future research, and for useful publications reporting your findings. Sincerely yours, Herbert Berry, III, Ph.D., Field Editor for Behavioral Pharmacology in LABORATORY ANIMALS. Mr. Synar. Now, this was a letter from Barry to you, and I want to quote from it. Quote, "I share the distress you expressed in your phone conversation of the 18th of September, that the Philip Mor- ris Company has issued an injunction against the publication of this paper." Dr. DeNoble, you have worked for other companies since Philip Morris, how do you compare these types of actions, which we have just detailed and the company's efforts to keep your work confiden- tial with other companies you've worked with? Mr. DeNoble. Before I answer, let me just say that there is an error in the letter. The company never issued an injunction. They just told me they would, if I couldn't get it out. So that's an error. 95 I have never had this happen to me. I've never heard of it hap- pening to any other scientist that I've ever talked to. This is very, very unusual. Paul? I don't know if Paul has. But I don't know if anyone else has tested the waters and gone against an agreement like this, like we signed. I mean, that was clearly Mr. Synar. Well, let's talk about that agreement, because you ob- viously have a confidentiality agreement. The last 10 years you haven't been free to talk publicly about your work. There have got to be other researchers in that same situation. How do these agree- ments work in practice? Are they, in effect, a complete bar to get- ting information to the very people that the information is sup- posed to serve? Mr. DeNoble. I've never had an agreement — I've never had an agreement with anybody else like this. This is the only agreement that I've ever had. Mr. Synar. This is unique to the tobacco industry? Mr. DeNoble. No, sir, it's not. Industry has agreements that you will not divulge proprietary information, that you will not take data with you when you leave. Those every company has. This agreement was probably similar to those agreements, but it was being enforced in quite a different way. This was used to prevent us from publishing information that did not relate to a product, did not relate to a marketing issue. It just didn't relate to an3rthing like that. It was just the science. And what we found wasn't liked. Mr. Synar. Let me conclude with just this general question. Dr. DeNoble, if I could. You are presently employed where? Mr. DeNoble. I work with the Department of Mental Retarda- tion with the State of Delaware, servicing folks who have- -or citi- zens who are mentally retarded. Mr. Synar. And Dr. Mele, you are where? Mr. Mele. I work with the Defense Department. Mr. Synar. OK. What has this experience over the years told you about the tobacco industry? What does it tell you about the char- acter and the trustworthiness of this industry? More importantly, what did it feel like on April 14, 1994, as you watched as the rest of America did, the testimony of the seven chief tobacco executives of this country on the issue of whether or not, one, tobacco is deadly; and second, that nicotine is not addict- ive. What did you feel like at the moment when you saw that? Mr. DeNoble. That's a very difficult question to answer. You know, when I first agreed to appear before this committee, I prom- ised that I probably would not go out and make public policy. It's difficult to watch those hearings and to feel good about what hap- pened to us. I would very much like to stick with the issues surrounding the laboratory, and would very much like to stick to the issues in the data, and would very much not like to personalize this. That's the best answer I can give you, sir. Mr. Synar. Dr. Mele? Mr. Mele. It just brought back to me the amount of data and type of data that we had collected and that was going nowhere. And in a very limited sense, that data should be out. I don't know 96 about broader public policy issues, but we put a lot of effort into collecting that data. They asked us to collect it, they suppressed it, and it remains suppressed right now. It may be of use to the world, it may not. That should be put out and let the scientific community judge. Mr. Synar. Thank you both. Mr. Waxman. Mr. Synar, if you'll just yield to me. Not only did they suppress the data, but due to these agreements they had with you as researchers, and I assume they have this with all their re- searchers, they have been able to keep people who work for them from coming forward to talk about what they know and what they've done even as employees of the tobacco industry. I want to tell you that I think you have come to us in good con- science, concern, and with a great deal of courage to make this presentation. And I hope others will be coming forward as well. Mr. Wyden? Mr. Wyden. Mr. Chairman, thank you. I'm going to go back to the laboratory in just a second, Dr. DeNoble. But, Mr. Chairman, I would like to enter into the record at this point a Wall Street Journal article, February 11, 1993. Mr. Waxman. Without objection, it will be put into the record. [The article follows:] m THE WALL STREET JOURNAL \oi t c \\i NO :<)**■ rHLRSDAV. Fl BRL'ARY II. mi M • II «5f > ; C F N T S Smoke and Mirrors How Cigarette Makers Keep Health Question 'Open' Year After Year Council for Tobacco Research Is Billed as Independent But Guided by Lawyers An Industry Insurance Policy By ALix M Freedman And L^LRiE P. Cohen S!tiff Rtpor.tn. of THE W ALL STREET JOLRNAL This IS ihe slop, of ihe longest -running misinformation cam- paign in U.S. business hisior\, and how it may ultimately back- lire on lis corporate sponsors. The tale opens in 1954 Cigarette smoking, like tail fins and the new music called rock-and-roll, was fun and glamorous. Bui a warning had just been sounded ihat smoking might not be good for you. .^ scientist al Memorial Sloan-Ketiering Cancer Center had painted tobacco lars on the backs of mice and produced tumors. The tobacco industry met this sudden threat head-on In full-page newspaper ads headlined "A Frank Statement to Cigaretie Smokers." tobacco companies announced that a new research group, funded by the industry but independent, would examine "all phases of tobacco use and health." Its solemn pledge. "We accept an interest in people's health as a basic responsibilii>. paramount to e^ery other consideration in our business." The tobacco industry's main vehicle for damage control was up and running. Sowing Doubt For almost four decades, the Council for Tobacco Research in New York has been the hub of a massive effon to cast doubt on the links between smoking and disease. Sponsored by U S tobacco companies and long run behind the scenes by tobacco-industry lawyers, the os- lensibh independent counal has spent millions of dollars advancing sympathetic saence. .At the same time, it has sometimes disregarded, or even cut off, studies of its own that implicated smoking as a health hazard. "When CTR researchers found out that cigarettes were bad and It was belter not to smoke. »e didn't publicize lhat" in press releases, savs Dorothea Cohen, who for 24 years until her retirement in 1989 wrote summaries of grantee research for the Council's annual report "The CTR is just a lobbying ihing We were lobbying for cigarettes. ' Many companies under atiack for their products have underwrit ten research to buttress safety claims. What sets the tobacco industry apart is the scope, aggressiveness and persistence of its under taking. For decades nval tobaa'o companies have acini in conten to comhal the growing bodv of evidence linking their products to cancer, heart disease and emphysema. Cheap Insurance The US Centers for Disease Control today links 454,000 deaths a year lo smoking. The surgeon general has declared smoking "the single largest preventable cause of death and dis- ability," cuing "overwhelming" evidence from no less than 50,000 studies. Vet the wisp of uncertainty supplied bv the Council has always been enough to protect the S50 billion in- dustry in Congress and especially in court, and tobacco com- panies have never paid a dime in product liabihtv claims. Addison Yeaman, a former Brown & Williamson Co. law- yer and et-chairman of the Council, says the passage of time hasn't altered his faith in this view e.xpres.sed at a Council meet- ing in 1975: The "CTR is (the) best and cheapest insurance the tobacco industry can buy, and without It, the industry would have to invent CTR or would be dead." Michael Pertschuk, a former chairman of the Federal Trade Commission, finds the industry's defense extraordinarv : "There never has been a health hazard so perfectly proven as smok- ing, and it is a measure of the Council's success that it is able to create the illusion of controversy in what is so elegantly a closed scientific case." A Legal Peril But now Ihe device the industry has so long used lo deflect attack has become its biggest vulnerability. That ;s because the Supreme Court last year said smokers can sue, accusing the in- dustry of deliberately hiding or disorting smokuig's dangers. And ihe U.S. aiiornev's office in Brooklyn, N.V . is conduct- ing a criminal investigaiion into whether the industry used the Council to defraud the public. Whether anyihing will come of the criminal inquiry — and whether plaintiffs can convince juries that the industry did in fact misrepresent health hazards — are very much open ques- tions; just last monih. one jury rejected allegations of a con- spiracy. But if plaintiffs should begin to succeed, perhaps bv gaimng access to now -secret Council documents, they could turn on iis head what up to now has been an almost io;alK winning industry strategy. The Council for Tobacco Research declined to respond to questions about its activities, as did all of the Big Six tobacco companies — Phillip Morris Cos., RJR Nabisco Holdings Corp., American Brands Inc., BAT. Industries PLC (parent of Brown & Williamson), Loews Corp. (parent of Lorillard) and Brooke Group Ltd. (parent of Liggett Group). At the outset, many in the industry thought the late- 1953 crisis posed by the Sloan-Kaiering mouse research was entire- ly manageable. With the Council, "the industry was told that in the best of worlds, we'd do a great service to mankind," says James Bowling, a former Philip Morris director. "Our product either would be exonerated or, if involved (in causing cancer), they'd identify the ingredients and we'd lake them out. We thought this was marvelous." So apparently did some scientists. The Counol snagged a noted figure, Clarence Cook Little, as its scien'uHc director. Thanks to his renown as a former Umversiiy of Michigan presi- 98 c'rnl and director of a prestigious laboratory, the Council was able to attract an illustrious scieniific advisory board, which culled through proposals from a who's who of American scien- tists who sought its research grants. Over the years, it has doled out more than $200 million. But the Council's role was never just research. It was largely a creature of Hill & Knowlion, the public relations ftrm, which cigarette merchants retained when (he mouse research came out. Hill & Knowlion installed the Council in the Empire State Build- ing in New York, one floor beneath its own ofnces, with one of the PR Turn's staffers as the supposedly independent research council's executive director. Hill & Knowlion also began pub- lishing a newsletter that reported such news items as "Lung Cancer Found in Non-Smoking Nuns," and it helped authors generate books with titles like "Smoke Without Fear" and "Go Ahead and Smoke." Some people, including many in the news media, were skep- tical of the Council. "To reporters, the Council was never in- dependent," says Earl Ubell, a veteran science reporter at WCBS-TV in New York. "It was a wholly owned subsidiary of the tobacco industry." But in the interest of balance, jour- nalists writing on smoking and health routinely included the Council's views. And many smokers lacked the professional skepticism of reporters. "You would have to have lived in that era to under- stand — they kept providing false reassurances, so I had no idea that smoking was so very dangerous," says Janet Sack- man, who once appeared in ads as Miss Lucky Strike and who now has throat cancer. As early as 1958, however, the Council had strong intima- tions from studies it fmanced that smoking could be dangerous. "Cigarette smoke condensate is a weak mouse skin carcinogen," said a Council-financed study completed in thai year. Ensuing Council-financed research found more links to dis- ease. In 1961, a siudy of 140 autopsies at a Veterans hospital in Iowa City, Iowa, said "a history of cigarette smoking is sig- nificantly related to the incidence of carcinoma." In 1963, researchers at Philadelphia General Hospital and the Universi- ty of Pennsylvania linked chronic smoking to earlier coronary artery disease and a higher Incidence of coronary occlusion. The Council summarized such results in its annual reports, but it often chose other research lo stress to the public. Ms. Cohen, who wrote (he summaries, cites a 1965 study (ha( said pregnant women who smoked had smaller babies and were more likely to give birth prematurely. But the industry in 1982 submitted to Congress a study (he Council hadn't financed, say- ing tha( smokers had no greater risk of premature babies and (hat low birth weight wasn't a problem. "In the '60s." says Ms. Cohen, "there was so much bad news about smoking that there really wasn't much the CTR could put out, but anything they could find they would use." THE LAWYERS STEP IN By 1964, keeping (he case open was no longer jus( shrewd public reladons; It had become a legal imperadve. As more Americans came to believe smoking could kill, (he number of tobacco liability sui(s jumped to 17 from seven the year before. And in that year, (he Surgeon General labeled smoking a heal(h hazard. I( "was a serious, s(unnlng shock," says Mr. Bowling, (he former Phillip Morris director. "That's (he s(age a( which (he lawyers became a lo( more involved." Needing a defense from science as never before, yet dread- ing (he legal exposure (ha( adverse research would bring, (he indus(ry crea(ed wUhin (he Council a Special Projects division — with lawyers, not sciendsis, a( (he helm. Much of wha( i( did was shrouded in mys(ery. "Everything was cloak-and- dagger," recalls John Kreisher, a former as$ocia(e sciendfic director of the Council. "We weren't allowed on (heir floor." The core of (he lawyers' operadon was a vast database, stor- ing (he world's li(era(ure on (obacco and heal(h, da(a on foes and sira(egy documents. The lawyers began shuttling the globe, looking for research and expert witnesses. They sough( out s(udies suppordng causadon of lung cancer by fac(ors o(her (han smoking and research suggesdng (he complex origin of all diseases linked to tobacco. Overtures lo scien(is(s usually were handled by outside law firms, especially Jacob. Medinger, Finnegan & Hart in New York. It also served as counsel (o (he Council, and i(s Edwin Jacob (ook (he lead role a( the Special Projects unit. This ar- rangement offered crucial advan(ages. Notes Roy Morse, a former research chief at R.J. Reynolds: "As soon as Mr. Jacob funded" a scieiuific study, "i( was a privileged reladonship and it couldn't come mto court" because of legal rules protecting attomeys a week, for 1 10 weeks, 19 oui of 9''S mice got cancer — versus seven out of 651 con- trols However, the tumors weren't squamous-cell carcinomas, the kind usually seen in human lung cancer. And there was a 10''"o possibility the results were due to chance, whereas scien- tists prefer no more than 5<''o Even so. Dr. Henry says the study buili a "very strong case" thai cigarettes can induce cancers in animals. This was to be the first of several ex- periments. But lawyers from Jacob Medinger told Microbiological the project would go no further. "When a contract is canceled giver these kinds of results." Dr. Henrv says, "reasonable scientists might conclude the liability issue must have suddenly become apparent to this group." In fact, savs Dr. Kreisher, Ihe Council's former associate scientific director. Council law- yers "worried like hell" about it. Microbiological and the Council parted ways, but the tobacco industry goi plenty of mileage oui of the Microbio- logical mice In 1984. ihe Council issued a news release not- ing the absence of squamous-cell lung cancer in the lab's study. The timing wasn't coincidential: That year lawyers from Lig- gett. Phillip Morris and Lorillard began taking depositions in the landmark case of .Mrs. Cipollone, a New Jersey woman whose family claimed she had died of smoking-related squamous-cell lung cancer. .And ai the federal trial four years later, a witness for the defense said the fact that the smoking mice didn't get squamous-cell carcinoma (although some did get cancer) showed that "cigarette smoke has not been shown to be a cause of lung cancer" The witness also put Dr. Homberger's Syrian hamsters to good use. Smoking hadn't produced any more than "micro- invasive" tumors in the hamsters, noted the witness, toxicol- ogist .Arthur Furst. Dr. Homberger, regretting he had agreed under pressure to use this milder wording, calls this use of his report "baloney," adding: "It was cancer beyond any question, not only in our opinion but in the view of the experts who looked at the slides." Dr. Furst declined to comment. The tobacco companies succeeded in planting doubt in some jurors. "I didn't think it was proven scientifically that smoking caused her lung cancer." says juror Barbara Reillv She says that under pressure from other jurors, she and iwo other holdouts went along wiih a finding in favor of the Cipol lones, but managed to hold the damages to $400.0(X) instead of Ihe $20 million some wanted to give. The award was based on false safely assurances by cigarette companies in their pre- 1966 advertising. An appeals court overturned Ihe verdict, saying ihe plain- tiffs had to prove Mrs. Cipollone had relied on the ad claims. In December, the Cipollones withdrew the suit rather then retry il, citing the cost. The advent of this suil had coincided with the end of the Council's contract and Special Projects research, as well as the waning influence of Jacob .Medinger, which departed un- der pressure in 1984. Tobacco industry lawyers say privately that executives and attorneys grew fearful that the Council, though designed to deOect liability, would wind up incurring just that, because it could be portrayed as having breached a public pledge to do independent research. LEGAL LANDSCAPE SHIFTS In fact, by the mid-1980s, the industry had begun to face the very suits against the Council that it feared. In one, the Cipollone family's lawver. Marc Edell. sued the Council in 1984 on behalf of Susan Haines, the daughter of a lung-cancer viciim. To prove his claims of fraud and conspiracy. Mr. Edell has been trying to get access to the 1,500 Council documents the industry has kept secret bv invoking aiiornev -client privilege. Such privilege can be abrogated in case of fraud. and last year a federal judge in Newark, citing possible evi- dence of fraud, set in motion the process of making documents available to Mr. Edell The judge. H. Lee Sarokin. who had been hearing tobacco lawsuits lor a decade, wroie a ^ca!hlng opinion saying that the tobacco industry may be "the king of concealment and disinformaiion" A federal appeals court removed him from the case last September for failing to mainiain the appearance of impar- tiality. .A new judge will decide ihe critical is>ue of whether the industry must divulge any of the 1. 500 Council documens. In the meantime, plaintiffs' attorneys are pinning their hopes on the Supreme Court's ruling last June, The ruling, which grew out of the Cipollone case, said that although cigarette warning labels prevent smokers from bringing "failure to warn" cases, plainiiff? may file suiN alleging iha: cigarette makers intentionally hid or misrepresented tobacco'^ health hazards. This has led some to view the Council lor Tobacco Research as the key to recovering damages irom the industry. But doing so may not be easy. At the end of January, a state court jury in Belleville. 111., rejected the allegation thai companies had conspired to play down tobacco's dangers. Some say winning such a case may depend on getting access to sealed Council documents Also facing an uphill battle is the criminal invesiigaii.in by the U.S. Attorney in Brooklyn. N.V. Prosecutors are fac- ing siatute-of-limitations problems because the Special Projects unit was disbanded more than five years ago But what may prove the best protection for the tobacco industry is the readiness of certain scientists to read the evi- dence differently from the majority. Says Dr. Colucci. the ex- Reynolds employee; "The scientists can come from Mars, bu: no matter how obscure or how misbegotten, a- long as ihcv are willing to tell the scientific lie that "it's not proven." the tobacco industrv is off the hook" ■ 101 Mr. Wyden. This article makes it very clear that what Dr. DeNoble and his associate are talking about is not some kind of isolated case. What you are describing according to the Wall Street Journal, not exactly an organ of anti-business kind of thinking, has gone on on a number of occasions. So I'm going to take you back to the laboratory, Dr. DeNoble, and I understand that you would be more comfortable there. But I think that the American people need to know that publications like the Wall Street Journal are outlining some specifics, the kinds of things that you've described very clearly today. Mr. Waxman. If you'd yield to me because Mr. Wyden. I'd be happy to yield. Mr. Waxman. Some people may not have read that article, and I would recommend it to people to read it. But that article indi- cated a multi-decade period of effort by the tobacco industry to sponsor research and then to suppress research to make sure that what they knew didn't get out so they could always have that deniability. There was not only deniability. They used their research findings to try to make things look as if they were still open questions rath- er than concluded scientific issues. And so I thank the gentleman for, again, raising that article, and I think it's appropriate to have it in the record. Mr. Wyden. Dr. DeNoble and Dr. Mele, let's talk about this mat- ter of tolerance for nicotine. My sense is you all understand the science better than we do, of course. Tolerance implies when an animal or a human being gets a diminished effect with repeated doses of a drug, and it's one of the indicators of a potential abuse liability or addiction. Now, Dr. Mele, I guess maybe we'll start with you on this. Did your work find that rats developed a tolerance to nicotine? Mr. Mele. Yes, we did. Mr. Wyden. Now, we've got a manuscript that you wrote with Dr. DeNoble entitled. Development of Behavioral Tolerance Follow- ing Chronic Nicotine Administration. Mr. Chairman, I would ask that this be entered into the record as well. Mr. Waxman. Without objection, that will be the order. [Testimony resumes on p. 123.] [The paper follows:] 102 DEVELOPMENT OF BEHAVIORAL TOLLERANCE FOLLOWING CHRONIC NICOTINE ADMINISTRATION Paul C. Mele and Victor J. DeNoble It is well documented that tolerance develops to many of the effects of nicotine following its repeated administration. In humans, tolerance to the pressor and subjective effects of intravenously administered nicotine has been reported (Jones ^al_., 1978; Rosenberg et al_.. 1980). In rats and/or mice, tolerance develops to nicotine-induced convulsions (Behrend and Thieves, xJiJ;, electroencephalographic arousal (Hubbard and Gohd, 1975)^ and increases jn corticosterone secretion (Benwell— and Ralfour, 1979; Balfour, 19§p) and -*n- urinary catecholamine levels (Westfall and Brase, 1971). Behavioral iy, toler- ance develops to nicotine-induced suppression of locomotor activity (Behrend and Thieves, 1933; Falkenborn e_t al_., 1981; Hatchel and Collins, 1977; Keenan and Johnson, 1972; Morrison and Stephenson, 1972; Stolerman et al., 1973; 1974) and responding maintained by fixed ratio (FR) .schedules of reinforcement (Domino and Lutz, 1973; Dougherty et al_. , 1981; Hendry and Rosecrans, 1982). In contrast, feeding studies suggest that tolerance does not develop to the decreases in body weight and in food and fluid intake produced by nicotine (Baettig et al_. , 1980; Falkenborn etal_., 1981). For schedule-controlled responding. Domino and Lutz (1973) reported that .the first administration of 0.25 mg/kg.of nicotine suppressed lever pressing under and FR 15 schedule of water presentation for the majority of a Is minutes test session; recovery of control response rates occurred rather abrubtly towards the end 'of the session. Daily injections of nicotine resulted in a' progressive attentuation of the suppression. By day 15 of chronic dosing only a slight suppression of responding was evident at the start of the session. Dougherty _et al_. , (1981) reported a similar finding using an FR 50 .schedule^ These investigators also demonstrated that once tolerance developed, suppres- 103 sion of responding was reinstated in a dose-dependent manner by higher doses of nicotine (0.35 - 0.65 mg/kg). It is unclear whether the development of tolerance to the behaviorally disrupting effects of nicotine is due to altered concentrations of nicotine at the receptor (i.e., dispositional tolerance), to altered sensitivity of nico- tine receptors (i.e., functional/physiological tolerance), or to certaip behavioral or environmental factors (Dews, 1978; Schuster,' 1978). A variety of ■ * compounds have been examined with a procedure designed to separate the influ- — ■ - - -. - "^ ence of behavioral from disposftiona'l and/or physiological mecJftnisms of tolerance (Campbell and Seiden, 1973; Carlton and Woglin, 1971; Chen, 1969; Harris and Snell, 1980; Le Blanc etal_., 1976; Meltzer and Rosecrans, 1982; Murray et al_. , 1977; Woolverton and Balster, 1979). This procedure involves the chronic dosing of different groups of subjects either before or after the experimental session. The test performance of the group dosed before the session is therefore altered by the compound, whereas the performance of the group dosed after the session is not altered. Once tolerance develops in the group dosed before testing, the group dosed after testing is administered the compound presassion as a test for tolerance. If the before group Is found to be more tolerant than the after group, then it is implied that factors arising from the disruption of the test performance by the compound (and nol^he mere repeated administration of the compound) were instrumeataL-in detenntning the extent to which tolerance developed. - . , While the present study was in progress Hendry and Rosecrans (1982) reported using the before/after paradigm to evaluate nicotine tolerance in mice responding under an FR 25 schedule of sweetened oilk reinforcement. Acute nicotine suppressed responding in a dose-related manner (0.2 - 1.6 mg/kg/s.c). 104 A dose of 1.2 mg/kg of nicotine which reduced response rates to 151 of control levels was then administered daily until tolerance developed in the before group. Responding in the after group was not affected by postsession injec- tions of nicotine. When the nicotine dose-effect functions were redeterained while chronic dosing continued, the two groups of mice were found to be equally tolerant to the rate-decreasing effects of nicotine. These findinos -jfire Interpreted as indicating that behavioral variables do not influence the development of tolerance to nicotine. ^,- «.a , ^ The present study used the before/after dosing paradigm to investigate whether behavioral factors may be involved in the development of tolerance to nicotine. In rats responding under an FR 32 food schedule, tolerance to the disruptive effects of nicotine developed with chronic dosing. Behavioral factors were found to be involved in the development of tolerance to nicotine, since the before group showed a significantly greater degree of tolerance than the after group when comparisons were made at several times during chronic dosing and once chronic dosing was terminated. METHODS Animals Fourteen naive male Long-Evans hooded rats (Blue Spruce Farms, ^taoont, N.Y.), 90-120 days old and weighing 325-350 g at the start of the experiment were used. The rats were maintained at approximately 851 of their ad libitum weights which was determined from the last five days of a two week free-feeding period; weights were maintained by restricted feedings with Purina Rodent Chow approximately 30 minutes after daily testing. Animals were singly housed in wire mesh cages in which water was always available. Temperature and humidity 105 were controlled and a 12 hour light (0700 to 1900 hrs) - dark cycle was 1n effect. Apparatus Four identical oprant conditioning chambers (Lehigh Valley Electronics Ho. 143-25), each contained a sound and light attenuating cubicle (LVE No. 132-02K were used. . On, one wall of the chamber were two levers (LVE No. 121-05), a pellet receptacle, six cue lights (lever lights), a speaker and a house light. -r -^ _ ^ A pellet dispenser delivered one 4S~nigrbod pellet (Bio-Serve) with^ach opera- > tion. White noise was constantly present in the testing room and an exhaust fan mounted in each cubicle provided ventilation. Programming of experimental contingencies and recording of data were accomplished with the use of solid state logic module digital counter and cumulative recorders located in an adjoining room. . _ • .. i*". Procedure Rats were tested initially in daily sessions under a fixed ratio 1 (FR 1) schedule for either 60 minutes or until the food pellets were delivered, which- ever occurred first. There was no attempt to hand-shape the lever press response and all rats were responding reliably after a maximum of sexen days. Food pellets were delivered for responses on the left le\ter-only. Responses on the right lever had no programmed consequence but were recorded as a measure of general activity. After 2-3 sessions in which 100 food pellets were delivered under the FR 1 schedule, session duration was decreased to 30 minutes and the FR response requirement was gradually increased over a 2 to 4 week period until an FR 32 schedule was in effect. Responding under the FR 32 schedule stabilized after 4 to 6 weeks of testing daily, Monday through Friday. 106 stability was defined as the absence of any consistent increasing trends In response rates over 10 consecutive sessions. Once responding stabilized, sterile 0.91 physiological saline injections were given once or twice per week for several weeks to adapt the animals to the injection procedure. Dose-effect functions for {-)-nicotine (nicotine hydrogen tartrate. Chemicals Procurement Laboratories Inc.) were then determined. (-)-Nicotine (0.5, .1, .2, .4, .8 mg/kg as the base in saline particle) administered only once per week If the following criteria were met. A given day served as a baseline control, flay (day 1) if the response rate -toe— wat^day was within the rati^ of rates obtained over the immediately preceeding 5-10 days of stable responding. Saline was administered on the next day (day 2). If responding after saline remained within the range of previous stable responding, (-)-nicotine was administered on the following day (day 3). This sequence occurred once per week with the remaining two days serving as baseline sessions. Injections were administered s.c. in a volume of 1 ml/kg of body weight. (-)-Nlcotlne doses v/ere administered in an ascending order. A complete dose-effect function was determined for each rat and then repeated. (-)-Nlcotlne effects were expressed as a percentage of the mean of the preceeding baseline and saline data. These percentages were averaged to give mean saline and (-)-nlcotine effects for each rat, which were then averaged across animals to yield group functions.- Four weeks after the completion of the acute (-)-nlcotine ^ose-effect determinations the chronic dosing phase was begun. The rats were divided Into two groups (N=7 per group) and watched for overall session response rat. Saline was Injected twice per day for five consecutive sessions, with the mean of these five sessions serving as control data for the chronic dosing phase. For the next 30 consecutive days, one group of rats (the before group) received .8 mg/kg of (-)-nicotine before and saline after the session. The other group 107 of rats (the after group) received saline before and .8 mgAg of (-)-nicotine after the session. Injections occurred 10 minutes before and after the session. On day 31 of chronic nicotine dosing the after group received the .8 mg/kg dose of (-)-nicotine before the session as a test for tolerance; saline was administered after the session. The before group received its usual pre- session (-)-nicotine and post-session saline injections on day 31. Fonowing day 31 the before and after groups continued to receive their usual pre- and ■ post-session {-)-nicotine or saline injections except that testing occurred • only on Monday through Friday. 'On"Tve§ren^~tfie rats from both groups^received a single injection of .8 mg/kg of {-)-nicotine. Beginning on day 52 of chronic {-)-nicotine dosing the acute (-)-nicotine dose-effect function-s were redeter- mined. One day per week (Thursdays or Fridays) a test dose of (-)-nicotine was substituted for the usual presession injection, .8 mg/kg (-)-nicotine or saline, in both the before and after groups; saline was administered post- session to both groups. The substitute doses of (-)-nicotine were .2, .4, .8, 1.2 and l.d mg/kg adrainistered in an ascending order. Additionally, both groups of rats received saline presession as the substitute dose and .8 mg/kg of (-)-nicotine post-session the week before (day 45) and the week after the acute (-)-nicotine dose-effect function was redetermined. Chronic (-)-nicotine dosing was terminated after approximately 100 consecutive days. Si rats received their last dose of chronic (-)-nicotine on a Exiday. Following ter- mination of chronic (-)-nicotine dosing the persistence of tolerance was examined over the next four weeks. Animals were tested Monday through Friday with Wednesdays serving as baseline sessions, Thursdays serving as saline control sessions, and Fridays serving as (-)-nicotine test sessions. On Fridays .8 mg/kg of (-)-nicotine was administered presession to all rats. 108 Data Analysis Performance measures included overall session response rates and the time to complete the first FR. Response frequencies were also collected in five successive six minute bins to examine the within-session time course of (-)- nicotine's action. RESULTS " All rats had characteristic FR rates and patterns of responding {Ferster and Skinner, 1957). Food pellet__d£llvery was followed by a sh&t pause in lever pressing and then by a high response rate that was sustained until the ratio was completed and the next reinforcer was delivered. Figure 1 shows the initial dose-effect functions for the effects of {-)-nicotine on response rates (filled circles). The overall session baseline response rates (mean ± SE) were 2.43 ± 0.30 responses/sec for the before group and 2.39 ± 0.24 responses/sec for the after group. Nicotine produced small decreases in overall response rates at the lower doses (.05, .1 and .2 mg/kg) and more pronounced dose-dependent decreases at the .4 and .8 mg/kg doses (Figure 1, top). The dose effect functions for the before and after groups were similar. The typical pattern in the cumilative records following nicotine adminis- 0- tration was a suppression of lever pressing early in the session foFowed by recovery of control-like rates after the completion of several ratios. Occasionally, rates of responding following recovery exceeded control rates. The time of maximal rate reduction, therefore, occurred during the first six minute segment of the session. Response rates during minutes 0-6 were reduced in a dose-dependent manner and to a similar degree in both groups of rats "(Figure 1, botton, filled circles). Rates were decreased by 50 - 60% by .4 mg/kg of (-)-nicotine and were almost totally suppressed by .8 mg/kg. 109 Af-TER QO no z »o o 4fJ_^ _, ■/» 60 o s § 5 M U 0 < CSiUi J .4J.L6 UO 170 DO SO 60 40 20- 0 C S iU .1 z o A 4 H NICOTINE (mg/kg) Figure |. Effects of nicotine on FR 32 response rates during the total 30 minute session (top) and during the first sijc minutes of the session (bottom). The initial dose-effect functions were determined before chronic nicotine dosing. The redetermined dose-effect functions were determined beginning after 45 days of chronic nicotine^ dosing. . ^ The before group (left side) received nicotine chronica'Hy before the session. The after group (right side) received nicotine chron- ically after the session. Each point represents the. mean: of seven, rats; vertical lines indicate 1 S.E.. Points above C represent control responding; the mean is indicated by 100% on the ordinate. Points above S indicate saline administered twice presession as part of the redetermined dose-effect functions. no Overall session response rates averaged for the five saline control sessions preceeding chronic (-)-nicotine administration were 2.62 t 0.29 and 2.59 ± 0.23 response/sec for the before and after groups, respectively. .These control rates were similar to the control rates occurring previously during acute nicotine dosing (s^e aba«e). On day 1 of chronic dosing with .8 ng/kg of (-)-nicotine, the overall session response rate for the before group was reduced to 48.6 ± 9.3% of its mean control level {Figure 2, top). This reduc- tion was not significantly different from the reduction to 40.9 ± 7..1> of control found with the same dose_ of _ (-)-nicotine previously^administered acutely. Daily dosing with .8 mgAg of (-)-nicotii;e resulted >n a gradual attenuation of the reduction in response rate over the first 10 days (i.e., tolerance). From day 10 to ay 30 overall response rates were reduced to 80- 90% of mean control levels. For the group receiving (-)-nicotine after the session, overall response rates did not differ from control values over the first 30 days of chronic dosing. On day 31 both groups received .8 mg/kg of nicotine before and saline after the session. Response rates v/ere reduced by nicotine on day 31 to a significantly greater degree in the after group than in the before group (Student's t-test, p<,05). In the before and after groups, respectively, response rates were reduced to 90.6 ± 9. Si and 62.6 ± 7. 41 of control values on day 31. The reduction in response rate in the before group was significantly less than the reduction observed in the after gro^ (p<.05), suggesting that the before group was more tolerant than the after group to nicotine.' To determine whether tolerance had also developed to some degree in the after group, the effects 'of (-)-nicotine on day 31 were compared to those obtained during the initial dose-effect determination. The initial reduction in overall response rates to 40.9 ± 5.0% of control was significantly greater Ill o t— z o u UJ < U1 z o uo- 00- no- i«o < 5*0- ^ - 20- 0- uo CO 100- ■o o «0- «> 60 lU i 20 H 20 2J 30 iO i\ 60 72 — T r l» 90 1— ir 30 1 n B 20 2J SESSIONS CHRONIC (-)NICOTINE 0.8 mg/ko 45 jl 60 72 to 90 Figure 7^ Effects of daily administration of 0.3 mg/kg of nicotine on FR 32 response rates during the total 30 minute session (top) and during the first six minutes of the session (bottom). The before group received nicotine before and saline after the session; tjte after group received saline before and nicotine after-the session. On day 31 both groups received nicotine before and saline after the session. Each point is based upon the data from seven rats; vertical lines indicate 1 S.E.. Points above S represent saline control responding; the mean is indicated by 100% on the ordinate. Saline control points are the mean of five consecutive saline sessions which immediately preceeded chronic nicotine administra- tion. 112 than that found on day 31 of chronic dosing {p<.05). This indicates that some tolerance to (-)-nicotine also developed with postsession administration. In the before group, response rates during the first six minutes of the session on day 1 of chronic dosing were markedly suppressed to 7.7 ± 4.8% of control levels. This was similar to the response rate reduction to 3.6 ± 2.6% of control found with .8 mg/kg of {-)-nicotine administered a'cutelyr Mea t rates of responding increased gradually across sessions of chronic dosing jnd were relatively stable from sessions 21 to 30 at eo'^to 74% ^f control. Responding in the after group was unaffected by the postsession adimni strati on of nicotine except for several sessions in which rates were slightly decreased {days 7 and 9) or increased (day 26). On day 31, presession administration of nicotine reduced response rates during minutes 0-5 of the session in the before group to 68.1 ± 13.7% and in the after group to 17.7 ± 4.7% of control values; this difference, was statistically significant (p<.05). Nicotine produced slightly though significantly (p<.05) smaller decrease in response rates in the after group on day 31 than it did initially before chronic dosing; response rates were reduced initially to 3.2 ± 1.7% of control levels (Figure 1). For approximately 70 additional days the before/after dosing regimen was continued. Ov^r this period the overall response rate of both groups increased slightly and stabilized such that the before group's mean rate wa^at about 100% and the after group's mean rate was at abouf'lZCJF of control levels (Figure 2, top). Responding during the first six minutes of the session in the before group continued to be suppressed throughout chronic dosing with the average nicotine rate at about 80% of the mean control rate. The nicotine dose-effect functions determined during chronic dosing are presented in Figure 1 (open circles). Compared to the initial dose-effect functions, response rates in both groups of rats were decreased less by all doses of nicotine after chronic dosing. Attenuated rate decreases were greater in the before group than in the after group; the+r difference was most pro- nounced at the .8 mg/'.05- (ptO.O). Redetermination of the dose-effect functions revealed shorter 114 c «3 OJ E CM CO o ei 1 e> t O 1 41 1 -M 5 o • 1 1 OJ r-t o O ration se-eff ^ h~ *J o 1 cr> 1 trt -o CV 1 +1 1 ■» c -o 1 I •»- • cr * ■H +1 +1 +! OQ£ "^ o •.- i- •r— f-^ f^ CM CM C ■•-» +-> UJ C7 O CO CO t~. in . to t-l C^^^*'*~ c 3 . CTOJ-C^ CT ■ ^.ifi H- +1 t— 1 en precee red tw Ine ad ■M O ««- «»- ency i lo (Me o o 1. »3- • -fl o +1 ■» CM & o Cvi lO ro tely niste nicot 1 ■ to IT. "3 o T3 1 — t. vo vn to ir> <0-r- 1 J- "O o a> 0 cv +1 +1 +1 +1 -C T3 •'- GJ lO C •«7 OJ c M_ X vj O ro r*. 00 13 e o 1— -2. CO CM CM CM E to J- •r- CJ ., * 1 1 o c ■a 1-r -t-l 1 1 +1 1 1 -- in •'- to t: O fO CM aj o w CJ «/> u J= I— 4J -M JZ '-' «. CI tt> <• c fa Dl 1 o. I lO tt 0) J- «/> O o o o CO CM <• ir> ■o o •« C t- •«- (2u ■o ^ •0 *J -o v> o I R> CI M r^ OJ I. E = V. LU zr 5 .-• CM 1 c 4J e c o 4-. -O 1 1 ■fl ! -H Nico secor 1 ' CO t-l f base admin ssions (A «/) 0) V» OJ t- o CO +1 CM r-« CO ■H +1 an 0 tine e se a. u ( — ^ O r«. -(J- OJ - »— 4 5 CJ V» *J 4-> _J ci. _j ex: 1 O 3 ■^ _ -. a ■c c "S o 7£ UJ ZK. UJ ■° R o cr: .-• o; 1 — 4) tJ -r- «3 •^- o 13 o u_ UJ CO UJ •t- a; ••— C > H- i-t c o o o ■»-> T- 19 4J »- ta •!-> i_ 1 -^ "O c a> •»- z S F c •r- -C . 1— • M_ «J in lo 4-» •<"» LU %/% C lo I. ^ «*I C7I e Ol . .coo 4-» • «>«fl^ u 4J 0) c .— o X) -MO «■ "^ t— .^-~ •=■ us o I/O i- ^ •H o C <*- 19 C 0) s «/» ■.-^ c o «/) -^ •rs «/» c *«- ^ o e> o «/> 0) in •-• CO c •r- ♦-» W1 «/< t. CJ t- •^.«^ o c ttJ . . •♦-» lO o in 'CVJ O CM in csj- +« CM CM +1 CO .— I +1 .— • in •H CM CO ■H +; CM o •^1 CM cn CM +1 CO in ■H o CM •9 o CM +1 in cr> o O •—I .— I CO c •o 13 ■4J O' u c: o u x: u er c •o c ex O) . iini i/t o CM VO CO ♦I CM IJ ■ in •o (X OJ 3 O t- ▼- cr. «» f c ■•-> o o J3 I/t in O V ■•-> «l u > o. ■r" 4-> ■o =3 «> O t- V v v> *J c o •ir- o c •r- 01 E > t3 ••- c o •^- •4-» c o <3 u (i» •^- 116 latencies than observed initially in both groups at all doses tested (Table 1). At .2 -.8 mg/kg the redetermined latencies of the before group were not different from control, while at .8 mg/kg the latency of the after group was substantially lengthened compared to its control. Further, the two groups differed significantly from each other at .8 ng/kg (p<.05). The 1.2 and 1.6 mg/kg doses Increased latencies in both groups with greater increases observed in the after group. The persistence of tolerance as determined by weekly administration^ o^ .8 mg/kg of nicotine following the cessation of chronic dosing is slmwn in Figure 3. Response rates in the before group were reduced less than h\ the after group by nicotine during weeks 1 and 2. By week 3 response rates were reduced to a similar degree in the two groups by nicotine. Since both groups exhibited a small loss of tolerance each week over weeks 1 to 3, it was necessary for the before group to show a greater loss of tolerance than the after group In order for both groups to respond similarly to nicotine during week 3. Response rates were similarly or slightly less affected by nicotine delivery during week 4 compared to week 3, suggesting that a stable level of responding had been achieved with weekly nicotine administrations. Response rates were reduced less by .8 mg/kg of nicotine during weeks 3 and 4 than during the initial dose- effect detersii nations (filled circles), suggesting that some degrea^of toler- ance persisted in each group. ^ Following cessation of chronic dosing, latencies to complete the first ratio in the before group were lengthened less by nicotine than were latencies in the after group over all four weeks (Table 3); group differences were sig- nificant for weeks 1 and 2 (p<.05). Latencies increased in each group over weeks 1 to 3, although only the before group showed significant increases from U7 o ae Z o u 1/1 z o 0£ O wo- »0- 60- 40- 20 0 no-t DO 80- 60 40 70- 0- !♦ S A H'h" h r+i-r+1 rti rh rfl \t\ t]t » A SAL » A NIC k A B A SAL NIC B A S A SAL NIC » A t A SAL NIC . *- s rfl i\ rli f^ ^1-n ■■"t «ta B A K A B A SAL NIC WEEK 1 B A B A SAL NIC WEEK 2 B A B A SAL NIC WEEK 3 E A B A SAL NIC WEEK 4 Figure j. Persistence of tolerance to the effects of 0.8 mg/kg of nicotine on FR 32 response rates following cessation of chronic dosing- Response rates are from the total 30 minute session (top) and from the first six minutes of the session (bottom). The before group (B) had received nicotine chronically before the session; the after group (A) had received nicotine chronically after the session. The weekly testing sequence was baseline (Wednesday). saline^Thursday) and nicotine (Friday). Data are as percentage of respective control mean, indicated by 100% on the ordinate. Control for the saline (SAL) was the proceeding baseline session. Control for nicotine (NIC) was the mean of the preceeding baseline and saline sessions. The points to the left indicate the initial acute effects of 0.8 mg/kg of nicotine. Vertical lines indicate 1 S.E. 118 Table 3 Effects of .8 mg/kg of nicotine on latency (Mean ± SE) to complete the first fixed-ratio when administered once per week following the cessation of chronic nicotine. BEFORE Nicotine Administration Baseline Saline Nicoi;"r: Initial Week 1 16 ± 2 19 ± 6 13 ± 2 13 ± 2 10 ± 1 14 ± 5 17 ± 4 637 ± .79 29 ± 15 -, 49 ± 19 161 ± 65 ' 95 ± 27 Bt Week 2 Week 3 Week 4 14 ± 5 16 ± 5 25 ± 10 *• 1*. ■•• AFTER Nicotine Administration Baseline Saline Nicotine Initial 18 ± 2 17 ± 2 572 ± 54 Week 1 15 ± 3 16 ± 2 150 ± 58 Week 2 18 ± 2 16 ± 3 194 ± 62 Week 3 16 ± 2 19 ± 7 254 ± 77 Week 4_ 18 ± 4 16 ± 3 171 ± 64 119 week to week. Nicotine-Induced increases remained shorter than those observed during the initial dose-effect determinations. DISCUSSION The present results confirm the findings of previous studies which demon- strated that tolerance develops to the behavioral effects of nicotine following chronic administration {e.g., Ntorrison and Stephenson, 1972; Stolc;i.,.i, _^ ^ , 1974; Jones et£l_., 1978), including tolerance to the disruption of FR respond* ing (Domino and Lutz, 19734-0ou9l>erty -et al . , 1981; Hendry and Ros"fecrans, - -- - -^ 1982). These results extended previous findings by demonstrating that once tolerance develops to a given dose of nicotine, higher doses are required to produce effects quantitatively and qualitatively Similar to those. observed before tolerance developed. Thus, nicotine tolerance was seen here as a shift to the right in the dose-effect functions for measures of response rate reduc- tion and increases in latency to complete the first ratio. There is general agreeinent that tolerance is defined as a lessened effect of a given dose of a compound following its repeated administrationl and by the recoverability of the initial effects by administering higher doses (Krasnegor, 1978). Shifts to the right in complete dose-effect functions have not been reported previously In studies of nicotine tolerance. The alterations in the effects of ^icotine following chronic administration reported here satisfy both criteria^or iden- tifying tolerance. The major finding of the present study was that the development of toler- ance to nicotine was highly dependent on factors arising from the nicotine- induced disruption of FR responding, rather than on the mere repeated adminis- tration of nicotine. Thus, behavioral factors appear to be critically Involved in the mechanlsji(s) underlying nicotine tolerance. This is evidenced by the 120 finding that the before group was oore tolerant than the after group when comparisons were made after 30 days of dosing, and by the greater shift to the right in the nicotine dose-effect functions of the before group than the after' group when these functions were redetermined during chronic dosing. The tolerance reported here was not only dependent on behavioral factors stemming from nicotine-induced disruption of FR responding, however, since tht> after group also showed some tolerance. This finding suggests that the development of tolerance to nicotine under the conditions used here' involves two components. One component evident" only in the before group involves a behavioral adaptation of the organism to the disruptive effects of nicotine on schedule-controlled responding. This is consistent with the reinforcement density hypothesis which states that tolerance to the behavioral effecs of a - compound is more likely to occur when the compound interferes with an organism's ability to satisfy the requirements for reinforcement; that is, when exposure to the compound results in a loss of reinforcement (Schuster et al ., 1966; see Corfield-Sumner and Stolerman, 1978 for a review). The other compon- ent of tolerance more directly implicates certain adaptation mechanisms result- ing from the repeated exposure to nicotine; these mechanisms would be expected to operate in both the before and after groups. These mechanisms are typically thought of as alterations in distribution and/or receptor sensitivi^j[Levine, 1978). It is presently unclear how behavioral, dispositional and rraptor sensitivity factors interact in situations where behavioral tolerance occurs. In contrast to the present results, Hendry and Rosecrans (1982) concluded that behavioral variables do not influence the development of tolerance to nicotine. In their study, male mice responded under a FR 25 schedule of sweetened milk reinforcement. Tolerance to the rate-decreasing effect of 1.2 mg/kg of nicotine (free base) developed in the before group after 30 days of 121 dosing. Redetermination of the nicotine dose-effect function (.2 - 1.6 a»gAg) while daily dosing continued showed that the before" and after groups were affected similarly at all doses. Following cessation of chronic dosing, both groups lost tolerance at similar rates. Since factors such as age, gender and strain have been shown to influence the behavioral effects of nicotine in both rats and mica (3ryson et al_. , 1981; Hatchel and Collins, 1977; Morrison, 1968), and since the mouse has only recently been used in behavioral pharmacological studies involving schedules of inforcement, critical comparisons between this \^ study and this present onecannot be- made at the present time. "^ . Nicotine administered acutely decreased food-maintained FR 32 response rates in a dose-dependent fashion. The reduction in total session responding was due to a complete suppression of responding early in the session followed by a rapid recovery of control-like rates. Similar effects of nicotine on FR schedules have been reported previously in rats {Pradham, 1970; Domino and Lutz, 1973; Dougherty et al_. , 1981), mice (Hendry and Rosecrans, 1982) and squirrel monkeys (Davis etal^., 1973; Spealman et al_. , 1981). In contrast, Harrison (1967) reported that at doses similar to those used in the present study (.05 - .4 mg/kg), total session response rates were increased in rats responding under an FR 30 water reinforcement schedule. In Morrison's study, however, the daily session was 90 minutes in duration; the session (Ktern of responding consisted of.an initial reduction in respondi ng fol 1 owed %j^' 1 arge rate increases after 60 minutes had elapsed. In the present study, small Increases in rates were observed in some subjects following recovery of responding after nicotine administration. More consistent rate^ inert*.** v nay not have been observed here because test sessions were 30 minutes In duration. Pradham (1970) also has reported that nicotine increased FR rates during 60 minutes test sessions. /FR and continuous avoidance components alternated with- 122 in a multiple schedule, and not when FR occurred alone or as part of a nultiple fixed-interval fixed-ratio schedule, the nicotine-induced rate Increases were most likely due to an interaction between the water and shock conditions main- taining response. H- NICOTINE 0.8 mg /kg ' ^ O 120-j BEFORE LU 1 UJ 2 120 H AFTER 100- - • INITIAL « DAY 31 o REDETERAAINATION SUCCESSIVE SIX-MINUTE SEGMENTS 123 Mr. Wyden. Now, you have indicated that your work showed that rats did develop the tolerance to nicotine. You have indicated that this is one of the warning signals of potential abuse liability or addiction. I'm curious, my understanding is that you submitted this particular manuscript that I cited, to the management of Phil- ip Morris. You were seeking approval to publish the results. When you asked them for approval to publish those results — re- sults that to me seem important for the public — were you denied the right to publish them? Mr. DeNoble. Yes. Let me just say two things about that work first. We were certainly not the first to demonstrate nicotine toler- ance, that has been shown for a long time. This study identified certain behavioral parameters that contributed to nicotine toler- ance. So after conducting this study and asking to get it out, and sub- mitting it, we thought it was a relatively benign study because, al- though tolerance is a characteristic of many drugs of abuse, it is not necessarily a predictor of abuse, but it is a characteristic of many compounds. We thought it was relatively benign. The company saw it as very threatening because the word "toler- ance" was appearing at that time in the Diagnostic and Statistical Manual of the American Psychiatric Association as a criterion or an indicator of drug dependence. By using that criterion, they felt this work was too dangerous and one, would not let it go out, and two, did not want further tolerance work to continue. Mr. Wyden. So, in effect, what you are saying is because you were showing that these studies were showing a tolerance for nico- tine, this would establish a drug dependence, and this was again defined by a major health group, the American Psychiatric Associa- tion, and this would be damaging to them? Mr. Mele. Well, let me clarify. I think Philip Morris' assessment of the work was wrong. I don't think tolerance, again, identifies necessarily dependence-producing agents. It is a characteristic of many of those but it is not a single identifying characteristic. But they misidentified the DSM manual and made their judgment. Mr. Wyden. In addition to saying that you couldn't publish the tolerance paper, did the management there take other steps to cur- tail your research into tolerance? Mr. Mele. Well, they preferred that tolerance work did not con- tinue. Mr. Wyden. So you were Mr. Waxman. If the gentlemen would yield. Let's just get names, if we could, for the record. Who are these people you are talking about? Mr. Mele. Dr. Jim Charles was the one who came to my ofiice with the manuscript review request and asked me to write an in- ternal document, but that it could not go out because it dem- onstrated tolerance. And in his mind, or somebody's mind, it indi- cated a dependence-producing situation. Mr. Wyden. In terms of what happened after they said you couldn't publish the paper, did you communicate to the manage- ment, Mr. Charles specifically, that you wanted to examine wheth- er rats develop tolerance that would cause them to suffer physical 124 withdrawal symptoms? And then the management said, you are not allowed to do this work? Mr. Mele. Not specifically in that way. Our plan was with these data to pursue the role of tolerance and other aspects of nicotine use. To see how tolerance would influence self-administration, to see how tolerance would influence physical dependence. We weren't able to pursue those studies as a result of this study. Mr. Wyden. But the management said that you could not pursue that additional work? Mr. Mele. I don't recall specifically talking to them about those specific studies, but just tolerance in general was something — was not something they wanted pursued. Mr. Wyden. Dr. Mele, do you know Dr. Kathy Ellis? Mr. Mele. Yes. Mr. Wyden. Now, Dr. Ellis testified about the tolerance issue at the hearing on April 14th, when she appeared with the CEO of Philip Morris, Mr. Campbell. Now, let me read you what she said to our subcommittee then. She said, and I quote, "The strict pharmacological definition of addiction involves three different criteria: they are intoxication, physical dependence, and tolerance. And to my knowledge, there is no evidence that nicotine or cigarette smoking plays in any of these definitions." So it seems to me what Dr. Ellis did was, in effect, deny the very work that you did at Philip Morris. Mr. Mele. I don't know what access she had back then to our work. I would assume currently, in her current position, she would have been aware of it. So, yes, she was not recognizing that, nor recognizing a large body of literature on nicotine tolerance. Mr. Wyden. Ajnd she was a colleague of yours at the Richmond research center, isn't that correct? Mr. Mele. Correct. Mr. Wyden. Mr. Chairman, again, I think what we have here is another example of a serious misstatement by the Philip Morris Company, contrary to the findings of Dr. Mele's report. Dr. Mele, of course, has indicated that he was a colleague of Dr. Ellis' at the Richmond research center. What Dr. Ellis said to the subcommittee is that Philip Morris has no evidence that nicotine causes tolerance. So I would hope that be- fore too long we ask for further information on this matter, because it appears to me to be yet another serious misstatement by Philip Morris. Mr. Mele. Congressman, I would just like to add, and clarify that. Kathy Ellis did not work in our laboratory, she had her own laboratory, but we were part of the same division. Mr. Wyden. Mr. Chairman, I yield back. Mr. Waxman. Would she have had access to your work? Mr. Mele. In the beginning, I don't know. I don't think so be- cause it was kept very secret. Although at one point, once we were allowed to present our data to the division and to the rest of the research center, she would have been familiar with it. Mr. Waxman. OK. Thank you. Mr. Wyden. Mr. Chairman, I yield back. Mr. Waxman. Thank you, Mr. Wyden. Mr. Kreidler? 125 Mr. Kreidler. Thank you, Mr. Chairman. You have said that the purpose of the analogue program was to develop a nicotine ana- logue that had the brain effects of nicotine, but not the heart ef- fects, if I recall correctly. Was the initial idea, as far as you under- stand, to develop a safer cigarette? Mr. DeNoble. That's correct, yes. Mr. Kreidler. Where were the analogues developed? Mr. DeNoble. They were synthesized at the Richmond center, the organic laboratory. Mr. Kreidler. And do you know who headed that clinical group? Mr. DeNoble. Dr. Jeff Seaman headed the group. Chuck Shevdarian was also another chemist in the group. Mr. Kreidler. They were at Philip Morris then? Mr. DeNoble. They were back in 1984. I don't know where they are now. Mr. Kreidler. OK. It is my understanding that part of the ana- logue testing was done in Rochester and part in Richmond. Could you tell us what the relationship between the work in Rochester and the work in Richmond was? Mr. DeNoble. Yes. The analogues would be synthesized in Rich- mond, Va., and they would first be sent to Rochester, Dr. Leo Abood's laboratory. What Leo would do would be screen the ana- logues in a receptor binding assay, to see whether the analogue rec- ognized the nicotinic receptor, you know, in brain. He was using torpedo fish membranes, but it's the same thing. At that point we would determine whether or not it had the same — whether the receptor said, gee, you look like nicotine. We would then get some data on whether or not it produced contrac- tions in guinea pig ilium, which would be a predictor of cardiac ac- tivity. At that point, that data would be sent back down to us in our laboratory, and we would screen the compound. If it was good data, if it met the criteria of good data, we would screen the compound in our tests in animal behavior to determine whether it looked like nicotine. Mr. Kreidler. So it was, at least, the tobacco version of nicotine that was causing the cardiovascular type of reaction then, as far as you could determine? Mr. DeNoble. I'm not sure I understand the question. Mr. Kreidler. The cardiovascular responses of nicotine were as- sociated with the tobacco form, and there were perhaps some other forms of nicotine Mr. DeNoble. There is a couple of different forms of nicotine, but the presser effect you get is with the L-form of nicotine, yes. Mr. Kreidler. I see. I would like to distribute Exhibit 18-A, which was part of the 1980 memorandum explaining the work of the nicotine receptor program in Rochester, Mr. Chairman, if that is all right? Mr. Waxman. Without objection, that will be submitted for the record, and identified as the next exhibit in sequential number. [Exhibit 18A follows:] 126 :'! libit^ T«l I 43 PHIUP MCRRIS U. S. A. I mn-oFf I cc com espoNoeNC £ neiiii««». Tiiiiiit Or. R. I. Sclifama -C0NFID£3^T J. I. Charlas il>lCr"'- • i*^: "1; . Mi:* '•• •'••-I '..;,■•-'• ••*- -■^■.•— •«» . -i^ «, »^ .; ^., . *^~3'.^ •^^. _ ,-r^- Hlcotia* Is a powarful pharmacolofictl aivnt wttk -. ." .BUltipl* sic*s of action aad «*r b« tha aott {■poftant .:'- „■ CMBoaaat of dfarattt smoU. Klcotlaa aad aa undaritandinf of itj proptrtlas ara laportaat to tha continuad wall--' balnt of OUT cijarttt* bujlnass slnca this alkaloid hai* baaa cltad oftaa as "tha rtasea for laoklai" aad thaorlaa hAV booa advaacad for "aicotlaa titratioa" by tha laokar.' Nlcotln. _ij kaowa to hava affects oa tha cantral aad paripharaX aarvous systaa as wall, as iafluaaciaf aaaorr, loamiag, pala parcaptioi respoasa to strass aad laval of arousal. - -•-.— '-r.. :• . -''-'"-' It is aot suprisiaf that a coapouad with such 'a aultitua* of af facts would hava propartias which ara considarad - -jt.^ ■ undasiribla by tha anti-iaoking forcas. Claias ar« aad* ' • that Bicotino ia cigaratto saoka can iaduea chast paia aad irrafularltias ia cardiac rhytha whan a parson vltA a eoaproaii cardiovascular systaa saokas or whan parsoas with cardiac disaasa ara axposad to high concaatratioas of sid* strata saoki . . '. ■ . . -- <«y ••••• .^-... • •. _. -.^^.-j •••5...-,; ' For thas* raasons our ability to ascartaia tha structural faaturas of tha alcotia* aolacul* which ara raspoasibls for its various pharaacologieal propartias caa laad to tha dasign of coapouads with anhaacad dasirabla propartias (caatral ;. norraus systaa affacts) aad aiaiaizad suspact prep«rtias ' -^ ' (paripharal narvous rystaa affacts). Thara ara aaay opportunit ^for acquiriag propriatary coapouads which caa sarv* as a fira fouadatioa for. saw aad iaaovativo products ia tha fatura. --^ ,.: :: j-y^'r-*:-\::-:: ■. • -.■ . Tha abova is aa axcarpt froa an introduction to tha aicoti prograa which I wrota oa 12/1/78. My views hava net significas ehangad siaca that tiaa. I baliava that aicotin* doas play an iaportaat rola ia tha saoking process. How iaporcaat that rola is reaalas to b* determined. Tha receptor program at tha University of Rochester is an integral part of tha aieotir.a prograa and can ba justified in a nuabar of ways. Aa initial thought was that Dr. Abood would hava tha kaowledg* and tachniq to perfora screening of nicotine analogs for G4S activity. Tha synthesis group has created a nuabar of iatarasting conpoun which are now being screened by Or. Abood. Ia addition Or. Abood was to carry out fundaaoneal studies on sites and aachanisas of action of nicotine in tha brain. That research is in progress. Z^^ } j:'..^ ^^oama ■■ 127 I lat'la on an additional matting with Dr. Abood and [h't. S&fldars, Saaaan, and Chavdarian during Dr. Abood' s last visit. I foufid tht discujsions tc b« usaful and fait t.HaC Dr. Abood was doinj loaa vary intarajting work which can ultisiataly b« of banafit to Philip Morris. I also utilizad Dr. Abood as a consultant during that visit and ht oaut joaa good sug|«stioas and I thought tha tiaa was wall spent. la suaaaT7, tha aicotina racaptor program at tha Univarslty of Rochastar is an Intagral part of our ovarall aicotlat proft«*- ^* combination of basic rasaarch on tha ■_ pharaaeolofy of tha nicotina racaptor coabinad with tha capability to scraan nicotina analogs for CNS activity coBplanants our intamal synthatie and bahavioral afforts ia tha nicotina proyram. Tha program is Justlflad ia my viaw °«s a dafansiva rasponsa to tha anti-saoking foreas criticisms of nicotina and also as fundamental rasaarch into tha natura of our product and how it af facts our customors, tha smokars. This antira program involva? complax tachnological pro"bla«i and tha banafits to ba darlvad from tha program will not ba raalixad iaaadiataly. Indaad tha banafits will nacossarily . b« of a long-tara natura and may hava diract baaring on our markat position in a 10-lS yaar tiaa framm. Howavar, if wa do not hava tha basic rasaarch rasults this program will provida wa will not bt ia a position to raspond if and whan tha prassuras to changt do occur. JlC/mro -A*«fa 128 Mr. Kreidler. I find the first sentence of the memo particularly interesting. It states, "Nicotine is a powerful pharmacological agent with multiple sites of action and may be the most important com- ponent in cigarette smoke." This certainly paints a different picture of nicotine than the picture painted by the tobacco company execu- tives 2 weeks ago. Do you have a response to that? Mr. DeNoble. This statement, that it is a powerful pharma- cological agent, justified much of the research at the research cen- ter, I mean, the whole thrust of research of this program was work on nicotine not as a flavorant but as a pharmacological agent. It was our belief back then and my belief today that nicotine is an agent in cigarette smoke that is reinforcing, and it is a contribu- tor to why people smoke. That was the premise of our whole pro- gram. Mr. Kreidler. Now I would like to show Exhibits 19, 20, and 21, which are the pictures of rats in the analogue program. Mr. Kreidler. Doctor, would you please tell us what we're seeing in these pictures here? Mr. DeNoble. The poster on, I guess, my right, is a picture of an animal who has been anesthetized. And we are placing a canula, basically a needle, into different areas of its brain. The work that came out of Leo Abood's lab in Rochester indicated that if you placed nicotine directly in the brain, that the animal would have a particular behavioral response. And he went on to show, very elegantly, that effect was only produced with nicotine- like drugs. So we went back to our lab, cannulated animals to see if we could replicate and extend his findings and use it as a tool. The center picture is an animal who is reaching up to grab a pellet of food. He's got a brain canula, and we injected 5 microliters of nico- tine into his brain, and that's the same animal in the last photo- graph. You can see he is not responding to the food pellet. That syn- drome was called prostration syndrome. It was unique to nicotine. The animal becomes splayed, he becomes unresponsive for about 12 minutes. We went on to characterize that behaviorally, to show pharmacologically that it was an effect of nicotine on brain recep- tors. And that was a primary screening tool in our laboratory in the nicotine analogue program. Mr. Kreidler. Did you succeed in developing a nicotine analogue that would have the effects that nicotine has on the brain but does not have nicotine's effect on the heart? Mr. DeNoble. We did identify a series of analogues that met our minimal criteria for that effect, yes. Mr. Kreidler. Did Philip Morris ever use the analogues, to the best of your knowledge? Mr. DeNoble. No, sir. I have no knowledge of that. Mr. Kreidler. Do you know why not? Mr. DeNoble. No. We had several discussions about what we would do with it when we found it. And once we found it, nothing was done with it. The indications to us were that we'll take a wait- and-see attitude. Quite honestly, I think that scientifically that was an interesting finding. It could be conceived of as a major breakthrough, in my 129 mind, to disassociate brain effects from peripheral effects. But they never chose to follow that to the next logical scientific conclusion. Mr. Kreidler. Do you have any suspicions that level of research might be something they couldn't keep control of at some point in the future, that might have influenced whether they wanted to fol- low up on these analogues? Mr. DeNoble. No, I don't believe that. I think that the research facility was quite capable of following up on those analogues and doing a lot more work. And, quite frankly, sir, it may have been done. I am just not aware of it. Mr. Kreidler. I see. Smoking causes over 150,000 deaths each year from heart disease. Your work at Philip Morris shows that there might be a replacement for nicotine in cigarettes that would duplicate the brain's effects of nicotine but would not have nico- tine's effect on the heart. Yet, after you succeeded in developing an analogue, Philip Mor- ris' response was to put your discovery on the shelf. Presuming that no follow-up was done, does that trouble you? Mr. DeNoble. Well, sure. I mean, it troubles me a lot. To the best of my knowledge it was put on the shelf. It may not have been put on the shelf. Also, recognize that there is a large leap from our laboratory, from Rochester data, from in-house data, and going into a product. I mean, this analogue would have to go through many, many, many other tests. And I think from a scientific point of view, it was dis- turbing that they didn't choose to do those other tests. At least, we have no knowledge that they did. Mr. Wyden. Will the gentleman yield? Mr. Kreidler. I yield. Mr. Wyden. I thank my colleague. Let me just be real brief Wouldn't it have been in the public interest right at that point to aggressively have pursued this new research? I mean, here we have a situation, my colleague has basically said that the evidence looks to us like it was put on the shelf, a situation where smoking causes 150,000 deaths as a result of heart disease. My colleague has pointed out, you know, here is an opportunity to really do something to help people. Wouldn't it have been in the public interest to have aggressively done the research right at that point, so that you and other scientists would be able to tell us today what you know about it? Mr. DeNoble. Yes, sir, absolutely. Mr. Wyden. I thank my colleague for yielding. Mr. Waxman. Will you also yield? Mr. Wyden. Certainly. Mr. Waxman. I thought one of the ideas of scientific inquiry was that you go as far as you can go and then other scientists can pick up from where you left off. But if this information is never made public, or never given to other scientists, there is no way that some of these advances can be pursued. And I'm hoping that we can follow up further this trail because this is a new revelation that perhaps cigarettes maybe could have been made healthy, but at least could nave been made in a way that would have avoided the deaths from the heart problems that came from the nicotine. 130 We've always heard about nicotine as an addicting substance, but now we're learning nicotine is a problem that affects the heart as well. Could you give us the name of the compound that might have been a successful analogue? Mr. DeNoble. I'm not a chemist, but I can give you — it was called two-prime methalnicotine. Mr. Waxman. Thank you very much. Mr. Kreidler, did you want to pursue further questions? Mr. Kreidler. I think my time has expired. Thank you very much, Mr. Chairman. Mr. Waxman. Dr. DeNoble, did you look for other substances in tobacco or tobacco smoke that have effects on the brain? Mr. DeNoble. Yes, we did. In late 1981, early 1982, we raised the question of whether or not there could be other things in ciga- rette smoke that may have biological activity. Mr. Waxman. And what did you look at? Mr. DeNoble. What we did was we did basically a computer search of the components that are identified in cigarette smoke. And we looked through the list and we found — a compound that stuck out in our mind was acetaldehyde. This is a compound that has a reasonably high concentration in cigarette smoke; it's a high- ly volatile compound. And it was really kind of serendipitous because the work — ^you really wouldn't think this is anything hot, but I had just come off of doing post-doc where I recognized that acetaldehyde is a major metabolite of alcohol. And there were some theories in the 1970's that this metabolite would react in the brain with other chemicals to form other chemicals, and that may be the basis for alcohol ad- diction. Well, that theory did not hold up. But what struck me was — and it didn't hold up because your liver is making acetaldehyde, and by the time it gets to the brain, it is all chewed up anyways — ^but here you have a situation where aldehyde is going right into the lung. And there are only three ways to get things into the brain quick- ly. One is you put it in the brain, the second fastest way is you put it in the lung, and the third fastest way is you put it in the heart. So it struck us that this compound was getting in the brain, maybe it's doing something that has reinforcing effects. Mr. Waxman. And I want to show you a chart, which I'd like to have entered into the record, without objection, as Exhibit 22. It's made from a slide of your acetaldehyde work. [Exhibit 22 follows:] 440 360 40 131 600 . 520 X 1 I 280 200 1 no 1 MCOTf«UflAg) to 8.0 &0 0 8j0 ACeTALDEHYDE(>ioAg) dJO 0 &0 8J0 ao 132 Mr. Waxman. Will you tell us what kind of tests you did on acet- aldehyde and what the graph represents? Mr. DeNoble. This work was reasonably late in the development of the acetaldehyde self-administration procedures. We dem- onstrated that acetaldehyde, like nicotine, would maintain behavior and would be reinforcing in rats. This particular slide looks at the interactions between acetal- dehyde and nicotine. If you give a rat — if you would focus on the second bar where it has 8.0 and below it there is a zero, that is 8 micrograms of nicotine. And that will maintain about 100 injec- tions per day. If you go now to the fourth bar, again, the zero and the 8, that is 8 micrograms of acetaldehyde. That maintains, it looks like, around 230, I guess, injections a day. If you now put them together as in the first, third, and the fifth bar, they interact, and the ani- mal presses a lot more than it would have pressed for either one alone. This was a demonstration that nicotine and aldehyde combina- tions are more reinforcing than either of the drugs alone. They interact behaviorally. Mr. Waxman. That is a significant finding, isn't it? It confirmed that if you have cigarettes, not just with the nicotine but the acet- aldehyde, that it is even more addictive than nicotine by itself, and there is this reinforcement. Is that a correct statement? Mr. DeNoble. It leads to some interesting speculations about the role of nicotine and aldehyde in cigarette smoke. Importantly, very importantly, all the work that we did, most, if not all of it has been replicated by other researchers around the world, even though we had not published it. This work has never been replicated, so I think we have to look at this as really a scientific inquiry. But it does raise some fas- cinating possibilities. Mr. Waxman. Well, it means that even for animal tests, we're looking at the addictive nature of nicotine, that nicotine with acet- aldehyde is even more of a reinforcer, more of an addicting sub- stance, is that in combination? Mr. DeNoble. In this experiment, that is correct. Mr. Waxman. And Philip Morris, rather than encouraging this kind of finding to be made known to the world, what did they do? Mr. DeNoble. This was a very high priority project. We were not allowed to even discuss this outside of the research center. We were permitted to give talks on nicotine, but never on acetal- dehyde. Mr. Waxman. And this has never been published before? Mr. DeNoble. No, sir. Never. Mr. Waxman. I want to leave the area of the work that you did, the two of you, on nicotine and acetaldehyde. I want to ask you about the work of other scientists that you may have observed or known about at Philip Morris. I begin with the dangers of exposure to environmental tobacco smoke. As you may know, the entire tobacco industry, including Philip Morris, maintains that exposure to environmental tobacco smoke is not a health risk. Dr. DeNoble, while you were at Philip Morris, was anyone conducting research on the effects of exposure to envi- 133 ronmental tobacco smoke or what is also known as side-stream smoke? Mr. DeNoble. Can you give me a moment, please, Sir? Can I take a moment? Mr. Waxman. Yes. [Mr. DeNoble confers with Mr. Mele.] Mr. DeNoble. We are aware of a research project using a plant called Tradesscantia. And the goal of that project was to look at the effects of side-stream smoke on the plant's ability to either repro- duce or repair itself. Mr. Waxman. Do you know who was conducting that research project? Mr. DeNoble. I don't know the specific name. It was under the control of Dr. Jim Charles in the biochemistry department, but I cannot remember the specific scientist's name. Mr. Waxman. OK. Dr. Mele, do you have any information on that? Mr. Mele. It was, I believe, Dr. Terry Loo, or Terry Woo, a fe- male researcher. Mr. Waxman. And what do either of you know about this re- search? What can you tell us about it? Mr. Mele. I remember one briefing of the biochemical research division where slides were presented of these plants in closed con- tainers. The plants exposed to the side stream smoke were seri- ously debilitated, wilted, and so forth. Plants exposed to — it was ei- ther mainstream smoke or fresh air — I believe there was a com- parison between side stream and mainstream — were less debili- tated, indicating that side stream smoke was more toxic to these plants. Mr. Waxman. Toxic. Did it create any genetic changes or did it simply kill the plant? Mr. Mele. Well, just the way they looked, just visually they were wilted and falling over and that sort of thing. Mr. Waxman. And what happened to the work that you are de- scribing? Did Philip Morris allow this important work to be pub- lished, or do you know whether it suppressed publication of that? Mr. Mele. My understanding is that work stopped. If it contin- ued, we didn't know anything about it. Mr. Waxman. Let me ask you about other tests sponsored by Philip Morris on the effects of painting components of tobacco smoke on the skin of mice. Tell us about that, whatever you know about it? Mr. Mele. I'm just aware that those studies were performed. Dr. Jim Charles worked with another scientist before I was there, I be- lieve. Those studies were more or less commonly discussed in the cafeteria. I never saw any data or evidence of those studies, and I don't know what happened to those studies. Mr. Waxman. Dr. DeNoble, did you ever see a presentation on this research? Mr. DeNoble. Yes, I did. The research was conducted at a con- tract laboratory facility outside of Philip Morris. The purpose of the study was to investigate various components of smoke that had been liquefied on mouse skin. It's a test for carcinogenic activity. 134 I'm not a teratologist, and I can't interpret that data, but I do re- member seeing the slides and hearing the presentation. Mr. Waxman. And what did the mice look like? Mr. DeNoble. A lot of the mice had fairly open lesions and wounds from a variety of substances placed on their skin, but I do not know what those substances were, other than they were smoke components. Mr. Waxman. And would nitrosamines have been involved in that? Mr. DeNoble. Nitrosamines? No, that was a different research project. That was Dr. Jim Charles' research project. They were looking at the effects of nitrosamines on the lung's ability to repair itself using a chromatid exchange procedure in the lung. Again, that is out of the area of my expertise. I attended some meetings and presentations, but I couldn't give you the Mr. Waxman. And do you recall what results there were from these nitrosamine studies? Mr. DeNoble. In general terms, that the lung's ability to repair itself was impaired after exposure to various nitrosamines. Mr. Waxman. An issue that has received some attention recently is whether the FTC — Federal Trade Commission — test method ac- curately measures the amount of nicotine consumed by smokers. At our March 25th hearing. Dr. Kessler said that this test method doesn't accurately measure actual consumption because the tobacco companies can manipulate the test. One example of manipulation he cited was putting ventilation holes in cigarettes which are then covered up by the smoker's lips or fingers. Did either of you observe any research conducted by Philip Morris on this issue? [Mr. DeNoble and Mr. Mele confer.] Mr. DeNoble. There was some research that was done and, again, I'm a little vague on the specific results of the research. At the time there was a cigarette on the market that either had ven- tilation holes or tubes inserted — not tubes, they were tube-like — what do you call it? Mr. Mele. Channels. Mr. DeNoble. They were channels inserted in the filter, and that would allow a smoking machine to smoke the cigarette with- out crushing the filter. Research at Philip Morris was done where they actually observed, they filmed people smoking and they no- ticed that the people would actually crush these channels as they would put the cigarette to their mouth. Not everybody would do that, but there was evidence of a fair number of smokers delivering a lot more of the smoke phase to the lung than would be delivered in the machine. Mr. Waxman. Do either of you recall the names of any of the re- searchers? Mr. DeNoble. The name was Frank Ryan, Francis Ryan. Mr. Waxman. And what they determined was that some smokers did cover up the ventilation holes with their fingers or their lips, so that the FTC tests which didn't do that might have had a dif- ferent result than what was the actual consumption of the smoke in the individual involved? 135 Mr. DeNoble. That was the general conclusion. That work was also under the control of Dr. Bill Dunn. Mr. Waxman. Thank you. Mr, Bliley? Mr. Bliley. Thank you, Mr. Chairman. The only thing I'd like to point out, we had a lot of talk today about contracts. I have an employee agreement here by Abbott Laboratories, and I'd just like your unanimous consent to insert it in the record and to read just a little bit of it? Mr. Waxman. Without objection, it will be received for the record. Mr. Bliley. It goes on to say what the employees will do, and the second paragraph, it says, "All memorandum, notes, records, reports, photographs, drawings, plans, papers, or other documents made or compiled by or made available to employee during the course of employment with Abbott, and any copies or abstracts thereof, whether or not they contain confidential information are and shall be the property of Abbott, and shall be delivered to Ab- bott by employee immediately upon termination of employment with Abbott." So I just mention that to say that it's not uncommon to have contracts of confidentiality with employees. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bliley. Mr. Wyden? [Testimony resumes on p. 147.] [The employee agreement referred to follows:] '\ .*. 136 IMFLOYEG AOREEMENT ACRE£MEhT md* b«t«r(tn AB^TT UBOJUTORJM ("ABBOTT'), md lh> untlfnunrJ cr.p:jv« ("DJPLOYEE"). VrlTNESS lh« fo)lc*in|; EMPLOYEE U tfptti by ABBOTT in ■ potltjon of truK «nd conii(J4?L0VE£ lo miJie dli<»writi, rnvtmicwi. arpro^>ninty oi ■ outovilicMi uicAil to AB30TT or its lubtidJirtd of afniUitd compiTMi. U a 10 the mutvil befltfit of ABBOTT wd EMPLOYEE th«t ABBOTT jrouct m njhrj n C^ficJci ijil Inforauiion vi4 obtiln th« benefit ef ditcortrir*, s>witloBS, baprovemend. ^nd innovnions dev«luprd by iti enploycet In toftiidertUon of the ixteution of thii A|r»«ment by other key onplo>e:i ii) ADBOTT. ik mutcal >.jffe- menu Mnuined herein ind in conB4cnUon of the preunt and future ein?loy.'V.:i of ilic LMPLOYkk b/ AliUOTT itii^ieel: 1. "Cocfjdentil Infometlon** ihiD tatin mcihodt, proectKi, ttchniquei, diup priulictt. rvrrejhiff. .am- pound*, ccmpoiibonf. orti/ilani, equipment, texuch deti, clinietJ end phiimecvtugiuai diii. irtnleeiinj jni uiei infoimitJoa. p«riomwJ diii, cuHcxner llitt, finencW tfeU, pUm irvd ill other knuw-lio*' tnd iradc u;::cii vhich ire in th< pooetsion of AB90TT, dr any of iu kibKiiivict or iffSitted cvrnpinicj. ^nd Mrhioh hjve noi bMa pt)b{Iihed or ditidoted to the |enenl publk. 3. AQ diccovertei, invenitoni, improvtmcnti. end innovitiofti, vhethei pitcni3b>e ur iioi (ineludii'-i jH liju lai recordt p*itamln| ihonio}, whkh EMPLOYEE miy int«nt, diwcver, ori^sie. or cunL-eisre diirf\{ ihc 4l»ao«il:i, mveiiiimi. iinpruvtmerta. 0( lnr)o%ationt 10 ABBOTT. 4. EMPLOYEE (hall et&cn tA ABBOTT EMPLOYEE'i entire light, title, and inicrsti lO uny of the di» eovirtei, inventiCfli. improvementi. and innovitloni dewribed In Pinirapl; 3 of (hj Aireertcii and any re'ettd \JS. or foreiin patenti and patent applioiCJons: shJii exicuu my iAittumenli cco»id«rn wuniieciion with uch •sirvity and ihit] pay to EMPLOYEE reuonable cotnpeniitiofi for my tlmi ipeni by E.MPLOYKk pjr'otmiiii fuch dwtiee It die requax of ABBOTT after termination o(.|mp1oynient. 5. EMPLOYEE Aill net, without the written toneeni of ABBOTT, dut«n the leim of cmp!<->inei'i wnl; ABBOTT or ihereifiei, ujt for Ihe benefit of E.MPLOYEE or otheri, oi diselOK to oihere. iny CvnildcrUjI InformiUon obtained during the eourie ofeinploynwr.l »itli ABBOTT. 137 AUtiori. Tor t (xnoa oi oni ycir aA«r ih* i«imiPiilop ef trnplojrmtni vlih AHOTl, •■'■^t^ dinciiy oi IndjrecUy, fot tht btntfli of EMPLOVEE or othirt. in toy icL-vlty « titipiovmeni c th« filihfvil f«rfomi»ji(« gf uhl(A 11 Muld b« rauontUx iniinptKd ihii EMPLOYEI weuM ^ r«qulre4 Or t\f*)rrr4nt wiih ABBOTT. Thl>rov»n»n( ihtJ roi U csnilru(4 10 limit Ifi »Ay wfy £MPtOYES'i obl>|itX>« txic lo UW or dltclOK Canj'id«ntltl Ir^Tormiiioit ti iti fort^ ir Puigrtph 5 «bovi. 7, This A|re«iix3i jhill rol be con»irye4 (o Itm.'i In itiy w*y my "ihop riihu" or otl'tr conmcr ".i» or conliidcil tighii of ABBOTT, ir or tc iny dlKOvixin. ln«r\iion», Imprjwncr'i. ini Inrtovitom. tnd In or 10 iny CoafWentJiI InfonriUon which A8BCTT Kji or miy Mvf by >1nut of EWtOYEE'i »mpio>n>cr.( e. 1 1 ii undenlood ih.it t.iher ABBOTT or EMPLOYEE miy \tm\na'^ the ersploynetti t«llt.or.^^.ip ti »ny iitn«. Upofl nicS terirtniilon EMPLOYEE %hk\\ idvlM ABBOTT of the num iftd »dJr»$t oi" LMPLOYEEl ir.(en<:e4 (\)tjr« employtr. Th» pjfilei' oblifjiiow onder ihrt Atr«rt-itjM ihiU turvivt t«6*i Uimmiior. of employr^M. 9, If iny proviiioo or ptoyiiionj of »hli A|f«ment tfiiJI b« held to be wn^nforctibie by iry court, 'J-,* it- ffiiklnj ptxTvuJoBt iKjII b« uniiTecud *nd ihilf ccnl!nue in fjll fort* irtd enVti. Tfcu Agrtenwnl ihill In;*:* (0 the btntm of wd b* blfwJ;»H upon ABBOTT, in Wiccittori v\i uiijni ir.d EMPLOYEE. EMPLOYtri hrtn, extcuion, lad idniniitrttori. Wlioeu Employ*! Addrcti ABBOTT LABORATORIES D«tf^, „....- ; >9 By_ It NortJi Chletgo, lUiTM I tcknowfed^ recxipt cf «rd »tfee to comply with the foL'owIrtj; I. ACuidf to rfuCorpofiu AntlirvatindConfUiofl3iwf»vtPo»KiM; J, Coip«fii« Policy So. 3*-1, lll^l PoiiiJcii and Govtmmtnul Piymt.nu; 3. CorpotiK Policy No. 34-8. Cnttriiinmeni. Gift! ini Fi«iLi»linj PsymfPti; 4. CorpOfiU Policy No. JO-i.Re^wiremniU for Rcieate of C»ofiderMiil InfominioB.ina 5. Cerpofitc PdIIQ' No. 34-9, United Sdici Political Cofltrlbjtiont. Employet Employee Numbtc 3i»^R4 la 138 «&l IELANE8B CCNnDthaiAL INTOKMATTOff ANV IKVINTIONS ACRfCMENT «f Mi i*ytop»ip°r Mir rw'M **' *< •*> '<><<' «k tfitc<«lwr« i» mS*t cm- Itofwa af iW CMi»l»rl >^y Mcrti or co«5UkAt«l (nrornuiM nUt\f4 ID *r pc«e»i»«. >rt«J«ci. mt^in»rf, tf^rttvt •» ir»d» «w«muilM fl«ii hn »} tny onnt, t^fkjm or iwfiu*»iui*t *f «m*. or «i « Malt, tt %t4 mydnrKW, urfCM tO ti/thctrnt ;■ «rtlln< Hy M M \)k fvWic tf»fl te c«7;«d i^tJt eommitnluic U ijit/y ft lA>«<*d MTfonuM Ku k>«j M li tr^ffi ai lAe lime, ind MCk liiYTTw ttwyirrW. TV Er.»Ur»< at <.ti^wAi« of (WCafywT (nVr 4wn*t Of ifiir ■•mmciion «r Ikw i«f^) *%*«<. txtailt PUMI lpf"a'K>« K^ tMi'llKWclVa tutttd ttktiKt to udt ■*«««• lltiM llW iliyr9««rMm •■'W fiooTfi 0^ tticrWT tJltmf rhmrM tar •try CmM'T t*4 ihill -lU tfl wdi Mher aaeni ii ih« Conr^uiy pt|> ill (MI4 Md dv«rr< Incurred it pnovtrr) mxK liroMnloni tAd i»wpKnwintt<> ■/ ii (>tl< a to prcdci ilmm. i. Th« ('em(«ny >M)r i«Jp ihn Ammwih to m* wMUUrr or ifllidnJ cv»«r*iioK»k«w tnj aotkni coatuwd lMr«tn lAjJ iffoci Ik* Cemftiii't «>|hf Ml Mtrrinaii *» »)1«)-aM »f tW ImfhfH- Tfrmin«iiM of twh an^loypK*) ihrf ■« nfirv* dto tMfkrtt Utm in| «( U> o«t;^ii»T% HMk/ rira^ngA II) h(r«o(. Ml m diiffaM lirftntwc^ »f. undtr Fifttnfid (tl |M«of. |« camanwl- tM« tn4 pnXM iti'rtrHitU lArf iMyr«~«Mak mamNW or M* 4. On Ik* trWnoiion of h« iinlfymm for »«> nuan. tt* tffl(!(.j)ml t)wU forrHwUt «mIi ItW CtwiiW/'t yrMilM lad ikifl Jdirr kp w IS* f »«T«7 III tatvtmn, ftm, in^^i^ r ff^' «•■) trty rfiiiatiotM -*-'--' "^^ "--f-i] |- -jnllliiitn or tflliuicJ t«rfcrtu3n. mtiictt t\ij 6c k !■ powcalM m vMr MiGQnu«l. Dia E(P Mv, t-M 139 THE DOW CHEMICAL COMPANY Th# basi» ol Dow'i aucc**! regdoi In i« ompIoyBae and rti9t«chnolo^y md re(ri»d Informjtion whlc^ they ge.ntrate. The ccntlnuwi oroAir+i of Do«V (JepenOi on rt» itudty to malrtjln Itt compethlva edga which not only requir«s xhe generation of new teciinoloyy but eojolly tht proteit'on of lt« exittina technology. In addition to teohnolooy, Dow has d«v»Ctntiel information of efty third porty learned by me ea a Dow •mployea and with reipsct to which Oow hat en ob<(catJor to rralntiln tuch in secrecy. At e Oow amployee, I ahall not \jm or dlM'oie to Dow any trade t*» ip terrrntfvi tt*ge<, jniede by me, ■oglefj'^ Wnfly i« oftaJi^W^lfilSJrtTS WJiKTTj^ bual<*'*'*r>4»t. 140 ,. •no . . - • An^lj 2; ai('*t p'ow end lu •g«n(» In crvpir'ng p«i«nt •ppti&»1ion« In til courrtfiti of tht wortd rtl*tin(i to th« um«i lign trt^ rf»(Ivir to Dew • II pip4n n»C«itirv th*r«10 lnclu(3l'^fl <»■ »lQnm»mj Q^ Plt«nt •ppllClrtoot trd plt»n;»; »/\d will fllv« all lofcrmnlon «nd i»«JrrK)nv. i!fln III pipan ind (Jo all ttiinw which rr »y bt rvMflid or r«Qu»«Ud by 0ow to obtiln, BXtertd, r«'Mut, mUntiln or »nfofC« luc^ p«l9nt» WNen »ny «M!r1»nc« relating ie> »«t«fit »ppl!c«t!on» li r(ii«fed itlAr rpy tfrtployrrtnt Oow will piy rr* • ftiMMb.'* lum, t» d«4fmln»tf by C>ow, for Article 4 — Documenta I •cJcrgw'wJQO that I'l orlgin»l$ jnd coplii of drtwinjii, bluBpfinii, rnenj«l», rsjorti. n&tebookj, Piwiflt, p^'«n jr\e t•'n^ir^*•.lof^ cf rrty •n^p'oyn^«nt. I will llm.lirty retyrn ill olhir prop«riy «f Oow tuch ei •Qulprrt*rit umpJn. trigidvlt md bioioe'cil cultuni. Article 5 — Notification for I period of five y»*r» ifler teirnln^uon of my jmcloyment *!t}i Dow, i Ij"^ '" mform Dow cf my emptoymerri lfldudlf^g my wy syilin'.&hip. I accept which Ir\veiv»g n irti of t»c>iio'6gy or bo-'K9^ 'or Dow Ift ih» fill fivi y»ef« of my •rr.pioymem M Pow, before enterirvg Into luch employ- AnIcI© 6 — Acceptance I fuvi reed the >fl'ecm»nt eo'efully iid I jrv- d«rst4nd end j«;«i;t >L It ii to be r«t'cecTlve to the ditt of my flttl employment by Dow ind II In tdaitlon to iny r'iQY.\s end obiis*',!orii of myielf end Dow ^nOer iny prtvicos ann- ployM igreemsnt |ign»d ty me. I underftend that in ^he event that Dow ihoufd wafve any part of thie Aj'^ement or thaj 8ny part ghould b« daiermir^Bd to bi unenf6rc«abl«, I flnn not thereby relieved from the remaining provi- •ignt of the Aflreemerit My obllaatlona hereurvder will contJnug in ihe event I am trirsferred to a different locetion or ■islQoment by Dew «nd af^er termlnrtion of my employment with Dow. D*ted Signed _. MiBter No. Division, Department of Subjldliry Location — WtneM 141 w[OPPBreSi „„_____ [lu^'o^^T*>,T - wcaq CA^rmuvi^ WHU^tAl \H uKa*rt 9'^ ll •irplor>« v I* ttieu; t» M fn»*>CW COU^AiW, INC. or • lcti<EM< OO^^ANV, INC. nm». *nt»'|r ivfwrw t» M "<0<>rCM" whlc^»yv f«fir«ne* li ^ i—^ntt •(p^aprltl• le Ih* •mployn>«nl «l Iht gnd»ni|f)*4) anrt It 4m'-ou» «i ctt«iii. Ir^ W egnllnuing Hid »rp'7rrr«nU, wrth ccrfl4l-iit»|>gn g( KOfPCM, tn* hM or will r«vi IM etpcnj\;\f qI viing KOPPCnS' tscK, •ppninCM, IicjiiiIm iruj iMhnlcal IflfjfUVUI*!. NO*l, THERE^OKE, In c«nild«rMion o< tht frvniatf *n4 t< ut tivierntnt ud Ihf Hivy »ai< t^«r«• l t^iwii w lnv«ill;«|l« m wricn KOPF£l^ !• * >i«r»«f1or mtf b« *iKK*< ef \H»f»iXt4. tnd »Mi;, M a.M at Mi&rt|«». »twfs po(ilBl«, naka iiiW«Ki«
  • « that liT>f, arxi tll palwu, lenaallc ao4 f»r«ign, «sli prtfiTy of KCPPEPI; In th« ovcfM iSai KOPPCM hta not Inolcaud a 4a«ir« to uM or t* raiilivia riy(i lo an invwitlon 04r)> ;«lv«Cl »r ma>«ni iwch a raiM.'M li yaMid, KOf^nAI artd ill loccau^t and cufiomra ihaii n»i ba iiakia it any iiw 'v tny i»'«ci>«e 9I u\e iiv«^ilan: •I Ml . laatilyi Hi ahall, upr tarminilloA ef intil«yn«Al witfi KQPPEAI. (Vit ever la KCPP£W tll net**. ir«nt«ran«4. noliiMM, orrtirqi tni o(h«« rooertfi In oonr«ei.en w[in hia awcliyinont •paeil'iaily cciarw cy tft* tlifrd pari- irtpti.namit; II balni wnMntv«d t^•( l>i«»« raA«rdi ind Iht Infotiailpn cfnl'iMd \tmut in »l all tiMl IM aoit prBp*ny si KOP^CM; HI rapraiaiiii iMt r4 Ml ng i^ramant with Hha/i wnien will 'ntvrfvn «it!i tM c^ratioit »f tMi ao/*» fnafltj Thlt ninftiit IMIl ^nxf* 10 IM banailil of md iMll oa blnOln| upon KOPPEW, Ita luMistor* jnd iiii|f < jnd upor Ihi undo'ilgnid. Mi hairi. '»efenf««i*«i. adulniilrtlorj. mkoIvi. IH Miljni. IN TEiTlMONY WMKPCOP. IM UPiSdxIlgnaa, htlndlnj to Id InHly MuK Hauby. ^al al|«)ft m.b.H.f Pefrollt« Corpofflrlcr of Conodo, l>6., P»tro|;it Frone* 5. A., ^trp||>« Inferno Honol Cocporotiofi, Ptfrollta Li/nlt^d, S«urti Amarlesn P«trol!f« CdrporoHon, and any other luUidiory of te'id Pah^llt* Ccrp«ratloni in eonjl^fflt'oo of my •rr^loym^Af of cofiMm.'«d «mptoyn^«fll \f> ony copocify by »t>e eompqny (wl\fch ftrw Ineludii NtrolIf« Coo «ompony oil Invenflofti , dl»c«v«f !« and im^ovemcntt (whetfier or not thay ore potentoble) conceived a reduced 'o p>t3Ctic« by me, loJely or In collQbe>«iHo« with otferi, from the rime of ontwJnj the eompony'i employ until I teove (1} which ore u»eful in iht boiineii, work or invtttipaflont of 'he cornpany, or (3) which rewlt from or ore wg^wfed by any work which I mgy do for Of ©o beholf of the compony (if on applieatlor for patent fw ony yjch Invention, diicovery or ifrprovement be rwde by me within lix (6) month* after ! leave the contpany'i e-nptoy, uieh Invenilon, dlicovery or improvement ihqll be pr«iumed to have b«en conciived during the period o' my employment), (I) To outil the compony during and lubtequent to MCh employment If) every proper 'May (witfeut choree to tf • compony bwt at iti expcnte) to obto'n pgtenti or oH\erwite protect luch Invenlioru, dtjeovtr'w ar»d Improvementj in ony and oil cowntrlei ojeinit appropriation by otferi; all tycK Invention*, dUeoverie* ond Improvement! (whether patented or not) ond any patent! tf^t may litue thereon to be tf e i«le and exelui've property of the compony and being hereby auigred thertto^ end for the pwrpo»e of thit clauM t« execute and d« all »uch documenfi, aetl ond thlr^gt ot the compony may deem neceiiory or rfe«Ir«ble. (C) Te irake end irainlQin adequate and current written recordt of oil iwch inventioni, diicoverfei ond ?iT^>rovef»»ent», !n the form of ftotti, iket«hei, dnswlrgi, or reporti relating thereto, which reccrdi iSoll be ond remain the proper^ of and 9v«lloble to the compony of oM tin (D) Except at the compgny tnoy athenrrtte conienr In writing, not te ditdote or to d'lCUM with othert eulilde the con^ny at ony tiff>e (except ot my C^rt'pony Aitlei may require) either dvring or »«b»e^went to my empteyment, gny informotlon, knowledge or dotg of o confidential noture I ft«y receive durir^ the cowrie of my empleyirent reloring to the compooy'i builfwH proeedurei, formulae, methodi, machine! >->li* ouriid« ^ scope e' rfili osrt*m«nt, or (2) rlBh^> Qf otl^ri ariiing out of o^llgqtioni Incvrrod by m« - (a) prior fe tKI| ogreermnt, or (b) etherwiM eufjtd* rh« tcopc of fh7i ogreeminf. In the tvtnt of my 'aW^xs ta g'v« rorlct under (h« cirevimfanc^i iptclHed in (1) of tKa foregoing, the company mgy osttm* fhgt no ujc>i e«nflleflng 'nviniloo, dfico«ery cr improvemenf t»hh, ord I ogre« tKot t will mak« no elgim with mpect th«r«to. Thii ogreemtnt may f>e)| on behalf of or In r«i^«t to tf« corrpany, be changed or modified or releottd, d'lC^orged, obondoned or etherw?ie ttrminoted, in whole or in port, except by on injtn.«t gnd lost nemci itT full) Potei (To be written In by EmployetT Accepted; PtTROllTE CORPORATION Secretory Atteir; JeoreTafy" Vice fteildent Date: Accepted: »r (Swbildlory, IFony) (Potitior^j Dotei 144 Employment Agre^msnt I, In consldirarion of mj ttr>p\ofti\M\ by RoSm onj Hqo9 Corrpanj ord tHt compintoM»n end bfn«fiti o(l«*i;r»t ppoceiiet oF mon/'ac'vr* «' R»hm Ofid Hooi C^mpgny, ort ihe prop»f ty e( ftohm grd Ho«i Cwnpoif/ »* "••" 8* ""/ m^wntlipft C«A*oln(d In r*««orch r«cerd(. flnoflclal re««rdt, payroll rtesrdt, poftennet rec»rdi, and «M »tVe ci/ttidtn or otf*! ijn<»vfKorii*d p«rwrii eiTf«f *r4i'le om^ojrtd by Rohm and Hooi Cempany or ofi»(*t)fd|. I will not •rgcga in eriy buti^«it InteretU er bvtineit ectivitici which, in rht opinion ef Rohm »id Hwi Compony, conflict with tht inUrtgit ef Rc>im ond H«oi Qcfpcn)/. III. tfiwMl narf.l Vi I Oit^i on tomtinotion of my «npl4yif«ft»4 lo roi.fn ro Rohm ond Hooi Company all pop*f«, "ofc*, be^i, M Atho' dofwnoiM* or pro^arry be'onginf to Rotvn and Kooi C«mf3ty or rtleiing !e iti bviintil. Exffcuf*^ In. ihii. . ^«f ef . nsHimr' ■ .tWAk' ROHM AND HAAS COMPANY irnrrr M*M lit ■!«. t'tT 145 oy i3nTKMT Aoroacarf In con*ldar«on without obllgatioa on tie p*rt of Ca«»aay to «a3M any further ccopeo^atlon, roy^lt/ or p4yB^t t« se. Z vlll a^slat th« Coapejiy and/or Ita Eoodrieea (wlthoot charga tut at no expense to fi») &t axQT tlJttc (ind la every proper vay to obtain aad aalntaln for Its sjid/or thalT own benefit patent! for all luob Lsvvntlopi, dii coverlet or liaprovesenta and copy- rl^^ta for all eueb desl^a, l.(b} Ihla a^reeaeat, bovever, fioea not cbll^te tut to aaalgn to the Con^aay aay InveatloO/ diaeovery/ laptoveaeat or dcsl^a vhioh, in the judgoent of the Coqpany, doei not relate to the bualntu effcrta or reieATch and developoeat efforta In vhich, during the p«rlod of ny tsfloyosnti the Coopany It tctuidly eng&gad or reaaos&bly vould be expected to becoma engaged, 2. Except u ay dutlea during ay eaqployse&t with the Coapany may require or a^ the Ccopany say othexvlse contact in writing, X viU not At any tloB diacloae or uae, either during or suboeguent to sy ofleyMot, any inforsfttion^ knowledge or data t receive or develop diirlng ay eoployeent Mlrd-oii li oonaidvrtd proprietary by the Coet^inf or which relfttea to the trada lacrets of the Coopany aa oontalz:ad in formlta, tUilnest proccBBeBj nwthodJ; taa«hinea/ macufacturi^g prooeaaea, oonpotltlonBi inv«ntlonf| diicovvriea or otherwlae or which the Cox^any hc4 received In confidence froia othera. iTelther will I dlaeloae to the Canij>«iny or induce the CoPTeny to uae any prcprlrbary inforoatlon or trad« lecreta of othert cscopt M B«y be properly received by &■ in conseotlon with a^ ea^iloyatnt for diaclosure to or uic by the CcacpAny. 3. During the period of eaployuent, 1 vlll not Independently eng&ge in the sama or aloilajr linec of butineia or research aa tha.t cairrled on by the Ccsapany, or directly or indirectly; serve, advlie or be taploytd by any' Indlvldujil, fire or corporation engaged in the laae or a simllajr Una of bujlneia or research aa that carried on by the Coxpany. U. Aa UA«d h«r«lii, Ccap&ny shall laean the Dlvlalen or flMbBldlMy of Textron Inc. Idtntlflel above ana any luhsidlary corporation, Dlvlaion or unit adainiatrativaly affiliated vltb the Coa^any. 146 9t yfy o'blig&tlo&a harcunder aft/ not ^e changed or Bodlfivd, Mletsed, diichsxged, ftbwid^jned or tennltftted, in vhole or La p&rt except by an lait.rua*nt la vrltiog •Igned ty wi ofrtc«r of the Coap^ay. 6. aiB fegr<«wnt »h^U fee bicU-aj upon By helra, jersowd r«prt«eatfttiv«, lucceason tni uaigcs. 7» Except aM «e-t forth VxloWi I h&ve do Lgreea»ntfl with, or obligitlaiu to othWB, In conflict vlth the forejolfl^ wd I do not cva or b*v* *a lnter<«t in *ny patent, patwt application, copyright or uzipittattd lnv«fitlonB. 8, upon &ay tersLaatlon of ay ssyloyaent, 1 9h*il reVoin all prcprlttary or notpvblic retorda aod docusienta of or pertaialiitf to the Coe^&ay tJjta in vy po«B 892-0805 Supervisors: Thomas Bernadzikowski. MA.. George Steinfels. Ph.D., Len Cook. Ph.D Wrong! ully terminated 154 -4 1992 - Present: Senior Behavior Analyst, Department of Mental Retardation, 1901 DuPont Highway, Wilmington, Delaware. 19720 (302)577-4928 Supervisor: Scotl Daner. MA. Still there. Question Number 2: I have not been discharged, asked to resign or left employment involuntarily with the exception DuPont Merck who I have filed a lawsuit against. See answer to Quesiion Number 4. Question Number 3: I have not been counseled for poor performance of any kind, including, but not limited to. charges of improper research procedure or manipulation of test data or research conclusions at any of the positions that I have held. In fact, I have been given outstanding reports of my research and management skills, as well as, accomplishment awards for outstanding scientific contributions, Question Number 4: I have filed a lawsuit against DuPont Merck for wrongful termination in the Superior Court of Delaware. 1 expect that this lawsuit will come to conclusion within a year. As I do not wish to jeopardize any legal position that I may have, I suggest you address further questions direaly to my counsel, Mr. Bayard Snyder. Esq.. Suite 830, PNC Bank Building, 300 Delaware Avenue, Wilmington, Delaware. 19899. Telephone Number: (302)637- 8300. In addition to the above positions, I have also held adjunct teaching positions at the following universities or colleges: University of Delaware. 1989-1990, Trenton State College, 1986-1987, Virginia Commonwealth Universitv. 1983-1986. State University of New York. 1976-1978. City liniversity of New Vork, 1 976-1 978. The answer to questions two and three apply to these positions as well. I have addressed your questions to the best of my knowledge and I would welcome any further questions related to issues before the subcommittee. Respectively. Victor J. DeNoble, PhD 155 LIST OF DOCUMENTS WHICH HAVE BEEN RETAINED IN COMMITTEE FILES ■ On May 9, 1994, Philip Morris submitted additional documents to the Subcommittee that pertain to the work of Dr. DeNoble. The following documents from Philip Morris have been made part of the record for this hearing and are available for review by the public at the office of the Committee on Energy and Commerce and the office of Representative Henry A. Waxman: Philip Morris Interoffice Correspondence, Discrimination Studies. May 7, 1980. Philip Morris Interoffice Correspondence, Possible Restructuring of the Behavioral Research Lab. June 18, 1980. Philip Morris Interoffice Correspondence, Research Progress Concerning Discrimination and Prostration Studies. August 18, 1980. Philip Morris Interoffice Correspondence, The Behavioral Pharmacology Program. October 14, 1980. Philip Morris Interoffice Correspondence, Progress in Behavior Pharmacology Laboratory. March 27, 1981. Philip Morris Research Center Manuscript Review Board Information Sheet, Studies on the Effects of Intraventricular Infusions of (-) -Nicotine on Behavior Maintained under Fixed Ratio Schedules. January 20, 1981. Philip Morris Interoffice Correspondence, Progress Report. August 24, 1981. Philip Morris Research Center Manuscript Review Board Information Sheet, Brain Sites Involved in the Mediation of the Behavioral Effects of Intraventricularly Administered (-)- Nicotine, March 1982. Article published in Psvchopharmacology . Behavioral Effects of Intraventricularly Administered (-) -Nicotine on Fixed Ratio Schedules of Food Presentation in Rats, by Victor J. DeNoble, Yvonne Dragan, and Lisa Carron, Spring 1982. Philip Morris Interoffice Correspondence, Progress Report. April 21, 1982. Philip Morris Interoffice Correspondence, Project Number 1610 (Behavioral Pharmacology) Objectives and Plans — 1982-1983. July 20, 1982. Philip Morris Interoffice Correspondence, Promotion of Dr. Victor J. DeNoble to Associate Senior Scientist. March 1, 1983. Philip Morris Interoffice Correspondence, Behavioral Pharmacology .Annual Report — 1983. June 1, 1983. 156 Philip Morris Interoffice Correspondence, Prostration and Discrimination Tests. June 14, 1993. Philip Morris Interoffice Correspondence, Project 1610 (Behavioral Pharmacology) Objectives and Plans. 1984. September 6, 1983. Termination of Chronic Acetaldehvde Administration Does Not Result in a Physical Dependence Syndrome. Philip Morris Research Center, (not dated) . Philip Morris Research Center Manuscript Review Board Information Sheet, Effects of Chronic Nicotine Administration and Its Termination on Schedule-Controlled Behavior in Rats, (not dated) . Nicotine as Positive Reinforcer for Rats: Effects of Infusion Dose and Fixed Ratio Size. Victor J. DeNoble, Paul C. Mele, and Francis J. Ryan, Philip Morris Research Center, (not dated) . Development of Behavioral Tolerance Following Chronic Nicotine Administration. Paul C. Mele and Victor J. DeNoble, Biochemical Research Division, Philip Morris Research Center, (not dated) . Federation of American Societies for Experimental Biology, Federal Proceedings, Abstracts. 70th Annual Meeting. St. Louis Missouri. April 13-18, 1986, Volume 45, Number 3, March 1, 1986. REGULATION OF TOBACCO PRODUCTS TUESDAY, MAY 17, 1994 House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment, Washington, DC. The subcommittee met, pursuant to notice, at 9:58 a.m., in room 2123, Raybum House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. Waxman. The meeting of the subcommittee will come to order. Just over 1 month ago, this subcommittee heard remarkable tes- timony from the leaders of our Nation's largest tobacco companies. Testifying under oath, they told us they believe that nicotine in to- bacco is not addictive, that tobacco doesn't cause disease, and ad- vertising doesn't encourage children to smoke. In stark contrast to the findings of the Surgeon General, tobacco company executives argued that tobacco is simply one of many health risks encountered in everyday life. Two weeks ago, we heard testimony from two Philip Morris re- searchers whose innovative but secret work could have alerted pub- lic health officials in 1982 to the addictive nature of nicotine. More recently, news reports have revealed evidence that knowledge of the addictive nature of nicotine was well known within the tobacco industry 20 years before Drs. DeNoble and Mele began their work for Philip Morris. This morning's hearing is a continuation of the subcommittee's investigation of the tobacco industry. We are trying to answer a dif- ficult question: Did the tobacco companies implement one of the most concerted and well organized conspiracies of silence in cor- porate America? In a 1992 opinion involving the Liggett Tobacco Group, Federal Judge H. Lee Sarokin testified that the tobacco industry may be the "king of concealment and disinformation". Recent reports in the media suggest that Judge Sarokin was cor- rect. Despite industry assurances to the contrary, it now appears that a voluminous body of nicotine research was conducted over 30 years ago by the British-American Tobacco Company in England and shared with the U.S. tobacco industry through BAT's subsidi- ary, the Brown and Williamson Tobacco Company of Louisville, Ky. Reports in the New York Times, Wall Street Journal, Washing- ton Post, and other news outlets suggest that the adverse health effects of tobacco, including the addictive nature of nicotine, were by the early 1960's known and accepted by senior company officials (157) 158 at Brown and Williamson. According to an account in the New York Times, these research findings so shocked the industry that a decision was made in 1963 to withhold this information from the Surgeon General's Advisory Committee on Smoking and Health. Had this information been made available, a growing number of public health authorities believe public policy toward tobacco may have been dramatically altered. On May 11, the subcommittee invited Mr. Thomas Sandefur, Jr., of Brown and Williamson and Patrick Sheehy of British-American Tobacco to testify concerning these serious allegations. Mr. Sheehy of BAT notified the subcommittee by letter that the company would not appear to answer questions on this matter. At the request of Mr. Sandefur's attorney, we have agreed to postpone his testimony until Friday, May 20. In light of this postponement, we will hear from only one witness this morning. Joseph Califano is currently the director of the Cen- ter on Addiction and Substance Abuse at Columbia University. As domestic policy advisor to President L3mdon Johnson and Secretary of Health, Education, and Welfare under President Jimmy Carter, Mr. Califano is uniquely qualified to comment on the impact of the tobacco industry suppression of research during the critical, forma- tive years of U.S. tobacco control policy. During congressional hearings in 1965, Congress heard tobacco industry scientists repeatedly criticize the findings of the Surgeon General's 1964 report. They argued that any effort to link cigarette smoking to human illness or mortality was, quote, "a considerable element of guess and gamble", end auote. But the 89th Congress didn't hear from those who conducted or evaluated the tobacco in- dustry's secret research projects. The Congress didn't have the 1963 memorandum referred to in the New York Times where Addison Yeaman, the general counsel of Brown and Williamson, ac- knowledged that cigarette smoking was addictive, an admission more sweeping and clear than the findings of the Surgeon General. Mr. Califano will testify on the impact withholding the informa- tion had on Federal efforts to curtail tobacco use and the cost to the Medicare program. In fact, the Center on Addiction and Sub- stance Abuse at Columbia University has concluded that cigarette smoking is the largest single drain on the Medicare trust fund. Un- less Congress recognizes this fact, the high cost of cigarette smok- ing will continue to threaten the Medicare system and will cause the expenditures of untold billions of health care dollars. Before recognizing other members of the subcommittee for their statements, I want to make some brief comments about our hear- ing for next Friday. We expect the chief executive officer of Brown and Williamson, Thomas Sandefur, to testify before this sub- committee. The tobacco industry may not like it, but their days of secrets on health research and health impacts are over. The public has a right to know this information, and this subcommittee will not be intimi- dated by the industry's cadre of lawyers and public relations spe- cialists. In meeting our responsibility, this subcommittee will pro- ceed fairly and protect the rights of every witness who testifies. Mr. Sandefur's lawyers have made a clearly inappropriate re- quest to review documents the subcommittee has received in the 159 course of its investigation. In a letter yesterday, however, which I am releasing today, I agreed to a special accommodation to address Mr. Sandefur's concerns. In Friday's hearing, the subcommittee will limit the subject matter of the hearing to Mr. Sandefur's pre- vious testimony before the subcommittee, to documents he volun- tarily provides this subcommittee, and to information provided in recent news reports. Brown and Williamson and other tobacco executives will receive fair treatment by this subcommittee, but they will not receive spe- cial treatment. I want to recognize other members of the subcommittee for com- ments they wish to make and call on Mr. Bliley first. Mr. Bliley. Mr. Chairman, I wish to join you in welcoming Mr. Califano to this subcommittee. I am always pleased to hear from former Cabinet officials about their work in other administrations. I know that being an administration official is often a thankless task. Individuals who take on these positions deserve our thanks for their years of public service, and I think we can all benefit from the insights former officials can bring us after they leave office. Mr. Califano, today you are providing the committee a study which purports to show the cost of substance abuse to the Medicare program. If one turns to the methods section of your report, it is clear that the key factor determining your estimates is the esti- mate of the relative risk factor for acquiring a given disease. Clearly, the relative risk factor presented in terms of a percent- age is the foundation of your entire study. The important question then is, how did you determine the risk factors for a given disease or condition? Here is what you say on pages 12 and 13 of your May 1994 re- port in the methods section. 'When possible we selected studies that were targeted at the elderly population. However, we found that the elderly population is not often the focus of medical or epi- demiological research. In lieu of elderly specific relative risks, we use relative risks for the general adult population." My understanding of this statement is that very little epidemio- logic data exists on the efiects of tobacco, alcohol, or drugs on the elderly population, of those 65 years and older. Therefore, you cal- culated your risk factors on studies which were based on the gen- eral population. Let's look at an example, coronary artery disease. This disease affects many of the elderly for multiple reasons, many of them cen- tering on diet. However, in your study you attribute 64 percent of all coronary artery disease to substance abuse. Possibly this risk factor was calculated from a study of individuals much younger, say from 25 to 45 years of age, and among this age cohort this may be an accurate estimate of the risk of substance abuse for coronary artery disease. However, to then take this number and generalize it to the elderly population makes no sense. If one looks at the elderly population, it is possible that 64 per- cent of coronary artery disease is attributed to high fat diets. Therefore, Mr. Califano, I want you to please make available to this committee the specific studies on which each of your risk as- sessments on pages 17-20 are based. Additionally, I want an age 160 cohort tabulation for each of these risk factors. This will help us and the press to determine the validity of your study. Thank you, Mr, Chairman. Mr. Waxman. Thank you Mr. Bliley. Mr. Wyden. Mr. Wyden. Thank you very much, Mr. Chairman. I want to commend you for calling this session today and particularly to have former Secretary Califano. I think this subcommittee in recent months has taken a special look, Mr. Califano, at the ramifications of smoking for children, and I have shared Chairman Waxman's views that is exceptionally im- portant because we know that a substantial number of smokers are hooked before they are age 18. But I think that you, with this new study, are making a very im- portant contribution by turning the debate over smoking as it re- lates to senior citizens and to Medicare. I think you and I have talked about it before, but I was, at home, the codirector of the Gray Panthers for a number of years before I was elected to the Congress, and I have to tell you, in my view, one of the saddest aspects of American life is to see senior citizens suffer as a result of smoking and to see all these problems of em- physema and heart disease and the like, and I think the contribu- tion that you are making with this report has at the bottom line the basic kind of proposition that if you want to protect the Medi- care program, you ought to try to discourage smoking, and I think that is an important contribution and look forward to your analysis today. Mr. Chairman, one additional comment, if I might, with respect to the tobacco executives who will be coming on Friday. It seems to me that if those tobacco executives had reason to know that nic- otine was addictive and if those tobacco executives had reason to know that tobacco smoking was carcinogenic, and if those tobacco executives manipulated the law to insulate themselves from civil li- ability, then my view is that the American people ought to have a right to know that and they ought to have a right to know whether or not these corporate executives protected their interests and their corporate profits rather than the health of the American people. So I think the session that you have scheduled for Friday is a very important one. It is time to lift the veil of secrecy on the to- bacco industry in this country. Friday's session is a step in that di- rection. I look forward to our witnesses and yield back. Mr. Waxman. Thank you Mr. Wyden. Mr. McMillan. Mr. McMillan. I thank the chairman and would like to add my welcome to Mr. Califano who has given this country distinguished service, and we appreciate that. Mr. Chairman, I know you are well aware of my particular inter- est in controlling excessive costs in health care. I serve on the Budget Committee and have brought up in this broad a committee, issues related to Medicare and Medicaid over a long period of time. Entitlement spending, as we all know, has basically been driving the budget deficit for the better part of the last decade and, unless we do something, will continue to drive it for the next decade. It clearly needs our focused, careful attention. 161 I am particularly interested in hearing from Mr. Califano about his work on alcohol, drug, and tobacco misuse in relation to Federal spending as it may impact Medicare and Medicaid, and I am de- lighted that this committee is for once considering cost containment in this area rather than cost expansion, which is usually what we are engaged in. It is my conviction that we don't consider this issue enough in a very constructive sense. Frankly, I would have expected that HEW would have long ago addressed the issue of threats to health imposed by anything, any substance, whether it is tobacco, alcohol, drugs, fat, or we could go on and on. It seems somewhat ludicrous that we are all of a sudden awakening here in 1994 and trying to find fault with others who may have had some kind of information back in 1950's that pre- sumably we didn't have access to. I think I first smoked in 1950. I understood perfectly well the fact that smoking might be detrimental to my health; I think ev- erybody who smoked understood that. Perhaps you did, Mr. Chair- man. I think you used to smoke. I think we also understood the fact that it was habit forming. Whether you want to call it addict- ive or not addictive perhaps depends upon the individual. I think we need to try to define that word more precisely and define more precisely how we apply it to a whole array of substances. But for you to sit here and try to suggest that your decisions not to act were because one company or one group of executives had access to information that the public didn't have access to back in the past that they conspired to withhold from the American people is absurd. I think we all understand to some degree what the risks are here, and I am perfectly willing to look at them, and I think perhaps the industry is as well. I didn't receive the study that Mr. Califano was a part of until yesterday and haven't had a chance to examine it in detail. The first I heard of it was on the news media this morning, when it was ballyhooed as to what number of deaths tobacco contributed to among the Medicare population, which is a bottom line sound bite kind of conclusion, which is exactly what was intended. I don't think this informs the public, it doesn't inform senior citi- zens, it doesn't inform me, and I think we need to be taking a real careful look at that because we run the risk of perhaps deluding the senior population into thinking that if they only deal with to- bacco and alcohol, that they are going to avoid the Grim Reaper. That clearly is not the case. On a personal note, my mother, who was a smoker, passed away of heart failure last summer. She smoked most of her life. Did she pass away because of smoking or not? She was 1 month short of 90. You know, I think we need to — and I am as seriously concerned about the facts here as anybody else, but what this committee can do as a favor to the American people is to focus on facts instead of perception, and I hope, Mr. Califano, that you will help us do that this morning. Thank you. Mr. Waxman. Thank you, Mr. McMillan. Well, we are here to focus on facts, not perceptions and not anec- dotes, and that is why we are pleased to have Mr. Califano as a 162 witness to give us the results of a study of the Center on Addiction and Substance Abuse which Mr. Califano chairs. I am pleased to have you here again before our subcommittee. Mr. Califano was Secretary of Health, Education, and Welfare. In 1979, he issued the most comprehensive report on the adverse health effects of tobacco published to that date, and he noted the fact that there was a shocking increase in smoking among children and young teens. Today Mr. Califano is here to tell us about the concern for an- other generation, the seniors who are under the Medicare program. Mr. Califano, as is our custom in these tobacco control hearings, we would like to swear in all witnesses, and I want to inform you that at the desk there are the applicable rules, or should be the ap- plicable rules, of the House and of this committee which informs you of the limits of the power of this subcommittee and the extent of your rights during your appearance. Do you or any of those accompanying you have any desire to be represented by counsel or advised by counsel during your appear- ance here today? Mr. Califano. No, Mr. Chairman. Mr. Waxman. ok. Do you or any of those who are with you ob- ject to appearing before this subcommittee under oath? Mr. Califano. No, Mr. Chairman. Mr. Waxman. OK. If you have no objection to appearing under oath, I would like you to stand and raise your hand. [Witness sworn.] Mr. Waxman. Please consider yourself to be under oath, identify yourself for the record, and then we would like to have you proceed with your testimony. TESTIMONY OF JOSEPH A. CALIFANO, JR., PRESIDENT, CEN- TER ON ADDICTION AND SUBSTANCE ABUSE, COLUMBIA UNIVERSITY Mr. Califano. Mr. Chairman, if I may just — ^there was one phrase that was left out of the statement, just for those who have it, on page 5 in the second full paragraph where the sentence should read: "The word 'addiction' does not appear in the first Sur- geon General's report, except to be rejected in connection with smoking." Mr. Chairman, my name is Joseph Anthony Califano, Jr. I am president and chairman of the Center on Addiction and Substance Abuse at Columbia University. This is my full-time occupation. I gave up the practice of law about 2V2 years ago to pursue this. Mr. Chairman and members of the committee, it is a privilege to be invited to testify before you this morning. I was Secretary of Health, Education, and Welfare when you became chair of this sub- committee. I admired and respected your work and the work of this committee, all of you — Congressman Wyden and others — then, and I have ever since. As I said, I am now full-time chairman and president of the Cen- ter on Addiction and Substance Abuse at Columbia University. I was Secretary of HEW under President Jimmy Carter and Presi- dent Lyndon Johnson's assistant for domestic affairs. 163 The Center on Addiction and Substance Abuse at Columbia is the only national organization to bring under one roof all profes- sional disciplines needed to study and combat all types of sub- stance abuse — illegal drugs, alcohol, pills, and tobacco — in all sec- tors of society. Our mission is to inform the American people of the costs of substance abuse throughout society and the impact on their lives, to find out what works in prevention and treatment, and to encourage all individuals and institutions to take more responsibil- ity to combat substance abuse. You have asked me to testify, Mr. Chairman, about how the con- duct of tobacco companies which has been disclosed in recent news reports and in the New York Times — news reports in the New York Times and the Washington Post has affected Government policy over the past 30 years. Mr, Chairman, I have been in public life for most of the past 35 years. I have been picketed, I have been attacked for one position on one issue or another, but I have never been subjected to such a crude attempt at intimidation as I was last night. At about 5 p.m. last evening there was delivered to my office at CASA the fol- lowing faxed letter: "To the Honorable Joseph Califano, Center on Addiction and Substance Abuse, re: May 17 hearing of the House Subcommittee on Health and the Environment. "Dear Mr. Secretary, King & Spalding represents Brown and Williamson Tobacco Corporation. We understand that you will par- ticipate tomorrow in a hearing of the House Subcommittee on Health and the Environment that may include a discussion of one or more articles appearing recently in the New York Times. Those articles included references to documents believed to have been sto- len and which are subject to a State court injunction. A copy of that injunction is being provided with this letter." And it enclosed a copy of an injunction which purports to block anybody from talking about these documents. Mr. Chairman, this is a blatant attempt to intimidate me, to ob- struct the work of this committee, and to scare me off of testifying. I will not be intimidated, and I will lay out the facts based on those news reports, which is the only knowledge I have of their activities. I would like to submit this for the record, Mr. Chairman. Mr. Waxman. Without objection, we will receive that document for the record. Mr. Califano. For 2 years the Center on Addiction and Sub- stance Abuse has been conducting an analysis of the cost of sub- stance abuse to the health care system, the entire health care sys- tem. This is the first undertaking of its kind. As the initial phase of this analysis, last year we completed and published a study of the costs of substance abuse to the Medicaid program. I have provided copies of the study to the committee and ask that the Medicaid study be entered into the record. Mr. Waxman. Without objection, that will be the order. Mr. Califano. The Center's study found that at least $1 in every $5 that Medicaid spends on inpatient hospital care can be traced to substance abuse. That is at least $7.4 billion in 1994, and 40 percent of that amount, about $3 billion, is attributable to tobacco use. On average, Medicaid patients with a substance abuse as a secondary diagnosis are hospitalized twice as long as those patients 164 who have the same primary diagnosis but do not have a substance abuse problem. This week the Center on Addiction and Substance Abuse at Co- lumbia University is releasing the first study of the costs of sub- stance abuse to the Medicare program. I have provided copies of the study to the committee and ask that it be entered in the record. Mr. Waxman. Without objection, that will be the order. Mr. Califano. The study found that nearly $1 out of every $4 of Medicare spent on inpatient hospital care is attributable to sub- stance abuse, $20 billion in fiscal 1994. This study is based on the epidemiological medical evidence, 321 footnotes cited in the mate- rial backing up this, Mr. Bliley, and also on the inpatient hospital records of Medicare which are available throughout — for the year 1991; 80 percent of that amount — 80 percent of that $20 billion — is due to the long-term effects of smoking cigarettes, including lung cancer, strokes, heart disease, and respiratory ailments. The risk factors were adjusted to avoid taking into account the problem of fat or what-have-you. And, finally, I would note that for the study we had an advisory committee which included some extraordinary people like Dorothy Rice, probably the greatest health statistician in the United States of America. Over the next 20 years, substance abuse and addiction will cost the Medicare trust fund more than $1 trillion for inpatient hospital care. Smoking is the largest single drain on the Medicare trust fund, poised to take $800 billion over the next 20 years. The April 11, 1994, report by the trustees of Medicare warn that Medicare will run out of money in 7 years. During that time, $128 billion of Medicare inpatient hospital costs will be due to cigarettes. The prevalence of smoking among Medicare recipients is high. More than 36 percent of Medicare recipients are former smokers, and nearly 20 percent currently smoke. Three out of five current smokers, about 58 percent, and one-third of the quitters smoked more than 10 cigarettes a day for more than 35 years. This puts the Medicare population at much higher risk of getting smoking-related diseases because people over 65 who have smoked tend to have done so more heavily and for longer periods of time than younger Americans. The high prevalence of smoking among the elderly is especially disturbing in light of the documents reported in the New York Times and the Washington Post over the past several days. These reports revealed that in the early 1960's the cigarette companies knew that nicotine was addictive and that smoking caused cancer and heart disease but kept their knowledge secret in order to sell their products. Had the American people known 30 years ago what the tobacco companies kept from them about the deadly and addictive nature of cigarettes, hundreds of thousands of premature deaths and bil- lions in related health care costs among today's elderly population could have been avoided and billions of taxpayer dollars could have been saved. The evasions, lies, and transfer of documents overseas by the to- bacco industry to prevent any Government agency or cigarette-in- 165 jured patient from finding them has distorted U.S. Government policy for 30 years. On January 11, 1964, Dr. Luther Terry issued the first Surgeon General's report on smoking and health. In his report. Dr. Terry and his distinguished advisory committee concluded that, "Ciga- rette smoking is causally related to lung cancer in men", but found the data for women less extensive though it pointed in the same direction. The report also concluded that, "a relationship exists between cigarette smoking and emphysema, but it has not been established that the relationship is caused." As for that disease, the 1964 Sur- geon General's report said that, "a causal relationship has not been established." The report could only associate higher mortality of cigarette smokers with many cardiovascular diseases. The word "addiction" does not appear in the first Surgeon Gen- eral's report except to be rejected in connection with smoking. In- stead, the report says, and I quote, "The habitual use of tobacco is related primarily to psychological and social drives reinforced and perpetuated by the pharmacological actions of nicotine." Mr. Chairman and members of the committee, compare what the tobacco companies knew about cigarettes and nicotine at the very time Dr. Terry and his committee were preparing the first Surgeon General's report. On July 17, 1963, 6 months before Dr. Terry issued his report, one Brown and Williamson executive wrote — and I quote "We are, then, in the business of selling nicotine, an addictive drug." The industry also had far more evidence of the health hazards of cigarettes with respect to cancer, respiratory ailments, and heart disease which it consciously decided not to share with the Surgeon General in order to preserve its profits. Instead, tobacco company executives chose to launch a big lie public relations and lobbying campaign to dispute what they knew to be true. What was the re- sult? In 1965 I was working on the White House staff of President Lyndon Johnson. The administration was pressing to put warning labels on cigarettes. The tobacco industry wanted no labeling or la- beling as weak as possible. The law which Congress passed in 1965 provided only that packages of cigarettes carry labels saying, "Ciga- rette smoking may be hazardous to your health." That relatively weak admonition was not changed until 1970 and again in 1984 as evidence of the dangers of smoking accumulated and thanks to the work of this subcommittee, I might note. It was not until 1972 that the Federal Trade Commission was able to ex- tend the warning to cigarette advertising as well as packaging. Had the administration and the Congress known what the tobacco industry knew, the warnings in the health public health program of the U.S. Government would have been much stronger. In December 1966 when President Johnson and I were discussing his State of the Union Speech, I suggested that he recommend leg- islation to require tobacco companies to reveal the tar and nicotine content of cigarettes in their packaging and advertising. The De- partment of Health, Education, and Welfare and the Federal Trade Commission wanted the President to propose such legislation. 166 Johnson had always been reluctant to move aggressively on ciga- rettes and often remarked how hard he had found it to quit smok- ing after his heart attack in 1954. Perpetually at odds with the south because of desegregation, he didn't want to make his political life any more difficult in tobacco-growing States. As I pressed my case, I lit a cigarette from one of the two to four packs I smoked each day. Johnson pointed his finger at me and chuckled confidently, "The day you quit smoking those things, I'll send your bill to Congress." I didn't quit smoking until October 1975, and Johnson never sent the bill to the Congress. The suppression of scientific knowledge that cigarettes were ad- dictive had its most profound effect on Government public health policy during the Carter administration when I was Secretary of Health, Education, and Welfare. Mr. Chairman and members of the committee, I have over the weekend discussed the following testimony with President Jimmy Carter and with Dr. Julius Richmond who was Surgeon General of the United States when I was Secretary of HEW. President Carter had instructed me, as Secretary, that he wished to mount a major public health promotion and disease prevention campaign. Every physician and public health official whom I con- sulted said that any serious health promotion effort had to target smoking. I decided that the time had come for a second Surgeon General's report to assemble all the research of the intervening years and lay it out before the American people and the Congress. On January 11, 1979, the 15th anniversary of Dr. Terry's first report, we issued ours. Dr. Richmond and I were able to state that the evidence that cigarette smoking caused lung cancer, heart dis- ease, and numerous respiratory ailments like emphysema was — and I quote — overwhelming. This changed the nature of the dia- logue on cigarette smoking and eventually led to strengthening la- bels on cigarette packaging and advertising. What has never been revealed is the debate we had in 1978 and 1979 over whether cigarettes were addictive. Dr. William Pollin whom I had appointed as director of the National Institute of Drug Abuse, had urged the Surgeon General to declare cigarettes addict- ive. I also wanted Dr. Richmond to do so, but Dr. Richmond felt that we did not have sufficient data to make that finding. Since we knew that the tobacco interests would attack any report we issued, we believed it was imperative that we be on unimpeachable ground in all we said. I therefore agreed with Dr. Richmond, and we de- cided not to declare that cigarettes were addictive. In discussions this weekend with President Carter and Dr. Rich- mond, we all agreed to this. Had we known what the tobacco com- panies knew and had we been privy to their research on the addict- ive nature of nicotine and their ability to manipulate the amount of nicotine in cigarettes, the 1979 Surgeon General's report would have found cigarettes addictive and we would have moved to regu- late them. Unfortunately, the President of the United States, the Secretary of Health, Education, and Welfare, and the Surgeon Gen- eral of the United States were all victims of the concealment and disinformation campaign of the tobacco companies. It was not until May 16, 1988, almost 10 years later, that Sur- geon General C. Everett Koop was able to state unequivocally that 167 cigarettes and other forms of tobacco "are addicting"; nicotine is "the drug in tobacco that causes addiction" and "the pharmacologic and behavioral processes that determine tobacco addiction are simi- lar to those that determine addiction to such drugs as heroin and cocaine." Another impact of the industry's suppression campaign on Gov- ernment policy relates to research on a less hazardous cigarette. I use the term "less hazardous", Mr. Chairman, rather than the in- dustry's term "safer cigarette" because the only safe cigarette is one that is not lit. In August 1978, President Carter spoke of the possibility of a safer cigarette. He was concerned about the tobacco farmers at that time. Based on the advice of Dr. Richmond, I told the President that there was no such thing as a safer cigarette, that what little research had been done seemed to be going nowhere, and the talk of one would undermine the public health. The National Institutes of Health had funded some outside re- search on reducing the hazards of cigarettes under the direction of Dr. Gio Batta Gori. That research was not promising, and Dr. Rich- mond and I decided not to pursue it. Had we known what the to- bacco companies knew at the time, we would undoubtedly have conducted additional research to see if there was any possibility of producing a less hazardous cigarette. To this day, however. Dr. Richmond reminds me that our scientific knowledge suggests that as long as cigarettes contain tobacco there is no such thing as a safe cigarette. Thus, in two respects the tobacco companies' disinformation and concealment campaign distorted the policy of the Carter adminis- tration. First, they were able to avoid any attempt to regulate them by hiding the research they had on the addictive nature of nicotine; and, second, they led us to commit fewer resources to researching the possibility of a less hazardous cigarette. The success of the anti-smoking campaign after the second Sur- geon General's report is evidence that knowledge about the dangers of smoking affects the smoking habits of America. In the 13 years from 1965 to 1978, the portion of the population that smoked fell from 40 percent to 34 percent, a decline of 6 percentage points. In the 13 years since 1978 and the release of the second Surgeon Gen- eral's report in 1979, the portion of the population that smoked fell from 34 percent to 25 percent, a decline of 9 percentage points, a 50 percent greater drop. If our message had not been diluted by the big lie advertising of the tobacco companies in their effort to portray smoking as chic and healthy, we have every reason to believe that the drop in ciga- rette smoking would have been much faster beginning in 1964. Perhaps most disturbing, by deciding to conceal and deny the deadly consequences and addictive nature of smoking, tobacco com- panies brought — tobacco companies bought the time to scrounge for new markets. They chose two targets that were particularly vulner- able to the advertising pitch of cigarettes, women and minorities. According to a report in Vogue magazine, in the 1960's, the to- bacco industry placed 90 percent of its magazine ads in publica- tions aimed mainly at men. By the late 1970's the industry was running half its ads in women's magazines. It paid off for them. 168 From 1965 to 1977 the portion of men who smoke fell from 50 percent to 41 percent, but the portion of women who smoke barely moved, from 32 percent to 31 percent. During the same period, the smoking rate among whites fell from 40 percent to 35 percent, but among blacks, African Americans, it barely budged, from 43 per- cent to 42 percent. Today roughly 29 percent of the black popu- lation smokes, compared to only 25 percent of whites and lung can- cer has surpassed breast cancer as the leading cancer killer of women in the United States. Tobacco is history's number one serial killer. Tobacco counts among its victims some 9 million Americans who died from smok- ing-related diseases between 1964 and 1994, the 30 years of con- cealment and disinformation. This year, cigarettes will kill another 430,000 individuals. Cancer and heart disease victims of cigarette smoking fill intensive care units and hospital beds across the Nation. Some 54 million Ameri- cans are addicted to cigarettes, and another 8 million are hooked on smokeless tobacco. Today's tobacco users are tomorrow's car- nage. You have asked the Center to help you quantify the cost to Medi- care that could have been avoided had the tobacco companies re- leased their own research in 1963 and publicly warned Americans about the health consequences of smoking and the addictive nature of nicotine. From 1965 to 1993, we estimate that Medicare spent $128 billion on hospital inpatient care related to tobacco use. If 10 percent fewer people were smoking during those years. Medicare could have saved $13 billion. Looking forward, a 10 percent reduction in the number of Ameri- cans who smoked could save $80 billion in Medicare hospital costs over the next 20 years. While precise predictions are speculative, Mr. Chairman, what we can say with certainty is that if we had known then what we know now, we could have saved billions of dollars in Medicare spending alone and we could have averted mil- lions of premature deaths and disabilities. Today the case for increasing the excise tax on cigarettes and for FDA regulation of tobacco is overwhelming. Congress should raise the cigarette tax by at least $2 a pack. That would cut the number of smokers by almost 8 million people and over time save almost 2 million lives. A $2 tax would raise at least $20 billion a year in revenues. Some estimates run much higher. This would compensate the American taxpayer who is paying a $19 billion tax that the tobacco companies and tobacco use imposes on Medicare and Medicaid. The higher price of cigarettes would be most effective in deter- ring children from smoking. Children are especially vulnerable to the lure of cigarettes and the slick advertising of the tobacco com- panies. As the Surgeon General recently confirmed and as Con- gressman Wyden noted, virtually no one starts smoking after they are 21 years of age and for too many teenagers cigarettes are a drug of entry to the world of hard drugs. Using data derived from the National Institute of Drug Abuse National Household Survey on Drug Abuse, the widest survey in the country, the Center on Addiction and Substance Abuse has 169 shown the link between cigarette smoking by 12- to 17-year-olds and the use of hard drugs. Our analysis, which you will find as at- tachment A to my testimony, reveals that 12- to 17-year-olds who smoke cigarettes are 12 times more likely to use heroin than those who have never used cigarettes, 51 times more likely to use co- caine, 57 times more likely to use crack, and 23 times more likely to use marijuana. [The analysis referred to follows:] 170 Ceiilrr on iew«ort. r ENL'E. N.W. WASHTNGTON. DC goooe 47oe 202/73J-050O PACSIMWJK coa/eee-373T 101 rsACBTncc street ATLANTA. GEORGIA 30303-1763 TELEPBONT 404/!l7C-ie00 TTirx: SV2ai7 CIMCSFALD ATI, FACSIMILE: 404/872-5100 May 16, 1994 120 WliST 4STB SIRETT NEW YORK. NY 10030-4003 TBtrPHONS: eie/83» 8100 FACSOflLC: 2l3/SBe-S233 Via Facsimile 212-9S6-802Q The Honorable Joseph A. Calif ano, Jr. Center on Addiction and Substance Abuse at Columbia University 152 West 57th Street New York, New York 10019 Re: May 17 hearing of the House Snb~ conmittee on Health and the Environment Dear Mr. Secretary: King 6 Spalding represents Brown & Williamson Tobacco Corporation. We undsrstand that you will participate tomorrow in a hearing of the House Subcommittee on Health and the Environment that may include a discussion of one or more articles appearing recently in The New Ycrk Times . Those articles included references to documents believed to have been stolen and which are subject to a state court injunction. A copy of that injunction is being provided to you with this letter . Theod Hester 174 NO. 93CI04806 JEFFERSON CIRCUTT COURT DIVISION TEN ROBERT L MADDOX, ET AL PLjMNTIFFS VS. ORDER UNKNOWN DEFENDANT BY HIS ATTORNFV DEFENDANT J. FOX DEMOISEY Before the Court ii the PlaintifPj, Wyatt, and Intervening Plaintiff i, Brown & Williamson Tobacco Cotp. CB & W") Motion for a Tetnporvy Injunction and the nmultaneous motion by tbc Defendant, MeneD WiDiams ("Willianu") To Dissolve the Prejent Re»triining Order. Both panics h«ve fHed extensive brie£t and written arguments lupportiDg tbeir re«pective positions IS well &s responding to the opposing parties motions. The PlaintiS also filed a reply brief to the Defendant's motim and response menKHandum. Having reviewed those wcxrxKssdum u wefl as having coostdered the oral argumena heard by the Court on September 29, 1993, and having reviewed the deposition of the Defendant WilEamt. the Coort makes the following Findings of Fact and Coochuions of Law. pursuant to CR 52.01 and 65.04. The Defendant Williams was employed as a paralegal in the Plaintiff Wyatt law fnrn frotn Januaxy 6, 19S?, to seme period prior to July 1993. There exist within the PlaintifPi firm an analysis project foe the btervening Plaintiff B & W. Williarm was assigned to this project (affidavits of Ernest Oenents, Sosan Mays, Lorraine Harrison, and Baibar* Boiasky). As a result of his employment, the Defendant was reqniied to sign a nondisclosure agreement similar to one attached to the original complaint oo Exhibit 1, or Exhibit B attached to the Plaintiffs Motion far Tea^xMvy Injunction (these are similar, but diffaent farms). The 175 Defendant deniei recognizing either document *i one he hu ever signed (Defendant depojition page 14. line 22). Both fonw were ihown to him during hij dcpoiition. The DePeodim goct on to tay that he may or may not have ligncd a similar document (dqxjsition page 15, line 4). The Defendant's counsel raiaes the question of where is the original signed contract However, in a letter to the PUintifF dated July 9, 1993, counsel admits to having reviewed the nibject eQipIoyrQcat contract and acting in accoidance with that contract advised the Defendant to retuni the doCTunentJ to the Pliinoff (Exhibit D to Dcfendant'i Brief to Dijolve the Restraining Order). The Coun believes, based on the exhibiti and the Defendant's evasive anawer that the cootraet exists and a copy is in the Dcfendant'i possession. Paragraph Three, in both fbma, cleariy indicates an employee, npoo terminanoti, will not reiDove any confJdeotial mfSwinatJOo, reproductioo or penonally made records and will immediately return any wch records tJrudy removed (emphasis added). Counsel for the Defendant emmeously concludes thii paiagra^h it limited to material taken at the time of termination. Such a restrictive reading of thi» pnagraph ii neither logical nor wodcable. The logical extension of the Dcfendant'i reasoning woold require him to ntara only those documents in his hands when he's told he's terminated. In pafonouce of Ac contract, the Defendant should have remmed all documents, inchidtng selfnMde copia related to his employmeaL The second docunmt to have been signed by the Defendant wu a 'Coofidentiality of InfbiTTiatioa* form expreamg the Plaintiff Wyati's fmn policy (Exhibit 1 attached to the original complaint and Exhibit A as atached to the Plaintiffs Motion for • Temporary Injunction). The Defendant admits to recognizing the document (depositioo page 13, line 2), but then questioru whether or not the signature on the second page as his (deposition page 17 line J2. 176 5 through page 18. line 13). The fimn policy clearly prohibits diKlosure of any nuoen involving cHenu to persons outside the dnn. During the Defendant's cmpk>ynient with the Plaintiff Wy»tt he wu penmBed »cce» to confidentJa] matters involving the Intervening Plaintiff B A W. Apparently, whfle eojployed be made copies of docunmts al the finn and took tbem hoine (or nuy have taken the otiginali out of the office, copies, then returned them). Tlie DefetKlaat, through coonael, lubsequently on July 9. 1993, notified the PlaintifF of ttie existence of this separate file. On advice of counsel these documents were returned. The Defiendant Aea threatened to sue the Plaimiflj unless his daitu for proposed mjuries were settled. The Plaimifls have lepeatedly referred to the Defendant u a tfiief and 4at hil actions resulted in a theft of documents from the Plaintiff Wyatt Clearly in oor cunwt age of photocopy technology and under our rules of evidence (KRE 1003 and 1004) a copy may be the equivalent of the original. The Deflmdant's actions could potentially fell unda the purview of sevenl statutes within the penal code inch>ding Burglary in the Third Degree (KRS 511.040) or Crinainal Trespass is the First Degree (KRS 311.060) assuming he entered iolo die building wi^out permission and with intent to take documcnu afler his employment coded or at any time he did not so have pemiission. Other potential charges inchide Theft By Extottioa (KRS S 14.080) although it would appear there would have to be a threat of a lawsuit to acooopliah a theft and not a theft and then threatening a lawsuit The defense set out in KRS 514.080(2) is an afBmative defense which wouki have to be asserted after the Defendant is so charged. Aoodter possibility inchidcs Misapplicxtioo of Entrusted Properties (KRS 517.110). This list of criminal charges i$ not meant to be exhauitivc, but certainly Defendant! counsel must believe hii client could be charged with a cnminal ofTcna* or he would not have encouraged hina repeatedly to assert hii FifUi Anxndmeni right against icif- incriminatjon during the deposition on Octob« 6. 1993 [It U imponant in this Couiti final analywa to remember how the Defendant c*me into poatewion of these document! «i thii Cwt scenario is dearly distinguishable from caats cited by the Defendant in detennining whctha oc not a crime/ft^ud exception to the attoracy-clicnt privilege exists. Set alto Supreme Court Rnk 1.6 (b)]. Shortly after die return of die copied docunvntt, the Defendant reveals thai he had prepared a namrive and a sealed copy of aame was provided to the PlaincifF Wyiu (Septetoba 22, 1993, letter fnxn the Defendant's counsel to Plaintiff, attached as Exhftit G to Defendant's Brief to Dissolve the Restraining Order). The nanative (juotes vexbatiin, docuaaents already retunicd to the Plaintiff (Affidavit of J. Keodnck WeDs). The Court is able to gleeoj from the Defendant's Brief tiiat the narrative may inchide infomutioo from various sources includiag documents taken from the Plaintiff, information the Defendant "learned' during the course of his employment work product of non-attorney's utilized by the Plaindfft Wyatt and Brown ft Williamson i.e. accountants and infarmation from third parties not associated with this litigatiaa. Tbe Defeodants are concerned solely with the fint three categories and as they may be protected by die attorney-client privilege. Tbe Plaintiff has asserted diat die infbrmatioa taken by dw Defendant wfoetfaer documents or knowledge is subject to the attomey-cKent privilege. Aldiough diis Court recognizes that not all infbrmatioa widiin an attorney's file is subject to die privilege, it is safe -4 178 to »$sum€ that thu informatjon wxs confidcnn«l or else the Defendant would have been able to obtain it from a third source. Likewise, infonnation compiled by statisticians, accontanti, scientisu. etc. in preparation for f\>ture litigacion is alto so protected. The Defendant asserts that even if privileged, the privilege is not absolute. This Court recognizes that a long line of cases, bodi Kentucky and Fedcrai decisions, as weil at our own Suprenie Court Rule 1.6(b) hoid that the privilege does not extend to comnamicationt between attorney and client where the ctienf t purpose is the furtherance of a future ioterKlfid criioe or fraud. Standard Fire Insurance Co. v. Stnithhart Ky.. 211 S.W. 441 (1919); Ridta^ V. CotPmonweaJtfa. Ky., 75 S.Wld 737 (1934); Strong, ct al v. Abner. Ky, 105 S.W.M 599 (1937); Clark v. U.S.. 289 U.S. 1. 77 IIA. 993. 53 S.CL 465 (1933); U.S. v. Zolinj U.S. , 105 IM. 469. 109 S.O. 2619(1989); Haines v. Liggett Gn>up. Inc.. 975 F.2d 81 (3td Cir. 1992). Before this Court can determine whether the allegedly privileged conniBDcatioaa &I1 within the crime/firaud exceptioa an m camera review would be necessary. Bat before evec that hearing can be conducted, the Defeodant Williams would have to present evideace sufficient to support a. reasonable belief that an in caroera review may yiekl evidence establishing the ■ applicabQity of the crime/fraud cxccptioo. U.S. v. Zoliri. 109 S.Ct, at 2630; Haines v. Liggett Group. Inc.. 975 F.2d at 96. A blanket rule allowing judicial examinatioa of die disputed doounents based on bare allegations of Graud is no more favored than a blanket role barring such review. U.S. v. Rgynolda. 345 U.S. 1, 97 L-Ed. 727, 73 S.Ct 528 (1953). Before engaging in in camera review to detenoine the applicability of the CTtme/fraud exception, *the judge should require a showing of a Actual basis to support a good faith bdief by a reasonable person' Caklwdl r. District Court, 644 ?2i 26, 33 (Colo. 1982). that m camera review of the 179 maicnalj may reveal evidence to csubliih the claim that the crime/fraud exception applicj. U.S. v. Zolm. yupra at 2631. 2:olin rcmeyensation for a disclosure of tosh information nor to repair the damage to society's confidence in flie privilege if such a breach is permitted. Such disclosure would be detrimenta.' to the integrity of the Plaintiff Wyatt and the 181 woricing relationship it enjoys with the PUinOfT B cfeT>danfi Motion for an in camera review and to dissolve the Tcmpofiiy Restraining Older ire DENDED. The Plaintiff « Motion for a Temporary Injunctioo is CRAffTED, and IT IS HEREBY ORDERED that: 1. Defendant, Mcndl Williams, and his agents, attorneys, mccessoa and assigns, and all persons participating with, or acting on his behilf or within his control oc direction or in concert wift him, and aO persons who arc iafonned of tha Resotining Orda are hereby restrained and enjoined from (a) Disclosing to anyone other than the Plaintifft of Intervening Plaintiff any naterial or infonsatiofl in the possession or control of the said Defcnriant, Meireil WilHams, inchding, without limitation and whether in the category of "privileged' or "confidenjial' or otherwise: (i) all docianenta, coiiniuta discs and drives and other stongc/retheval systems and other tangible and dectrooic materials and things belonging to Plaintiff or any of their clients, including, without limitaaon, Intervening Plaintiff, B & W; (it) all informatioQ contained dierein and thereoa, all infcxmadon learned therefrom, and aQ informatiaci leaned in coanectioa with the employment of MeneQ Williams by Plaintiffs or Intervening PlainfifT; and (iti) all documents, maaoscripts, namtives, reprodoctioos, copies, storage and retrieval systems and charts, graphs or tables 182 on which any part of (i) or (ii) in this deHnition ha^ been collected, stored, portrayed, summanzcd, or refcTTcd to, in any manner. (b) Using for aay purpose ot in any tnanncr any of the nuterial or infonmtion defined in pangnph 1(a) hereof; and (c) Reproducing in any way any of the material or information dcfioed in pangnph 1(a) hereof. L Defendant, McneU WiHiana, and all other pcrsoni and cntitiei bound by thii Teinporaiy Injunction are hereby directtd to innnediatcly turn over to John T. B*Jlantiiie, Ogden Newell A Wekh, 1200 One Riverfront Plaza, Louisville, Kentucky 40202, »fl of 4e ibove-descnbed material and inforniation in sealed cont2iner(s); and ruch seal(s) shall not be broken, and the container's) shaD be stored by John T. Ballantine in such loanner as the panie* naay agree and, failing any such agreement, shall be kept by John T. BaPantinc under lock and key until ftmher order of the Court. 3. The Pbintiif shall post a bond of SI, 000.00. SO ORDERED, at o2 ' ' a ^jg^ qq January 7, 1994. cc: John T. Ballantine J. Fox DeMoiscy Gordon A. Smitfa THOMAS B. WINE, JUDGE DATE: -9 -I 7./^^^ ENTERED IN COURT J4N /t994 TONY MIL^R, CLEW OapunrOorti 183 THE COST OF SUBSTANCE ABUSE TO AMERICA'S HEALTH CARE SYSTEM Report 1: Medicaid Hospital Costs July 1993 I. INTRODUCTION Health care reforin has emerged as a major issue on our nation's domestic agenda. But, as the history of health system reform efforts has repeatedly demonstrated, providing quality care to aU Americans at reasonabfe cost is no mean task. It requires an examination of all the factors that contribute to health care inflation, including administrative costs and inefficiency, inappropriate and excessive use of services, malpractice and defensive medicine, emerging technologies, and excess capacity. Eliminating unnecessary Cesarean sections may save $1 billion, eliminating unnecessary bypass surgeries may save a little more, reducing excess capacity might save several billion, but, in the hierarchy of cost containment opportunities, another cost of far greater magnitude ranks high on the list: tiiat of reducing substance abuse and addiction in all its forms—including tobacco, alcohol and drugs. CASA -- The Center on Addiction and Substance Abuse at Columbia University - is conducting the first national, comprehensive study of the costs of all substance abuse - legal and illegal drugs, alcohol, and tobacco - to the nation's health care system. The first phase of this study, funded by the Henry J. Kaiser Family Foundation, focuses on the inpatient hospital costs of the Medicaid program. Subsequent reports will assess the costs of substance abuse to the rest of Medicaid (e.g., outpatient hospital costs, emergency room services, payments to physicians), Medicare, other public programs. Blue Cross/Blue Shield, commercial insurers, institutions and individuals. -7- 184 Impact of Substance Abuse and Addiction on Health Care Substance abuse and addiction is not confined to one Ulness. Its costs to the system go well beyond what is spent on direct treatment. Substance abuse is ubiquitous, reaching every comer of health care from ailments such as cancer and cardiovascular disease to trauma, birth complications and AIDS. Substance addiction and abuse is the sole cause for diseases such as alcohol cirrhosis and fetal alcohol syndrome. It is also a major risk factor for other costly health problems, including lung cancer and coronary heart disease. It complicates all sorts of otherwise unrelated diseases and ailments, such as severe bums and pneumonia, adding days and dollars to treatment. Estimates vary about the total direct and indirect cost of substance abuse to the health care system: they run as high as $140 billion a year and, thus, represent a significant portion of the total health care bill. Whatever the cost, it is clear that achieving meaningful health care reform win be difficult without addressing the problem of substance abuse. Substance abuse affects health care expenditures in both the long-term and the short-term. What we are seeing in health care expenditures, including Medicaid's, is the result of the cumulative effects of using and abusing substances over many years. This leads to illnesses such as heart disease and cancer. However, some costs stem from the more immediate medical effects of substance abuse — birth complications, injuries resulting from violence and accidents, AIDS, and strokes among younger people who overdose on drugs. Reducing the longer-term costs is important, but these shorter-term costs have special relevance in the context of health care 185 reform, since they promise more immediate savings. While substance abuse will never be eliminated entirely, some consequences are so immediate that even gradual reductions in use will pnxiuce savings in the short term. Medicaid and Substance Abuse Medicaid was chosen as the initial area for analysis for a variety of reasons. First, the skyrocketing costs of the Medicaid program top the concerns of nearly every governor in our nation. The program does not provide adequate health care to poor people, yet its costs are breaking state budgets. The current crisis prompted the Henry J. Kaiser Family Foundation to create a commission to examine Medicaid and investigate ways to improve the program while containing costs. Second, the Medicaid program covers a large number of pregnant women and children. Substance abuse has a significant impact not only on pregnancy and birth outcomes but also on life-long health care costs for infants bom to substance-abusing mothers. Lastly, the growing problem and mounting costs of AIDS is disproportionately borne by the Medicaid program since it is often the payer of last resort for a population disenfranchised from the private insurance system. In any assessment of where best to target limited resources, the impact of substance abuse on Medicaid expenditures must be considered. This study demonstrates that substance abuse takes a heavy toll on already limited Federal and state tax doUars, yet there is no explicit 186 reimbursement of substance abuse treatment or prevention services under Medicaid, nor are states required to offer such benefits (thougli some states offer limited services). Substance abuse is not a problem only for Medicaid recipients, nor are they necessarily the most costly population in this regard. Smoking, alcohol and drug abuse are equal opportunity problems affecting aU segments of our society regardless of income, race or social status. Indeed, the techniques we have developed to analyze Medicaid costs through medical and epidemiologic evidence forms the foundation for our broader study of the relationship between substance abuse and morbidity across all populations and all payers. Background Enacted in 1965, Medicaid was intended to take care of the medical needs of low-income individuals who were either part of families with dependent children, permanently and totally disabled, or elderly. The program is not only directed at the acute care needs of this population, but also finances long-term care for the needy elderly and chronically ill. Unlike Medicare, which is considered social insurance and funded through a combination of payroll taxes, premiums, and general Federal revenues, Medicaid is a welfare program, with eligibility linked to the Aid to Families with Dependent Children (AFDC) and Supplemental Security Income (SSI) programs, and is funded through general revenues generated by the states and Federal government. -10- 187 I J Medicaid is a state-administered program in which the Federal government matches state payments on a formula basis. While all states are required to meet certain federal requirements with respect to eligibility and benefits, considerable latitude is pennitted in determining eligibility, the inclusion of additional benefits, and the method and level of payment for services. In fiscal year 1994, the combined Federal and state payments under the Medicaid program are estimated to reach $146 billion. Of this, total hospital costs (including psychiatric facilities) will represent 28 percent or $41 billion. Since 1980, Medicaid costs have grown at an annual average rate of 13 percent, as opposed to only a 4.4 percent annual increase in the Consumer Price Index (CPI). n. METHODS Many studies have sought to estimate the cost of substance abuse, in one form or another, to society (See Chapter V). For the most part, these studies have analyzed the cost of one or two substances. None has estimated the costs of all substances to a particular insurer. While buUding upon earlier work, we go beyond it in a number of ways. CASA's study quantifies in a single report the total cost of substance abuse in all its forms (tobacco, alcohol, and legal and illegal drugs). It enlarges earlier efforts to incorporate fmdings from epidemiologic research in health care cost analyses. Based on the best available epidemiologic studies, we have determined the proportion of patients who acquired diseases or conditions as a result of the abuse of alcohol, drugs, or tobacco. These related costs are factored into our total cost estimate. Finally, this study suggests areas for further research and for new policy directions to address the problem of substance abuse and its costs. The following section briefly describes CASA's methodology for estimating Medicaid inpatient hospital costs related to substance abuse. A technical paper describing this methodology in more detail is being prepared for subsequent publication. 188 General Hospital Inpatient Costs In order to estimate hospital costs associated with substance abuse, we have divided these costs into four general categories: 1) Direct treatment of substance abuse; 2) Treatment of medical conditions totally attributable to substance abuse; 3) Treatment of medical conditions where substance abuse is a major risk factor; and 4) Treatment for medical conditions whose length of stay was extended due to complications arising from a secondary diagnosis of substance abuse. We calculated the costs for each category by multiplying the number of hospital days attributable to substance abuse for the diseases and conditions in each category by an average inpatient hospital cost per day. To estimate the number of Medicaid substance abuse-related days in each category, we used hospital utilization data from the 1991 National Hospital Discharge Survey (NHDS) ' applying the following criteria: 1) Direct Treatment - If the discharge had a primary diagnosis of either substance dependence or substance-induced psychosis or poisoning, the hospital stay was assumed to be for the direct treatment of the substance abuse problem. For these diagnoses, 100% of the hospital days were attributed to substance abuse. 'The National Hospital Discharge Survey is conducted annually by the National Center for Health Statistics. It is a national sample of more than 400 short-stay hospitals, producing over 200,000 discharges annually. The data are abstracted from the patients' medical records and include demographic information, up to five diagnoses coded according to the International Classification of Disease (ICD-9-CM), surgical procedures , length of stay, and expected source of payment. The sample is weighted to derive national estimates of hospital utilization. -13- 189 2) Treatment of Diseases Totally Attributable to Substance Abuse - In Category 1, the hospital stay was specifically for the treatment of the substance abuse problem. For this and the next category, the hospital stay was for treatment of a medical disease that may have been caused by the use or abuse of a substance. In this category are discharges that had a diagnosis that either specifically mentioned a substance in its name (e.g. alcoholic cirrhosis), or that the National Institute on Alcoholism and Alcohol Abuse considers as solely attributable to alcohol (e.g. pellagra), or that involve a secondary diagnosis of substance abuse in 1(K)% of the NHDS cases reported (e.g. esophageal varices). Since the hospital stay was for medical treatment of diseases caused solely by substance abuse, 100% of these hospital days were attributed to substance abuse. 3) Treatment of Diseases Where Substance Abuse is a Major Risk Factor - From an extensive review of epidemiologic research (see Bibliography), CAS A identified 72 conditions and diseases that have substance abuse as a major, but not the exclusive risk factor. These include diseases such as lung cancer and low birth weight associated with smoking; accidents and cardiovascular diseases associated with alcohol use; and premature strokes and AIDS associated with drug use. The prospective, population-based or case control studies used for this analysis often calculated (or provided sufficient data for CASA to calculate) a Population Attributable Risk (PAR) for a specific substance and disease. PAR is an epidemiologic term meaning the percentage of a given illness that could be prevented if the use of the substance were eliminated.' In other words, the ' These PARs are based on the best available epidemiologic research investigating the relationship between substance abuse and morbidity. For some diseases and conditions, there was clear evidence that a relationship exists between substance abuse and the occurrence of the condition, but prospective or case control studies which calculate PARs had not been conducted. In these cases, we employed other -14- 190 PAR for cigarettes and lung cancer is 87% indicating that 87% of lung cancers could have been prevented if there were no cigarette smoking. Based on extensive research, we assigned a PAR for each of the 72 substance-abuse related diseases (which are listed in the Appendix). With the help of a medical records coder, we then identified the diagnostic codes associated with these diseases. For each Medicaid discharge that involved any of these primary diagnoses, we multiplied the associated PAR for that disease by the total number of Medicaid days reported for that diagnosis to determine the days attributable to substance abuse. Two health problems, AIDS and birth complications proved particularly difficult with respect to estimating their costs resulting from substance abuse. For example, determining AIDS days was difficult, given that an ATDS-related condition (such as pneumocystosis) is often the primary diagnosis and AIDS is only listed secondarily. In fact, only 10,0(X) Medicaid discharges had AIDS as the primary diagnosis, clearly an underestimate. To further complicate matters, not all cases that have AIDS as a secondary diagnosis are hospitalized due to AIDS: someone may be hospitalized for an appendicitis and only coincidentally have AIDS. Thus, these hospital days could not be attributed to AIDS or substance abuse. To get a more precise estimate of AIDS -related hospital days, we identified the primary diagnoses for all Medicaid discharges that had measures than PARs, including estimates from large surveys and from medical experts. For example, in the case of AIDS, we used 1992 Center for Disease Control (CDC) surveillance data to estimate the percentage of these cases that were caused by intravenous drug use (IVDU). This surveillance data does not establish causality, it merely categorizes new cases by the risk groups they fall into. In 1992. 55% of new pediatric AIDS cases, and 33% of adult cases fell into the IVDU risk group. We applied these percentages to total reported Medicaid AIDS days to estimate those that were substance abuse-related. -15- 191 a secondary diagnosis of AIDS. Then, consulting with physicians specializing in AIDS care and research, we selected those primary diagnoses that are AIDS-related. These AIDS-related hospital days were added to the hospital days for patients discharged with a primary AIDS diagnosis and then multiplied by the percentage of Intravenous Drug Use (TVDU) as determined by the Center for Disease Control (CDC) AIDS Surveillance (see Footnote 1) to determine substance abuse related AIDS days.' Birth complications also required special analysis. Since the abuse of a substance is not responsible for the admission (i.e., the birth itself), but only for certain associated complications, we needed to calculate the marginal impact of those complications. For alcohol, the number of incremental days was a simple calculation of the difference in the number of days where alcohol was indicated as a secondary diagnosis. With respect to the impact of smoking, a PAR was applied to low birth weight babies and the number of days was calculated as described above. However, the length of stay for a normal neonate (2.3 days for each discharge) was deduaed from this since, absent the complication, this number of days still would have been used. For cocaine-exposed babies, costs related to birth complications were estimated based upon a 1986 study by Phibbs, et al of the added days associated with babies exposed to cocaine and other drugs. The results of this study (based upon a multivariate analysis) estimated that, in *A similar problem exists for other diseases such as lung cancer where, after the initial diagnosis, fiiture hospitalizations would be for other problems or procedures such as respiratory distress or chemotherapy. However, disentangling the overlap between alternative causes for these other diagnoses and those attributable to the lung cancer made it difficult to count those days in our estimates. Thus, there is reason to believe that our estimates are low since this problem would exist for a number of diagnoses. -16- 192 the case of a baby exposed to cocaine, the average length of stay was eleven (1 1) days longer than for one without this exposure. To estimate the incremental days attributable to drugs, the total number of Medicaid births involving maternal cocaine use (8% of all births) was multiplied by 11 days. 4) Additional Days for Medical Treatment Due to Substance Abuse Complications - In addition to being a risk factor for getting certain Ulnesses, active substance abuse at the time of hospitalization can also complicate an illness and add to the patient's length of stay. For example, substance abuse can compromise the inmiune system, reducing the body's ability to fight infection or some substance abuse problems (e.g., delirium tremens) need to be stabilized before doctors can treat the primary medical condition. To estimate the cost of substance abuse comorbidity, we computed the difference in length of stay between those discharges with the same primary diagnosis with and without substance abuse as a secondary diagnoses, controlling for age and sex. The total number of incremental days identified in this way were counted as substance abuse-related Medicaid days.* For each of these four categories, we estimated 1991 costs by multiplying the identified substance abuse-related days by an average hospital inpatient per diem cost of $750. This per diem estimate was based on 1990 Medicaid costs per day inflated by the hospital component of ' With respect to this fourth category, our analysis understates the impact of substance abuse comorbidity due to limitations of medical reporting (See Underestimation Issues). -17- 193 the CPI to 1991 levels. Psychiatric Hospital Inpatient Costs Since the National Hospital Discharge Survey only includes general hospitals, we employed a different method to estimate substance abuse-related Medicaid psychiatric hospital inpatient costs. The 1991 Survey of the National Association of Psychiatric Health Systems indicates that 1 1 % of patients in their facilities had a primary diagnosis of alcohol or substance-related disorders. Multiplying this percentage by 1991 Medicaid expenditures on psychiatric inpatient care, we estimated that substance abuse-related Ulness in psychiatric hospitals accounted for $238 million in Medicaid costs in 1991. '•'■■,..-' This is a conservative estimate of substance abuse's impact on psychiatric hospitals. Psychiatric hospitals often do not list substance abuse as the primary diagnosis because many insurers wUl not pay for psychiatric care unless the primary diagnoses is a specific psychiatric disorder. A large percentage of the psychiatric inpatient population are dual-diagnosed with a psychiatric disorder as the primary diagnosis and a substance abuse disorder as the secondary diagnoses. The limitations of our data restricted us from estimating the costs of these clients, but anecdotally we know that the dual-diagnosed population is increasing and that these clients use a much greater percentage of psychiatric hospital staff resources. Underestimation Issues These estimates of the cost of substance abuse to Medicaid are likely to be lower than the actual -18- 194 costs. First, while we have attempted to pull together all available q)idemiologic research on the health effects of substance abuse, more research is needed. Our results only reflect the current state of the art in this area.' Second, studies reveal that identification and reporting of substance abuse problems by medical practitioners is poor. For example, estimates of underreporting of substance abuse secondary diagnoses run as high as 60%. For reasons of confidentiality and concern over insurance reimbursement, physicians are reluctant to record * substance abuse unless it relates directly to the primary diagnosis or the treatment plan. Assuming that only 40% of cases with substance abuse actually listed it on the medical record, the complicating costs of substance abuse comorbidity may be two and a half times higher than estimated here. Third, there is little identification of tobacco use or abuse of prescription medications on the medical record: our estimates only include the complications of alcohol and illicit drug abuse. Fourth, using an average hospital cost of $750 per day may be low if substance abusers require a greater intensity of services. For example, if substance abuse bum patients are more likely to stay longer in the Intensive Care Unit (ICU) at an average cost per day of $3,000, these additional costs would not be captured in our analysis*. Finally, our estimates do not include general hospitalization costs of caring for people who join the Medicaid rolls, and benefit from its coverage, due to job loss, disability, or poverty, related to substance abuse. ' The association between illegal drug use and resulting illness has not been as thoroughly studied as that of smoking and alcohol because drug use is less prevalent in the general population and more difficult to identify since subjects are reluctant to admit openly to illegal conduct. Alcohol studies are also somewhat limited, due in part to the greater difficulty in establishing level of use (self-reporting of alcohol use is less reliable than that of tobacco because heavy use of alcohol has a negative social stigma). Even for cigarette smoking, a great deal of research is available on illnesses highly prevalent in the population such as lung cancer and heart disease, but less is available for less prevalent diseases, such as Crohn 's disease. Thus, our study only includes those diseases and conditions that have been clearly documented as related to substance abuse. We attempted to use the best research available, recognizing that the field of epidemiology is constantly evolving and sharpening its findings. Further inquiry into other related conditions would most likely significantly increase substance abuse-related Medicaid hospitalization costs. 'A study at Johns Hopkins Hospital revealed that 28 percent of 435 ICU admissions and 39 percent of ICU costs were substance abuse-relaxed (Baldwin et al). 195 m. RESULTS In 1991, Medicaid spent $4.2 billion, or 19.2 percent, of its $21.6 billion in inpatient hospital expenditures on substance abuse-related care. Based upon these results, it is estimated that for fiscal year 1994, substance abuse related costs would rise to $7.4 billion. The largest share of Medicaid substance abuse costs in hospitals — $3.4 billion or 81 percent of the total costs ~ was for medical treatment of substance abuse-related illnesses and conditions and for the increased length of stay required for patients with a coexisting substance abuse disorder. Treatment for obvious substance abuse disorders such as drug overdoses, delirium tremens, drug or alcohol dependence and abuse, and substance abuse psychoses in general and psychiatric hospitals accounted for $0.7 billion of the $4.2 billion. Most surprising, our analysis of the epidemiologic evidence reveals that 72 conditions requiring hospitalization are wholly or partially attributable to substance abuse (they are listed in the Appendix). And this list is probably not complete; though we reviewed more than 3,000 articles and papers, we were limited by what q)idemiologic research has been done to date. The following charts and tables display and describe our findings in detail. -21' 196 Charts 1-4 Charts 1 and 2 summarize the impaa of substance abuse on Medicaid inpatient hospital utilization and costs. Charts 3 and 4 break down these results by substance and by the short and long-term savings that can be accnied as a result of reducing substance abuse. Substance abuse-related hospital care accounted for 19.2% of total Medicaid hospital costs and 20% of total days in 1991. The reason for the discrepancy between the percentage of costs and days is that some of the days are in psychiatric hospitals which have a lower average cost per day than that of acute care, general hospitals. Chart 3 breaks down substance abuse-related costs by the substance involved. Tobacco and illicit drugs contribute more to Medicaid hospital costs than alcohol. The unexpectedly high proportion of hospitalizations attributed to illicit dnig use is due to birth complications resulting from cocaine use (Phibbs et al). Since Medicaid disproportionately serves women and children, a very large share of overall Medicaid hospitalization costs are, therefore, for births and biith complications. The dnig-related costs associated with birth complications may be somewhat overstated: while a significant portion of these costs were attributable to dnigs, some may also be attributable to alcohol since many drug addicts also abuse alcohol. The high correlation between drug and alcohol use among these pregnant women makes it hard to separate out the effects or determine -22- 197 < J which substance is the real culprit. In either case, whether as a result of alcohol or drugs, or both, the problem of adverse birth outcomes is strongly associated with substance abuse. Chart 4 breaks down the short- and long-term impact of substance abuse on morbidity. The $2.93 billion total in Chart 4 does not add to the total in Chart 1, since Chart 4 includes only costs related to substance abuse as a risk factor in other conditions and does not take into account substance abuse as either a secondary diagnosis or a direct treatment cost. The reason for including this table is to note that reductions in substance abuse can have a real and immediate impact on costs. In the case of birth outcomes, trauma, AIDS, and strokes among younger people, reducing substance abuse can have a significant immediate effect on health spending. By contrast, in the case of diseases like lung cancer, where the disease is acquired through long term abuse of a substance, reducing current substance abuse will not immediately affect health care costs ~ the savings would be accrued over time as less people in the future acquire those diseases. -23- 198 CO I. QJ CA (A 0 s U < CQ o u A 0 CA CQ 0 S pfi .^ S a X Q o\ 2 fH CI M a-- ^ o C a 0 0 •■N ^ • «N X) X) vo cs • t ^^^ "^ M iA ^ M -M tfi 0 U 'O 0 * > Q ^^H ^^^ II 1 ^^^ ^^k tJ 3 a ^^^^^ ^^^^^^B « C/5 0 HHh ^JH^HIil S^ S ■Bi wtM^^M ._ -^ •8 ^^^^^^^m in^J^^^^^^^^^^y ^^^H ^^^^^^^v u • M ^1^1 ^^^^^^^^r 0 _ •o ^^^H ^^^^^^^^^^ 'O V ^^^1 I^H^^^I^^N •■•' 5 -w s 1 © Cfl «c 1 « 0 ,§ ^ • • VI Q Q fS 5« S 1 ^ < 1 c u g CQ 1 1 ,fl a I? u § 1 1 0 ' S<5 200 -o ^ ^M 5 "5 1 o ^ ««• Vi g 2 B 5 « ^^1^^.^ Q pfi ^ ^^^^^^^^^^k U S .^1 ^^^H^^^^^^^^^ C c2 ^^^H ^^H ^^H^^^^^^^^ Substa ays by 1 I'l ^B jQ IH Bl^^^^^^^^w^ ^^H H^SnnnnSSnnn>n^ *3 "i ^H l^^^^^^^^^^^^^^y*^ M5 ^^ ^^^^^^^ ■^ S Med Hospl j3 ^ S 73 1 Drugs 41% a •• •c r5 1 8 o • 00 rf 0\ ^ ■ T ■ o M «* «% s ;a ^ o o la o U"^ o «' r-* IS It bus «9 «« ^ a ubstance A Total HospU X u 1 c u c "5 3 X o a 0 0 u 12 4-1 I s c V 1 u u c % 3 »4 -a II 3 Q C/5 • • C9 3 'it a c y> c 0 < I a 0 ■j? c U u *3 i/i 1 e u E 3 U ' "5 ■■n 4-* ed N a- 0 ■M 3§ U j5 "a a 0 5 "5 u U e 4-* o u ■■fi 0 u a c o E X 3 C/] 0 o X 3 X U M Q 4-1 e u a 4^ ►3 u M a X < i u 0 c '5 c 5 c 0 o CO u M 3 X < a a II Q u D 1- 'u < u a ■•5 •a < < X a 203 Charts Chart 5 breaks out the substance abuse costs in terms of the four categories of costs. The largest share -- 71 percent - of substance abuse costs are for treatment of diseases and conditions where substance abuse is a major risk factor. Direct treatment of substance abuse disorders, such as detox units, accounted for only 19 percent of substance abuse-related Medicaid costs. i Chart 6 Chart 6 details the direct treatment costs for substance abuse in general hospitals. These costs break down fairly evenly between alcohol and drugs. This chart does not include the approximately $240 million for substance abuse treatment in psychiatric facilities. The direct treatment costs in general hospitals are often not for any therapeutic treatment but, rather, for short-term treatment of immediate symptoms (e.g. , stabilizing or detoxifying the patient). Costs in psychiatric hospitals include more long-term therapies such as psychotherapy and drug rehabilitation. Charts 7-8 TTie next two charts portray in some detail the impact of substance abuse as a major risk factor in a variety of diseases. For 1991 , 3.9 million hospital days costing Medicaid close to $3 billion dollars were due to diseases or trauma where substance abuse was a major attributable risk factor. These charts portray the pervasive impact substance abuse has on all aspects of health care. Babies bom with complications due to the mother's abuse of substances during pregnancy are the major contributor to these costs and account for 32 % of all Medicaid hospital days. Cardiovascular diseases (15.7%) and respiratory diseases (15.7%) are the second and third leading diseases where substance abuse is a major risk factor. The Appendix shows the specific attributable risks of the various substances to diseases identified through the review of the epidemiologic literature. 204 S -fi^ •■■ o ^ s »=^ u u 2 5 a « ha e 0 Z 0 'J n (N M n W 0 ^ •a U a >^ ^ u u e H u ■a e o a u Q "o ja o u s ^ 0> Tf in S ^ w m o* <»■■ X vn in « c .c u c X c u a jc < "c C ■J •D C ■J C •J c c 'E o y. '5 0. o U a o •D e u a o Q < z < W5 60 P "S 0 o D Q 0 a a < c u •a e u a u ■e c c 2 c u BO a &o a c h ca ^ X* l~-" x' PI I I 3 S ? Q Q id I 0 205 4J ^ s £i < O 1—1 00 c !7; ri fi rr — ^ "^ ■w ■■1 C/3 5 A 5 "s 72 ^ 0 VO (^ •* »-H O^. t^ vC f• yj D U 0 0 •ft 1"^ C« rj tc E a c c u U 0 u — i ft •2^ c c « y "E. E a < < 2: w s ■0 73 ;:i c ^ o C a E Q u v. > c/: 5 5 5 2r S5 c 1 re a c 3 C X y c c > 0 0 2 w ■si ^ 3 • • au Z u Cii a z < U d. Q 0 E- h 1 ^ e t*- •25 5 "^ '^ ?tj u \r. w 41 0 £ 1 U 206 CHART 8: DETAILED BREAKDOWN OF MEDICAID DAYS ATTRIBUTABLE TO SUBSTANCE ABUSE AS A MAJOR RISK FACTOR Disease Davs ATOS 211.627 Complications in Pregnancy 155.483 Abortion 1 ,067 Abortion Placentae 4,878 Ectopic Pregnancy 23,970 Premature Rupture of Membrane 1 1 , 1 63 Spontaneous Abortion 11,452 Placenta Previa 40,981 Preterm Delivery 61,971 Neoplasms 265.899 Bladder 4,077 Brain 16,923 Breast 4,183 Cervix 8,873 Colon/Rectum 16,968 Esophagus 20,396 Kidney 5,953 Larynx 15,890 Liver 3,562 Lung 77,955 Oral Cavity 21,199 Pancreas 4,497 Stomach 12,503 Ureter 1,749 Other 51,171 Respiratory Disease 612,974 Asthma 102,447 Bronchitis 50,405 COPD 125,828 Emphysema 16,754 Influenza 7,237 Pneumonia 224,787 Other Respiratory 85,517 -34- 207 Disease Cardiovascular Disease Cardiomyopathy Coronary Heart Disease Endocarditis Hypertension Myocardial Infarction Peripheral Vascular Disease Cerebrovascular Disease (Stroke) Trauma Bums Newborns Congenital Defects Low Birth Weight Birth w/Cocaine Complications Digestive System Crohn's Disease Pancreatitis Peptic Ulcer Stomach Ulcers Duodenal Ulcer . ' Other •' ■ Dementia Epilepsy ■ ., :• ; Hepatitis A-C Diabetes Leukemia Low Back Pain Pelvic Inflammatory Disease Rheumatoid Arthritis Seizures Total 1991 Days Total 1991 Medicaid Costs Days 614.463 5,271 324,114 48,894 21,148 87,741 127,296 189.406 339.478 16.313 1.261.366 79,616 155,006 1,026,744 113.343 7,516 84,468 1,102 9,470 10,787 129.726 8,101 14,878 5,756 3,405 40,243 4,026 35,705 9,832 7,780 3.910.078 2.932.558. D2 *Numbers may not add to toted due to rounding -35- 208 Chart 9 The attributable risks used for this study may understate the impact of substance abuse in precipitating some diseases because they were primarily based upon only one substance. People who abuse multiple substances have a much higher risk of getting these diseases than those who abuse only one substance. Our PARs do not take into account the synergistic effect of the abuse of multiple substances in part because epidemiologic research has not thoroughly assessed the synergistic effects of poly-substance use, and because prevalence rates for people who abuse more than one substance - on Medicaid or in the general population - are not available. Chart 9 highlights the synergistic effect of dual-drug use: heavy drinking combined with heavy smoking dramatically increases the risk of throat cancer. People who smoke and drink are 135 times more likely to get throat cancer than those who abstain from both. In addition, they are 27 times more likely to get this disease than people who only smoke. This is also true for oral cavity cancer. Those who drink and smoke are 24 times more likely to contract oral cavity cancer than those who do not smoke or drink; they are 10 times more likely to contract this cancer than those who only drink. -36- 209 ^ UD tf « ^ eases y ce Abus •s S ■ «o C ^ ^ tl^i^ r* J b^ f — nkin; nergi ncer by ^^H C H r^ MB - u w u 0 and Dri ncer Syi iryngeal Ca ■ - n - c u ec J. c > c ;3 ^^^j 1 « ** s ^^^j . ;^ ^B 0 O a t£ ^^B •a 0 ^^^W avy Sm of I'hn ypopharyn -^ ^H B = H 1 i a •e 1 ^^^^^ra — ^1 1 HBI an W Ui kN C 0^ ^ 5! c a E 'C c 1 9: isks fc o •o 1 15 0 O B e <3 a s E Cf9 >^ ^ Ch elati o Z 1 f< 2 § S 210 Charts 10 - 14 Chans 10 through 14 highlight the differences in length of stay for Medicaid patients with and without a secondary diagnosis of substance abuse ~ by substance, by age and sex, and by selected diseases and conditions. As noted in the methods section, our estimates of the additional days of care required to treat patients with a secondary diagnosis of substance abuse are limited by the medical reporting of these problems. Cigarette smoking is rarely if ever recorded as a secondary diagnosis: yet, for some conditions such as pneumonia continued heavy smoking lengthens the course of recovery. Even for alcohol and drugs, studies show that as much as 60% of cases with secondary substance abuse problems go unrecorded. If true, many patients who have a substance abuse problem are incorrectly placed in the category of patients with no secondary diagnosis; since they have a longer average length of stay (ALOS), they artificially inflate the ALOS for the category without a substance abuse diagnosis, thus reducing the true difference in length of stay. Moreover, the data can demonstrate a longer length of stay for many diseases where substance abuse is a comorbid condition, but they cannot portray the greater intensity of care that many of these patients must receive as a result of a substance abuse problem. As discussed above, many of the additional bum days may be spent in the Intensive Care Unit (ICU) where additional costs per day are much higher than the $750 average daily cost we used to compute cost differences in length of stay. This also understates the cost of substance abuse to Medicaid. -38- 211 Chart 10 shows that the ALOS of the Medicaid patient without a secondary diagnosis of substance abuse is 4.99 days. When a patient has a secondary diagnosis of drug abuse the ALOS jumps to 8.4 days. With a secondary diagnosis of alcohol abuse, the ALOS increases to 8.94. If the patient has a secondary diagnosis of both alcohol and drug abuse, the ALOS jumps to 9.83 days, nearly double the ALOS for the patient without a secondary diagnosis of substance abuse. These figures represent average lengths of stay, but as can be seen from Charts 12-14, some diseases demonstrate much more significant differences. The ALOS was in fact shorter for some patients with a secondary diagnosis of substance abuse. This does not imply that these patients benefitted from the use of alcohol or drugs. Rather, the differences probably result from an aberration in the data due to the small sample of patients within these diagnoses, or from the financial or social undesirability of these patients, which can lead to early discharge or transfer (dumping) to another facility. More research is needed to examine the disposition of such patients with respect to inadequate or incomplete medical care, or a lack of sufficient attention to treating their substance abuse problem. Chart 11 compares the ALOS by sex and age for those with and without a secondary diagnosis of substance abuse. Males stay 4.2 days longer with a substance abuse problem, and females 3.1 days longer. Much of the difference in ALOS in the under 15 age group is accounted for by the effect of substance abuse on newborns (see the next chart). Note that the ALOS is greater for both genders and all age levels for those with a secondary diagnosis of substance abuse with the exception of males in the 15-44 age bracket. Given the fact that Medicaid covers men in much -39- 212 of the age range from 21 to 64 only when they have a serious and pennanent disability, the "undesirable" hypothesis described previously may explain this, since this group includes those with chronic alcohol or drinking problems as well as those diagnosed as having both mental illness and chemical dqwndency problems. Hospitals may stabilize these individuals and then discharge or transfer them quickly to nursing homes or psychiatric facilities, accounting for their shorter length of stay. According to Chart 12, babies bom to mothers who abuse substances during pregnancy remain almost three times longer in the hospital than babies bom to mothers who did not abuse substances. In utero substance abuse exposure often results in low birth weight, premature delivery, and its sequelae, mental retardation, and congenital malformations. Here again, the difference in ALOS does not include the effect of smoking during pregnancy, which would likely make these differences even more dramatic since smoking is associated with low birth weight and other adverse effects. Chart 13 reveals that AIDS patients with substance abuse as a secondary diagnosis stay about one-third longer than those without this diagnosis. Nationwide, 32 % of all adult and 55 % of aU pediatric AIDS cases are attributable to intravenous dmg use. Considering that AIDS is a protracted disease that may take ten years or more to run its course and involves multiple hospital stays, the total impact of even a third longer length of stay has significant cost implications. Medicaid patients with a primary diagnosis of bums, pneumonia, or septicemia and a secondary diagnosis of substance abuse stay more than twice as long in the hospital as Medicaid patients with the same primary diagnosis but no substance abuse (Chart 14). For example, bum patients with a secondary diagnosis of substance abuse have an ALOS of 12.6 days compared to 5.6 days for bum patients without the secondary diagnosis. 213 .Si* fill r i * 1 I - Ml rl| a < £ a fl u .J 00 s I C^^ r a a 5- V5 214 OX) a 4> "^ 2-1 • - i •■5 s u ■a < 3 X) 3 s < •- S X) 3 00 o o o IT) V^ o 00 en «s o m vO en ■6A r- ^. 00 o^ «? c^ i£ 00 o^ 2 Tt 00 00 vo '^ K ON 'O 00 2 1/-) ON ON CN CT; ly-i CO 0^ 00 00 rn o i^ *>o ^ Tt ro en 00 II u vn ^ TT 5 + rt r* V U-5 in -!j- "^ + i/i in m ^ -^ ^ o a to •a <3 f"-) ■^ 215 S „ onger base o < 1 s ^ 2 2 J§ J ^ S •. >^ B m ■ ^ W 2 SI tx-x*x%;>X;X 1 "" 1 ec E 1 ! 1 X'X'X"X*X'X*X*X;I;;;X;:;X;X; % "o ^ s u 1 1 1 i 1 1 is ^ ^ 1 1 1 1 1 1 1 1 c_ 3 00 NO ■* cs s 5 A T-" ^ u O § s 216 O CI o a I «5 !/5 •r ^ u S 5 C/2 ro i 1 •a. t to I I! % s £ 3 < >< 8 c 2 •^ 1^ M : 0 t^ i * m ■ fV rJ --- (jl — - o a 00 ^ e a I !5 CO fi o I r a E? o "J 217 c c c e B G SOURCE: National Hospital Discharge Survey. 1991. Chart 14: Medicaid Patients with Secondary Diagnosis of Substance Abuse Stay Longer Average Length of Stay for Medicaid Patients with and without Substance Abuse C 0 ff c 1 3 -S £ V. 3 ^ ■ 00 00 <> ri 00 1 00 - ill 2 i a. 0 ''*'Ji'^'^'Ji'^'^'^'^ 1 1 Burns Pneumonia 218 Chart 15 This chart details the percentage of individuals in both the Medicaid and general populations who use each respective substance. The prevalence of drinking and drug use are projected from national figures from the National Health Interview Survey data adjusting for a larger female to male ratio in the Medicaid population (females have a lower drinking rate) and for a lower socio-economic status (those in lower socio-economic status have higher drinking prevalence). r The figures do not account for overlapping use of drugs. Medicaid-specific smoking prevalence rates by age and sex were obtained from the National Medical Expenditure Survey. The significantly higher percentages for smoking among the Medicaid population are of concern, particularly since these figures are most pronounced for women during their reproductive years. The numbers on alcohol and drug use are self-reported. Since individuals tend to be reluctant to admit to alcohol abuse or illegal drug use, consumption rates for heavy alcohol use or drug use are likely to be significantly understated for the whole population, not just for Medicaid. -47- 219 y CQ 4^ ^ ^ 03 P^ e a 0 0 ON cn 00 U «PN S 0 E a 0 ' 2 ates for ulation 42.7% 14.3% d so 9 C3 60 0 o s § C» 0 < S 1 ' F 3 o U C/3 u fe E SJ 1 I ^S C o> a •»< sr a c ■t: a II ^•« ^ J 5 — S "3 a c I 6 222 Chart 17 In an era of competition, prospective payment and cost-consciousness, patients with comorbid substance abuse problems are less attractive to most hoq>itals. Since they are likely to use more resources, they may be less profitable to the institution than a patient without such complications. Patients perceived as socially and financially undesirable can place a hospital at a competitive disadvantage. This problem can be seen most dramatically with respect to Medicaid where some form of prospective payment is used as the basis for reimbursement. For example, as Chart 17 indicates, patients with a secondary diagnosis of alcohol or drug use have an average case mix index that is 41 % higher than for those patients without a secondary diagnosis. The case mix index is a measure of resource consumption for patients for a given group of diagnoses and often serves as the basis for payment. However, these patients stay on average 68 % longer in the hospital than patients without a substance abuse problem. Thus, they may be more expensive than level of reimbursement would reflect. As a result, those hospitals that have a larger share of patients with substance abuse as a comorbid condition may be at serious financial disadvantage. This, in turn, makes such patients less attractive, and limits their access to hospital care. -51- 223 iJ A CQ -«■« C o u a B P iJ Sfi V3 >» "cS CO -M s a V3 V3 o 0^ S C/) S ,fi o < V3 0^ fl ;^ o e !5 CQ i« CA a .Q 3 yi CQ 1 •5 1? Tt q ^ 00 v{ 00 5 wa vO OS e :s Case Mix p u v. 3 8 d C W •^j ui X) 3 C/3 u o 3 1-; ■■ ' & < ' . r & U 3 ca eQ •o .^ 3 s 3 C/3 w 4-1 3 0 J3 8 <*^ c ^ *i 2 c/: (A ^ 4^ !*-< 8 c IM .2 o s *■! 2 c2 ^ ' >0 ■a I 5; I 8 c 224 IV. POUCY IMPUCATIONS At least one in five dollars that Medicaid spends on hospital care is related to substance abuse. This finding of the CASA study, combined with its identification of over 70 medical conditions attributable in whole or in part to substance abuse, has profound implications for substance abuse prevention and treatment under the Medicaid program. Moreover, given the pervasiveness of smoking, and alcohol and drug abuse through all segments of American society, the implications go beyond Medicaid to the entire health care system in this country. Investing in Research We need to increase our support for research that will tell us what works in prevention and treatment, for whom, and at what cost. Through the Federal Agency for Health Care Policy and Research and the National Institutes of Health, we are currently investing a considerable amount of money in evaluating and identifying more cost-effective treatment approaches for a variety of medical problems. Given the tremendous cost of substance abuse and its impact on such a wide range of medical problems, greater investment in evaluating substance abuse treatment may yield even greater benefits in reducing morbidity and costs. In addition, with respect to basic research into the causes of diseases, the Federal government invests almost $10 billion studying diseases such as AIDS, cancer and cardiovascular diseases. Yet, it spends only 5 % of that amount on research into what causes substance addiction and abuse, a major risk factor for these and many other ailments. Finally, while a considerable body of qjidemiologic research already exists identifying the -53- 225 relationship between various substances and morbidity, there are stiU many gaps in our knowledge base. The interaction of smoking with a wide range of diseases has been well established; yet, the research is much less thorough with respect to alcohol, and is even more sketchy for legal and illegal drugs. It is important that we get a better understanding of the risks presented to us by these substances separately and synergistically. Guaranteeing Treatment We need to ensure that appropriate substance abuse treatment and continuing care is available to all who need it and is covered in all public and private insurance programs. This includes coverage for treatment of all substance abuse, including cigarettes.^ Currently, the Medicaid program has no explicit substance abuse treatment benefit and no mandate that the states provide such services. Limitations on the kinds of facilities and counselors who can be reimbursed further restricts access.' Treatment in general appears to suffer from misplaced priorities. In a short-sighted effort to cut costs, and due to skepticism about treatment effectiveness, the Administration, Congress, and private payers have been cutting back on the kinds of treatment that they cover. The reduction in private coverage shifts more of the cost back to the public sector, including Medicaid. ^ For Medicaid, the number of women in the reproductive years who smoke, combined with high rate of birth complications, argues strongly for smoking cessation programs. * Medicaid is an underused resource with respea to substance abuse. For a more complete discussion of what is possible under the Medicaid program, CASA has recently (April, 1993) prepared a study entitled 'Maximizine the Use of Medicaid Under the ACCESS Demonstration Proeram. An Opportunity for Change. ' -54- 226 A distinguished woridng group of 19 experts in drug abuse research and treatment convened by CASA in collaboration with The Brown University Center of Alcohol and Addiction studies, concluded in March of this year, that "the inclusion of a substance abuse treatment benefit is a vital part of true health system reform. " In response to this concern, the group designed a low- cost comprehensive benefit package.' Increasing Access In addition to expanding the services covered under existing programs, we need to ensure that no one who needs help is excluded by virtue of being ineligible for coverage. Currently, low- income male IV drug users between the ages of 21 and 64 are ineligible to participate in the Medicaid program. Finally, we need to target prevention and treatment efforts to high-cost, vulnerable individuals. Services must be made more accessible to attract at-risk but hard-to-reach individuals in inner city schools, shelters, community health centers, etc. Pregnant women are a particularly important group to reach. Substance abuse-related complications of newborns account for a staggering 32.3% of all Medicaid hospital days. Yet many treatment centers will not treat pregnant women because of concerns about legal liability. The GAO estimated that only about 1 1 % of the pregnant women in need of drug treatment actually receive care. 'This document, available through CASA, was entitled 'Recommendations on Substance Abuse Coverage and Health Care Reform. ' The paper was issued in March of this year. -55- 227 V. PREVIOUS RESEARCH Alcohol and Other Drug Cost Studies At present the most comprehensive studies on the economic costs of alcohol and other drug use are those commissioned by the Alcohol, Drug Abuse and Mental Health Administration in the 1980s. Cruze (1981) and Harwood (1984) studied the combined cost impact of alcohol and drug abuse and mental illness to society. Both studies, conducted by the Research Triangle Institute (RTI), estimated the total economic impact of alcohol and drug abuse and mental illness (ADM) disorders, including the direct costs of diagnoses and treatment of patients suffering from these illnesses, indirect costs associated with loss of earnings due to reduced or lost productivity, premature death, and other related costs. In their estimates of treatment and costs, the RTI studies refined previous estimates by "identifying specific diseases and illnesses that are related to alcohol, drug abuse, and mental illness (ADM) and allocating costs based on the proportions of the illnesses or diseases that are attributable to ADM." However, these attributable proportions were almost solely alcohol- related: no drug-related illnesses were included. In some cases, furthermore, estimates ranged from 0.2% to 70%. Nevertheless, this work did provide a analysis of the alcohol literature and established a clear link between epidemiologic research and cost analysis. In 1988, Rice, et al updated Harwood's cost analysis. Like Harwood, Rice attempted to estimate the total societal costs of alcohol, drug abuse, and mental illness (direct health care costs only accounted for 24% of these total costs). For estimating direct health care costs, however. Rice did not use the attributable percentages employed by Harwood. Instead, she -56- 228 created a methodology for addressing issues of comorbidity. Using tlie National Hospital Discharge Survey (NHDS), Rice first estimated the cost of alcohol, drug, or mental illness- related as a primary diagnoses following Harwood's model. Then, recognizing that secondary diagnoses of substance abuse complicates the treatment of other diseases and thus adds to hospital costs, Rice also calculated the additional days of care rqwrted for all primary diagnoses that had a secondary ADM diagnosis. Rice acknowledges at the outset that her estimates are low, restricted by the information reported on the medical records. In fact, many studies have documented that underreporting of secondary diagnoses is common, especially for conditions such as substance abuse that do not require direct treatment but contribute to longer stays and are considered embarrassing by the patient. Costs of Smoking Quantifying the costs of smoking has been a major public health issue since the 1960's. Annually, the Surgeon General issues a report on smoking and health which summarizes all current epidemiologic evidence on the relationship between smoking and disease and death. The most noteworthy of these was Reducing Health Consequences of Smoking: 25 Years of Progress, issued in 1989, which reported smoking attributable fractions (SAFs) for ten selected causes of death using data collected in a four year, fifty state study conducted by the National Cancer Society. These SAFs represent the proportion of deaths for a given disease that could have been avoided if cigarette smoking were eliminated. Many economic cost studies have relied on these estimates to calculate the number of smoking- attributable deaths for specific regions and the number of years of potential life lost as a result of smoking. Some have also employed these mortality statistics to estimate hospital utilization -57- 229 and costs. However, mortality SAFs, which measure smokers' risk of dying of a disease, arc different than morbidity SAFs, or smokers' risk of contracting a disease. Thus, mortality SAFs cannot be used reliably for estimating morbidity or hospital costs. Recognizing the shortcomings of using mortality SAFs in estimating health care costs, Rice (1986) developed a different methodology for identifying smokers' attributable risk of using health services using NHIS data. For people who had neoplastic, circulatory, and rcspiratory diseases. Rice analyzed the use of hospital days and physician visits by smokers compared to non-smokers by age and sex. From these ratios, Rice was able to calculate morbidity attributable risks which she then applied to hospital and outpatient expenditures for these diseases to estimate annual smoking-related health care costs. While not as disease-specific as the mortality-based studies. Rice's methodology set a standard for estimating aimual health care costs associated with smoking. In addition to these point-in-time estimates, others have studied the lifetime costs of smoking. For example, Manning concludes that the cumulative impact of excess medical care required by smokers at all ages far outweighs shorter life expectancy. Hodgson using survey data from the National Medical Expenditures Survey (NMES) and the National Health Interview Survey (NHIS), breaks down the differences in smokers and non-smokers expenditures by payer, revealing that over the long term, payers that cover the younger age groups (i.e. private insurers and Medicaid) bear a greater burden of smokers' costs than does, for example. Medicare. These studies have current relevance in countering the arguments that measures designed to reduce smoking (e.g., increased cigarette tax) will, in fart, increase health care costs. -58- 230 Other studies have estimated the costs of specific diseases (Harwood, 1985), of specific sub- populations (Phibbs, 1991; Rivo, 1990), of distinct hospital departments (Hauswald, 1989), and of state health expenditures (Rice, 1991; Spiegel, 1990) associated with one or more substance. Most of these studies employed some version of the Rice or Harwood methodology. 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Q. 235 ^ ^ ^^^ m in en CM o rt CN n CO (D .- ^ ^^ ^^ ^ ^ ^ 05 CO CO ^ in o CD CO CO «- CO CO ^ CO O) OJ 05 05 O) c c C C C 2 !^ J^ ^ ^ o o o o o E E E E E CO CO CO CO CO o c ■5 OT 0 o> 0 3 0 Q ■a c T3 (Q C O) O) OJ 05 C3) nj O) O) c o c c o .£ C "5 c _c 1^ £ '^ 12 £ j^ .2 ^ !2 12 o o o o o o 0 0 0 0 E u E E iiJ E E CJ E E CO < CO CO < CO CO < (/i CO ra c o JO CL > o c ID c 05 0) 0) > Q 5 S 0) u <^ u. c , ro w w U 03 0) (n O O ~ C C ± (Q re 0) O (J CL re re re c c c 0) 0 0) CC QC CC ■g o re E 0) CC 0) CO 0) 0) o o c c re re O CJ o o re re E E o o 05 W _2 re 0} 0) D D o o re re E E o o CO CO o CO 0 c ^ re 0 c 0 o» c 0 re re 0 E re "re ^ 0 ♦i^ 0 236 THE COST OF SUBSTANCE ABUSE TO AMERICA'S HEALTH CARE SYSTEM Report 2i Medicare Hospital Costs May 1 994 THE IMPACT OF SUBSTANCE ABUSE ON MEDICARE INPATIENT HOSPITAL COSTS INTRODUCTION The Annual Report of the Trustees of the Federal Hospital Insurance Trust Fund released in April 1994 projected that the Medicare program will rxin out of money in seven years. This projection of future insolvency for the Fund— which pays the vast majority of hospital costs for the elderly and disabled~is due in large part to the fact that Medicare payments for hospital costs continue to grow at an alarming rate, outstripping the revenues paid into the Fund. In responding to this crisis, invariably, the proposed solutions involve raising taxes or cutting benefits. In all these discussions, however, little time is spent in thinking about how we can keep elderly people healthy and avert hospitalizations. The worst example of this is our failure to move aggressively on the pervasive impact of substance abuse, including tobacco, alcohol and drugs, on both Medicare and overall health costs. Based on our fmdings, $20 billion 1994 inpatient Medicare hospital payments will be due to substance abuse and addiction. If the problems of substance abuse did not exist, we would not now be concerned about the solvency of the Hospital Trust Fund. Over the next seven years, substance abuse will cost the Trust Fund ahnost $170 billion. For future generations worried about the continued survival of this program, over the next 20 years, Medicare will pay out more than $1 trillion for hospital care related to substance abuse. Past studies'' have provided evidence of the impact of substance abuse on health care. Further, these studies have tended to underestimate the full magnitude of the problem because they either focus on only one substance or have not taken full advantage of the epidemiologic research that relates substance abuse to virtually every major disease category. 237 Despite such limitations, these studies still provide a powerful argument for the inclusion of substance abuse in the cost containment debate. In addition, they demonstrate the need to understand more fully just how critical this issue is if we are to address seriously not only the concerns over the solvency of the Medicare Trust Fund, but health care reform in general. The CASA Study In 1992, CASA~The Center on Addiction and Substance Abuse at Columbia University—initiated a comprehensive study documenting the full extent to which all substance abuse, including alcohol, drugs and tobacco, contributes to the costs of the health care system. Combining a critical review of the medical and epidemiologic literature linking substance abuse as a risk factor for a wide variety of medical conditions, with extensive consultation with physicians and researchers knowledgeable in this area, CASA is in the process of estimating the magnitude of this problem and its associated costs. The first phase of this project, which examined the extent to which Medicaid hospital costs might be attributed directly or indirectly to substance abuse, was completed in July of 1993.'* This study found that at least one in five hospital days under Medicaid, or $7.4 billion of Medicaid hospital costs in 1994, could be linked with the use or abuse of alcohol, tobacco or drugs. For diseases and health conditions as disparate as cancer, stroke, heart disease, AIDS, trauma, and birth complications, substance abuse has been documented to be a major risk factor. When these health effects are considered, substance abuse takes a major toll on the Medicaid program. And these estimates are undoubtedly still low because of both the underreporting of the problem and the fact that the available research, particularly for alcohol and drugs, is incomplete in documenting the full impact of substance abuse on morbidity. 238 In addition, while many had argued that the effects of these substances on disease were long-term, and the results of efforts to control abuse and addiction would not be seen for many years, the CASA study found the opposite to be the case. In fact, two-thirds of the costs of substance abuse to Medicaid were related to short-term health problems including those associated with trauma, AIDS and birth complications, where the impact on health can be seen abnost immediately. Efforts to control the use of these substances can lead to immediate savings to the health care system. The current phase of CASA's work deals with the impact of substance abuse on the use of inpatient hospital services under Medicare. As suggested in a recent study reported in the Journal of the American Medical Association^ which examined alcohol-related hospitalizations in the elderly, the costs of alcohol abuse to Medicare can be significant. But, when all substances— as well as all the health problems related to them~are considered, the costs to Medicare are astronomically higher: more than 50 times as much as was estimated in that earlier study. Using the methodology from the previous CASA study of Medicaid (described in Appendix I), but accounting for the differential impact of these substances on the elderly, as with Medicaid, substance abuse proved to be a major contributor both to morbidity and to the costs of health care for the elderly and disabled. 239 RESULTS The High Cost of Substance Abuse In 1991*, there were 2.2 million tobacco, alcohol, or drug-related Medicare admissions which accounted for 20% of all Medicare hospitalizations. Because these substance abuse-related cases tend to be more expensive to treat than the average hospital case, the amount actually paid out by Medicare for substance abuse-related care was even higher, accounting for 23% or nearly one-fourth of the total Medicare payments for hospital care.*" Substance abuse-related cases cost more to treat because they required almost 26% more hospital staff and other resources than Medicare discharges that are unrelated to substance abuse. We estimated that Medicare discharges for conditions where substance abuse was a major risk factor had a Case Mix Index (CMI - a measure of resource use) of about 1.51, compared to a CMI of 1.21 for diagnoses not related to substance abuse. As displayed in Graph 1, in dollars. Medicare spent over $13 billion of its $57 billion inpatient short-stay hospital expenditures on substance abuse-related care. These amounts exceed the 1 out of 5 dollars spent in the Medicaid program for substance-abuse related conditions. i Based upon these results, it is estimated that, for 1994, substance abuse-related Medicare hospital costs will rise to $20 billion. These costs include substance abuse-related care for both elderly and disabled Medicare recipients, with the disabled comprising 12% of these costs. * 1991 is the most recent year that National Hospital Discharge Survey data is available. ""See Methods section for discussion of how payments were calculated. 240 Si CO O § la e ^ OS a 3 to 5- e .0 I Graph 1 241 As can be seen in Table 1 , the largest share of Medicare inpatient substance abuse costs— $12.5 billion or 97% of the total— was for medical treatment of illnesses and conditions attributable to the abuse of alcohol, drugs and tobacco. These are conditioits that do not mention substance abuse in the diagnosis, but are ones that have been repeatedly shown in epidemiologic research to be associated with the use of at least one of these substances. In contrast, treatment for conditions that explicitly mention alcohol or drug abuse accoimt for only 4% of all substance abuse-related discharges, consuming 3% of those costs. This low percentage of alcohol and drug diagnoses is misleading, and is probably more reflective of a reluctance by physicians to classify the elderly population as alcohol or drug dependent, than an indication of a low prevalence of alcohol or drug use among the elderly and disabled. Underreporting of substance abuse as either a primary or secondary condition for this population is clearly a problem as depicted in Graph 2. While 5% of all Medicare beneficiaries are considered heavy drinkers and 3% report using drugs (see Table 2), only 3% of Medicare patients in the hospital had a diagnosis that mentioned either alcohol or drug use or both. Since alcohol and drug users tend to be at greater risk for medical care, we would expect them to make up a larger, not smaller, proportion of the hospitalized population. In fact, separate studies measuring alcoholism alone among the hospitalized elderly indicate that 9-20% actually have a drinking problem." This wide range in estimates of alcohol problems suggest that identification of alcoholism varies considerably across physicians. Thus, relying solely on diagnoses that explicitly mention alcohol or drugs on the medical record in order to measure the prevalence and cost of drugs and/or alcohol problems in hospitals grossly underestimates the full impact of substance abuse on Medicare costs. 242 U VI CA •"^ O Ov u 0^ ^■^ W3 s ;j JS ■X* ^ ^ 0^ ^ c :| w 5« s JQ S c» » ^ c u Q. X u c c .2 c .2 2 c _2 E 'E E S IE 0\ 00 On On O 00 < Z 0\ o\ c o 5:^ '5 r^i o u E u u (/I o c a a E 00 3 •T3 C re O u u OS u 1/3 CO u re C/5 (/I 3 X) < u u c re re u CM X) 3 — < c .2 re a. ■o u 3 O" U t/5 re Q "re c o u B re jD 3 CO ■a < C/3 O B re re •T3 B o u > > X c H 68 O a--^ 3 w ^ 3 T .•i e JS o 'q ^ *- ■C « 5 5 E C 1-5 C5 U ^ -^li e ^ -§5 ^ fe-§ S ^Q C/i *: ^ U < u V (3 u c 4-* a) 3 X) 3 ■a C/) u vs •a- 41^ .H c vS V «^ T3 C "" u 0 2 z 1 — 1 LJ Graph 2 r s u •a .1 244 0^ u 0^ a e fji 5 "3 a a ^ o c ^o 13 & a> & C 5 O fi T3 O c U CQ • • fs ^ ^m^ pfi CQ H 0^ C O a c o c 0^ o C CA o^ en od vd o on O C/D (73 U 00 00 O O o (N (/2 00 < = Table 2 E I •2 & fc 5 s ■■■* a I Q •2 O to 245 Drug use among the elderly also accounted for a very small percentage of the total discharges, even though more than 3% of this population admit to using drugs in the last year. This low number is, in part, indicative of a lack of research connecting illicit drugs with disease, and does not imply that drugs present no problem for the elderly. Further, since we were also unable to find sufficient data fi-om the epidemiologic literature to quantify the health effects of the abuse of prescription drugs, we could not estimate the extent of that problem either. Thus, our estimate of the impact of drugs--both legal and illicit~on Medicare is undoubtedly low. There is clearly a need for more research to understand and quantify the impact of all drugs on morbidity and cost. Since the elderly are such large users of prescription drugs, this research is even more critical with respect to that population. In total, we found more than 60 conditions that are associated with substance abuse covering virtually every major disease category (Appendix II)'. In the Medicare population, more than half of the substance abuse-related hospital admissions were for cardiovascular diseases, 15% for respiratory diseases, 12% for neoplasms, and 7% for bums and trauma (Table 3). These results differ somewhat from the earlier Medicaid study where the adverse impact on birth outcomes represented the major contributor to the costs attributable to the substance abuse. Further, in comparing substance abuse problems in the Medicaid and Medicare populations, the impact on Medicare was much more a result of the long-term effects of smoking. More than 80% of substance abuse-related Medicare hospital costs was for treating smoking-related medical conditions - from lung cancer to chronic pulmonary This number is lower than the 72 substance-abuse related conditions identified in the Medicaid because further analysis led us to combine some specific diagnoses into broader diagnostic categories. Appendix II provides an even more detailed breakdown of the substance abuse-related discharges in all the conditions identified. 246 9i as S < B es •*^ 09 S CO .2, 2 «2 ^^ e2 u V) 4> ^ ec a u s es •g Q < « s H (ai e ^ ^ (A 04 Z OA a u rn o 00 ■* o\ Ov o »o o Tf vq yj P-_ r-; ■^ VO vO oo' oT On' rf oC o o "O (N ■^ •^ ■^ f^ ON ^ fn u u > o •5 10 k. 'q. (0 a. 0 u CO E 3 to 0 Vm U U > u on k- u x: < u u Of 2 <^ u Q o Q Table 3 o C o 0 U-) r-' ~ NO 15 a 0^ X 'O a> o S c^ Vi fj a> 1- > w > o K jO >> o j^ u ^ w c« -^rf h QJ a O S DA u o a c^ a> H b u o • Pi* ■o 'O V ^ QJ o a 4) S ;m > o X o fi J3 o ^ • p^ ti ■^ (/) u O o H On a u s 2 u S Gra2h_3 249 difference between the two groups would have been greater. Nevertheless, despite this problem, complications resulting from a secondary diagnosis of substance abuse accounted for SI 08 million in added cost to Medicare. These figures represent average lengths of stay in Medicare but, for some diseases, the difference in length of stay was much higher. For example, for patients with pancreatitis, those requiring major joint and limb reattachments, and those with pathological fractures with a secondary diagnosis of substance abuse, patients stayed approximately twice as long as their non-substance abusing counterparts (pancreatitis 17 days vs. 8 days; major joint 24 vs. 10; pathological fractures 17 vs. 10) (Graph 4). However,' for other diseases, the ALOS was, in fact, shorter for some Medicare patients with a secondary diagnosis of substance abuse. For example, patients with respiratory infections and inflammations, cellulitis, and GI obstruction, who also had a secondary diagnosis of substance abuse, stayed less time in the hospital than non-substance abusers (e.g., respiratory infections 8.4 days vs. 11.7 days, cellulitis 7.4 vs. 8.6, and GI obstruction 3.7 vs. 7.4) This does not mean that patients with substance abuse needed less care. There are several possible explanations for why these substance abusers had shorter lengths of stay. It may result from an aberration in the data due to the small sample size of patients within these diagnoses, or because of the premature departure caused by some patients signing out against medical advice. However, it may also reflect the financial or social undesirability to hospitals of many of these patients which, in turn, may lead to their early discharge or transfer to another facility. In this context, it is worth noting that, if this hypothesis is true, as the forces of competition in health care intensify, these results suggest that such "undesirable" patients may be increasingly pushed out prematurely from some institutions. Further, the nature of the 250 S » w ^ '4id s e 5 a> - ^ '^^ s CQ ^ PL, U 3 0^ © < -^i^ •»** ^ O O tJ 'O ^ » >s -s: S C« 0^ C/^ 6^ s: •** x: s ,.? o 1 *^lJ C § o u 5 • • ^ -« J3 1 a ^ •^ C8 ^ b §0 ;5 2 o vj X. 3 < ^ i» < u c O eg c 1/5 2 3 Xi to 3 o (O # s D ■ a i-i c ea 3 •a , ..^ While this study focused on substance abuse in short stay general hospitals. Medicare also pays a significant amount in psychiatric hospital costs. According to a survey of psychiatric hospitals, 15.6 percent of total admissions were for alcohol and drug abuse- related disorders. This does not include cases where another diagnosis may have been recorded or the substance abuse was secondary to a mental health problem. But, applying this percentage to Medicare psychiatric costs, in 1991 Medicare spent an additional $160 million on care for substance abuse in psychiatric hospitals. CONCLUSION Substance abuse is a pervasive problem that is not limited to one segment of our society. Rather, old and young and rich and poor are all equally vulnerable to its effects on their health. Further, substance abuse cannot be viewed only as a single disease entity, but must be considered as a problem that permeates every aspect of our health system and is a risk factor for all major disease categories. Not only must physicians concerned with addiction medicine address this issue, but all physicians, regardless of specialty, must be aware of the fact that alcohol, tobacco and drugs are a major factor in both causing and complicating the medical problems of their patients. Thus, physicians— as well as other health care professionals-must be both capable of, and willing to identify substance abuse and take the stq>s necessary to address it. This may range from discussions with their patients about their substance abuse problems to referral to appropriate treatment. 252 But, the problem does not rest solely upon the shoulders of health care providers. What has been sorely needed in the discussions of how to contain health care costs is a discussion of how we can improve our health and reduce the morbidity that leads to those costs. To do so, we need to acknowledge the importance of substance abuse as a major factor in causing and complicating the health problems of our citizens. As a nation, we have not yet made the commitment to address the problem of substance abuse. For example, the U.S. is the only industrialized nation among a group surveyed which had a tobacco tax that amounted to less than 50% of the cost of a pack of cigarettes. U.S. total taxes amounted to only an average of 30%. In addition, most other countries have considerably greater regulation on all forms of tobacco advertising than does the U.S. Among 19 countries rated in terms of their control of advertising, the U.S. ranked 18th.' Nor have we invested sufficiently in the research necessary to identify and target effective interventions, or even to imderstand fully the relationship between various substances and illness. As we found in our own work, while there has been extensive epidemiologic research linking cigarette smoking and a variety of diseases, fewer studies relate alcohol to disease, and even less is known about the full impact of illegal drugs. Whether, in the end, we discover that substance abuse is responsible for 20 or 30 percent (or more) of health care costs may be less the issue than the fact that we already know that literally hundreds of billions of dollars are spent each year on health care as a result of substance abuse. As a result, the ftiture solvency of the Medicare Trust Fund is inextricably intertwined with what we do today to reduce substance abuse in all its forms-among our citizens. Preventing diseases that result from substance abuse and prolonging a healthy life for the elderly can be a much more potent weapon against rising Medicare expenditures than the 10 253 multitude of other, more frequently discussed cost-containment measures or benefit reductions. If there were no substance abuse, the Trust Fund's solvency would not be in doubt for almost twice the period than the Trustees are now projecting. But this issue extends beyond the Medicare program. Debating the broader issues surrounding health care reform without either acknowledging the impact of substance abuse, or including the prevention and treatment of this problem an integral part of that reform, will be a costly mistake, making it impossible to provide universal access at all; or at a cost that, as a nation, we can afford. 11 254 APPENDIX I: METHODS The methodology for this study relied primarily on the existing epidemiologic literature, as well as on consultations with physicians knowledgeable about substance abuse and related disorders. Epidemiologic Literature Search We conducted a Medline search of epidemiologic or etiologic studies that identified substance abuse (tobacco, alcohol, or drugs) as a major risk factor for acquiring a given disease/condition. In this search, we selected individual studies, reviews, or meta-analyses, that quantified either a relative risk or an attributable risk, and that generally met the criterion established by the Surgeon General for establishing causality.' Specifically, we favored studies tliat 1) reported stratified relative risks by levels of consumption or by age and sex, 2) demonstrated a dose-response relationship, 3) found diminishment of risk upon cessation of use, and 4) had findings that were generally consistent with other studies. In addition, with a very few exceptions, we used studies that measured the abusers' increased risk of acquiring a disease relative to a non-substance abuser (morbidity studies), as opposed to their increased risk of dying of the disease (mortality studies)."** Studies that were reviews or meta-analyses of other studies took priority since they combined the results of multiple studies and often reported a composite attributable or relative risk. If these were not available, we selected large prospective or case-control studies and calculated an average relative risk from these studies. When possible, we selected studies that A complete bibliography is available from CASA. 12 255 were targeted at the elderly population. However, we found that the elderly population is not often the focus of medical or epidemiologic research. In lieu of elderly-specific relative risks, we used relative risks for the general adult population. Population Attributable Risk Relative risks in epidemiologic studies are calculated by dividing the incidence of disease in the exposed group by the incidence in the disease in the non-exposed group.' Some researchers go one step further and calculate the risk, not just for the individual, but to the larger community, by measuring the Population Attributable Risk (PAR). The PAR is the proportion of cases for a given disease that may be attributable to an etiologic factor (e.g. cigarene smoking) and is calculated using the following formula:' bir-l)*l where b = prevalence of substance use in the population r = relative risk for a given disease For each disease or medical condition where a substance abuser's relative risk was reported in the epidemiologic literature, we calculated a Medicare-specific population attributable risk (PAR) using relative risks reported in the studies and the specific prevalence estimates for tobacco, alcohol, and drugs in the Medicare population. Appendix 11 provides a listing of those conditions, the related substances and their PARs. The PAR was computed using the above formula or, where different relative risks were reported by current and former users or by level of consumption, the PAR formula was revised to reflect this specificity. 13 256 Where diseases had joint multiple PARs for different substances (smoking and alcohol), the alcohol PAR was weighted by a factor of 0.5. For the Medicare population, we used a prevalence of 9% for heavy drinking based on studies of drinking in the hospitalized elderly population. The prevalence of drug use was obtained from the 1991 National Household Drug Survey, and smoking from the 1987 National Medical Expenditures Survey. For most smoking-related diseases, we calculated PARs using prevalences for current and former smokers with their respective relative risks (see TABLE 4 in Results). However, for malignant neoplastic disease, some scientific evidence suggests that once smokers have reached a certain threshold of smoking (more than 1 0 cigarettes per day for more than 35 years), their relative risk is not diminished by cessation.'" Smoking over a long period of time may have an irreversible oncogenic effect which is not altered by quitting.'"^ For the Medicare population over 65 we found that 32.7% of former smokers meet the criterion of having smoked more than 10 cigarettes per day for more than 35 years. For this reason, we considered this subset of former smokers to be equivalent to current smokers in the PAR calculations for cancer. Once PARs were computed for all diseases and conditions, 1CD-9-CM codes were matched to the general diagnostic categories used in much of the epidemiologic literature. For example, the lung cancer category included lCD-9 codes 162. 2-. 9 (malignant neoplasms of the bronchus and lung). However, if the ICD-9 codes were not specifically identified in the original study, with the assistance of a medical coder and several physician consultants, we selected ICD codes that fell into the general disease classification and then matched the PARs for that disease category with the associated ICD-9 codes (see Appendix II). 14 257 I n o to o z o u ^ 3 O o -s a. Z c>i •o c 'E 'E 'E 'E 'E 'E 'E o n o o o o o o o o o 0< CLa CU O. o o 0, a. o 5 c o c c c u u u u u ^ ."H rs ."2 ^ u G "G o G o o o o o < < < < < I o 8 I I I I I o a o u oj m n d m in r~ •^ od>oQONOsr^)irir~ t in vS " " " ~ so vO t~ •5nQO\Osr^)mr~oooNO — t^ t^ 0\ On On On On On On U E S c 1 s ■§1 ^^ o o o a. ^ u o E 11-5 ■So* ' >n'0 >»^ ^ ■£ M o g- o « 3 E .2 = !•= O « w 0, U U •s o o o ■c -S •'s o o o "(3 <* "(S >. «' »-' tt 3 5J **-(« — O -s O t §■ t u a u o c ^ = < o S U _ > O o c u u J2 ■q. .2 "> > 4> I C O 00 ON O — fsmTtodoood [^ininm>o>nmm>r) r-~0O0Q0O0O0O0O0O0O O^UIUUUUJUUU C u > E'-S s I ■to? 00 o o 13 bO "e e c I- u ^ o w o _ u 13 ^ c is ss « 3 E k. 60 O _ >» >-. 2 Xi X) o 00 ao i^ C C (« ■= 'E — •o <« 00 c IS X .2 " 13 M- E .S 13 C c c o o o c .2 £ ■Sou ■< CL. PL, c E .2 o .E ° I o o '^ '2 '9 "'2 3 Cl. u. -n &• tA y 2 2 c 2 "2 _ c c -jj n .5 "« u o a u o « "G 'G ^ G 0 V3 < < ^ < § — nt^inm — — -- — o r^ '^ ^ ^. - § ~ a(oo""^f^'~~oQoo >4D ^ 13 55% <13 Neoplasms Bladder Cancer s 188.0-188.9, 233.7 49% M 39% F Breast Cancer Cervical Cancer Cheek and Gum Cancer Colorectal Cancer A s SLT A,S 174.0-174.9, 233.0 180.0-180.9, 233.1 143.0-143.9, 145.0,234.8 153.0-153.9, 154.0-154.1 230.3-230.4 15% 28% F 86% 33% M 18% F Esophageal Cancer A, S 150.1-150.9, 230.1 100% M 97% F Laryngeal Cancer Leukemia Liver Cancer Lung Cancer A,S S A S.PS 161.0-161.9, 231.0 204.0-208.9 155.0-155.2, 230.8 162.2-162.9, 231.2 100% 20% 18% 93% M 83% F Oral/Pharyngeal Cancer A, S, SLT 140.0-141.9, 143.0-149.9, 230.0 100% M 82% F Pancreatic Cancer S 157, 230.9 37% M 31% F Prosute Cancer Renal Cancer S S 185, 233.4 189.0, 233.9 7% M 43% M 17% F Renal Pelvis Cancer Salivary Gland Cancer Stomach Cancer S SLT S 189.1 142.0-142.9 151.0-151.9, 230.2 62% 10% 35% M 28% F Ureter Cancer Vulvar Cancer Cancer, General S S S 189.2 184.0-184.9 V073, V66.2, 198.89, 199 V58.1 71% 24% 54% M 22% F 17 261 Respiratory Disease COPD S 491.0-492.9, 493.2, 494, 86% M 496 74% F Influenza s 487.0-487.1 30% Other respiratory dis. s 510.9, 511.0-511.9 37% M 512.0-512.8, 513.0, 518.0. 35% F 518.3, 518.81, 518.82 Pneumonia s 480.1-480.8, 481.0, 482.1- 482.9, 483, 485, 486 29% M Cardiovascular Disease Cardiomyopathy A Cerebrovascular Disease S, D Coronjuy Artery Disease S Coronary Heart Disease S Endocarditis Hypertension IV D A Peripheral Vascular Dis. S 425.1, 425.4, 425.9 37% M 431.0-435.9 70% M <65 73% F<65 33% M65+ 16% F65+ 410.0-410.9, 411.1-411.9. 64% 413.0-413.09. 413.2-414.09. 414.2-414.9, 427.41, 429.2-429.29, 427.41. 429.71, 429.79 413.1. 414.1, 427.1,427.41. 18% M 427.5-427.69, 427.71, 429.79, 31% F 428.0-428.19, 428.9, 429.3 421.0, 421.9 75% 401.0-401.9, 402.0-402.9 18% 403.0-403.9, 404.0-404.9 642.0, 642.2, 642.9 415.1. 416.9, 440.0-448.9 75% 451.0-451.9, 453.1-453.9, 454.0-454.9 Pregnancy Complications Placentae Previa Premature Rupture S Spontaneous Abortion Preterm Delivery Newborns Congenital Anomalies S, C S 641.0-641.1, 762.0 658.11, 658.13,658.2, 761.1 634 644.0-644.9, 656.3-656.6 740.0-759.9 26% F 32% F 37% F 18% F 20% rv D = Intravenous Drug Use; S = Smoking; A = Alcohol; SLT Smokeless Tobacco; PS = Passive Smoke. 18 262 Low Birth Weight Congenital Syphilis Digestive System S S 764.0-765.9 090.0-090.9 Cirrhosis A 571.5 Crohn's Disease S 555.0-555.9 Duodenal Ulcers A, S A 532.00-532.90 Pancreatitis, Acute A 577.0 Pancreatitis, Chronic A, S S S 577.1 Peptic Ulcers 533 Stomach Ulcers A, S A 531 44% 36% 18% 72% 32% 46% M 3% F 90% M 33% F 25% M 14% F 29% M 8% F Endocrine and Metabolic Diabetes S 250.0 4% F Other Bums A, S,D 940.0-949.9 23% Cataract S 366.1,366.3,366.45,366.9 3% M 2% F Dementia A, D 290.1,290.2.290.3,290.4, 294.1, 294.9 11% Epilepsy A 345.1,345.3,345.9 27% Hepatitis A IV D 70.1 6% Hepatitis B IV D 70.2, 70.3 12% Hepatitis C IV D 70.51, 70.59, 70.9 36% Low Back Pain S 724.2,724.5,724.8,724.9 5% Pelvic Inflammatory Dis. 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You have been sent a letter of warning, law- suits have been filed all over the place against media figures and networks to try to keep them from feeling free to tell the story about what is going on today in these hearings and in this inves- tigation, and as I indicated in our opening statement, there have been unreasonable requests — in fact, legal requests to this sub- committee— which will not be permitted to keep us from doing our work. Our responsibility now is to pick up from what we know today and try to make public policy that is appropriate to the dangers of cigarettes, and we know now that cigarette smoke is the leading cause of premature death and disease. We are paying a price be- cause, as you indicated, these figures are absolutely astounding. Nearly $1 out of $4 Medicare spends on inpatient hospital care is attributable to substance abuse, $20 billion in fiscal 1990 — 1994; 80 percent of that amount is due to the long-term effects of smoking cigarettes, including lung cancer, strokes, heart disease, and res- piratory ailments. We are looking at this Congress to reform our health care sys- tem, but our health care system can't be reformed if we are not going to do something to try to prevent these kinds of cost for the future. Can we hope to hold down health care costs, human suffer- ing, premature death, without regulating tobacco? Mr. Califano. Mr. Chairman, I think that health care reform is doomed unless substance abuse across the board is attacked front and center, and I think it is essential tobacco now be regulated. All the health care reform is, in a sense — most of the conversa- tion, unfortunately, tends to be on what I would call sick care re- form: How do we treat people? That is really closing the door of the armory after the destructive weapons are already out there, and we have got to move aggressively in this area. Mr. Waxman. One of the results of not knowing for the last 30 years about the dangers of cigarettes to the full extent that we now know is that cigarettes, to everyone's amazement when they hear it, are virtually unregulated. They are not regulated by the Food and Drug Administration; they are not regulated by the Consumer Product Safety Commission. There is a law at the Federal level that says that States refrain from selling cigarettes to minors. Is that law being enforced, and are there steps we can take to make sure that cigarettes are not sold to minors? Mr. Califano. I think the enforcement is very spotty, Mr. Chair- man. It is interesting to note that in situations in which it is en- forced, relatively modest fines on small businessmen who run candy stores or newspaper stands that sell cigarettes has resulted in their changing their conduct. I think it is imperative to enforce 291 it, because we also have to recognize that one of the ways children get hooked is by these individuals that sell them one or two ciga- rettes at a time. I mean it is just like a drug dealer who will give you a little bit of cocaine or a little bit of pot. The cigarette com- pany— the cigarette retailers will give you one or two cigarettes, then they get you hooked, and then you are into it. Mr. Waxman. The law in every State in this country prohibits the sale of tobacco to minors, and yet over 60 percent of smokers today started smoking when they were younger than 16 — 16 — and over 90 percent of the smokers today started when they were under 21. So for them to have started smoking at that age, they were evi- dently breaking the law when they were able to obtain those ciga- rettes. But smoking is not only dangerous because — to kids who start smoking, they may get addicted, but can you tell us about the link of cigarette smoking to other hard drugs? Mr. Califano. Well, Mr. Chairman, I note in the attachment to my statement, we have done an analysis. The National Institute of Drug Abuse conducts something called the National Household Survey on Drug Abuse. It is the most — involves about 30,000 households. It is the most extensive survey of its kind about drug use in America, and we — based on our analysis of that survey, it is clear to us that children who smoke, 12- to 17-year-olds, are far more likely to use illicit drugs than those who do not smoke. I cited in my testimony the figures of all smokers. If we go to heavy smokers who are teenagers who smoked more than one pack a day, the numbers become staggering. They are 51 times more likely to use heroin; they are 105 times more likely to use cocaine; they are 111 times more likely to use crack. And this is a serious problem, there is no question about it. For teenage America, ciga- rettes are a drug of entry into a world of harder drugs for many, many teenagers. Mr. Waxman. Mr. Califano, my 5 minutes is up for this round of questions, but I want to thank you for what you have had to tell us. We expect the tobacco industry to cooperate with this subcommit- tee because we are dealing with a very important public health danger. But I, like you, want to indicate that no one should be in- timidated any longer by this tactic that might have worked 10 years ago or 20 years ago of trying to intimidate. We are going to do our job on this subcommittee, we are going to treat people fairly, but we are not going to be turned aside for any reason because what we are doing is as important as anything the Congress can do when we are dealing with the health of the American people. Thank you very much. Mr. Califano. Mr. Chairman, thank you very much. I must say that in 35 years, most of it in public life, I have never, ever been subjected to something like that. I have never received a letter like that enclosing an order as preposterously broad as that. It was a blatant attempt to intimidate me, and, as I said, Mr. Chairman, I am not going to be intimidated on this subject. Mr. Waxman. Well, I commend you, Mr. Califano. Mr. Califano. Thank you. Mr. Waxman. Mr. Bliley. 292 Mr. Bliley. Mr. Chairman, thank you. Mr. Califano, you testified today that had the Government been privy to what the tobacco companies knew back when you were in office, much would have been done differently. Well, my reading of your Surgeon General's 1979 report — and, Mr, Chairman, I ask unanimous consent that it be made a part of the record. Mr. Waxman. Without objection. Mr. Bliley [continuing]. — Reflects that it contains many of the same findings as those being touted today as new and startling rev- elations allegedly concealed by the tobacco companies. [Testimony resumes on p. 320.] [The report follows:] 293 a z o i z o z < il z iJ £ CO « S » c •=. i; «j til e s a 3 3 .» 3 C S •S 3 ' S S c S| pu- is - ? I ^ : 11 1 C « 9 tf d 3 3 3 t li I $1 S I, I i' " J I a = E i ■? .E - t i - £ S 3:i p 5 §2 ■= i ii "o to 3 i S V 3 .|l — *?**<- f'S £ - w ^ * - = c bo.S S = " ., -5 = 1 a ° ? = ~ = S = " " £ i 5 .2 ^ 1 1 -s ^ : ■si c'^- - 5 = E a J — -3 ^ ^ Si g cs e ^ 3 u ■^ £ f i 1 w <^ H j: * V c -• <= ^ V- ■ a .2 o 3 § II Si E 3 E " I It .■:; c 4 = 5|3 >. E 9 3 CO -a ^ § E E t: = - in? E g »«- it a.?ji S ■= -• M * c " — is c = Q.3 E a -g S-,5 ME li £ «i 5 .£ « u " £ = « . 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Let me illustrate. Number one, a supposed revela- tion concerns the tar and nicotine levels in cigarettes and how they have been affected by what some have called secret processes em- ployed by cigarette manufacturers. Your testimony refers to this as manipulation, as others on this subcommittee and in the media have done, claiming that, had you known about companies' ability to manipulate the amount of nico- tine in cigarettes, you would have regulated them. Mr. Califano, your 1979 Surgeon General's report devoted nu- merous pages discussing the decline in tar and nicotine levels, and in the preface on page 12 you noted that this decline resulted from important changes in cigarette production technology, the develop- ment of tobacco sheet reconstitution, improvements in cigarette fil- tration and cigarette paper, the generic manipulation of tobacco strains, and increased use of plant stems and other tobacco por- tions formerly regarded as waste. Two, your testimony today also notes that had the Government been privy to companies' information about the addictive nature of cigarettes, the 1979 Surgeon General's report would have found them addictive and would have moved to regulate them. But de- spite the 1979 report's equivocation on the issue of addiction as compared to the successor 1988 report, nicotine and smoking is re- ferred to as an addiction in a number of places. For example, in the preface on page 15, your Surgeon General re- port stated, and I quote, 'Tet perhaps because nicotine is a power- ful addictive drug, millions of smokers seem unable to translate this information into personal action." On page 11, your Surgeon General report stated other studies suggest that very few smokers can satisfy their addiction on less than 10 to 12 cigarettes daily. And on page 97 of chapter 14 your report noted that nicotine has long been viewed by some persons as an addictive drug. You then quoted the following statement from the third report of the Royal College of Physicians of London, 1977, and I quote, "To- bacco smoking is a form of drug dependence, different but no less strong than that in other drugs of addiction." Three. Let's talk about some of the supposedly suppressed ciga- rette company research that, had you been privy to while at HEW, you would have acted differently. Despite what may be said in the press, this subcommittee so far has only heard in detail from the research of a former cigarette company employee. Dr. Victor DeNoble. So I have to assume that his work is included in your charge. However, Dr. DeNoble made clear at our last hearing that his work did not prove addiction. He simply found that rats would self-administer nicotine and thus that it was a positive reinforcer. Let me quote from page 11 of chapter 15 of the 1979 Surgeon Gen- eral's report: "Research has shown that animals may self-admin- ister nicotine." On page 7 of chapter 16 your report referred to several works that "emphasize the key role of nicotine as a reinforcer." On page 7 of chapter 15 the 1979 report stated, "Whether or not nicotine is the only reinforcing agent, it is still the most powerful pharmacological agent in cigarette smoke." Nicotine's role as a pri- mary reinforcer is referred to throughout the report. 321 So let me sum up. Mr. Califano, you come here today to claim that the cigarette companies conducted a disinformation and sup- pression campaign regarding the issues that you note have been in the press and considered by this subcommittee recently: So-called nicotine manipulation by secret processes employed by cigarette companies, the decline in tar and nicotine levels of cigarettes and what that means in terms of receipt by the smoker, animal tests that demonstrate that animals will self-administer nicotine, the role of nicotine in cigarettes as a positive reinforcer, and the debate over the addictive nature of nicotine in smoking. You claim that, equipped with this supposedly suppressed infor- mation, you would have acted differently during your tenure at HEW. Yet a report that you authored 15 years ago raises all these same issues, makes these same findings, or refers to sources that did. This proves that you did have the information that some would have us believe has only recently emerged and again that nothing is new here. Isn't that correct? Mr. Califano. Mr. Bliley, it is not correct. If I may respond, there was an enormous debate at HEW when I was Secretary on the issue of whether or not cigarettes were addictive, and the arti- cles that you are citing, they were articles on the other side of those issues in that same Surgeon General's report that were at- tached as part of the accumulation of data. I personally, as I indicated in my testimony, tried to get Surgeon General Richmond to formally declare cigarettes addictive and nico- tine addictive as Surgeon General Koop was able to do 10 years later. I was — I recognized the dangers of smoking, and I wanted to alert our people to them. The medical evidence, the research was not there. Had we had the additional research of the tobacco companies — and I hope the tobacco companies will come forward with every single bit of re- search and every document they have in this area so that we can lay all this out — we would have moved much more aggressively. We would have welcomed the opportunity to regulate cigarettes. Second, it is the relationship between addiction and manipula- tion that makes the manipulation so sinister. The tar was coming down, cigarettes — they were producing low-tar cigarettes and low- nicotine cigarettes — in quotes — trying to deceive the American peo- ple in saying, "These are healthier cigarettes; you can smoke these." Well, we now know — we now know that was nonsense, they are not healthier cigarettes, they create cancer, they create heart dis- ease, they create emphysema. So we did not have the formal find- ing, and C. Everett Koop, who was as aggressive as any Surgeon General in the history of this country in battling cigarettes, was unable to make that finding until he had been in office a while. Mr. Bliley. But you admit — in your statement you said that there is no such thing as a safe cigarette. Mr. Califano. That is correct. Mr. Bliley. And so you had the information. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bliley. Mr. Wyden. 322 Mr. Wyden. Thank you, Mr. Chairman, and thank you for an ex- cellent presentation, Mr. Califano. Let me join Chairman Waxman in saying that I also am very glad that you are speaking out about the tobacco industry's at- tempt to silence you. In my view, you are doing what the tobacco industry fears most, and that is speaking out, bringing the sci- entific facts to the American people, letting our citizens see the health consequences of smoking, and my view is we are going to win this fight because people like yourself, people in positions of in- fluence, are willing to come forward, take risks, and we commend you for it. Mr. Califano. Thank you, Mr. Wyden. Mr. Wyden. Let me, if I might, start by asking you this. As a former attorney, I wonder if you might comment further on news reports alleging that tobacco industry lawyers sought to insulate tobacco companies from liability. My question to you is, what would have been the ethical course for tobacco company attorneys who al- legedly had access to research and studies indicating severe health impacts relating to smoking? Mr. Califano. I think there are a whole series of ethical issues. I think these are not easy questions, Mr. Wyden, for lawyers to face. I do think that the legal profession in this area has got to take a hard look at itself, that when you begin to say either destroy documents — and I don't know whether anyone said destroy docu- ments here, but we will see over time, I am sure — when you begin to say don't conduct research, when you begin to say move the re- search out of the United States so it can't be subpoenaed, we don't want anyone to find out that we have this evidence that cigarettes kill or that cigarettes cause heart disease when we are being sued by people, I think there are serious questions about the ethics. There are ethical questions across the board here. I mean, what of the ethics of scientists keeping — keeping this secret? What of the ethics of businessmen who maintain their profits by selling some- thing, saying things about it they know not to be true, suppressing the evidence that they are lying as they are selling their product? There are really serious ethical questions throughout. I mentioned the legal profession because I spent so much time as a lawyer, and I think there really are profound issues here that I hope the American Bar Association, Bill Hide, the president, will take a good look at. Mr. Wyden. Let me ask you a question about Medicare, and again I think this is an exceptional contribution you are making. I remember all my days in senior citizens centers, and you vir- tually walk in and you see the horrible consequences of smoking with seniors and others suffering, and I think it is a great contribu- tion you are making with this Medicare analysis, and I am very troubled by something I saw in one of the papers this morning indi- cating that you felt that the share of Medicare costs attributable to tobacco was going to increase because women who are heavy smokers — this was reported in the New York Times — are beginning to enter the covered 65 and older group. I have seen some trends along the lines of what you said with advertising that would suggest that this is going to be a very seri- ous problem, because a lot of the tobacco company advertising real- 323 ly seems to target young women, and so what you have is a situa- tion where young women get addicted very early on, and then I gather there is a prospect based on your report that this is a sig- nificant factor in raising Medicare costs. Could you comment on that aspect? Mr. Califano. I think it is a significant factor. We have to re- member that the heavy smoking by women came almost a genera- tion after the heavy smoking by men, and women who smoked a lot are just beginning to enter the over-65 group, and that will un- doubtedly have the impact of increasing costs on Medicare. There is an element here that really is truly disturbing. I noticed in one of the news reports that the tobacco companies had evidence of the ability, potential, I guess, of nicotine to suppress appetite, and one of the things we didn't realize in 1978 was how relevant being thin and continuing to smoke for a woman was because she thought it would help her keep thin, suppress her appetite or what- have-you. What the cigarette companies bought, what they really bought by this campaign of suppression and disinformation, was the ability to hook millions of American women over that 30-year period because in the beginning of this period they were not smoking at the rates they are smoking at now. Mr. Wyden. I think that is a very important point, and my con- cern is that pattern of trying to target young women is continuing today. What you are talking about is evidence that it took place years ago, and my concern is, you look at the advertisements today and how it seems to be the key to independence for young women and the like seems to reflect a continuing pattern. Mr. Califano. I would hope, Mr. Wyden, that the committee would give some consideration to looking at the marketing prac- tices of the cigarette industry in this and other areas. Mr. Wyden. Let me ask you about the research — and I gather over the last few years this research has accelerated — indicating that when senior citizens who have smoked for a considerable pe- riod of time, even in that kind of situation, when they stop, their health can still improve significantly and that there is a prospect for reduced Medicare expenditures. Is that correct, and what is the state of that research? Mr. Califano. Yes, I think that is. There is research to that ef- fect. I think the Department of Health and Human Services has a lot of it. I think we have to recognize that what we are talking about is keeping people healthy and independent for a longer period of their life. That will both make the quality of their life much better and reduce the cost to the Medicare program, so that if senior citizens, if older Americans, if middle-aged Americans will quit smoking, they are likely to have much longer periods of independent living and quality living and longer periods in which they won't be a drain on the Medicare trust fund. Mr. Wyden. You are absolutely right about this matter of pre- vention. You know, the Medicare program really shows the insanity of our priorities. Medicare Part A pays these huge checks for hos- pital bills, the check goes from the Government, you know, to the insurance company, then Medicare Part B pays virtually nothing 324 for prevention. You know, Medicare Part B has a tiny preventive component. So I am very hopeful that we can get your message to the Con- gress about the need to rebuild this system and focus more on keeping people well rather than sick care, and substance abuse is at the heart of it, and we thank you for the contribution. Mr. Califano. Thank you, Mr. Wyden. Mr. Waxman. Thank you Mr. Wyden. Mr. McMillan. Mr. McMillan. Thank you, Mr. Chairman. I really do hope we can get down to facts so that senior citizens or young people can have sensible guidelines that they can live by and not simply hyperbole. You mentioned — and I want to try to get a little better under- standing of this — that you had received a letter. You didn't state who the letter was from. Mr. Califano. I did read it. The letter is from a lawyer, appar- ently a lawyer at King and Spalding. Mr. McMillan. Is there a signature on it? Mr. Califano. Yes. It says Theodore M. Hester. It says, "King and Spalding represents Brown and Williamson Tobacco Corpora- tion. We understand that you will participate tomorrow in a hear- ing of the House Subcommittee on Health" Mr. McMillan. I understand. Who is the letter from? Mr. Califano. Theodore M. Hester, who enclosed a copy of this injunction. It was obviously Mr. McMillan. And the letter makes reference to documents. What documents? Mr. Califano. Let me just read the letter and then Mr. McMillan. You don't need to read the letter. Mr. Califano. It says it may include a discussion of one or more articles appearing recently in the New York Times. Mr. McMillan. What are those articles? Mr. Califano. These articles included references to documents believed to have been stolen and which are subject to a State court injunction Mr. McMillan. Are they stolen? Mr. Califano. "A copy of that injunction is being provided to you with this letter." I have no idea, Mr. McMillan Mr. McMillan. Are they stolen documents, Mr. Califano? Mr. Califano. I have no idea, Mr. McMillan, but the order they enclose purports to prohibit any discussion of these by all persons who are informed of this restraining order, which is, I think — I haven't practiced law in a long time, but I think that is a — cer- tainly unconstitutional. Mr. McMillan. What is the restraining order that you are refer- ring to? Mr. Califano. This is a restraining order issued by a judge in Jefferson County, Ky. Mr. McMillan. What does the order state? Mr. Califano. Well, let me read it because it is the order by which I think they hope to intimidate me and stop me from testify- ing. 325 Mr. McMillan. Is this a Federal judge seeking to intimidate you? Mr. Califano. It is the hired lawyers for the tobacco company and the tobacco company Mr. McMillan. AJl lawyers are hired as far as I am concerned. But is this a court order? Mr. Califano. This is a court order signed by a judge named Thomas B. Wine dated January 7, 1994. I don't know if we have any other copies of it, but we may have. Mr. Waxman. Mr. McMillan, would you yield to me? Mr. McMillan. I would like the Secretary to answer my ques- tion. Mr. Califano. It is an order dated January 7, 1994, signed by Thomas B. Wine, and the order prohibits, as I said, among other things, "All persons who are informed of this are hereby restrained and enjoined from disclosing to anyone other than plaintiffs or in- tervening plaintiff" — which was Brown and Williamson — "any ma- terial or information in the possession of said defendant" — some- body named Williams — "including without limitation, and whether in a category of privilege or confidential or otherwise, all docu- ments, computer discs and drives and other storage retrieval sys- tems and other tangible and electronic materials and things be- longing to plaintiffs or any of their clients, including without limi- tation Brown and Williamson, all information contained therein and thereon, all documents, manuscripts, narratives, reproductions, or using for any purpose in any manner the" Mr. McMillan. Please don't read — don't read the letter. I think we are referring to documents that allegedly have been taken, sto- len, and are subject to court order with respect to their restitution, and what you are referring to as intimidation is actually the result of an order of a Federal district court judge. Is that correct? Mr. Califano. This is not a Federal district court judge, this is a judge in — in, as I said, in Jefferson County, Ky. Mr. McMillan. OK. I stand corrected. It is a State judge. Mr, Califano. Let me say, you know, I am a lawyer, I have rep- resented a lot of people, I have also been on and off in public life. I have never, ever received anything like this in my life. I am ap- palled that somebody would send something like this, have it deliv- ered, it arrives on my desk at 5:00 the night before I am supposed to testify here. It is an obvious attempt to say, "We want to intimi- date you, we don't want you testifying. Look at this order. We may file something against you. We may try and use up your resources. We" Mr. McMillan. I am not a lawyer, I am just a poor lay Member of Congress, but I think it refers to documents that are the subject of court order. Mr. Califano. It refers to articles in the New York Times. I mean if we can't discuss articles in the New York Times in this country and before this committee Mr. McMillan. I do it every day. I don't necessarily accept what they say or what anyone else says, I try to use my own judgment. But I think the documents are subject to a court order, and I think it is misleading to simply suggest that it was done to intimi- date you. That is very much at issue here, as I understand it. I 326 haven't seen the documents, and I don't know that anybody on the committee have seen the documents. Have you seen the documents, Mr. Chairman? Mr. Waxman. If you will yield to me, I would like to know if Mr. Califano has these documents. Mr. Califano. I do not have these documents. Mr. Waxman. So you are being told to not talk about some docu- ments you don't have by some court in Kentucky, and you get a let- ter from a lawyer saying don't talk about anything that has to do with anything that has to do with these documents, which means even though you have read it in the New York Times, you are not allowed to talk about it. Isn't that what is really going on? Mr. Califano. Also, in terms of intimidating, we are a small, not-for-profit research, and we do demonstrations for drugs to try and find out ways to help young kids stay off of drugs. We do re- search. We are about to try a research program for prisoners. We are a very small not-for-profit operation affiliated with Columbia University, and when that kind of a letter and that kind of an order comes, I can't tell you how that shook up people at the Cen- ter on Addiction and Substance Abuse. These are young research- ers. These are people who have devoted their life to fighting sub- stance abuse, to trying to find out how to help this country fight it, and then some heavy lawyer — heavy law firm comes in and says, "By God, you can't testify, and if you do, we are going to go after your organization or you." That is what this says. Mr. McMillan. I will reclaim my time. You brought up this issue, I didn't bring it up. I haven't seen the documents. You seem to think these documents contain information that, had you had it some years ago, you would have acted differently, and I think that is a question that we need to raise questions about. The gentleman from Virginia has very appropriately brought up information that you had access to a long time ago that perhaps would have enabled you to take action or your administration to take an action that it didn't take. So I think what is in those docu- ments may be of interest to us or what is in any other documents that may have been available to the public or to the Secretary of HEW at various — or the Surgeon Generals at various points in time. Are we on the 5-minute rule today? Mr. Waxman. We are taking turn turns of equal time. It has been over 5 minutes. Do you want to take another minute? Mr. McMillan. Well, I will see what I can do. I haven't had a chance. I would really like to be able to get into your study more in more detail, but it was marked for release, I think, today at 10 a.m. Apparently some people got it yesterday. Apparently the press got it before 10 a.m. this morning, and it makes a number of assertions in there that I think really should be examined fully in terms of their import. It is important to deter- mine to what degree substances contribute to death. But I think it is very important that we do that with sufficient detail so that we can really tell the difference. As I understand it, a very high proportion of causes of death are attributed to substance abuse, and — what is the reciprocal of that? What is it normal to die of? 327 Mr. Califano. Well, the issue is — there are two issues. One is the issue of disease and what those diseases cost. That is what lays the tremendous burden on the Medicare program, not the deaths, it is the taking care of somebody with emphysema, it is the taking care of somebody with lung cancer, it is the taking care of some- body with cardiovascular disease or chronic bronchitis, and it is the disability that often goes along with that. These costs, for example, do not include the cost of disability. The Social Security disability system pays, I am sure, at least $2 billion a year as a result of people disabled by smoking. This study — it is the diseases that are the most relevant factor in terms of the cost of the Medicare. We do lay out as clearly as we know how the exact methodology we do to do this as part of our study, and your staff can examine it. We would be happy to answer any questions. As I said, there is a bibliography of the articles used, but it wasn't based solely on the epidemiological medical information, it was also based on an examination of the hospital records of inpatient Medicare patients. I also maybe could take this opportunity — I noted that Mr. Bliley mentioned that we indicated in our methodology that we found the elderly population not the focus of medical or epidemiological re- search; in lieu of elderly-specific relative risks, we use relative risks for the general population. The fact is that is one of the reasons why these numbers are probably conservative, because the risks for the elderly who have accumulated much — many more years of disability and disease from smoking are more — are likely to be a more expensive popu- lation. Mr. McMillan. When we have had a chance to really study your report, would you be willing to come back and testify on the sub- stance within it instead of the conclusions? Mr. Califano. I would be happy to testify on any aspect of this report or help this committee and you, Mr. McMillan, any way we can, to provide any information you would like. Mr. Waxman. Thank you, Mr. McMillan. Mr. McMillan. Thank you. Mr. Waxman. Mr. Califano, we heard from researchers who, in the early 1980's, were doing work on addiction. They had been told by Philip Morris that they, because of a contract with Philip Mor- ris, couldn't disclose their research. They had a confidentiality pro- vision in their agreement as employees of Philip Morris. Now they were able to come before us because we asked the executive from Philip Morris to release them from that confidentiality agreement, and we got some testimony. Now that is, those confidentiality agreements, are one of the other ways tobacco companies use to try to keep information that they had in-house about tobacco. We have heard about a court order on some documents which evidently a judge in Kentucky feels shouldn't be revealed, but you don't have those documents, do you? Mr. Califano. Mr. Chairman, I have no documents. I have never seen any documents. I never heard of this judge or this order real- ly, and I also — all I know is, as I can say, is what I read in the newspapers, in the New York Times or the Washington Post. 328 Mr. Waxman. So you are discussing documents based on an arti- cle you read in the New York Times. Mr. Califano. I am discussing documents based on the New York Times articles by Mr. Hiltz. Mr. Waxman. So if a court order would apply to you, as this let- ter seems to suggest, because you read an article in the New York Times, everyone watching this hearing on C-Span would probably also be enjoined from discussing this information about some docu- ments that had been referred to and characterized in an article that you have talked about from the New York Times. Mr. Califano. That is right, Mr. Chairman. I think you should note, when people do something like this, it is not only an attempt to intimidate me but it is an attempt to send a signal to anyone else this committee might want to call as a witness to say, "If you are going to go before that committee, you better beware." I mean that is what I mean when I say I also think this is a blatant at- tempt to obstruct the work of this committee. Mr. Waxman. Well, it is called stonewalling. It is called intimida- tion. It is trying to put a chilling effect on everybody who might have some information or some ideas about the problems of tobacco and its use and the consequences of it to this country. You were there in the early days when our policy was formulated 30 years ago in the White House with President Johnson. You were there as Secretary of HEW under President Carter. You indicated that you were very cautious in your decisions as to what you would characterize. You said in your testimony the head of the National Institute of Drug Abuse of the United States said to you as the Sec- retary that you ought to talk about the addiction from cigarettes; you felt you didn't want to make that statement so unequivocally because you wanted to be absolutely sure of any scientific assertion that was made in any Government position. I find it amazing to have you criticized now for having known 15 years ago what the executives of the tobacco industry 3 weeks ago still denied, and that was that cigarettes are addictive, and then to criticize you for not having acted on the inforaiation because you tried to be responsible and prudent by the way you handled that very issue. I must say that I am just really quite astounded at the over- reaching of the tobacco industry to try to, even at this day, to keep information from getting to the public. Now you were there when the policy was formulated. Now iron- ically enough, you are in a position where we are evaluating 30 years of this policy where we did not take further action to stop smoking in this country, and the Medicare program may go broke, health care reform may be a sham, if we have to pay for the enor- mous health care costs because of cigarette smoking and because people weren't warned about addiction when they decided to exper- iment, usually as kids, with this particular product. Isn't that real- ly what we are talking about? Mr. Califano. That is, Mr. Chairman, you are absolutely right, and you put your finger on the most important hot button cur- rently, which is that health care reform is doomed to fail unless we deal with cigarette smoking and, I might add, some of the other 329 substance abuse too, alcohol and drugs, but cigarette smoking is the number one cost culprit, there is no question about it. Mr. Waxman. Well, I think that is why we have got to stay, on this subcommittee, focused on this issue and not in any way be dis- tracted from our responsibility by ludicrous suggestions that read- ing articles in the newspaper might well be something that we shouldn't talk about in a very distorted kind of legal reasoning. Mr. Wyden. Mr. Wyden. Just one last question again in terms of the trends you might see in the tobacco industry, Mr. Califano. There have been a number of stories in the press, most recently again this weekend in the New York Times, about the tobacco in- dustry's very aggressive efforts to promote these markets overseas, particularly in Asia. I think that there was one report, it might have been this weekend or another, that talked about millions and millions of children, for example, in China, in effect, being targets of this kind of smoking campaign. I wonder if what we are seeing here now is another part of this historical pattern of the tobacco industry to buy time to cultivate another market. It seems to me what you saw again yesterday is try to silence everybody possible. The tobacco industry wants to run the best censorship program that they can, and then buy them- selves some additional time in order to get at these very lucrative overseas markets, particularly in Asia. Is that a view that concerns you? Is that, again, part of this pat- tern of, they are always trying to look at upcoming markets? Mr. Califano. Mr. Wyden, I am profoundly concerned about that, not only because of what it says about these individuals, the tobacco companies, in selling their products overseas, often without any of the warnings that we have here, taking advantage of illit- erate populations, taking advantage of poor people, and getting them hooked on this drug, but I fear for what damage these compa- nies will do to the country I love, the United States of America, be- cause I was at an international conference in London this Feb- ruary, and there were people from Malaysia, and Columbia, and other parts of the Far East, and in the course of the conference, this colonel, the number two military officer in Columbia, turned to a couple of the Americans, and he said, "We are stopping the ex- port of cocaine from our country. People are dying to stop cocaine from going into the United States. You are pouring cigarettes into our country. You are killing far more of our people and maiming far more of our people than we ever had with this. What are you going to do about it?" And I must say, as an American, I was em- barrassed, as were the other Americans that were at that con- ference. Mr. Wyden. As you know, communications, you know, are global, and people in Asia are going to be getting the same facts as we Americans are getting, so the truth is going to get out. I mean I guess the tobacco companies can keep running, but they are never going to be able to hide completely, and I just hope that we can help discourage smoking among young people in our country and also keep the tobacco companies from buying time to addict mil- lions of other youngsters overseas and giving our country a bad name in the process. 330 Again, thank you for an excellent job in your service. Mr. Waxman. Thank you, Mr. Wyden. That figure from the New York Times, 50 million people in China will die from our export of cigarettes, I just think that is an incred- ible statistic. Mr. Califano. What are the Chinese going to say to our children when they come to really appreciate that fact and who killed those 50 million people? Mr. Waxman. Mr. Califano, you have our deep gratitude for your appearance today, and I want to commend you on your work and your testimony. Thank you. Mr. Califano. Thank you, Mr. Chairman. Mr. Waxman. We stand adjourned. [Whereupon, at 11:33 a.m., the subcommittee was adjourned, to reconvene at the call of the Chair.] REGULATION OF TOBACCO PRODUCTS THURSDAY, MAY 26, 1994 House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment, Washington, DC. The subcommittee met, pursuant to notice, at 10:18 a.m., in room 2123, Rayburn House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. Waxman. The meeting of the subcommittee will come to order. Several weeks ago the subcommittee heard disturbing testi- monies from the chief executive officers of the major U.S. tobacco companies. Despite the overwhelming preponderance of scientific knowledge, these executives denied that tobacco is a cause of human disease or death. These views were not new. In fact, tobacco industry representa- tives have systematically disputed major health findings on the dangers of tobacco for more than 40 years. y This morning we will hear from the chief executive officer of the f tobacco industries' research organization, the Council for Tobacco Research. The tobacco industry established the Council for Tobacco Re- search, or CTR, in 1954, in response to emerging research reports and public fears over the relationship between smoking and cancer. Originally known as the Tobacco Industry Research Council, the Council changed its name to the Council for Tobacco Research in 1964, the year the Surgeon General, Luther Terry, declared smok- ing a major cause of lung cancer. When it was established, the Council described itself as an agen- cy for research into questions of tobacco use and health. Its re- search decisions were to be guided by a distinguished Scientific Ad- visory Board assuring its grantees complete scientific freedom. But as we will learn this morning, secrecy replaced openness and public relations replaced science. Today we will begin to peel the cloak of secrecy covering the Council for Tobacco Research. The subcommittee is releasing a Ma- jority staff report today that shows from the very beginning the Council was a public relations ploy, a seemingly independent re- search body whose real purpose was to promote the idea that smok- ing is safe. As the documents reveal, the Council for Tobacco Research was invented not by scientific researchers seeking answers to important health questions, but by public relations experts seeking to calm (331) 332 public fears. And the Council's primary activity was not the sci- entific search for truth but rather, an extensive and lavishly fi- nanced public relations campaign that was in the words of the to- bacco executives, "entirely pro-cigarettes." Last year, in an article entitled "Smoke and Mirrors", the Wall Street Journal accused the Council of being the longest running misinformation campaign in U.S. business history. Federal District Court Judge Sarokin who reviewed documents in the Council's spe- cial project file was quoted as saying: "Despite the industries' promise to engage independent researchers to explore the dangers of cigarette smoking and to publicize their findings, the evidence clearly suggests that the research was not independent, that poten- tially adverse results were shielded under the caption of special projects, that the attorney-client privilege was intentionally em- ployed to guard against such unwanted disclosure, and that the promise of full disclosure was never meant to be honored and never was." The documents Judge Sarokin viewed remain a closely guarded secret of the tobacco industry to this day. The charges raised by the Wall Street Journal and Judge Sarokin are serious and go directly to the heart of the tobacco industries' credibility. Today, the subcommittee will explore the extent of the CTR's sci- entific independence and the nature of its interest in public health. The subcommittee is committed to lifting the veil of secrecy that has surrounded research programs of the tobacco industry. I hope today's hearing will help us understand what tobacco industry science really means. Before calling on our witness, I want to recognize members of the subcommittee for opening statements and to call on Mr. Bliley first. Mr. Bliley. Mr. Chairman, today we will hear in greater detail about the Council for Tobacco Research, a private nonprofit organi- zation that uses funds from the tobacco industry to support re- search into questions of tobacco use and health. As with other to- bacco-related issues that this subcommittee has considered re- cently, only one side of this issue has been aired in the press. It is, therefore, critically important that once again our deliberations attempt to separate fact from fiction and that we opt for good pol- icy rather than good headlines. We must approach today's proceedings with an appreciation of the fact that the Council for Tobacco Research has been in oper- ation for 40 years. We must also appreciate the fact that during re- cent times some members of the public or the scientific community and even of this body have come to see tobacco as an item not worth studying and that any scientific organization that is not ac- tively trying to drive the tobacco industry out of business and smokers underground must be instead promoting tobacco use. Hopefully members of the subcommittee will treat our witness fairly today and let him explain as fully as he may need to concern- ing what is undoubtedly a long and complex history. To emphasize the one-sidedness of this debate, permit me to focus on the second of the purported basis for the requested inves- tigation. In particular, an article that appeared on the front page of the New York Times on May 7. I refer to Chart 1. 333 The New York Times story claims that an executive of Brown & Williamson Tobacco concluded as early as 1963 on the basis of the company's own research that cigarette smoking had been shown to cause or contribute to the development of lung cancer, heart dis- ease, and emphysema. The article went on to charge that the com- pany had attempted with some success to hide its conclusions on smoking and health issues from the Federal health authorities, the U.S. Congress, and the American public. Three weeks later a short editor's note buried at the bottom of page 2 of the New York Times below advertisements for Timberland Shoes, Ethan Allen furniture, and a public auction for Persian rugs and sundry other items acknowledged that the earlier Times story had been erroneous and I refer to Chart 2. According to the editor's note, the earlier article had incorrectly quoted Brown & Williamson's general counsel as saying that the company's research had shown that cigarettes contribute to certain health problems when in fact the general counsel was simply pre- dicting what the Surgeon General was likely to say in his 1964 re- port to Congress on cigarettes. Finally, Mr. Chairman, I must regrettably note my concern over the conduct of this investigation. As you well know, these hearings are quite a departure from our usual legislative hearings where it is clear what the universe of inquiry will be. In this particular case, we are presented with a hearing that could easily encompass any activity of the Council during its 40- year history. I think everyone would agree that without the docu- ments that the Majority intends to focus on, it is impossible for members and staff to properly prepare. Thus, I thought our agree- ment to share documents made sense. Your staff did agree to share the Majority staff report with my staff but only on an embargoed basis. I was disappointed to learn that at 4:30 yesterday afternoon my staff was informed that none of the other documents would be available to them until midnight or 1 o'clock this morning. In my years as the Ranking Member on the Oversight and Investigations Subcommittee, Minority staff were afforded timely and adequate access to those documents that were the subject of the hearing. I thought I had the assurances that this subcommittee's investigation would be conducted in a similarly professional fashion. I regret that I was mistaken. Thank you, Mr. Chairman. [The charts referred to follow:] 334 CHART 1 THE NEW YORK TIMES, SATURDAY. MAY 7. 1994 Tobacco Company Was Silent on Hazards By PHILIP J. HILTS WASHINGTON, May « - Inter- nal documenis from a ir.tjor lobac- co company show (hat executives struggled with whether to disclose i« the Surgeon General what they knew in 1963 about the haiards Of cigarettes, at a time when the Sur- geon General was preparing a re- port saying for (he ftni time that cigarettes are a major health haz- ard. The executives of the. company, the Brown & Williamson Totiacca Corporation, chose to remain si- lent, to keep their research results secret, to stop work on a safer cigarette and to pursue a legal and public relations strategy of admit- ting nothing. In more than lOO docuiiiencs, t«- ters and cables from the IBM's and I970's thai provide a rare look at the Internal discussions among to- bacco executives, the officials spoke of the hazards of cigarette* and suted plainly to one another that nicotine is addictive In one document, the company's geoeraJ counsel said Brawn & WU* llemsoA's research had found chat cigarettes caused or predisposed people CO lung cancer, contributed to heart disease and might cause emphysema. The statements con- tradict the tobacco Industry's con- tention over the last three decades that it has mm been proved Uiai cigareues are hamtful or that nico- tine IS addicuve. The question ot addiction has taken on ImportMicc In recent months after (he Food and Drug Administration said for the first lime that It would consider regulat- ing cigarettes. To establish control over cigarettes, the F.D.A. said, It must show that nicotine Is addic- tive and that tobacco companies Intentionally exercise control over the amount of nicotine in cigarettes to maintain smokers' addiction. Officials of Brown & WiUtamson, which makes Kool, Vk:eroy and other braixjs. refused to comment on the documents but sent a letter to TTie New York Times today sug- gesting that the documents had been "stolen by a former employee of a law firm doing work for Brown fc Williamson." The company said the documents should not bt dis- closed because some of them may be subject lo attorney-client privi- lege and may be covered by an tnjuncuon forbidding their release. Tbe injunction was Issued by Judge Thomas B. Wine of Jefferson Cir- cuit Court in Louisville. Ky. Judge Wine is presiding over a case in which Brown L Williamson is suing a man named Merrell Williams, who they say stole documenis from the company. A lawyer for The New York Times Company, Adam Lipuk, said be did no: believe thai the injunction applied to ihe newspaper. "Under the Su- preme Coun's decisions, injunctions may be directed only to specific par- lies to a lawsuit," he said- "injunc- tions directed to the whole worW are ineffective." . Some documents were obtamed by Tl>e Times from a Government offi- ctaJ wlKi was dlstumed about the tes- timony in the House last month by the top executives of it;* seven biggest American tobacco comparues, in which they said Uiiti nicotine was not addictive. The official said that the documents were also given to Repre- sentative Ron WyjJen, Democrat of .Oregon, a smoking opponent who has lieen working on investigations of to-y -bacco companies m recem weeks/ Mr. Wyden said that he had found the documents to be "very dtsuirbingr and that he had turned over the docii^ ments to Representative Henry A. Wazman. cbalrman of the House En- er^ and Commerce Sutx:ominiitee on Health and the EnviroamenL Mr. Waxman's subcommittee has h'ekl several hearings on the tobacco industry, including the one at which the top executives ustifled. Mr. Wy- den asked each of the executives Whether in his opinion nicotine was -addictive, and each answered no. Thomas E. Sandefur Jr., the chair- man and chief executive of Brown L Williamson, said In his testimony, "I Jbelieve nicotine is not addictive." In response to a request for any re- search Che company has on nicotine .and addiction, he said he would turn over documents, but added, "We do i>ot have any animal research." 335 CHART 2 rWQMAS ^ JULEV J. ConfirtBS of the Bratcd States fiODst of TUjnrtBOitanws IDaihlnguii. BC 2051 i-iw? May ^A. 1»94 303< I|l>n>l '••M««» kill Tha N«w York T;n>e3 arti=:« fi.led with ir.acc-racy waa fror.c page r.sws while chV correction w«« in tmy print burled Insid* the newspaper. As Paul Harvey woMld »ay: 'And now for th« cmI scory' She JfeUr J|ark Stme$ W«W yOWf, SATVKOAY. MAY il. im Editors' Note A front-paRt article on May 7 re- ported thai iiuernal dwuments showed evidence of a debate among tobacco industry executives in 19C3 on wholher to disclose what they knew aboui ihc hazards of cigarcitos. While the documents do provide evidence of such i dcbole. several paragraphs of the article, including one paragraph on the front page> de- scribed part of one official's report incorrectly. The article quoted the fjcncral counsel of the Brown & Williamson Tobacco Corporation, Addison Yea- man, as saying iho company's re- search showed that cigarettes con- tributed to lung cancer, heart disease and emphysema. In fuct, Mr..Ycaman was not de- scribing Brown & Williamson's own research but was predicting what the Surgeon General would soon say m the first major report on the hazards of smoking. P-c^cX 336 Mr. Waxman. Before I call on our next colleague, I want to indi- cate to Mr. Bliley that the documents that will be referred to today are not documents that Brown & Williamson has argued about. We have shared documents that we received from the tobacco industry as quickly as we have been able to share them with the Minority. The staff report which was produced today was shared in advance with the Minority. We will continue to attempt to be as cooperative as possible with you and your staff so that we can have a full and fair hearing. Mr. Synar. Mr. Synar. Thank you, Mr. Chairman. The Council for Tobacco Research has spent the past 3 decades bullying scientists into reporting that cigarettes are less cancer causing than private and government-funded subsidies have found. The Council for Tobacco Research has refused to publish studies that the tobacco companies did not approve and the CTR has struc- tured itself so that all research results are protected by attorney- client privilege. The purpose of attorney-client privilege is not to allow attorneys to aid and abet tobacco companies' fraud on the American people. Attorney-client privilege does not protect attorneys who squelch findings of cigarettes causing cancer in rats nor does it protect at- torneys who falsely deny the health hazards of smoking to Con- gress. We need to be asking ourselves, "Are the attorneys employed by the tobacco companies functioning as counsel or as tobacco com- pany executives?" Does the attorney-client privilege extend to deci- sions made by the CTR and tobacco company attorneys to fund or not to fund a project or to withhold study results? I hope we are able to learn more today about the practices of the Council for Tobacco Research, and I look forward to further inquir- ies into the approaches used by the tobacco industry attorneys in shielding their clients' conduct from public scrutiny for over 30 years. Thank you, Mr. Chairman. [The opening statement of Mr. Synar follows:] Statement of Hon. Mike Synar Ladies and gentlemen, the subcommittee is holding this hearing to shed some light on the activities of the Council on Tobacco Research (CTR) over the past 40 years. The country's largest cigarette companies set up CTR in 1954 to provide the American people with what was supposed to be objective scientific evidence of the effects of smoking on one's health. We know today that CTR has spent the past 3 decades bullying scientists into reporting that cigarettes are less cancer-causing than reported by privately- and government-funded studies. We also know that CTR has refused to publish studies that were not to the liking of tobacco companies, and that CTR structured itself so that all research results would be protected by attorney-client privilege. These ac- tivities are detailed in the February 11, 1993, Wall Street Journal article that I have attached to this statement. [See p. 97]. Attorney-client privilege is intended to encourage a client to fully disclose his or her activities to an attorney, so that the attorney can provide the client with com- petent representation. It is not the same as the privilege which ejcists between a clergyperson and parishioner or a doctor and patient. Those are relationships of con- science or health. An attorney is there to defend a client in court. The purpose of the attorney-client privilege is not to allow attorneys to aid and abet tobacco companies' fraud upon the American people. Attorney-client privilege does not protect attorneys who squelch CTF's findings of cigarettes causing cancer 337 in rats; nor does it protect attorneys who falsely deny the health hazards of smoking to Congress. We need to be asking ourselves, are the attorneys employed by tobacco companies functioning as counsel or as tobacco company executives? Does attorney-client privi- lege apply to decisions made by CTR or tobacco company attorneys to fund or not to fund a project or to withhold study results? I hope that we are able to learn more about the practices of CTR today, and I look forward to future inquiries as to the approaches used by tobacco industry attor- neys in shielding their clients' conduct from public scrutiny over the past 30 years. Mr. Waxman. Thank you, Mr. Synar. Mr. McMillan. Mr. McMillan. Thank you, Mr. Chairman. First, I would like to thank Dr. James Glenn — I don't think any- one has thanked you yet — for joining us today to discuss the issues related to studies funded by the Center for Tobacco Research. It is my understanding that the center engaged in funding of specific disease-related research and the understanding of it for over 40 years. Before we get to those matters, I have a few questions which should be asked at the beginning of this hearing. We have spent a great deal of time on the issue of tobacco and more than a few people, myself included, are interested in finding out what it is we hope to accomplish other than satisfying an ad- diction to public attention. I was present when we recently voted legislation out of this subcommittee that restricts smoking in public places. Although it took several informational hearings and three markup attempts before we were successful, that legislation is now in the hands of the full committee. Since that legislation has moved, why are we continuing to hold hearings on tobacco? Does the chairman propose to address specific legislation and, if so, what is it? Mr. Chairman, if you would grant us the courtesy, it would be nice to evaluate the information which we obtain in the light of some specific proposal. As yet, you have identified no specific legis- lative goal which these hearings are intended to further. As al- ways, I would be interested to consider your legislation on its mer- its and on its impact on people instead of repeatedly beating the tobacco industry into the ground without apparent legislative pur- pose. The members of the subcommittee obviously feel they know enough about the issue generally, otherwise you might have a greater attendance record. Perhaps if you offered a legislative pro- posal which we could focus upon you would get as many members here as we do TV cameras from time to time. Mr. Chairman, if we have legislation, let's consider it. If not, let's quit perpetuating classic government — spinning wheels, accom- plishing nothing, wasting the time and money of everyone except for lobbyists, lawyers and public relations experts. There are other issues such as the reauthorization of the Safe Drinking Water Act, or health care reform which we could and should be working on in this subcommittee. As a matter of fact, I am going to leave in 2 minutes to go do just that with respect to trying to shape a health care reform proposal that the Energy and Commerce Committee might find a majority to support. I would like to conclude with one final query. I received just a few minutes ago a thick sheaf of documents that is labeled "the 338 Hill and Knowlton documents: How the Tobacco Industry Launched its Disinformation Campaign", which I understand was taken from files in some depository. Could I ask the question, if these papers include all of the matter that was in those files? Or have they been selected for a specific purpose and other documents concealed? With that query, I yield back the balance of my time. Mr. Waxman. I think the gentleman has asked a number of ques- tions and made some comments and I ordinarily wouldn't seek to respond, but I feel I must. I can't think of anything more important for this subcommittee, which is the Health Subcommittee, to do than to inquire about to- bacco, which kills over 400,000 Americans each year. For 40 years, we have had a veil of secrecy by the tobacco industry on what they have known, what they have done, and how they have tried to package and convince the American people to disregard the over- whelming scientific information about the dangers from tobacco. We have been fair in this subcommittee to the chief executive of- ficer of Brown & Williamson when his lawyers called and asked, we gave them a postponement. One would think they would want to come forward and answer all the news articles that have charged them with serious, serious dereliction of responsibility to the public. In fact, actions that would make one believe that they have been engaged in a conspiracy to hide from the American peo- ple information that they knew early on about addiction of ciga- rettes and the dangers from cigarettes which even to this day they did know. We think that the tobacco industry should be forthcoming and go on the record and inform not just the oversight responsibilities of this committee but for the purposes of developing a record for legis- lation. We have the bill on environmental tobacco smoke, which this subcommittee has reported. But we have Mr. Synar's bill which would give the FDA jurisdiction over cigarettes, the first time any government agency would have regulatory jurisdiction over tobacco. I have sponsored legislation as well dealing with the advertising of tobacco products. So I think what we are doing is quite appropriate and the way we intend to proceed and have proceeded is eminently fair and I intend to continue to call the hearings when it is appropriate for the subcommittee and when it will give an opportunity for the to- bacco industry to speak on the record and to answer inquiries which they even refuse to this day to answer when asked by re- sponsible press. I thank the gentleman. Mr. McMillan. Will the gentleman yield? Mr. Waxman. I certainly will. Mr. McMillan One of the themes of this hearing today will probably be the fact that we had a group of attorneys in this insti- tute who were making judgments about scientific research and I would submit that the activities of this committee are precisely the same thing. We have a group of lawyers who are trying to make judgments about scientific research. What I would like to do is to examine the fact with respect to the two pieces of legislation that you mentioned and try to really 339 hone in and see if there are things that need to be done to address those questions and let's move on with the legislation instead of en- gaging in an ongoing PR extravaganza. I thank the chairman. Mr. Waxman. The theme of this hearing is to get out the truth. That is why this hearing is being held and why we have witnesses before us to respond to questions that they have been unwilling to respond to in any other place, whether it has been from members of the press or from anyone else who is seeking to get that informa- tion which I think the public ought to have. Mr. Wyden. Mr. Wyden. Thank you very much, Mr. Chairman. First, let me say to the gentleman from North Carolina that we are here for one reason, and that is to save lives and help improve the health of the American people. The gentleman says that law- yers on this committee are all getting together to make judgments. What we are doing is following up on the recommendations of vir- tually every objective medical group in our country. We are not lawyers conducting medical inquiries. We are Members of Congress elected by our constituents to work on health care issues, and it seems to me when the Surgeon General, the American Medical As- sociation and the World Health Association all say that we need these measures to improve the public health, we have an obligation as elected officials to follow up on what these health groups are saying. Personally, I think it is high time that this committee inves- tigates the pseudoscience that has been purveyed for years by the Council on Tobacco Research. As we go to our witness, I would like to read what the Wall Street Journal had to say on this matter. They said, and I quote: "For almost 4 decades the Council for Tobacco Research in New York City has been the hub of a massive effort to cast doubt on the links between smoking and disease. Sponsored by U.S. tobacco companies and long run behind the scenes by tobacco industry law- yers, the ostensibly independent council has spent millions of dol- lars advancing sympathetic science. At the same time it has some- times disregarded or even cut off studies of its own that implicated smoking as a health hazard." Then they quote an employee named Dorothea Cohen, who worked there for 24 years saying and I quote: "When the Center for Tobacco Researchers found out that cigarettes were bad and it was better not to smoke, we didn't publicize that in press releases." She goes on to say, "The Council for Tobacco Research is just a lob- bying thing. We were lobbying for cigarettes." So I for one think it is high time we fmd out exactly what this organization does. It seems to me when the Wall Street Journal — not exactly an organ of antibusiness opinion — talks about the ac- tivities of this organization in the fashion I have described, it is our obligation as public officials to pursue it. I yield back my Mr. Waxman. Rather than yield back your time, would you yield to me? Mr. Wyden. I would be happy to. 340 Mr. Waxman. You made reference to a seminal article in the Wall Street Journal about how cigarette makers keep health ques- tions open year after year. The Council for Tobacco Research was the subject of that article. This article cited the Council for Tobacco Research as refusing to answer any questions. They refused to answer questions for the Wall Street Journal, New York Times, any of the representatives of the press in this country that gives out information to the public. Well, I think they should be called before the Congress of the United States to give out the information that I think is appro- priate for us to know about their activities and their presumed sci- entific inquiries — whether it is genuine science or public relations science, whether they are engaged in what they say they are sup- posed to do, which is to pursue the truth, or whether they are try- ing to lay a veil of secrecy over that truth. I do want to point that out. The press can't insist on these an- swers but the Congress of the United States will insist on answers to these important questions. Mr. Greenwood. Mr. Greenwood. No, thank you, Mr. Chairman. Mr. Waxman. We will leave the record open for other members of the subcommittee who wish to insert statements in the record. Mr. Waxman. Our witness this morning is Dr. James Glenn, chairman and CEO and president of the Council for Tobacco Re- search. Dr. Glenn, as is our custom in tobacco control hearings, we would like to swear in all witnesses. I want to tell you that at the desk next to you are the applicable Rules of the House, and the Rules of the Committee. They will inform you of the limits on the power of this subcommittee and the extent of your rights during your ap- pearance today. Do you or those who will accompany you desire to be represented by counsel or advised by counsel during your appearance here today? Mr. Glenn. Perhaps so, Mr. Waxman. Mr. Waxman. Well, you are entitled to be represented by counsel. I want to inform you of that fact. Do you or those who you have asked to accompany you object to appearing before this subcommittee under oath. Mr. Glenn. No, sir. Mr. Waxman. If you have no objection, I would like to ask you to rise and raise your right hand. [Witnesses sworn.] Mr. Waxman. Please consider yourself to be under oath and iden- tify yourself for the record and proceed with your testimony. TESTIMONY OF JAMES F. GLENN, CHAIRMAN, COUNCIL FOR TOBACCO RESEARCH, USA Mr. Glenn. I am Dr. James F. Glenn. I am a surgeon. I am chairman, president and chief executive officer of the Council for Tobacco Research, USA. I am pleased to be here and happy to cooperate with this com- mittee in their investigations. I am even more pleased to be able 341 to bring to public record the facts and the truth about the activities of the Council for Tobacco Research. By way of personal introduction, I am a native of Kentucky. I had my undergraduate education at the University of Rochester. I received my medical degree from Duke University. I have post- graduate training in general surgery at Harvard in the Peter Bent Brigham Hospital. I subsequently had neurologic training at Duke University after completing a tour as a flight surgeon during the Korean War. I served on the faculty at Yale University, Bowman Gray Univer- sity, and for 18 years I was chairman of the Urology Department at Duke University Medical Center. I then served as dean of the medical school at Emory University in Atlanta and then as presi- dent of Mount Sinai Medical Center, Mount Sinai Hospital and Mount Sinai Medical School in New York. For the past 7 years, I have been associated with the Council for Tobacco Research, also serving simultaneously on the faculty of the University of Kentucky, first in the capacity of director of the Lu- cille P. Markey Cancer Center at that institution, and currently as chief of staff of the University Hospital and dean for Clinical Af- fairs. My curriculum vitae and bibliography are available to you and I will be happy to answer any questions about that, but I thought I would not belabor that. I am, of course, certified by the American Board of Urology. I am a member of some 35 professional organizations. I am currently president of the International Society of Urology, and I have served as president of the Southeastern Section of Urology, the American Association of Genitourinary Surgeons, president of the Clinical So- ciety of Genito-Urinary Surgeons, president of the Society for Pedi- atric Urology, president of the Society of Pelvic Surgeons, and other associations. I have authored one of the best selling textbooks in urology and I have some 270 publications in my bibliography, which is before you. I joined the Council for Tobacco Research in 1987 at their invita- tion first as a member of the Scientific Advisory Board then as their assistant scientific director, subsequently as scientific direc- tor, and I am currently chairman, president, and CEO of the orga- nization. There has been recently a great deal of negative press about the Council for Tobacco Research. We have been accused of being a public relations ploy for the tobacco industry. We have not re- sponded to many of these inaccuracies in the press because we didn't want to appear as a public relations arm. It has been said that we have concealed research from the public and provided misinformation about tobacco use and disease. Quite the contrary. Indeed, I reject both of those implications. As this hearing pro- gresses, I hope to demonstrate to you that the activities of the CTR have been open and aboveboard at every turn. The Scientific Advisory Board does not consider whether research results will be favorable or unfavorable to the tobacco industry. We are scientists and we seek scientific truth. 342 We encourage independent investigators to publish their results in reputable journals, preferably peer-reviewed. The industry exer- cises no control over our activities, over the granting of funds for basic research, or the sort of research that will be pursued. The Council has never diverted any research into special pro- grams or special projects for the purpose of suppressing research. Those who have worked with the Council over the years, as I have, recognize these allegations to be untrue. Let me try to give you some facts to replace these erroneous speculations. The Council is a private, nonprofit organization that sponsors re- search into questions of tobacco use and health. It was founded in 1954 as the Tobacco Industry Research Committee, later changing its name to the current one. It has been funded primarily by the five major tobacco manufac- turers over the years. The awards are approximately $20 million per year at the present time, making the Council for, CTR one of the largest private granting agencies in the Nation. We have awarded over $220 million over the years, funding some 1,380 projects by about 1,000 biomedical investigators. All this research has been performed by independent scientists. The Council for Tobacco Research does not accomplish research on its own. We have no research facilities. We are simply a funding agency for independently accomplished private research. The funded research has been done at preeminent medical insti- tutions throughout this country and abroad. We have grants at Harvard university, Johns Hopkins, Duke University, the Univer- sity of Texas, the Mayo Clinic, Scripps Research Institute, the Na- tional Institutes of Health, and several Veteran's Administration hospital facilities. A large number, perhaps the overwhelming majority of the re- search projects that we have funded, have been co-funded by other distinguished granting agencies including the National Institutes of Health, and its National Cancer Institute, also by the Environ- mental Protection Agency, the American Cancer Society, the Amer- ican Lung Association, and the American Heart Association. I am sure if you have perused the 30 copies of the annual reports that we have provided for you you will see the nature of the re- search and also the credits of those efforts both to the CTR and si- multaneously to other agencies. The funding is provided for research in certain key biomedical areas. Cancer leads the list. Over half of our grants at the present time are devoted to some aspect of malignant disease. Cardio- vascular diseases have played an important role. We are support- ing research in cellular and molecular biology and developmental biology. Epidemiology has been an interest, though fading, because epi- demiologic studies are not at the cutting edge of science any longer. We are progressively funding research into areas of genetics, im- munology, the neurosciences, and I might mention that currently we are sponsoring a conference here in Washington, DC, which is under the auspices of the New York Academy of Sciences and it deals with the functional diversity of interacting receptors. This conference is a special conference of the New York Academy. 343 Our sponsors were willing to add additional funds to our re- search fund in order to sponsor this conference. It is now in its sec- ond day here in this city. It is comprised of some of the most distin- guished neuroscientists in the world. Our focus has been on basic research. In recent years all medical research has focused on the macroscopic to the microscopic. We are now down to the cellular and molecular level as the basis for dis- ease. Until we understand the mechanisms that can induce cell regulation and deregulation, we cannot answer the fundamental question of what causes cancer, for example. We believe that we are providing the best opportunity for under- standing the processes and mechanisms of disease, specifically those that are statistically associated with smoking. This program is consistent with that of other granting agencies such as the NIH, American Heart Association, American Cancer Society. Our grantees who are a broad spectrum of basic biomedical sci- entists for the most part are assured complete scientific freedom in conducting these studies. The grantees alone are responsible for publishing their results. We do not publish papers. We do publish an annual report with abstracts of all of the papers published by our grantees. This is done as a summary and a service to the bio- medical community, and you have that information available to you. The grantees in general are encouraged to publish in peer-re- viewed journals ana publication is encouraged in every instance. We have never suppressed publication of any articles. There are more than 5,000 basic biomedical contributions in the literature reporting results of CTR sponsored research. They are in the most respected journals, and I will be glad to list those for you, if you so desire. Now, how does the CTR function? The CTR functions very much like a study contribution of the NIH, and I speak from personal ex- perience in telling you this. We have a Scientific Advisory Board of 15 very distinguished bio- medical scientists from all over this country and Canada. Appli- cants are encouraged to submit to us a preliminary inquiry trying to determine whether we would have an interest in supporting their research efforts. These preliminary inquires are reviewed by members of the Sci- entific Advisory Board. In general, about 50 percent of the prelimi- nary inquires are encouraged to be resubmitted as full grant appli- cations. When the full grant application is submitted, the Scientific Advi- sory Board members review these. All members of the Scientific Advisory Board review all grants and two or more of the Scientific Advisory Board are asked to submit written reports regarding these grants. Then twice yearly the Scientific Advisory Board gath- ers for a day session during which they rank and score these grant applications. Clearly, we are not able to support all of the good research that is submitted to us, but we do fund grants to the extent of 12 per- cent of the submissions. This is approximately the same as the funding level at the National Institutes of Health at the present time. 344 I hope that some of this has served to dispel any unwarranted suggestions about the Council. I am particularly disturbed that your source of information is the Wall Street Journal. The article is totally misrepresentative of our activities. I have been asked why we did not respond to the Wall Street Journal. The simple answer is, where would we start? So many inaccuracies are included in that article that it would be impossible for us to make an appropriate and full defense. I am proud of the Council for Tobacco Research. Our record is a very distinguished one, as you will be told by representatives of other granting agencies. We rank with the major private funding organizations of the Nation in supporting independent research by outstanding investigators. There have been a number of break- throughs that have occurred as a result of our research, and I will be happy to list those for you, if you would like to hear about them. Basically I think I could mention three. We supported Dr. Stanley Cohen, subsequently a Nobel Laureate in the identification of the epithelial growth factor as a key to un- derstanding cell regulation. We supported also Dr. Alfred Knutson, the man who first devel- oped the two hit theory of the development of cancer. This led to the identification of the gene that causes the lethal retinal blastoma cancer of the eye in children. We supported Dr. Henry Lynch for many years in developing his genetic library, library of familial cancers. Dr. Lynch and his li- brary were the linchpin, if you will, in the recent work accom- plished at Johns Hopkins in identifying the nonfamilial nonpolykosis colon cancer gene. A major breakthrough in our un- derstanding of the genetic basis of disease. I am very proud of the work of the Council for Tobacco Research. I am proud of my association with it. I am proud of what we do. I am proud of our staff and of the fact that the industry has chosen to support this independent research activity. Thank you very much. I am happy to cooperate and will be pleased to answer any questions that you might have. [Testimony resumes on p. 357.] [The prepared statement and grantee institutions of Mr. Glenn follow:] 345 The Council for Tobacco Reskarch-U.S.A.. Inc. Supporting BioMtaJiCAi, Investioation Testimony of James F. Glenn. M.D. As Chairman, President and Chief Executive Officer of The Council for Tobacco Research -- U.S.A., Inc., I am pleased to be here today at your invitation to testify about the Council's research program. Before describing for you the contributions the Council has made to the progress of scientific knowledge about diseases associated with smoking, I would like to provide some information about myself. Personal Background I received a Bachelor of Arts Degree in General Science from the University of Rochester in 1950. I then attended Duke University School of Medicine, receiving a Doctor of Medicine degree with honors within three years. From 1952 to 1954, I was trained in general surgery at Peter Bent Brigham Hospital in Boston. After serving in the army as a Captain and Flight Surgeon, I returned to Duke University in 1956, where I was Assistant Resident and then Chief Resident in Urology. In 1959, I became an Assistant Professor of Urology at Yale University School of Medicine. From 1961 to 1963, I was an Associate Professor of Urology at Bowman Gray School of Medicine. In 1963, I was appointed Professor of Urology and Chief of the Department of Urology at Duke. I 346 The Council for Tobacco Research -U.S.A.. Inc. Sl'Pportino Biomedical Investigation remained at Duke until 1980, when I became Dean of the Emory- University School of Medicine in Atlanta, where I was appointed Professor of Surgery. In 1983, I left Emory to become President of Mount Sinai Medical Center in New York City, where I also served as Acting Dean at the Mount Sinai School of Medicine from 1983 to 1984 and as Professor of Urology. In 1987, I returned to my roots, joining the University of Kentucky College of Medicine as Professor of Surgery. Between 1989 and 1993, I served as the Executive Director of the University of Kentucky Medical Center's Markey Cancer Center. In 1993, I became Chief of Staff of the University of Kentucky Medical College Hospital, a position I continue to hold. I am certified by the American Board of Urology and am a Diplomate of the National Board of Medical Examiners. I am licensed to practice medicine in Kentucky, Connecticut, South Carolina, North Carolina, Georgia and New York. I am a member of 35 professional organizations, including the American College of Surgeons, the American Surgical Society and the American Urological Association. Among the various positions I have held in professional organizations are President of the International Society of 347 The Council for Tobacco Research-U.S.A.. Inc. Si-PPOBTiNO Biomedical Investigation Urologic Surgeons; President of the American Association of Genitourinary Surgeons; President of the Clinical Society of Genito-Urinary Surgeons; President of the Society for Pediatric Urology; President of the Society of Pelvic Surgeons; and President of the Society of University Urologists. I have authored or co-authored over 270 publications in medical journals, as well as numerous chapters in medical textbooks. Attached to my statement is a copy of my curriculum vitae, which lists the honors I have received and further detail about my professional experience, as well as a bibliography listing my publications . I became associated with the Council for Tobacco Research in 1987, when I was invited to join the Scientific Advisory Board and to serve as the Council's Assistant Scientific Director. In 1988, I became the Scientific Director, a position I held until 1991. I became the Council's Chairman and CEO in 1991, and assumed the additional role of President on January 1, 1993. As the head of the Council, I have responsibility for the Council's budget, which includes both grants and operating expenses, and for assuring that the Council's 348 Thk Council for Tobacco Research-U.S.A., Inc. Supporting Biomeujicai- Investigation Staff, the Scientific Advisory Board and the Council's grantees are fulfilling their respective responsibilities. The Council and Its Mission The Council is a private, non-profit organization that sponsors research into questions of tobacco use and health and makes the results of that research available to the public. The Council is funded primarily by five tobacco manufacturers. The Council currently awards approximately $20 million a year in grants-in-aid to assist biomedical research, making it one of the largest private grant-giving organizations funding scientific research in the United States today. The Council uses its funds to support established experts as well as promising new researchers at universities and medical centers in the United States and abroad. All of the research funded by the Council is performed by independent scientists. The Council does not itself operate any research facilities. The Council and its predecessors have awarded in excess of $220 million to fund over 1,380 projects performed by approximately 1,000 researchers. Our grantees include three Nobel Prize laureates. A substantial portion of the researchers receiving Council grants have received co- 349 The Council for Tobacco Research -U.S.A.. Inc. Supporting BioMEnicAL Investigation funding from both governmental and non- governmental entities, such as the National Institutes of Health (including the National Cancer Institute) , the Environmental Protection Agency, the American Cancer Society, the American Lung Association, the American Heart Association and other leading sponsors of medical research. The Council has funded research at most of the preeminent medical and scientific research institutions in the United States, including Harvard Medical School, Johns Hopkins University, MIT, Yale University, Stanford University, the University of Chicago, Columbia University, Princeton University, the University of Texas, the Mayo Clinic, Scripps Research Institute, the American Red Cross, the Salk Institute, the National Institutes of Health and several Veterans Administration Hospitals, to name but a few. Attached to my statement is a list of institutions that have received grants from the Council. The Council funds grants in a variety of biomedical fields, including cancer, cardiovascular diseases, cell biology, developmental biology, epidemiology, genetics, immunology, neuroscience, pharmacology, pulmonary diseases, radicals and virology. The investigations that have received Council grants have varied over time as the 5- 350 The Council for Tobacco Research-U.S.A.. Inc. SUPPOHTINO BlOMEXHCAL INVESTIGATION direction of scientific research has changed. In earlier years, in addition to funding other research areas, the Council funded epidemiological studies, animal inhalation studies, cell culture research, basic clinical research and pathology studies. The Council has also sponsored conferences on various areas of research, such as animal inhalation and cell cultures. In more recent years, the Council's focus has been largely on basic cellular and subcellular research, which today is believed to provide the best opportunity for understanding the processes and mechanisms of diseases, including those that have been statistically associated with smoking. The Council's increasing allocation of grants to basic research reflects the progress of science generally and is consistent with the evolution of research programs at other funding agencies concerned with questions of tobacco use and health, such as the National Institutes of Health, the American Heart Association and the American Cancer Society. The Council's financial support has been an important resource for independent research that advances knowledge about tobacco and health. It has sponsored pioneering work in identifying familial cancers, the role of genetic factors in cancer formation, and the identification 351 The Council for Tobacco Research- U.S.A.. Inc. Si ppoRTiNO Biomedical Investigation of oncogenes. The Council was instrumental in supporting early work on the role of free radicals in the etiology of diseases and in opening up the new field of growth factor research. This work, like the rest of the research supported by the Council, has added to the scientific knowledge of the mechanisms and processes of diseases statistically associated with smoking. Council grantees are assured complete scientific freedom in conducting their studies. They alone are responsible for reporting their findings in the accepted scientific manner -- through medical and scientific journals and societies. Publication of research results is encouraged in all instances. That Council grantees respond to this encouragement is attested to by the more than 5,000 publications that have appeared reporting the results of the Council -funded research projects undertaken by its 1,000 grantees. Those articles have appeared in the most respected peer- review journals, including the Journal of the National Cancer Institute, the Journal of the American Medical Association, the New England Journal of Medicine, and the journals Cancer. Heart and Circulation. The Council also prepares and distributes an annual report that contains 352 The Council for Tobacco Research-TJ.S.A., Inc. Slpportino Bioueoicai. Investigation abstracts of publications appearing during the year that resulted from research funded by the Council. The Council has also, to my understanding, contracted with investigators to undertake research projects on specific matters that involved larger and longer-term commitments than was normally available through the grant program. In addition, I understand that the Council in the past administered funds for special projects that particular companies had separately arranged for investigators to perform; these special projects were not part of and did not impact the Council's grant program. Nor to my knowledge is there any truth to the notion that such special projects were used to suppress the publication of research results. Procedures for Awarding Grants The Council's grant -review process is similar to that used by many other granting agencies, such as study sections of the National Institutes of Health. Funding decisions by the Council are made upon advice received from its Scientific Advisory Board ("SAB"). The SAB is composed of distinguished scientists from various fields of biomedical research. With the exception of the Scientific Director, who is a full-time Council employee, SAB members retain their affiliations with their academic and research 353 The Council for Tobacco Research-U.S.A., Inc. SiPPORTiNO Biomedical Investigation institutions. There are currently 15 SAB members, including three members of the National Academy of Sciences. The SAB members receive a per diem allowance in connection with attending meetings, but they are not compensated for the much more substantial time they spend reviewing applications between meetings. The SAB has an Executive Committee, which consists of the Chairman and Vice-Chairman of the SAB, the Scientific Director and three other SAB members. The grant process begins with the receipt of a proposal from an applicant. Independent investigators send preliminary applications to the Council, describing their . proposed research. The preliminary applications are read by several members of the Executive Committee of the SAB. The Executive Committee then votes to encourage or discourage the application. Final, full applications are distributed to all members of the SAB. Each final application is also assigned to two members of the SAB selected on the basis of their knowledge and expertise in the relevant scientific field. These reviewers are given primary responsibility for evaluating the proposal in detail and presenting it to their SAB colleagues. The SAB meets twice a year to discuss the applications and to rate them by secret ballot. The SAB's 354 The Council for Tobacco Research-U.S.A.. Inc. SiPPoRTiNO Biomedical Investigation ratings are then used to establish a priority ranking among the applications, which I, in consultation with the Council's scientific staff, apply in allocating specific grant awards. The SAB is informed of the precise awards made by the Council . Most grant applications request a three-year period of support. Grants are awarded, however, for one year at a time. For the second and third years of a typical grant, the researcher must submit what we call a noncompeting renewal application. These applications are reviewed by two SAB members -- generally the same two SAB members who were the principal reviewers of the original grant application. The full SAB then votes whether to recommend the applications for approval. Some applications for grant support involve areas of inquiry about which SAB members believe they would benefit from consultation with experts and specialists outside of the Council in considering applications. In those occasional instances, n-,embers of the SAB recommend to the Council's scientific staff scientists or physicians who are knowledgeable on the particular subject; these individuals are then asked to assist in reviewing the grant 10 355 The Council for Tobacco Research-U.S.A., Inc. Supporting Biomedical Investigation application. These scientists are selected because of their distinguished credentials and their particular expertise. If, after the completion of the typical three-year grant cycle, a researcher wishes to receive further support from the Council for an extension of the same research project, he or she must submit a competing renewal application. Competing renewal applications are evaluated through the same process by which full original applications are evaluated. In evaluating grant applications, the members of the SAB bring to bear their understanding of the state of scientific knowledge in the areas covered by the grant proposals. The SAB members consider the results of previously reported research in any particular field, which might include research performed by Council -funded investigators, in evaluating whether a particular proposal is meritorious. The SAB does not consider, for any type of grant application (original, noncompeting renewal or competing renewal), whether any of the investigator's prior research produced results thought to be favorable or unfavorable to the tobacco industry. Industry sponsors exercise no control over the decision to fund a particular grant application or 11 356 The Council for Tobacco Research -U.S.A., Inc. Supporting Biomedical Investigation with respect to the publication of the results of any sponsored research. Selection of SAB Members and Other Peer Reviewers The Council selects for the SAB distinguished scientists who can bring cutting-edge expertise in various areas of biomedical research. The Council seeks to maintain a wide range of expertise on the SAB, so that the appropriate biomedical areas are represented in the grant application process. When a vacancy occurs on the SAB, the Chairman of the Cou.icil and the Scientific Director solicit from SAB members recommendations for a successor. As a general matter, the Chairman of the Council or an SAB member will contact individuals who have been recommended and ask them to attend an SAB meeting to give a presentation on their research. After candidates have attended an SAB meeting, SAB members and the Chairman of the Council will confer to see if there is a consensus to extend an invitation to join the SAB. ***** I am proud of The Council for Tobacco Research and my association with it. The Council has provided vital support to nearly 1,000 independent researchers. Its research program has played a key role in advancing our knowledge of diseases that have been associated with smoking. I thank the Subcommittee for this opportunity to present this brief picture of the Council and its contributions to biomedical research, and I am happy to answer any Cfuestions you may have. 357 Mr. Waxman. Dr. Glenn, thank you very much for your testi- mony and for being here today. I appreciate your being here and since you are our only witness, if you need to take a short break at any time, let us know. We are going to go through some areas and give you the oppor- tunity to respond to some of these things that have been said and tell us more information about the Council on Tobacco Research. I find your comments about the Wall Street Journal article inter- esting. You didn't comment to them before they did the article and then afterwards they had so many inaccuracies you didn't want to respond. This is your chance and we want to go through some of these is- sues with you. In recent months, we have begun the process of learning more about the tobacco industry. We still, however, need to know more about this Council on Tobacco Research. I want to go back over 40 years. In 1954, the major tobacco companies joined together in issuing a "frank statement to cigarette smokers", a copy of this statement is Exhibit 4, and excerpts of the statement are displayed on the chart, which we would like to have displayed. Are you familiar with this statement? Mr. Glenn. Yes, sir. Mr. Waxman. You know at the same time the companies created the Tobacco Industry Research Council, the previous name for your Council for Tobacco Research. Mr. Glenn. Yes. Mr. Waxman. I released the staff report today on Hill and Knowlton documents, which were written from 1954 to 1956. These documents provide considerable insight into the founding of your Council, and I would like to ask you some questions about these documents. In 1953, there was tremendous public interest in the hazards of smoking. In that year, for instance, Dr. Winter of Sloan-Kettering published a major study showing that mice painted with tobacco tars developed fatal cancers. A copy of this report is Exhibit 1. The Sloan-Kettering report received significant public attention at the time. Are you aware of this report? Mr. Glenn. Yes, sir. Mr. Waxman. The tobacco industry was very concerned about the Sloan-Kettering report and other similar work coming out in the early 1950's. In fact, on December 15, 1953, an unprecedented meeting of the CEO's of the major tobacco companies took place to respond to these reports. Are you aware of that meeting? Mr. Glenn. Yes, sir. Mr. Waxman. I have a memorandum written by Bert C. Goss of the public relations firm Hill and Knowlton as Exhibit 2. Mr. Goss and the founder of Hill and Knowlton, John Hill, attended the De- cember 15 meeting. Mr. Goss' memorandum memorialized what happened. Are you familiar with his memorandum? Mr. Glenn. I think I am, Mr. Waxman. Mr. Waxman. This memorandum is crucial in understanding the strategy of the tobacco industry. In attendance at the meeting were Paul Hahn, president of the American Tobacco Company; Joseph 358 Cullman of Benson & Hedges; Parker McComas, president of Philip Morris; Whitney Peterson, president of U.S. Tobacco. According to the memorandum, the meeting is the first time these CEO's ever met out of a social context. They are taking this extraordinary step because they agree that the health criticisms are extremely serious and worthy of drastic action. At the meeting they agreed that what is needed is not more science or research but a public relations campaign to counter the mounting evidence of the adverse health effects of smoking. In their own words they decide they should sponsor and I quote, "A public relations campaign which is entirely pro-cigarettes." The plan of action is fleshed out in another Hill and Knowlton memorandum written just 9 days later. This is Exhibit 3, entitled "Preliminary Recommendations for Cigarette Manufacturers." In this memorandum, Hill and Knowlton recommends that your organization be created for explicitly public relations nonscientific purposes. Are you familiar with this exhibit? Mr. Glenn. No, sir. Mr. Waxman. The memorandum states and I quote, "The under- lying purpose of any activity at this stage should be reassurance of the public... It is important that the public recognize the exist- ence of weighty scientific views which hold that there is no proof that cigarette smoking is a cause of lung cancer." The memorandum goes on to recommend that to achieve this public relations purpose, the industry should create the Council for Tobacco Research — then called Tobacco Industry Research Commit- tee; and the memorandum further recommends that the very first action of the new organization should be the assurance of a frank statement, like that we talked about earlier. As you can see, your organization was not thought up by sci- entific researchers who perceived a need to know more about health effects of tobacco, it was dreamt up by the public relations experts who perceived the need to calm public fears. It is not fair for me to ask you if you are familiar with all the documents in this subcommittee report. You have not had a chance to study them all thoroughly. Instead, I want to describe for you some of the early activities of the Council for Tobacco Research. I will describe these activities and ask you a simple question, are these activities scientific in nature — as you say is the devotion and goal of the Council — or are these public relations activities? Let me begin with a simple matter of staffing. According to these documents, the Council for Tobacco Research hired 23 public relations experts from Hill and Knowlton in 1954, its first year of operation, and 35 public relations experts from Hill and Knowlton in 1955, which would be its second year of operation. Can you explain why a small organization that is supposed to be purely scientific needs to employ the services of 2 to 3 dozen public relations experts? Mr. Glenn. Mr. Waxman, on the basis of my knowledge I would have to reject that. The Council for Tobacco Research has been the research arm not the public relations arm for the tobacco industry. Mr. Waxman. Well, we have Exhibit 10 which shows the budget of the organization at that time. It indicates the charges paid to 359 Hill and Knowlton, which of course no one would argue is a sci- entific organization. This was before you were there at the Council. At that time, they were spending money on 2 to 3 dozen public relations experts. According to these documents, one of the activi- ties of the Council was to turn obscure research findings that were favorable to the tobacco industry into headline news around the country. A good example of this is Exhibit 13, a confidential public rela- tions report on the activities of the Council and I want to read to you from page 6 of this report. "A report from the New Zealand public health official, published in a British medical journal, attrib- uted the increase in lung cancer incidence to air pollution and not to smoking. Advance information of the date of publication was ob- tained from contacts in New Zealand and England when it ap- peared and it was brought to the attention of the United States press. Stories and editorials on it appeared in many newspapers." Dr. Glenn, is this activity, encouraging the media to write stories about obscure research favorable to the tobacco industry, a sci- entific activity or public relations activity? Mr. Glenn. Mr. Waxman, my answer to that, I have to tell you that in 1954 I was in the Korean War as a flight surgeon so I may not be au courant with what was happening in the press at that time. I will say that these documents were not made available to me until this young man began passing them here to the witness table. So I really haven't had a chance to review them and I have had no opportunity to develop any response. This is ancient history and I really cannot verify it one way or the other. Mr. Waxman. Well, I am asking you from the documents I have described, and I have acknowledged the fact that you were not there, if the Council were working on encouraging writers of news- papers to cite obscure scientific articles and they were trying to get favorable articles written, would you consider that, what I have just described, as scientific research activity or public relations ac- tivity? Mr. Glenn. I appreciate the way that you have phrased the question. I was not there. But I can tell you that the Council for Tobacco Research and its research arm have been directed by a Sci- entific Advisory Board of very distinguished people from the begin- ning. Mr. Waxman. But I am asking you to answer for me whether you consider the activity I described for you scientific in nature or pub- lic relations in nature? Mr. Glenn. Mr. Waxman, the activities of the Scientific Advisory Board and the Council for Tobacco Research have always been dedicated to science. Mr. Waxman. Let me Mr. Glenn. Whatever activities that may have been accom- plished by Hill and Knowlton are beyond my knowledge or recollec- tion. Mr. Waxman. Hill and Knowlton was paid a substantial amount of money by the Council. According to these documents, another ac- tivity of the CTR was to commission free-lance authors to write fa- 360 vorable articles about cigarettes. These articles would then appar- ently be published under the name of the free-lance author with no acknowledgment of the link to the Council. For instance, Exhibit 9, a report on tobacco industry research committee information activities contains this entry on page 4, "C.B. Colby, free-lance popularizer of science was retained for re- search and possible writing of articles concerning all the hazards of modern life which people are cautioned against and leading to the conclusion that in spite of all the death scares, you still live longer." Is hiring a free-lance popularizer of science urging people to ig- nore death scares a scientific inquiry? Mr. Glenn. That is beyond my knowledge, as you must know. I notice this memorandum, however, is an internal memorandum of Hill and Knowlton. They, indeed, are a public relations firm. But they were independent of and separate from the Council for To- bacco Research to my knowledge. Mr. Waxman. I dispute that. We will move on to other Members who have questions and we will come back to some of these points. Mr. Bliley. Mr. Bliley. Dr. Glenn, could you identify those who serve on the CTR Scientific Advisory Board, what their background is? Mr. Glenn. Yes, sir. Let me go to my notes lest I miss somebody. The Scientific Advisory Board consists of at the present time 15 very distinguished individuals; alphabetically they are. Dr. Leo G. Abood, professor of Pharmacology and Biochemistry at the Univer- sity of Rochester; Dr. Barry G. Amison, chairman of the Depart- ment of Urology and director of the Brain Institute at the Univer- sity of Chicago; Dr. Drummond Bouden, chairman of the Depart- ment of Pathology, University of Manitoba; Dr. Michael Brennan, director emeritus of the Michigan Cancer Center in Detroit; Dr. Carl O. Croci, director of the Thomas Jefferson Cancer Center, Thomas Jefferson University, Philadelphia; Dr. Ra3anond Erickson, professor of Molecular Biology, Harvard University; Dr. Joseph Feldman, professor of Immunology and research director emeritus at the Scripps Institute in California; Dr. Gordon Gale, professor of Medicine and Endocrinology at the University of California, San Diego; Dr. W. K. Yaclick, professor and chairman of the Depart- ment of Microbiology at Duke University; Dr. Manfred Camofski, professor of Biochemistry, Harvard University; Dr. Henry Lynch, Creighton University, director of the Department of Preventive Medicine, and the same Lynch to whom I referred previously who is responsible for our most recent understanding of genetic disease for — as the basis for cancer; Dr. Harmon McAllister, a biochemist and our current scientific director, also a member of the board; Dr. Barry Pierce, chairman emeritus of the Department of Pathology, University of Colorado; Dr. Judith Swain, professor of Medicine, di- rector of the Division of Cardiovascular Disease and Medical Genet- ics at the University of Pennsylvania; and Dr. Peter Vote, formerly chairman of the Department of Microbiology at the University of Southern California, now director of research at the Scripps Insti- tute. 361 Mr. Bliley. Isn't the role of the CTR's Scientific Advisory Board comparable to the role of similar advisory boards? Mr. Glenn. Yes, sir. Mr. Bliley. To your knowledge to what extent have the member companies attempted to influence the research activities of the Sci- entific Advisory Board? Mr. Glenn. They have never attempted to influence our activi- ties in any way to my knowledge. Mr. Bliley. How long have you been in your present capacity? Mr. Glenn. In my present capacity 5 years, 4 years, but associ- ated with CTR for 7 years. Mr. Bliley. There have been some recent criticisms of CTR largely arising from the Cipollone case. Before the plaintiff's law- yers and the media began their criticisms, there was an interesting article that appeared in the July 1985 edition of the New York State Journal of Medicine, the article quoted among others, Joanne Shellenback, the Director of Press Relations with the American Cancer Society in New York. She said of CTR and I quote, "They are legitimate. We are very critical of the tobacco industry in terms of their advertising prac- tices and many of the things that they do but here is an area where they seem to be doing something by the book in promulgat- ing good research. So I can't criticize them across the board." Do you think that CTR has been unfairly criticized recently? Mr. Glenn. Yes, sir, and I think it is by inference that we are supporting smoking which is certainly the furthest thing from the truth. We are an independent agency, we have the respect of medi- cal investigators and institutions across the country and through- out the world. We are regarded as a good source of funding particu- larly for young people with fresh new ideas and approaches to the questions of basic biomedical investigation that are so fundamental to our understanding of cancer, cardiovascular disease, and others. I think the statement from the American Cancer Society is en- tirely in keeping with the reputation we hold in the medical com- munity. Mr. Bliley. You mentioned in your written oral statement that three researchers funded in part by CTR have received Nobel prizes in physiology on medicine. Could you name them? Mr. Glenn. Yes, sir. I think I mentioned Dr. Stanley Cohen of Vanderbilt University for his work with epithelial growth factor. The second was Dr. Barry Nazerath of Harvard University, who really was the father of modern molecular biology. And the third Nobel prize winner was Dr. Harold Varmus, currently the Director of the National Institutes of Health. Mr. Bliley. Beyond the three researchers funded in part by CTR that have received Nobel prizes, can you give this subcommittee some idea of the quality of the research which has been funded by CTR? Mr. Glenn. Well, I think the quality speaks for itself. As you pe- ruse the annual reports you will see that we have moved to the cutting edge of basic biomedical research. I think the quality is tested by some of the examples I gave in my opening statement of individuals who have made major breakthroughs in our under- standing of basic disease process. 362 However, you must understand that our review process and the selection of grantees to be supported is a very critical mechanism. We receive well over 1,000, close to 1,200, inquiries and applica- tions per year. We are able to fund only a minute portion of those total inquiries and applications. So we are really — we really are picking the cream of the crop it would seem. I think our judgment has been borne out by the succession of the investigators. Mr. Bliley. What is the publication policy of CTR? Mr. Glenn. We encourage all investigators to publish ever3d;hing that they wish to publish. We have never discouraged publication. I would cite as an example the fact that we were approached by Dr. Edward Campbell of the University of Utah recently. Dr. Campbell is one of our grantees and he is working on the problem of emphysema. He has identified a genetic defect that leads to an alpha 1 antitrypsin deficiency and in those individuals perhaps represent- ing some 3 to 5 percent of patients with emphysema, this enzjrme deficiency predisposes them to emphysema. He inquired of us whether he should publish these results, and we said, most certainly you should publish those results. Those are the individuals who are most susceptible to emphysema and cer- tainly those who should be kept away from the risk factors such as smoking. Mr. Bliley. There has been recent criticism that the research funded by CTR doesn't have anjrthing to do with cigarette smoking and health. Does your experience support this criticism? Mr. Glenn. No, sir, we are supporting very fundamental re- search into molecular and cellular biology, genetics and immunol- ogy which are the fundamental questions that must be answered before we can address questions of therapy and social habits. Mr. Bliley. It has been claimed that research has been chan- neled or funneled into CTR special projects so that adverse results could be suppressed from publication by claiming that they were subject to the attorney-client privilege. I understand that many publications resulted from CTR special projects. I also understand that all of the privileged documents were reviewed by special master Joel A. Persono who was ap- pointed by Judge Sarokin and who later became a United States magistrate judge. In the special masters report he states, and I quote, "The research projects themselves were conducted by inde- pendent scientists affiliated with a variety of academic and re- search institutions who were not applied by or related to the to- bacco industry. These researchers were permitted to publish the re- sults of their research with credit given to the CTR." Is that consistent with your understanding? Mr. Glenn. Yes, sir. Mr. Bliley. I also understand that some researchers who re- ceived CTR special projects funding were co-funded by other fund- ing agencies and that a lot of this research was published in peer review journals and acknowledgment to special project support was requested; is that right? Mr. Glenn. Yes, sir. I would point out that special projects were projects that were desirable for our sponsors. However, our sci- entific director reviewed these projects for scientific accuracy, for 363 methodology, and the CTR then served merely as the funding agen- cy for such projects. However, your first — initial statement is correct. Some 250 peer- reviewed articles were published as a result of the various special projects that were accomplished. Mr. Bliley. Some of what people are claiming here today doesn't make sense. If a researcher was being funded by both the Federal Government and a CTR special project grant, how could CTR pre- vent publication? Mr. Glenn. We couldn't, Mr. Bliley. You can't prevent a bio- medical investigator from doing anything he wants to do. He cer- tainly will publish at his discretion. We wouldn't presume to tell him not to publish. On the contrary, we have encouraged publica- tion. Mr. Bliley. Would you submit a list of publications and presen- tations which are believed to have resulted from CTR special projects for the research? Mr. Glenn. Would I submit such a list? Mr. Bliley. Obviously, you can't do it today but the record will be open, and I am sure the Chairman will keep it open for that. Mr. Glenn. It is available to you, Mr. Bliley. We have submitted our annual reports for the last 30 years, which I am sure that much of it to people who are in different professions and even to me on occasion must look like Greek, but I think if you will ask competent biomedical investigators, authorities in the field to re- view the research reported in these annual reports you will see the very high quality of the research that has been done. Mr. Waxman. Will you submit to this committee for the record a list of all the research funded under the special projects? Mr. Glenn. Yes, sir, we will cooperate with you in any way. [The following information was received:] As I explained in my testimony, Council Special Projects were research projects that the Council's sponsors wished to fund. Tr. at 46. These research projects were funded by the sponsors, and were administered by the Council, separately from the grant-in-aid program. We have prepared a list of all Council Special Projects for which the Council has a file. That list includes the following information for each such project (where such information is available from the Council's files or from published sources): (a) the name of the principal investigator or investigators; (b) the institution or institutions with which the principal investigator or investigators were associated; (c) the title or subject matter of the Council Special Project; (d) the dates of funding of the Council Special Proiect; (e) the total amount of funding provided by the Council; and (f) a list of the publications that apparently resulted, or may have resulted, from the Council Special Project. Some of the publications identified on the list appear in the Council s Special Projects files; others have been collected from other sources. In a number of instances, it is not clear whether a particular publication resulted from Council Special Project funding. My statement at the May 26 hearing that 250 peer-reviewed articles are believed to have resulted from Council Special Projects was based on my information about the number of publications that either were in the Council's files or have been col- lected from other sources. Several clarifications should be made to that statement. First, our list sets forth over 400 articles or presentations that resulted or may have resulted from Council Special Projects; so far, I understand, conies of about 250 of these articles or presentations have been obtained, and that unaerstanding was the source of my statement at the hearing. Second, most but not all of these 250 articles or presentations were peer-reviewed. Third, abstracts relating to Council Special Projects publications were not included in the Council's Annual Reports. We expect to provide this list to you promptly after we have reached an under- standing with the subcommittee staff with respect to procedures for the subcommit- 364 tee's handling of such materials provided by the Council. In the interim, I respect- fully request that this letter be included at pages 47 and 106 of the May 26 tran- script. Mr. Waxman. Thank you. Mr. Bliley. Thank you, Mr. Chairman. Last question, Mr. Chairman, if I may. I further understand the documents related to CTR special projects research including proposals, interim reports, final reports, and publications have been produced to plaintiffs counsel in discov- ery in some cases. Is that correct? Mr. Glenn. That is correct. Mr. Bliley. Thank you. Dr. Glenn. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bliley. Mr. Sjniar. Mr. Synar. Thank you, Mr. Chairman. Welcome, Dr. Glenn. Let me go back to something Mr. Waxman was questioning you about. The Wall Street Journal on Thursday, February 11, stated the Council's role has never been just research and it was largely a creature of Hill and Knowlton, the public rela- tions firm. Do you deny that? Mr. Glenn. Yes, sir. Mr. Synar. How does that square with the fact that in a 1954 memo. Exhibit 10 in front of you — do you have it? Mr. Glenn. Yes, sir. This is the first time I have seen it, Mr. S3mar. Mr. Synar. All right. That is interesting, Dr. Glenn. Usually when you take over a cor- poration as someone who is going to run it, one of the first respon- sibilities is to learn the history of the corporation and to learn the corporation's inner workings over the years. You are telling us you have not taken that time to do that? Mr. Glenn. Mr. Synar, I have taken over a number of organiza- tions in my career and I am well aware of the procedure. This is a Hill and Knowlton internal document. Mr. Synar. But it is from the founder of Hill and Knowlton to the chairman of the CTR. The paragraph says, attached are budget estimates for oper- ations of the Tobacco Industry Research Committee during the cal- endar year 1955, which would be the first year of its creation. Then it goes into the next paragraph, as you can see, the budget for the stafi" operations provides for 35 different staff members of the Hill and Knowlton Corporation. Now, doesn't that fly in the face of your answer to Mr. Waxman that the Hill and Knowlton operation was separate from CTR, since the budget shows that it was fully funded by CTR? Mr. Glenn. Mr. Synar, I am not sure of the thrust of your ques- tion. Mr. Synar. Were you Mr. Glenn. Hill and Knowlton documents are not in our files. Mr. Synar. The point is Hill and Knowlton was basically CTR, were they not? 365 Mr. Glenn. No, sir, on the contrary from the beginning CTR was composed of independent scientists serving on a Scientific Advisory Board. Mr. Waxman. If you would yield to me, that document was writ- ten to the head of the Council for Tobacco Research. I don't know why it wouldn't be in your files, but it was written by Hill and Knowlton to your committee and I presume paid for by the Council. Mr. Glenn. Mr. Waxman, I think you are presuming a lot. This is a confidential memorandum internal to Hill and Knowlton. It mentions the CTR but it is not in our files and there was no way I can know that nor do I know who paid for this. Mr. Waxman. This one does not indicate that it is confidential. Mr. Glenn. I am sorry. Mr. Waxman. It doesn't indicate Mr. Glenn. Are we looking at Exhibit 9? Mr. Waxman. No, 10. Mr. Synar. Exhibit 10. Mr. Glenn. Again, I can't speak to this because I have never seen it until this moment, but it would appear to me to be a Hill and Knowlton internal document. Mr. Waxman. Would you confirm for us that Mr. Timothy Hart- nett was the chairman of the Council for Tobacco Research? Mr. Glenn. I can't confirm that to you, no, sir. Mr. Waxman. Have you ever heard of him? Mr. Glenn. No, sir. Mr. Waxman. You never heard of him. OK. Mr. Synar. Mr. Synar. Dr. Glenn, you are proud of your scientists on your board. Have any of these Nobel prize winners done research in the area of tobacco or how it affects health? Mr. Glenn. The Nobel prize winners? Mr. Synar. Yes, that serve on your board. Mr. Glenn. The Nobel prize winners that I mentioned, Mr. Synar, are former grantees of the Council for Tobacco Research. Mr. Synar. Let me move on. A review of the Council Mr. Waxman. Just before we go too far I do want to indicate for the record that the annual report, 1963-1964, from the scientific di- rector of the Council for Tobacco Research indicates that Timothy V. Hartnett is the chairman, W. T. Howe is the executive director, and Clarence Cook Little is the scientific director. Mr. Glenn. I was not aware of Mr. Hartnett. Doctor — Clarence Cook Little was the first scientific director, very distinguished man, president of the University of Minnesota, founded the Bar Harbour Library, credited with establishing the basis for fundamental lab- oratory animal research. Mr. Waxman. I am sure Mr. Hartnett was also quite distin- guished. He was chairman of the Council and did receive that memo from Hill and Knowlton. Mr. Synar. Mr. Synar. Dr. Glenn, answer my question, did any of these grantees, the Nobel prize winning crew, do research on tobacco and how it affects health? Mr. Glenn. Mr. Synar, every one of them has done fundamental research to help us understand underlying disease process. 366 Mr. Synar. I didn't ask you that. Mr. Glenn. I know you didn't ask me that, Mr. Synar, but what you asked me was very naive. Mr. Synar. Did they do research in tobacco research and how it affects health, yes or no? Mr. Glenn. Yes. Mr. Synar. Will you provide that for the record? We would like to see it. Mr. Glenn. I would be glad to provide the papers published by these Nobel prize winners. Mr. Synar. In the area of tobacco and how it affects health. [The following information was received. Documents referred to hereinafter in these responses have been retained in subcommittee files.] As I testified on May 26, the Council has funded three investigators who have v/on Nobel Prizes: Dr. Baruj Benaceraff of Harvard University, Dr. Stanley Cohen of Vanderbilt University and Dr. Harold E. Varmus of the University of California at San Francisco. Dr. Benaceraff, who was awarded the Nobel Prize in 1980, received a Council grant from 1972 through 1974 for investigating "Control of Specific Cellular and Hu- moral Immune Responses to Neoplastic and Non-neoplastic Tissues." Item A in the Appendix includes three publications acknowledging the Council's support of Dr. Benaceraffs research. Dr. Cohen, who was awarded the Nobel Prize in 1986, received a Council grant from 1987 through 1993 for investigating "The Role of Lipocortin in the Cellular Re- sponse to EOF." Item B in the Appendix includes six publications acknowledging the Council's support of Dr. Cohen's research. Dr. Varmus, who was awarded the Nobel Prize in 1989, received a Council grant from 1984 through 1986 for investigating "Functional Analysis of Cellular Oncogenes Activated During Tumorigenesis." Item C in the Appendix is a publica- tion acknowledging the Council's support of Dr. Varmus' research. As I explained to the subcommittee on May 26, the Council-funded research by these Nobel laureates was basic biomedical research aimed at improving our under- standing of fundamental disease processes — which is the kind of research that is now believed to further scientific understanding of the effects of tobacco use on health. Dr. Benaceraff conducted pioneering research into the humoral immunological response of the host when presented, attacked or invaded by can- cerous growths. His work has provided important insights into how regulatory mechanisms may operate in defense of the host organism. Dr. Cohen studied cell growth factors and their role in regulating growth and differentiation. His investiga- tion of genetic controls of growth factors opened the door to our understanding of mechanisms by which normal cells become cancerous. Dr. Varmus' pioneering work with oncogenes made important contributions to our overall understanding of how healthy cells become transformed into cells that can no longer control their growth and therefore become cancerous. Mr. Glenn. Mr. Synar, one does not have to specifically inves- tigate tobacco as a product Mr. Synar. Dr. Glenn, you just said under oath that they did have expertise in research in tobacco and health-related issues with respect to tobacco. Is that correct? Mr. Glenn. Fundamental understanding of basic cellular and molecular biology is the basis for understanding scientific truth which will then let us understand the specifics of a vehicle such as tobacco. Mr. Synar. That is a very convenient way to say that they are not conducting tobacco-related research, isn't it, Dr. Glenn? Mr. Glenn. No, Mr. Synar, it is not. 367 Mr. Synar. Let's go on to the review of the Council for Tobacco Research published in the July issue of the American Journal; Ex- hibit 19, if the staff will provide that to the Doctor. Doctor, let me quote from Exhibit 19 from the American Journal. "Most of the CTR-funded grant supports biomedical research not related to health consequences of smoking. In a recent survey of principal investigators funded by the CTR grants in 1989 almost 80 percent of the respondents indicated that none of their research, current or past, examined the health effects of smoking. "Furthermore, the vast majority of industry-supported research that addressed the health affects of smoking produced findings con- sistent with the Surgeon General's conclusion that smoking is a major cause of numerous diseases." Are you aware of those findings. Dr. Glenn? Mr. Glenn. I am aware of Dr. Warner's article. Mr. Synar. Do you agree with the central conclusion? Mr. Glenn. What is his conclusion? Mr. Waxman. The conclusion that the CTR research is not relat- ed to the health consequences of smoking. Mr. Glenn. What was the Mr. Synar. That is what the statement is, that the CTR research is, quote, "not related to the health consequences of smoking." Do you agree with that? Mr. Glenn. No, sir. Mr. Bliley. Can these documents be made available to the mem- bers? We don't have them. Mr. Waxman. We will get them to you immediately. Mr. Synar. Do you know Dr. Brennan? Is he not a member of your Scientific Advisory Board? Mr. Glenn. Yes. Mr. Synar. In an article, "Pack of Lies", a BBC documentary, Dr. Brennan is quoted as saying that during his service on the Sci- entific Advisory Board, "very little of the CTR research is related to determining the relationship of smoking to ill health." Dr. Brennan goes on to say in this BBC documentary that, "cer- tainly less than Vio of the funds awarded are awarded for the sci- entific study of tobacco-related effects." Is Dr. Brennan correct? Mr. Glenn. He is correct in the sense that we — I have spent mil- lions of dollars in the past in supporting studies where experi- mental animals were exposed directly to tobacco smoke and that sort of thing. It was very unrewarding. As the Surgeon General's report will point out to you, there has never been an instance in which lung cancer was observed in animals exposed to intense to- bacco smoke. It was an unrewarding avenue of research and we focus now on molecular and cellular aspects, as I have explained. That is what Dr. Brennan was alluding to. Mr. Synar. So the quote that, certainly less than one-tenth of the funds of the CTR awarded are awarded for specific study of to- bacco-related effects; you are saying only 10 percent of the budget has anything to do with tobacco? Mr. Glenn. When he says specifically related to tobacco prod- ucts, he is talking about research with nicotine, talking about 368 Mr. Synar. No, he didn't say specific tobacco-related products, he said tobacco-related effects. Mr. Glenn. That would include nicotine. Mr. Synar. Are you familiar with your Council report of 1993? Mr. Glenn. I am. Mr. Synar. Out of the 296 studies in your index, where you fund- ed about $19.5 million in grants; as I see from the index only 10 or about 10 of the projects have anything to do with tobacco. Do you dispute that? Mr. Glenn. No, sir. Mr. Synar. So you don't devote much research to cigarettes or the death of the 434,000 Americans a year, do you? Mr. Glenn. Because, Mr. S3aiar, medical research in general has taken the turn towards basic fundamental understanding of cell regulation and deregulation. Until we understand these processes, we cannot explain any diseases. And our research is at the fore- front, along with that of the National Cancer Institute and the Na- tional Institutes of Health and the various other private funding agencies. Mr. Synar. Dr. Glenn, has the Council for Tobacco Research con- ducted or financed research that has found that smoking cigarettes or using oral tobacco increases the likelihood of a person developing lung cancer or heart disease? Mr. Glenn. I didn't hear your question, sir. Mr. Synar. Has the CTR conducted or financed research that has found that smoking cigarettes or using oral tobacco increases the likelihood of a person getting lung cancer or heart disease? Mr. Glenn. Yes, sir. Mr. Synar. Will you provide that for the committee? Mr. Glenn. Yes, sir, it is provided in the annual reports that you already have at hand. Mr. Synar. Dr. Glenn, has the Council for Mr. Waxman. Just a moment, we want to receive specifically from you an answer, do not just refer us to some other document. We will hold the record open but we want a specific response to that question. Mr. Synar. You will provide that full report? Mr. Glenn. Yes, sir. [The following information was received:] At the hearing, I was asked about studies funded by the Council that found that tobacco use increased the hkehhood of disease. With all due respect, this request is extremely naive, and therefore very difficult to respond to meaningfully. Modem scientific studies into the etiology of chronic diseases typically focus on narrow ques- tions, the answers to which contribute to a broader understanding of disease proc- esses. However, as a general matter, each such study, standing alone, does not state that smoking does or does not make the chronic disease more likely. The reported research findings have implications for the relationship between smoking and dis- ease that are far more subtle, complex and cumulative. Consequently, in many instances, it is difficult to determine — and it ultimately is a subjective matter — whether a publication is deemed to have found an increased likelihood of disease. Indeed, I believe that any two persons who might review the full set of publications resulting from the Council's grants in response to this re- quest would come up with different sets of documents. As I stated on May 26 in response to this request, abstracts of publications resulting from CTR grants and contracts have appeared in the Council s annual reports, and we can make the pub- lications themselves available to the subcommittee for its review. 369 With these qualifications, we are providing in the boxes marked "Box 1" and "Box 2" copies of over 375 publications resulting from Council-funded research that could be considered to indicate that tobacco use may increase the likelihood of developing diseases or conditions that have been associated with smoking. (These documents were selected from the Council's files of publications resulting from Council grants. Those files are not complete since not all publications have been provided by the researcher or located in the Council.) We have used our best efforts to compile for the subcommittee a complete set of such publications, in light of the difficulties re- ferred to above. In addition, in order to reduce the burden on the subcommittee, we are not providing copies of publications that simply rely on or refer to previous re- search findings associating smoking and diseases, and in a number of instances we are not providing copies of publications that are preliminary to, or repetitive of, pub- lications that are being provided. Mr. Synar. Dr. Glenn, has the CTR conducted or financed any research into the matter that nicotine is addictive or has an addict- ive quality to it? Mr. Glenn. We have sponsored a very large amount of research into nicotine. We have been very concerned about the question of addiction. We have funded researchers who have established the habituation of nicotine. We have not been able to establish addic- tion. Indeed, we asked Dr. Jerome Jaffe, Director of the Addiction Center at the National Institute of Drug Abuse to address our Sci- entific Advisory Board on this question in 1989. Dr. Jaffe and our Scientific Advisory Board had a lengthy exchange. Dr. Jaffe was unable to assign properties of addiction as they are classically defined to nicotine. We have continued to pursue the question and are doing so now. Indeed, a large part of this conference that is taking place here in Washington today deals with nicotine and nicotinic receptors. I think the committee should know that the central nervous system, the function of the central nervous system and myoneural junctions depend upon two sorts of chemical receptors. They are classified as muscarinic and nicotinic. Perhaps the word "nicotinic" is unfortunate but nicotine and nic- otine analogs we derive from the various foods that we eat, to say nothing of nicotine that might be in tobacco is critical to normal neural function in the human being. Mr. Synar. Just a couple things on that very one point. Dr. Jaffe is a member of the National Institute on Drug Abuse that did find that nicotine is addictive, is he not? Mr. Glenn. Dr. Jaffe is — was at the time he appeared before us the Director of the Addiction Center for the National Institute of Drug Abuse. Mr. Synar. All right. Now beyond Dr. Jaffe, let me repeat this question very clearly. Have you conducted or financed research that has found nicotine is addictive or has an addictive quality to it? Mr. Glenn. We have definitely established that there is habituation to the use of nicotine. We have not established addic- tion. Mr. Synar. Will you provide for the record all of the reports and studies with respect to nicotine and its addictiveness? Mr. Glenn. Yes, sir. Mr. Synar. Thank you. 370 Mr. Waxman. Mr. Synar's question was have you financed stud- ies on nicotine and nicotine addiction. You then answered that you have concluded it is habituating. Have you financed studies? Mr. Glenn. I misspoke, Mr. Waxman. I didn't conclude, the in- vestigators concluded. We funded the projects. Yes, sir, extensive. Mr. Waxman. You will give us details of those studies. Mr. Glenn. Yes, sir. Mr. Waxman. In fact, the studies themselves? Mr. Glenn. Yes, sir. [The following information was received:] The two boxes of documents marked "Box 3" and "Box 4" contain copies of over 560 publications resulting from Council-funded research that appear to examine the effects of nicotine. (As explained above, the set of publications from which these doc- uments were selected is incomplete.) Again, we have used our best efforts to compile for the subcommittee a complete set of such publications. As I mentioned during my testimony on May 26, during the week of my testimony the Council sponsored an important seminar on central nervous system receptors, including the receptors that respond to nicotine and its analogues. Item I in the Ap- pendix includes copies of the program from that seminar and of the abstracts pre- sented at that seminar. Mr. Waxman. Mr. Greenwood. Mr. Greenwood. Thank you, Mr. Chairman. Good morning. Dr. Glenn. Mr. Glenn. Good morning, Mr. Greenwood. Mr. Greenwood. In all of my questions I am going to be refer- ring to the February 11, 1993, Wall Street Journal article. The article notes that the Supreme Court last year said smokers can sue, accusing the industry of deliberately hiding or distorting smoking dangers. Can you inform us as to what the record of those suits has been, the number of such suits filed, and whether your organization been a defendant in those suits? Mr. Glenn. In the two suits mentioned in this article? Mr. Greenwood. I am asking a more general question. Has your organization been sued as a result of the Supreme Court's ruling that the industry has deliberately been hiding or distorting smok- ing dangers? Have you been a defendant in such a suit? Mr. Glenn. The Council for Tobacco Research has been named defendant in a number of tobacco-related actions. Mr. Greenwood. Can you tell us about the status of those cases? Have any drawn to conclusion yet? Mr. Glenn. There have never been adverse findings against the Council for Tobacco Research. Indeed, in the Cipollone case the court found that activities of the Council for Tobacco Research were essentially irrelevant to the action at issue there. Subsequently Judge Sarokin issued a statement relative to the Haynes case in which we were not named as a defendant citing some 1,500 secret documents of the CTR as reported in the press. That simply was not true. The 1,500 documents must belong to somebody else because they certainly didn't belong to us. Mr. Waxman. So you are saying in one case the court found for the Institute as the defendant, is that what you said? Mr. Glenn. Yes, sir. Mr. Waxman. Ajid have there been cases where the courts have found for the plaintiffs? 371 Mr. Glenn. Not against the Council for Tobacco Research, no, sir. Mr. Greenwood. OK. There has been a lot of questioning about the freedom of the researchers who have been funded bv the Insti- tute, freedom to pursue their research as they would he directed scientifically and freedom to publish. Are those assurances contrac- tually guaranteed to the researchers? Do they have contracts with the Institute that say clearly, you are in charge of directing the course of this research and, second, you are entirely free to pub- lish? Mr. Glenn. There was no contract per se but in the grant award letter every grantee, there is a paragraph to the effect you are en- couraged to publish your results. We look forward to receiving re- prints of your publications and that message is reiterated to grant- ees repeatedly. Mr. Greenwood. Have you made those letters available to the committee yet? Mr. Glenn. I can — I am not sure that we have, Mr. Greenwood. I would be happy to provide them. Mr. Greenwood. If you would give us a sample of those. [The following information was received:] Item D in the Appendix is a copy of a form letter, with attachments, that is pro- vided by the Council to successful grant applicants. One of these attachments, ' Im- portant Procedural Information for Grantees", refers specifically to publications by grantees. Item E in the Appendix is the Council's Statement of Policy, which is sent to all grant applicants. The Statement of Policy makes it clear that the Council ex- pects grantees to report their findings in medical and scientific journals, and re- quests that any publications acknowledge the Council's support. Our Statement of Policy also says, in very clear terms: "The Council desires to have scientists work with the greatest freedom, without domination of any kind. It will make no attempt to direct the administration of a project once started, to influ- ence its course or to control its results ..." That is the Council's fundamental pol- icy: to give complete scientific freedom to its grantees, and to let the chips fall where they may. Mr. Greenwood. The question of the independence of the re- searchers that receive your grants further comes into question in the Wall Street Journal article. I will quote, "for both men defying conventional wisdom has been rewarding; Dr. Seltser says he has received well over $1 million from the Council, Dr. Sterling got $1.1 million for his special projects works, the 1977 to 1982 court records show." Can you inform this committee how the level of the grants com- pares with normal practice? Were your grants particularly high? Was there any attempt by the Institute to make sure that sci- entists were not so well paid for their research that they felt they would be inclined to feel that they couldn't receive grants as lucra- tive elsewhere? Mr. Glenn. Most of our grants are much smaller in nature. The average grant from the Council for Tobacco Research is of the mag- nitude of $75,000 to $80,000 per year for 3 years. However, there are projects that are deemed of such importance that we have given prolonged funding to them. The classic example of this is the research done by Dr. Ljnich in the epithelium cancers. We have supported Dr. Lynch for many years because the NIH did not see fit to do so. It is now proving to be a gold mine of basic information about genetic disorders and their relation to disease. 372 So, yes, some of the grants have run to very large numbers sim- ply because of the protracted nature of support. Mr. Greenwood. When you provide a grant to a university or to a research laboratory, does the Institute control the amount of grant that can be taken by the individual researchers for their sal- aries? Mr. Glenn. Yes, sir. We do. We regard — in general, the salary of the investigator is to be a responsibility of the institution. We try in as many instances as possible to limit financial support to support personnel such as lab technicians, to the purchase of sup- plies, experimental animals, publication costs, so forth. So it is unusual for an investigator to receive any or even a sig- nificant part of their salary from the grant. Mr. Greenwood. OK. Another quote from the Wall Street Journal article, "Today Dr. Hamburger adds that Mr. Jacob — and I assume Jacob is from the law firm — told him he would never get a penny more if the paper was published without making the changes." This went to the issue of a study that was done by Dr. Ham- burger years later at the Rose Cipollone tobacco liability trial in Federal Court in New Jersey. The issue is whether the researchers could use the term "cancer." Apparently the allegation in the arti- cle is that the law firm representing the Institute did not want the researchers to use the term "cancer", they wanted them to use more obscure medical terminology. Dr. Hamburger allegedly re- sisted that and claims he was told by Mr. Jacob that his refusal would end his funding. What is your response to that allegation? Mr. Glenn. First of all, I didn't know Dr. Hamburger and I didn't know Mr. Jacob. But I do know the circumstances. Dr. Hamburger was a grantee of the Council for Tobacco Re- search. He was working on the induction of lung tumors in ani- mals. His work was very nonproductive. He was able to produce only a superficial change in the epithe- lium of the lung, never any tumors. As a consequence, the Sci- entific Advisory Board declined to extend his funding. He was fund- ed I think for some 6 years. But the work was nonproductive and they did not renew his grant. I think his statements may reflect some bitterness at the fact that his funding was not continued. He was not successful in get- ting funding from any other agency. Mr. Greenwood. How do you respond to that part of his allega- tion that says that he was asked not to use the term "cancer" in his research but to use Mr. Glenn. Because our Scientific Advisory Board could not con- firm that he had induced cancer; only superficial changes. Mr. Greenwood. Another quote from the article, "By 1968 the Council had begun putting researchers under contract for many studies. This gave it the right to control both the studies design and publication of the results." I believe in response to an earlier question that I asked, you indi- cated that there were not contracts, they were in fact grant letters. There seems to be an inconsistency. Mr. Glenn. No. Contract research was done. It was not a promi- nent part of the activity of the Council for Tobacco Research. As 373 I am informed, there were some contract studies in years past. There are none today. In years past, there was a major contract with microbiological as- sociates, and some several million dollars were spent in exposing laboratory animals directly to tobacco smoke in an effort to produce tumors. It was an unsuccessful effort. It went on for a number of years and finally the Scientific Advisory Board, which had over- sight over this contract research, decided that it was inappropriate to continue with the research and the contract was terminated. It ran through its end. It simply was not renewed. Mr. Greenwood. Did that contract contain within it terms speci- fying the relative amount of freedom of the researchers to direct the research or their freedom to publish? Mr. Glenn. Yes, sir, as a matter of fact a major publication re- sulted from that Micro-Biological Associate's research work. Mr. Greenwood. So the contract did specify that the researchers were in control of the direction of the research and were free to publish their findings as opposed to the contract specifying that the Council would determine the course of their science and whether or not they could publish, is that correct? Mr. Glenn. Yes, sir. To my knowledge there never was no re- striction. I think a number of publications by Micro-Biological Asso- ciates resulted from that work. Mr. Greenwood. Could you make a copy of that contract avail- able to this committee? Mr. Glenn. Yes, sir. [The following information was received:] Item G in the Appendix includes copies of each of the Council's contracts with Microbiological Associates, Inc. ("MAI"), together with contract renewals. The Coun- cil spent some $12 million under the MAI contracts on a large-scale, long-term study of the effects of smoking inhalation on mice. I was mistaken when I told the subcommittee that these contracts contained no restriction on publication by MAI. The Council has had no research contracts during my tenure, and I had erroneously assumed that the Council's policies with respect to publication by contract researchers were the same as its policies with respect to publication by grantees. Since my testimony, I have learned that the MAI contracts provided that the Council's prior written approval was required for MAI to publish its research findings. Such provisions are customary in research contracts. It is my understanding that the results of the major inhalation study performed by MAI were published in complete and unedited form. In addition, MAI published dozens of articles based on its Council-funded research. Item H in the Appendix is a list of 89 publications or abstracts that appear to have resulted from the Council's support of MAI, at least 73 of which acknowledge support from the Council. Mr. Greenwood. Finally, Mr. Chairman. Another quote from the article: "But lawyers from Jacob Mettinger told Micro-Biological the project would go no further. When a contract is canceled given these kinds of results, Dr. Henry says, reasonable scientists might conclude the liability issue must have suddenly become apparent to this group." You already disputed the use of the terminology contract being canceled, you said it simply was not renewed. Was it in fact the case that the decisions about whether such a contract would be continued was made by lawyers from Jacob Mettinger or was that decision made by the Council? Mr. Glenn. To my knowledge — again, Mr. Greenwood, I was not there — but to my knowledge what I have been told, Scientific Advi- 374 sory Board determined that they had spent several million dollars, it was nonproductive, and they could put the funds to better use in other activities. Mr. Greenwood. So it is your testimony that the lawyers from Jacob Mettinger simply were the conveyers of information from the Council to the researchers, that they did not participate in the deci- sion-making mode as to whether the contract would be continued or how the course of the research would go? Mr. Glenn. I have no direct knowledge of that. I believe that to be the case. Mr. Greenwood. Thank you, Mr, Chairman. Mr. Waxman. Thank you, Mr. Greenwood. Mr. Wyden. Mr. Wyden. Thank you, Mr. Chairman. Mr. Glenn, do you know a gentleman named Mr. Addison Yeaman? Mr. Glenn. No, sir, I don't know him. Mr. Wyden. You have no knowledge of him? Mr. Glenn. I know of him. I do not know him. Mr. Wyden. I thought since you lived in Kentucky and I under- stand he spends a fair amount of time in Kentucky also, that you may have spoken several times over the years? Mr. Glenn. No, sir. I have never met Mr. Yeaman, I have never talked to him. Mr. Wyden. OK. Do you know a woman by the name of Dorothea Cohen? Mr. Glenn. I don't know her, Mr. Wyden. She was terminated as a librarian at the Council about the time I joined the Scientific Advisory Board. Mr. Wyden. So you have no recollection of any discussions with her on various tobacco issues over the years? Mr. Glenn. No, I have never discussed it with her. I am sure the committee knows Ms. Cohen is very ill. Mr. Wyden. That is not what I asked you. I wanted to know about two individuals and whether or not you had any discussions with them. The first was Mr. Addison Yeaman. You have told us under oath that you do not know Mr. Yeaman nor have you had any discussions with him. Is that correct? Mr. Glenn. That is correct. Mr. Wyden. And the same is true for Ms. Cohen? Mr. Glenn. That is correct. Mr. Wyden. Thank you. Could you cite a particular research report funded by your orga- nization which argues there is a causal relationship between to- bacco use and lung cancer? Mr. Glenn. Mr. Wyden, I cannot because I cannot accept the causal relationship. Causal relationship in medicine and science is a 1-1 proposition. If one were to encounter the tuber bacillus and they get tuberculosis, that is cause and effect. The industry and the Council for Tobacco Research freely acknowledge the risk factor of smoking. Nobody denies that. We certainly recognize it. The vast bulk of our research has been directed towards some disposition of that particular problem. We cannot accept the term "cause" in a scientific sense. 375 Mr. Wyden. I ask because one would think that as an allegedly objective organization, you might possibly have funded just one paper that argued the kind of causal relationship that virtually every unbiased medical organization in our country argues exists. You have told us you have not funded one, and we accept your word. Mr. Glenn. Mr. Wyden, I reject the premise that we are a bi- ased— I reject the premise that we are a biased organization. I re- ject the premise that smoking causes cancer. I reject the inference that the purpose of our activities has been to obscure the truth. On the contrary, they have been dedicated to developing scientific truth. Mr. Wyden. Well, is it true that you do not agree with all of these organizations? Mr. Glenn. No, sir. Mr. Wyden. The Surgeon General, the American Medical Asso- ciation, and the World Health Organization have all talked about the causal link between tobacco use and these illnesses. Let me ask you another way since you cannot cite us any report that addresses this causal link. What percentage of your recent research has even looked at the causal links between smoking and cardiovascular problems, emphy- sema, and cancer? Mr. Glenn. If you accept cause in the lay sense, I would say all of it. If you use the term "cause" in the scientific sense, I would say none of it. We are looking for the underlying problems that predispose indi- viduals. For example Mr. Wyden. You just said that if you look at it in a scientific sense — these are your words, not mine^and your organization is a scientific organization, you have not done any research to exam- ine these causal links. Mr. Glenn. Mr. Wyden, obviously I didn't make my point and I apologize for that. Mr. Wyden. Please feel free to elaborate. This is an opportunity for you to set the record straight. Mr. Glenn. No one has been able to demonstrate that smoking per se causes any diseases. It is clear that it is a risk factor, and we all knowledge that. Nobody can live in this world today without recognizing that smoking is a risk factor for lung diseases, cardio- vascular diseases, perhaps for many things we don't even know about yet. On the other hand, what we have got to find out is why the cell goes wrong. If it is exposed to this environmental agent, tobacco smoke, what makes the cell go wrong? We know, for example, that 93 percent of smokers smoke for years never developed any lung disease, 7 percent do. Why is there that vast discrepancy? Why do some people escape this injury completely? That really is what we address our research to. Mr. Wyden. Do you believe that smoking causes cancer? Mr. Glenn. No, sir. Mr. Wyden. Do you believe smoking is addictive? Mr. Glenn. No, sir. 376 Mr. Wyden. Do you realize your opinion stands alone in compari- son with all of these major medical groups that I have cited? We are talking about isolation. We are not talking about some sort of Mr. Glenn. Mr. Wyden, I am not isolated as a scientist. If you asked scientists to give you a scientific opinion about cause and ef- fect, you will find that I am in the vast majority. The risk factors of smoking are well-known. Nobody is arguing about that. What I am trying to impress on you is that there are much more fundamental issues here in the matter of predisposition to various disease processes that must be elaborated before we can address other fundamental issues. As to the matter of Mr. Wyden. I don't know how an issue gets more fundamental than looking at questions of cause, efiect, and addiction. You told me from a scientific standpoint that you don't even look at any pos- sible connection between smoking and disease, and I think that is an extraordinary statement for an organization like yours to make. This leads me to the additional area I want to explore, which is, in my view, that you are a public relations shop essentially posing as the National Cancer Institute. You have said to my colleagues again and again that you are doing all this scientific work. You just told me that you have not done any recent studies to look at the causal links between smok- ing and disease, and I would like to now ask you what kinds of ac- tivities you perform in a public relations sense. Certainly Ms. Cohen told the Wall Street Journal that you were a public relations shop and a lobbying shop. I quote her, "The Council for Tobacco Re- search is just a lobbying thing. We were lobbying for cigarettes." Do you perform public relations functions or lobbying functions? Mr. Glenn. Mr. Wyden, I won't respond to your editorial but I will respond in the matter of Ms. Cohen. Ms. Cohen has multiple sclerosis. It is an established medical fact that people with this se- vere debilitating neurologic disease develop mental problems as well. Since making that statement to the press, Ms. Cohen has called our office and tearfully apologized for her statements. I am very sorry for the lady and I really don't think her name ought to be invoked in this Congressional subcommittee. Mr. Wyden. In your opinion, at the time that she made these statements to the Wall Street Journal, she was not capable of being objective or truthful? Mr. Glenn. That was her statement to our staff" member. Mr. Wyden. All right. Could you get us anything that would doc- ument that? I have not seen an3rthing that would suggest that she repudiated it at any time when she was capable of doing so. [The following information was received:] At the May 26 hearing, I was asked to supply documentation for my statements about Dorothea B. Cohen, the former Council employee to whom comments were at- tributed in the Wall Street Journal article of February 11, 1993. We had intended to respond to the subcommittee's request for documentation by obtaining an affida- vit from Ms. Cohen, setting forth her view that the Wall Street Journal article was inaccurate. However, Ms. Cohen has moved, and we have been unable to locate her. We have spoken with Dr. John E. Bevilacqua, Ms. Cohen's treating neurologist (who is also her cousin.) 377 Dr. Bevilacqua has provided us with a letter dated August 20, 1994, describing Ms. Cohen's medical condition as of that date and as of February 11, 1993, when the Wall Street Journal article appeared. Dr. Bevilacqua has asked that his letter be treated as confidential, in deference to Ms. Cohen's privacy interests. We expect to provide Dr. Bevilacqua's letter to the subcommittee promptly after we have reached an understanding with the subcommittee staff with respect to procedures for the subcommittee's handling of materials provided by the Council. In the in- terim, I respectfully request that my letter be included at page 78 of the May 26 transcript. I have learned that I was mistaken when I testified on May 26 that, following the publication of the Wall Street Journal article, Ms. Cohen called the Council and apologized to one of our employees for the statements attributed to her in the arti- cle. What happened was that shortly afler the Wall Street Journal article was pub- lished, Ms. Cohen was contacted on our behalf and said that she had been mis- quoted in the article. The fact that Ms. Cohen had stated that she had been mis- quoted in the article was reported to an officer of the Council, who in turn reported that to me. As a result, I formed the mistaken impression that Ms. Cohen had called the Council, but my basic understanding about what she did say was correct. Mr. Wyden. Let me ask you about one other area, Mr. Glenn. Have lawyers from any of the tobacco companies that fund your re- search ever attempted to exert influence on research in progress? Mr. Glenn. No, sir. Mr. Wyden. Mr. Chairman, I yield back. Mr. Waxman. Thank you, Mr. Wyden. Dr. Glenn, you gave a very precise scientific answer to Mr. Wy- den's question about the link between cigarette smoking and all these diseases like cancer, emphysema, and heart problems. But if I asked you as a scientist in an independent organization for your recommendation to me as an adult whether I ought to smoke or not, if I am concerned about those diseases, do you advise me to smoke or not? Mr. Glenn. Mr. Waxman, you know, I have been asked that question by many patients who suffer from diseases that are known to have smoking as a risk factor and I would tell you what I have told all of them. For example, a patient with a bladder can- cer. There is the implication that by-products of smoking may ag- gravate bladder cancer. I tell those patients spontaneously without them asking that I think they ought to stop smoking since it is a risk factor. Mr. Waxman. If I was asking for general health advice, do you think that people ought to smoke or not? Mr. Glenn. I think people ought to have free choice. It is a legal product as is alcohol and other substances. I think they should have the information and I think that the information is readily available both in the scientific community and the lay community. Mr. Waxman. I am not asking you for what public policy ought to be and whether people ought to be permitted to smoke. I am asking you from you as a scientist and health expert what your recommendations are. Do you think people ought to smoke? Mr. Glenn. I think that is a very simplistic, Mr. Waxman. Do I think people ought to drive automobiles at 140 miles an hour on the interstate? Clearly there are risk factors involved in everything we do every day. I think every patient should Mr. Waxman. I assume, then, you would tell people that they shouldn't smoke at 140 miles an hour? If you are willing to tell them that about speeding, would you also be willing to tell them that you think that they ought not to 378 smoke because it is taking an inordinate risk, that they may well get cancer, heart disease, emphysema, and bladder cancer, and all these other problems? Mr. Glenn. I come back to what I have said before, 93 percent of people who smoke never develop lung problems. On the other hand, I know perfectly well, and I tell patients, 80 percent of the people who die of lung cancer have been smokers. The interesting aspect is that 20 percent of people who die of lung cancer have never smoked. Mr. Waxman. Dr. Glenn, I suspect that you have strong views of your current mission of CTR. Can you share with us what you see that mission to be? Mr. Glenn. I see our mission to be one of elaborating fundamen- tal mechanisms of diseases and we have found that the specific re- search into exposing animals to cigarette smoke is superficial and nonproductive. Mr. Waxman. My staff is telling me that since we are starting a second round of questions, if you want to take a break we can take a short break now. Mr. Glenn. I am perfectly happy, thank you, sir. Mr. Waxman. OK. Could you help us in understanding how CTR is funded? I believe the original budget in 1954 was $1 million. Is that correct? Do you know? Mr. Glenn. I believe it is, Mr. Waxman. I forget. Mr. Waxman. The current budget is $19 million. Mr. Glenn. Nineteen million five hundred fifty thousand dollars. Mr. Waxman. Where does the money come from? Mr. Glenn. Comes from the five major sponsor companies. Mr. Waxman. From 1994, what was the method of apportionment of funding among your member companies and what are the actual dollar amounts? Mr. Glenn. I can't tell you the actual dollar amounts from each company, but roughly the contributions of the companies are based upon their market share, a formula that they derived years ago. Mr. Waxman. Would you give us for the record that information, and all past budgets and the share each company paid for each year of your organizations existence? Mr. Glenn. I am sure we can develop that. [The following information was received:] We have prepared three separate tables setting forth the dollar amounts contrib- uted in each year, by each contributor, to the Council and to the Tobacco Industry Research Committee ("TIRC") for the General Fund, for Council Special Projects, and for the Council's Literature Retrieval Division ("LRD"). (I understand that LRD was a division of the Council from 1971 until 1983, that LRD compiled medical lit- erature for the use of the tobacco companies, and that LRD's assets were trans- ferred in 1983 to LS, Inc., a corporation that is unrelated to the Council.) This fi- nancial information is non-public, and the Council's members regard it as confiden- tial. We expect to provide these tables to the subcommittee promptly after we have reached an understanding with the subcommittee staff with respect to procedures for the subcommittee's handling of materials provided by the Council. In the in- terim, I respectfully request that this letter be included at page 82 of the May 26 transcript. We have collected copies of the audited financial statements of the Council and its predecessor for each year from 1963 through 1993. (In 1983, the Council changed from a calendar year to a November 1 fiscal year.) We have also collected copies of budgets for each year from 1954 through 1962; we are unable to locate financial statements from before 1963. Again, this financial information is non-public, and 379 the Council and its members regard it as confidential. We expect to provide these tables to you promptly after we have reached an understanding with the sub- committee staff with respect to procedures for the subcommittee's handling of mate- rials provided by the Council. In the interim, I respectfully request that this letter be included at page 82 of the May 26 transcript. Item F in the Appendix is a copy of the Council's current by-laws. Article III of the by-laws provides the method of apportioning the funding of the Council among its sponsors. Mr. Waxman. What is the tax status of the CTR? Mr. Glenn. We are a not-for-profit organization. Mr. Waxman. With regard to your organizational structure — you are in charge of the organization, is that correct? Mr. Glenn. That is correct. Mr. Waxman. Can you tell the subcommittee what the Commit- tee of Councils is? Mr. Glenn. What the Committee of the Council is? Mr. Waxman. Or Councils. Mr. Glenn. I am not sure I understand the question. Mr. Waxman. Well, I have heard there is a Committee of Coun- cils. I want to know does it function within CTR or is it an inde- pendent organization? Mr. Glenn. Mr. Waxman, I don't recognize the term at all. Mr. Waxman. You don't know what that is? Mr. Glenn. I will be glad to explain our organizational structure, but I don't understand that question. Mr. Waxman. OK. Can you make research funding decisions without first obtaining specific approval from anyone else? Mr. Glenn. Yes, sir. Mr. Waxman. Have you ever done this or are you aware of any instances where the chairman has done this? Mr. Glenn. Where the chairman has made the decision? Mr. Waxman. Right. Mr. Glenn. I am sure you understand that our Scientific Advi- sory Board really is the decision-making board and it functions much like a study section of Federal Government organizations. Al- most identical. Mr. Waxman. Is that also known as the Scientific Liaison Com- mittee? Mr. Glenn. I don't know that term, Mr. Waxman. Mr. Waxman. OK. So you have never heard of a Scientific Liai- son Committee, but there is a Scientific Advisory Board, is that correct? Mr. Glenn. Yes, sir. Maybe it would simplify things, Mr. Wax- man, if I were to tell you that the Council for Tobacco Research, of which I am president, chairman and CEO, consists of 15 individ- uals, 5 of them hold PhD's or equivalent degrees in basic medical sciences; the remainder of the staff are largely clerical in their ac- tivities. Mr. Waxman. Let me ask you on a different topic, do grantees and contractors get paid directly by CTR or is payment made by individual tobacco companies? Mr. Glenn. Grantees of the Council for Tobacco Research are not reimbursed directly. The institutions that they represent become the grantee and they, the institutions, are responsible for distribu- tion of these funds. That process is identical to that of the NIH. 380 Mr. Waxman. The institutions, you mean the universities or Mr. Glenn. The universities, or the research institute. Mr. Waxman. Are those institutions paid by CTR or are they paid by the individual tobacco companies? Mr. Glenn. By CTR. Mr. Waxman. And how many people work for or are under con- tract to CTR at the present time? Mr. Glenn. Under contract? Mr. Waxman. Yes. Mr. Glenn. We have no contracts at the present time. We have independent research grants but no contract research at the present time. Mr. Waxman. How many of your employees are legal staff? Mr. Glenn. None. Mr. Waxman. How many, not counting the Scientific Advisory Board, are physicians and scientists? Mr. Glenn. Not counting the Scientific Advisory Board, six in- cluding myself. Mr. Waxman. And will you provide for the record the past and present personnel roster with aivisions by areas of job responsibil- ity for each year from 1954 to the present time? Mr. Glenn. Yes, sir. [The following information was received:] We have prepared a list setting forth the names, years of employment and the current (or terminal) position of employees of the Council and TIRC from 1954 to the present. I should advise you that while our staff expended considerable time and effort in trying to compile a list of all Council employees, the list may not be com- plete or totally accurate because the Council's records for this 40-year period are in- complete. In deference to the privacy interests of the persons whose names appear on this list, we regard it as confidential. We expect to provide this list to the subcommittee promptly after we have reached an understanding with the subcommittee staff with respect to procedures for the subcommittee's handling of materials provided by the Council. In the interim, I respectfully request that this letter be included in the May 26 transcript. Mr. Waxman. In 1993, what percentage of CTR research and what percentage of CTR research funds involves projects directly relevant to the health hazards of smoking and can you provide in- formation for us for each past year? Mr. Glenn. Well, our mission, Mr. Waxman, is to investigate the areas relating to tobacco and health and all of our research can be said to be relevant to that issue. Mr. Waxman. And how much is directly related to health haz- ards of smoking? Mr. Glenn. Again, Mr. Waxman, I am repeating what Mr. Wyden asked me and that is that all of the research can be related to issues of tobacco and health. Mr. Waxman. Mr. Bliley asked you for a submission for the record of publications from presentations resulting from CTR's spe- cial projects, and Mr. Greenwood I think made some similar re- quests. You said in response to Mr. Greenwood you were not holding any special projects documents. Would you give us all documents in your possession relating to special projects, including grant applica- tions, grant reviews, all correspondence with the recipients of these grants? 381 Mr. Glenn. Mr. Waxman, the special projects were not submit- ted as a regular grant. Therefore, we have no grant application. These were projects that were deemed worthy of pursuit by our sponsor companies. We were asked to be the administrative servic- ing agent only. So we don't have grant applications in the true sense. We know the nature of the project but they do not go through the regular granting process and they do not impact upon our research budget. As I further said, there are no special projects at the present time either. Mr. Waxman. I would like to draw your attention to Exhibit 18, if staff would make that available to you. This exhibit is a series of letters written from scientists to to- bacco industry lawyers, including the firm of Shook, Hardy & Bacon seeking research grants. For instance, the first letter is from Dr. Eleanor MacDonald. She is submitting a budget to enable her to complete work on environmental factors that cause death, dated June 27, 1977, and she seeks $88,773 to complete the work. Did the Council fund these projects after the lawyers approved them? Mr. Glenn. Mr. Waxman, this was in 1977 and that precedes my time. These are not records from our files so this is entirely new to me. I really can't comment authoritatively about it. It appears to me to be a letter from an investigator who was accomplishing a special project but that is really all I can tell you. Mr. Waxman. We have Exhibit 16 which is the list of CTR spe- cial projects. Let's be sure that you have that exhibit. The first page exhibits that Dr. Eleanor MacDonald received a grant of $88,773 in August 1977 from the CTR special projects, 2 months after she wrote the lawyers at Shook, Hardy & Bacon. One would think either this is a coincidence or demonstrates that law- yers were actually reviewing and approving CTR special projects. What do you think? Mr. Glenn. It would not surprise me at all. Attorneys are called upon as expert witnesses and expert investigators all the time. I have been called many times as an expert witness in medical mal- practice actions, and it doesn't surprise me that the attorneys might have recommended a contract with an investigator. Mr. Waxman. Why wouldn't the Science Advisory Committee be reviewing this? Why would lawyers be reviewing it? Mr. Glenn. Because it is outside the purview of the Scientific Advisory Board. I don't know the nature of the project. I have not seen this document until this moment. Mr. Waxman. Of course this is CTR money that is being used to fund the special project. Mr. Glenn. It is industry money, Mr. Waxman, and we merely acted as the administrative agent in funding the research. The companies and the attorneys I am sure do not have any par- ticular expertise in dealing with university finance offices which are unique. Mr. Waxman. Why wouldn't the tobacco companies do this on their own? Why would they use you as an intermediary? Why would they engage in this device? 382 Mr. Glenn, I don't know why they chose to do that, Mr. Wax- man. Mr. Waxman. Why would CTR want to cooperate? Let me read to you from the Los Angeles Times of today; in 1978 memos to top B&W executives — they were told that CTR solved a huge legal quandary involving the industries' need to both fund re- search and be able to dismiss adverse findings, and they are avoid- ing this research dilemma to a responsible manufacturer of ciga- rettes which on the one hand needs to know the state of the art and on the other hand cannot afford the risk of having in-house work turn sour. The point here is the value of having CTR doing work in a nondirected and independent fashion as contracted work either in- house or under B&W contract which if it goes wrong can become the smoking pistol in a lawsuit. So this seems to indicate that the companies used you or your organization as a way to have a deniability for that research which could come back to haunt them in lawsuits. Is that an accurate statement? Mr. Glenn. I don't think so. The nuances escape me a little bit. But let me put it to you this way. Any time the CTR served as the administrative agent for special projects, we informed the recipient of those funds that should they publish they should acknowledge that this was a special project funded through the Council for To- bacco Research. That tag line appeared on their publications so it was different from a research grant. This was — this was essentially contract work and we served as the funding agent only. Mr. Waxman. Why wouldn't they acknowledge on their document that the company actually funded them? Mr. Glenn. In many instances as I understand it — this is before my time — several of the companies might have joined in funding a specific project. We were the funding agency. Mr. Waxman. What I read to you from the LA Times was a memo from the general counsel of Brown & Williamson explaining that this is what they were doing, they are trying to get by this legal quandary. Mr. Glenn. I can't respond to that. I have just seen the memo- randum— the article. Mr. Waxman. Why don't you look it over. We are going to have to take a break, you may have heard the bells ring, to respond to a vote on the House Floor. We will do that and return as quickly as possible to continue our inquiries. [Brief recess]. Mr. Synar [presiding]. Doctor, if you could join us at the table again, please. The Chair recognizes the gentleman from Virginia for questions. Mr. Bliley. Thank you. Dr. Glenn, why did the companies not conduct special project re- search in-house, do you know? Mr. Glenn. No, sir, I don't know. Mr. Synar. Hit your microphone, Doctor, so we can hear you. Mr. Glenn. No, sir, I don't know. 383 Mr. Bliley. Dr. Glenn, I am not a scientist but I was intrigued by your testimony about the current focus of CTR research at the molecular level in your belief that the keys to unlocking the mys- teries of chronic diseases is to be found by this research. Would you tell us some more about how your views compare with those of other scientists? Mr. Glenn. I think my views are consistent and consonant with the views of other scientists. One of the most significant things being done in medical science today is the human genome project to which our government has devoted a great deal of money and effort. In essence, once the human genome is decoded we will be able to identify the genetic — genetically normal patterns and the deviations from the normal patterns that predisposes us to a lot of diseases. A theoretical pos- sibility is that we could identify people who are subject to some dis- ease in the future, and we could either genetically alter their gene's chromosomes or we could advise them about avoiding the risk fac- tors that might predispose them. It is a very exciting thing. Perhaps by the turn of the century we may have some very posi- tive answers in this area. Mr. Bliley. Dr. Glenn, has CTR-funded research produced re- sults which indicate connections or possible connections between smoking and disease? Mr. Glenn. Yes, sir. Mr. Bliley. During your tenure, has CTR had a public relations function? Mr. Glenn. No, sir. Mr. Bliley. Don't other funding organizations have PR func- tions? Mr. Glenn. Well, to the extent that they engage in fund-raising activities, we don't do that because we are funded by the industry. The American Cancer Society, the American Heart Association, do indeed have extensive public relations efforts, and it is entirely ap- propriate that they do that, because they are raising money from the general public in order to engage in research projects. Mr. Bliley. I noted. Dr. Glenn, in my opening remarks, my con- cerns both about the misapprehension that can result from quoting excerpts from documents out of context and the difficulty of accu- rately developing the facts before this committee since we were not provided until the last minute with the documents that will be shown to witnesses. In a very short time I have had to review the Majority staff re- port and its attachments. I note other documents not mentioned by other members of this committee that should be brought to the public's attention. In particular, I am going to read from Exhibit 8, which is a Hill and Knowlton memo dated July 31, 1954. It seems to me pretty clear that from the beginning CTR was to be involved in relevant research into tobacco issues and health. And I will now begin to read. "In mid-December, 1953, executives of leading tobacco companies decided some kind of joint action was imperative in the face of widely publicized attacks alleging a link between cigarette smoking and lung cancer. Representatives of Hill and Knowlton, Inc., were 384 invited to meet with these executives for consultation on ways and means of dealing with the problem. "At this first meeting, it was agreed that the wisest course of ac- tion would be for the industry to find out through objective re- search what truth there was, if any, in the charges being made against it. Mr. Hill stated it would be a serious public relations mistake for the industry to make any move that could cause it to be accused of disregard of people's health and under no cir- cumstances could the industry afford to engage in direct con- troversy with its detractors. With the acceptance of these prin- ciples. Hill and Knowlton, Inc. was asked to recommend a program to implement them. "After 2 weeks of intensive study of the problem, public relations counsel developed a step-by-step program which was discussed at a meeting with a small group of public relations representatives of a number of tobacco companies. Valuable suggestions were made at this meeting and the program was put into final shape and submit- ted to the principals at another meeting the last week in December. "Taking into consideration court ruling inhibiting the industry from ordinary trade association activities, the program rec- ommended: "One, formation of an industry group to be known as the Tobacco Industry Research Committee, dedicated to sponsoring and financ- ing research into all phases of tobacco use and health. "Two, establishment of a Scientific Advisory Board, to be com- posed of distinguished research scientists and educators, and a sci- entific director to guide the research objectives. "Three, undertaking of continuous editorial research into rel- evant scientific, statistical, and medical material, past and current, for an effective information program. "Four, keeping the public informed regarding the committee's ac- tivities. As a first step, the newspaper advertisement outlining the industry's plans was proposed, copy for which was submitted. "The program and the public statement advertisement were ap- proved. The agreed-upon approach was to sponsor genuinely objec- tive research and to bring to public attention the fact that there is now no conclusive proof that cigarette smoking is a cause of lung cancer and other serious problems of human health." And I thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Bliley. Mr. Synar? Mr. Synar. Thank you, Mr. Chairman. Dr. Glenn, which law firms presently represent CTR, or do you have in-house counsel? Mr. Glenn. Debevoise and Plimpton. Mr. Synar. So you have outside counsel? Mr. Glenn. Outside counsel. Mr. Synar. What are the duties of the counsel? Mr. Glenn. What are the duties of the counsel? Mr. Synar. Did you have inside or outside counsel? Let me ask that general Mr. Glenn. We have outside counsel, Debevoise and Plimpton, and their duties are to address any legal issues which effect CTR. Mr. Synar. Do you have in-house counsel? Mr. Glenn. No, sir. 385 Mr. Synar. ok. Now, do the outside counsels get to see any of the CTR research results before the research results are an- nounced? Mr. Glenn. No, sir. Mr. Synar. OK. So they see it only afterwards? Mr. Glenn. If they see it at all. Mr. Synar. OK. In the past has that been the case? Mr. Glenn. To my knowledge. Mr. Synar. Could it be, could it be that they have been able to review it prior to? Mr. Glenn. Prior to? Mr. Synar. Releasing the results. Mr. Glenn. I don't know, Mr. Synar, but I would think not. Mr. Synar. Mr. Glenn, your memory is very selective today. Mr. Glenn. Dr. Glenn, Mr. Synar. Mr. Synar. Dr. Glenn, your memory has been very selective dur- ing this hearing. You seem to not remember anything prior to 1987. Will you make available all materials that are central to this hearing prior to 1987 for subcommittee review? Mr. Glenn. We will cooperate. Mr. Synar. I didn't ask you that. Will you provide all of the ma- terials available in the files of the CTR for this subcommittee? Mr. Glenn. All of the materials that you request will be pro- vided. Mr. Synar. I am asking you for all of them. Mr. Glenn. I don't think you want all of them, Mr. Synar. Mr. Synar. I want all of them. Will you provide those for the committee? Mr. Glenn. We will cooperate fully with the committee. We will provide whatever you require. [The following information was received:] At the hearing, Mr. Synar asked me to provide "all materials that are central to this hearing prior to 1987" and "all of the materials available in the [Council's] files." Tr. at p. 98. I responded that the Council would cooperate fully "and would provide whatever you require." Tr. at p. 99. I did not understand Mr. Synar to be asking for every piece of paper in the Council's files. Rather, I thought he was hav- ing me confirm that we wovQd be responsive to the subcommittee's requests. Indeed, I have no way of knowing what documents Mr. Synar regards as "central to this hearing." And it certainly would not be feasible for the Council to produce all of its files to the subcommittee. We estimate that those files include over 2.5 million pages, and I respectfully submit that it would serve no purpose to deluge the sub- committee with documents beyond those that the Council has already gathered in response to the subcommittee's broad requests. I respectfully request that this letter be included in the record. Mr. Synar. The FDA, Dr. Glenn, is currently very interested in the content of tobacco products and its effects on health as you can see from some of the previous hearings that we have had. If the Food and Drug Administration requests any studies that the CTR has conducted or funded for nicotine or any other ingredients con- tained in tobacco will you freely provide those studies and related documents to the FDA? Mr. Glenn. Yes, sir. Mr. Synar. Thank you. Do you know a Dr. Leo Abood, who is a member of your board of directors? Mr. Glenn. Doctor? Mr. Synar. Abood. 386 Mr. Glenn. Yes, indeed. Mr. Synar. Are you familiar with his work on nicotine analogs? Mr. Glenn. Yes, sir. Mr. Synar. Why doesn't the CTR sponsor a nicotine analog or even more research based on nicotine since you have this very val- uable doctor on board who could evaluate and supervise the re- search? Mr. Glenn. I don't understand your question, Mr. Synar. Mr. Synar. You have an expert on staff in this area. Why don't you sponsor or fund research in that area so that he could help you evaluate it? Mr. Glenn. You are asking me a negative. We have sponsored a great deal of research on nicotine. Mr. Synar. On the nicotine analogs? Mr. Glenn. And nicotine analogs. Mr. Synar. OK. You have described your background and medi- cal training. Would you discourage your grandchildren from smok- ing? Mr. Glenn. I would present them with the facts at an appro- priate time, and I recognize that parents and grandparents often don't have any control over the actions of their children. But would I certainly Mr. Synar. What are those facts. Dr. Glenn, that you would give your grandchildren? Mr. Glenn. I have told my children and I would tell my grand- children that smoking is a risk factor for a number of diseases. I would also tell them it is an expensive habit. Mr. Synar. Would you encourage them? Mr. Glenn. Encourage them what? Mr. Synar. To smoke? Mr. Glenn. I would encourage them to make an intelligent deci- sion. Mr. Synar. So you would neither encourage nor discourage? Mr. Glenn. On the contrary. I would tell them the facts; I would encourage them to make an intelligent decision. It is a personal de- cision. You can't decide for them. Mr. Synar. Would you say that the facts might indicate that they shouldn't smoke? Mr. Glenn. I would say that if I were presented with the facts about smoking today that I would choose not to smoke. I can't say what my children would do. Mr. Synar. You have some impressive academic and publishing background credentials. You published I think close to 400 articles. Your field is urology, correct? Mr. Glenn. Correct. Mr. Synar. What was the background of your predecessor? Mr. Glenn. My predecessor in what? Mr. Synar. As chairman. Mr. Glenn. As chairman? Mr. Synar. Yes. Mr. Glenn. Mr. William D. Hobbs was the previous chairman. He was a former officer of R.J. Reynolds Tobacco Company. Mr. Synar. So he was not a medical physician? Mr. Glenn. No, sir, he was not. 387 Mr. Synar. Could you help me? What does a urologist know about conducting tobacco research? Mr. Glenn. Mr. Synar, I am a medical administrator. I am also a scientist. I have done bench research. I have done a lot of clinical medicine. There is not much difference between research into uro- logic problems and research into other problems. The fundamental techniques of biomedical research are fairly universal. Mr. Synar. So that is what qualifies you in the area of tobacco research? Mr. Glenn. I am qualified to administer a program of research. I don't accomplish research myself in these areas. But I am very qualified to administer a research granting program. Mr. Synar. Thank you, Mr. Chairman. Mr. Waxman. Thank you, Mr. Synar. Mr. Wyden? Mr. Wyden. Thank you, Mr. Chairman. Mr. Glenn, does your Mr. Glenn. Dr. Glenn, Mr. Wyden. Mr. Wyden. Dr. Glenn. Mr. Waxman. And this is Congressman Wyden, Dr. Glenn. Mr. Wyden. Does your operation offer a system for storage of files? Mr. Glenn. I misunderstood the question, Mr. Wyden. Mr. Wyden. I am interested in knowing whether your organiza- tion has a system for storing studies, for example, studies done by researchers, your grantees on other researchers. Do you have a sys- tem for storing this? Mr. Glenn. We have a system for storing all of the information relative to the grants that we make, to the reports that the various investigators send us periodically, to papers that are published by those investigators. Extensive file system. We maintain these files for indefinite periods of time. I hope that is responsive to your question. Mr. Wyden. It is. You store research, CTR research, and presum- ably some research done by other scientists as well. Mr. Glenn. The Council for Tobacco Research doesn't do any re- search. Congressman Wyden. Mr. Wyden. Your grantees do, is that correct? Mr. Glenn. The grantees do it. And the specifics of their inves- tigations are maintained in their files. What we store are their in- terim reports to us and any papers that are published, but we do not, for example, maintain a file of their laboratory journals or manuals. Mr. Wyden. Who has access to this stored material? Mr. Glenn. Anyone. Mr. Wyden. Anyone? Mr. Glenn. I Mr. Wyden. The Washington Post, the Wall Street Journal, and the New York Times can come on down and see your storage and information retrieval system? Mr. Glenn. Well, that would pose a significant burden and I think we would have to ask counsel whether that is appropriate. Mr. Wyden. Could this committee come down and see it? Mr. Glenn. Well, we have agreed to provide you with any infor- mation that you want from our files. 388 Mr. Wyden. Then access is not in any way limited. This commit- tee, the newspapers and all of the scientific organizations that have interests in this could look at your research files in a consistent, orderly fashion? I am coming down, because I would like to see it. Can I arrange to see what is in your files? Mr. Glenn. Yes, sir. We would welcome you. Mr. Wyden. All right. Mr. Chairman, I yield back. Thank you. Mr. Waxman. Thank you, Mr. Wyden. Dr. Glenn, this is what we would like from you on the record. We want a list of all of the special projects, a copy of the research re- sults, any correspondence between CTR and the tobacco companies, and/or the researchers regarding any of these special projects. The dollar amount spent on each of the special projects; the itemization of whether and where each special project was published, or if it was published at all; and any other documents in your possession relating to special projects. Mr. Glenn. Yes, I understand. Mr. Waxman. You will cooperate with us and get those to us? Mr. Glenn. Yes, sir. [The following information was received:] We have gathered 14 boxes of documents, consisting of about 30,000 pages, from the Council's files on Council Special Projects. The vast majority of these documents are from files that are arranged alphabetically by the name of the principal inves- tigator or, in some cases, the investigator's institution. There are also documents from files containing financial information about Council Special Projects and docu- ments from Special Project desk files of certain Council employees. Approximately Va of these pages consist of applications and pre-publication reports by researchers, or evaluations of a researcher or of his or her research. We believe that the informa- tion that is reflected in these documents was provided to the Council with a reason- able expectation of confidentiality, and we therefore regard these documents as con- fidential. We expect to be able to provide all these documents to you promptly after we have reached an understanding with the subcommittee staff with respect to procedures for the subcommittee's handling of materials provided by the Council. In the in- terim, I respectfully request that this letter be included in the May 26 transcript. In addition, I am advised that there are 54 documents from these Council Special Project files that are subject to claims of attorney-client privilege, attorney work- product protection or joint defense privilege asserted by the Council or its sponsors. We do not intend to provide 51 of these documents to the subcommittee, and we intend to redact the other three. None of these documents constitutes a researchers' report of his or her results or findings. (As stated above, the Council has not as- serted any privilege with respect to such results or findings; and my understanding is that none of the Council's sponsors have done so.) No communications with sci- entific researchers are being withheld on privilege or work-product grounds. [Subcommittee Note: On October 19, 1994, the Council for Tobacco Research sub- mitted to the subcommittee the list of special projects administered by the Council. This list is part of the public record of the hearing and is available for public review in the office of the Committee on Energy and Commerce and the office of Rep. Henry A. Waxman.] Mr. Waxman. Now, in the Haines case Judge Sarokin said he had 1,500 CTR documents in his possession. Will you provide any of these Haines documents that are in your possession, and will you ask the tobacco companies for them and then submit them to us? Mr. Glenn. Mr. Waxman, you will have to ask the tobacco com- panies. None of the 1,500 documents to which Judge Sarokin re- ferred were CTR documents. None of them. Mr. Waxman. They were identified as CTR documents. Mr. Glenn. I am sorry? 389 Mr. Waxman. They were identified as CTR documents. Mr. Glenn. By the press. I think if you will read the judge's statements, you will find that there is some ambiguity. These were documents apparently referring to CTR, but none of these docu- ments were a part of our files at CTR. None of the 1,500 documents to which he referred are in our files or were ever in our files. Mr. Waxman. Do you know of any reason why a committee of the Congress shouldn't have those documents? Mr. Glenn. Mr. Waxman, again, that is something that you can deal with the sponsor companies about. Mr. Waxman. My question is, do you know of any reason why they shouldn't be given to us? Mr. Glenn. I don't even know what the documents are, Mr. Wax- man, so I can't respond to that. Mr. Waxman. Then how do you know they are not CTR docu- ments. They are from before your time as chairman. Mr. Glenn. Mr. Waxman, I assure you, they are not documents from the CTR. Mr. Waxman. And how do you know that? Mr. Glenn. I know that because we have examined this issue as carefully as possible, and Mr. Waxman. Who is we? Mr. Glenn. We internally, the Council for Tobacco Research and its staff in conjunction with counsel. Mr. Waxman. And have you been able to identify these docu- ments? Mr. Glenn. No, sir. Mr. Waxman. Then how do you have knowledge of these docu- ments if you haven't been able to identify these documents? Mr. Glenn. I have knowledge of them only from what I read in the paper. Mr. Waxman. You just told me that characterizations by the paper of CTR documents were not accurate. Mr. Glenn. It is not accurate. Mr. Waxman. And you know that not to be accurate because you reviewed these with your attorneys and perhaps others. Is that cor- rect? Mr. Glenn. Correct. Mr. Waxman. So how do you know what the documents are or are not? Mr. Glenn. As I said, Mr. Waxman, we reviewed this internally with our staff and we were further advised by counsel that these were not our documents and were not a part of our files. Mr. Waxman. Then you have not seen the documents? Mr. Glenn. No, sir. Mr. Waxman. Has your staff seen the documents? Mr. Glenn. No, sir. Mr. Waxman. Have your lawyers seen the documents? Mr. Glenn. I can't answer that. I Mr. Waxman. Then how can you tell us what these documents are or are not? Mr. Glenn. I have told you Mr. Waxman. You told me all you know about it is what you read in the newspaper. You said the newspapers, however, have identi- 390 fied them as CTR documents incorrectly. How do you know it is in- correct? Mr. Glenn. It is incorrect, I am advised by our own staff and by counsel that these documents were not CTR documents. Mr. Waxman. How do they know? Mr. Glenn. How does counsel know? Mr. Waxman. How do your staff and your counsel that is advis- ing you know that? Mr. Glenn. Mr. Waxman, I don't get the thrust of the question. I am simply stating to you a fact, and these are Mr. Waxman. You have told me they have not looked at the doc- uments. Have they or have they not? If they have not, how can they know whether they are CTR documents or not. Mr. Glenn. I don't know how counsel can know this, but I accept their reassurance as it stands. They are not our documents. Mr. Waxman. Now, if they are your documents, would you urge that we receive them? Mr. Glenn. I have no objection one way or the other, Mr. Wax- man. They are not our documents. I will be happy to review the documents if you like and tell you whether or not they are CTR documents piece by piece. Mr. Waxman. Well, we would like that and we accept that offer. That would be very helpful. And will you ask the tobacco companies, or you obviously asked them for them, ask them to receive those documents so you can re- view them, and then will you submit them to us if they are CTR documents? Mr. Glenn. No, sir. I think that is your prerogative, but it is not mine. Mr. Waxman. Well, I am asking you to get documents that are CTR documents. Mr. Glenn. They are not CTR documents, Mr. Waxman. Mr. Waxman. If they are CTR documents after you review them, will you ask the tobacco companies to make them available to us and will you make them available to us? Mr. Glenn. Mr. Waxman, I don't have the documents. They are not CTR documents. I don't know where this 1,500 CTR documents business came from. But they are not our documents. Mr. Waxman. It comes from the judge in the case. The judge in the case said they had 1,500 CTR documents. Mr. Glenn. They are documents that perhaps relate to CTR, but they were not in our files. They are not a part of the CTR records. They are not CTR documents. Mr. Waxman. How could they relate to CTR? Mr. Glenn. I don't know. Mr. Waxman. You just said that you heard that they relate to CTR. Mr. Glenn. They may carry a message that says Council for To- bacco Research in it somewhere. I don't know. Mr. Waxman. Well, a few minutes ago you told us that your peo- ple did a very careful review of these documents and you know that they are not Mr. Glenn. No, I did not say we reviewed. I said we did a careful review of our files and I did a careful inquiry of our staff, and I 391 also submitted the question to counsel, and I am reassured by ev- eryone that none of the alleged documents are from our files. They may relate to CTR, but they are certainly from someone else's files. Mr. Waxman. If they do relate to CTR and you then find that to be the case, will you submit them to this committee? Mr. Glenn. I don't have the documents, Mr. Waxman. Mr. Waxman. Well, you are going to ask the tobacco companies for the documents. Mr. Glenn. No, sir, I am not. That is not my prerogative. Mr. Waxman. Then how are you going to review them for us? Mr. Glenn. I will be glad to if you will submit them to me. Mr. Waxman. Well, I don't want to play games with you. Mr. Glenn. I am not playing games. Mr. Waxman. You just said a few minutes ago that you will re- view the documents and if they are CTR documents, you will sub- mit them to us. How are you going to review these documents? I presume you will ask the tobacco companies for them. Mr. Glenn. I assumed that you would submit them to me. I would be happy Mr. Waxman. Why would you presume that? Mr. Glenn. From your statement, Mr. Waxman. Mr. Waxman. My statement was that I was going to submit doc- uments to you? My statement was, will you ask the tobacco compa- nies for these documents. Mr. Glenn. And I said no, I will not ask the tobacco companies for the documents; I think that is your prerogative. The documents are not my documents, and they are the property of someone else. Mr. Waxman. You don't know whether they are your documents or not. Mr. Wyden? Mr. Wyden. Thank you. If you will just excuse me, I think this is an area maybe we can resolve this way. Do you consider these documents relating to special projects part of CTR files? Mr. Glenn. I don't know which documents you are talking about, Mr. Wyden. If there are documents in our files relating to special projects, we will be happy to provide them. Mr. Wyden. Thank you, Mr. Chairman. Mr. Waxman. Dr. Glenn, do you know whether these 1,500 docu- ments exist? Mr. Glenn. No, sir, I frankly do not. Mr. Waxman. OK. You indicated to me a few minutes ago you are going to review them one by one and see whether they are CTR documents. Mr. Glenn. I would be glad to if you would submit them to me. Mr. Waxman. Well, you know, this is a key point. These docu- ments, 1,500 documents, are being kept from the public. I don't know whether they have been kept from you, but they relate to you, they have been described as CTR documents and I think that once they are known to the public, they are going to be pretty damning. Now I don't see you willing to cooperate with us in getting those documents. Are you willing to ask the tobacco companies to clear your organization? To give Congress the information that the pub- lic ought to have, or are we being stonewalled and being told we 392 are not going to get the documents because you are not willing to help us get those documents presuming you don't already have them and you are just refusing to give them to us? Mr. Glenn. Mr. Waxman, let me be as plain as I can. The docu- ments are not CTR documents to my knowledge. I do not have ac- cess to the so-called 1,500 documents. They are the property of someone else. I don't know whose property they may be. I have not seen the 1,500 documents; I would be happy to review them if you submit them to me and tell you whether or not they relate to inter- nal activities of the CTR. But I think — other than that, I really can shed no light on the issue for you. Mr. Waxman. Well, Dr. Glenn, let me just tell you, I am going to submit some questions to you for the record and we may have to have an additional hearing on this very point. I want to ask you about special accounts. In preparing for this hearing, we have discovered references to a CTR account called Special Account Number 5. Does this account support scientific re- search, and who has or had control over this account, and will you provide the subcommittee with a list of the individuals who re- ceived funding from this account, the amount of funding, and the purpose of funding? Mr. Glenn. We will. Mr. Waxman. Can you answer any of those questions now? Mr. Glenn. I have no idea what Special Account Number 5 is, Mr. Waxman. Mr. Waxman. OK. Well, we believe this was a lawyer-adminis- tered special projects fund, but we will get a chance to find out whether that is accurate or not when you submit it to us. I would like to know what is Special Account Number 4. Does this account support scientific research? Who has or had control over this account? And will you provide the subcommittee with a list of the individuals who received funding from the account, the amount of funding and the purpose of funding? Mr. Glenn. We will, and we will cooperate with you. Would you identify what special account 4 and 5 might be? I don't know. Mr. Waxman. Well, we will try to provide further clarification and ask you to cooperate with us. [The following information was received:] I was asked on May 26 to provide information about "Special Account Number 4" and "Special Account Number 5." No such accounts are currently maintained by or for the Council, and so far as we can determine no such accounts have ever been maintained by or for the Council. I respectfully request that this letter be included in the record. Mr. Waxman. Well, Dr. Glenn, I thank you for your presentation here today, and as I indicated, we may have you back. But let me just review what I think we have learned today, not just from your testimony, but from documents that we have put on the record. The Council for Tobacco Research was started by public relations people, conducted public relations activities such as promoting re- search results favorable to the tobacco companies. It funded special projects, but did not control the selection. It acknowledged that to- bacco companies selected and controlled the special projects. It ac- 393 knowledged that lawyers for the tobacco companies may have se- lected the special projects for the tobacco companies. I want to indicate that in my view this paints a disturbing pic- ture of public relations masquerading as science, and we will look forward to further clarifications to hopefully disabuse us of some of these facts. But I think the documents that we have already put on the record establish much of that case and are really troubling as to whether this is a scientific inquiry as it has been represented. I thank you very much Mr. Glenn. Mr. Waxman, may I ask a question? Are you im- pugning my integrity? Mr. Waxman. Well, Dr. Glenn, you represent the Council of To- bacco Relations. You don't know much about what went on before you got there. We introduced documents that indicated the kinds of things that were done by the Council. And it didn't just stop be- fore you got there. In 1990 there was a letter to kids at school that indicated — this was a statement that I will submit it to you as Ex- hibit 15, if we can get that over to you. A letter written by RJR Tobacco Company in 1990 to the principal of the Willow Ridge School in Amherst, N.Y., and RJR is responding to the questions of fifth graders about the health risks of smoking. I don't know if you are familiar with that letter. Are you? Mr. Glenn. No, sir. Mr. Waxman. OK. Well, I am going to read to you what they say. I am quoting. "The tobacco industry is also concerned about the charges being made that smoking is responsible for so many seri- ous diseases. Long before the present criticism began, the tobacco industry in a sincere attempt to determine what harmful effects, if any, smoking might have on human health established the Council for Tobacco Research. Over the years the tobacco industry has given in excess of $162 million to independent research on the con- troversies surrounding smoking. "Despite all of the research going on, the simple and unfortunate fact is that scientists do not know the cause or causes of chronic diseases reported to be associated with smoking. The answers to these many unanswered controversies surrounding smoking we be- lieve can only be determined through much more scientific re- search." Now, this letter illustrates how the tobacco industry uses the Council for public relations purposes to this day when fifth graders ask about the risks of smoking, the existence for the Council for Tobacco Research allows the tobacco companies to say, we don't know and we are still trying to find out. I am not impugning your integrity, but I am telling you that there is a tremendous gap between your insistence that CTR has not focused on public relations and all of these documents we have put on the record which indicate that the Council for Tobacco Re- search has been used exactly for public relations and not fully for scientific inquiries. 394 Thank you for being here, and we will have further opportunities to work together. That concludes our hearing today and we stand adjourned. [Whereupon, at 12:55 p.m., the subcommittee was adjourned, to reconvene at the call of the Chair.] [The following material was submitted for the record:] 395 V^NCER^ + AMERICAN LUNG ASSOCIATION. ^"''Asro"c"uon .^ ^ cr\^\C.'TW * I Fighting Heart Disease K J Avknuk New YoKJt NY 10099 Jamb T. Ot-ruN, M.D. Caicr KxAcvTTvs Oiiiuaa September 27, 1994 BY HAND Hon. Henry A. Waxman Chairman Subcommittee on Health and the Environment of the House Committee on Energy and Commerce 2415 Rayburn House Office Building Washington, DC 20515-6118 Dear Congressman Waxman: By way of re-introduction, I am the Chairman, Chief Executive Officer and President of the Council for Tobacco Research — U.S.A., Inc. (the "Council"). As you will recall, at your invitation I appeared before the Sub- committee on Health and the Environment on May 26, 1994. At the May 26 hearing, I answered to the best of my knowledge and ability all questions that were put to me. Many of those questions appeared to reflect inaccurate pre- conceptions or misinformation about the Council and its work. In this letter, I would like to (1) explain how the supplemental information provided in this letter has been limited because we have not had an opportunity to discuss procedural matters with the Subcommittee staff (Part I of this letter), (2) reiterate some of the main points I made during my testimony (Part II), (3) provide further informa- tion and docximents in response to requests by the Subcom- mittee (Part III), and (4) clarify several statements that I made to the Subcommittee (Part IV) . 404 Hon. Henry A. Waxnan -2- September 27, 1994 I. The Council has cooperated fully with the SubcoB- mittee and is continuing to do so. Imnediately after I testified on May 26, we began the very substantial task of collecting the documents and information that had been re- guested by members of the Subcommittee. As you may be aware from discussions with the Subcommittee staff, we have sought to discuss with the Sub- committee staff procedures for the Subcommittee's handling of documents and information provided to it by the Council. In particular, some of the information and documents involve matters that we regard, for one reason or another, as confi- dential. We e5q)ect to provide to the Subcommittee the in- formation that it requested. However, before doing so, we would like to try to reach an understanding with the Subcon- mittee staff with respect to the Subcommittee's procedures for handling and disclosing materials that we provide to the Subcommittee. Until last week, we had understood that we would have an opportunity to do that. Apparently, however, the Subcommittee has decided to afford such an opportunity to the tobacco companies — but not to the Council. It might be helpful for you to know the factual background of this situation. In August, as we neared the completion of the process of collecting information and documents, our counsel, Judah Best of Debevoise k Plimpton, called William Schultz of the Subcommittee staff to arrange a meeting concerning the Subcommittee's procedures for han- dling materials provided to it by the Council. Shortly before that time, we had learned that since June the Subcoa- mittee staff had been discussing with the tobacco companies the procedures that would govern the companies' production of documents and information to the Subcommittee. Mr. Best advised Mr. Schultz that the Council was prepared generally to be governed by the procedures that were agreed to by the tobacco companies, and was prepared to raise one additional confidentiality issue that is unique to the Council. Mr. Best twice scheduled meetings with Mr. Schultz to be held early in September, but both meetings were postponed. At no time were we advised that a discussion of the Subcommittee's procedures would be inappropriate or unavailable to us. 405 Hon. Henry A. Waxman -3- September 27, 1994 On September 21, while our counsel was awaiting the rescheduling of the aeeting with Mr. Schultz, we were advised for the first tine by Ripley Forbes, also of the Subcommittee staff, that the Subcommittee needed to receive information from the Council within a week, without waiting for any discussions about procedures. Because we believe it is fundamentally unfair to require the Council to provide documents and information without affording us even an opportunity to discuss the Subcommittee's procedures, we are now providing only certain materials to the Subcommittee. This letter describes the balance of the information and documents that the Council has gathered in response to the Subcommittee's requests. Promptly after an understanding has been reached as to these procedural matters, the Council will make these materials available to the Subcommittee. In the interim, with respect to responses to the Subcommittee's requests that are af- fected by the confidentiality issue, I respectfully request that this letter be included in the record. Earlier today, our counsel explained to Mr. Forbes that we would be pro- ceeding in this way, and Mr. Forbes indicated that it would be appropriate to do so under the circumstances. I reiterate that the Council will continue to cooperate fully with the Subcommittee in this matter, and that the Council does not object to providing full and com- plete information or documents to the Subcommittee. Rather, our concern arises from the possible disclosure to others of non-public information and documents without any procedures to control such disclosure, and from the possible impact of such disclosure on pending litigation against the Council and on the legitimate privacy interests of others. II. Preliminarily, I would like to provide you with some of the basic facts about the Council. The Council and its forerunner have awarded more than $230 million in grants-in-aid and contracts to indepen- dent research institutions and scientists for scientific research. The Council, which is funded primarily by five major American cigarette manufacturers, is now awarding approximately $19.5 million in research grants annually. 406 Hon. Henry A. Waxinan -4- September 27, 1994 Scientific research funded by the Council has included grants to leading scientists (including three Nobel laure- ates) , who are affiliated with many of the country's most distinguished research institutions. (These research insti- tutions are listed in one of the attachments to my written testimony to the Subcommittee, dated May 25, 1994.) Most of the researchers funded by the Council were also receiving support from funding organizations such as the National Institutes of Health, the American Cancer Society, the Amer- ican Heart Association, and the National Cancer Institute. The research funded by the Council relates to issues of smoking and health. The focus of much of this research is the etiology of diseases associated with smok- ing. To a considerable extent, meaningful research into the etiology of those diseases involves basic research into disease mechanisms, much of which takes place at the cellu- lar and sub-cellular level. Accordingly, in recent years, an increasing proportion of the research funded by Council grants-in-aid has been devoted to such basic research. That trend is consistent with developments in scientific re- search. It is this kind of basic scientific research that much of the scientific community believes will provide answers to questions about the causes of chronic diseases and about the relationship of smoking to those disease mech- anisms. The researchers who receive Council grants are selected on the basis of ratings given to their applications by the Council's Scientific Advisory Board ("SAB"). The members of the SAB have been, and are, distinguished scien- tists of unimpeachable integrity. The researchers who receive Council grants conduct their research independently, without control by or inter- ference from the Council. They are expected to publish their research findings in scientific journals, again with- out interference from the Council. Over 5,000 such articles have been published, the vast majority of them in peer- reviewed journals, as a result of research funded by the Council's grants and contracts. To the best of my knowledge, none of the results or findings from research sponsored by the Council (includ- ing research funded as Council Special Projects) has been kept secret or has been suppressed in any way. The Council 407 Hon. Henry A. Waxnan -5— September 27, 1994 has not asserted any privilege with respect to the results of, or the findings from, any such scientific research. III. Together with this letter, I an subnitting on behalf of the Council an Appendix and four boxes of docu- ments. I explain below the contents of the Appendix, of the four boxes of documents, and of the information and docu- ments that we are not now providing, as discussed in Part I. Publications by Nobel laureates (requested in May 26. 1994 Transcript ("Tr."> at p. S4> . As I testified on May 26, the Council has funded three investigators who have won Nobel Prizes: Dr. Baruj Benaceraff of Harvard University, Dr. Stanley Cohen of Vanderbilt University and Dr. Harold E. Varmus of the University of California at San Francisco. Dr. Benaceraff, who was awarded the Nobel Prize in 1980, received a Council grant from 1972 through 1974 for investigating "Control of Specific Cellular and Humoral Immune Responses to Neoplastic and Non-neoplastic Tissues." Item A in the Appendix includes three publications acknowl- edging the Council's support of Dr. Benaceraff's research. Dr. Cohen, who was awarded the Nobel Prize in 1986, received a Council grant from 1987 through 1993 for investigating "The Role of Lipocortin in the Cellular Re- sponse to EGF." Item B in the Appendix includes six publi- cations acknowledging the Council's support of Dr. Cohen's research. Dr. Varmus, who was awarded the Nobel Prize in 1989, received a Council grant from 1984 through 1986 for investigating "Functional Analysis of Cellular Oncogenes Activated During Tumorigenesis. " Item C in the Appendix is a publication acknowledging the Council's support of Dr. Varmus' research. As I explained to the Subcommittee on May 26, the Council-funded research by these Nobel laureates was basic biomedical research aimed at improving our understanding of fundamental disease processes — which is the kind of re- 408 Hon. Henry A. Waxman -6- September 27, 1994 search that is now believed to further scientific under- standing of the effects of tobacco use on health. Dr. Bena- ceraff conducted pioneering research into the humoral immu- nological response of the host when presented, attacked or invaded by cancerous growths. His work has provided impor- tant insights into how regulatory mechanisms may operate in defense of the host organism. Dr. Cohen studied cell growth factors and their role in regulating growth and differentia- tion. His investigation of genetic controls of growth fac- tors opened the door to our understanding of mechanisms by which normal cells become cancerous. Dr. Varmus' pioneering work with oncogenes made important contributions to our overall understanding of how healthy cells become trans- formed into cells that can no longer control their growth and therefore become cancerous. Information sent to grant applicants (Tr. at p. 65) . Item D in the Appendix is a copy of a form letter, with attachments, that is provided by the Council to suc- cessful grant applicants. One of these attachments, "Impor- tant Procedural Information for Grantees," refers specifi- cally to publications by grantees. Item E in the Appendix is the Council's statement of Policy, which is sent to all grant applicants. The Statement of Policy makes it clear that the Council expects grantees to report their findings in medical and scientific journals, and requests that any publications acknowledge the Council's support. Our Statement of Policy also says, in very clear terms: "The Council desires to have scientists work with the greatest freedom, without domination of any kind. It will make no attempt to direct the administration of a project once started, to influence its course or to control its results . . . ." That is the Council's fundamental policy: to give complete scientific freedom to its grantees, and to let the chips fall where they may. List of Council Special Projects fTr. at pp. 47. iMi- As I explained in my testimony. Council Special Projects were research projects that the Council's sponsors wished to fund. Tr. at 46. These research projects were funded by the sponsors, and were administered by the Coun- cil, separately from the grant-in-aid program. We have prepared a list of all Council Special Projects for which the Council has a file. That list in- 409 Hon. Henry A. Waxnan -7- September 27, 1994 eludes the following information for each such project (where such information is available from the Council's files or from published sources) : (a) the name of the prin- cipal investigator or investigators, (b) the institution or institutions with which the principal investigator or inves- tigators were associated, (c) the title or subject matter of the Council Special Project, (d) the dates of funding of the Council Special Project, (e) the total amount of funding provided by the Council, and (f) a list of the publications that apparently resulted, or may have resulted, from the Council Special Project. Some of the publications identi- fied on the list appear in the Council's Special Projects files; others have been collected from other sources. In a number of instances, it is not clear whether a particular publication resulted from Council Special Project funding. My statement at the May 26 hearing that 250 peer- reviewed articles are believed to have resulted from Council Special Projects was based on my information about the num- ber of publications that either were in the Council's files or have been collected from other sources. Several clarifi- cations should be made to that statement. First, our list sets forth over 400 articles or presentations that resulted or may have resulted from Council Special Projects; so far, I understand, copies of about 250 of these articles or pre- sentations have been obtained, and that understanding was the source of my statement at the hearing. Second, most but not all of these 250 articles or presentations were peer- reviewed. Third, abstracts relating to Council Special Projects publications were not included in the Council's Annual Reports. Me expect to provide this list to you promptly after we have reached an understanding with the Subcommittee staff with respect to procedures for the Subcommittee's handling of such materials provided by the Council. In the interim, I respectfully recjuest that this letter be included at pages 47 and 106 of the May 26 transcript. Statements by Ms. Cohen (Tr. at p. 78K At the May 26 hearing, I was asked to supply documentation for my statements about Dorothea B. Cohen, the former Council em- ployee to whom comments were attributed in the Wall Street Journal article of February 11, 1993. We had intended to respond to the Subcommittee's request for documentation by obtaining an affidavit from Ms. Cohen, setting forth her 410 Hon. Henry A. Waxman -8- September 27, 1994 view that the Wall Street Journal article was inaccurate. However, Ms. Cohen has noved, and we have been unable to locate her. We have spoken with Dr. John E. Bevilacqua, Ms, Cohen's treating neurologist (who is also her cousin). Dr. Bevilacqua has provided us with a letter dated August 20, 1994, describing Ms. Cohen's medical condition as of that date and as of February 11, 1993, when the Wall Street Journal article appeared. Dr. Bevilacqua has asked that his letter be treated as confidential, in deference to Ms. Cohen's privacy interests. We expect to provide Dr. Bevilacqua's letter to the Subcommittee promptly after we have reached an understanding with the Subcomaittee staff with respect to procedures for the Subcommittee's handling of materials provided by the Council. In the interim, I respectfully request that my letter be included at page 78 of the May 26 transcript. I have learned that I was mistaJcen when I testi- fied on May 26 that, following the publication of the Wall Street Journal article, Ms. Cohen called the Council and apologized to one of our employees for the statements at- tributed to her in the article. What happened was that shortly after the Wall Street Journal article was published, Ms. Cohen was contacted on our behalf and said that she had been misquoted in the article. The fact that Ms. Cohen had stated that she had been misquoted in the article was reported to an officer of the Council, who in turn reported that to me. As a result, I formed the mistaken impression that Ms. Cohen had called the Council, but my basic under- standing about what she did say was correct. Financial information fTr. at p. 82) . We have prepared three separate tables setting forth the dollar amounts contributed in each year, by each contributor, to the Council and to the Tobacco Industry Research Committee ("TIRC") for the General Fund, for Council Special Projects, and for the Council's Literature Retrieval Division ("LRD") . (I understand that LRD was a division of the Council from 1971 until 1983, that LRD compiled medical literature for the use of the tobacco companies, and that LRD's assets were transferred in 1983 to LS, Inc., a corporation that is unre- lated to the Council.) This financial information is non- public, and the Council's members regard it as confidential. We expect to provide these tables to the Subcommittee promptly after we have reached an understanding with the Hon. Henry A. Waxaan -9- September 27, 1994 Subcommittee staff with respect to procedures for the Sub- committee's handling of materials provided by the Council. In the interim, I respectfully request that this letter be included at page 82 of the May 26 transcript. We have collected copies of the audited financial statements of the Council and its predecessor for each year from 1963 through 1993. (In 1983, the Council changed fro» a calendar year to a November 1 fiscal year.) We have also collected copies of budgets for each year from 1954 through 1962; we are unable to locate financial statements from before 1963. Again, this financial information is non- public, and the Council and its members regard it as confi- dential. We expect to provide these tables to you promptly after we have reached an understanding with the Subcommittee staff with respect to procedures for the Subcommittee's handling of materials provided by the Council. In the in- terim, I respectfully request that this letter be included at page 82 of the May 26 transcript. Item F in the Appendix is a copy of the Council's current by-laws. Article III of the by-laws provides the method of apportioning the funding of the Council among its sponsors. MAI contracts fTr. at p. 70). Item G in the Appendix includes copies of each of the Council's contracts with Microbiological Associates, Inc. ("MAI"), together with contract renewals. The Council spent some $12 million under the MAI contracts on a large-scale, long-term study of the effects of smoking inhalation on mice. I was mistaken when I told the Subcommittee that these contracts contained no restriction on publication by MAI. The Council has had no research contracts during my tenure, and I had erroneously assumed that the Council's policies with respect to publication by contract researchers were the same as its policies with respect to publication by grantees. Since my testimony, I have learned that the MAI contracts provided that the Council's prior written approval was required for MAI to publish its research findings. Such provisions are customary in research contracts. It is my understanding that the results of the major inhalation study performed by MAI were published in complete and unedited form. In addition, MAI published 412 Hon. Henry A. Waxnan -10- September 27, 1994 dozens of articles based on its Council-funded research. Item H in the Appendix is a list of 89 publications or abstracts that appear to have resulted from the Council's support of MAI, at least 73 of which acknowledge support from the Council. Council employees fTr. at p. 85). We have pre- pared a list setting forth the names, years of employment and the current (or terminal) position of employees of the Council and TIRC from 1954 to the present. I should advise you that while our staff expended considerable time and effort in trying to compile a list of all Council employees, the list may not be complete or totally accurate because the Council's records for this 40-year period are incomplete. In deference to the privacy interests of the per- sons whose names appear on this list, we regard it as confi- dential. We expect to provide this list to the Subcommittee promptly after we have reached an understanding with the Subcommittee staff with respect to procedures for the Sub- committee's handling of materials provided by the Council. In the interim, I respectfully request that this letter be included at page 85 of the May 26 transcript. Studies associating smoking and diseases fTr. at 59) . At the hearing, I was asked about studies funded by the Council that found that tobacco use increased the like- lihood of disease. With all due respect, this request is extremely naive, and therefore very difficult to respond to meaningfully. Modern scientific studies into the etiology of chronic diseases typically focus on narrow questions, the answers to which contribute to a broader understanding of disease processes. However, as a general matter, each such study, standing alone, does not state that smoking does or does not make the chronic disease more likely. The reported research findings have Implications for the relationship between smoking and disease that are far more subtle, com- plex and cumulative. Consequently, in many instances, it is difficult to determine — and it ultimately is a subjective matter — whether a publication Is deemed to have found an increased likelihood of disease. Indeed, I believe that any two per- sons who might review the full set of publications resulting from the Council's grants in response to this request would come up with different sets of documents. As I stated on 413 Hon. Henry A. Waxman -11- September 27, 1994 May 26 in response to this request, abstracts of publica- tions resulting from CTR grants and contracts have appeared in the Council's annual reports, and we can make the publi- cations themselves available to the Subcommittee for its review. With these qualifications, we are providing in the boxes marked "Box 1" and "Box 2" copies of over 375 publica- tions resulting from Council-funded research that could be considered to indicate that tobacco use may increase the likelihood of developing diseases or conditions that have been associated with smoking. (These documents were selected from the Council's files of publications resulting from Council grants. Those files are not complete since not all publications have been provided by the researcher or located by the Council.) We have used our best efforts to compile for the Subcommittee a complete set of such publi- cations, in light of the difficulties referred to above. In addition, in order to reduce the burden on the Subcommittee, we are not providing copies of publications that simply rely on or refer to previous research findings associating smok- ing and diseases, and in a number of instances we are not providing copies of publications that are preliminary to, or repetitive of, publications that are being provided. Nicotine studies fTr. at pp. 61. 62K The two boxes of documents marked "Box 3" and "Box 4" contain copies of over 560 publications resulting from Council-funded re- search that appear to examine the effects of nicotine. (As explained above, the set of publications from which these documents were selected is incomplete.) Again, we have used our best efforts to compile for the Subcommittee a complete set of such publications. As I mentioned during my testimony on May 26, during the very week of my testimony the Council sponsored an important seminar on central nervous system receptors, including the receptors that respond to nicotine and its analogues. Item I in the Appendix includes copies of the program from that seminar and of the abstracts presented at that seminar. Council Special Projects files (Tr. at p. 106K We have gathered 14 boxes of documents, consisting of about 30,000 pages, from the Council's files on Council Special Projects. The vast majority of these documents are from 414 Hon. Henry A. Waxaan ' -12- Septeaber 27, 1994 files that are arranged alphabetically by the naae of the principal investigator or, in some cases, the investigator's institution. There are also docvuaents from files containing financial information about Council Special Projects and documents from Special Project desk files of certain Council employees. Approximately one-third of these pages consist of applications and pre-publication reports by researchers, or evaluations of a researcher or of his or her research. He believe that the information that is reflected in these documents was provided to the Council with a reasonable expectation of confidentiality, and we therefore regard these documents as confidential. We expect to be able to provide all these docu- ments to you promptly after we have reached an understanding with the Subcommittee staff with respect to procedures for the Subcommittee's handling of materials provided by the Council. In the interim, I respectfully request that this letter be included at page 106 of the May 26 transcript. In addition, I aua advised that there are 54 docu- ments from these Council Special Project files that are subject to claims of attorney-client privilege, attorney work-product protection or joint defense privilege asserted by the Council or its sponsors. He do not intend to provide 51 of these documents to the Subcommittee, and we intend to redact the other three. None of these documents constitutes a researcher's report of his or her results or findings. (As stated above, the Council has not asserted any privilege with respect to such results or findings; and my understanding is that none of the Council's sponsors have done so.) No communications with scientific researchers arc being withheld on privilege or work-product grounds. "Special Accounts" fTr. at dp. 115-16. 117> . I was asked on May 26 to provide information about "Special Account Number 4" and "Special Account Number 5." No such accounts are currently maintained by or for the Council, and so far as we can determine no such accounts have ever been maintained by or for the Council. 1 respectfully rec[uest that this letter be in- cluded at pages 116 and 117 of the record. Blanket request fTr. at p. 99) . At the hearing, Mr. Synar asked me to provide "all materials that are cen- 415 Hon. Henry A. Waxnan -13- September 27, 1994 tral to this hearing prior to 1987" and "all of the mate- rials available in the (Council's] files." Tr. at p. 98. I responded that the Council would cooperate fully "and would provide whatever you require." Tr. at p. 99. I did not understand Mr. Synar to be asking for every piece of paper in the Council's files. Rather, I thought he was having Be confirm that we would be responsive to the Subcommittee's requests. Indeed, I have no way of )aiowing what documents Mr. Synar regards as "central to this hearing." And it certainly would not be feasible for the Council to produce all of its files to the Subcommittee. We estimate that those files include over 2.5 million pages, and I respect- fully submit that it would serve no purpose to deluge the Subcommittee with documents beyond those that the Council has already gathered in response to the Subcommittee's broad requests. I respectfully request that this letter be in- cluded at page 99 of the record. IV. I would also like to clarify several points that I made during my testimony on May 26. I was questioned on May 2 6 about documents that are exhibits to the Majority Staff Report, dated May 26, 1994, and entitled "The Hill and Knowlton Documents: How the Tobacco Industry Launched Its Disinformation Campaign." As I testified, I had never seen Exhibits 9 and 10 to that Report, which appear to be documents prepared by Hill £ Knowlton in 1954. Tr. at 49, 51-52. To reiterate, these documents and the events they describe predate my tenure at the Council by three decades. Following the hearing, we reviewed the Council's files, and as a result we have learned that, contrary to my belief as of May 26, the Council's files do contain copies of Exhibit 9 and of a portion of Exhibit 10. Reviewing the exhibits to the Majority Staff Re- port indicates to me, as a reader of these documents in 1994, that Hill 6 Knowlton provided resources to help orga- nize TIRC and gave assistance to TIRC's public relations efforts during its early years. In hindsight, I do not find it surprising that documents prepared by TIRC's public rela- 416 Hon. Henry A. Waxnan -14- September 27, 1994 tlons advisors tend to focus on public relations. By the same token, it is not surprising that the minutes of Scien- tific Advisory Board meetings from the same period discuss almost exclusively matters of scientific research and the award of research grants by TIRC, with virtually no refer- ence to TIRC's public relations activities. (At its Septem- ber 20, 1954 meeting, for example, the Scientific Advisory Board discussed and adopted a Statement of Policy for TIRC that closely resembles Item E in the Appendix, including policies about scientific freedom and publication.) I have no reason to believe that the public relations activities reflected in these documents had any effect on TIRC's pro- gram of funding scientific research. The Council has not been involved in such public relations activities during my tenure or, to the best of my knowledge, for many years prior to my association with the Council. Today, the Council's contacts with the media and the public are limited to advising them of the Council's research-funding activities in a general way, and advising the scientific community of its grantees' activities through the issuance of its annual reports. It remains my strong belief, based on my personal knowledge and my conversations with others, that the Council as I know it, and as it has existed for decades, has had as its principal function the sponsorship of scientific research into questions of tobacco use and health. I testified that the SAB is "really" the decision- maker with respect to funding by the Council, but did not explain precisely the Council's decisionmaking process. Tr. at 84. It currently works as follows: 1. When a full, formal application for a grant- in-aid is received by the Council, it is assigned to two SAB members (and, on occasion, an outside reviewer) for review and evaluation. The full SAB then rates each application on a numerical scale. The Council's scientific staff then prepares a list of these appli- cations in an order that reflects the SAB's numerical ratings. 2. As a technical matter, I have the final au- thority to award grants-in-aid. As a practical matter, however, I defer very heavily to the SAB's numerical ratings, and those ratings are by far the predominant 417 Hon. Henry A. Waxman -15- September 27, 1994 factor in determining grant awards. After each SAB meeting, the Council's scientific staff and I review the SAB'S numerical ratings. We may reduce the amounts of some awards, either as directed by the SAB or in order to permit the funding of additional grants. On rare occasions, we diverge slightly from strict adher- ence to the SAB'S numerical ratings — for example, to improve the balance of the Council's research program among various scientific disciplines. The SAB is fully aware of this procedure, and it is informed of the final funding decisions at each meeting when it ap- proves the minutes of its previous meeting. I advised the Subcommittee that the Council has been sued in a number of cases and that no court has made a finding of liability against the Council. After stating that the jury in the Cipollone case had rejected the allega- tions of fraud regarding the Council, I answered "yes" to Congressman Greenwood's question as to whether a court had found for the Council as a defendant. Tr. at 64. That answer was substantially correct, both in that (i) the Cipollone jury rejected allegations of a conspiracy to de- fraud involving the Council and (2) in several cases courts have granted motions for summary judgment dismissing cases brought against the Council. In fact, however, the Council was not a defendant in Cipollone. Finally, I wish to make it clear that my testimony about the relationship between tobacco use and health re- flected only my personal views, and not those of the Coun- cil. The Council as a body takes no position on these issues. I trust that this letter and the documents and information that are either enclosed with or described in this letter respond adequately to the Subcommittee's ques- tions about the Council. We remain willing to continue to cooperate with the Subcommittee and its staff to address any further inquiries that you may have. Respectfully yours, Glenn, Enclosures 418 THE HILL and KNOWLTON DOCUMENTS: HOW THE TOBACCO INDUSTRY LAUNCHED ITS DISINFORMATION CAMPAIGN A Staff Report, Majority Staff Subcomnittee on Health and the Environment This aajority staff report of ths Subconnittes on Health and the Environment analyzes doctiaents that describe in detail the formation and early years of the Tobacco Industry Research Committee, a joint tobacco industry group now known as the Council for Tobacco Research. The ostensible purpose of the Tobacco Industry Research Committee was to provide "aid and assistance to the research effort into all phases of tobacco use and health." In a full- page advertisement run in over 4 00 newspapers on January 4, 1954, the major tobacco companies explained that they formed the Research Committee because they "accept an interest in per-)ie's health as a basic responsibility, paramount to every other consideration in our business." The documents obtained by the Subcommittee were written by top officials at the Hill and Knowlton public relations firm, an advisor to the Tobacco Industry Research Committee during its formative years. The documents show that contrary to the industry's public assertions, the real purpose of the Tobacco Industry Research Committee was to "sponsor a public relations campaign which is ... entirely *pro-cigarettes. ' * The goal was "reassurance of the public" through "communication of . . . the existence of weighty scientific views which hold there is no proof that cigarette smo)cing is a cause of lung cancer." The public relations campaign was so extensive that in 1955 the Tobacco Industry Research Council hired 35 staff members of Hill and Knowlton to conduct the campaign. The documents describe in detail the massive campaign undertaken from 1954 through 1956 by the Tobacco Industry Research Committee to influence public opinion. They explain how during these early years the Tobacco Industry Research Committee: transformed obscure scientific reports favorable to the industry into headline news across the country; courted the editors of the nations' major news organizations, advising then in personal meetings of "the need for editorial responsibility in handling stories that rouse unwarranted fears"; influenced the content of news reports in major newspapers, magazines, and television shows, including the New York Times, the Washington Post, and the Edward R. Murrow Television Show; planned a 17-step public relations campaign to respond to one particularly unfavorable report; influenced medical opinion by sending hundreds of thousands of copies of booklets prepared by the 419 Tobacco Industry Research Coaalttee to "all doctors* in the United States; established "personal liaisons" in organizations liXe the Anerican Medical Association and American Cancer Society to secure "advance information ... concerning research" and "first-hand knowledge of the theories, methods, and personalities of those involved in research on tobacco and health"; and ultimately succeeded in shifting national opinion, so that by 1956 Hill and Knowlton could report that "neither the press nor the public seems to be reacting with any noticeable fear or alarm to the recent attacks." As recounted by one Hill and Knowlton executive in 1953, the chief executive officers of the leading tobacco companies were "emphatic in saying that the entire activity is a long- term, continuing program, since they feel the problem is one of promoting cigarettes and protecting them from these and other attacks that may be expected in the future." Forty years later, the Council for Tobacco Research is still in operation and the campaign of disinformation continues. Chronological Summary of Kev Documents December 1953. Dr. Earnest Wynder and his colleagues at the Sloan-Kettering Institute in New York City publish research showing that cigarette tar condensate causes fatal cancers when painted on the skin of mice. The research study, a copy of which is attached as exhibit 1, attracts massive media coverage. December IS. l»53. The chief executive officers of th« nation's largest tobacco companies meet on the morning of December 15, 1953, at the Plaza Hotel in New York City to discuss the implications of the new health research. Hill and Knowlton executives attend the seeting and, later in the day, write a memoranduB susmarizing the meeting. The memoranduB is attached as exhibit 2. The aeeting is unprecedented: it is the first time th« CEOs had Bet together outside of occasional dinners honoring an industry leader. In attendance were Paul M. Hahn, President, American Tobacco Company; Joseph F. Cullman, Jr., Chairman and President, Benson k Hedges; 0. Parker McComas, President, Philip Morris k Co.; and J. Whitney Peterson, President, U.S. Tobacco Company. At the meeting, the CEOs agree that the health criticisms are "extremely serious" and "worthy of drastic action" (p. 3). According to the memorandum, "the officials stated that salesmen in the industry are frantically alarmed and that the 420 declin* in tobacco stocks on th« stock markat has caused gravs concern" (p. 4) . According to the Bemorandua, "the chief executive offlca^-j Qf all the leading tobacco companies — R.J. Reynolds. PM. BtH. U.S. Tobacco Company. BtW — have agreed to ao along with a public relations DroS4. Hill and Knowlton writes a "Public Relations Report and Recomendations for the Tobacco Industry Research Committee." The report is attached as exhibit 7. By June 21, 1954, the Tobacco Industry Research Committee had selected a scientific advisor (Or. Clarence Cook Little, a former director of the Anerican Cancer Society) and a scientific advisory board. According to Hill and Knowlton, with these steps in place: "The Committee now has the basis needed for carrying on a long-range plan of public relations activities. ... These activities will endeavor to keep the following facts before the Public; 1. That there is no proof that smoking is a cause Of lung cancer; 2. That an impartial and independent Board of scientists, doctors and educators is advising the TIRC, as a public service, on all aspects of tobacco use and health; 3. That the TIRC is determined, through a long- range program, to make every possible effort to help get the facts through laboratory and statistical research." (p. 2) August 17, 1954. Hill and Knowlton sends T.V. Harnett, the Chairman of the Tobacco Industry Research Committee, a "Confidential Report of Activities through July 31, 1954." The confidential report, and an accompanying cover letter, are attached as exhibit 8. The cover letter to Harnett calls the report "highly confidential" and "request[s] that you retain it only for your personal consideration." The letter warns that "no additional copies be made and that this copy not be placed in files." The report itself is 24 pages long and describes many details of the public relations campaign being run by the Tobacco Industry Research Comaittee. The report sakes it clear that Hill and Knowlton — not the independent scientists — actually ran the Tobacco Industry Research Committee. According to the report: "Since the Committee had no headouarters and no staff. Hill and Knowlton. Inc. was asked to provide a working staff and temoorarv office space. As a first organizational step, public relations counsel assigned one of its experienced executives. W.T. Hovt. to serve as account executive and handle as one of his functions the duties of executive secretarv for the Tobacco Industry Research Council." (p. 3) The report further states that Hill and Knowlton "provided 423 assistanc* In ael«ctin9* th« Scientific Advisory Board (p. 3), "propo««d" Dr. Littla for th« Scientific Director (p. 3), and "handled liaison, aaendaa. orqanirational plans, businesa affairs, reports, and materials for aeetinos of the TIRC fandl t-,^a Scientific Advisory Board. ... in addition to developing <}^frAt.ina procedures for the research proaraa' (p. 5) . The report provides a "case history" that describes how the Tobacco Industry Research Conunittee would transform an obscure scientific report favorable to the industry into national headline news (pp. 7-9). According to the case history, "advance checking" by TIRC revealed that Dr. Hueper was scheduled to give an unpublicized report "concerning the lack of a proven link between lung cancer and smoking" in July in Sao Paulo, Brazil. TIRC reproduced the report and two pages of highlights and established a "special liaison" in Sao Paulo "to give word of Dr. Hueper's delivery as quickly as possible, so as to enable distribution of the talk while it was still newsworthy." As soon as the talk was given, "personal delivery of the Hueper release was made to important newspapers and services as well as distribution to science writers, editorial writers and feature writers." In the end: "Although may of the writers covering the Sao Paulo meeting failed to mention the Hueper talk in their dispatches, it is significant that, as a result of the distribution in the U.S.A.. stories cmestionina a link between smoking and cancer were given wide attention, both in headlines and stories. In some press accounts, the Hueper story took precedence over the reports of Drs. Hammond and Wynder, even though the latter were made available to the press in advance of their delivery on a hold-for-release basis." The report describes many other efforts of the Tobacco Industry Research Comaittee to influence nedia, including "special personal contacts" with Time. Newsweek. U.S. News and World Report, and Business Week (p. 9); preparation of editorials entitled "The Saae Old Culprit" and "Truth Makes a Slow Crop" that were "widely used in ^hoae town' dailies and weeklies throughout the country" (p. 10); and "assistance ... provided to the New York Tiaes for a Suixiay Magazine piece ... on "Why People Ssoke," which discussed soae of the now- abandoned old charges against cigarettes" (p. 12) . In many instances, the Tobacco Industry Research Coaaittee worked behind the scenes to influence the content of individual articles. In one case, the intervention of TIRC resulted in "seven revisions and five qualifying additions" to a story in Cosmopolitan magazine that "was already in type" (p. 10). In other cases, it was quicker and more effective simply to hire free-lance authors to write favorable articles for the Tobacco Industry Research Committee: 424 "Especial ly-vritt«n articles ar« bsln? dsvsloped that can b« used or adopted for use in various aedia receptive to or seeking aaterial relating to the subject. ... To achieve this objective aore quickly and effectively, the free lance services of qualified science vriters are being used." (p. 23) Another iaportant function of the Tobacco Industry Research Council was to infiltrate anti-saoking organizations to obtain "advance inforaation." According to the report: "Personal contacts are advantageous not only in disseminating and gathering information but for enlisttnort a research prograa devoted prlaarlly to the public Interest": Arthur Hays Sulzberger, the president and publisher of the New York Times; Helen Rogers Reid, chairaan of the board of the New York Herald Tribune; Jack Howard, president of ScrlDDS-Howard Newspapers; William Randolph Hearst, Jr., president and publisher of the Hearst Consolidated Publications; and Roy E. Larsen, president of Luce Publications (p. 1). The memorandum describes how the Tobacco Industry Research Council influenced the content of the Edward R. Murrow Television Show: 425 "A conf«r«nc« was h^ld with Edward R. Hurrov, Pr*d Pri«ndly, hi« producer, ... at th« Tobacco Induatry Research Comalttee offices in tha Qipire State Building. . . . Tha Murrov staff eaphasized tha intention to present a coldly objective progra* with every effort made to toll the atory a> it stands today, with special effort toward balanced perapective and concrete steps to show that tha facts still are not established and aust be sought bv scientific means such as the research activities tha Tobacco Industry Research Conaittea will support. Mr. Murrow was assured of continued cooperation fro« the Tobacco Industry Research Comaittee to the extent possible under the scope of the TIRC prograa." (p. 2) The nenorandua describes how an article being prepared by Leonard Engle for Harper's aagazine "use[s) TIRC as a source of information" and "should lend weight to the industry's contention that there is no proof of the charges and that there are many other factors that enter strongly into the increasing incidence of lung cancer" (pp. 2-3) . It also reports that in the Washington Post "a feature story by Nate Haseltine us[e8) long excerpts from paper by Dr. Hueper, which was supplied his in personal contact through Hill and Knowlton, Inc., Washington office" (p. 3) . Finally, the aemorandua describes the tactic of hiring free-lance authors to write ostensibly independent articles favorable to the industry, reporting that "C.B. Colby, free lance popularizer of science, was retained for research and possible writing of article concerning all the hazards of modern life which people are cautioned against and leading to the conclusion that in spite of all the death scares, "You Still Live Longer" (p. 4) . Moveaber 2€. 1954. John W. Hill, the founder of Hill and Knowlton, writes a aeaorandua to Hartnett, the chairaan of the Tobacco Industry Research Comaittee, on "Proposed Budget for 1955." The aeaorandua is attached as exhibit 10. According to the meaorandua, "the budget for staff operations provides for the use of all or part of the tia« of 35 different staff aeabers of Hill and Knowlton, Inc." (p. 1). This coapares with 23 Hill and Knowlton staff who wers hired la 1954. The aemorandua also explains that the budget includes $70,000 to print 200,000 copies of a boo)clet describing the Tobacco Industry Research Council for distribution to "all doctors" and $2 50,000 for "one nationwide advert iseaent reporting to the public at the end of TIRC's first year." All told, in 1954 the Tobacco Industry Research Comaittee spent $477,955 on payments to Hill and Knowlton and on advertising -- slightly over 50% of the organization's entire 426 budget. In 1955, th« public relations and advertising expenditures were budgeted to increase by 13% to $539,400. In 1994 dollars, this would represent an expenditure of over $2.5 ■illion. Xpril Z%. 1955. Hill and Knovlton writes a confidential "Public Relations Report" to the Tobacco Industry Research Council. The report is attached as exhibit 11. The report finds that after a year of intensive public relations activities, "progress has been aade" (p. 1) . Specifically: "The first "big scare" continues on the wane. There is much general awareness of the big IF factors involved. ... Treatment of the cigarette-health issue in public media continues to improve from the Tobacco Industry Research Committee point of view. Even adverse stories now tend to carry modifying statements. Positive stories are on the ascendancv." (pp. 1-2) However, the report also warned that "the next major public problem" will be a report by Drs. Hammond and Horn, scheduled for release at a conference of the American Medical Association in June in Atlantic City: "There is no reason to hope that the . . report will b« in any way better than the one last year. There is no reason to hope that it will not result in widespread attention in the press. The A.M. A. meeting this year is closer to the major news centers than it was last year in San Francisco. " lUy 25. 1955. One aonth after warning about the upcoaing Hammond-Horn report. Hill and Knowlton sends the Tobacco Industry Research Coiaittee a "rundown of the status of certain steps being taken in anticipation of the June 6 presentation of the second Hamaond-Horn report." The rundown is attached as exhibit 12. The report trom Hill and Knovlton details a 17-step prograji for anticipating and responding to the HeAsond-Horn report. Among the steps outlined in the report are harvesting the results of the Tobacco Industry Research Council's earlier contacts with the Edward R. Murrow television show. Step 8 calls for "provid[ing] all the assistance possible in making the two Murrow shows, scheduled for May 31 and June 7, as timely and positive as possible" (p. 2) . Step 9 is "transcribing pertinent sections of the Murrow show immediately after its presentation, and providing copies of these transcripts to major news outlets in New York early in the morning following the show" (p. 2). February 14. 1954. Hill and Knowlton writes another 10 427 conf idantlal "Public Relations Raport" to tha Tobacco Industry Research Cosaittaa. A copy of tha report is attached as exhibit 13. Tha report finds that the activities of the Tobacco Industry Research Council have shifted public opinion in favor of the tobacco industry and succeeded in isolating nany of the industry's critics. According to the report: "A large proportion of the attacks against smoking Bade recently, and expected to continue in the next few months, originate with the sase small group of critics who have led the anti-tobacco aoves of the past two or three years. Neither the press nor the public seems to be reacting with any noticeable fear or alarm to the recent attacks." (p. 1) The report also notes the success of the program to influence medical opinion: "A factor that has become more noticeable ... is that, more and more, doctors and scientists are voluntarily speaking up at medical meetings to express disagreement with the flat charges made against tobacco. They do not exonerate tobacco but say that the case against smoking has not been proved and that much more evidence is needed." (p. 2) Furthermore: "Another aspect that also is becoming more apparent is the great emphasis being placed by scientists in this country and abroad on the role of air pollution as the major cause of lung cancer. Two recent scientific reports on air pollution and health received national newspaper attention. The subject is being treated by the press as a new, interesting and important phase of the overall situation." (p. 2) Despite these important successes, the memorandua warns against "any attitude of complacency in our public relations approach, especially when we consider ... it is not possible at this time to assess fully the probable impact of federal government reports and activities that are indicated in the months ahead" (p. 1) . July 11. H5i. Hill and Knowlton writes a confidential memorandum to Hartnett, the chairman of the Tobacco Industry Research Committee, regarding "Conferences with Life and Reader's Digest. The memorandum is attached as exhibit 14. According to the memorandum, Dr. Little of TIRC met with the Deputy Managing Editor of Life, Robert T. Elson, on July 17. At the meeting: 11 428 *Dr. Littl« ... pointed out th« iaportanca to th« public of receiving a balanced presentation of all the facts and underscored the need for editorial responsibility in handling stories that rouse unwarranted fears." (p. i) The next day, on July 18, Dr. Little net with OeWitt Wallace, the editor of Reader's Digest. At this meeting: "Dr. Little stressed the importance of the public not being stampeded into undue fears and the great responsibility held by major publications to keep the public adequately informed so that they would not tend to over-simplify the problem and expect a "push-button answer" to problems so complex as cancer and heart disease." (p. 2) 12 429 CANCER KISEARCH \M.IX N« It. PPL IU-44, Dr«r»bo l«>) C«pvTl|h< mi tty C«MW lUvwrk, Uc ^'«.V%.V>'^ \ Experimental Produaion of Carcinoma with Cigarette Tar* EnNMT L. WvNDEH.t EvAIITS A. GraHAM, AND AdELE B. C«0MNGE« {D^pcrtmml tf Swf^, M'MJhV"" r'aiV^nty .VA»rf ^ MMteinr. a. torn*. Vc^ nd At />•• vua t ItJtihtt tf Sb Htmarmi Cmtm }m Ctftr i*4 AUut t>umim.SmYmk,SY.) Th* Ujcrv*iinj fre^u«o<;y of prtin*ry c»nc«r of the luof ia iriAny p*rt« of t}>« world hoj woujed ^At inUTc*! is tKi* cooditioB fttxi bu ftimuUud t acarcb for u explAoatioc. In 10^, ^yrtiu ud Graham (40), OD the bMi* of * diaicftl ulA rUtit- IjcaJ Investix&tion, presented evideoce of • red uviciatioQ b«tw««Q lucg cmicer uA nnokiof, *»• peciaDy of <:igw«tl«. Tbtse d*U h«v< b««B w«U ■ub«taDtiat«d by * Ur^-*cA]e British rtudy by Doll and Hill (d, 10) Doth ftudicj (bow«d tb4t tJ>« ruk of d«veloping ukrxxt of tb« lung uicr«L*ej io direct proporlJov to th« unount of nnoldug. Ten other recent itudies reftched (imiW concKuioox (S, 11, 15, SO, 21, i4, M. SS, M. 4<). In 10£«, The CouAcil of Intemttiond OrganiiAtboJ of )4ediaU Sciescei convened a fyrnpotiuin on the eodemiolo- gy of lung CAOcer tod »gre«d tint tLe present cri- dfoat poiaU to ft rd&tiotohip betireca long cAaccf «nd cigarette UDokbg (It). TobAei of tho6e reULioc- ihip« kt* not 10 complete m th« uggettiv« (SS. 41). Hm bci«*ti(» ii ditected toward d«temiiiiii( ia Uboratory aaimilt whether there ftre ~»"''^ gniie fikctot* b eigarette ODoke. Mta; Attempt have bcea aud* wHh tobacco product* to bduce caocer* in « variety of experi- mental animak. 71m &nt vaa tvpurled by Broadi IB 1900 (4). Be painted guine* pigs with tobacco "juk«" for an unksowb period of Ume and de- * Thii tDTtstjfitjoo »M nf/fetXtA Vy • itaeaieh fnal (ms tW Nuiooal C«nMr lMtJ(«U of tW KttieMl LuUMo ^ BultK ISbUe Beahk Bwrtee. t PrcMSl A4)ai«a: M«««rial CeoUr (or C«n«*r ud AllM DiM»Ma, M« Em( SUtj-fifiU SOwi, N«* Yeri II. K.Y. K«o«v«d (or p«k6Mti«a Jwnc •, IMS. •cribed epithelial proUferatioo Subsequectty, many diflcrtat approacbe* to Um problctn •«« undertaJien with Tariou* tv'pct of tobacco, diS0> ent methodj of tar prrpantiOD, and different i^ ci«s of animali Many of tLoiic aluJies were cftrnad oo for too brief a period of time or with too Irw aQimals to be regarded u sigoi/icftot. Hoffmaea aod hJsuKCJate* (l7),forinstjTKe,painleda(iiiiMli for only 14 dayt, at which tinte they noted ^ix loM. Wacker and Schmincke ()7) observed pr> liferatioa d epilbelium in rabbits' cats %\ dajri after a subcutaaeoai iojectioD of pipe tar. The first recorded erprriment with mice aad with tobacco tart aa the luspccted carcinogen vm the ooc juft died by Uoflmana and co- worker*. T\t more detailed o/ t^ (ubaetiuent itudiei are lIjtBrf in Table I. Thii t*bk attempts to fuau&«n«e tkt B>ethoda ued b iJU various itadiet aad tkc i» MiKs obtaiaed. Ik many iastsoce* the method tf study was not deacrTbed In fuflScient detail to gi^ aO tb« In/onnatioa considered esae&tJal. From this iurve7 of the Gt/r«faiie it is found that, before our stikiy, aD the previous atlcupts to produce experiBcatAi c«aocr in mice witli tobMs products were meceuf ul ai the prodoctioo «l oa^ •even epiienooM c*noer« of the sfcja. ScveraJ iavtstifaton attenptcd to bduce p^ iDODATj tumore ia mice with tobaooo aoohk Loctfij tad eo>wQfien (M) obtabed oeg»tm i»> sohs b tlus maaatr. Cainpbdl ((), sad ««Meia^ Enmbeig (13). kowtvcr, ebim to h«ve rauad • agnlficaatty kigker pttecatage o( riihanuT adenomas b the cspcnmcntAl thaa b the eeeM group. It is doubtful that luck a fladbg Is btpo^ tant At aay nte. so tar these Betbods have ast induced true facuacliiogcnic csaciooinM. The mAJosity ol the iarestigalun wot Ung witk tobacco tars used rmbbHs as the exparimenta) •» tnals (14, tS, tT-St. M). In view ol the fact tk« the preaeot work deals with mice we ihall ooff briefly list aonc ol tbs itudies with rabbiU. Rois reported the production of carcinoooM b rabUl can after painting the can with a distillate d tobacco (tt. 90, St). Sugiura (M), in atteuptbg Ui 430 Wtkohi 0t d.—B*perimenlal CcrcinoiM wiU CifnO* Ttr uma c*rciao|eo, » preant la tobacco, bat Ncnt ftadicJ by Dtff tad co-workeri (I) baJed ob tb« •jwoie coabrot oi vanouj t/pei of EoropeAn tobacco Undi to pUc« lea eapbMif oo t^ laor> ftok element Heat, cigvettc paper. fUvoni|. tad vetting AfCbU havt baea Nggcftcd w etwlofie fuciort b tbc prodtMtioa of cai»oer. bat it «»Q«t b« soled tbat clinical evjde&ce bJu alao poiatcd to cigar-naokiog, pipe-iniokiof, aad toba«o-ebrw- h^ a« potabk (actors ia tbe production of eaacer of tb« re«pintoi7 aad aOmentaxy tract Tlie actual caKioogeme agtat or acentj 'a to- bacco KQain to be idenliiled. Studiej combiaiDC cbemJcaJ aad biologic effort* leading to l^oir >d«o- tification are n/geDtl/ needed SbouJd one be able to identify definite carriaogeoj aad lueceed o> re< moTug t}>etn, or at kaft m reducing tbei/ quaAtity in tobacco, proper preventive toetbodj would be at baod. Such JtudJej may furtber our ocderttaoding of buinaa and animal cardnogeneaii and inay lead to tbe developnyeot of practical preventive mcaa- ures agaiait caooer. SUIQLUIY AND CONCLUSIONS I. A cigarette tar coodesaat* wai oblained vitb a nsoViDg maciuM whicb timulaled bumaa raok- iag babiti. Tbe rerilUng tar waa dlnohed ia aoe- tooe and applied to tbe backt of CAPi mice is a doaagQ of 40 mg. of tar/acetoD« tolotioQ i timet a w«ek. Coatral mio* were paiated vitk acetoaa. t. Of 81 tarrtd mice, 0t per cent drvek>pcd papiDonua. Tbe firvt lesion wai noted ra tbe SSd week, and tbe mean time of appearance vu M weeks. $. Of 81 tarred mice. M ^t cent developed kia- toIoficaOy proved earcinomaa. Tbe firtt careiaotaa waa obaerved ia tba 41d vedc. aad tba avengt tkoe of appearaaoe w«« 71 veeka. Of 91 mica aSve at If DQontba, Si per cent developed eancce. Sevea- S-ot* weeki oookitutei approfimatHj oae-balf of • Ufa ipaa of CAPi miea. Tbii oorreipaadt rou^ilj witb tbe fact alreadj aotad tbat ia tba btunan about 90^45 year* of aaokiaf. «r approi- tBately ooe-batf tbe fife ipaa. ara laqaliad far tW pro«)Qctioo of broachkfenic eaidaoaa. 4. One earemetna va* traarplaatad for 4 feBcr* atk>oa aad aaotber oae is currcBtly growiag ia tkt IStJi generatioe. g. Control mice painted witb acetooc akme abowed no ilda ksioas. At tbe end of tO moatbi of painting, &9 per cent were still living, compared to 08 per ci-nt ia tbe group paiated with tobacco tart. 6. Tbe group of mice painted with crotoa oil ia addition to tbe tar, starting ia tbe 7tk mootb, cannot be properly evaluated because of a greater Doaber of deatba oecwnag dnriag tba Utb aad 14th montbi, ahboQgk witbja tbe period of obser- vftiioa no icceleration of cancer fonnatioa was noted. 7. Tbe group of mice started witb aeetoM and receiving erotoe oil begiaaiag ia the Ttk aoatb sboved rou^eaing and tbickeoiag of tbe cp^ dermis, but ito ttunor focmatioa was noted. 1 AA CA?i Bijoe painted witb OJ pe cent •olutioa of metbrlcbolsatbrcoe hi •oetooa drvvt- oped cancer whbb 4) mootbs 1^ Sr^ papiBerna appeared during tbe 8tb week, vitb aver> ap> peaxaoce during tbe 7tb leek. Tbe flnt carei- ootna WW obaerred during tbe Ittb week, witb a mean time of appearazMe of 19 week*. 9. Tbe resuHi obtained with CA?i mice estab- lisb condeujed cigarette tar at a carcioogq for iriouse cpid«rmi*. l^kcae ttudlM provide a tool to detennioe and isolate tbe possible cardoogenie ageijt(i) within tobacco tar. kX. prejent It is not known wKicb fractioo or fractions in. tobacco tar* are carcinogenic Combined chemical and biologic studies are now rn progress to search for aicb agents. Such itudiea, in view of tbe coroQary eSoi- cal data relating nrtoking to various types of caa* cer, appear urgent. Tbey may resuH not only la furthering our knowledge of carcinogeaesis, bat ia promoting Ksae practical aspects of eaacer pta- vcntioB. AOCNOWLSlXiMXNTS TW ttUtfi TiA U oryrw Ottk gnUiAt U Caka 1. Cook. Va/? C«j Cnv, %ai C^iKnia Ciaa) o< Wukjagtoa L'aj'inHy Sdioai «wta] Lif««>c>UM «f lu llh|wl Cudmoptk LdSm^ Km. I. Cmcw, 14:1*1«-«1, ISM. 1 BaB«o«.LDwiagaietuSMUa|CsaHUagCacw? C40«««i*'* BakK ^l-H IMI. 4. iaosea. A. TUamJeW ia a^njaiuai tWliniiAw mm m M> ■!«■* «4 He»i^wwb im ■ilfiM C»»Aw. BA. J. Caaew, 1: 1-M. 11*1. 431 HKU WCXCROtNI) KATCTIAl CM THE CICAaSTTE IKPOSTIT ailNT Th* followinf ia/oraitioa w»s |lvta us by th* presideots of tht leadinf tobacco coopinics at tht Hotel Plaia this ■ornia(. I, Participants Thert is do trade association Id the cigarette ijidustry. This is because the tobacco coopaoies are preveoted by the dissolution decree of 1911 aad the criminal convietioas under the Anti-Trust Act in 1939 fro* carrying on «any group activities. As a Batter of fact, before the current health crisis arost, cigarette aasufacturers never aet together at any tiae except at dinner* honoring soce industry leader. The group vas called together by Mr. Paul Hahaa, President of the American Tobacco Ccnpaay. The chief executive officers of all the leadiof coopaaies - t, J. XeyBolds, Philip Horris, Benson k Hedges, V, S. Tobacco Coapany, Bro«D h Villiaeson - have agreed to go along with a public rela> tions profraa ob the health issoe. Liggett k Nyer* it not partleipatiag la th* orgaaitatioa beeaus* that coeipany feels that the prefer frocedts** la to ipore the «hol« coatro> versy. In addition to th* cigarette coapani**, th* tvo iaportant groups of tobacco growers involved ar« enthusiastically supporting the new prograa. Together these tobacco grower* represent tea* 600,000 fants and 2,700,000 farmers. Obviously, th* tobacco (rowort ar* th* political strength sloog with th* 1,300,000 retail tobacco outlets. Th* tobacco growers will b* represented by officials of the grower organitatioos, II, Organisation Because of the anti-trust background, th* coeipanies do not favor the incorporation of a foraal association. Instead, they prefer strongly the organitation of an inforaal coonittee which will be specifically charged with the public relations function and readily identified as such. 432 For txaapl*, Mr. Raha r«port«4 th«t on* &««« th«x had coosld«r«4 was the "Tobtcco Industry CoBiiltt** for Public laforaitioB.* John Hill surges t«d that h« felt tht word "research* thould appear alon^ vlth "iftforxation" ia the title of th« coe«ittee. in. The Indmtry't roition The Industrr !• etroeily convinced that there ii no eouad • cleotifie baii* for the charfce that have been aad*. They believe that the sore sensational tccusatiooa la the recent papers vere preaature aad in soae cases represent publicity issued in the hopes of attractlag funds and support for further research. They point out that the Kationil Cancer Institute of the U. S. Public Health Aitoioistration, vhich is i governaent egency and supported by Congressional appropriatioos, has officially refuted the tie-up betveca cigarette saoViog and cancer, Kevertheless, they realitc that the industry should not engage serely in a defensive campaign, replying to and ansvering Individual research papers or aagaiine articles. They feel that they should sponsor a public relations caapalga vhieh Is positive in nature and is entirely "pro-cigarettes,* They ar* confident they can supply us vith conprehensive aad authoritatlva scientific aaterial which ccopletely refutes tb* health charges. They are also enphatic in saying that the entire activity It • long-tera, continuing prograa, since they feel that the problea Is cd« of proBoting cigarettes and protecting thea froa these aad other attacks that say be expected in the future. Each of the cocpany presidents attending caphasited the fact that they consider the prograa to b* a long-tera on*. IT, lespoftses to Questions The conpaaies* answers to questions put thea by Joha Hill aad the undersigned provide valuable backgrouad. They are as follovs: Vill th* clgarett* coapanies orgaaise theasclvtt Into aa association publically announced, vhieh will openly sponsor their public relations activities? The coopaaies replied that they had no desire to set up a saoke screen or "front*' type of organisation. They are perfectly willing to sponsor any stateaents that aay be issued or any institutioaal advertlsiag that Bay be recoomended and approved. Do th*f tcccpt th« princlplt that public health If paraaount to all als*, and vould the/ issu* a public ttattMat spelling this ovt? Evaryoo* prasant vholtSaartadljr a^raad to thia principla and readily coniented to widespread di»f eainatioo of i sound itateaent of principlet. Ciatribution of aueh a atateaeat it wu a(rotd vould probably be the first »tep in the public relation* projri* that Hill and Knowltoo vould recooaend. Do the caop»ai«s consider that their own adver- tisini ano ca«j>«titive practice* have been a principal factor in creatine a health problea? The coopanies voluntarily admitted this to be the case even before the M, U89 A PKELDIiyAlT K£COn« aamfactorert eaa sajr or ref^ala fra saylac that eaa stop people froa b«ia( iaterested la their health, aor allay their fear of caaeer. So lce( as the causes aad core of this 4rea4 disease reaain unknova people vill be subject to vaves of fear reftrdlaf it. It is laportaat that tha Industry do aothiaf to appear la tha llfht of beljt( callous to cons i derations of health or of belittliac aedlcal ra« search which goes against cigarettes. The industry shoald lose ao tlae la aaklag it coapletely clear ta the Aaericaa people that it is not usaindful of the public healtii. There is an evident orgeney about the aatter vhich aakes it advisable to suggest certain isaedlate steps. A fully rouaded»out progra 437 vill b« devtloped vhcn there hat been tooufh tiae to Bake a aore coapre* henslv* study of additional asp«ct« of the problea aod to think throufb various coursei of action and projects. ITie situation is one of extreae delicacy. T^tn is such at stake aod the industry (roup, in aovioc into the field of public rela- tions, needs to extrcise great care not to add fuel to the flaaes. nie recooaeoded approach is conservative and lonjTange. Ve t>- do not believe the industry should indulge in any flashy or spectacular ; ballyhoo. There is do public relations nostrua, known to as at least, which will cure the ills of the industry with one swallow. The need is for a roundly rnnr» B«nt of fundi. In addition, it it Laportaat that tha (roup aatabliab proc«dur«a for axpeditioua clearajac* of any policy atateaenta it aajr decide to issua. Tha follTwlng recoaaendatlona ara tubalttad for couidaration by the ■anufacturers: 1. Htidquaxters of the Coraaittee. Heidquarters should ba established in Kew York City, 2. Ntae of Ccaanittee. The follovin^ oaac is subaitted: Tobacco Seseirch Conaittee. 3. Set-up and function of Connittee. Tha «ord "research" should ba included in the a&ae of tha Caalttea to establish tha fact that tha (roup vill carry on or sponsor fundaaental scientific research and vill not be solely an inforaation agency. The Comittea's research should b« of tvo kinds: ^ (a) scientific, aedical research (b) editorial and statisticsil research into partiacst phases of the current controrersy. The Cooaittaa shoold b« prepared on coapeteat sclaatifle advice frca outsida the ia<5\stry to give substaatial support to obJactlTt non-duplicating aediral research that is acat likely to ba productiva proaptly of conTincinf results. The CoBwittee should have a Director of Kesearch, a aedical research authority of unquestioned national repute. The Director would have such research assistants as aay be required. The Besearch Director would serve as spoVesaan for the Conmittee on aedical and scientific natters. 439 Th« CoaittM ahould alio form u Airitorj io«rd coapMtd of a group of (li>tln(uiih«d mo ftoa the flflda of MdlclM, r«s«arch tad •ducttloa. TtMSo ahoold b« mb «ho«« latofrity !• bcjrood 4uMtloa« Th« Dlr«ctor of l«i*trch and th« Adrlaory Board ahowld b« coo- •ttltod by th« C««treh« Th«r« (hoold b« cot 19 •t th« hoadquu'ttr* of th« Couitt**, aad«r tb* diractioa of tht losotrck Director, a continuing research project to collect, coordinate and disiodnate (where practical) available iAforaatioa on varloaa aedieal research actirlties beariAg on pertinent phages of cigarette* and he«lth. At tlae peraits, this project vould explore such questions as: a, Vh/ do &ice shov no tendency to deralop lung cancer in ex« perincnts vhere they live half their liTes in SBok»-filIed chaabcrs; b, Thy, in tcae experiaents, do mice shov a tesdenc/ to deralap •kin cancer, vtiea painted over a p«riod vith tobacco tart • vhereas efforts to produce lung cancer in nice, by keeplnf the* iaaersed ia tobacco saoke, Kara failed? c, Vhy has the rise In lung cancer been aost aarked aaoag ■•&, Although the greatest rise ia the as* of eigarettas ia tha lut 3S yaara aeeaa to hsT* been asoag voaea? d. Why does tha rate «f log cancer rtrj so greatly b«tve«« certaia eitias, although the per capita rate of dgaretta consmptioa ia these cities seeas approziaately the saaef a. That is the correlatioBf if any, batvaea lung cancer and cartaia changes in Aaaricaa life • a«ch u staadily iacraaaal Industrlaliiationi, increased wbanisatioa, and tha rlsi^ problaa of ataospherie pollutioa ia aany of ow vbaa caatws) f. Thy is cancer of the Itaig on the increase, vhereas no such rise appears in siailar illness of tha tongue, lip or throat? f. Is the incidence of liaif cancer less in rural areas than it is in urban areas, and if so what ia the per capita coo* ttaptioa of cigarettes in these respective areu? h. Is the Incidence of luag cancer greater in cold cllnates than ia aild cllaates and in the south, and if so vhat is the per capita coosiaptloa of cigarettes la the respective areas vhcra this differential saeaingly occurs? 441 i, TtM ftfvM of tfc« Dftaon Suajroe CtBC«r T\md MtlBtt* la ItU tv«ot/>tve thouiksd deaths Ttcm Ivof eaactf Ia th« Onlttd St4t«s la an tstUtttd pop\ilttloo of oTtr oo« huadrtd fifty ■illloB iodiTldu*li. Tho rtport la th« N«» Tork H«rild Trlbun* u of Suodijr, I>eceab«r 13th, qtiotad th« Brltlab Mtdleal Socltty u tdylsli^ that tb«r« vw« thirtam thousMd caja* of lui^ caacar la Croat Brltala lajt /aar. With Brltaia approxlatttl/ ona-qaartar tha ilta of tha Oaitad Stataa, thalr lacldanco of Ivai caaeor voald ba approxiaataly four tlaaa aa fraat aa tha Daltad Stataa. That ara tha facta about this aad «tut la tha iacldaaca of cliiato, ate. la tha daralopaant of lua( caacar r j. It It poailbla that En^laad, vlth a lar(«r parcanta^a of lta( caacar Incidanca, aay poaalbla haTa obtalaad this raiolt dM to tha fact that tha tobacco for thalr dgtrattaa la not trtttad la aa/ va/ with ctsiafr Should tha efficacy of caslBg oaad la tha Baaufactura of Aaarlcaa clgarattei ba itvdiad u poaslbl/ aa aatldota to tha dalatarlous affacta of tobacco, If aa/f k. Vlth tha artaosloa of h\aaa lift dua to alracla <^u(a, ate. vhat la tha parctota^a of tha lacraaja of loa^ caacar, If amy, coaparabla to othar dlaaasai durlaf tha past taa yaart? 1. Vhat tkj ba tha affact on tha si(oJLf Icaaca of ttatlatleal coaparliooi of lora accurata dlafaoalt durlaf tha past faw ysart lato spaclfle causes of daath? a. Vhat ara tha baaaflts aad aaJoTaaat darlrad froa saokla(, ^ both by sciaatlflc tests aad by aaasuraaeat of saokar r«> actions aad attltodas? ^ B« Vhat ara tha saokiaf habits of lon^-llrad dittlafulshad pubUe "^ leaders? 0, That ara the hvaaa Ilia arroaeousl/ attributed to tobaeee ^ OTer the centuries? There are aaa/ slallar Haas of laqulr/ which haTo so far baaa pursued vlthoirt daflalthre aasvara. They should ba explored still aor« ▼liorousljr, aad vlth still greater resources) aad the results studied for their asefulaets u s aatter of publle laforaatloa. 7, Public Opinion Poll, A national surra/ of publle oplaloa Is needed to determine attitudes twrard cigarettes aad tobacco held bjr (a) the aedlcal professloni aad (b) the public at large. The results of such 442 -7- ■ poll should b« helpful ia devtloplng aor* •ffcctiwljr th« eootlAalof pro- graa of public lafonntloe that majr b« r«qalr*d to offset uitl-clf«r«tt« proptf tnda aad to flT* juatlflad roassurtACO to tho public, 8, Whita Papar. Tha CoMittaa shovld dlatribata u tow m ^ possible a sciantific fhita Ptpar_difestiBf aoTcnt ar&ilAbla opijdon ot authorities ob cigarette saokiaf aii4 luBf caac«r. 9. gelations »ith the Press, An Important function of tha Camittea will be to see that the pertinent facts are nade arailabla to the press. In addition to any current stateaents or releases that aajr ba issued, back^ound aeaoruda of facts aay be circulated to the press vhea occasion requires. The Ccsaittee, of course, vill ba alert to what is being published or said on the subj«ct of concern to tha lnduatr7 and If an/ aisstateaents appear, the facta vill be offerad to proper (ovcaa. In tha case of itgaiines, the facts vill ba placed ia the hand* of editors for such use as atjr suit their purpose*. Arailabla for this vork vill ba the publicity staff of public relatioaa coonsal. Aaj publi- city tctlvltiaa, of course, vill b« adapted to ewraat need* tad epportvd* ties as indicated by treads ia public aad profassioeal opialoo aad diaoissleaa, 10« ladio and TaleTisiott, Millioea of people are laforaad aad thalr attitudes laflueaeed by radio aad talerlaioB, It vill be l^ortaat to keep eoaaaatatora and other key people ia bro«dcastin| avara of tha CoBBittae's existence and of any facts it aay ajsaabla. Moreover, the Conaittee should be on the alert for public dis» cussioo prograns where spokesaen for the facts as the Coaaittee seea thea alfht be velcoaa. Public relations counsel has a radio and televisioa specialist vho can function ia this area. 443 Pluu itMold b« •xplofd for glvli^ att«atloe to Um po«ltlT« Mp«ct« of (Mkli^ throofh 101100 pletvrta tultAbl* for tolvrlaloo as* u ««11 u grot^ ihovlBCt. 11. CoMlttoo *• > •cnrcm of ftct». TIm »ork of tho CoaBitto* la th« fl«ld of public laforBttloo ahovld bo (och u to ottablijh th« Coaalttoo u • ralitbl* tobroo of iAdaatrjr facta oa thla iabj«et, aad a flov of •oquiry bj aail, tolephoao and p«raoaal rlaltatloa aoat llkalgr caa bo •xp«ct«d frtdaall/ to d«T«lop« Tho Coaalttoa ihoold dorolop aa rapidi/ as poaslbla aatarlala, data aad atatlstlca bfarlai oa rarloua aapocts of th« clgaratto Indus trj, aad hart adoquata staff to lasuro aatlculous attaotioa to all aaqalrlaa froa tha pross or pubUe, 12. InforaattoB for spoclal frowpa. Attaatlca should b« g Itw to aatarlal oo clgarattos golag to spoclal groups sach as vcaaa*s clabSi gardoa claba and othor organliatloBS that hara diactasloe aad study pr»> graas, aad corractloas offorod la th* eas* of aajr alslafonatloa aotod. 13. luhlflgton ActlTlHaa. Tbo ffashiactoe offlea aad staff of public rolatloaa coaaaol will b* arallabla to plaea acearata' aad iv>te* data laforaatloo lata tho hands «f appropriata Caaaltt^aa of Cof^aaa, Coegrossaoa aad Saaatora fk-oa tobacco atatas, and lataraatad goTonaaat officials. 14. Matariala for coapany dlstributloa. It Is aztraaalj laportaat that tha facta aad vlava as doTalopod by tha Ccaaltta* b« coMualcatad proaptly to Taricua alaanta vithla tha ladostry itsalf, Eaployaas, stockholdars, distributors, grovars and othara should kaov tha facts la ordar that thay can spoak latalllgaatly vhaa tha sabjact is dis* \ cussad la thalr ova groups. 444 IS, Wdietl Croiy. Tli« Coaaltt** vlll M«d to kt«p abr«ut 0t profrtat of rtrioua ■•dictl ktMclaticiu tad groi^. 19» CoopTttlco of *tt>T irotp«, Tlit Coaltt** ahoold txplort tad daralop to th« grt&tMt wctAat that it e«B, tl)« pottlbillty of eoop«ratloa trcm allltd p-ot^t ladb u frovtn, retailer* and dlatrlbotwa. At already aottd, it haj not baaa praetleal to dartlop a f^ill progru la tha brlaf spaca of tlaa availabla, Tba affort baa baaa to outliaa a baalc policy approach to tha problea aad to iadlcata tha dlraetloa vhlcb tba activity ihould taka la laplaaiotii^ policy. fa ballaTa that tha eorraet path to follow la eaa of patlaat, coatlaulBf, 8ur»-footad praaratatieo of tha facta to tho publio •• facta tupportad aad docuatattd by carafol roicardu 445 . t't^i^'^^'^i*. ^y^w\ H > I A! Frank Statement to' Cigarette Smokers I ^ «tCt«.T I J ihtPl) iSlI C'lArtllUmfilinj [Allholfh CO'Klutl^J H) >loc:«n nf prrft voojI >ijnd."t. unctr rc^aTk. l^o«c^f,^»c Jo VM he'*** I^»l *n\ ^tlry^ Al iSe ^i«t iiTK. •« l^tl >l i«|'" >** puH* "iief»<( to oU • itnii«ii 10 (tM r»c1 i»ni culntii d«k lo" J«t>i lelKt. irWit- lion. and citjejmeni le nvanlind Al p^ iincot anotlxT di«in| ihov )car> c»"«« »u>« hckl ■! i«»fio<>iiNt («< nncKaB; oary di^ej<« ofiKc hvmjft Sodv One SjoaciKcv ck|i(M^^d>•" 'c do«<( lo ■«( ih« pjMrti tcvic b^.-vkJ b) ilM f(t«(il tfjKHll Ht™ ia il>« ini»cf:' 1 J U'a a>T l^'if aM aW amMaKt r* ite troart fil*n M* ' all pbM) If itWcn iw tml ImM. TUa )rta ImkM M >!n •( con k> ii ■MtiKa n pUi K almdr ^H^ irtbvtrt br MhUMi fMirwl^i 2 Fw ikh rtrfom «t »a n(IK^Ia^ I j*M M««rT >rwt I ' co« b* 4 irt iaicnd la fa aboaai «. TOKAcdo INDUSTRY-RESEARCH COMMITTEE Dlarta|u*W I. TbM ]. 1Kaf ibrff l| M a(rt^«MBl ^maat iht aatborilin irtaid- )•( aliai ib« uaa |i. i Tkal iWtt' ti ~) proj' "•" C'if""> «ykl"l o »M af lb« nmn. ' I ' ' - 4. Tbal CfMTi pwrajitaf ia|ia ripmit a^rtiai >M Ha Awnt'nW tft''! '^\ 1*<^ '•'« i* ac aw af aaar •• nr« It. la Mai^aH bj Wc xtcft'if ifiKmi ii prapl °i bnhh ai a batic 'nftm- itbiftj. paiioMNM io rtcnri itm c( a l« ur4 ToaJLCci coi mut^ abcTloJ »<»kH4i.-ar ua. <0*ll»T nauf Hoaait ^ ea. im. r« a. 1 irrMiaa mbMca c«Mf asT aHntf- Htanju>» tca<(co cxo*u< uaocuneo o aaetHua. rota«0 to this. In addition to tbe above coat coTercd In the |2$0,000 ap- I proprlatioD, a cost of X^.Tll vaa Incurred to transalt by telegraa 1 -^ the revUed liit of «pop»or» and the prescribed change In headline. -^ i \ Ob authorltatloo by tbe Chalraaa, U tobacco industry \ I publications vert added to tbe list and rceclred tbe saae two-p«g« • rerslon of the advertlseaent vbleb appeared in tbe press publication*. | j Total cost of space and preparation for tbl* vlll be approxljuttaly ; I #3,606. This vll^^nSe tW^t«l adTcrtlslng expeodltura, not including reprint*^ To lata 200,000 reprista of tbe adTtrtiaeaeat have bcaa ord*r«d by tba eoa^aniaa. Additional AdTertislng Solieita tioo Tb* question of czt«ndiag tb* adwrtisiag to appear ia • Taricty of additional publications vaa auggeated, ia scat instaacta by rriMlttii aeabcrs and, ia other*, by diraet aolieltatioe froa tht publication*. 9m *« iaeluded tb* food aad dr«g trad**; tb* aagre and labor pre** a* veil aa tb* foreign languac* prca*; aad tb* b*w* veeklic* •• Tia*, Bevsweek, and U. 8. lev*. It 1* our reec—iadatioe that ao further advcrtiaeacat be placed ualng tbe original atateaeat, aad that tb* above suggested groups of publications be carefully conslder«d ia relation to aay subseq^ient plan* for nev advcrtiaeaent*. Tb* circulation of all tb* above groups, vlth tbe possible exceptloa of tbe foreign languag* pre**, can b* considered to bav* been reached ia large aeasur* by tbe original daily newspaper advertising. 447 •t* n. RBytsT yew RgBnfrs reow w.a.t.p. Mr. Kolodfi/ of th« Rational Aaioclatlon of Tobacco Blttrlbutort baa Indicated ht la VIIILD4 to dlttrlbuU tba tUU* wDt advtrtUcwDt to 1,000,000 tobacco dealer* throusbout tb« eouatry. la tabloid tlM, production of 1,000,000 rtpriata vould coat about $3>000. III. PRESS RilJASt ATO PRESS COVIRACt The prett release acLaoucclog foraation of the Coaittet v&< given national dlttribution aod vat vldely covered by nevspaper, radio, TV aad tbc aa^azlnei. Typical clipping* of this coverage have been tent to Cceoittee seabert. Editorial cooDeot vaa noit favorable, tb editorials •till being received froa all over the country. rV. I5T0RXATI0W AWP CORPXSPONDEWCt During the f irit vcek after appearance of tbe ad, vt handled aaay penonal aod telephone calls, Including professional ■en offering services, crsckpota and others. These vere in addi- tion to the Bany inquiries fro« the oetvorks and the press. During the first tvo veeks after the appearance of the ad, over 1,000 telegrau and letters vera recaired at lill and Xnovltoa offices. A prcllnlnary analysis indicates that objcctlvt or prO'tobacco coaaenta na better than tvo to one. ▼. waTuc or coMPAjrf rbeabch ciRECTore Cbalraaa Baha called a Meeting of Research Dlreetora of tbt tobacco coapaaies eo tbursday, January 7« A report oa this Betting vill be presented to the Tobacco Industry Research CcoBittee. VI. 'vBrre PAPP* A draft of the "Vhitc Paper" vaa subnitted to the Reiearcb Directors Advisory Coonlttee and suggestions froa these officials art being coordinated into a revised draft for final clearance. ni. CALLS OH ADVPfflSDW ACCTCIE3 Kessrs. Bill, Ooss and Littln have called on senior executlTts of the principal advertising agencies to obtain their suggestions ax>d ccsBenta. la addition, a aeetlng of the Research Directors of advertising agencies vas called to discuss the Batter of • poll and dtpth survty. 448 Nay 3 TO: TCBACCO IHDUSIW RESEABCH CCWaTTEI M: Beport oe mtC booklet, "A Scleotifle Pcrapectivt on tb« Clgarctt* Controverty" Tb» booklet, "A Scientific Perspective od the Clferctt« Cootrovcre/.* vat rcleaied April \\, 205,000 coplee being printed. It vae teot to. 176.800 doctors, general practitioners and specialists. It also vas seat to tb« deans of medical and dental colleges. The booklet and tbe covering press release vent to a press distribution of 15,000. Included vera editors of dally and veekly newspapers, consiaer magatlnes, veterans ugatlnei and ■edlcal and dental Journals, news syndicate Bsoagers, business edltora, editorial vrlters, science vrlters, radio and TV comentators, newa col- umnists and nembers of Congress. Several days In advance of tbe release date every doctor and publlaher who bad given penelssion for quotes in the booklet received copies vlth a letter thanking thea for their courtesy. One of these doctors, Edouard D. Cagnon M.D., M.S., r.R.C.S., replied as follcvs: "... A perusal of thla report and especially of tbe paragraph that concema oe baa lapressed ae as being a non-biased statement of facts. ..." y One week after tbe press asillng a letter, over tbe signature at th« Chairman, 0. Parker McCooas, vent to llli key publlaher. .na m,Ai^ h^,^. calling their attentloo to tbe booklTC Polloviiig arc several typical replies, to the Chairman'a letter: ^ . - "... I have read it vlth Intereat an4 have had It read by tbt heads of our Radio and Television News Departments as veil as the head of tbe ABC Continuity Acceptance Departoent.' . Robert Z. Klotner, Presldeot, Americaa Broadcasting Ccapaagr "... I have been a cigarette aaoker for scoe forty-five yeara I as atlll a pretty healthy apeclBeo • despite the fact that I have bad to listen to a lot of acarc talk about cigarette smoking. Vhat I believe the feneral public needa and wants la ■ore light and not ao such hear." - Roger B. Perger, Presldeot C Publisher, Tbe Cincinnati Bnquircr "Many thanks for sending ae a copy of 'A Scientific Perspectiva on the Clgsrette Controversy.' 1 shall look forward to futura material as It is Issued." • Roger Dakln, Editor, Colller'a "Thank you on behalf of Mr. Robert B. Reed, our editor, for your letter of April 111 and for the brochure titled 'A Sclen- tific Perspective on the Cigarette Controversy' vblch accca- panied it. Ve know only too veil of the aany unprovea clargea that have been made against the use of cigarettes. Ve aball, therefore, read thla brochure vlth a great deal of Interest." - J. T. Bingham, Associate Editor, Country Gentleman 449 -2- "Thli vlll acluiovledge your letter of April lU with Its enclo- 8uret, vhlch I am •harlng vlth ay aaaoclatet." - Arthur Eaya Sultberger, Publleher, The Hew York Tlaea puBLicrry PLAct?gjrr The Publicity DepartneDt of Hill k Koovlton, loc. aeot the booklet aod releaae a week Id advaoce of release to the Dewa Bagatlcea. Severml days Id advaoce, ' preaa, Detwork, vlre aervlcea aod colwolat cootacta verc alerted by c.-.ie and Id peraoo. The booklet vaa hand delivered, to oeva- paper desks asd tobacco trade publlcatlooa Id the Rev York area. Bill k Kncvlton, Inc. field offlcea Id Lee Angelea, Chicago, Cleveland, Plttaburgh and Washington, D,C, alerted local preaa, radio and TV to the atory. Our Loa Angelea field office made special placemeot to dalllea, radio aod TV etatlona Id Vest Coast states. PUBUCITY RESULTS Substantial atorlea of aeveral hundred vorda each were uaed by Aaaoclated Presa^^Unlted Preaa, International Neva Service and Dov-Jonea vlrea. All Rev York dalllea, Business Week, Nevaveek, PrlDter'a Ink, AdvertlalDg Age, and Editor k Publisher carried atorlea. At this vrltlng, Tlae la planning a atory Id Ita next leaue. The SuDday I.Y. Daily Neva (clrcu* latloD 3,800,000) gave feature treatment to the booklet on their editorial page, devotlDg the major part of the page to ccDnent and a cai^ooD. AP radio Devs teletype sent the story to approximately 1,U00 radio statloDa, Henry Gladstone did a piece oo it for his Mutual ayixSicated buaioeas oeva program. Max Roby alao uaed it 00 bis KMX (Los Angeles) CBS Pacific Coast nevs program. The atory vaa carried by Jiundreda of papers and radio stations throughout the country. The Waahington, D.C. Evening Star, the Cleveland Revs snd the Chicago American carried apeclal staff -vritteo stories developed vitb the help of Hill k Knowlton, Inc. field offices. Becauae clipping aervlcea are alvaya several veeka behind, only a reprt* aeotative aampllng can be ahovn vitb tbia report. Pbotoatats of scae of the neva atorlea and edltorlala are attached. Bill k KDOwltoo, Inc. cb atta. • HILL AJTB KNOWLTOH. ixc. 450 PUBLIC MLATIOre REPORT AHB RECOMKENIHTIOfS FCR TCBAcco vmjsvn research cc»*cnTn ~^FFf (A« dltcussed aod approved od June 10 by a group of Public Relations people repreaeoting a oumber of Company meabera at the T6bacco loduatry Research Coenlttee. Thla group meeta at Interval* with Public Relations Counsel, to diacuaa TIRC Public Relations problems.) Early In the life of the Tobacco Induatry Research CcxMlttet, It vas accepted as a basic principle that every effort should b« aad* to avoid stimulating aore adverse publicity and controversy on the subject of tobacco and health. That prloclpla has been and vlll continue to be carefully adhered to In the work carried on for the Ccoalttee. Revertheless attacks on the Industry recurrently stimulated by various Individuals and groups antago- nistic to tobacco, have been Increasing, and acne elements of the press are continuing to feature unfavorable aspects of any medical report bear- ing on tobacco. On Its part, the Ccaalttee properly has refrained from engaging la any direct controveray with the Industry's critics. It has stood upon the basic statement of January l> ai)d upon the synposlia of views of 36 scientists Issued by the CooDlttee In booklet form In April. Both of these statements received wide and favorable cooDent In the press. 451 •2. Id public relatloDt reccmseixSatloct •uteltt«d to tb« Halii CGaalU«« In January, It vaa conteBplated that a baaH for an affirmative progra* of pubilc Inforaatloo would b« provided vhen the Scientific Adrliary Board aod Scientific Director had been aelected and were at work, and when rarloui preliminary editorial reaearch project* were well under way. Theae thln^ have been acccnpllahed and the Ccxaalttee now has the baala needed for car- rying on a long-range plan of pubilc relatlona activities aimed at estab- llahlng the TIPC In the pubilc mind as a constructive force In scientific research. These activities will endeavor to keep the following facts before the Public: 1. That there is no proof that saoklng Is a caua* of lung cancer; 2. That an Impartial and Independent Bo«rd of sclentlstf, doctors and educators 1* advising the TISC, as a public serrlca, ce all aspects of tobacco use afd health; 3. That th« TIFC la dttarmlnad, through a long-rma(t profraa, to make every poaslblc effort to help get the facta through lab* oratory and statistical research; U. That Initial fusda for reaearch have been appropriated and more vlll be provided aa warranted to help In getting the answers by scientific meana; 5. That all the laboratory research reco^^nded by the Advisory Board and financed by the TIFC vlll be carried on by recognited and independent laboratories, institutions and hoapltals. 452 Report of AetlTltlet At background for the reconBeodatlona vblcb follov, certain active and eootlnulag projecta are briefly aunaarlted: Preaa Conference - 71rat formal aanouoceaent of the appolntaent of Dr. Clarence Cook Little aa Director of Reaearcta vaa nade at • Preaa Cod- ference, June 15, In Rev York City. A tranacrlpt of the conference bat been aent to all TIFC aembera. Preaa, radio and televlalon coverage via extenalve. TPC aa a Source of Information - CoBnlttee hesdquartera la atetJlly gaining recognition ai a aource of authoritative Information on the subject of tobacco and health. The reeult la that nevs and magatlna vrltert, column- lata and camentatora are turning to the Conalttee and Ita public relatione counael more and more for Information. Thla vlU increaae aa the Advlaory Board geta Into action and more material la releaaed. Aa part of thlt aenrlca, blbllographje fllea are b«li< developed for two purpoaee, (a) public relatlona reference; mod (b) technical refereace. Cllpplnga have been alfted for algnlflcAot atorlea and ten publicity reporta have been made to the TSIC. Mleatatementa Corrected - Reporta and atatementa appearing In the preaa, radio, televlalon and nevareela are carefully monitored. Whenever aitatatementa are made atepa are taken to correct the record. Thla hat been done by peraonal contact and lettera to the editor. 453 Coverage of Medical Meeting! - With the cooperation of the AKA, th« AaerlcaD Cancer Society, the Kev Tork Medical Society and Induatrjr people, cloae check li kept on nedlcal meetlnga. A calendar of coalng eventa having to do vlth tobacco and health la heiog oalntalned. The Important onea art pereonally covered through Rev Tork ataff or field office* and report! art being aent to the TUtC, Ita Scientific Advlaory Board and Induatry Technical Comlttee. Where poaalble, abatractt or terta of laportant papera are ob- tained for TIJtC diatributloo. foreign Surveya - Aa propoaed In the January 15 progrtB, tnd apprortd by the Main Comlttee, aurveya on the clgarett« controveray havt been ece- ducted In European countrlea. Reporta havt been aadt on Svltttrland, Bel> glum and the Nether landa, and detailed reports are In preparation on France and England. Bill and Xnovlton, Inc. oireraeae aaaoclatea vlll contiout to vateh develoiaenta In theat countrlta, particularly In Greet Britain, vhtra tbt government haa taken an official poaltloo. / Correapondence and Cellert - A large volxaM of public relation* cor* reapondence, vhlch at timet ha* topped over 100 letters • vttk, contlmiti frca lay preaa, trade prea* and the Induatry. Individual lettera have been aent to a large number of doctor* vho vrote detailed cogent* on tbt 'Scltn- tlf Ic Perapectlve" booklet. Peraonal and phone call* of the aaaa type art Increaalng. 454 Id keeplAg vltb tbe objective* outlined on page one of tbii u< raodxa, tbe foll^flag recoaa«D<3atloos are preaented: Beierve fund - It If auggeated that when tbe preaent fund of $500,000 for reaearcb la exhauated, or before, tbe Co^lttee give conalderatlco to aettlng up a substaDtlally larger reserve fund for reaearcb over a period of two or three yearg. Thu will keep before the public a more accurate view of tbe nagaltude of tbe Job the Industry baa undertaken, and tbe alncerlty of Ita purpose. Beleaiei • As developnents warrant, and aubject to approval of tbt Scientific Advisory Board, information ce tbe work of tb« Board should b« released to tbe public. Three such aDoouncements have been made. A« grants are made the essential facts of each should be released to tbe press. It seems probable that the Adviaory Board will coca forth with soae d«v and Intriguing Ideas for fields of research. Dr. Llttlt would b« tha l^eal spokesman for the Board ia connection with aucb report* or any other atate- ments to be made to the preas, oo tbe air, or bafora groupa. Various oppor- tunities for television appearances for Dr. Little will be explored. Results of medical statlatical research to be authorized by the TOtC ahould provide valuable information bearing upon tobacco use and health. It ahould be iji order, aubject to clearance in each case with the TUC, to release some of this information to the praas. 455 Science Writer* Tour - A* •oon ai enough graoti are operating, • tour of foae of the aoat significant researcb projectt should b« arraafcd for science vriters. This would be similar to the project conducted 'by the Aaerlean Cancer Society In April, when 0 scae top science wrltere vere taken on a tour of the principal laboratories engaged In cancer re- search. Much goc«3 publicity resulted for the Cancer Society and ite '* funds drlTe. Background Hgmo and Booklet on TUC and Its Advisory Board - A brief editorial memo giving the facts about TIPC and Its aedlcal board Is prc^poeed as a follov-up to the press conference. This vould be distributed to special press such as science vrlters, aedlcal press and organl tat loos; alto to col* umnlsts, editorial vrlters and Sunday editors. The aaterlal In this edltco-lal aeao could be developed into a dlgslfled and effective booklet for vlder public distribution to doctort, ate., aa a follov>up to the 'Scientific PerspectlTe' booklet vhlch vat Issuad la April. Editorial Contact Project - A progran of Inforaal contacts la being developed to enable Dr. Llttla to better Infora laportant eleaeots ot the publishing field, and scientific and editorial vrlters, regarding the ca»- structlve alas and policies of the Tobacco Industry Researcb CoBlttee and Its Scientific Advisory Board. This activity vlll be centered la the la- portant publishing center of Hev Tork. lo addition, public relations staff aeabers should Tlslt publls^rs, editorial vrlters and ccnnentators In other principal cities. 456 Editorial Wetorch • Cootloued eaphaali ahould b« given to tdl> torlal reaearch. In tbe January 15 prograa, tvo llnea at Inquiry m*t% auggeated: (a) amokiog bablta of loog^llvad dlatlogulabed public leadcra; aod (b) huoao ilia erroneoualy attributed to tobacco over the centurlea. The aecond aubject haa been found more marketable and haa received tbe placeoent eophacla thua far. Id addition, researcb ahould be carried forth oo (c) current aclcn- tlfle opinion holding that no caae haa been proved agaioat tobacco; (d) the many theoriea about cancer cauaea; and (c) the paycbology of hov tbe public la carried avay by over-alaplified reading of acientiflc axperiaeata. All the material reaultlng froa tbla reaearcb vculd b« made available to Intereated vrltera for magatlnea, nevapapera, columna, radio and tele« via ion. Rone of thia vould be for aponaorablp or relcaae by TOC, 457 s^Vv^b^A- % y Z. V. Btrtottt Ctrl Tcoapion' Ifpert tbrovi^ July 31 ^k- Amcm\ 17, W*- rKf tttfche.* rrprrrt rnrt^lnrj'tif "tjji^irt, er you vlll §tt, t:.cjli ke co3iideif<<'TdSiycoaf I6e2ltet-VD<1 receive tts tinl- Bvr of clrculetlen! — F-jvrvCf, yoj rs/ v»nt losr of the oth«P Fl^lliZli* of _tbe To'..bcc; ^tyiuttr. Peietrc^ CocElttcf to fee c" fccve t eor>~. Stouli vou ^eelrc to »sXt cooler •vcUtVlf t» I fo , it 1( tufgtitec thei ycTu cp{-CL6 » note tc the frost cf the report tc till eff»ct: 'Zzt tttachei report It i.ie>.ly co=f l^cirttiil. It Ir rc;ue«tef tLst )0-j rctclL it only for yovir pertor.tl cocddcrttlOD ^ni for tV.T of yojT lanefllttc »teoi>Mef; tlic thft ng td^ltloaal ccplti \ ce or.tc en! t>at t^lt ccyy^j^e. flt;»c_ly_gS»^ ■ — •'. e:: I titu:^^ the ci.r.lrr:.r.cl Ip ol t!»t ^ol&:r& jDiustrj- Keicrc;. Cc-r.lttec, I tfkei f^r t aclellef rersrt fror ^fAiz reletlone (Cjneel In orocr thct X c0al< "b* fully iDforM:: or, \>4 putlie rdftloot tnJ infortstlori projima to dJ>tt. "At I rcid It, It oeeurrtJ to t then voul< \>t Berlt It VrlDct^r xht report to yojr t*.t executlvee of leading tobacco coopanlee decided •one kind of Joint action vas laperatlve In the face of vldely publicized attack* alleging a link between cigarette emoklsg and lung cancer. Repreeentatlvea of Hill and Knovlton, Inc., vere invited to aeet vitb these executive* for coneultatioo ca vays and means of dealing with the problea. At thi* firat aeetlng, it vas agreed that the wisest course of actiee vould be for the industry to find out, through objective research, what truth there vas. If any, in the chargea being aade against it. Mr. Hill stated it vould be a serious public relations mietake for the induatry to aake any sove that could ca::ee it to be accused of dieregard of people 'a health and under no circusstancea could the industry afford to engage In direct controverey vlth its detractors. With tie acceptance of these principles. Hill and Knovlton, Inc. vas asked to reconoend a prograa to ijBplement them. 459 -2- After tvo veeka of IntentlTe ttudy of the problem, public relation* counsel developed a itep-by-step pro^aa vhlch vat dlacusaed at a meeting with a •mall group of public relation* representatlvei of a nuaber of tobacco ccapanlet. Valuable suggestlona vere aiade at thli meeting, and tbe program vaa put into final •bape and auboitted to the principal! at another meeting tbe last week of December. Taking into coneideraticn court ruling Inhibiting the industry frco or- dinary trade association activities, the program recafflsended: 1. Fonnation of an industry group to be knovn as the Tobacco Industry Pesearch Conalttee, dedicated to sponsoring and financing researcb Into all phases of tobacco use and health, 2. Establishaent of a Scientific Advisory Board, to be conposed of distinguished research scientists and educators, and a Scientific Director, to guide the research objectivea. 3. Undertaking of continuoua editorial research Into relevant aclentif- Ic, etatiatlcal and medical material, paat and current, for an effec- tive Information program. It. Keeping the public Informed regarding tbe CcnBlttec'a activitlea. Aa • first step, a newspaper advertiseaeDt outlining the icduatry'i plana vaa proposed, copy for vhich vas aubaitted. The prograa and the public atatemeot advertiaement vere approved. Tb* agreed-upon approach vaa to aponsor genuinely objective research and to brln^ to public attention the fact that there la now no conclusive proof that clgarett* amoking la a cauae of lung cancer or other aerioua problems of huisan health. On January k, the advertisement and neva announcement appeared and tbe Tobacco Industry Research Cccanittee vaa In being, vlth Paul M. Bahn aa Chairman for the first three months. 460 -3- Slnce the Committee had do bea(J Dr. Little alao approved an announcement of the outline of research adopted by the Scientific Advlaory Beard. Dr. Little '• skeleton outline was devel- oped Into a full stateaent for general release to preae and radio, vlth resultant wide end favorable attention. Reaction of the press to such steps has been generally good, as exea- pllfled In a column by Valdemar JCaeapffert of The Fev Tork Tlaes. dean of the country's scientific writers: "The case for and against tobacco consumption as a cause of cancer aay be settled by the Tobacco Industry's Research Coonlttee of which Dr. C. C. Little, former director of the Aaerlcan Cancer Society, is head. Many vlll argue that an lapartlal inveatlgatlon can hardly be expected frcn a body of experts paid by the tobacco Industry. Dr. Little Is an eminent geneticist, a type of scientist who has the courage to face facts and to state thea.' Because of his scientific approach. Dr. Little correctly feels that the industry must sake no controversial statement on ecientlflc matters unless fully supported by facts and approved by the Scientific Advisory Board, Mr. Rartnett as Full-Tine Chairman Final step in the formal organization of the Tobacco Induatry Research 462 CoB»lttee waf th« lelectlon of Tlaothy V, Hartnett, retiring president of Brova aod Wllliaaeon Tot)acco Corporation, aa full-ttme chairman, rather than to contlBue rotating the chalraanshlp. He aaeuaed hli dutlea on July 1, vlth appropriate public announceoent. Throughout the formative period, Chalrmana Hahn and McCcoai provided valuable leadership In developl-^ both the organizational and public relatlona aspecta of the Caanlttee's vork. Mr. Hoyt, with staff assistance, handled liaison, agendas, organizational plans, business affairs, reporte, and materials for meetings of the Tobacco Industry Research Conitlttee, the Scientific Advisory Board, and the Industry Technical Coonnlttee, In addition to developing operating procedures for the research prograa and carrying on continuing contacts vlth the Cooaittee and Advisory Board meabers. Periodic meetings are held vlth public relations representatives of the various ccapanles. Worthwhile suggestions have cone fron member* of this group, both at the meetings and In thelft InterlJB. cmgy puBUC relatiows ACTiyrrns The Information vortt of public relations counsel vas carried en and developed throughout the formative period of the Ccncittee. It includes several categories of activities vhlch will be described in detail. 1, TISC As An Information Source A continuing Important function is to build up the TI?C as a reliable and authoritative source of facts relating to the tobacco and health problem. That this Is being done Is Indicated by the growing number of Inquiries from writers and editors of various publications, newspapers, press services and broadcasting coopanles. 463 At a part of tblt work, tbe building aod salirtalalng of t TI?C library of basic loformatlooal material li In progresi. Preaent oaterlali Include: 1. A croaa Indexed card file on medical and aclentlflc paper* regtrilBg sacking and health that are noted by the H. Y. Academy of Medicine ' In sone 2,500 medical Journala publlahed throughout the vorld. Moat pertinent material Is obtained In full. 2. Basic books dealing with tobacco, Its history, and other relevant technical or general vol'jaea. 3. Special files of all pertinent press clippings. U. A cross Indexed card file on medical opinions regarding the cigar- ette controversy as noted In press, radio and other popular media la cccplled from the clipplrvgs, 5. full texts of speeches, aciouncerents, panel discussions, and slxllar material vhlch are germane and available. 6. Data relating to other related pi-^ses of smoking and health, both here and In foreign countries, obtained froo established source*. This Includes published material from 0. S. Department of Health, Education and Welfare, Bureau of Internal Revenue, Department of Agriculture, Food and AgrlculturaJ. Organization, the Tobacco Merchants Association and the 0. N. 7. Curriculum vltae of Scientific Advisory Board members Is maintained on file, as veil as scoe Information about their scientific vork. II. General Neva Releases Eleven general news atorles have been distributed since the formation of the Conaalttee. In each Instance, direct personal contact was made with major news outlets In the press, radio and magazine flelda, through ataff 464 Bembere In New York and field offices. An Indication of the reeylte has teen In- cluded In tbe photostatic nevs sunsarles that have teen sent regularly to Cccnittee aefflters. The releases were: 1.. Announceaent of the formation of the Ccmalttee, January U, 195^. 2. Abstract of Dr. Bosenblatt's paper, March 17, 195**. 3. Announcesent of publication of "Scientific Perspective," April lU, 195'».' 1*. Selection of Scientific Advisory Board, April 27, 195l*. 5. Research Projects Invited for consideration by Scientific Adviscry Board, May 18, 195"*. 6. Appointment of Dr. Little as Scientific Director of the Tobacco In- dustry Research Coantlttee and Chairman of the Scientific Advisory Board, June 15, 195'*. 7. Dr. Little's stateoent regarding the HaBSDond-Horn Report, June 22, 195>». 6. Mr. Hartnett appointed Chairman of tbe Tobacco Industry Research CooBDlttee, July 1, 195>», 9. Dr. E. B. Wilson becoces a member of Scientific Advisory Board, July 20, 195'*. 10. Dr. Hueper'B talk at Sao Paulo distributed with "Highlights," July 26, 195i». 11. Dr. Little announces scope of research program, July 28, 195'*. Each press announcement is prepared and distributed individually, ac- cording to the type of story. A cese history of soae of the steps taken- on one release is that of Dr. Hueper's talk at Sao P^ulo, Brazil: 465 1. Advance checltlng on the Sixth Internatlon/Cancer CongreBi rtvealed that Dr. Hueper of the National Cancer Institute wai scheduled to talk en "Envlronaental Cancer of the Lung." (Other Information, of course, vas also obtained and follcwed up.) 2. The Hill and Knowlton, Inc., Washington office, requested to follw up on this Information, obtained frca Dr. Hueper an advance copy of his talk and sent It to 5ev York. 3. Study of the paper showed It contained nevsvorthy material concerning lung cancer and particularly concerning the lack of a proven link be- tween lung cancer and smoking. 1». Further Inquiry In Washington brought out that no press distribution of the talk vas contenplated either by Dr. Hueper or the National Cancer Institute. In view of this, permission fron Dr. Hueper vas obtained to distribute copies of bis talk to the press, on his strict condition that this be done only after it vas certain that be had actually delivered It -- placing it in the public dcnaln. 5. Reproduction of the 17-page paper, of two pages of highlights, and of a covering note to editors froo Hill and Knowlton, Inc., and all prep- arations for distribution were made In advance of the talk. 6. Special liaison with representatives In Sao Paulo vas established to give word of Dr. Hueper's delivery as quickly as possible, so as to enable distribution of the talk vhile it vas still nevsvorthy. Hw- ever due to postponement in Dr. Hueper's presentation, this notifi- cation did not arrive until after 2 o'clock Monday afternoon — quite late to begin press distribution. 7. Personal delivery of the Hueper release vas made to important nevi- papers and services as veil as distribution to science writers, edi- torial vrlters and feature vritere. Evidence of use of the material 466 -9- !■ still 'being observed. (7or exaaple, 'Science In Review," page E-7, New York Tiaea, Sunday, A'j^uet 1; INS Sunday column for August 8; U. S. NevB and World Report, August 6, page 85.) 8. Although aany of the vrlters covering the Sao Paulo meeting failed to mention the Hueper talk in their dlepatches, It Is significant that, as a result of the distribution In the U.S.A., stories ques- tioning a link betveen sioklng and cancer vere given vide attention, both In headlines and stories. In some press accounts, the Hueper story took precedence over the reports of Drs. Haamon^ and Wynder, even though the latter vere made available to the press in advance of their delivery on a hold-for-release basis. Ill, Special Assistance to Press, Radio, Magazines and Others This category might include many more Items than those listed since there have been numerous telephone calls and personal contacts made on which the ultimate results are not yet known. Following ere seme exaiaples of such assistance; 1. Considerable source naterial was read and digested to provide facts for a column written by Hal Boyle, distributed nation-wide by the Associated Press. (Hote: Many of the basic facts also are incor- porated in material given to other writers.) 2. Special personal contacts are being made regularly with Time. Wevsveek, U. S. Nevs and World Report, and Business Week editors to encourage use of TIRC material. 3. Through personal contacts, advance information vas obtained that a UP prominent magazine intended to report a grovlng lack of Interest in the TIBC program on the part of participating coopanles. This ref- 467 -10- erence vai reaoved frcn the story wfcen the facts were brought hefcre the magazine editors. \J U. By personal contact, advance knowledge vas obtained of a story on smolclng by Bob Consldtue for Cosnopolltan Magazine. Information vas supplied resulting In seven revisions and five qualifying addl- tlons to the story which vas already In type. 5. Considerable Inforaation and assistance vas provided Donald 0. Cocley In the preparation for his story In True Magazine. This entailed conferences with the author to vork on factual revisions. 6. Further research and asseabllng of material and personal conferences have been extended Mr. Cooley to provide hia requested aid in his vrlting of a l»8-page, lov-priced book for nevsstand sales and angled at the Idea "Tfou don't have to give up smoking," 7awcett Publications Is Issuing the book entitled "Smoke Without Tear." In late August and early September. 7. Personal discussions vlth editorial vriters and the supplying of material preceded the appearance of several positive editorials la the Rev York Dally Wevs. 8. Several other editorials vhlch have appeared In nevspapers through- out the country were the result of information provided by mall or through direct personal contacts by branch office staff members of Hill and Knovlton, Inc. Edltorlsls In the influentisl Wsshlngton papers are an example. 9. Two editorials vldely used In "hooe tovn" dailies and weeklies through- out the country were prepared for and then distributed by the U. 6. Press Association. These were "The Same Old Culprit" and "Truth Makes a Slov Crop." Over 100 clippings of these have already been received. 468 -u- 10. Through personal contacts radio and TV nevsaen and connnentators receive frequent Information concerning TIRC activities. Some of the results of such efforts shew In the press-radlo-TV reports. For example, Dr. Little's press conference vas reported on film on: NBC-TV network, "Today"; NBC -TV and CBS-TV syndicated nevsreel*, UP Movietone Nevs; and H3M Telenevs, both of vhlch go to scoe 80 TV stations. Radio uses Included Lyle Van, WOR; Frank Edwards, MBS network; the Yariee Network; KEJ, Los Angeles and the regional MBS West Coast network; CKIV, Windsor, Ont.; KNX, Los Angeles; KABC, Los Angeles, and the regional ABC West Coast network. At other tlaes, many programs which Indicated «n Interest In presenting TIRC facts sought an Interview or appearance by a TIRC spokesman but these requests could not be filled. 11. One negatively-aimed program (WTffiT) which was being scheduled on the cigarette controversy was postponed after discussion of TIRC facts. 12. Another TV program (ABC-TV, Martin Agronsky) , which did deal with the cigarette controversy, ended on a favorable note after confer- ences with producers and presentation of facts. 13. A special radio script for a Louisville, Ky. radio Interview with T. V, Hartnett was prepared and used. 1^. Conferences were held with Dwlght Macdonald regarding article he was preparing for The New Yorker. Macdonald was doing research on an article that was to be a blast at the tobacco Industry. "Special data" he wanted were "accurate figures" regarding the number of scientists who were unconvinced by charges ageinst smoking. A list was prepared of over 100 eminent cancer experts, each of whom had 469 -12- stated since 19*^8 that, In hie (or her) opinion, no conclusive evi- dence has been establisbed linking tobacco and lung cancer. Other lofonDatloQ also vas supplied. No article by Macdonald on this Issue has yet appeared. 15. Assistance vas provided to the Nev York Tlces for a Sunday Magazine piece which appeared on Sunday, July U, on "VThy People Smoke," which dlBcueeed acme of the nov-abandoned old charges against cigarettes, 16. The Loulaville Courier-Journal story on the Kentucky Heart Association statement was obtained in Nev York froo Loulaville ^y telephone and supplied to the news services, editorial writers and columnists. The story was carried by INS, the Sew York Journal-American and other papers. 17. Early In the public relations prograa, an Informal survey of maga- zines, features and syndicates was undertaken to see what, if any, articles were planned on the smoking controversy, and to follow up in any way possible. Twenty magazines of nation-wide circulation were checked and It was found five magazines were vorklnit on plecet and contact was established with authors and editors. Such regular checking continues as standard practice, requiring numerous contacts weekly. 18. Conferences were held with and materials supplied to Hertha Striker of Coronet Magazine for possible article. 19. Special Fact Sheet on TIBC was supplied to Dr. Charles S. Cameron prior to his talk before the National Press Club in Washington in June. The material was used In his question-and-answer period. At the same time, multiple copies of True Magazine with Don Cooley's 470 -13- emoklng article were eade available at the Press Club for pick-up following the Caiaeron appearance. 20. Special conferencea are held with AP, UP and lUS science writers. Theee have been helpful In obtaining guidance on attitudes of writers, in learning best sources of inforaatlon from theai, and In learning best methods of supplying Infomatlon to thea. 21. Often news releases become available late In the day, when nost "inside" newspaper matter is set. Personal outlets with wire services, including telephoning texts of releases, are necessary to get coverage. Frequently, this means Individualized services, such as the handling of a story on Dr. Little's press conference to International News Service, which was unable to send a man to cover the conference. 22. Conversations were held to supply information to Robert Hellbroner whose balanced piece on the cigarette controversy appeared in the June issue of Today's Voaap. 23. Available material was supplied to Sheldon Blnn of the New TorX World -Telegram k Sun for his January series in the Scrlpps-Howard papers and for his article in Real Magazine issue of May. 2U. Personal conferences were held with writers for the W. Y. Post, which ran a well-balanced series on the cigarette controversy. IV. Editorial Research and Materials Public information for the TIRC has been handicapped by the time required to pull together an adequate body of organized factual material. This applies not only to the current controversy in the news, but to facts relating to many other aspects of smoking, suitable for suggestions for use by news writers, colunmlBts^ magazine vrlterSi and others. 471 -Ik. (The program approved by the Industry In December contained a recoccenda- tlon for the developnent of euch editorial research material and this research Is In process, vlth much of the material now In hand. One aspect of this research bears on public attitudes, but Is not directly concerned with either medical or statistical research. Therefore, It Is being done by Hill and Kncvlton, Inc. research staff menters, and by outside science vrlters. The purpose Is to have a supply of color- ful and Interesting Lnfonnation on hand for writers.) Scoe of the scientific and editorial materials already distributed or still In preparation are: 1. "A Scientific Perspective on the Cigarette Controversy." This vas undertaken before a Scientific Advisory Board or a Scientl ic Di- rector had been naaed. It vas held necessary and urgently timely to present to leaders of public opinion the fact that there was no una- nimity among scientists regarding the charges against cigarettes. Quotations frcn some three dozen research and medical authorities were assembled from authoritative sources In this country and abroad. The Law Conmittee ruled It would be necessary to get t written per- mission for each quotation. This Involved getting clearance, In most cases, frcn the publications as well as froo the Individual scientists. Sone weeks were required to cover this ground, but on April lU, 1951* the booklet came off the press and copies were dis- tributed to doctors, scientists, editors, and many others. The pub- lication has since been used as source material for writers on the subject. It was widely publicized and resulted In many favorable editorials, Including a lengthy one In the June, I95I* Issue of the Weatern Journal of Surgery, Obstetrics and Gynecology. 472 -15- 2. A special pacXet of timely background infonDatlon vas ccnplled follov- Ing the HaaiDond-Horn Report In San Francisco and hand-distributed or mailed to editors throughout the country. Included In this packet vere: Statements by Dr. Little, Dr. Cameron and the American College of Chest Physicians; excerpts from Dr. Weller's report and Dr. Mc- Connlck's statement and an information eunniary on TIBC. 3, A basic Information folder has been assembled to include all im- portant material on TIRC. This Is Intended for hand and mall dis- tribution on an Individual basis to by-line writers on the subject, new contacts in the various media, and others who are plsnring arti- cles. Included at this point are: The original TIBC advertisement, a statement concerning origin and purpose of the TIBC, a "Scientific Perspective," the column by Hal Boyle, the release on Dr. Little's appointment, a condensation of Dr. Little's June 15th press con- ference of the TIBC, press background material, historical tobacco facts. Dr. Hueper's paper, and the release describing the scope of research interests. U. In final stages of preparation Is a Background Memorandua on the Tobacco Industry Research Cconittee, designed to set forth succinctly the organization, research policy, scope and purposes of the group. This will supplement and become a part of the Basic Informction folder and will also be available to answer inquiries about the Conmiittee. 5. "Editorial Canment on Tobacco and Health" is nearlng ccnpletion. (Due to be distributed on or about August 20.) This is a 20- page compilation of newspaper editorials, by-lined articles, and columns relating to the smoking and health controversy that have appeared 473 -16. • ■ throughout the country. Copies of this booklet vlll be distributed to nevspAper editors and vrlters to provide Informstlon and stlsu- late positive action on future editorial vrltlog. Material vas carefully screened to select articles which were well-balanced but at the same time would not unnecessarily antagonize. Peralsslon to reprint was obtained from each publisher, syndicate or author. V. Informational Reports to ITHC A continuing effort is made to keep members of the TIPC and related conralttees Inforaed of current or anticipated events. This function entails the reading and culling of hundreds of published clippings monthly; of monitoring radio progrsuBs; of mail and personal contacts with sources of news or developments in publications and in medical and research organizations; and then determining what is of sufficient laportance for special conniunicatlons to the TIBC. 1. Regular reports are being made to TIRC groups on editorial, news, feature, radio and magazine attention given to the subject. These ccnprise selected pieces that are representative of published mate> risl. Special mBllings of such coapilatlons are made frca time to tlce on specific articles or events. 2. Other iaformational mailiags to the CcBnlttee have Included: a. Advance notice on Reader's Digest article that appeared In the July Issue - May 3, ig?**. b. Report on the Industrial Health Conference, Chicago. c. Report on the article, "The Hannful Effects of Tobacco," appear- ing In the magazine, "New York Medicine." d. Report on the American Association for Thoracic Surgery Con- ference in Montreal. 474 -17- e. Report on the National Tuberculosis Association meeting In Atlantic City. f . Transcript of the Dr. Charles S. Cameron talk at the National Press Club, g. Report on the American Association for Cancer Research session at Atlantic City. h. Preliminary report on the Aaerlcan Medical Association Conven- tion In San Francisco. 1. Excerpts from the Annual Report of the British Empire Cancer Campaign. J. Advance report on plans for the International Cancer Congress In Sao Paulo. 3. Much reporting la done that does not go out In mailings. For ex- ample, leading life Insurance coupanles vere checked as to their plans to adjust premium rates for smokers, as had been reported In scoe press accounts. It vas found no such move vaa conteaplated and this information vas passed along Informally to interested ccmmlttee aemberB aod press contacts. VI. General Contacts -- Nev and Old Personal contacts are advantageous not only In disseminating and gather- ing information but for enlisting support and advice on problems. Rela- tionships established with scientists in connection with the "Scientific Perspective,' for example, helped lead to selection of several members of the Scientific Advisory Board. 1. Personal liaison has been established in such cancer, research, and medical organizations and associations as the American Medical As- sociation, American College of Chest Physicians, American Cancer Society, Sloan-Ketterlng Foundation, New York University School of \ 475 -18- InduBtrlal Medicine, National Cancer Institute, International Cancer CongrcBB" Cancer Prevention CoBmlttee, as veil as vlth Individual doctors and scientists. These continue to make possible obtainliig advance infonnation or papers concerning research belag done in this and related fields. 2. Personal contacts with selected science vriters, editorial writers, columnists, publishers, magazine writers and editors are being broadened, In relation to TIRC activities. This is In addition to normal press relations activities or handling of specific requests and projects. 3. Mailing lists, another Important fora of direct contact, are tailored for maxlffluin effectiveness. In addition to general paper and vire service Hats, special categories are maintained for the Association of Science Writers, medical Journals, trade associations and trade publications, by-line vriters vho have shown an interest in the sub- ject, selected free-lance vriters, editorial writers snd columnists, nedical columnists, and tobacco country newspapers. Regular revision, additions and deletions are made. U. Several movies have been screened. 'Alcohol and Tobacco: What They Do to Our Bodies" (Coronet Films) appeared to present a resl problem, but this has been withdrawn. "One In 20,000" featuring Dr. Ochsaer was screened and several approaches have been made to sell TPC full rights to the film for $250,000 (no doubt a bargaining figure) but these overtures were definitely and emphatically rejected. This film still apparently has not been made available for distribution. A Fox Movietone nerwsreel featuring Dr. Ochsner was screened with • 476 -19- recoaaendatlon of no action. A proposed antl-totacco flla, "Slw Suicide," vas Investigated; this project had been abandoned at last report. VII. Meetlnga -- Calendar, Coverage and Reports 1. A calendar of state, national and International medical and sclea- tlflc meetings vhlch may bear upon the subject Is kept up to date. Information contained In these lists Include the location of tbe meeting, its sponsorship and the persons in charge. Agendas are obtained by correspondence and/or personal contact. ..Whenever desir- able and available, abstracts of appropriate papers to be preseited are obtained In advance. (See discussion of Dr. Hueper's paper under -r.) 2. Individual coverage of medical and scientific meetings such as the AMA meeting in San Francisco have resulted In first-hand knowledge of tbe theories, methods, and personalities of those involved Ir the research on tobacco and smoking, in an avareness of reactions to and ' an understanding of the theses vhlch nay be expected to be advaoced from various Individuals In the future. 3. On-the-spot coverage of these meetings also makes possible securing for TISC such items as the tape recording transcript of Dr. Hasrond's presentation at the AMA meeting, the original press release and of- ficial statements on vhlch newspaper accounts are based, transcripts of papers given and press conferences held, contact vlth the press representatives es well as scientific personnel. A representative at Sao Paulo, for Instance, alerted U.S. newsmen to Dr. Shear's talk, although no copies of his paper were available. (See AP dispatch from Sao Paulo, Pueblo, Colo,, Chieftain, July 27, 1951*.) 477 •20- VIII, Foreign Studies and LlalBon Upon approval by TIRC, Hill and Kncwlton, Inc. aeked Its assoclatea la England, France, Switzerland, Belglun and Holland to submit reports oo the SBoklng controversy In their respective countries. Summaries of these report*, except the one fron England, have been prepared and distributed to TIBC menber*. The British report is In course of preparation. In March, Mr. Hill had a meeting in London vlththe heads of the to- bacco Industry of Great Britain, Including Sir Robert Sinclair, and Messrs. Oppea- bela and Partridge. The vork of the TIBC vae explained to the British group, and certalji suggestions from them regarding the "Compendium" were received and submitted to Chairman Hahn. Also, it vas suggested to the British group that the Hill and Kncwlton, Inc. English associate, Alan Campbell -Johnson, could if desired act as liaison through which the British Industry could clear information regarding devel- opments which it desired to conmunlcate to TIBC. This arrangement was confirmed bj Mr. Hartnett •. en he was In London later in the Spring. 478 -21- A FCRV.ARD LDOt^ Although the industry has been bedeviled by sensational head- lines generated often by publicity seeking researchers and a seeming revival of the anti-cigarette crusade, the trend is beginning to turn. In 1953, no voice was being raised in behalf of the Industry. Press comment was almost entirely limited to a reflection of unproven theories which most people were accepting as proven facts. No balancing inforna- tlon was being rr.ade available. The progress of the Tobacco Industry Research Cotrrilttee's program Is bringing greater acceptance of the industry's sincere efforts. The publicity acconpanylng each step taken so far by the Tobacco Industry Research Committee, particularly since the selection of the Scientific Director and the Scientific Advisory Soard, has helped bring understand- ing that the charges against tobacco are not proven and are not joined In by a large body of scientific opinion. The bolk of editorial comment now appearing approves and, at tines, applauds the action of the Industry. There are, however, many indications that the researchers and associations who have led the attacks against cigarettes are going to con- tinue their efforts publicly and are even more anxious than ever to Jus- tify their position and put their case before the public. Recurrent publicity about such attacks can be expected and is anticipated* It is not enough, of course, to be prepared to answer (or pre- pared not to answer) attacks when they come. It is necessary to continue building a broad base of public knov.ledce of the total story. Progress is being made along these lines i 1. Basic Public Approach. In all endeavors, continuous emphasis is placed on (a) inforning the public of the 479 -23- 4. Special Editorial Material. Especially-written articles are being developed that can be used or adapted for use In various media receptive to or seeking material relating to the subject. These will not be limited to the cigarette controversy but will often deal with broader fields of research on cancer and other health questions. The purpose is to spread a wider understanding of all factors Involved without directly encouraging continuing articles on just "The Controversy." To achieve this objective more quickly and effectively, the free lance services of qualified science writers are being used. ^ 5. Conoressional Information. A congressional information project is being developed, designed to better inform those members of Congress from leading tobacco-interest states whose constituents have a direct interest in the problem. 6. Publicity for Grants. The Judicious use of information con- cerning the research grant program, Just now getting started, will include irmediately the announcement of grants as they are made as well as follow-ups as some of the research gets underway. Proper handling will be worked out in conjunction with the Scientific Advii .y Board. 7. Special Editorial Services. Several projects are ncm under- way to provide special material to v.Titers, publishers and radio-TV producers for work they plan relating to the sub- ject. Among those now in progress are Jack Ratcliff, for story idea in Cosmopolitan; Leonard Engel for tentative (Page 22 is missing) 480 -24- Haroer's assignment} I). S. News and World Report for pro- posed interviews with Drs. Hueper and Shear of National Cancer Institute! Fred Friendly of the Edward R. Murrow show; United Features for a possible series on Dti Kueper's workj Ernie Heyn of American Weeklvt Wade Nichols of Red book and Bluebook; Sumner Alhbum of Newspaper Enterprise Associa- tion; and Pete Arthur of Associated Press Features. 8. Review of Scientific Papers. Recent scientific papers are being reviewed in detail and findings sunmarized in-order to supplement and improve the amount and quality of informa- tion that can be made available. This will be organized according to subject matter (i.e., "smoking machines and what is being done with them" and the like). 9. Continuing Projects. In conformance with the Public Relations Report and Recommendations approved on June 10, activities are going forward in broadening and intensifying press and public contacts; the search for and compilation of information, here and abroad; making full use of material that can be issued as general press releases; channeling background information where it will be most effectively used; encouraging v.Titert and others to regard the Tobacco Industry Research Committee as a reliable font of basic information; keeping the Cornnittee informed on all significant developnents; exercising constant alertness for possible new attacks on the industry or support for the industry's approach to the problem; and constantly evaluating the progress and activities to assure maximum effectiveness and new approaches and action as developments warrant. 481 ^ BILL AKB KNOVLTON. u.c. /«=■, ' r/zfC Ca7< /^Jf jY Ulcu SUBJKT: Tobacco Industry Peeearcb Co^lttee Information Actlvltlea, August and Stptenber, 195'*. The following la a auamary of recent major public relatione projects for the Tobacco Industry Research Ccnnalttee covering August through September. In addition, assistance was given to varloua nevs and feature writers In response to Inquiries. Conferences with Publishers Conferences with several major publishing groups In New York City were planned and carried out for Dr. Clarence Cook Little, Scientific Director, and Timothy V. Hartnett, Chairman. Sessions were held with the following: New York Tlces: Arthur Hays Sulzberger, president and publisher; Charles Merz, editor; Turner Catledge, managing editor; Julius Ochs Adler, vice-president and general manager; Lester Markel, Sunday editor; Orvll t. Dryfoos, assistant to the publisher; Robert K. Pluab, science writer; Luther Huston, Washington Bureau and Dr. Matthew Rosenscbein (an M.D. Like Mr. Dryfooe, be Is a aon-ln-law of Mr. Sulzberger). New York Herald Tribune: Mrs. Helen Rogers Reid, chairman of the board; Geoffrey Parsons, former chief editorial writer, now retired Into a conaultlng capacity; Luke Carroll, news editor; Earl Ubell, science editor. Scrlppe -Howard Newspapers; Jack Howard, president, Hearst Consolidated Publications. Inc.: William Randolph Hearst, Jr., president and publisher; Richard 1. Berlin, president of the Hearst Corporation (the magazine corporation); Clen Neville, editor. Hew York Dally Mirror; Frank Conlff, chief editorial writer, Hew York Journal American, and assistant to Mr. Hearst; Seymour Berkson, general manager. International Kewe Service; Sam Day, managing editor, Wev York Journal American. Luce Publications: Roy E. Larsen, president. At each conference Dr. Little outlined the scientific approach being devel- oped by him and the Scientific Advisory Board and made clear the freedom of action given the Board and research grantees. Mr. Hartnett explained the industry's long-range Intention to support a research prograa devoted primarily to the public Interest. Each session resulted in Interested questions and lengthy discussion, both of the Industry's problem and of the scientific soundness of the Tobacco Industry Research Connlttee approach. Constructive suggestions were made 482 on the approach to the public InforBatlon program. There waa alao ex- presalOD on the part of the publlaher-partlclpanta that the aeeiloos had been moat helpful In clarifying the Tobacco Induatry Research Committee program. Edward R. Murrov Televlalon Shov Continued asalatance has been given to the ataff of the propoaed "See It Now" program being developed for presentation later In the fall, the exact date not yet aet. A conference waa held with Edward R, Murrow, Fred Friendly, bla producer, and Arthur D. Morae, reeearcher and writer, at the Tobacco Induatry Fe- aearcb Committee office* In the Empire State Building. Mr, Hartnett and Dr. Little were In attendance, In addition to representetlvea of Hill and Knowlton, Inc. At thla conference Mr. Murrow m&de clear hla Intention to follow through on the prograa, end Indicated the only pcxlblllty of hli dlecarding It would be the finding that the material collected waa not suitable for telling a good story through the medium of television. The Murrow staff emphasized the Intention to preaent a coldly objective pro- gram with every effort made to tell the story as It statds today, with special effort toward balanced perspective and concrete steps to show that the facts still are not esvabllahed and muat he sought by scien- tific means such as the research activities the Tobacco Induatry Research Coomlttee will support. Mr. Murrow was ssaured of continued cooperation from the Tobacco Industry Research Camilttee to the extent possible under the scope of the TIRC program. In fulfillment of this assurance, Mr. Morse waa aaalsted In visiting the Jackson Memorial Laboratory at Bar Harbor, and In Interviewing Dr. Paul Kotln, University of Southern California, Los Angeles. Included also was the filming of a sequence of Dr. Kotln In hi* laboratory In Cali- fornia. Arrangements were also completed for the shooting of separste sequences with Dr. Little and Mr. Hartnett early In October. Magazine Articles and Wrltera In addition to routine contacts or conferences, the result of which are not yet certain, the following can be reported: Investor's Reader: Pereonal conferences were held and material Supplied to Kiss Anne Holden, staff writer for the Investor's Reader, pub- lication of Merrill Lynch, Pierce, Fenner & Beane. The article appeared in the September 6, issue and although primarily devoted to financial •- nalysls of the companies, Ita references to the actlvlilea of the Tobacco Induatry Research Conmilttee were well balanced. Harper' a •■ An article being prepared by Leonard Engel for Harper's nagazloe waa re-scheduled from the November to the December laeue. Mr. Engel continued to use TIRC ss a source of Infomatlon and. 483 near the completion of hlB vrltlng, waa put In touch vlth Dr. Kotln, at Mr. Engel'i request, for Information concerning proved carclnogena in air pollutanti. Engel'a article vill not he aolely a defenae against the cigarette attacks, hut will atteapt to analyte the charges In the light of the widely prevalent akeptlclan concerning the extent to which cigarette emoklng can he Implicated. On halance It should lend weight to the Industry's contention that there Is no proof of the charges and that there are many other factors that enter strongly Into the Increasing Incidence of lung cancer. Current Medical Dlgeat: As a reault of dlstrlhutlon by Hill and Knowlton, Inc. of Dr. W, C. Hueper's tali at Sao Paulo, a condenaa- tlon appears as the lead article In the October lasue of Current Medical Digest, which came off the press at the end of September, The Wllllaas and Wllilns Ccopany, Baltimore publlshera of the magazine, Bays that the publication reaches the 123,000 doctors In the country under 65 years of ago who are In active practice. Special conferences were also held with Jules Blllard and W, C. Bryant, U.S, Neve and World Peport; Art King, TV Age; Marguerite Clark, Neveweek; Lawrence Anderson, Ajierlcan Press. Hevepaper Writers Washington Poet: A feature story by Nate Haseltlne using long excerpts from paper by Dr. Hueper, which was supplied hla In personal contact through Bill and Knowlton, Inc., Washington office. International Wews Service: The Sunday feature story distributed in mid-August by International News Service science writer Jack Ceiger was developed primarily fron the Hueper talk, Aesociated Press; Through Pete Arthur, feature editor and Alton Blakeslee, science editor, material has been supplied for the basis of an Associated Press feature story, or series, on the development of the To- bacco Industry Research Committee, Two sessions with Dr. Little were set up for Mr. Blakeslee to get Bore background for the article. The piece awaits a news peg before being completed and sent out. Wev York Post t Post-Hall Syndicate; At the request of Column- ist Sylvis Porter, considerable material was rounded up and made available concerning Internal Revenue Service figures on cigarette manufacture and removals. Miss Porter was also referred to Harry 8, Wootten for further industry information which she desired concerning cigarette sales outlook. Science Writers Personal contacts with science writers for general purposes as well at for specific assignments were expanded. Included In personal contacts were: Alton Blakeslee, Associated Press; Jack Ceiger, International News 484 Service; Fobert Pluab, Kev York Tlaea; Earl Ubell, Sev York Herald Tribune; Folsnd Berg, Loclt Hagailce; Marguerite Clark, Revaveek. In addition, a nunber of vrlters were Intervlewd for reaearcb reportf, looking tovard possible magazine articles. C. B, Colby, free lance popularlzer of science, vaa retained for research and possible vrltlng of article concerning all the hazards of modern life vhlch people are cautioned agalnat and leading to the conclusion that la spite of all the health acaree, 'Tfou Still Live Longer." Robert T. Miller, an experienced researcher, vrlter and public relations man, vae assigned a research report on the vide range of things common today which are suspect as carcinogens. A tentative agreement was reached with another writer to popularize the technical Hueper paper but this has been postponed. Special conference was held with Pat McGrady, science editor of the Amer- ican Cancer Society, who has been critical of aome of the material Issued for the Tobacco Industry Research Committee, specifically the "Scientific Perspective" and Dr. Hueper's paper, Mr. McGrady was informed of the great precautions taken prior to the preparation and distribution of botb of these. His objections were also checked informally with other science writers and there appears to be little agreeaent with Mr. McCrady's posi- tion that these materials should not have been issued. Material Issued An announcement of Dr. Julius Ccnroe's addition to the Scientific Advisory Board was released to the press on August 19. Two other releases were prepared for and are awaiting clearance by Dr. Little and the Scientific Advisory Board. They deal vlth the statement of policy on research grants end a news announcement on the issuing of the first grants. Three statements by Dr. Little that could be used In the event • press ccDDsent is needed were prepared and are being cleared vlth the Scientific Advisory Board. The booklet "Editorial Comment on Tobacco and Health" was distributed widely to press and information leaders. Some strategic use of this material has already been noted, both In the press and on the radio or TV. Mailing and Lists A special mailing was made to selected papers in tobacco areas in l6 states. This Included a letter informing the editors of material avail- able concerning the Tobacco Industry Research Ccunittee, a copy of the "Editorial Caaaent" booklet and the "Scientific Perspective." These same papers will be Included in future distribution of releases and background material. Special lists were also prepared on radio coomentators throxighout the country who have been noticed as devoting more than passing Btte7tlon to the tobacco and health issue. Hill and Kncrwlton, Inc. lO/T/Sl* 485' »rpraiterM,l»M I*-* KCMOaAlOUII TOi Mr. TbMUy T. brtMtt ^faO«j Vcki W. Mil : „ X.' I-. ri-' t' *- I. -44 • :. ^. f %. ■ P" • vy'«*.tTi» 'ft£i Titfiini Mmittt fcr i»W . -a m A-n vV^ «(^'»i t-' < r;.r.> Ix-ihu^ . JUtxUd »j«Vidn( wtlwilM for «p«nll«u ml tW T»bft«o« Mastry tMMirek CooiMiaM 4uiaK Ui eaiaakx fMr UU, TW W%«t f«r yidblid Uf«rsAtlM MtlrttlM r«C>«U Ui LaerMM^ MttTHI«t mai«e»**sMr7%7 cT««lj|(pr**« - -« 'TW bsjfot t*r (teff optrttlau prorliai for tka *»• ml uilffui rfttt tlm« «ii\nt pr«Tld»i f«r •■< ftdditlatl tttJI mmmhmi U fts«lj( «d i vrttlBg, •^ttarUl r«*«4jeh i."^ e«r«r«^ ml xiUitlfle ft»d baAaaI ED««tla(». iBlorsAtloMl t^slatuoe to otter orxuluttaos lii«r«at*d U WlpUg vttk tb* >#kU4 •4*o>tlM pro^rAB U r«a*ct«^ tn tte b«d(at far tUid cCDom ud to tacrmAMmi prvrtsioa {«r trsrtl •tya»»». ru b«dK«t tfr Prlatlaf , BooU«ti. ate. U i^Mn at f7«.tM. TUj 99*v tkTM Uit»44»I«M^&«Bi. tte flrat «f tWs WUc • UeHmt 4Bwrthlj« tte r«M&r«k yr«cr«JB ml tkt TabAOM hdajtr; K«M&r«k Cwinittt— , TUj wobU W p#>llsk^ to fummiM if M«, MO to «r4n- to mmrrmr all 4oat«r», mImm vriurt. m4ilort nd •dtt«rUl vrtUn b»4 ts prmrl6m a n»^ araltokW tar Attrib-^im A k^otU at b*Am1 aad aotostlfle aiMCtofa. Tto B«^l«t bad^ alM pro^det for a s[«aatl«8-«ad-«a«v«r beeUst, nujtiij 1«9,MI, t« bt Aljtr1b««d t« BM^cAl. toUatiflo, •ai«rUl aad ethar cr'V** TUa voali aerar tka ff^)Mt af tcbaoeo aad W^lth mar* brvadly. cl*toc par- I aa tkc fommmmi mmUrmimrtj, / Tba tUr< tt«a la prvrlalaB tar a vlda malllM af «l Uaat mm r^rtot af n tsportut aad balfM arttole aaob aa tba Laeuo'd Bn(al ytaoa to tW Daoambar Utw af BA&PEE^ lb«ulac, vblcb la a«T«r«d m4«t tba aatlinitail mj^m^mmt for IIM. The reprint to be mailed In 1955 has not yet been selected, of course. to ^**^^j»_ foa will Mta tbat tbtrt ar« adifltlanal r«««mm«a4ad projaota. TVa fir at lt«iB U PM.HO for aoa aatian-wlda a4i'artla!a^^r*»orttot to tke p*- Ue it tba •aTaTllBC'a flrat yaar. Tbc'aaoaodprarlitoa U for tvo aAfltlnail 486 Mr. TlBathjr T. pr«MBtia( fcne «r Ua aiMllsat ba^Im} ta4 wtlcatlflo bformatlM if « tolyfil aitvrt wVLA kut»o>at ft^vIUhU tn U« put cicU B«tiA, u4 « a*r« ltxKit»4 booU«t U»»4 M Urtnbla •4ltt«rUl AtUatlM U Ub«M« tad kMlftk. TVt rsprii* b«d(«t tUoestkb VMM b« «m4 t» glv* wU*r vljdklltty U tMtlMr •ill^ «r apM- f«( M propoMd. PlMJt W( tta kB*w If ^m m*4 csrtkUs futhar (r«a «^ ••• <", ■'. 2 vif/ . ;^ « li- U- t.r C. ;■ ». ..•.:/. ...I':.. ' ' '-^ ' ■ t : >■>■'■' r. .-■ l.r;: t,. 1.:.. * .1 i- .■ I.- r- Mte %: an }«Wv i ■• e- . . J^.'. ( .. . I. :: : \ ■ -' * ■ » ■ • ' »" . - '■ ' 1 . T ■ , « ■-. • I • V. .;•• ; < i... U i • T- .. sLi i . « ,, . c^: : f -.•.. .. it .•- ■: ■ :.:.:.' I.. ; 1 I . : -■ t. ■ , 487 aiLL A.vT> KSOVLTON. inc. COHFIDEHTIAL Fl'SUC RELA7ICNS R£?OBT to the TOBACCO IKDUSTRY PiSEAPCH CCMMinSE April 28. 1955 The foundation vhlch the To"bacco Industry Research Cnrm1 ttee has 'been 'building is gaining strength in bnDth 'breadth and depth. T^e progress of the scientific prcgraj: develcped 'by the Scientific Advisory Ecard is an essential end pervading force. IV.e sound approach to the prc'ble^: by the Scientific Ad\-lscry Beard has encouraged other qualified scientists to speak out courageously in questioning those vho would liTlte off the lung cancer prcbler: as a 6~.oid.ng pro'blea. Of necessity, efforts to bring the kncvn facts 'before the pu'blic continue to be in the nature of an educational caipalgn -- slow, unsensatlcnal, factxial. Neither the clrcur.stances nor the available loforsatlon lend themselves to the sensational treatsient accorde;! the aajor indictments of tobacco 'jse. Factors Show leproved Position Nevertheless, progress has been made. On the positive side, these factors stand out: 1. Tne first "big scare" continues on the wane. Eiere l8 much general awareness of the big IF factors Involved. In sooe In- stances, the accusers have gone to such extremes that their credibility is being questioned by their colleagues in their own profession. 2. The research prograr. of the Tobacco Industry Research CoEstlttee has won wide acceptance in the scientific world as a sincere, valua'ble and scientific effort. IVils is due prL-narily to the stature of the men serving on the Scientific Advisory Board, the soundness of the research prograia developed, the csiliber of research so far approved, and of the investigators receiving grants. 3. The status of the Tobacco Industry Research Cocaiilttee Itself has 'been eahanced by the freedon of action granted scientist*, the increase to $1 million of research funds, and the o'bvlous sincerity of approach to the probleris. Both goverrxentel and institutional groups in the field of health have shown recognition of the contribution the Tobacco Industry Research CcDilttee is making. -1- 488 1». Ther« It greater aod growtog expression of the position that cigarettes do not and should not stand convicted. TMs Is evident In both the scientific and lay canounltles. Su£plelon Is still wide- spread tut the lynching party seema to have been called off, at least teaporarlly. 5. Treatment of the cigarette-health Issue In puhllc media cottlnues to Improve fron the Tobtcco Industry P.eeetrch Coraalttee point of vlev. Even adverse stories dov tend to carry modifying stateiCDts. Positive stories are on the esceEieiacy. They may not alvayc be In the places we wc -d like to see thea and they may not always say the things we would like them to say. Put at lee^t they are now showing up aad they do cast doubt on the clgirstte attacks. A y»ar ago attacks pre- donlr.eted and they were generally limoderate. Issue Being Kept Alive On the other side of the ledger, vs have to face up to these situations: 1. The clgtrette-health issue Is still considered top news. This is often more arpexeDt at a local level thai In national cews. While there is a growing tendency to enphssize the uncertainties and disputes in the issue, the end result Is to keep the controversy con- stantly alive. 2. Medical, dental and other groups continue to schedule cigarette-health discussions, oftentimes for the apparent purpose of stimulating interest In their me'tinge. 3. Anti-tobacco crussdere continue to ride the health Issue. Our clippings show coctinual local activities by the Anierlcen Teiperaace Society, the Seventh Day Aiventlsts, and slallar groups scheduling lectures and movies dealing vlth the cigarette and health issue. Dr. Ochsncr and Dr. Wynder continue to be the leading ertl-tobacco crusaders of stature In the medical and scientific world. h. While the Anerlcaa Cancer Society has t*tcper*d Its ea- phasls on the lung cancer and scoklng issue so far as its national fund drive pjbllclty is concerned, It continues to play up snokiag and lung cancer in its literature. Local groups also use the Issue, particularly the Hanaond-Hom findings, in their fund raising drives. 5. An Increasing n'Jiber of scientists and researchists are anxious to report on their works InvoTvlng cigarettes. Of late, most of these have been anticipated and, when cecefsery, steps are taken to deal with the findings. Th»3e reports Include studies on the relation of tobacco and heart as well as tobacco and lung cancer. -2- 489 (Page 3 is missing) 5. A 6,000 vcrd ffiAruserlpt by^oha Pfelffex. vell-kflOVB science writer, bag teen prepared and rs now in process of preparation for vide use. This discusses the "?lght Against Luag Cancer," vlth til elements placed in perspective. It is designed as the t&sls for a T.I. B.C. docvcent and for other public distribution naterlaJ, for articles and for policy stat-enents. 6. Cleeraaces are continuing for a possible brochure of nev8 rejcrts of doctors and scientists who question the cigarette link or express reBtrvatlons about It. It Is felt that publication should not be rushed, but the material Is kept up-to-date for possible quick lEBuaace. 7. Current scientific reports are screened as they appear for possible Inclusion In a new scientific perspective, as well as for adding to scientific files for special reference aiid distribution. 8. Peprints of t^eJA^A^ITjirilcle by Dr. Williaa Plenhoff are being wldely_jdlstrlbutea ty-iBiljIi ledla through the publishers of Pageant. A news notice sijciariiing the article was widely released by the iLagazlne. 0. The article by Dr. Herbert Arkln appearing in the April Issue of CUFJU^n MEDICAL D1G£ST Is being reprinted for broad distribution. 10. Kewo releases 0: aaao'dscenents of grants and Increase of the research funds to $1 million were widely published. A special article concemlE>g partlcipstlon of the Medical College of South Carolina was prepared for and used by the CHAPLESTON NEWS AND COIjBIER. 11. Infontstion wts supplied for the article "Phoney Cigarette Scare" Id tie March 23 lesue of PEOPLE TODAY; for "A Psychol- ogist on the Cigarette Scare" In the April issue of PCPllAS MEDICINE, and for a piece scheduled for the Aug-jst lesue of ARGOSY nagtzlne. 1?. InfonLstlon supplied to TV station KAIB In Alexandria, La., was used April 17 when Dr. Ochsner appeared on a local program devoted to a review of his book. Fevtews from CALIFORNIA MEDICDJE and the A,MESICAN PUBUC HEALTH ASSOCIATION JOURKAL, as well as Dr. Rlenhoff's article in PA^IIEAirT, provided inforcatlon for the rebuttal. After considerable negotiation, recent permission was obtained to distribute to radio stations recordings of a panel dis- cussion on the problea."; of a^ng, featuring three doctors, including Dr. Elmer Hess, president-elect of the A:ierlcaa Medical Association, in which the question, "Does Smoking Shorten the Average Life?" was inter- estingly discussed. 490 13. Ttt book, "Why stop Smoklag?" by Albert Ostrov bas been offlcladly published axid first prcootlon started In Chlc| lest Prldey. A special press release C(X=enting on the book has prepared by the jrubllsher, E. P. r>utton for distribution to press «ji3 radio stations throughout the country. Most recent information is that~ the book has already gone into a second printing. lU. A proposed syndicated feature story devoted almost entirely to Dr. Wynder'e opinions and research vas checked by the editors for additional facts and InforiEatlon. dls story is being held in abey- ance pending possible develoineDt of a series. 15. The Public Affairs Ccoalttee pacphlet by Pat KcCrady, science editor of the American Cancer Society, has been Is- sued under the title, "Seeking : L-oag Ctncer?". Though the contents are not cor.petlble vith T.I.B. C. policy, they vere~greatly and .help- fully modified from the~orlg'.D&i canuscrlpt. A n'jcber of outstanding cancer scientists contributed s-^gestlons for editing this manuscript and modifying its original string indictment of cigarettes. 16. Gathering, analyzing, preparation and distribu- tion of various materials continued. The Research Prograa booklet was mailed to all doctors and scientific Journals and institutions, in- cluding the membership of the American Assocl'-.tlon for Cancer Research. Reference files of relevant abstracts froo pertinent scientific articles are being augmented for a vide variety of uses, 1 ^cludlng Individual requests from students and scientists, newspaper ad magailne vrlter*, and Industry members. Useful magazine and newspaper articles are re- produced, when permission is obtained, and made available to public lofonnatioD media. OlfTLOOK FOR lyySXlKTS. FTTTURZ At this particular moment, the immediate past looks better than the lansedlate future. The next major public problem vlll be the second Eammond- Hom report. IWs Is now scheduled to be given before the American Medical Association meeting frcn June 6 to 10 In Atlantic City. There la no reason to hope that the second report will be in any way better than the one last year. There is no reason to hope that It will not result in wide- spread attention In the press. The A.M. A. meeting this year is closer to the major news centers than it was last year in San Prenclsco. The progreni of the Tobacco Industry Research Connittee should help neintaln press and public perspective on the findings reported by Drs. Hanmond and Ham. 4dl PROPOSALS FOB INC-SDIATE FVTJRE The To"bacco Industry Pesearch Ccmlttee first appeared before the public with an assurance that the industry Itself would assume leadership In research into all aspects of tobacco use hni. health. Die Industry is now moving into a position of leadership. This brtngs with It a greater responsibility to the press and the public. The T. T.R.C. will have to live up to the expectations it has created on two fronts: First, by pushing ahead soundly but steadily to get at the facte through widespread scientific investigfitlon; Second, to report to the p'jblic where it stands in the search for the desired infonaatlon aYout cancer and its causes, as yell as the relationship of tobacco use to ether phases of health, and to describe to the public the nature and scope of T I.P.C. -sponsored resesLrch. This calls for a core active and outspoken position. No longer can we expect the press and public to accept the terse cosment that "nobody knovs any answers." Positive steps being planned end recocnended for the ijnnedlate future, in brief, are as follovs: 1. A strong affirratlve report in mid-May by Dr. Little of vhere the problea stands today and what progress has been inade through the efforts of the T, I.P.C. This sho'ild be a prepared statement dis- tributed to the press and accccpanled by a discussion vlth Dr. Little, science and other vrlters psj-tlclpatlng. 2. Carefully spaced distribution of basic inforoatlonal material designed to implemeat the position set forth by T.I.R.C. This vlll Include: a. "nirough PAGEAJTT magazine, the article by Dr. Bienhoff is nov going to important InformAtion mfdia. b. A reprint of Dr. Herbert Arkic's article analyzing the Haanond-Hom methods, vlll be reedy for mailing to media the latter part of May. c. A special report of the fight against lung cancer -- the Pfelffer manuscript -- which vlll put the cigarette issue in its proper perspective. This should be set for scr-.etlme in Kay or June. d. Beproductlcns of nevs reports quoting prcninent medical or scientific figures vho caution against condexnlng cigarettes on the basis of present evidence. e. Announcement of nev grants bringing the total to more vlth Dr. Little's press conference. 3. A strong positive statement is being prepared to serve as the Tobacc^lndustry^esearch C^t^ee;. cc^jnt o-^^e -^Ha^ond-^^^^ Horn report. This should be e statement ircm .-ur. ^^^ t the affirmative approach. 492 V.-lk'rivbi+l.^i,;. ■,•■;:.•••,. •', -> ••» , <---■..■■• , . \ ^ b( :^ ^ •■ i mtsirv * the foUcvin^ i« a jxsAan 6f the statos of cerUlA st«pg ' belAe taVen in vzticiieUaa of the ^oae 6 jTCBefitaUOA of tha ctcood Easaocd-Hooni rtport e^t AtlasUe Cltjn ', ■ . 1. teprlots of t2tf 2r. WteJboff article la PLgeejit ttrt ' . riftilad OD Mfijr ^ to cnar co^flete llets of sr.Mie L&fara&tlan aedia« ftlrly ffxA ttVBje^pcr rtsjceiz^, both editorial aad &evij h^Tt al» reaiSy Wea »5tlced. £. fir* t rcjorlatf froa the ArUa artlele ta CuiTeiit Melieal Digest v«re Bailed to ov eoajplHt liate* thla ¥aa a foUovup %9 the crlgiaal ^ihUeatlOD of the artiela «&A yv-eas rtle&ae vhleb vu aast out ^ the tl^est at that tiM* - ^. Aa aaaouuijeaeat of g^aatSi trlacla^ the total to dat* to |J<^,000, 1* t«lac le*ep&red tor releue Vednecda/, Jnaa 1, vlth ^ ttantn^ leheduled for Triity, Usj £?• 5* llecordiags of the *Qrovla£ Old Byoio^vr,* featviae • dliextfaloa oo BaoMn^ vlth tbr. Bess, etc., vhleh vc all have beard uod trvaserl^ts of «hich ire here, ha^t be«& seat out to eertaia tf radio statiOQfi aAl cose rejco-t of their use, or latesded iifi«| ha.?9 alread/ beea redeired* <• H^rlaf report oa I^. Little*s tress ecofereaoe yna ^ |v«p&r«d for the radio-TV oevs service, AIR LIES, aad dlstrlt«tod throu^ that oreBnlxatlcft la their aervlee of Uz^ 00. 493 1 W V » T» Tw ^tortalj art »cl»Auled for Airtrlb'ctlon "hy tb* tr, p. IVeet A5«y1rHoei« fce first U • brl«f emzxij cf fir. • >f7Qrt« Tb« fte^co&f schftSaled tat M» 9xsm fi wbIUm of t^ r»» ' ■S, Effort* bftvt U«A eadc fco Irorld* »11 t3i« ftMUtttftf .-- ft3C«lM« lA nklM t2)« tan M;^r9V thorn, •ch*dtiled fcr flsf 51 aal Juat T# •» ti««l7 *oa potltlTt M jo6«ibli. ^4 Arrsn^eaeate bcTt be«a Bale »- «z3d VlU W «9T0r«d lA det«il toler li wpaxete Baooreaaua — far traMcrlbJjvg l^rtlneil ■ " ItctlooJ of tLe IhsTcir ibov t£r;edlst«X3r efW ii« jresnUtloa, &nl prondlxg eoplM of tli««e trsaacrlrU to taj« orw wU«ti 1* Eer Tort earlj la ti* »aniifl« foUcvla^ tbc fliaf*, 10. ArrBBsesenis tere t>e«a nale for •O'vwa^ flf th« iLlCA. Be«ti£as> LceloUxg th« e7=j>O0laB «t th« ib«rlc«n Colle^ of Cbcrl fhj-slcLsn* Iji Atlantic City ca June 8, tblch nil Ificlirli Br. OchrtacT aaong tii« jartlcljcnts. : ]>cns7>d £ahn {Jxju to go t« Atlcatie City, fbaxrtSMJ, . June tj eftS rrtura Tuftelay, Jvoe 7* V« hrre %eea «£«Tired thst W vULl W clTss preM prlTlUgM to iitt«iid the rsrlajB atsftou (errsafied throu^ B«a flHlc la Chie&so)* Xs kddltioa« Jftck 6ei4sr ylJA« to «tt«nd tb« BMtlaf Vot «XB£t •rrBzi£eaest< for Mjc here ftot )net be«n rrnflraa^t . ' II4 tnfta of the tt&teseat to te isewd ct the tls* «f the BaEnE3Skl-Earc report are la jprejcxutloD «-> csA jrobthl/ «IU coDtlaue to >e Kp ustU \i» luX alauk*. th« foUovlnc core 1*m lirvctlj r«lBtaAt IE. Tbt proposed Irgocy ^tce, ty ttLck l^eddy, U ear •chelnled for the August Issue aal tt» latest rerlKlOQ vt hsT« •e«a la proof foos chovi that it vUl be «b ertreoely yxltlvt is. A ner sajniiae entitled Ifcle tXltetreted wrrlM » jodtlTC plec« Vy Albert Abeatenal* tols is the first i««t» of tbttt '^s^'^r^ aad It 1« bela^ distribute bj the Aaarleaa Ben Oaqpaoy. Cm asthor Is t!^ mbw ■s'l vbo adite^ (f ) trot* (t) the place that a^p^rel a couple of Bocths a^o la Foj^ilag KollelAe* 494 J ^ssLi: • • • * . . ^ 15* A Tfopj^irifl TcnloD 4f tbs Pf«i£f« flAM baf teat f ojaaUOD Is fcvEllfi^ile cq lt» rtaVus. .^ ' X$. S5a« yrojottd 5r. Btrry Or««ae V>3k be^ !>««» rfadttaA to i^ ebalrasa of tbe Ucr Coinltte^ for ca ojlixioQ e« to. TIRC't dlitrlUrtloti of this. Vten Jribliehdd, io tdeattflo *Bd jsihlio Uljrzries. ?lilt book coralA jrdbeUy hit Itte in ibe fall if wrtrj* t2iljQ« goftft JFsll — especiUl/ vith »r% 8hit«ei4e« 17, lo dftfUlte sorrM bATt l>«ao n&le |ret cao£>rai£c tbt liQeelWUtjr of a jroolutst eUUcUclaa (ArtLnJ) for »e K^'0\^XTOK. inc. 495 ■ - 7?^C /fn ATTACaaC #1 CONFIDENTIAL . j^ PUEIIC RELATIONS REPOST to the TOBACCO EOUSTRY RESEARCH CO"WITTEE rtbruary l**, 1956 Oi^eral Introduction The period tciiedlately aieed vlLl produce a considerable nuiber of scien- tific papers, medical meetings e::d public statements both generally and specif- ically concerned with the 8ubje:t of saoklng and health. Additional reports, ceetlngs, bocks and articles v-11 focua etlll r.ore attention on this subject in the next four nonths • With respect to this increased activity, hovever, two points should be recognized; 1. A large proportion of the attacks against smoking made recently, and expected to continue in the next few montha, originate with the same small group of critics vho have led the acti-tobacco moves of the past tvo or three years. 2. Neither the press nor the public seeas to be reacting with any notice- able fear or alarm to the recent attacks. This outlook does not vej-rant any attitude of complacency In our putllc relations approach, especially vhen ve consider what could be the impact on the public of a possible announceaeat (which has been r\nored) by researchers al- leging that they have Isolated and identified a carcinogen In tobacco. Also, it is not possible at this tine to assess fully the probable Impact of federal government reports and activities that are Indicated In the months ahead. With a nucber of grantees at or near the stage of public reportini; on their research to d^te, the cciduct of the Tobacco Industry Research Cociittee will be closely scrutinized bv the scientific world, as well as the press, as to the stand and attitude ass.=ed toward those reports . Protection of tr.e in- tegrity of the industry's position in this regard is vitally necessary, and con- clusive reaffiraiation tr^t trje freedom of thought and actiOH hfls been given TIRC grantees can be rewarding. Our public relations efforts will continue to be directed toward: (a) keeping the press well inforcei of the balancing aspects of the situation as new attacks arise, and (b) increasing the prestige of TLRC's own efforts by showing that TIRC Is helping ta gain the needed facts through adequately fi- nanced and carefully planned scientific research. The research program of the Scientific Advisory Board has now progressed to a point warranting fuller description of its acconplishments and alms within the fields of science and rceiicine. With the val-jable guidance and assistance 496 2. of Drs. Little euad Hockett, steps are beljig worked out to give doctora aod ecl- eatists greater knovledge of the scope, coopositlon and nature of the prograa. Mea::vhlle, the TLRC contlnuea Iccreasingly to benefit froa the leadership which Dr. Little, Dr. Hockett and the neicbers of the SAB are providing. Dr. Little's forthconilng editorial and speeches vlLl he a further contribution to the prestige of the TIRC research program. The Recent Months A factor that has beccnae more noticeable since the last TIRC meeting Is that, more and more, doctors and scientists are voluntarily speaking up at med- ical meetings to express disagreement with the flat charges made against to- bacco. They do not exonerate tobacco but say that the case against smoking has not been proved emd that much more evidence Is needed. Another aspect that also is becoalng more appejent is the greater emphasis being placed by scientists in this country and abroad on the role, of air pollu- tion as the major cause of I'-ing cancer. Two recent scientific reports on air pollution and health received national newspaper attention. The subject is be- ing treated by the press as a new, Interesting and important phase of the over- all situation. Meanwhile, reports adverse to tobacco froa two major sources, which pre- vlo-osly received much publicity, were largely ignored by the press In recent months because of their apparent failure to contribute ajiythiog pertinent or different to the problem. In England the sit-jation as regards the press appears to be quite differ- ent than that in this country. Tnere is frequent and increasing mention of at- tacks on smoking in. the British press. Tne Future Smoking and health vlll be the subject of many papers and sysposla at scientific meetings during the next several months. Sane of the papers vlU be given by TIRC grantees, one of whom is scheduled to present an exhibit and paper at three medical meetings. Several grantees have submitted papers on their re- search findings to date for publication in professional Journals. Reports by grantees, whether they are made at meetings or appear in scien- tific Journals, may lead to requests from the press for cement by TIBC. Re- gardless of what the reports say, TIRC Intends only to restate its guarantee of canplete scientific freedom to thos*" who have received, and will receive, re- search grants. Such action will en.- ance the acceptability and sincerity of TIRC '6 research prograa with the scientific world and the public at large. Several TIRC grantees already have presented papers at separate medical meetings but none received any press mention. Meetings at which smoking and health are expected to be discussed: 1. Feb. 2U, Long Island sub -section of the American Chealcel Society, Brooklyn. The entire day is devoted to tobacco. The morning session, to be 497 (Page 3 is missing) H. 3. The NCI la dolug a retrospective atudy of lun^ cancer aad emokla^ hab- its Id women. k. Dr. Wynder, la coHaboratlon vith a etatlsticiaa at the Hational la- BtltutoB of Health, Is reported preparing a paper from Wynder'e material relat- ing to lung cancer etatietlcB In vciaen. (This n^y be one of the paper* Dr. Wynder vlll present In April.) 5. The Veterans Administration study Is continuing. 6. Tvo govemnieat health statletlclons axe studying old VA records vlth regard to influenia, gas exposure and other respiratory conditions of men In World War I. This study vlll be coEpared with the VA study. 7. The NCI Is considering a retrospective study that also vould make use of the Census Bureau survey. T-ls would replace the previously proposed study of the relatlorisblp of smoking to mortality among wccen eaployed by the govern- ment and covered by federal employe Insurance. The latter plan has been dropped, at least for the present. Other factors of public relations Interest to TIRC are Dr. Little's forth- COTiing report (in May) on the progress and accoaplishcests of the research pro- grajn, the talks he will give at tiree medical meetings and the editorial he has written for CA^CSR KESZARCE, official publication of the Amerlcaji Association for Cancer Research. Dr. Little will speak March 5 before the Wayne County Medical Society in Detroit. On June 5 be vlll present a paper at a synposlum on "Cancer of the Lung" at the Third Rational Cancer Conference in Detroit. On June 7 he vlll speak at a syapcslum on "The Present Concept of Bronchogenic Carcinona" at the annual meeting of the Aaerican College of Chest Physicians in Chicago. The Third National Cancer Conference Is co-sponsored by the Aaerlcaa Can- cer Society and the National Cancer Institute. The planning ccwniittee for the meeting has s'jggested to Dr. Little that he speak on "Etiology and Lung Can- cer -- Tobacco" and also has asked him to participate In a panel discussion on etiology. The editorial Dr. Little has vrltten and the talks he Is to give vlU in- crease scientific appreciation of the research program and will be of interest to science reporters In their norMil coverage of such occurrences. Cancer Month April has been designated "Cancer Month" and during the next fev months the American Cancer Society vlll conduct an active campaign to achieve Its goal of $26,000,000. The build-up has been apparent in recent weeks: 1. An article on I'oog cancer and smoking by Dr. Charles Cameron, the ACS' medical and scientific director, appeared in the January issue of THE ATLANTIC. Virtually the entire text was word for word from his report of 1953- 195'^. The ACS wrote a news release on the article which was released to local newspapers by various ACS divisions. 498 Dr. Cameron also haa written a book, "The Truth About Cancer," which It expected'to be published in March. The book contains a section on smoking and lung cancer and will be proaoted natloTially by the ACS. 2. The Jeb. 10 issue of U.S. NEWS 4 WORLD PEPORT featured an Intervlev with Dr. C. P. Rhoadfi, director of the Sloan -Kettering Institute, on "Is A Can- cer Cure Near?" One section dealt vith Dr. Rhoads ' conclusions on cigarette smoking as a cause of lung cancer. 3. The lead article In the Feb. 8 issue of the WALL STREET JOURNAL was on cancer chemotherapy. The February issue of McCALL'S magazine has a human Interest article based on Sloan -Kettering. The science editor of Scripps-Ha.'ard Newspaper Alliance carried a column on cancer Feb. 7. It, Columnist Ed S-ollivan is national campaign chairman for the ACS drive. In his syndicated column of Feb. 5* SullivELn said that cancer research doctors "are planning a statement th^t will Jolt the country in March." This may be a report by Dr. VyTider and his associates alleging that they have isolated a carcinogen In tohacco. On Dec. 27, 1955» speaking from the floor at a 'X'jng Can :er -Tobacco Controversy" session at the American Statistical Association meeting, Dr. Wyr.der said that he will announce soon the Isolation of a substance In cigarette smoke, "not benzpyrene but a member of the benz- pyrene family," which has, in every instance, produced t'jmors in animals. 5. The March issue of READER'S DIGEST has a condensation of an anti- smoking editorial that appeared In the December I ?5 issue of S0UTHWE5TERM MEDICmE, Journal of three southwestern medical societies. 6. The June issue of GErOATRICS will be devoted entirely to the subject of cancer and will have an editorial written by Dr. Cameron. Highlights of Recent Activities 4 1. The biennial report of the Sloan-Kettering Institute, Issued Dec. 7, purported to disclose "new" evidence linking smoking to larynx cancer. The re- port also dismissed air pollution as a possible causative factor in lung cancer. A TIRC statement was released to help put the report in fact'jal perspective. General press treatment of the report did not stress the smoking and health sec- tions. 2. Two papers on benzpyrene in cigarette paper and tobacco were given by the Rand Development Corporation before the American Association for the Ad- vancement of Science meeting at Atlanta, Ga., Dec. 27. Hill and Knowlton, Inc., arranged for coverage of the meeting at which the Rand company's claims were challenged by Dr. Louis Fieser, a Harvard University professor who is an author- ity on benzpyrene and related cccpounds. The Rand papers were widely publicized and Dr. Fieser 's cosaents also appeared in many of the newspaper stories. 3. Dr. Hermond and Dr. Eerkson appeared on the same platform Dec. 27 at a session on the 'Xung Cancer -Tobacco Controversy" at the meeting of the American Statistical Association in New York. The American Cancer Society made available a release on Dr. Hammond's paper but none was Issued on Dr. Berkson 's talk either by his own organization or the stctistical group. There was little press mention of this session. 499 , • - •- ■ . I*. A report from a Nev Zealand public health official, published In a British medical Journal, attributed the increase in lung cancer Lncidence to air pollution and not to snoklng. Advajace inforaatlon of the date of publica- tion VB8 obtained fran contacts in ffew Zealand and England and vhen it appeared it vas brought to the attention of the United Statea press. Stories and edi- torials on it appeared in laany nevspapers. 5. A paper by Dr. Hueper appeared In a publication of the D. 8. Public Health Service In January. Advance copies of the article, vhlch described cig- arettes as only a minor possible contributory factor, if any, In lung cancer, vere obtained and distributed. Stories were carried by several nevs vlre serv- ices and appeared in nevspepers throughout the country. It also vas mentioned on many radio and television nevs broadcasts. 6. A book on the scleatlflc aspects of smoking and health, being vrltten by science writer Eric Northrup, is expected to be jrubllshed by June 1. 7. A year-end statement by Mr. Eartnett vas released to and published in a D\CBber of the tobacco trade magazines . 8. Releases vere issued on nev TIRC grants and the addition of $500,000 to the research fund, and stories on both appeared In many nevspepers. A story has been prepared for release at an appropriate time en the continuance and ex- pansion of the TIAC medical student fellowship program. 9. The editor of a cocpaay which prepares pacphlets for employe reading racks requested Information for a proposed pamphlet on sucking and health. He later decided to discard the smoking and heeilth angle and Instead Is planning a condensation of a 195'* popular-priced book on "How To Stop SaDking." 10. The 1956 WORLD ALMAJiAC was published and contains a balanced treat- ment of the subject of smoking and health. Inforaatlooal naterlal was given the editor several months ago. 11. Informational material, both from TIRC and other sources, continued to be supplied to large numbers of doctors, scientists, science writers, stu- dents and otljers Interested In smoking and health - x»c 500 ri* L AKD KNOWLTON, Inc. CONFIDENTIAL \^Klo July 19, 1956 CONFERENCES WITH LIFE AND READER'S DIGEST. JULY 17-18. 1956 MEMORANDUM TO: Mr. Timothy V. Hartnett ThU memora-ndum will summarise our contacts with LIFE staff mem- bers on July 17, and DeWltt Wallace, editor of THE READER'S DIGEST; on July 18. Participants on behalf of TtRC were Dr. Little a.id Messrs. Hartnett and Darrow. LIFE ConUct This was a luncheon-meeting Initiated at the Invitation of Mr. Robert T. Elson, Deputy Managing Editor of LIFE. Those attendL- ^ .'or LIFE were: Mr. Elson; Albert L. Furth, assist- ant to the editor-ln-chlef; George Hunt, assistant managing editor; Warren Young, science editor; Ed Kern, science writer; Hugh Sldey and Miss Allx Witteborg, sci- ence researchers. In extendlAg the original lovitatloo, Mr. Elson stated an Interest ia having LIFE'S science staff gain a fuller appreciation of Dr. Little's personal Tlews on the subject of cancer generally, particularly his estimate of the importance of fact(T8 within the lodividual as opposed to external stlmoll. At the luncheon, which was conducted in a friendly and congenial at- mosphere, Mr. Elson asked Mr. Hartnett to open the discussion by outlining the thloldng behind the formation of TIRC a;id describing Its organizational set-up. A number of interested questions were prompted by Mr, Hartnett's description of TIRC policies. Particular note was taken of the freedom of action given the SAB, as well as grantees. Dr. Little then covered a number of aspects of the broad subject of cancer In a brief talk along much the same lines as his presentation at the last meeting of the TERC on February 14, 1956. He pointed out the Importance to the public of receiving a balanced ^ B/eserrtSTTbn of all the facts and underscojed the need for editorial responsibility y in handling stories that rouse unwarranted fears. ■'T^ ^-- 501 ?r~' . • - - ■ • ■ QuestloDS from those present liydlcated an active Interest In what Dr. Little had to aty. Vtlille their gcbedules did DOt permit as much dLscussloo as might have been desired by several of the LIFE staff members, It was pointed out that Dr. Little would be happy to talk further on those items of special inter- est to them at a later date of their choosing. Arrangements were made to send aloog certain materials of inter- est to the LIFE staff members. A visit to TIRC and HIU and Knowlton, Inc., by some of the editors and writers Is to be arranged at an early date. This wUl provide an opportunity for up-dating on the scope and nature of Information avail- able and provide further knowledge of how TtRC and SAB operate. An opportunity j( ^ of the LIFE staffers to meet Dr. Hockett will be provided on the occasion of that visit. READER'S DIGEST Contact This was an afternoon meeting at the READER'S DIGEST headquar- ters offices near PleasantvlUe with DeWltt Wallace, editor, and James Monahan, senior editor and Lois Mattox Miller, roving editor, attending for the publication and Dr. Little, Mr. Hartnett aod Mr. Darrow for TIRC. This was a most pleasant and congenial discussion. Mr. Wallace said that through Mr. Monahan and Mrs. Miller be had a good uaderstaodlng of TIRC and what it was doing but would welcome know- ing more about It. Mr. Hartnett briefly outlined the background of TIRC, discussed some of the problems In organizing an industry approach to the question and made clear the open-minded approach that had been adopted. Dr. Little stressed Importance of the public not being stampeded -^ into undue fears and the great responsibility held by major publications to keep the public adequately informed so that they would not tend to over-slmpUfy the problem and expect a "push-button answer" to problems so complex as cancer and heart disease. Mr. Monahan expressed the belief that the Scientific Advisory Board and Dr. Little had thoroughly dissipated any skepticism about the sincerity of the TIHC program and the Industry's support of it. He commented that a phe- nomenally good job had been done in getting the research program under way so quickly on such a sound basis. 502 -3- iBlderable Icnowledg* of TIRC., J;V_'',L".'.-".i 8 sftm-' .r- •*''rf' Both he «jid Mrs. Miller Indicated eons bul said they wanted to be even more closely kept op to date In the fxiture.'r Tb«yi'r-I:^*^i ■?•'■■•" aUo asked to be alerted on all materials of slgnlflcanoe dealing with any aipeot ^•,r-.'.r^ i.f.''. tobacco and health. Copies of the June, 1956, Issue of CANCER RESEARCH|"ln-V?4S^-^>^v"S eluding aD article by Dr. Kotln; CANCER NEWS, Including the American CAn«»r^/^.-£?i- -.''■*-'- Society story on environmental cancer, and a recent Armour Research balle Including a report on air pollution research, were given to Mr. MoniJb&s as pies of the recent literature of Interest. ■• ••*■_..-. •?•;■' -*j";- ;'■■ ■■, i'-'v- '. " The recent Robert Buck article "V.'hy an Airline Pilot Quit Smok-y/:' ..• Ing" was discussed with Mr. Wallace. He expressed surprise that their Research , ' Department had not caught the error which referred to 900 people Involved in : -^ - ; tests as "airmen" when ttey were actually college students. Both Mr. Monahan and Mrs. Miller expressed Interest In visiting TIRC and Hill and Knowlton, Inc. , offices to gain a better knowledge of data and services available which might be helpful to them on future assignments. Mr. Wallace said they would be happy to talk further any time we felt it was war- ranted. Hill and Knowlton, Inc. 503 tfifkl^ /S R J R«ynoids Tobacco Company January 11, 1990 Principal Willow Ridge School 480 Willow Ridge Drive Xjivherst, NY 14150 Dear Sir or Madan: , "• J ■'■ A nuTTvber of your fifth grade students have written R.J. Reynolds Tobacco Company commenting that '■hey do not feel our company should allow the use of our brand naoes on children's toys and candy cigarettes. As information, R.J. Reynolds Tobacco Company's policy is not to allow our brand names to be used on toys or candy cigarettes and any current use of our brand names in this fashion is not sanc- tioned by our company. Some of the students also commented about the controversies surrounding cigarette sBioKing. The tobacco industry considers smoking to be a custom for those adults who derive pleasure froa it. We believe that whether to snoke or not is a decision that should be freely aade by individuals who have reached the age of mature judgment. Accordingly, our advertising is directed to adult smokers and not younger people. The tobacco industry is also concerned about tie charges being \ made that smoking is responsible for so nany serious diseases. I Long before the present criticism began, the tobacco industry, in I a sincere attempt to determine what harmful effects, if any, \ smoking might have on human health, established The Council for 1 Tobacco Research--USA. The industry has also supported research \ grants directed by the American Medical Association. Over the 1 years the tobacco industry has given in excess of $162 million to 1 independent research on the controversies surrounding smoking -• I more than all the voluntary health associations combined. I Despite all the research going on, the simple and unfortunate I fact is that scientists do not know the cause or causes of the I chronic diseases reported to be associated vith smoking. The 504 H.1 »W— <<6Mcs i;SA Principftl Pa9« Tvo January 11, 1990 answers to the many unanswered controversies rurroundlnq sino)clng and the fundamental causes of the diseases oft«n statistically associated with sacking -- we believe can only be determined through much more scientific research. Our company intends, therefore, to continue to support such research in a continuing search for answers. We would appreciate your passing this Infonaation along to your students. You nay also, be interested In the tj>closed publications presenting the position of our coepany and the tobacco Industry on the issue of youth smoking. Sincerely, 9''^ 4*^ (Mrs.) Jo P. Spach Manager, Public Information Public Relations Department JFS/JBd Enclosures 505 X i -rV^-v^ j;- ; *'■; ''-y r '.' • Exhi bi t 1 6 ■•^ ^- "*' "r — 1 .-■■■. ■! 7 ^-■[^■■■^•^V'^'^^ 1 ^ » "^ - I 4» . - ■ "Him f j . te r • « • • » » t" All f •• • I!'!!-! rit-i f • < > • to « ■ ?i » « -- • • M • t ( { - IK {'--.It 11 if l :■ m » M 3( t » I • :{{! t c ^ • • • r c c » * ■ u • - - . > » ■ir fc — • • • V •■ f • * • i » • • > i « • i k • to » to ■ to c - • • - .' . ei r. r;itor • • ■ k ■ e < ■I. »■ . ■t-^.-." ■ J : %• 1 I . til. f ?:: k:-l .^ -ti :,i ,-.,'i i z.% - c • < • «- t: • -.1", lli^t »- • • jJhI — * • Hflj % ktr il'h' e 0 « X • *- •t!: to.>-.r *-!«•- '•"*•; Hi! ?nin e u *j ^ r. ?: 1 « e 1 1 f 506 •J-T »t.*-^. »,» J5 fc V * * -• ■ ' X-- •- » « w --: * * f ^ • ^ zs f > • •> • • ••• — •< « b i> • ^ i • ••■ C • «r • #«r I • b • «••• lev*' I I 1^ t.: • • • ■ r e » • • • » ft " • to rs k » « « • • - « e • » ^ • • » 0 0 fc w " • " 8 • i a K t ^ ^ to » • b e • ► e " » k c w 5 ; 9 b « • 0 » ■ • - •• — •.•"<. li f C to * 2^ • * ^ « « X . < 1 . 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L » - » • - • r • « . . . » I • ( a C w • il a; b t [! 11 e u- r. f • 523 cof;,-ict7,'m[ Uvta J, .'«cak • 2 • !(«««ab«r 23, .Hi v«ne ca corpucanx* c^a riiulea far a aara pracUa «pfraii«l. V« sow \«v« «ve& tataruiva 44C« far uavit UOO pac'.taea wcA :hata tarta cascart, 4aa cAa 'i** »t « «e«pv4i«r :« laairaala far c>.a i&4i/aaa. TSa «ala ia«a la Ota c^pa at vark la t7alaa4 huaa* partenaal ta aaatac la c.ta paia^ciAlai, 4rau«ua caak a/ r«vi«v-La( raeeraa, eaafimas facta, aaa cadlni lata. rro« f4nda aada availAAla ca a« by cAa Vtac llavia 7A daapieal, ! laall hava lupparc far cwa paepla vtto hav« curraatly ^aas werklai a« :.Ma pra;*ct. T^a work raaUf rtqulraa at Uaat evo aora paapla, hewavar, aad th« f'^4a I m laanlr.i for wiU b« to aupport thaaa ac^ar cwa paepla. Z eurriael/ ^ava plaead grant appUeatlavj w-tth evo dlffaraf.t t|anelaa :Mt will lonoyaea :.^«lf aaelaloaa '^ aia^SacasAat. Shavila ^oeS t|«aelaa ra^et :>.a 4pp::cacia«a — a itrssi paaalilllr/ ^^ (^^* *'• vr.aa ao eaa laasa :a waAC ca iv.pp«r: tll-l;al raiaartA— I tftall aaa4 e>.a >.alp I hava elta4 uatll I lan caspoia 44i^cijna; saw (raa< applleatlsna to at.lar aganelaa for luppert tftar .'.04 ^0, ;3i4. i; ro^t waat ripnata. fvirthar daaeripttooj, or aay athar lafarsatlaa a^evc t.Ma victar, plaaaa '.at M mov. I ttuXi '»• a«ac |raca/vd far aay halp j9\t aa4 rovir tollaa(vtaa eaa pravtia. SlaearalT T^v** .^c^ iUvas %. ralsjtala, M. 3. A^aoelata Prafaaaor of yia41:la« AJU/I? M ^ 524 CONFIDENTIAL University of Hav/aii at Manoa Bthivionl Biolofj Libaritory Pie.fic Siantdiul ^iitirch Ctntir Snyiit Hdl I'.l • UU T\* SU.: i Hen: i. Hawtii Ml!] Ttitphant Vii-JHJ April :; 137S xr. Edwin J. JAcsb «*ccb ( M«di."i9«r 1270 Aver.ut of t:- - Ar.«ri.cas Scc:.« ess«-tiil ftiturss oC our race.-.t ttlepr.or.* co.iverj«;i=.-.s cc.-.cerni.-.j th.t iu.-.din? *nd 03«r«tion of :>.• p«.-.dir.g research pro^ran on ce.-.etirs a.-.d to;:ac=o-rela:ed be^.avi^rs. It has been agreed by t>.e i.-.vesti;at = rs that : should serve as eoorii.-.ati.-.g investigator. In this role, I would ser'/e as the cc.--unication linJt between the i-vesti?ators and the ?rantin? consortiua. I would be respons;.2le for cocrdinatms the prsparit; and submittal of required fiscal and scientific progress reports and arranging for periodic r.eetings of the consult-ng and review panel. Responsibility for the scientific cond-ct of the research would be assur.ed by the principal investigators of the three separate pro:eets, as follo-./s: Hawaii study — Geoffrey Ashton Half sib-fvin study -- '.Tilssn Crur.7ac'.« princi?«l ir.v«itic4tors would b« rtssoniiblt Jaj «>:?«r.iitur«i en t>.tir particular ?ro:«ctj, tr.d would h*v« Jrtsic- to tra.-.i;«r ;--.-.ds aror.g bui?«t cata^or;.** as raquired. w-.^n r.utual cor.sant of t.*".* pri.-.ci?al invaitijator J involvtd, ;-.-.ii could t« tra.-.sftrrad baf.^t.-. ?ro;acti. Howavtr, all ax=«.-.ii^.rs s would bt .-ada in csr.olia.-.ct wi^n t.^a applicabla staca and '.' r. ;. v 9 r - si:y rulas of Colorado cr Hawaii, as rilavan^. T>.« consulting and raviaw panel will ba csriposad oJ scia.-.tis^s mutually accsptaola to t>.a invastijatcrs and to Or. Wiiiiin Cardnar. Aftar a pariod of apprsxi-iataly 13 months,-, a aaati.-.? of tha consulting and rsviaw panal will ba convanad to aval'.:ata prograss of t>.a pro; acts and to r.axa racsr.-r.andations to tha grantors concerning continuation of support. In tha casa of a raco.r.-andation to discontinue a pro; act, f-un.ds for phasing cut tha operations will be continued at least in a.Tount sufficient to r.eat staff personnel tiligaticns for a period u? to an additional Six .T.ont>.s, depending on the terrs of er.plo>ment. Assuming t.hat obligations have been undartaJcea to ersloy staff through the full second year, the 4.r.ount of savings frcrt the second year budget that would be r\ii9 by terr.ination of data collection and analysis after 13 -onths would be apprcxi.r.italy as follows: Hawaii study — S32,3T6 Half sib-f./in study — $50 , 737 AnL-nal study — S27, :6a IS obligations are undertAken only to provide 60-day notice of teraination of enployr.ent, then additional savings in the anou.-.ts of $7,400, $5,0C0 and $40,000, respectively .•night be radi. If the circcr.stances are such as to warrant a continuation of data collection and analysis during the phase out period, a negotiated axount not to exceed the budgeted a.-.ount for the next SIX r.ontns, but with a Ic.-.ger ti.-e li.r.it for expenditure, ••.ill :s .-ids availaole. In the event of fcvorsbla rcccr.-sr.dation at the ti.-e cJ S evaluation, research support will be continued, and a second .;,: evaluation r.eetmg will be held apprcxi-a-sly at the end cf 2: -onths. The purpose of this reetmg will be to evaluate progreji iT.i to aA;se recor.T.endations regarding funding for the fourth Ar.t fifth years of the study. 1 an anxious to "Know if the above is an accurate surriary of the principal points of our discussions. Sincerely, Q Gerald S. .ycClearn r.' 526 uNr."ERsrnr of California, san ftuncisco ■ --JS r'" •TKoek or vr^es«t »fcT4 i««««4a ■ fc*x"» r».- Dlr«et: (4U) 6««-l7U S«etiea of H« July 20, 1972 icsls(7 tad IsBuaeldfj Hr. Sdvln .'aeeb Laucartctla 4 Liuctrsttla Oai leclt*l*lltt Pliu Htv York, Mcv York iS020 Dear Mr. Jacob: CONflDEHTIAL A« par your rtquatc, *r.elesad la aa eueliaa of ch« radeaala rt: (cudy for liU4|a of cartcla Z» (aaecypaa co chreale ebacruetiv* dlsaaaa, atpaelally, taphyitaa. I did te:« o( ehlj racldttala pr«vlou.4]Ti hewavar, wi:h tha appaaraeea ot cha daca chae cha alphai-aosltryptia (i=eeypaa aca Xiaxad to tha Ca lanecypa leeua aakaa rvaa aora aaaja. To acar: t.haaa studlat, I :Mak li would ba bar.afldal Co hava Dr. Joha Vivlae waUs as cha ?rlael.;al lavaadtacor, aiaea ha vat tb« first CO daaeastrata chac a |lvaa Ca |aaoeyp« vat llakad co halghc of l^nia* rasponsa co any anti{ta la aaa. ( Ua fava you a raprlac ea chl»; hevavar la Cha avaac you hava alsplacad It. Cha raforaata It: J. V. Walls, B. R. Fudaabari aad I. K. Maekty: Xaltdoa co cha husta aaclbedy raspenta to flaiallla co C« Caaot/pat. J. :=su-ol.. ^:130J-13U, 1971.) K* you knov, toaaalpha^-aaclcrypala tanoeypat v.tich ara rara art aet aateclacad vi:h raduccisa oi acclvlty of tha alphax-aacicrypsla. Thus, Cha oecunaaca e( asphysaaa la chat* paclaact al(hc aaraly radaet tha fact Chat ll.ikata of tMa loeuj to thlt leeut to cha Ca loeut rtchar chta cha face chtt tha PI* hoaetyfotat ara proaa to aaphytaaa. Aaethar raaaoa for hava Or. Ualla partlelpata la cMt srudy It that h« hat jutt dltcevarad tha flrtt buaaa (teatle aarkar for :|.H, (J.V. Wallt, J.T. Blausart aad V. H. Fudaabarg: Ruaaa Aatl-I^.M Iso-Aatibodlaa la Subjaect wich Salaedva I(A Daflelaaey. Clin, c^e. Iraueol.. la arasa). aad It It eoaealvabla that li COPO or taphysasa aleca i* eua co aa laictal iBJult by a vlrut or othar or|tnlt« to which tha aatlbody ratpeata It It.1, cha laaa data al{hc hold eruo chara. l.a. cha llakaia it dua to ItH gaaetyr* rac^ar chta I(C. PLAINTIPF-S EXHIBIT ^9 ^ « cascl.'j^ad 527 RoBk PnfcrFv^ AiTKTxaa Medical Assocuooc EJuaooo and Resevdi Foundibon (AMA-ERF) for a major study of smotong and dotase, injuaied in 196A and culmmaong in a (inai repon puNished in 1978.' The tndusiry irumpeis lh« magnitude of its restarch ef- fon by emptusizirg ihat, "In many years, industry awards exceeded that [sic] of any govemmeni department. They have al- ways far exceeded the smoking aixl health research funding of all voluntary health assooauons. . ."' In Congressional tes- tirtxxiy in 1982. the (hen-president of R J. ReyTX>lds Tobacco Company suted that "the lobacxzi industry is recognized as a leader in seeking ihe answers lo the ques- uons regarding smoking and health."' Also illustrating the indusny's use of the CTR program is a recently coiKluded CTgarene product liability tral in .Missis- sippi.'" During the trial, the attorneys for the .American Tobacco Company placed large charts before the jury identifying pror Tent uruversiues supported by CTR grants. The anomeys emphasized that many of the supported research projects were also funded by the .Ajnencan Cancer Society, National Cancer Insurute. and other major voluntary and governmental research-granting agencies. The tobacco attorneys specifically identified the mem- bers of the SAB by name and institutional affiliation, asking witnesses whether or not these were reputable scientists. At no time did the attorneys state ex- plicitly that the research at issue dealt with the health consequences of smoking; nor did they stale expliatly that any of the advisors or funded saentists questioned that smoking was dangerous to health. But the intent of the tactic was dear to estab- lish "innocence by assoaation," to create at least a modicum of doubt lo jurcjrs' minds that the relationship between snx)k- ing and disease i in this case, lung cancer) was definiuvely established; and to do so, in part, by associating the reputable SAB saentists with a search for the "as yet unknown" truth about the role of smoking in lung cancer monality. This courtroom experience typifies the industry's broader use of the CTR pro- gram. Mentioned nowhere in any industry public relations document is the faa that only a minority of industry-funded re- search addresses the relationship between sjTKJking and health. Nor has the industry ever acknowledged that the vast majonty of Its funded research that does relate to smoking and health has identified the same disease relationships identified in lens of thousands of studies funded by other sources. ' ' This indudes the findmgs ol the AMA-ERF siudy, which produced aeaiy 900 research rrporo aixl indiacd snoiang as a cause of lung cartcer, chronic otsDucxrvr pulmonary disease, and coro- nary disease. • To many knowledgeable observers, the tobacco industry's funding of scientific research represents an uivestmenl not in soence. but rather in public relations. This was ifie conclusion of US Dismci Court Judge H Lee Sarokin, who presided over a prominent cigarette product liability lawsuit in New Jersey. Judge Sarokin wroce thai, based on the evidence pre- sented at tnal, "the jury could reasonably conclude that the creation of [the Tobacco Industry Research ComrruttetCouixal for Tobacco Research) and the work per- formed was nothing but a hoax created for public relations purposes with [the mdus- uy having) no intention of seeking the truth or publishmg it." He concluded, also, that there was suffiaent evidence for the jury to find that "the industry ... en- tered into a sophisticated conspu^cy . . . organized to refute, undermine, and neu- trakze information coming from the scien- tific and medical community and, at the same time, to confuse and mislead the consuming pubUc m an effon to encourage ex3sting smokers to continue and new per- sons to commence smoking."'^ The CTR program IS part of a broader public relations campaign that has achieved notable success in misleadmg and decervtng the public. Survey research has consistently found that while Amerv cans recognize smoking as hazardous to health, they greatly underestimate the dangers of smoking, both in absolute terms and relative to other health haz- ards." In one poll, for example, lay re- spoodents placed "not smoking" tenih anxng the nation's health and safety pn- onoes. (Health professionals placed it firsL ) The lay respondents ranked "having smoke detectors in the home" six prior- ities higher in fourth position.' despite tlie faa that home fires claim about 6,000 lives per year, while cigarenes annually kill 400.000 Amencans. Ironically, the most imponani cause of home fire deaths is the CTgarette.''' Shon of a universal rejection of CTR funding by researchers — an outcome that certainly cannot be antiapated — tfie sa- enofic community has limited optioos with which to combat the cynical tobacco in- dustry campaign. A clear exception, how- ever, lies within the ready grasp of the CTR Scientific Advisory Board. Woven into the very fabric of the industry re- search funding process, the Board has itie abdity— some would uy obliptioD — to (xiMidy distaiKe iseV (aod tbeieby tbe soenufic community, whch it represents in the public mind) from the mdustry'i persistent assenion thai doubt rerruOTS as to whether smokiog is dangerous to health. Is the CTR Soeniific Advisory Board, through its coUecttve silence on the health consequences of smoking ii>- advertently conin'buting to misleading ifie public'' A L'S Senator suggested iho pos- sitiility nearly 30 yean ago. In 1963, Sen- ator Maunne Neubeijer charaaenzed de- velopment of the Tobacco Industry Research Comrrunee as follows: The CTtaijon of the TIRC. the brM«3uk! of [a) resourceful public relauons fins . . . was a stroke orf tn^nuity By offer- ing as bill miUiom of dollars of ioniy needed rnearch funds, the industry «'^s able to anracT soesosts of uoLT.peactv- able iniegnty 10 seTN« on a . Soenufic Advisory Board. As responsible u these . . . men wot- ;hey never.he«5S servttj the mduscy^s purpose of asso- ciating eminent saeausis wiih the .n- dustry position iflai 'Jie relationship 5e- tween smoking and disease had rxx >et been pruved.'* Recognizing this possibility, the Aus- tralian equrvaleni o( ;.he Scientific -XdMs- ory Board recently dosociaied its«L' from the industry positioD, publicly and collec- tively. Wnting in the Medical /ouna/ of Australia, the pand of saentific advisors to the industry-funded Australian To- bacco Research Foundation stated, un- equrvocally, that The membeis of the Soeniv/ic Advisory Committee are uoannous in believing thai smoking is an tnponani causaovc factor in several major diseases . . . [W)e strongly endorse the view thai iKe public should be hifly informed about the nsk in smokers, and we fully support any measures, wtich are consistent with the li^rry of nx mdr^ual, tfiai are (designed to reduce snoking.'' Qearty, there musi be considerable sympathy for this sceniific position within the Amencan Scientific Advisory Board. Among the six SAB members who have individually gone oo record through their responses to my query or thrtjugh their published work, there is unanimous agree- ment that cigarette smoking causes lung cancer. But seven of their SAB colleagues have not expressed thetr scientific judg- ments through either of these vehicles, and the Board as a whole has never n'^ucd a statement about whether or not ii •-up- ports the "party Ime" of the industry to which II provides saentific advice. July 1991. Vol. 81, No. 7 Amencan Jouial o( Public Health SJI Puftfc HlriU PaOcT Tl 528 Perhaps lite Buonj memben should noi be faulted for ihcir failure to rtspood 10 my query. The message comnunicaied lo ihc Board members by ihe office of ihe Scicniific Director of LI K may have seemed sufficiently ihrratening lo dis- courage a poll response thai selected Board members otherwise might have volunteered. In addition, quite indepeiv dcnt of that communicauon, some mem- bers may have found my approach to this matter, or the reason for my interest, of- fensive, and thus decided on these grounds not to respond. Regardless of their individual moti- vations, however, these saentisis lend their names and aedibility to a conscious tobacco industry strategy to use sponsor- ship 6( scientific research to sow doubts in the minds of the public about the dangers of cigarette smoking. As such, it might be hoped ihat the CTR Soentiiic Advisory Board would muster up the courage to take a strong public collective stand, as have their Australian colleagues, to dis- unce them.«h'es, as soentists. from the insidious, cynical, and misleading — and perhaps "brilliant" — public relations role played by industry funding of re- search. G Acknowtedgmeots I un iritefuJ to Stephen ModeD for roeardi assaiance. For hetp^ commenu on prwxius dn/o. I thank W A/idrvw Achenbaum. Fred Bookscin. Ronald M Davis. Rjchan) Day- nard. Mallhew Sljers. Michael Penschuk, Dome Rosenblan. and Dinah S«(ver Duruij prtparaijon of ihis manuscnpi. I *as supporifd in pan By grant no AOCDl 14 from the Naiiotttl Insoiuie on A^g to the Insniute of Geronto4- ogy. L'ruver^ty of Michigan. References 1. OpoBcne V. Uggen Croup^ Inc. Exhibit Pi 105. Tob. Prod. Lit. Rptr. 1988. 3JJ68-3JTO. 2. Federal Trade Corrunission Docket No. 9206. iSee also Meier B: Selling Of advis- ing'' Dispute senled on tobacco ads. Sew York Times. OcJober 21. 19W, p 18.) 3 On Tobacco: 21 O^cstxwa and Answers. Washington. DC Tobacco InsoTute. D.d. 4. In the PuNjc Interea: Three Decades o< InituDves by a Responsible Cgarene In- dusoy. Washingioa. DC Tobacco Insti- niie. 1986. 5. PoUay RW Propaganda, puffing and the public interest: Tbe sciena/W smoke screen for Qgarenes. Vancouver. Canada: His- lofy of Advertising Archrves. Universiry of Bntish (jDlumbia, March 1990. 6. Cummin^ KM, Soandra R. Gtngrass A. DavB RM: What soenosis funded by ihe tobacco industry believe about the hazards of ciganne smokaig. Am J Public Health 1991.81:871-883. 1. US Dep( of HeaJIfa and Human Services: Reduong the Health Coosci^ucDces of Smoking: 22 Years of Process. A Repon of Ihe Surgeon General. US DHHS. Public Health Service. Centers for Deexse Con- irtil. Center for Oironic Disease Preven- tion and Health Promotion. Office on Smoking and Health. DHHS Publ No. iCDCl 89-8411. Washington. DC Govi Prwung Office. 1989. 8 Comminee (or Research oo Tobacco and Health: Tobacco and Health. Chicago: American Medical Association. 1978. 9. Homgan EA; Tesumony before the Com- minee on Labor and Human Resounxs of the United Sutes Seiute. March 16. 1982. 10. Honon v. American Tobacco Company et al . Qv Ac. So. 12J23. Lafayette County Ctrc. Cl.. Mississippi. 11. f^ounol for Tobacco Research Annual Re- ports, 1957-1983, exoerpied ui Tob. Prod. Lit. Rpc. 1987; 2JJ&-5JO; 2J.J3-5.61; and 2i5. 102-5. 118. 12. Opuuon of Dtstna Judge H. Lee Sarokm, CipoSone v. Liggett Croup, Inc., United Sutes District Court for the Disina of New Jersey. April 21. 1988. 6S3 F. Supp. 1487 fD.NJ. 19881.- 13. McGuire A Ggarenes and fire deaths. NY Sute J Med 1983; &3:l»i-1298. 14. Neuberger MB: Smoke Soeen: Tobacco and the Public Welfare. EngeNraod CUSs: PrenoceHall. 1963. 13 Doyle A£, Rand M, PoweU LW. Sim- mondj W. Wing L, Zywn W: The Aus- tralian Tobacco Research Foundation. Med J Australia Feb. 1. 198S; 148152. Editor Search Committee Seeks New Editor for American Journal of Public Health An Editor Search Commmee is actively seeking a re- pljcemeni for Dr Michel Ibrahim, who has announced his resignation as Editor of this Journal, effective January I. 1992. The su-member search commmee welcomes and solicits nominations and recommendations from the APHA membenhip and leadership to assist them in identifying the best available individual for this important salaried position. Nominations and statements of interest should be submitted by August 20. 1 99 1 ; the commmee will meet several times to consider suggestions, applications, and support maienals of potential candidates. Names of potential candidates, along with letters of endorsement and other support matenals. should be sent to: Editor Search Commmee. American Public Health Associa- tion. 1015 15th St.. NW. Washington. DC 20005. The following cntena will be considered by the search committee in selecting the Journal editor • Comprehensive knowledge and broad perspective of the field of public health, with an appreciative understand- ing of us many disciplines and solid grounding in the basic sciences of epidemiology and sutistics: * ProfesMonal accomplishment and identity with the pub- lic health field, including respected standing among peers, combined with an extensive network of profes- sional contacts who can provide expenise in soliciting and evaluating matenals for publication: • Demonstrated research skills, with evidence fsuch as credited publication m peerreviewed journals) of firm grounding in a field of scientific inquiry within public health; • Demonstrated writing, reviewing, and editing skills, enabling authontative advice to authors on the suitabil- ity of prepared manuscnpts, facilitating informed con- sideration of reviewer assessments, and equipping for Ihe preparation of appropriate editorials as needed: • Freedom to devote half ume to editor duties: • Working knowledge of APHA and sympathy to its advocacy goals: • Easy access to Washington, DC: • An institutional base is deemed highly desirable, pref- erably in a school of public health, a university health sciences center, or a large epidemiologic research/ service organization. APHA IS an affirmative aaion/equal opponunlty em- ployer. 842 A/nencui Joutnil of PuMic HeaMi July 1991. Vol 81. hto. T 529 A PAJfOWkKA 5FECIAL HCVESTIGATIOH nrrO TRK TOBACCO nCDOSTRY A RJtSEARCB HRIK? nU<3Ation« are based on tlie toba;co industry's own Internal docuj«t:ntt> aiui testiaony froa thair own eaployaas. When tht iinX b«tveen -BOJtlnttA coirpani«$ tried to prevent crucial rtsearcji fro« Iwliiq publl£h«d. 7. How individuals within the industry were silenced. 3. Why key labs were «hut dnwn when they seeaed to be on the ver9« ot BAlcln? Isportant n«w discoveries. 4. Row a front orgeni-satioa was estAblished to try to giw credibility tw Lbe industry's own rasear^ efforts. f. And bow the industry secretly set up a covert research or9ani»«tion which organised the rcil a«dical recearch with a view to providing «via«nce and witr»«sse« solely to help the industry figrht litigtttlun. 6. How the in<)uittry-hired lawyars slowly doalnated tht scientists and furceU the tobacco firuo to fail in their attcsptc to narket safer cigarettes which WT?u1d have Rsved thousamls of lives. The only nan who has seen docuaent;* relating t? the whole coeplcx conspiracy calls the tobaooo indu£try "the king of concealftftnt and disinforstation". 530 DOLL k wYifpnt sHoot TM gmcgTOy Tbw story b«9«n iji 1953 wh«n th« tobacco industry was suddenly confronted with a new scientific Oisco%«ry of enoraous signilicance. Two scientists, on« British and ont Awerioan, simultaneoualy publlehsd tbe first studies linking CBokin^ with cane*r. Thsir rsporte attractsd sASsivs 9>Adia covftra^*. The British research wac o«rriad out by Profe*«or Richard Doll, rt was statistically based and its conclueivnii wer« damning. Doll says "When w« analyzsd the dat4 wa w«re able CO conclude that smoking was eaphatically a caust uf lunf cancar - not ^ust that It wa» associated with It." 9iit hta con^arvatlva aethodolvqy saant it voj the ^»orican who attr39 thit t>5« ceo'« ot all tn« aajor U* tob*coo companies Qad n«t together. Also preswit was John Mill# th€ ch«irs»*n of Hill Knowlton - tho bi9««spaper« across the country. The advarts ver« &ead*d "a PranX stateaent To cigarette Smeker«». T^ey said the industry accepted "an interoet in people's Qealth ao a bacic responfiihility. paramount td «verv other consideration in our business" and concluded by pledging "aid and a«ei»tanee into siBokinf and health". Tni» was seen a;* « brilliant strote^ which ^honourably' coahln^d short ter» PR expediency with wort&wlule long tern r«t>e^xb goals. But Ken wamer, a HiUiigan professor who hac presented €xp«rt te»tiBony in this ore*, believes It was a totally cynical manoeuvre. He says thA industry w«rt only interested in PR and had DO intention of conOucting any open and honest research into ^/nuking and he«lth. Panoraaa has obtained a 19C2 TlRC »ci«o which supports wamAr's view. "The 19*4 emergency was handled effectivaly. rro« this experience there arose a realisation by the tobavco industry of a public relations problwa that aust b« solved for the self- preservation of th« industry. Historically it would »ee» the TIRC prograaae has carried its fair share of the PR lood in providing Mterials to staap out bruch fir*s as they ro«e". 532 Kon«t^«le»a th« tob«cco industry (iid uftd«xtaXc a eignificant amount of ••cr*t ro«««rch Lnto tho ciftoking and Qe«ItA qUAAtlofl. raiiuraB« hae ob^ain«d « t^ahr of confidential industry reports detailing this work. I^^ett & Kyera oovmiacioned Arthur Little life ecience** division to investigate the linxfi DetwB^n saokinq and cancer. By 19*1 tnelr conclu^iuns were uTiAnbi^ou*; "There arc biological active aeteriala prceent in cigarette tob^crfl. Thase are caT)C«r r^uftin^, cancer proootiog, poisonous, &tioulatinq, pleasurable aiiU riavoarful". Dr Jan«B Mold worked as a research scientist with Lig^tt i Myere for nearly thirty y<>ar6. "By the early «0'6 we en Vnew that isioking cau««d canr.mr . »te jusc weren't allowed to tell aiiyona*. LorrilArd had eleo arrived at the fraxe conr.iuRion. They were de^p^r^tply trying to produce a safer ciyorette and had even written to Dr Wynder on the 9u±>j«ct saying "ve consider your work Above reproeeh, as usual*. Britieh ^^ericen Tobaoco'c reepcCBe was slightly nore theatrical. They becaae eo concerned th«ir secret research aight leoX out they resorted to the u«e of code words. Caacer become "Zephyr", jtouee expcriaenta b«case "Januc" eyperinertt^ and Oth«r ahiaal testjt became ''Con<3ueror" t<$t$. Jurt a fev yearc after publishing their "FranX Statement* the toDftcco industry had be^oae le^s than franX with their conauecrB. Tony van den Burgh aayc the industry knew ejtactly what the score wa«. "Our products were killing people". 9n pcCTKrri. ran To^cfn ftTP.KAwni. By the early sixtiec the tobacco industry harJ evolved several parallel stretAgies for dealing with the saoKiog and health crisis. They believed the key wee to pretend a debate was still raging about eaoXing and cancer and it was doing Sll it could to r»solvA things in an op«A an honest wey. To achieve this goal the Tobacco inrorration Research Cosusittee wj»« spilt in tvw; the Tobacwj Institute now handled PR whilet the Council for Tobecco Research haivlled scientific research. 533 l-f CTR initially fund«d restaxch pro;»ct» exauining the h«alth haz&rds of amoking but they v«r^ «b&ndon«d by 1964 whan th« US Surgoon a«n«ral puhltchcd hi6 report acc«pCii>3 tne llnxx b«tv««n saokLnQ and ca^c«r. Thi«i r«port »a<3e a product lifti^lllty lavsult kr\ LnevitAbility aoii th« ci4«^«tt« cottDonie* tumad to thair lavyora for b«lp. At thic Boaant a train of avantc b#9an chat would avAntuaiiy l*ad to control of an «ntir« Industxy pa*»inq to a littla )aicwn Kansas City law fira. ^ftooX, Hardy * Sacon ware ;»peciali»t3 in px^uct liability ard they alraady knew tha cisa of tha problem. Iccording to Robert waM, a Lorillard iawy«r at tft« tlaa, "By l^es David Hardy of SbwX Hardy 4 Bacon had beco»a tha ao«t important nan i« tba tobacco induotry". Tha lawyers quickly soved into CTR. Par.oraaa ha< obtainad a 1>65 »^»or*ndu» froa BAT's Xflerican sub«idiary, drown i Wllliaason. It shows now lawyers ber^an dt!v;iding tha thrust of CTR's raaearcb. Tha aaao, which ainutca a mo«tLng of industry genaral counKal , sayc "Category A" propofiais should ba "projects of ess»«nti«lly adversary valu«". in other words projects should b« prioritisad vhioh challenged the linkfi between Rjwicing and cancar. The nemo doesn't surprise Dr Mold. Ha noticed the CTR appeared to be treading water and not trying to break through in X«y areas. US now believes CTlt w probleas and it w«T* probably never intended to do so*. Other aocuaeht* show scientistii seeking CTR funding were eveatually required to write directly to the lawyers. Shock, Hardy 6 Bacon in Kaztsas City not to CTR in New York. By 1970 th*re could be little doubt *bout the real purpo«a of the tobacco industry's front or^nisations. Despite the 1»54 "FranX Stateaent" and aany later plcdgaa, they were for public relations not scientific research. A 1972 oeao fro» Fred Panzer, the vice-^residant of the Tobacco Institute, reveals the Industry's plan. "For twenty years th« industry has operated a holding strategy coneioting of oreatin^ doubt about the health charge without actually denying it*. US then say» Che tiae has coae to challenge the health charge by providing sene credible eltQrn«tivft<; (;uch as ti>« "constitutional hypcth««is". This su9ge««h »«l«ct«d against spdciflc siclantifiu 9oala, but rathar for various purpcftts such as public relation*, political rolatiens, po«ition for litigation ate. Thua, it seems otjviou* reviews of such progranB for scientific rwlavanca and aerit in the saoking and health field arc not li)taly to produce high retij>gs» . Dr rranci* Roa was the reeearch co-ordinator of tha British Tobacco ttPriiP.Brch Council. Be reaeabers visiting the CTR in 1972 and coalns bacX with the view that it waa *a distinctly ehady op«r»tion». It had «juicJcly b«co»« clear to him that tha whole operation was "lawyer driven" and th^ research was beijig ■deliberately constrained*. one person who the CTR tried tw constrain was Dr Frederick HenhuTfer. He had worked with thea since 1954 and built up what ha consider^ tr> he an open ana honest relationship. tn 1973 Or Hoaburger sada a breakthrough. Using a $ophi9ticat«d Kinoke inhalation aachine he succeeded in inducinq cancer of the lai/ox in 47% of a eroup of specially bred Syrian Colden haaatars- These results r»iftAd new warning fiagt dAOUt respiratory cancer induced by inhaled smoke. The CTR were shocked by Dr HoBburg«r's findings and ioBedlately forbade hia to publish until his work was confirmed by others. They also switched his funding froa grant to contract. A few Bontbs later Dr Dontenvill, a Oeraan professor, published the rcoults of a ciailar eurvay he had carried out uiilng Ceraan bred S/rUn hamsters. Uis anlaals were not as su;>wptible to cancer as Hosiburger's but Dontenwill still found that 4% got cancer of the larynx. The tobaccv industry iaaediately disni»ccd Dontenwill 's work as '*aavQrick* and CTR becaae deten*ined to prevent Dr Uoaburger from publishing. Taken together the two survays would be dyneaite. CTtt't Scientific. Director. Rob Bockett, and their le^al representative, sd Jacobs, visited Dr Uoaburger at his Kaune suaacr hou&e. They told his his work had been funded on a contract not grant basis aM so he did not have the right to publish. Hoaburger retorted that the aajority of the work had, mfaot, bean done on a grant bAsls. 535 J^cfjln Chen told hla if he pu^lishod he veuld "never get 4noth«r pcjvny froB CTR". Xft«r micb wrunqlip^ thay finally consented to publication providing Ch« word "c«w8 release with hia and wac to tell tJia press that thP tobacco industry was attempting to suppress iaportant scientific inlorBation about U>e hax-«ful effeot^ of sacking. He wa3 to point specifically to CTR*. zahn explained how tut intended to rubbish uombuxgcr and defalk CTR at the preos oonfereACd but, in the evsnt, it wa«Q't necessary. Zain san^ged to get the conferenc« c^nwelled without UoAburger Icnoviog. He end^ his aeao by saying "I doubt if you or Tea will w«rel ic cutting our throatA. We don't n99i to do it ourcelve***. AIt«r Ouagamer and the othar* left, several strange event* occurred. One of the key experlnents had involved kcepxng the rJocuaents and then shredding soot of thee. Again tce ccBpaoy cen offer no eicpl^nation. The biggeet Jritich laboratory was at Harroqate. It was jointly fundod by a nuxber of UK tobacco coopenie^ through the British Ivbacco Kesearch Council. Peter Lee was eapioyed there as a senior scientist. Re reaains a consul tant to the tobacoo industry. Loe says Rarrogete's vorX vlth ojiiasls failed to prove or disprove a conntjvtion betveew sacking and ill health. However It did becose apparent that thlft research route way running into a cul d« SAC. Rarrogate was clvsed down in 1974 and «uprlsix>gly the TKC abandoneU its research role. Lee has adeitted on canera that he hivself was convinced nf cae association between 9»o)d.ng and ill health, and that the vpideAxological work being condu<*ted at ttie tiav was pretty conclusive. He alxto adaits that the Industry lawyers were around to ensure Inter alia, that eaployeec did not say things the industry sight later regret. BAT. the largest tobacco co»paDy, continued to do internal research work at their laboratories in Southaapton. But conditions were difficult and the publication of results strictly controlled. Studies were labelledt "Must Mot Be <%hovB to ITnauthvriscd Personnel." Dr Jases Green was their Director of H»s*»rch. he becaae Increasingly disillusioned »it he tought to publicise many of their findings. In a aaao to hioself he wrote: "the position ot the tobacco cvaipanies is dosinatod by lege) consideration*. . . .it has retreated behind iaposxibie, perhaps ridiculous, demands for what \n FR terse Is callus •cientifio proof . .usujiI ly the first 538 rtaction of th« guilty*. Hl» wiaow, oiwyn Cr«on, recall* the j rK*.re»slngly bitter fiyht« bctvcon h«r husband and Um BATCO board. "They «imply ignored vhAt he tola tii«9". In 1980 Dr G^««n finally reslsned and w«nt public. M* told Pancraoa: "z b«liev« tihat nrokin^ can c«ua« hArm. I'm quite cure it can end do««. Znfact I quite sure it's • sajor factor in lung ctnc^r In our society*. Shortly «ft«rw&rdc BAT abandoned ill research into saoicing ^nd health. The legal doalnation of t2>« industry had placed the Ptt covpajiy. Hill Knovlton, in an impossible position. The Tobacvo Institute continued trt place a^ertlseatsnte saying they were actively Investloati/ig the affecta of eiBoking on health but the Pft profesaionale toaw tha truth. me orlqinal "FranX St«teaent" strategy vae a shaa. HUi Knowlton arqued liercely thot a better way for th« industry tv proceed wo4 to cor^oode the old products oay have soae potential he.^lth risXs and to swiftly introduce now tafar cigarettes. This would have the advantage f being honest and sight ev«A win baclc saoXer« wnc had quit. Hovevar tb« lawyare vould have none of it. Their view wa« the ind'oatry should tough it out. Ko cuncessiona and no eafer cigarattea. In 1970 Rill )fnowiton resigned the entire tobacco industry account. Lo«t Velaans recalls the final aonthft. "Everyone was frustrated. The lawyers just would not coniiidev any other etretegy". Tgy ther products were less safe and began inaiRting on euphealypv liXa "kinder on ycur throat" and "allder". Thace legal concerns were to dog the industry for the next thirty years underaining any attoBpt to devalop a genuinely safer cigaratte. une such attesipt vea aade by BAT in the 1970 's «ith the introduction of •Hon Tobacco rtaterials". HTH was Q Icce coaplex K^tarlax and less ^arAfuI thaA tobacco. 539 Panorasa Day obtained a copy of a legal c;plnlun about in^ givan to BAT in I«7«. The b«rri8t«r ;>aid that "All asecrtiuns that HIX is safa C^f ev«n safar) ahoold be eivcide4, oot least b*caus« of Ui« subsidiary iopllcation that Tobacco is not safw (or lass safa)". This sdvlA* prtvanted BAT froa aark^tinq WTM in a way tliac, would appeal to tha eonauacr and, coupled wiUi th« gonrerrus^nt ' e rafusal to givs NTK a tax Advantage over tobacco, n^arit KTM could naver b«caB« a visible prvduct. Xnothor atteapt to produce a aafar cigaratte wa* »ad« by Llqyet: t Kycr«. Tliey spent twerrty yoar* d^v^loping "Tajae* - a cigarette with a revolutionary Pallaoium catalyat. This oatalyat d««stroyed one of the major cancer caueing irvgradieot^ in SAoXt. It'e inventor was r>r J4fle« MolJ. He saye the Palladium catalyst would hav« saved "thouaondc of lives". But it was nevar narXeted. One roeson was the continued hostility of Ligget ( Kyer'e lawyers to tfle vlwle project. The xvost seriouc attor&pt CO nanufacture a oafer cigarette was aade by Rj Reynolds in 15t8. tteey epent $300 tiillioji developing a revolutioiiary new product called "iTeaier." It looked llxe a cioarette but ccuid ecr^ accurately be dcecribed as a nicctln* delivery systea. Prenier didn't bum to&acvw * it heated it. This aeant nucb of th* materials present In coir^entionai cigarette snoke vero not prwsent in Pre&ier. It really vas a aajor breakthrough. snooK, Hardy and Baoon, the industry's lawyers, didn't eee it in those tcme ■ Panorama TiAS obtained a scoo froa chea coKisencing on Preaier. They were very concerned that it "nay threaten current litigation etrategy". They warned that Reynolds' new product "con<;ed«s certain shoirtcouings of their existing producta" and repeated their view that "the devalopaent of this product ray Qave significant effects on the tobaooo industry's joint defence efforts". Preaier was pulled off the sarJeet thrf>e aonths after it had boon launched. Dr Hoffaaa of tha AaerlCan Health Foundation believes "thoucands of lives would have been saved If these Bodified cigarettes bed been properly aarVeted". PanoraJta has discovered that at laaet four Safer cigarette patents hav« been filed with tha U5 patents Office in the last three years. Honp. havt gone into production. 540 Th« industry '» big9«at »ecr«t only (^sj« to light last year when a US ju49t pu]Uli.6h*d * reaarkobXc le^al opinion. In 1988 .7odge L«e StroXln presided over th« Cipollono ca»«, th# only tobacco liability oac« tb« industry did not inititily win. L43t year SaroXin va« preparing to h««r his second tobacco &as« when be vac ask^d to rule ^n the admissibility &f a nusher of maustry docuaenU*. Md read a &A»ple selection *r«a concluded "the tobacoo industry ft«y b« the Xing of cuncealaent and difii. >->rBation'*. JjaroKln had uncovered the industry's innernost secret. Shortly aftervard* he was re»ov«d fron the case. Sarokin had found out CTK had never aj^andonod research intd the haArch in this division could be kept coapletaly confidential, coiHiiii*sioned solely on j» contract basis and orgdnised directly by lawyers thufi maXlnq it attorney/client privileged. X protective shield had been ocnetructed by the lawyer* CO keep diuaaqing research fro« disclosure, we have di^^covwred that epeaiai Project* worked secretly fron a tenth floor office at the CTR bulldinq in l«ew ifork, where they ran one of the biggest computer centres then in the US. n* plan to interview a rare pr inary source on this revelatory cubject. Given the publicity attached to the "Frank Stateaent" and the repeated plodge to infom the consuner, SaroXin believed the public had a right to kno* about special projects. He al*o Uellevttd that many of the tobacco li ability lawsuits would have had a different outcome had their r^seaxch been published. 3arokln argued that claiming this aaterial «ak attorney/client privileged was an abuse of the law end the lawyers should hA subiecC to a crisinal prosecution. Ke told t'anoraaa (on e bockground basis) do^ruments showed the fraud was orchestrated by Shook. Hardy and Recvn. Ken Warner ha* studied a list of Special Projects briefs. Be was aetounded. "speclai Projects wa» at the forefront of tobacco health research. I had no idea tho industry was doing such state of the art work". one of the key player* in Special Projects was Ur Frank Colby, the farecr Reynold* scjentist. He qav« « deposition saying he was "»» person wearinq two hate. No l, he we« a person in charge of R»D inforiMtion; K© 2/ he waa rA«ponsive to the lesjal dept". 541 A few yOAM •arlipr Col&y had explained th« way "Special Pro jeers" worR*^ to Dc Jvhn Slade, • prefaasor at th« Rob«rt Wood Johnson Medical School. Sladc V4S reviewing a cm pablieotion dealing with th* ehroi^lo exposure of mice to cigar«tt« RroVe and he waa puzzled. Th« book's conclusions supported the industry but it vae controversial work of a type not usually dor^e by rrs. .siade contacted Colby and »sXed hia to Ivmeh. Colby explained the project had originally been coa»is5ior.ed by Special Projects but whan tbe conclusions had coa« out so favoui^ably for the industry it was decided to transfer the book to CTR. "Don't expect too aany others" joked Colby as the lunch ended. Colby's short explanation providec the only Insight into Special Projectc yet given to the outside world. However nwre inforaation may cone out SOon - the Bi^woklyn DA's office hac launched a criflinal irvveetigation into CTR'c Special Projects. Judge Sarokin has identified th« fundasentai issues in this story which concern th« relationship between big business And the public. In hie Opinion he writes "all too often in th« choice between the physical health of v^x^nsuaers and the finanoial well being of liusiness, concealnent is chosen over difcr.losure, sales over sofcty and Boney over worsiity". PanoroiM's reveletiens will only add to Ms concerns. As tha industry's profit-s continue to rise; as the cigarette salesmen BOve into the uosu^pectino third world; as a new generation of gullible youxigeters in Britain and throughout the Mest take up the snoking htClt for the first tiae, the duplicity of the totecco iodustry is brought to light, it has already cost the lives of Millions of people wno bought their pack of lies. PLEASE NOTE: THIS IS hH INITIAL RESEARCH BRIEF ONLY. ALL ItA7I3^XAL MUST BE CH£CKSD PRIOR TO TRANSMISSION. 542 C^LU/ /B THE /f >7V£RSrrY OF TEXAS Srf. vf CAS'CER CESTER June 27, 1977 - / Kr. Don Hotl ihook Hjr^jr I Sacon 20t.l noor-M«rcantnt 3»nk Towtr noi Wjinut JUnsas City, Missouri 64106 Ot»r Don: G3!iFiOEiiTIAL Enelosed 1r i budgtt ta tntbit us to coirpl«t« t.it voluwt on tht — «nv1ponr.«nt*l fictarj «nd uch eaust of death, son Important asotcts -of -hich I reported at the Maxwell Conference as they pertain to lung -cancer, and the textSook on epidemiology which t>e publishing company -has suggested be written as a second volume to t^e 700 page incidence of cancer reference book, which will be published In October by the -Raven Press. The Claj-ton Foundation enab'-i us to continue our staff from June 1 and will carry us through Septar.ber, 1977. Mr. Maxwell wrote me a letter saying how much they enjoyed the talk and especially the question period and said that if I had been -the only speaker they would have enjoyed asking questions for the •M.floie three hours. I aissed you and Alex. This 1s my revised budget to go with the report 1 submitted earlier. £JM:eh cne. -Sincerely, Eleanor J. Hicdonald Professor of Epidemiology Cepartnt«nt of Epideoiology PLAJNTIFF'S EXHIBIT Of 77 «4-f*«T JOA I w 0 <\3/ i!o\ -os.'rTAL *so n«o« (.vjrrrtTT j.i-.v./.Mr.^ c»«>». tXTI \u:t ,1, noCLuii OlH:iC.'< »>c*^«tHc1»n (SO?) Assistant £s~i->' s» s*e.•' ••S3 C>* •!• Mr. Millia-i w. Shinn Shoox, H«riy ( 3AC3n 912 Gr&nd Avsnua Kansas Ci:'/, Missouri 64136 Cear Mr. Shi.-..-i: This is a rtq-oase Jcr s-.-cscr; a* a plan.-.i.-.q ^ra.-.t fsr nascpul-Torar/ rascar:.". srapar^tary -s i-^nxasicn oi a ;3r--al ?rc?csal en t.^.a affects ci tocacco a.nd air pollu- tants on t.^a 1— "^9. I am suiritti.-.g a curric-xlvjn vitaa for rvstlf a.-.i Dr. Xawa-TCio, v^ca I am tssi a.-.xious to 'U4la|.r r«Ti7t^ t 2Md«r -'•MUnL 31 V«.t )!.•( Scra.t Racluf.U.r Cttu Km Tsrk, )l. T. lOOD 0..r 141 I m wTlttat cat. «««rvr to d.«ertt. (brl.fly. a* you riqu.tt*.) tha r...«re& (sr wMca I ih&ll preb.bl/ nt*. tupperc (at th. ;«rlo4 (rn .'.au.ry ; ta Juna 30, 19i«. 7h. .muoc a««d.d 1. S 359}, wnie& laeludi* ] 3001 far . rti.ireA uil.c.ac vtt& * ^9H d^ir*., wha I. teciv.ly workiai oa t^. i.e. at e.ae.r »t eha I.rynx; ) :3i7 far a ..er.e.rt.l u.l.taac; 4a4 t 200 tat •Xac.U«n.aua auppll.a. T^. r.s.area csaaiatt at int.nilv. itudl.a at ttia ucjr.i caurt. •a4 patt«ca.r.p.utle aucca>. •( !!rr«8 dtff.riac eane.rt: lunc. r.et.A, .ad l.rrns. U. ^.v« werkid auc rp«ftl..rta b<«a sa^::td frea •eat (xlaelAi (tudl.i at cnc.r— Mlnly. ^.caus. :!ia d.c. v.r. rafariad aa oa cesplas ta ba unafad aad analrtad. Uain| prlaciplaa at "cllalcai tuanear", ay^alle lagle, and lat etvaery, w. h.v. wockad aut t^a cae-^al^ua. iat ldaatl!yla|. claaalfylat, ud «nilr«la« aasy "Tanabl.." e^.t !i.v« htth.rta ba.a :s^r*4. Tha raaulta af aur eurraat WAljtaa h.v. brau|ht Maatdarabl. cUrlllctiaa ea . Bvob.r at laauaa that H«t« ^Ita.rta ba.a rasard.d .a eantrav.ralal ar Upaaalbia ta aealyta-^baeauaa aa ana ^.J r*Ally htth.Ra verkad aut a v.y ta aaalyta thaa a/faetivalr> Vle& tha »•« tadknl^uaa, w. h.va arfaaliad cha data ta a (at* vhara thay eaa aow ba atarad la a cecputar, aaalyiad avaa aera lat.aatv.ly, an4 uda rvatiaia far practleai uaa la futura tppr.laaia at .tlalesy, pretaaala, aad tharapy. la a4dltiaa, va ha«« abtainad a g^aat daal at aav data aa tha ral.tlan- ahlp af elgaratta awktai ta r&« eauraa aad blalafle b.h.vlar, rath.r thaa tha eauaa, af thaaa thraa eanura. If dg.ratta «ekla| la .a hanful aa hu ba.a .i;.(ad, It ahould BAC aaly "causa" th.aa dlaaaaaa but ahould alaa s.ka thair aaaifaatatlona and outeoaa woraa la p.opla wha vara aaekara. Tat, la tha mforaai wialyaaa wa h.va den. aa far, aa aueh eliateal affaeta hava baan necad. Tha aaalfaatatlona a&d eouraa af tha dia.aa.a da not app.ar ta ba yealtlv.iy csrTalatad vlth tha anevmt, If any, af el|arac:a aaoklnt in tha aff.ctad ;atlaata. Our ^ aauMratad an.lyala af thaaa d.t4 baa ttltharta baaa lnfera.1, hew.v.r, .ad X new ^ H PLAINTIFF'S EXHIBIT crz7 546 COiVFIDtf/IMl t4wla J. J«eek - 2 - Movtabtf Z3, ;9«J v«ne t» M«9>4v« tucA lot«Mivi 44e« for Ucut UOO 7tci.itva plaead irtnt tppUettloaa vtch cv« dlfftrtr.c tttneita chtc will tueunct e.^tir daeltioot la ald-9aea£bar. Should boca ttiselti rtjaet cha tppU&tciooj-— t icroei pottlbtllcy la chli «ra wr.aa 30 oaa laasi :o waac to lupporc tll-litl rttatrch— I ihall aatd tSa >.alp I htvt cltad uacil I can cospota tddicisnai saw (rtat tpplleaciona ca ochtr aianeltt for iuppocc aicar .'ub4 ^0, 1H(. If yoM waac rtprlsci, furchar daacriptlo&j, or tnj achat la/orsacm about chla aaccar, plaaaa lac aa knew. I (hail ba a«at (rataful for aay nalp 70U tad /our cellaaiMta caa previda. Siadaraly Toura, .^C,.-. Alvaa X. Ftlsjcala, M. 3. ■toelaca ?rofaator of >Udi:ia« JJJ/lt K 547 COKFIDENTIAL University of Hav/aii at Manoa B.is l«tttr is for the ?ur?cs« of recording the esser.tial features of our recent telephone conversations concerning the funding and operation of the pending research program on eenet: and to'aacco-related behaviors. It has been agreed by the investigators that I should ser-. as coordinating investigator. In this role, 1 would serve as t c=.".unication li.-\J« between the investigators and the granting consorti'ua. I would be responsible for cocrdinating the prspa: and subaittal of required fiscal and scientific progress report and arrangi.ng for periodic rr.eetings of the consulting and revi< panel. wo Responsibility for the scientific conduct of the research uld be assuned by the principal investigators of the three separate projects, as follows: Hawaii study — Geoffrey Ashton Half sib-fvin study VJilson Cr-or.rac'Ner and Steven Vandenberg Anir.al study Gerald t. .earn PUklNTlFF'S EXHIBIT 548 2--Mr. iivi.i :. J«c:'3 Asr: Th* principal ir.vtsticAtors would b« rasponsibl* «or axpcr.dituris en thair particular projacts, and would hava !re«d:- to transfar funds ar.ong bud^at cata^orias as raquired. Wi^h nutual eor.sant of t.'-.a principal invastijators involvad, Jvir.ds could ta tra.-.sfarrad bafvean projects. Howavar, all axpe.-.di;-r*s would ba r.ada in cospliance with t>.« applicabla stata and Vnivsr- sity rulas of Colorado or Hawaii, as ralevant. T>.a consulting and review panel will be cor.posed of scientists rutuall/ acceptable to the investigators and to Or. Willim Gardner. After a period of apprcxinately 13 months, a aeetin? of the consulting and rsview panel will be convened to evaluate progress of the projects and to r.ake recor.Tiendations to the grantors concerning continuation of support. Zn the case of a reco.r.-aendation to discontinue a project, f-ur.ds for phasing out the operations will be continued at least in ar.ount sufficient to r.eet staff personnel obligations for a period up to an additional six .T.onths, depending on the ter-a of er.plo>"nent. Assu.-ning that obligations have been undertaken to cr.ploy staff through the full second year, the a.-ount of savings fron the second year budget that would be nade by ter^Mnation of data collection and analysis after 13 -cnths would be apprcxi.T.ately is follows: Hawaii study — $32,076 Half sib-f./i.T study — 530,737 Ani.-nal study — $27, 268 If obligations are underta!cen only to provide 60-day notice of termination of er.oloyrent, then additional savings in the anounts of $7,400, $5,0C0 and $40,000, respectively night be r.ads. If the circu-T.stances are such as to warrant a conti.-.uation of data collection and analysis during the phase out period, a nerctiated aT.O'unt not to exceed the budgeted a.-ount for the next Sii r.onths, but with a longer tir.e li.-it for expenditure, ••ill cs Tide available. In the event of favorable rsrc.-.-.endation at the ti.-e ci C evaluation, research suttort ./ill be continued, and a saco-.i .,: evaluation r.eetiT-.g will be held approxi.ratel/ at the end of 27 -o-ths. The purpose of this r.eeting will be to evaluate progress ind to na;;e recor.r.endations regarding f-unding for th« fourth and fifth years of the study. I an anxious to know if the above is an accurate su.T.Tiary of th« principal points of our discussions. Sincerely, Q. lYd E. .M Gerald E. .McClea: V 0 549 UNrVTRSITY OF CALIFORN'lA, SAN FRANCISCO <^r^T •ewcn • t^'ti • 0>'>T»< ■ uffl •cRook or >rTBie<* DUAjimx.vT or ttBiat S«ctlsa of Hs July 20, 1972 Dlrtct: (*LS) 666-17U icelet7 «^ Xa8uool0(7 Kr. Edvla Jacob laucarscola i Lauttrsttls Ooa Xockaftlltr Plau H«w York, Nav York 1C020 Oaar >ir. Jacob: CONFIDENTIAL Aa par your raquaae, aneloiad Is ao oucllna of ch« raeloaala rt: trudy for liixaga of ear^sin Ca (aaotypaa eo chroale obacrueclv* , dlsaaaa, aapaelally, aophytaaa. I did sosa of chU rational* praviou.«Jvi howavar, with cha appaarasca of cha dau chat tha alphai-iocitrypsln t*=ocypaa ara liakad to tha Ca (anetypa locus BAkas avaa aoia aaasa. To star: chasa atudlas, I thlak i: would ba baeafidal to hava Dr. Joha Vivlaa Walls as cha 'rlacipal Iavasci|ator, ilaca ha was cha firsc CO daooascrata thac a glvaa Ca (aaotypa waa Uajtad to haight of l^uaa rasponsa co any ancigan la saa. ( Ua gava you a raprlae oa chl»; hovavar la cha avaat you hsva adsplacad ic, tha rtfaraa:a Is: J. V. Walls, B. R. Fudacbarg aad I. R. Maekay: Salatloo to tha Husan antibody rasponsa to flagallla to Cm Casot/pas. J. :=;ur.ol., _i07 :liOJ-lJU, 1971.) As you knov, sosaalphd^-aatltrypsla ganocypas w.tich ara rara ara cot assoelacad with raduetloa of activity of tha a:?ha;-a.iei:rypsla. Thus, tha oeeurraaca of aaphysama la chasa paclaats alghc aaraly raflact tha fact that li.::J(aga of tMs locus to this locus to tha Ca locus rathar thaa tha fact that tha ?1* honotygotas ara prona to aaphysaaa. Aaothar raason for hava Dr. Walls partielpata la cMs study is that ha has Just diseovarad th« first human gacatlc aarkar for Ig.-<,(J.V. Walls, J.r. Blauaars aad H. H. Fudaabarg: Huaao Aati-IgM Iso-Aacibodlas la Subjacts with Salaetlv* IgA Daflclaacy. Clin. «.re. Irsucol.. in srass). aad It is coBcaivabls. that li COFO or aaphysaaa aloca is sua to aa iaitlal Insult by a virus or ethar organlsa to which tha antibody raapoasa is I(.1, tha aaaa data aight held trua thara, l.a. tha liakaga is dua to ItM gaaetypa rat^ax thaa IgC. PLAINTIFF'S EXHIBIT au f^*^ ^>a» m^» 30 •.tir.utd / / 550 Mr. Etfvla Jacob '• f«|t - 2 - July :0. IV2 COHFlDElillAL Out to tht f««t tJi*e 3t. '••U« li «a M.3., Ph.D., «sd ftirtl.-.i »*l*r/ for A«*ljc«ac ?r9;«stot of M»ii:i=t 4e th« ';alv«;si:y e/ Caii/orsi* (ir.eludiac friai* baatfl:*} i.* A;pr9xi=At«l/ JZJ.OOO p«r yt«r. tad liac* v« havt {ou=i It 1« Bueh MSi«r for « iralatd phytldaa (•specially « faculty aaaoar) to ebcala ceeparatioa froa tha various pulseaary tpaelalists hart, Kalsar loapltal aad echtr laatltutloaj .in tha lay Araa, Z thlak it would ba aucit •era affaetlv* to previda funds for Or. Wa^s tl^a aiaply for a poatdoe. Turthar, va would test for aaay aera Ca factors thaa orit'iaally prastatad, l.a. oet ealy tha aajer flva or iiz, but parhap* 20. Or. Ualla would alto raqulra about $2,000 for luppllaa. Tharaf ora,cha total aamiat would ba $30,000 for ea« yaar. If wa gat ratulta durlai this tlaa, va could put la for t NTH grtac for purtua this furthar tad pathapa ihift out allocatieat froa tha A."Jk-OJ |raat la part for this purpeta, tlaca tlpha^- aael:r7-psla gaeotypa characttrlxatloa by tha Ft(arhel aathod would ba ptrc of tha prejaet. Wa ara aquippad to do this. As you ara avact. Dr. Vails has baaa offarad aa Asseclata froftttor potlciea •Isawhara, tad aust aaka a deelsloa by Sapta^^ar 1; tharafora, ta early rtply would ba iraatly tppraciatad. Pltata lat us kr.ov if you ara iatarastad. Or. Walls would prafar s:tyla| hara if fua^s caa ba arraagad. TharJc you. Vary siactraly. H. Hu|h fudanbarj. M. 0. Profaster of -adiclfta, CC, Saa Fraacisco Prefassor of Saetarlology and Issurxioxy. l«'C. Sarkalay HiT/tw tad. Oucliaa of lacioaala it c 551 t/fMU/9 Public Health Policy Forum ■■'-■".. ■ - ; -'-■ W • i Tobacco Industry Scientific Advisors: Serving Society or Selling Cigarettes? ABSTRACT According to induary docu-- meots, cbe tobacco industiy has ex- ecuted t "brflliantJy conceived" strategy to "cieal{e] doubt" in the public's mind about whetber ciga- rette smokmg is in fact a serious cause of disease . A compooent of this straie^ has been the funding of sci- entific research "into the gaps in krKjwIedge in the smoking controver- sy." Grant review and selecboo are perforiDed by a group of itxlepeodent sdentisis. Knosk-iedgeable observer? believe that the oostesce of this re- search funding pcogram in general, and the Scieniific Advisory Board in particular, is intended by the industry to reinforce doubts in the public miiid about the severity of the hazards posed by szQoldng. Because the Ad- visory Board has never takes a public stance against the indusoy'i posilioa that the causal relatiocsfaq) between smoking and clis^a^ remains un- proven, I polled these scientists to determine whether they believed that smoking is a cause of lung cancel. Despite repeated opportunioes, only four of 13 board members respooded. all aSinnatively; two othen hcve oc- pressed their jvxjgnieot that smoking causes lung nncer in tbeir prote- sional publicatioas. Thus, c^er half of the Board members, and the Board as a wbde, have not gone on recotrJ as rejecimg the mdustry's "party line." It might be hoped that the American scientists would foUow the lead of the members of a similar body of scientists in Australia who have taken a strong and public stand against the industry position that smokmg is not an established cause of disease. [Am J Public Health. 1991;81:839-842) Kenneth E. Warner, PhD Introduction For nearly 40 years, the tobacco in- dustry has maintained that cigarette smok- ing has not been proven to be a cause of any disease. In what a vice president of the Tobacco Institute charaaenzed as a "brillianily conceived and executed" strategy, the industry has consciously striven to "creat(e) doubt about the health charje without actually denying it."' Tac- tics have ranged from anempis to define the smoking-and-health lexicon for soaal discourse (referring repeatedly, for exam- ple, to a scientific "debate" about the smoking-and-health "controversy") to publicly distorting the findings of scientific studies linking smoking to disease.^ Another taaic has involved direa sponsorship of biomedical research to lend credibility to the industry's claim that it "remains commined lo advancing sa- entifk mquiry into the gaps in knowledge m the smokmg controversy."' Toward this end, in 1954 the industry formed the Tobacco Industry Research Committee (TIRC), renamed the Council for Tobacco Research-U.S.A. (CTR) in 1964, "to pro- vide financial support for research by m- dependent saennsts mio tobacco use and health."* The public was mtrtxluced to this program in early January 1954 in a full- page advenisemeni run m 448 newspapers m 258 cities, reaching an estimated 43 mil- lion Amencans. Entitled "A Frank State- ment 10 Cigarette Smokers," the ad said that the industry would sponsor impartial saentific studies on the relationship be- tween smoking and health and would "let the results speak for themsetves." The ad assured readers that the tobacco compa- nies "accept an interest in people's health as a basic responsibility, paramount to any other consideration in our business . . . We ahA'ays have and ahvay^ wilJ cooper- ate with those whose task it s to safeguard the public health."' Readers of the Jouma need no as- sistance in evaluating the socenty of thai "frank statement." More can 30 years later, the industry continues to use this sponsorship of research to jnempt to cre- ate the impression of "soeaufic contro- versy," and of the industry s "well-inten- tioned commitment" to "raoMng" the "controversy." This is demonstrated in the foUowing statement fran a 1986 pub- lication of the Tobacco Insmuie: Industry suppon of independent re- search a in ^-'^•^y of S130 miflnn and has resulted in pubticauoB of nearly 2.6G0 soenuhc papers. £>vKn/ scien- ruts belifi* that qu^sncra relatv^ to smoking and health are wvesoKed, (emphass added) and the tobacco in- dustry will maJte new conBunr^nts lo help seek answers to those questrans.' While the individual components of this sutement are literally accurate, the intent and effea of theu- wording and their juxtaposition are to mislead. The state- ment implies that the industry's grants suppon research direaed at resolving "questions relating to smbkmg and health." In the main, ths s simply not true. Most CTR-funded grants support biomedical research not related to the health consequences of smoking. In a re- cent survey of principal invcsiigaiors funded by CTR grants in :989, almost SO percent of respondents aidicaicd that none of their research, current or past. Address repnm requests lo Kennelh E. V.ar- ner. PhD. Depanmeni of PutBC Heaiih Policy & Adfflinisu^iion. School d Public Healih, University of Michigan. ICO Wa^hmgion Heights. Ann Artot. Ml JJS1.^2(nv. This pa- per, submitted lo the Journal JuJy 17.1 WO. » a.s revised and accepted for pi^acaiion February 13. 1991. Juiy 1991. Vd. 81. No. 7 Ajnerxan Journal of P-abtic I (ealih V r«b6c f.adk Pvbcr Fa 552 examined ihc hcalih effects of snx*ing.» Funhcrmore. ihc vast majonty of ii«h»- iry^upponcd research that has addressed the health effecis of smokjng has produced findinc> consisicni with the Surgeon Gerv cral's conclusion that smoking is a major cause of numerous diseases.'"' The second sentence of the Tobacco Insiiiuic's statement might readily be in- icrprcicd to mean thai eminent scientists question whether smoking causes disease. V-Tule scientists do have questions about the specific mechanisms of causality, there is vinually no disagreement that smokjng IS a major cause of disease. In the above-mentioned survey of CTR grant re- apients. for example, over 90 percent of the respondents concurred with each of the following; "most deaths from lung cancer are caused by smoking", "snKike from someone else's cigarette is hannful to a non-smoker"; and "dgaiene smoking IS addictive."* In addition to disioning reality in its printed matter disseminated to the public, the tobacco industry has appealed to its ongoing "cotnmit[meni] to advancing sa- entific inquiry into ihe gaps in knowledge in the smoking controversy" in dealing with the media, in presenting congres- sional lestimony , and in defending itself in court against charges of produa liability. Examples are noted below. The industry's use of the CTR grant program raises a number of difficult and uoubling questxjns, including the follow- ing: Should saenttsis directly lend their credibility to the industry by serving as members of its Saentific Advisory Board, the body of independent saenusts who perform grant review and selection'' As either advisors or reapients of funding, what obligations, if any , do scientists have 10 the larger soaety as a resuh of their mvolvemeni in the CTR pnxess? For ex- ample, do they have a moral obligatmo to publicly suie their disagreement with the tobacco industry's position that smokiDg has never been proven to be a cause of any disease? Ai a purely pragmatic level, does the scientific knowledge generated by CTR-funded resean:h pnjduce sodal bet>- efits that outweigh the costs of the indus- try's deceptrve pubbc relations use of the process? At the most fundamental level, should researchers accept financial sup- port from an industry that annually know- ingly causes the deaths of sottk 400,000 Amencans?' These questions could be the subject of a detailed treatise in the general domam of the ethics of science. I leave that task to others. Rather, my purpose in this paper is simply to relate, and put into context, the saga of my attempt lo poll the members of the Soenufic Advisory Board to deter- mine whether or not they bebeve that smoking causes lung cancer. The experi- ence offers lessons to ihose who iTughi wish to tackle ihc more formidable assign- ment of an eihjcal analysis of saentists' involvement in tobacco industry-funded research. PoO Process and Results Elements of the public might be led by industry siaiements such as that quoted above to infer that the CTR's Scienufic Advisory Board (SAB), representing the broader biomedical saence community, shares the industry's "uncertainty" about whether smoking is a true health hazard. Because, as a body, the SAB has never gone on record as rejecting the tobacco industry's position, I wrote to each Board member on August 4, 1987 asking for a yes or no response to the following question: Do you t>e)ieve thai cigarette smoking causes lung cancer'' In answering this question, mierpret causality in its lay public meaning. You should respond in the afiiniuiive if you believe that smok- ing, or any of the components of aga- rene smoke, either iniuatesor prtxso- sequenily. ihe fits trial WIS declared a inisihaL I testified al ihc rcmaJ on September 11, 1990. My lestumiy did not indude mentioo of tbs poO. ' "CoQsisieni wnh tins Board member's a meni was i ptene convemoon wn)) mother Board member. Each of ftpproxmuiety 20 quesuons 1 asked efaaied the uirvvyuf reply. "May I )us thaok you far caOmg?" He refused tocqriaMi wfay be woutd OOI rofxind to the poL ^ Amencvi JounuJ of Public Health July 1991. Vol. 8U No. 7 553 Octcber, 1977-Se5:er;er. 1973 81om«tHc1«n (50?) J 12,000 Assistant EjidtfflloloslJt (1005) 14,S6"5 Assistant Eoldiffliolojist (lOC:) 14,865 StzrtUry (10«) 10.495 ProgrMotr {33t) 6,4S\ S/sttas Analyst (Consultant as "•«^»^) 3 . SCO -Subtotal g2j7g Coweutir Tlffit 4,800 • Consumablt Suppllts lioOO Travtl 3,000 -Fringt Btntflts (Salaries) 6.218 •• -Subtotal IS. 018 -Subtotal -77.194 -1S5 Overhead -11,579 "TOTAL 8fl,773 COf'FiOZCTlAL K -June, T977 554 tji^U^i^ JU) A W S T R A C I docQmcntmg (be hsztrdBoi optrette SDokiDg, the tobaooo izidustty denies thu smoking hu beea pnweo to cause disease. Tbe indusuy pro- foaes a deaie to dear up ifae oDok- ing asd beahh "quexooD" md oAea points lo its suppon o( the Qxsval for Tobacco Research (CTR) as evi- deocs of its inieresi is investigaliiig the beahb dasgen of siaoldng. This paper presents results dl a survey of CTR-funded scientists regarding their bebefs about the beahh daogen posed by siiK>king cigarettes. The vast majonty of sdeotiss funded by the CTR believe that cigarette smok- ing is an addiction that causes a wide range of serious, often fatal, diseases. This result suggests that tbe tobacco indistiy is unwilling to accept even the opinions of scientists it has deemed worthy of fun- sively documented cause of disease ever investigated in the history of biomedical researdi."' Despne overwhelming scien- tific evidence against agarenes, ihe to- bacco industry continues to assert thai controversy, debate, and uncertainty ex- ist among scientists concerning smoking as an imponani cause of illness.'^ Id 1972, a confidential memorandum frtMn a Tobacco Institute (TI) vice-pres- ident described TI policy as "creating doubt about the health charge without de- nying n, advocating the public's nghi to smoke without actually urging them to take up the practice, and encouraging ob- jective soentdk research as the only way lo resolve the question of the health haz- ard."' Industry spokespersons often pouit to the mdustry's support of the Cound) for Tobacco Research (CTR) as evidence of corporate inieresi in obtaui- ing saentific evidence on the "alleged" relationship between tobacco use and disease.' The CTR, formed in 1954 by cigarette manufacturers, describes its primary mis- sion as support of research mto questions of tobacco use and health.' The council awards peer-reviewed research grants to independent scientists who are assured complete scientific freedom m conducting and pubiishing their studies. Since 1954, the couDCi] has provided more than S150 million for 1,108 original studies by more Chan 700 scientisu.' In 1989, the CTR listed 204 active projects. We present results of a survey of CTR -funded mvestigaiots, which charac- terizes what the investigaiots believe re- garding the health effects of tobacco. Methods and Mataials The study population included the principal investigators of research projects funded by the CTR in 1989.' Of 204 mvestigatois Usted, 179 were kxated at univeisities or institutions in the United Sutes. This survey was rearided lo those working m the United StJKs. Eligible survey participants were mailed a one-page questnnnaire assess- uig their belieb about the relation be- tween cigarette smoking and various health complications and asking them to rank the importance of 10 different areas of tobacco research. Respondents were asked about their currea and past re- search on tobacco and their cigarette smoking suttis. A cover later suted that we were surveying "socnpsts who had ubiished studies on smobng and health and/or have received research support from organizations interested in the to- bacco and health issue." Of 179 questionnaues mailed to eli- gible scientists in July 1990, 13 were re- turned with an inoorrea mailing address. .\ total of 77 completed questionnaires were returned, which represents a re- sponse rate of 46*1 (77A66). No further anempt was made to elitx response. A comparison of responders and nonre. sponders revealed no significani differ- ences in academic credeocials (PhD vs MD), tnstiTutional affUiatioo (university vs other), or the nature of tie CTR-funded prriject (i.e., a tobacco sody vs a nooto- bacco study). Results Respondents were asked to "indi- cate the (iepee to which you beUeve tbe scientific evidence suggests a causal re- lationship with cigarette smoking" for K. MichaeJ Curanuogs, RisKfi Saandra, and Amy Gingrass are wnh the Depamueni of Can- cer Cooiral and Eptdemnioc. RoswcO Park Cancer Institute, arid Ronald Dwis s with the Othce on Smokmg and Health. Onicr tor Outxuc Disease PrrveDOOD and Hcaiili Prt>- modoo. Centers for Dtseax Conmil. Requests for reprmis saould be sent to fC Michael Cummin^ PhD. 4- cates the industry does not accept the opinions even of scientists whose research it funds. Although ackncwiedguig a need for additional investigaixxi of the mecha- nisms linking smoking and disease, re- spondents gave the highest priority to re- TAMf V-ftriW* Mod n* SnuMnQ tiSs: 1 Net S»cng ModM SUft S0MObtwO ■nnaCaniSaai % % % % EmphyflamB a&s ai7 . 1.4 Qvoric NdiUli n.i 2ad 1.4 1.4 HewttAMSM er.i Z7.4 2.7 2.7 UwtinhMgM 51J aoB 1ZS 4J Li#ig caxar 902 S.4 1>4 Carcar aim mouTi. tmtl 7«.1 114 ^ 13 10 24J 7S4 16J 1U 42 2B.1 >«rf Totaeo) Smoka, Smokkig la ooUng aa an AddcSon 1 Primary Caua* ol Uwq Canoar, and S Agrae 9ron^ Sawnert % Somewhil % Disagree OisaTea Scnwutl Stnri^ % % The amoka from someone else s (SgarsOa e hantj to a rorarroksf 5ZS Most (ieaths from kxiQ cancsf are canwrt by CjgarBOa smc*slrg 662 41.4 25.4 15J 57 - 8.5 1.4 - TABLE 1 Mian Ranfckiga (X Sm >n«ji1anea et 10 Anaa ol RiiiBih on Tafaacco Petcert RarMng Mean SandBR) Area as Top RaseardiAraa Rai** OevMkn Morty 54 29 19% SmoMng cessaon methods 52 zs 14% K4eQplB9ic doeaaaa 5.1 3-1 21% CanSmascular dtsaaaes 5.1 Z4 8% Pieyiarcy and lr*ar« h««i 4.9 2J 7% htomeoplasDc raspnaoy deeeeec 4.6 2J — PaBst« wnctong 27 24 9% e% Tobacco •conorntei and te^EMtan 3.4 14 12% Tntms ac^vtarg 3A 2.9 4% •^fta wig* tan t»r - i e n^ - ia search on tobacco use prevention and cessation. None of CTR's active research projects reiaie to these topics. Despite its stated mission to fund resean± into the eti- ology of diseases "alleged" to be related lo tobacco use, only 1 m 6 CTR-funded sci- entists reported conducting research fo- cused on the health effects of tobacco. We suggest that rather than sponsonng a genuine "program of research into ques- tions of tobacco use and health"' the CTR is a public rclabons vehicle Intended to foo- ler a false impresskm that dgaretie maiw- bctuieis are interested in iirvcstigating the sinokiiig and health "question." We believe sudi msuse of science raises senous ethical questnos for sdenlisis who accept funding through CTR or similar industry-supported entities. Evm assuming that adeiyaie fund- ing is m) zvailaUe elsewhere, tobacco in- disDy-supponed soentisis must ask them- selves whether the value of their research in expaikfing die body of biomedical knowl- edge ouiweigfas its utiliiy in funbenng the corporate inieiests of a busness whk± kills 434,CD0 Amencans every year.' O July 1991. Vd. 81, No. 1 Aaenae Journal a< PuMc Htydi 895 556 References 1. ■(}>€ Heatb\ Be>efiu of Snvhng i U.S. pqxrancBi d Health and Ht^aa Service*, PuNjc HeaJO> Servioe. Canxn far I>seaK Contral. Center fei Qimuc »»■ ease Prewnuon ind Health Pruiiiuoun, Of- fice 00 Smotant ux) Hearth. DHHS P\**- caooa No. (CDC) 9M416. 19W. Z Re3n& R. When we Band. Phiip h4crm Sfagaarx. SeptemberOciobeT 19%; 39. 3. Wartier KE. Seibig «mo*e qgo/rne arfwo^ asBtg and public heahK Washington, DC Aoiertcaii Pobtic Hc^di AmocmUm. I«K. 4. RIR orderad by FTC lo ihow caaK ■ Mr. FTT aac. Utaicy's tiagaatm irpan: To- bocax A(ri l«9-. 4(4):7-(. 5. OwteyG.Scieaoeandihecigarenr.\^i>«- MC*. Aprt 1. 1968: 66-67. 6. 1989 Report of the Council for Tobacco Resean^—U.S^. Inc. New Yoft. The Cowed (or Tobacco Reaearci)— IJSA lie 19n. 7. Reducing J** Health ConiequeiKa of Smoking: 25 Ytarz of Progrea. A Report of die Surgeon General U.S. Deparmeni al Hakh and Huran Servoa. Pobic Hedtt Service, CeMen far Doeaae CobboL Ce». tcr for Chnmc Dtteaac frrveotioe aid HeaAk PruiKHrjn. Office as Smobr^ ari He^dk, DHHS PuUkatn No. (OX:) » 8411, January 1«9. Dilfanan DA. MoJ onrf TekphoiK Sirvryi: Vte Design Method. New Yort John Wiey & Sonslnc 1?7«. Schuta JM. Smotdni-anjixaable nwn^iiy and yean al poicotiaJ bie Ion— UiMed Stale*, 1«8- AftWR. 1991; 40(4)*:-7]. Gun-Related Deaths Increase Further for Black and White Young Men The Departmeni of Heahh and Human Sovices (HHS) reported today thai one otil of 6ve deaths of teas and yotmg adults in 1988 was gtm related. Amcog ytxoig Bbdc males, dose CO half a( aD deaths were liie^ui related. Researcten st HHS' Naticnal Center for Heahh Statis- tics said the firearm- related death rate amoog Blade aod White males aged 15 to 24 years had rtrrlmrri is the eariy ISHh, but then rapidly nxjeased frooi 19S4 to 1988, espedaDy Cor teat- agers and partioitarly among Blade males. Between 1984 and 1 988, the firearm death rate among teenagers increased by over 40%, rising 20% fttxn 1987 to 1988 alooe. and reaching its highest level (o dale, 17.7 deaths per 100,000. "This study shows that (or the first time, the firearm death rates for both White aixj Black male teenagers exceirdrd the mortality frcxn all lutural causes of death," said HHS Secre- tary Louis W. Sullrvan, MD. "For young Bladt inales id par- ticular, the excessive firearm and homicide death rales are appaQing and hean-reixling. For Bladt males aged LS to 19 yeais, the firearm death rale and fbearm boobcide rale iDOre than doubted from 1964 lo 1988, with an increase of 38% from 1987 to 1988 akne. By contrast, ibe noiifiiejmi homicide rale remained rdativejy sta- ble. Black male teenagers woe almost three liines as likely to die Ercn gui>-related deaths than fitxn aO natmi catises al death. For White males 15 lo 19 years, the fiream death rate in 1988 for the first time r\i:eeiin^ that of natural causes, by 11%. HHS Assistant Secretary for Health James 0. Mason. MD, who beads the US Public Heahh Service, said, "The statistics show an American epidemic — without parallel in any other industrialized oaticDof the Oi^itld. PbysiciaB and odier dtizens need to work together to devise the same bixls of educabonal and prevcntioo techniques that we ise to attack other epademics." The findings are cmtaiDed in a study, "Fireami Mortality Among Oddren, Youth and Young Aduhs, 19'»-19e8,'' prty duced by NOS, a port of the Centers for Disease ControL The study ezammcs homicide, suicide, aixl uninteatioQal fire- arm deaths among those aged 1 to 34]«ais. 896 Amencas Journal of Public Health Jidy 1991, Vol n. No. 7 l.fnm lo Ibt EiSMr 557 6. CnrryjenAo EstadLrnco I96S-/974, M«r>- a|rua. Nicangua Banco CeninJ de Nxa- rapii. 19^5. 7 Mimeo repon Managua. Ncaragua: Oft- ana Ejccuirvi d< Encucstas y Censoa; 1977 8. Stcaragtitt 10 Anas en Ctfras Managua, Ntcaragua tr»tiiuio Naoonate de Esiadis- icn y Censns; l****- 9 Anuano EsiadiKnco de ^'icarvgno- Marv agua. Noragua: Co%^ Econ. 1982:1 1: 13- SecCaWwellJC Rnuie^todccieawd mor- t.iliiv tn poor cmintrics. Pnpul Dcy- Re\\ tW^;i:(2) 171-219 14. Drll D. Reich M. ed. Health. S'umnnn. anH Ecnttmnic Crves. Dover, Ma:«: Au- hum Hou^. I98fi 15, C"hcn LC Coping *iih ecooomic crisis: pi»lic\' developmeni in China and Indis- Hrallh Pnlin rUinn. I9fr'::(:):i.Vl-)49 Smidiford and Colleagues Respond It IS under«;iandaMc thai Richard G.irficld IS skeptical of our snggciUKm that impff^cd access w* hollh care was ihc f.icitif most likely to have hroughl ahoul the sharp fnlt in child moilality that began in Nicaragua in the mtd-l970s. It has pro\cn remarkably difTicull lo demon- siraie such an impact in ms This is in accord with nur impresston that the re- sources available to primary health care were increasing. That this spending was not entirely s^iakcd up by expansion of hospital-based care is clear fnjm the si- multaneous increase in the number of health centers and decrease in the number of hospuai beds per capita. Some of Garfield's data should be viewed with caution. Particularly suspect are the data for Ihe mimhcr nf medical visiis per capita. Not only arc iIk Hgurcs difTcrcnl from those that wc obtained from original sources in Nicaragua, but they alsti imply that each doctor in Nicaragua was seeing only about six patients per d-ny. It is difficult lo sec how the number of visits almost tripled between 1978 and 1980 while the number of doctors in the country fell by almost 10%. Because all of these data depended upon the aggregation of statistics between difTercnt institutioos, there was obviously plenty of scope for omission and overlap. In faa, the number of patients seen by doctors is probably not the nxjst valid indicator of health care de- livery, because it neglects the wort of nurses and auxiliary nurses who were siafTing most of the ambulatory care units in the country. Regarding Garfield's assertion that only a quarter of the population had ac- cess to health care by the end of ihe 197[>i. it should be pointed out thai a single esti- mate gives no indication of whether cov- erage was improving or not. Using Garfield's own figures, the number of births in health institutions (in our opinion one of the belter indicators of health ser- vice coverage) grew by an average of 6.0% per year from 1974 m 197R hm "nnh" K 4.2^ per year frimi lOWi m 1«IK. •'■**» Grvcn Ihc limitations in tlic »v.itl:il»K- information, any cxplaruilion far Nx-irt gua's inlcresiinp trcrxl in chid nwtnititx must relv to some dcprcc on spcoil.ii***^. based hop>efiiIly on s**iiihI ihrnry II"** ever, our sind\ nnd GnrlicW's rrih the poienitJin ,intl rh.- pitfalls of annl\7iiip and inlerfrrlinc i"ti tincly atllcctcH hrnllh infurmzii*!! '^^ refer Snndip^nf. htmiiR. WV. UUr/#^.i Gcnrge Dmey Stnrth, Mfi ItChr, Mi. M^r r/t^nrri Ctnk. MUfhn Requests fi»r rcpiriii<; ^iMntld tx en C-~>tp "" "^t-' tahryand Ucnhh Piitirw Rimtr. VJ M.n t.- - June 1^}*^ NiAx >(mV.NV Lf«dN-i»«»^: I9R4 t>iciin>(:nl Sll SA,'SrR_\«l 2. Roxeio-Bixin I Int.inl nxrtljfcv tii ( *-ii Rica: exptiuiinp ihe rcecnt vctin*- ^' -' Fnm rinnn. I'r^, ps? r.l ■^ Sf*X»r M. lhtti>\ lint* tf-ri '•'ni'-^ '" rtr \ - l>cp3rl.n!icnit« .[<■ t'L-id N;icn'it.il Auinnoiiu-i deNirni:-?"** 1987. 4 GnrfieM R. \V.I1i.iim C IhnF- .in.! T. . ■• UilHtn. lltr Sh iiiitxputii r.^prr^-tH • ( '•. fnril. HnphiMl: tlMAM; !«» Intimidation of CTR-FiHuletl Scientisls Claimed The July I'NI Jottnial cnrrof .i Pi'Ik-v Fonim disoi*isioo by Warner' and t p:'|v by Cumniings cl al.^ bcratm| scicniiM* whose work is supported by the Cn^indl f'n Tohacai Research (CTR) f(T onspctifKil ethicnl fniliircs .hkJ daimiiig thai ihc -Atnl <*l those socntisis (>nly serves lo rcinforir doubts in the public miTxl aNxji the so. criu of ha7ers, my .is^snonic^nn'n accept rcscnrdi gmnis fnim envcn>nKP'. unions. .itkI industry, irxiiHlii^ C*1"R \V'- reported rcsiilis. with ackn(TwtttgnK*niv i** speoal grnnisfrnmCrR when:ifpn«pn4''-. in nrKirc Ihnn ? dlogy. and rthcr j<<«ini.iK well krKiwn Uv iltc Ihorrxighncss of ilirn reviews. inHiiffiiigihc,^"imcwTyor'"i''''»' Pubbc Hciifth. f)lni(vsjy. »e h.-xl sr'»i»r ihinglos-iv that tlic reviewers and C(Iiinh\ ri p(ibli<;l*tr>r de^te scircc jcHimal sp.Tcc and dcsi-nic .ic knowledgmcnt to the source d himls. 1 197 Ajncncan iounuJ of PuWic Heahh September 1991 Vo* ?:. N- 558 Any survey like those cooduaed by Wjdicr anJ Cumniings cl al. inio Ihe be- Iiwls iif special gru"(» "f soeniisls raises il.c s|iccicf of ccnsorsliip ihmugh inlimt- J.iiu-ii. To suppress sucnlilic work be- L.iusc oi iL. coosequcntcs is jusi another excuse for iinposing censorship. More- iivcr, should one really discourage re- Mcwi of past research and the implemen- i..ium of new smoUngrelaied research ,h.,i IS cniically onented' Critical reviews i.i incorrect and nusleading practices in >ni>ikiiig-and-heallh research serve to 111 liliglit erroneous methods and have an ,.11(^11 lant hygienic effect on the condua .1 science. Al the same tune they do not ,i,.i;jie results ol properly conducted in- \t^llgJllons. But, inoti. imponant, scien- 1I.-.IS must be free to pursue wliatever ap- |.^jrs promising to llieni. For instance, i^ci-nt observations luve shown that Miu.lsing IS negatively associated with the i^Liive nsk of J number of ver> prevalent .iiid important diseases and with the se- ^ ^1 II) of their syin|>ioms. piiinjrily Alzhe- inivi's, I'.iikiiiMiiis, .ind preeclampsia. M.ould such lelevjnt ri.scarth be sup- ,,ie».-.ed because 11 niiglit increase the sale , 11 . ivj.iieties ' ( tXi scieiilihe dis-igrcenKnts i^.ill> affect the sale ol cigarettes?) h is uiifortun.iie lli.ii iiulividuals who .lie -.lumgly dedicated lo advancing a so- ojI good olien ap|Hiint themselves as tciai.lians of public molality. I shall seek to publish a full reply to W.iiiiet and (uniinings el al. in another l..iiiiial. Ill the mejiiiiinc I would be ,.U.ised lo send a copy of tliat reply or u 1 .1 mis of our work to iiileresied readers, il.kphone: (o*W) 733-13-)8/(604) 681- ;7tll;fax(«M)t)81-27ll2). D Tluudur I). Hurling, PhD U^,|iitsis lor rcpnnls sluxild IJc sent lo Thealoc 1 ) Sici ling, I'liU. Fjculiy ol Applied Sciences. vl»»il of Compuiing Sciciier. Simon Fraser linivcisiiy. Buniahy, Briiisli Columbu, Can- ...Ij VSA ISA. Itcrcrences I Wjriici KL.TiibjiuniiJusiryiCienllhcad- \ LM.n.: SeiviiiB s.iciely or selling cigarelles'? ImJI-uUiL H.Ml. PW1.8I;I!3V-842. ;. I'.iinniiiigs KM. S..ul>.lra R, Gini;rass A. Hums R Wlul >eiciilisl» funded Ijy the lo- l..«.eo iiKjusliy tvliev^ jl«>ul llie huards ol ei^jftlle Kiiulkiiig All, J I'ubUc Healllu l'i'JI,lll.8'J4 BV6 Cummings et al. Respond 1)1 Sicrling IS inoiiec-t in character- liiiUjout article' as an aileinpt to discredit .iiid uiliinidaie seieniisis funded by the ( icilloiTol^aceo Research (CTR). We .111 not qiiestKui the motives of these so- eniisls but rather the tobacco imtaaiy'i (Dotivitiao in oonmuinj lo supfxxt the CTR . Sin^ suied, we believe the goal erf tobacco industry nunagement is tKH to un- cover the truth about smoking and health — u is to sefl cigarettes. We asserted in our article thai the tobacco industry's purpose in funding the CTR is to manipuUie and control the flow to the public of scientific information about smoking and health. A recent mUng from a tobacco liabiUty case in New Jer- sey (Haines vs Liggett group) suppons this assertion.' The judge, in ruling about ihe admissibility of documents in the case, concluded that the documents contained "expliat admissioos" that the tobacco in- dustry had used the CTR to support its legal defense needs. Even today, the tobacco industry continues to deny the causal link between cigarette smoking and lung cancer. In re- sponse 10 a letter wnling campaign by a fifth-grade class in Amherst, New York, an R.J. Reynolds spokesman wrote, "the simple and unfortunate fact is that socn- iists do not know the cause or causes of the chronic diseases reported to be asso- ciated wiih smoking. More sdeniific re- search IS needed." The letter goes on to cue the industry's support of the CTR. Our article deaionstrales that almost all scientists funded by the CTR believe smoking causes disease and woukJ dis- agree with the assertion in the RJ. Rey- nolds letter. The faa that a few soentisu, such as Dr. Sterling, hold conuary views does not mean that there is significant controversy about tobacco and dsease, as the industry wants people to believe, only that there is not unanimity. Neither public health policy nor personal deci- sions about health need await uoiveisal agreement that a substance is dangerous. We had hoped our article wouk) sum- ulaie debate among scientists about tJ»e ethical dilemma of accepting funding from the CTR or similar industry-supponed en- tities ui light of the industry's possWe uses of such participation. Apparendy, we have succeeded. D K. Michad Cummingi. PhD. MPH KuatO Sdttitdn Ronald M. Dewa, UD K Midiael Cumuungs, PhD, MPH, o with RosweU Park Cancer Insutuie. Buflalo, NY RusselJ Soandra » wiih the Tobacco Coouol Program of the New York Suic Healib Depait- menl »nd Ronald M. Davis, MD. c. «iih the Mich^an Depanmenl of Public HeaWi. Lan- sing, Midi. Requeas far repcintt sboukJ be KBi ID K- Mehad Cmmings. PtlD. MPH, Smokaj Coo- uol Proaam, Rowti Pafk CaKH Inswuie, Etain«lCiitooStt,B.Jato.NYMaLHIUI. Rdierences 1. Oimnun^ KM, Scaodn R, Gmgnis A, Dav& R Whal xxausa hinded by llie lo- bacco indusiry bdicvt aboul the kazacifc of agarclte smoking. Am J Pubk IhalllL 1991;81;8«-896. 2. Uw IB. "Fraudl- Judge leleaso secret lo- baceo industry dooimeoii. r (1) Tte iKLft^Be* of Tba Cauacil iliiiir i m «i tbat tbo iatirVf ia tctla« ia fDod £&itb la rapportlac • Mrlsoa •ciaBXifie «ffurt to dot«i«lM tta ttucx* of aDkia« ea ISMa bMltk. Of eeurM, th« AM procna AUj tko ■■• faetioB. «=2n (2) tW Cornell prvrldoi tte laduxry vltA 4 dlroet twaa of -^ oeataet tat Istolllcwea la tha flaU of Mdleal ftmtrth lato toteeee ua •ad bMltt. -J> (3) Ao Coneil jreriioa t^ la^iatry vlth Ita om lelstlfle "" " »i»o mrym u •el^tlfle cpekaMM. PLAINTIFFS EXHIBIT 560 «al rvTia* aad It aay ba aaeaamry to (oMlrldo tka toplea ILttad abOT*. laeh £S2S££& ^tIo tbould wooivaja tho fttll0vla« al^Meta: (1) A fttU amlyala tkaalA ba aada of tba rtata of kMal«d«a «^«tlac raprdlM aaeh dliaaia or i«l*BtlAe topic, laiaaXiac or itatlac b«tk ataat U iBBva aad ataat la (2) ?T«J«rU tpcaaotad by &• CooeU la tka arm of tte pu-tleolar xofie at Urrimi atenOd b« daas^b^ aad aaalyMd, la tana of ttelr aeeo^liabad oeBtrtbntloa or Istaodad eoB'aribatleo ta tte atata of teevladn ra^rdlac tba ankjaet ndar rvrla*. oatUaa apaelfle araaa of tatur% raaaareh aa «*U a« TVVeaa of taeh raaaarch. THIS OOCUMCTT SUWKT T9 CONFIOMTlALin iOl(Et\IE?IT. 561 r. < 3 : »vi T%r7 mici lii« -JlLj 11«« for 3«i— --r:^ |£y TnMln'rrfil eoti*uli»nti. I e«rt*laly ■■ not jMJt ^rjpotlaj »cr« p*?*? wrt. I *»ii«^ Tt«D eaiplt*.«d, tha(« ntaaj-:^ rrrLwvt vlll baTv ailtl^lt a««t. ?baM omi' iacluil^ th« fnr.rnflag: (1) ThtTT V.H lafora our iaduj'Sv rpoatori of tha rtat« at »ci«ntinc taowl»d«« la thoM rt»«»jr:h fl«ldj *Meh ir« of (rmt«rt iat«r«(t to tb^, vHJ 4«icrl^ tha cxs%«st of ■wileml rttmstii rpOB*ar«l by Tha CouaeH tad itj rulatloB to riMaxcA fDia« on la tha (vcanl idastlfle rrmnralf/, tad •-hay will flaftily ouClaa eoaerru fatar* idaatlAe r«»a»rcJa yrofa**li aj wU u tba ob^actlTij of nch TropoMli. (2) T^M lasaarch Scrlavs eaa b« ;r«M)rt«d to, tad dlieajtad vlth tba 3A3 la ta (fTare to eratta t aor« eoacrtta Tr^m at rttwrtae* far Ua tctloEU of tha Bnanl. (3) &«M lUia«j-ea BrrlaOT. «t^ pr«ptr«d V7 tba oeMdJiioawl eoBsultaati , vould otonoualr ba of i«lua t« tba leiastlfle eoBBalty ((pacific nfctnea to ?ba Couaeil eaa ba tlijdaBtad or aodlflad). If «« tr« ntliflad vlt^ t Sarlaw «• eeuld caeeiuuc* i^ pabUemtlan. " ' (>»} T^M 1nii»«.t» «Quld ba of ccot v«lua la daallaf nth tha lijT vr^»t. Tbtrj vould ba ta id«al baek^wid rvaourca vtaaa ^oartionj »rott eaec«Riia< t (pacific leltatlAc probl^. Opoa ;iihl'.emtlaa of t Hatatrca iMTtnt la t fclastlflc iotaatl it eeuld ba proactod vith iel«ea vrltcra. ($) 9ueh eanerrta taajj^leal rvrlavi neuld ecrsalaly ba (ultabla for dl(t3^>i'tldB to prmetlela« pbrtlclaaa tad «ould bBf* t «p*cincity tad eeBa-ttaaaaa that v* tmm to fMl oar AbkmI l«part ItckJ. Our a9«rl«wa vlth Starllac «l|fct mm to (u«x«rt mbb TitfkllJ that vould arrtet thlj jropoaal. kwrvr, It itaold ba r— »iiti1. that St^rllac ^M« niwliiliinil to vark is Um (pacific eaBt«rt of tha 3uit»jii C«B«r«l'i Xoport vklXi eoHdjaloaad ocBSUltastj la thij eaM mold txr to •(■■arlM ouiil aelantlflc taorlMft without tor (padAl palalc laxaat. rill UniBii I, it mttM to aa that «• eoold tort out our mb fe>«ala far that* loaaarch larlaw if •• did pr«par« tha flrrt oaa on lia« eaaear vlthla wr oan (taffl ESvw, «t« la thU aaaa It al4ht ba coaA to c«t aoaa ootalda tMakl^. TiilMiii &Mpar la rrtlfit will tlJo rvrlav thli tofie for u«. 1^14 pivpuad eartalal7 r«qulr«a a craat daal of tffart tad tlaa tad, la timm eaoaa, rrm memmr, but It mmu to aa tha oalj psmcUeal «a7 to fat t ' oobarwt owkll rlav of tha raiaareh iltuatloe. It daaa't taaa lllalj i>- ' that tte At* or tbt fwUrtl tumi— ut U goiat to do thij Job fer oj tad ^ parbapa Inrtawl that Li ODa of tha tttraetlcB* of tha prepoaal. Vlthnt THIS 00C:JI.!£NT SUSJtCT f^ CCNflDENTlALlTY ACdtt.'UlNr. 562 •-iilj t'.ti 3f ulLjiIi I*. IJ rv/ dl^fle-jit vs ti'^bllth r(»«jx^ ?nor".l«i - •-- =r livtr»»t tij 3*3 la O* eoBctjt of ntms-:h jrlartltg. V« •»co'*. ^t« * xo i'-lt: ^roa icrt^c^. Cur 9«n ru^alitis&j to tba 3vgfu. S^^n^ u^ t ?^tc--rce ti til r^a ratmsiii 7»'?«r> la t^ rrport of t^ fT*tijlMS.x' t Zrwr.' Ulan oe 3aaj-( 3iiat>«, Ctaor taA Stroka. Tba f3r««els« jropoMl Mrrvf t rrahrr of pehlie rvlttidsj u ««II Li (ciastme puj7o««i. la ff?*ct It r^^gnlttt ttet &• Cooaeil Ij pr^^^t fclB^li^.s. orgaUatlae tad ttTatii fta t4aae* tU.« •eioUfle (1) Tb» pu^Ue la/ei«tt%i.ae aetlTlUat thmili ««*k to tall th* ) ^' M ' fxearf at xtet Tb* Couseil Ll iBd vbat it do«a . Saeh yahUe lafan«tt«a 1 •^ ' •etlTi«y 1—rr.rtr»t<« tb* coed vlll 4ad tha pnhllff uum.*ni af tba fpoa«a^ V''^ of Tba Couaeil. It ■lae daHDStr«t«t "^ ttaa vwy Tarwilth at r^tMj'ea '' currvBtly geiac famvrd timt ^uartloBa ra^rdlac tofcaeno «m lad baalth tr« far trot balac rvaelrad. *", , f-' (2) &• Cmmrll out of Iti own ta0*l«d«« of tba c«aml r«Mar«h { ^t*^ flfjatlaa tad oot of tecvladft of Couaeil fponsorod jerojoetj U la t podtioB to eoBflBt i«i>«i i>-^y OB tbaorict rt^rSlBf th« tf?»cti of teteeee om ob te^A taaalth tad dlJosM. la ae lyariil order, bv« tr* timti labile iafarsBtloB tetirttj proyeoals. I A. aHIA»HiJU3XIT ACTlTgJS &• Couaell tau i eeetlailac aMd to kM^ Ita tveaaon lafonad of tb* poTOM tad aeeaBpll«tBBst« of lt« precnm. ftrlac tte pk#t t«ro ymrt thla ^^"^ of ftetirity tea b«« mieh rod&ead. "Urn Comffil itaKild ods* bbt* ^^ tMk opyort«lU«« to tppwr b«fBP« »»nooa ia*Mtr7 p«q^ tad taaoeUtlona la ordar ta crplala Ita jre«^B, tad t&taa tpmUx^ cppwnaMt Oould te f fupport^ ^ tTpropriata laeml poblldtT offOrta. &• (Wmrtl cm •«-»• t ^^. r«al TBrpoM la kMpiac i^ tta aenla of latoatry wrtan tt kU. U^»la la _. ^/ rv^rd ta tta* t^ijr'IfH Tiaf 1-nt .-—<——<'>; ei^rveta Met±a(. Spaaehaa I or t«Ua b^tna ia^iatry arouaa ahgiUA ^ M tJMsU tad aw>-taeteleal m peaalhl*. A oeBTlatlo* tt«t a* Caoaall wvf* « r«»l jWfyaa »t "tSi 1«»«1 of «««, witfiiii^w. ^alaMlar« tad r«tail«a woU estalaly ba •Vpraelatad >r tte MBfteturlBc (poMon. Xffbrta ttould ta wda to oMAla a tott« uMtoff^^a* of t^ pra«rM oa tha part of tM aafaceurtac neaaera TT^il ill Co-talalj ooa of tte tiiiwi toMTd tbla wA ^mld ba tte lBia I ■ml of oevfeaet «ltb laftarcrr raaau^ tlrMtan tad rtaff . f«r thuTwea plMa fer i^ 9P« af oaMaet tatiaaa la«B««r7 r«Mar«b pvTpla tad tte SAX iboaXd >• jiitttart for^Mrd •« foleklr M poarlMa. yttrtt«apr»i tt* 4~.i^^» of l^bij«r7 iMtai ti paraooaal la tha tafotval eeafamea oa to ^vriM • CBOd praeadaet fer fstara jartlelpatiaa by laAiatrr pae^lJ la iMh aeaf«r«Deaa. th;s oc:. . '^ CCNFIOENTlAjn AGBEcMENT. 563 3. rT^jd ^/x2jc< ?3:-:::ry 2i« yent'iill'.i.tt f=r yc^iUtir/ =0 -.i* 3-r»r»ll yr^gm of Ti« Cor(i=x:ll: »t«-. It to«i, i« 1*. 37*^-^1, Mta'. It iu Ua--i«l i_-» >y ae ■.-.ri •i5»irt«d. -b. tfKtiLy'i ^jal'.^ rta-T so tiw AX* tobacco b«»lti ?re«r«« ti t jood rmplt of tiU ty?* of ^ihiisltr. I tii2± in »tt,«^ .*^-^a ^ ^^, tarou^i t ?*rtoiai ecBtirt to lax*r«t nj-ouj puiilcatlisnj Li «ritli< mch • tontJ. I tf^ild (u&s«rt thaM cffaf.4 flrtt b* aiA* *lti f]^^£^ la a f«v gwnanj. asiUc&l ^i^lioktlocj foeh u ^. n.ihb«in'i '^tedlal ^'T-^ 2S1*' ^ •*^ =»-••, I iwuid jrspoM to gtx la touci Tlti tte •dltarii ■Bsae^'ct of t^ aavtTapv or pBrloiia^ »atd tlt^ia? to ^t« *r» of our »elD»d to ^t tiia ladlrldaAi rt»« »rtt«r la touch with CoumU cnstaat verkia< la Ms otb u-«a. (for cn^la, Tith lAnoa tM bf;'f t^ la lAar >rttla<^\gi tneh rtarlM • aab«r of tlaaa «• «*»<»'•'-« pw^Mliy darmlop «^ eqp«2-:i-M «ad tbm '(• la • ;e«lUoo to tvprofteh mm of t^ aatloDkl juhHeatloDj neb u tha ^U^ Stj-aat Joarml, latloal Obtcrrvr tal aava ■M(itlr>a« . Tba ?ad«y't Haalth trtlela cujiautly la ^vpkrttlea or esa of tha 4rt1rla« Arvmloplac oat of tha 'vork p»opu«ad cberv aaj twrj ««U or rtrult la • feed lay laacuM* daacrlTtian oT acae iru»li« vMch rt ais&t la tsra rt^rlat tad oaa la plira of eur Jkacaial >«pert u t c^«rC daacrlTtlra yiaea tar aa« vltb tha piiblie. la •rdditlae, to ip^ailxlag 90 otibsU jro^ma, ?ba Couneil ■>>~''''« alae tewta a^ tttastloa to daT«l07ia« rtorla* aa tha tart of ladlrlAiaJ. pifftAaa. TlmiaTly, <»mi/ telanllfle raaaarch ortaaliatlaB toai s^h yihUe lafarvatloD «erk drcvtac »tX«ntloB to Iti ipooaerad nuafch prejaeta. 7^4 tnrk wiirt oartalalj te-ra to ta oarrlad out nth tact, tnx It Li aot fxelud«d f?QB t&a 2-aala of peatlblU^ 'or isqr obJactlcBj I havv haard. Aj t flrrt rba; I taiak It vooll te • coed Idas far aa to aaka ilt« rlilta vlth • a^ihar of tba xrl^rtlfle reaJ? to (rmstaaa tad 7r«jaetj that tm tad thty ba- Uara al^bt te of latar««t to tha praaa. *haaa ruita wobH ^tv oa t ahaaoa to arvlnkta tba cppaal of tha pre^aet tad tha faaV.T^i of tha p«atoa then obtal8li« TohXleltT r««ardla« hla wort. At tha mm tlaa tha eoBtaet ««aXl bo aada vlth tha pnhUc lafsnatloa offloar of tha ladlriAMl Crsataa lastltetiaa la ordar to ■'■If'^** thalr tttltada ta— jda yiblirtty. Afts thaaa ^^parttloDa, It aheuld ha pnaalhla to darmlov t rtarr altbar la ucwpaimtloB vlth tha crtataaa lartltatloB v by direct (VTroaeh to uwapapaja la tha pmatoa't trM. Maraly prttla* tbaaa pDhllelty tleaa lata tetlea veuld raquli^ e^ld«z«hla tl«a tad affort tad that la -rmrr Uttla lljdt to be* tax tha pr^etloD of toeh rterlaa Blfht ba oarrlad. TH.s occuv.:.;, .o->i.r ro CONflOENTUun AGSEt.'HENT. 564 Hjch K«vt«T» ;ropo«ad kbOT« ireuld ba oaa Mthcd for 7^ Cotaell to rtsvm t dijeujtlon of tb* id^tLfie iltuatloB r«(BJ*dla( tobacco u«a tad b«alth. la td^tloe, Tba Cooaell «>■>— 1<» one* aor* aaak ta uraac* t ISaltad avBbcr of ipitlnt rppmrtas** by tb* leloatlAe rtai? b«far« — illfl aad (ela&tlfle ^-oup* . duet tTpaart^i i*^ to ■• l««ltl9at« public lAfarsktidD trtlriSjr of Tba CouaeH. Tb* raaultisf lyr^m ibould ba pohllirlKd boXA at th« lae«l l.rr«l tad ytgafad fftr «0u«b la bdvmac* to th4t th«y eaa b« llstrl^tad to ««1^«« vrltan tad otter »mb*rt of tiia gaacnl prat*. It ku rOMAk M ttet a Tvry (raat dMl Lt lore tlat algbt ba dzvvB ft-oB Oiff lafanal aeiastlfle eoofarvBcat. Mm hcf« il 1 wilj opcrlaaead ths Act that It U peaalhlt to iarlta ladua-Qr r«Mareh yoplM to thaM MBf«r«Be««. It mm» to m that »mm tjrpa of vrittaa r^mrr itaeuld b« of thM* eiafaiatM^a. I m toOA that at laa«t oao* a lj«uad OB ooi of tbi lafOival eoBfaraoeat. It M^n to ■a thftt th«a« eeafaraaeaa twIiI rtUI b« kapt off- f ha rai-nrit aad Tlald mm yohlle InfOBsatlaa Taiaa. ■anallr 9r. Bbefeatt haj eleaa ralatlooj vlth at Icajt oaa or tw of tha partldpasta la tteaa oeafar«Bea«. I «eul4 lUa to laa Dr. Eoekatt t^ oaa or t«e each partldpasta aaka rr—iilrii «»»o«>>i« at tha murTualoa of a eoafar^ica to ^^rlda aa iafanml jr%** brl«fla< od tha jaj-tlraXtr •ubjaet to a (roup of lav Tort aelaBc* «rlt«ra. Soeh a brtafla« aaad net la a^ «7 rlolata tha eff-tha-raeerd tt»taa of tha ooBfartDca tad wuld ClT« oa paracnal oeetact vlth arlanra *Tlt«r« and iheold aot praaaat too mtb of a pr«hLB of aa^tl-r* pnbUrltj alaea tha nbjact of aeat oebfaraBcat ar« »~-»— <■— \ o-t'** *^ rtlU y%rr »ut la tba araa of 'aet taMlag.' f-t^f^A^w tte apylleatlaa of thla jropeaal to tha Oral. Cavltj CoBfaraaea, far P. gg aunJHiriL' ««Hi»i^ 0» enrast shlhit U yaxftctl/ ate^wta fer ■aatinn of aeiaBtifla oraaliatlaaa. Va Aroold rlav It aa niinl— aiiTillj' t^nitu tha ftai7 of wr niwnti jr'fCT" ■-' aaak to tei« It ?-»'-*■•'*■' vbara actoal raaaanh i^rtara vUl aaa It. .'• . ^«i.-.Mt,iT SUBJECT TO CCNflOENTIALlTY ACBauMT. 565 *ti«-. »• -mat to '^" r«t»nJ. prxc*-l3*r» lad m vlll bari to irert ttlj »«._, ^. Vbm **^ * aV CZtltlt U rrwr-.' m'.rd n t^OlTll vrndCTtAij tc >r^ar*-;lt It 4t «.''. (tat« MrtluT tj»ocl»tlor. «»«-.la«i, p^r*J.cilkr:y la kncj lAaticr «( ^t« ^'"^ not Itea ft* «5pa*r« TO SO««<' vlll girt a« our 9M rrrimn ttet «• lack. Aetlrltlat to publldM tha orvr&lX Tro^rmi at tb* (Wmi-I'l teT* gutliaad tai affarta to jublielia laUrldual rarai-gh pro J acta Itora «^kJiJ OS lffb«-Ladutry etam&leatloB U alae jgjpmaA. THIS DOCUMENT SUBJECT TO CONFIDWTlAUn AGS£iafl«T. 566 •d/ ' -.--v;*'" TO: Horace R.^^Xori^.e^jay FROM: rr«d PiftSer ^.^-j^T/'' SUBJECT; Th« ffop«r ?rcpc9«I It is my ttrorg b«li«< th»t w« now h4v« tn opportunity to t*)ct th« initi«tiv« ifi \\\% cigarttt* controversy, and start to tujrn it around. For n««rl/ cwenty y««ra, this industry has «mpIoy«d , • single strategy to defend itself on three nA^gr fronts — litigation, politic*, and public opinion. VThila the strate^ was trilliantiy conceived and executed ©ver the years helping us win '.".r-rrta-t bit-'.*-:.. it is only faxr to say chat it is not • nor was it intended to be - « vehicle Cor victory. On the contrary, it has alwaya been a holding strategy, consisting of -> creating doubt about the health charge without actually denying it — advocating the public's right to smoite, wlcJiout actually urging them to take up th« practica •- •aeouxaging objeative scientific research a« the only way to resolve the question of bttslth haaard on tho litioation fron^ for which tha strategy was designed it has been aucCQSSfal. rvhii* we have not lost a liability cast. this IS not because jurie* havo rejected 'ihe anti-s-e: ch« &«li«fi, attitudes and accior* of :zd^«s. juria*, iLsctd officials and gevernm«nt employ««a ar« f«r:a«^i. THJ STRATrfltC IMPASSE A« an indujtxy, zy\%z*tOS9, w« art SCffuoittad eo an -.H- defined middLt ground w^ich i< articulatad by variation* on th« th«m« chac, "th« cas« la not provtd. * xs th« r«c«n« hi«tory of U.S. involvemtnt in Vlttnam dwmonatxatad, ic u imposjiblt to hold thtpoblic on a nlddl* eoura« for a^y lan^th of tira«. Thtra ja«m« to b« no way that s«af public opinion can anfliga in a controy«r»y and «he««« an ansvtr that 90«« bttyond th« rang* of tith«r/or. In th« cigarettt controvtrty, th« public — •ip«elally cho«« who art prtstnt and pottntitl supporters (a. 9. tebacco dtar./* con<7r«s9n'"»n *.r.d htar"/ 1 sc^strt) — ^42t pcrtaira, j-d^r- Stand, and btliavt in tvidtnc* to sa«t»in th«ir cpi.iiona t?.as smokinq may not b« th« eauaal factor. A« «htn0^>.t«ia i.t. p«oplt who smoKt ttnd to difftr iiBpoctantly »• prtaaurt undtr which thty livt. * i.t. aa Jcitnct tdvanct^, moct and mort factors cont undtr suspicion as contributing to tht illntiJta for which smoking i« hlamod - tir pollution, viruats, J ^jiyzv^'^^ 568 .'-.azaris ind stresses. Ocr 1S70 putiic cpi.-.mn survey shcwevj -.-.a- 4 .T4::r-.:v (52%1 ttli.e'-'ed eh«t ci^aretta* are onW 3ra_st '-^e -a.-.v ca.sji of 5moV«r» h*vir<3 mere illnoases. It aisc lhcw«d t>.4t ha 1.5 of th« pecple who telievad th*c 3mo<«rs hav« mora illaaaa eh4ft nen-smo'Kers agcepced tn« consticucicnil hypothtais as th« «jcplan*cion. Thu», th«r« ir« millions Af p«epl« who would tot rectptiva to « r.«w m«9sa<3«. stating t Ci9ar«tt« tmekin>«d by a l^gitimata hou9«. In mtimzz, luch a voLum* would b« * «cs»nt«r - Surg«on 0«a«ral*s Rtporx. Th« principal authors would b« Surna Rcp«r and an «min«nt rasaarch acitnxist. Tt\m advisory panal-- hop«fully broadar.ad as a casulc of seap l -* would writa th« introduction. Tha industry'* fundinq r*la would b« fully ac)cftowitdgad, 6) Xa a boo'< tha matarial would b« markattd and pronotad ifl all cha many ways availablai maqasina condanaation, TV and Radio talk shows, nawspapor raviaws and intarviawi, advartising, 9ift distribution, ate. ate. kn6 b«st of all, it would only hava to b« laan — not raad — to te« b«Iiavad. . . just liXa tha Surg«cft Sanaral's raport. r?Ao cc: H. KAStanbauB w. Kloapfar, Jr. /' J 002 100 'J 7/57 570 FALSE AND MISLEADrN'O ADVEBTISING Exhibit 3 ^•'<^f Tobacco Industbt Research Committee, Veto York, N. 7., Auouat 1, 1951. Bon. John A. Blatkik, Chairman. Subcommittee on Local and Monetary Atfairs, House Committee on Government Operations, Washington, D. C. jEAB Mk. Chaibman : When Dr. Little appeared before your subcomimttee on Thnrsday, July 18, 1957. he agreed to provide the committee with certain fe pertlaent iniormation concerning the research program of the Tobacco Industry -.-* Besearch Committee. Dr. Little has asked me to forward you this material. %<; loTJ will find it enclosed. The Tobacco Industry Research Committee has appropriated for research frtnts $500,000 in each of the following years : 1954, 1955, 1956. and 1957. In 1956, a supplementary $200.iX)0 was made available at the request of the scien- tific advisory board. Thus, the total available funds thus far amount to $2,200,- 000. These fiinds have not been allocated exactly as appropriated, that is, on an ifinnal basis. To date the total grant awards made by the scientific advisory board to independent scientists in accredited institutions amount to $1,832,591.51. The additional material, which Dr. Little agreed to supply the committee and which is appended, is : ^ 1. ▲ statement concerning the origin and purpose of the committee, issued '^tt its inception. •^„^ 2. A statement of policy adopted in 1954 concerning conditions and terms un- ^^er which the scientific advisory board awards grants-in-aid. 8. A statement of the research program as adopted by the scientific advisory board in 1954. 4. An interim informal report of progress issued by Dr. Little, May 16, 1955. 5. The first formal report of the scientific director issued midyear 1956. 6. A list of the original grants showing the recipient of each grant, his institu- doo, the value of the grant, and the date the project was initiated. Also, a ■imilar list of renewed grants. This Information Is current as of July 1. 7. Thirteen abstracts of papers published in accepted scientific journals re- porting on research work supported in whole or in part by grants approved by the scientific advisory board. These abstracts are for inclusion in the 1954 re- port of the scientific director, as yet unpublished, and have been approved by the investigator working on each grant. Dr. Little has asked me to thank you for your courtesy in providing him the opportunity to apiicar before your subcommittee. If you desire any further information, pleasfi_lfit.us know. Sincerely, r'^ """~~~-.>^ ■"-~-^.,_W. T. RoTCT.fxccutive .^ecretarv. Attach.ment a Statement Co.ncerning the Origin ano Purpose of the Tobacco Industet Research Committee and Its Proposed Functions The responsible chief oflBcers of 9 of the cigarette and tobacco pcclucts manu- facturing companies in America, and 5 organizations of growers of leaf tobacco •aU tobacco warehouse associations have forqged the Tobacco Industry Research Committee in the interest of the public as well as of the industrv xn meet the tfaailenge raised br^^Hlely pubirdZWlTeiiortg In the press, purporiin^to link tobaijoo smoking with tin; euUbT of lUBj^ c^ftncer.' """ To a"voTd^c3!jkibltJ C'UUfUiJluiU and fiiliiUUdCTstanding concerning the orlginj_Bur- ^•e. and fuhct7on~or~n]li> wmmliree. the coiumittee mages^Feirolloving state- ~~^ I. EVENTS JTSTIFTINO FORMATION OF COMMITTEE The formation of the committee was prompted by the appearance of certain {JwUcatlons claiming an established relationship between cigarette smoking and •■"« cancer. ""^ ^^Typical of these reports is an article appearing in the .Tonrnal of the American *«lical Association (143 JA^!A 329. May 27, ig.'iO) wherein Drs. E. L. Wynder ?** E A Graham reported that applications of cigarette tars to the b.acks of mice *° produced skin cancers. 571 33S FaL.SE and MISLF.ADtNG ADVERTISINO In an addrt^ss bet'nre the annual fall bacco manu- ^^^llC'^rs amlTTrTTers enaagetrTQTB'eToSacco iniT'iftrf ''■'' ^''' in rJl^_^^' determi^a- tiQa^afT5ia_caDtroversy '11 iklM tfiiriii'm. ^Msf^ i^t r^'' '"'<'"=^''T~f^'Cni'l'l'!''_'j;!Lcpm petent scjentitic anthrj-Uvjo_^l1nd^ultiniate facts_\vhii:ti wHLl'spel the nrj^pt coji; fusl5ni"~3"ria ro communicate authoritative factual information on the subject to thepubiic. ~ " II. PLAX OF ACTION The committee announced in a full page advertisement appearing in 448 newspapers circulated throujjhqutthe United States on Monday, Januarjr^ krJo4. that it would meet the challenge "of these reports. The signing memberi |of the Tobacco Industry Research Lommittee predgWl to yiipport"by BnMClil lid. inj;fiditinn rn rhnt already contributed by individual companies, research ^ thp charge and direction_or a scientist or unimpeachable integrity and [ nanonalrep"r<> To guide and advise in tnis tleld? sciebHStS flisinterestea ui tji'e cigfretFe industry and of recognized ability and professional standing la medicine, education, and associated sciences mli.be mruea tO acT as aii ii- _yisory boyd. lis statement was subscribed to by the following companies, which now make up the committee : The American Tobacco Co., Inc.. by Paul M. Hahn, president 9 Benson & Hedges, by Joseph F. Cullman. Jr., president Bright Belt Warehouse Association, by F. S. Royster. president •9 Brown & Williamson Tobacco Corp., by Timothy V. Hartnett president Burley Auction Warehouse Association, by Albert Clay, president Burley Tobacco Growers Cooperative Association, by John W. Jones, president Lams .% Bro. Co.. Inc.. by W. T. Reed, Jr., president P. Lorillard & Co., by Herbert A. Kent, chairman Maryland Tobacco Growers Association, by Samuel C. Linton, general manager -* Philip Morris & Co.. Ltd.. Inc., by O. Parker McComas, president ■* R. J. Reynolds Tobacco Co., by E. A. Darr. president Stephano Bros., Inc., by C. S. Stephano, Sc. D., director of research Tobacco Associates, Inc., an organization of flue-cured tobacco growers, by J. B. Hutson, president United States Tobacco Co., by J. W. Peterson, president m. FORMATION OF THE COUMITTES Mr. Paul M. Hahn. president of the American Tobacco Co., on December 10 and 11. 195.'^, took the initial steps in the formation of the committee in & telegram sent to the following people : Joseph F. Cullman, Jr.. president, Benson 4 Hedges E. A. Darr, president, R. J. Reynolds Tobacco Co. B. F. Few, president, Liggett & Myers Tobacco Co. William J. Halley, president, P. Lorillard Co. Timothy V. Hartnett, president, Brown & Williamson Tobacco Co. 572 FALSE AXD MISLEADING ADVERTISING 339 J B. Hutson. president. Tobacco Associates, Inc. O. Parker McComas, president, Philip Morris & Co., Ltd., Inc. J. Whitney Peterson, president. United States Tobacco Co. .-Mr. Hahn suggested that these heads of the leading tobacco units meet to consider some action in response to these published reports. Thereafter, those luTited, with one exception,' met on December 14 and 15, 1953, and December 28, 1953, in New York City. At these meetings the conclusion was reached that the tobacco industry most '• . ^ka public action to meet these widely publicized claims. The committee was 1 1 forsied, and the Arm of Hill & Knowitoa. inc., oT 3J0 Fifth AVanie, 'New YorlT, j \ v<_X^gjis_engaged to assist the CQiufliiUee in effectuating i^s^ufpose^. The officers of the committee selected were Paul M. Hahn, chairman; J. Whitney Peterson, vice chairman; Joseph F. Cullman, Jr., treasurer; and Wil- son T. Hoyt, of Hill & Knowlton, Inc., secretary. It was the expressed inten- tion of the committee to have the chairmanship of the committee rotated every 8 months. It was agreed that expenses for the committee's activities, includ- ing expenditures for research, the advertising, the employment of Hill & Knowl- ton, and other similar expenses, would be defrayed by donations from the member firms based on their volume of business and by contributions to be agreed upon by other members. Arrangements were then perfected for inser- tlOD of the advertisement referred to in the newspapers throughout the country. The Bright Belt Warehouse Association, the Burley Auction Warehouse Asso- ciation, the Burley Tobacco Growers Cooperative Association. Larus & Bro. Co., Inc., the Maryland Tobacco Growers Association, and Stephano Bros., Inc., were Invited to join with the original group and became members of the committee. TV. LIMIT OF POWEES The purposes and objectives of the committee aT^, tn ai;l and assist research Into tobacco use and health, and particulftn7'T^to_tfc£_allegeareiaiionsnip peJ' tweqi^he tree ortghafico and_lung_cajic^.and jojBaKJeavSTTrtle-lu.Uiy put^^ factual inTormation on this" s ubject. It is the considered judgment ol the coS- mitw_Shatits activitiljll'lian beTonnned toTffg pqt'i^o§es_set forth abov^;ana thtrTTTsTirnowise to^ considered or~to operate. as a trade association 2!C^^m', ptrtlcTpali^ in anj. activity ox cjve consideration .^tp any maflers affecliflg~tlTg^ j ^OUBess conSuct or activities of its members, and that T13" ^m?Ittes in every l| mpecT ShBH cotrfonn to Iffw and aIT_ decrees or iudgmeats of _courts_a5ectIng or H retlTOig to the CobagcQ industry. TotEIsenj \h(^ gnmrpittpe is proceedini^ '^?^.*^_* thl aUrieeof legal counsel selected from among the counsel or nominees ol its ^"^ Tobacco Isdubtrt Research Committee, Paui. M. Hahn, Chairman. New York, N. T., January 25. 195i. Attachment B '^oiACco Industry Research Committee Statement or Poijct Containiwo Conditions and Teems Undes Which Project Grants Are Made (Adopted by the Scientific Advisory Board) '• Oenera] policy The Tobacco Industrv Research Committee is dedicated to the support of the to'eatigation of fundamental matters relating to a connection between tobacco «» and human health. In so doing the Tobacco Industry Research Committee ^<»6iiizes the importance of independent research by competent investigators. |2^«^ch policy and programming are tte responsibility of the Scientific Advisory f5*"^ <^iran&\are made only after careful consideration _bv the Scieotlflc ^j^y]*gry BBSfd of" thp THgrTBrgri^ynpnjigTaHpd of the qualifications of the_in- ■*22?S «nlTlIs-mstitTjnoF undertaking the work. f CrsrCoammtee desires to have scientists work with the greatest freedom and >Tl«?nt domination of ahy RlnffT-^t TPin~niak6 "no~afreni^ TO direct tfie ad- "^ittanou or the prolect 6Dgg atnrtgd, to influence its course or to control Ita *|^^ other than to be assured thtEf^e fundsjtifiljtroperiy e-tI)6Udbu lurJLe* Py*«"orgie grant and that all findings arereported in accordance with th' ^^.Jg^y^Drrgc-praetigg: ■ ^jRett 4 Myeri Tobacco Co. 573 340 FALSE .\^■D MI5LEADIXG ADVERTISING //. Payments and budgets Unless otherwise requested at the time of Initiating a specific grant, paymentii will be made quarterly in advance to the Institution at which research is oeinp conducted. * Grants may not be transferred from one institution to another due to a chane« in affiliation by the principal investigator without express permission. The contract for a grant may be terminated prior to normal expiration dat* by the grantee upon notification to the Executive Secretary of the Tobacco in duscry Research Committee with a statement of the reasons for termination Budgets are presumed to be accurate at the time of issuance of a grant. How. ever, if for unforeseen reasons, additional funds or reapportion of funds ar« required such request will be considered upon receipt of a complete statement of reasons for such change. At the time of expiration of a grant or in the event of its termination, un- ■expended funds shall be returned to the Tobacco Industry Research Committee If, at such expiration or termination, additional projects are anticipated and are approved such funds may, upon request, be applied against the new grant at the time of Its Issuance. ///. Reports Grantees are to furnish a report of activities semiannually. These need not be extensive but should be sufficiently Informative to permit the Scientific Advisory Board of the Tobacco Industry Research Committee to know who is being ac- complished. At the conclusion of a project a detailed report is expected which shall be given in writing to the Scientific Advisory Board. An expenditure report should be made by the grantee semiannually. IV. Exchange of information With the consent of the grantee, the Scientific Advisory Board may recom- mend the exchange of interim information between Investigators working r>n different projects if the interim results Indicate a relationship between projects. This would only be done with the object of assisting and expediting work in process. V. Publication and public information The Tobacco Industry Research Committee approves the initial presentation by the investigator of research resultg only in accented medical ami qcientiflc ioumals or beforp nccepceil medical or scientiflc^societies. It h^s^no ohieotion tq^ dissemination to the public of anv or all T^al conclusions from projects In these~ wd'yg;— — ■ Information from semiannual or final reports will be released publicly only with the^gglBisSion or the inreisiiigtog: jOUiujl uiaiJciety schedules the presentation of any findings from a ^e St.'lttmifll'' Advisory Hoarg will exDecT~^-«tatan>ent~or abstract ^om ffantee covering the date and general subject matter of his presentation. While no special funds are provided to assist publication of results covering costs of illustrating, typesetting or other expenditures, the Tobacco Industry Research Committee will consider a request for such funds upon presentation of the manuscript to be published. Attachment C The Research Program of the Scientefic Advisobt Board to the Tobacco Industry Research Committee the scientific advi80rt board Members of the Scientific Advisory Board to the Tobacco Industry Research Committee are : Chairman and Scientific Director : Clarence Cook Little. Sc. D., LL. D., Lit. D.. Director, the Roscoe B. Jackson Memorial Laboratory, Bar Harbor. Maine McEeen Cattell, Ph. D.. M. D., Professor and Head of the Department of Phar- macology, Cornell University Medical College, New York, N. Y. Julius H. Comroe, Jr., M. D., Chairman and Professor. Department of Physiology and Pharmacology, Graduate School of Medicine, University of Pennsylvania, Philadelphia, Pa. 574 FAL.5E AXD MISLLADEN-G ADVEKTISIXG 341 Leon 0. Jacobson. M. D., Professor of Medicine, University of Chicago, Director, the Argonne Cancer Research Hospital, Chicago. 111. Paul Kotin, M. D.. Assistant Profet^sor of Pathology, University of Southern California Mediml School. Los Angeles. Calif. Kenneth Merrill L.vnch. M. D.. Sc. D.. LL. D.. President, Dean of Faculty, and . Professor of Patiiology. Medical College of South Carolina. Charleston, S. 0. Stanle.v P. Reimann, M. D.. Sc. D., Scientific Director, the Institute for Cancer Research, Director, the Lankeuau Hospital Research Institute, Philadelphia, Pa. TVilliam F. Rieniioflf. Jr.. M. D., Associate Professor of Surgery, Johns Hopkins School of Medicine. P.altimore. Md. Edwin B. Wilson. Ph. D.. Professor Emeritus of Vital Statistics, Harvard Uni- rersity, Cambridee. .Mass. Associate Scientific Director : Robert C. Hockett, Ph. D. THE BESEARCH PROGRAM The Tobacco Industry Research Committee, formed in January 1954, to ■ponsor independent research into tobacco use and health, put into the hands of • Scientific Advisory Board the development and continuing supervision of a reacarch policy and program. Many doctors, educators, and scientists want to kaow about the Committee, the Scientific Advisory Board, the purposes and policies, and the research program. This booklet is intended to answer these ^aestlons. . "The Committee's approach has given the Scientific Advisory Board an un- usual, if not unique, opportunity to fosrer and guide the T^idest possible range of research by outstanding scientists and doctors under conditions of utmost freedom, " according to Dr. Clarence Cook Little. Board determines activities Because of the broad responsibility of the Scientific Advisory Board, scientists whose competence is securely established in their respective fields of knowledge u* asked to serve a« its Tnembers.~~~^1iey are given assurance of comn^ta^^ '^■^^ scientific freedqm_in_iheir work. ~- - — - -, ""-=**■* /%^ -'''^-^ Tire scientincTASvisory lioarH does not contemplate conducting specific labora- tory investigations as a Board. This does not rule out the possibility, however, tktt individual members may seek and, in competition with other applicants, obtain a research project under a Tobacco Industry Research Committee grant. This is the policy common to similar bodies such as the Committee on Growth 4Bd the National Advisory Cancer Council. The Board members retain completely their association with their institutions •nd. except for the Scientific Director, are reimbursed only for time and expenses '■'^^ed in their services to the research program. ^The Board determines the scope and direction of the research program ; re- ^htwt and solicits requests for research grants from universities, hospitals and y*y recognized research organizations or from individuals there situated. ■•filar monthly meetings are held by the Board to carry out its scheduled ••fk- In addition, members of the Board frequently undertake special assign- ■•■ts in connection with the development of the research program. , tfopc of interests defined _ Before undertaking a large-scale program of recommending grants to finance '•••rch projects, the Scientific Advisory Board laid the foundations on which ttl'rt'l* °' research projects could be developed and coordinated. First was •■•aeline.ntion of the scope of interests within which investigations should be 2***<>red. Second was the orjOTTftatlon of a program to assure that necessary ■■^^■tigation was undertaken without unnecessary ^flplication of work. z^ ^^f!tlJ]ireemainareas_J) ^■•onnine of interest sets out three main areas of investigation : » \ (p|_ ^*J]j^isieal and chemical composition of tobacco and accompanying prod- ^/ ' ^ ^» WdTfisJigarette papers iuid adCnves. ThifWvers the preparation, frac- ^t Ti« "°*^ analysis of tobacco andoT added substances. V fcfcniMi^^ changes in humans as well as in animals, in normal life or under ~ji pjJ^^ry_conditions. suRjected to various types, duration, and luiensity otTx- ^ Y^Tir f ^TUious tobaccos and derivatives, and other potential irritants. ^ w special interest are those of the motnU, Itings, glandlTheart. anOTJTlier 4a subjects of various ages, sex, and strains. ^ 575 342 FALSE AND MISLE^DEN'G ADVERTISENG '*'' 3. Smoking and other tobacco habits, and the emotional and phvsical mat ot smokers, with respect to establishment, duration, and mtensity of lobfl ** use. and correlation "f these data with metabolic, glandular, and nervous tr2? under various desrree* '■>t stress and '-hallense. '^T** m It is recognized that work has been done and is being done here and abm a these fleids. The Scientific Advisory Boar5he Board developed a coordinated research program in, 3(led not only lb a-certain facts with respect to the questions raTSwrWmcere ingToBgrro use and Bgdlth TTTir nls^ to ponrrihnfp t/\ rnrrh^r 'ihflcrjtafliUinJ ol cancer] heaiLL-di>''.i>'^ >elng accomplished. A tfaUlled report is exi)ected by the Scientific Advisory Board at the conclu- ilHof a project. EXCH.VMiE OF INFORMATION AND PUBLICATION ^Wlth the consent of grantees, the Scientific Advisory Board may reconnnend ■torbunge of interim information between investigators workins on different y'i**!* if interim results indicate a relationship between iiroje't*. The cnly of this exchange of information is to assist and exi)f> objecti'Mi to Nnination to the public in these ways of any or all final conclusions of the •tlgntors. "ben a journal or society sche are provided to assist publication of re-ults covering of illustrating. tyi>esefting. or other exi>enditures. rlie Tolinco Influstry fch Coniniitfee will ronsiiler reD .\IISLE-\D1XG ADVERTISLNG ^ i O^ THE TOBACCO INOL'STBT BESEABCU COililtTTEE The T'ibacco luduscry Research Committee was organized early in lo-j ^ is comprised ofjix tobacco mapufacturipg conmaniga and ei?ht associatin.-*** tobacco growers aud wurehoTliitJHUiU. Timothy ^<:^Hartnect> former Dresiri. " Brown J; WilIiam>oQ Tobacco Corn., is qtiaiipinn --Jir'*«l. TUtfniurtn.ses and objectires of the Commitlee are to aid and assist resi» ^' into tobacco use and health and to make available to the public factuaii;^!!*''* tio5"on this gnbject. . 'Mor^ in the light of wide publicity given to some statistical studies attemntinr J link tobacco use and lung cancer, the Tobacco Industrv Research Cnmn .. K^U^..«.. ;» U..™ „ „..>,K» :w:l;._ .- -; i j . . .. ' . . ^""^0.10^1 eratore » c^ rhe disea.^e indicate that many factors, such as various types of air pollution. u> suspects in lung cancer and other ailments. Medical and research scientists anw that no persuasive, definitive, and final conclusion has been established wither spect to the cause or causes of this disease. ^ The fact that cigarette smoking today should even be suspected as a caoa V, of serious fiUengn I* n^iiiiiiitir of fifiAp coflcernto tI16 tPPaggd IBflustry. Accoi^ -.^ ingly, the Committee pledges aid and assistance tO rH6 research effort into ifl \ phases of tobacco use and health. " ) STATEME>(T BT DR. LITTLE "The Scientific Advisory Board of the Tobacco Industry Research Committw has certain opiwrtunities and obligations of tremendous importance to the futait development of scientific research in the United States. "First, it can recommend financial support of basic or pioneer research on ti» own evaluation of individuals or InstitntioDs on the basis of promise or faitk rather than on a purely factual and materialistic standard. Pioneer reseuck is the creative idea phase of discovery. It is the absolutely essential forerunnv \ of progress to the project" stage ! "Second, the Board can itself plan and Initiate research in fields .and for pur- poses not now being covered. This is. I believe, an entirely new departure tor any indastry. Granting a group of scientists the power of creating new reseaicfc activity is a great and exciting development. •If we on the P.iurd have the wisdom and vision to plan creatively.. we may iw ''^'ff *'> J"atify TlUa gonf^dence placed in us. !{_ we do justify it. the tobacco ia- \ dustry will have made its t^rpatest conTribntion of service to mankind aad^may ^"- ■ ■ ■ ■ ■ will follow fr C- C. Lrmt / (', uu5>iry wu- . . _ _._ \ well establish a preceilent and pattern which other .industries will follow b Mippott of research." " ' .1 Arachkutt D \ 1 A. RZPOB OF PtOOBESB ^ Statement of Dr. Clarence Cook Little, Sclentiflc Director, the Tobacco Induitiy Research Committee, and Chairman, the Sclentiflc Advisory Board. Mad* at discussion with science writers, Monday, May 16, 1955, Tobacco Indust^ Research Committee oflBces, 5320 Elmpire SUte Building, New York, N. I.. r fA year has gone by since the Sclentiflc Adrisory Board to the Tobacco InduatiT Retfiearch Committee first met to discuss the course of scientific research to be financed by grants from this Lnduatry group. ^ At that time, many of us were strangers personally, though not scientiflcauy- As members of a newly created Scientific Advisory Board, however, we had » least three essential things in common. "* First, we had 'rrn niTrn a fraa rriP ^' '"^ond an Industry's research fund «» "•rjlinnrht bwt Tharin [f^^f w^ ■ challenge and responsibUlty. i "Secondly, we shared a firm belief that sound scienanc researcn -would cw, ^nue to unfold, however gradually, the solutions to perplexing health Pro''^®^ / Thirdly, and importantly, we were in full agreement that the arena of P^'^Jj ( controversy wa« fn h«» avoids In the Interest of constructive science and genntf* Vproyreas. 1 o BOSTON PUBLIC LIBRABY 3 9999 05706 6779 ISBN 0-16-046535-4 9 780 60"465352 90000