COLD WAR ERA HUMAN SUBJECT
EXPERIMENTATION
Y 4,G74/7:C 67/2
Cold Uar ERA Hunan Subject Experine..
HEARING
BEFORE THE
LEGISLATION AND NATIONAL
SECURITY SUBCOMMITTEE
OF THE
COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OP REPRESENTATIVES
ONE HUNDRED THIRD CONGRESS
SECOND SESSION
SEPTEMBER 28, 1994
Printed for the use of the Committee on Government Operations
,.v«
''EBi
S 1995
U.S. GOVERNMENT PRINTING OFFICE ^ ^'^'1l>1^|0|(^
85-647 CC WASHINGTON : 1994
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-046470-6
COLD WAR ERA HUMAN SUBJECT
EXPERIMENTATION
Y4.G74/7:C 67/2
Cold Uar ERA Hunan Subject Experine...
HEARING
BEFORE THE
LEGISLATION AND NATIONAL
SECURITY SUBCOMMITTEE
OF THE
COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OP REPRESENTATIVES
ONE HUNDRED THIRD CONGRESS
SECOND SESSION
SEPTEMBER 28, 1994
Printed for the use of the Committee on Government Operations
/
''^^ ' 5 1995
U.S. GOVERNMENT PRINTING OFFICE ^ ^'^'10l^lC4ll>
85-647 CC WASHINGTON : 1994
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-046470-6
COMMITTEE ON GOVEIUSfMENT OPERATIONS
JOHN CONYERS,
CARDISS COLLINS, Illinois
HENRY A. WAXMAN, California
MIKE SYNAR. Oklahoma
STEPHEN L. NEAL, North Carolina
TOM LANTOS, California
MAJOR R OWENS, New York
EDOLPHUS TOWNS, New York
JOHN M. SPRATT, JR., South Carolina
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
KAREN L. THURMAN, Florida
BOBBY L. RUSH, Illinois
CAROLYN B. MALONEY, New York
THOMAS M. BARRETT, Wisconsin
DONALD M. PAYNE, New Jersey
FLOYD H. FLAKE, New York
JAMES A. HAYES, Louisiana
CRAIG A. WASHINGTON, Texas
BARBARA-ROSE COLUNS, Michigan
CORRINE BROWN, Florida
MARJORIE MARGOUES-MEZVINSKY,
Pennsylvania
LYNN C. WOOLSEY, California
GENE GREEN, Texas
BART STUPAK, Michigan
Jr., Michigan, Chairman
WILLIAM F. CUNGER, JR., Pennsylvania
AL McCANDLESS, California
J. DENNIS HASTERT, IlHnois
JON L. KYL, Arizona
CHRISTOPHER SHAYS, Connecticut
STEVEN SCHIFF, New Mexico
CHRISTOPHER COX. California
CRAIG THOMAS, Wyoming
ILEANA ROS-LEHTINEN, Florida
DICK ZIMMER, New Jersey
WILLIAM H. ZELIFF, Jr., New Hampshire
JOHN M. MCHUGH, New York
STEPHEN HORN, California
DEBORAH PRYCE, Ohio
JOHN L. MICA, Florida
ROB PORTMAN, Ohio
FRANK D. LUCAS, Oklahoma
BERNARD SANDERS. Vermont
(Independent)
Julian Epstein. Staff Director
Matthew R. Fletcher. Minority Staff Director
LEGISLATION AND NATIONAL SECURITY SUBCOMMTITEE
JOHN CONYERS, JR.. Michigan, Chairman
CARDISS COLLINS, Illinois AL McCANDLESS, California
STEPHEN L. NEAL, North Carolina WILLIAM F. CLINGER, JR., Pennsylvania
CAROLYN B. MALONEY. New York JON L. KYL. Arizona
TOM LANTOS, California DICK ZIMMER, New Jersey
CORRINE BROWN, Florida
James C. Turner, Staff Director
Miranda G. KatsoyanNIS. Professional Staff Member
Cheryl A. Phelps, Professional Staff Member
Eric M. Thorson, Professional Stajff Member
Bennie B. Williams, CleHt
Cheryl G. Matcho, Clerk
Rosalind Burke-Alexander, Clerk
L. Stephan Vincze, Minority Professional Staff
(II)
CONTENTS
Page
Hearing held on September 28, 1994 1
Statement of:
Barrett, Elizabeth, New YoA, NY 53
Cole, Leonard A., Ph.D., professor of political science, Rutgers University 131
Conahan, Frank C, Assistant Comptroller General, National Security
and Internal Affairs Division, U.S. General Accounting Office, accom-
panied by Glenn D. Furbish, senior evaluator 11
Confers, Hon. John, Jr., a Representative in Congress from the State
of Michigan, and chairman. Legislation and National Security Sub-
committ^: Opening statement 1
Fites, Jeanne, Deputy Under Secretary of Defense for Requirements and
Resources 93
Gamble, Vanessa Northington, M.D., Ph.D., professor of the history of
medicine, preventive medicine, and family medicine, University of Wis-
consin School of Medicine 138
Nishimi, Robyn Y., Ph.D., Senior Associate, Office of Technology Assess-
ment 149
Olson, Eric, Ph.D., Frederick, MD 42
Osterman, Joseph, Ph.D., Director, Environmental and Life Sciences, Of-
fice of the Director, Defense Research and Engineering 98
Parker, Michael A., Executive Director, U.S. Army Chemical and Biologi-
cal Defense Command, Aberdeen Proving Ground 78
Rothman, David J., Ph.D., director, center for the study of society and
medicine, college of physicians and surgeons, Columbia University 112
Sabo, Hon. Martin Olav, a Representative in Congress from the State
of Minnesota 8
Soper, Gordon K., Ph.D., Principal Deputy Assistant Secretary of Defense
lor Atomic Energy 62
Letters, statements, etc., submitted for the record by:
Clinger, Hon. William F., Jr., a Representative in Congress from the
State of Pennsylvania: R^pared statement 4
Cole, Leonard A., Ph.D., professor of political science, Rutgers University:
Prepared statement 135
Conahan, Frank C, Assistant Comptroller General, National Security
and Internal Affairs Division, U.S. General Accounting Office: Prepared
statement 15
Fites, Jeanne, Deputy Under Secretary of Defense for Requirements and
Resources: Prepared statement 94
Gamble, Vanessa Northington, M.D., Ph.D., professor of the histoiy of
medicine, preventive medicine, and family medicine. University of Wis-
consin School of Medicine: Prepared statement 141
Nishimi, Robyn Y., Ph.D., Senior Associate, Office of Technology Assess-
ment: Prepared statement 152
Olson, Eric, Ph.D., Frederick, MD: Prepared statement 47
Osterman, Joseph, Ph.D., Director, Environmental and Life Sciences, Of-
fice of the Director, Defense Research and Engineering: Prepared state-
ment 100
Parker, Michael A., Executive Director, U.S. Army Chemical and Biologi-
cal Defense Command, Aberdeen Proving Ground:
Information regarding Air Force sponsored LSD tests Ill
Prepared statement 82
Rothman, David J., Ph.D., director, center for the study of society and
medicine, college of physicians and surgeons, Columbia University: Pre-
pared statement 116
(III)
IV
Page
Letters, statements, etc., submitted for the record by — Continued
Soper, Gordon K., Pli.D., Principal Deputy Assistant Secretary of Defense
for Atomic Energy:
Information regarding national radiation help-line numbers 77
Prepared statement 65
Wellstone, Hon. Paul D., a Senator in Congress from the State of Min-
nesota: Prepared statement 6
APPENDDC
Material submitted for the hearing record 171
May 1932, Leon Prodan, M.D., M.P.H., Dr. P.H. article from the Journal
of Industrial Hygiene entitled "Cadmium Poisoning: II. Experimental
Cadmium Poisoning" 171
Januaiy 1973, Arthur Spomer article from Atmospheric Environment
entitled "Fluorescent Particle Atmospheric Tracer: Toxicity Hazard" 195
Statement for the record by Roger Parloff, senior reporter for the Amer-
ican Lawyer 199
Statement for the record by Elizabeth Barrett, daughter of human experi-
mentation victim 204
COLD WAR ERA HUMAN SUBJECT
EXPERIMENTATION
WEDNESDAY, SEPTEMBER 28, 1994
House of Representatives,
Legislation and National Security Subcommittee
OF THE Committee on Government Operations,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in room
2154, Raybum House Office Building, Hon. John Conyers, Jr.
(chairman of the subcommittee) presiding.
Members present: Representatives John Conyers, Jr., Al
McCandless, and WilHam F. CHnger, Jr.
Also present: Representative Gary A. Condit.
Subcommittee staff present: James C. Turner, staff director;
Bennie B. Williams, clerk; and L. Stephen Vincze, minority profes-
sional staff, Committee on Government Operations.
OPENmC STATEMENT OF CHAIRMAN CONYERS
Mr. Conyers. The subcommittee will come to order.
Today's meeting will examine a tragic chapter from the cold war
era — the many cases, where our government sponsored secret ex-
periments on Americans in the name of national security.
Last year, Secretary of Energy O'Leary revealed that during the
cold war the government conducted widespread radiation experi-
ments upon soldiers, school children, hospital patients, and other
private citizens, many of whom had not volunteered to be experi-
mental subjects.
The radiation experiments are only part of the story. We have
learned that during the cold war the Department of Defense and
other government agencies also conducted chemical and biological
warfare experiments on Americans, as well as tests with various
drugs and incapacitating agents.
Because of security concerns, subjects of the cold war era tests
were often not informed that they were participating in an experi-
ment, and in other instances were not fully informed of potential
health risks.
Including the radiation experiments, we have learned that nearly
a half million Americans were subjected to some cold war era tests.
In addition to being secret, this national security research was
often conducted on individuals who had little choice in the matter,
including members of the military, prison inmates, hospital pa-
tients, and institutionalized individuals.
In one case, we have evidence that in the late 1950's the Army
Chemical Corps conducted a biological warfare test from an aircraft
(1)
flying over Detroit and dispersing particles of a cancer-causing
compound. Although the Army assured us there was no likelihood
of injury, I am deeply concerned about usin|^ our citizens as guinea
pigs, no matter how safe the Army might thmk a test is.
In other cases, the military and the CIA contracted with various
universities to do research on the influences of psychochemical
agents on combat troops. How did they accomplish this? They did
it by administering LSD and other psychochemical agents to people
who had no idea what had happened to them. They had become
part of an experiment without their knowledge or consent.
Sadly, this chapter from the cold war is not over. Today, individ-
uals who were injured in these experiments and their families are
still trjdng to find out the truth about what happened, and to se-
cure assistance from the government.
After Secretary O'Leary's disclosures, President Clinton estab-
lished a special advisory committee to review the radiation experi-
ments and to recommend remedial steps. But this body has only a
limited mandate — ^radiation experiments; it is not examining other
potentially damaging cold war experiments on Americans.
So this hearing is to begin an examination of the fiill scope of the
cold war experiments, and to begin a process of trying to provide
assistance to Americans who may have suffered injuries in them.
The General Accounting Office, the investigative arm of Con-
gress, has been very helpful. We have also received cooperation
from the Department of Defense. And we now have relatives of in-
dividuals who lost their lives in the tests who will tell about their
families' experience.
Finally, we have a distinguished panel, that will discuss the
many troubling aspects of this sad chapter from our national his-
tory.
Now, in addition to the radiation tests, the subcommittee will
consider Army biological warfare tests using potentially carcino-
genic compounds in 239 American cities between the years 1949
and 1956; atmospheric nuclear tests from 1945 to 1962 involving
over 212,000 individuals; Naval Research Laboratory full body
mustard ^as exposures on 3,000 subjects; Army and Navy skin
tests during the 1940's with blistering agents and ointments,
60,000 people involved; Army Chemical Corps tests with nerve
agents and psychochemicals on 7,120 subjects; CIA program of
drug testing and behavior control experiments during the 1950's on
several hundred subjects.
This hearing reads like a chapter from a science fiction novel. It
is hard still for me to believe that all this occurred after World War
II. It is a very sad chapter in our history, but one that needs to
be revealed, because hundreds if not thousands of people are now
coming forward. The only way we can make sure that tnis does not
go on is to continue to expose every part of it, every plan, every
diabolical strategy that was involved in these awful experiments.
And this committee is determined to make sure that just that hap-
pens.
Before recognizing the chairman of the Budget Committee, Mar-
tin Sabo, I am pleased to recognize Mr. Al McCandless, the ranking
minority member from California, who is also winding up a very
distinguished career in Congress as a leader on this committee. As
one whose helpfulness has been very important to the legislative
products of the committee, his absence in the next Congress will
be sorely missed.
Mr. M McCandless.
Mr. McCandless. Thank you, Mr. Chairman.
Today our committee addresses a topic of serious and tragic di-
mensions: government-sponsored human experimentation during
the cold war period. The value our Nation and society places on in-
dividual human life separates us from the vast majority of nations
in the world. In America, everyone's life deserves equal protection.
The sanctity of human life in our culture is largely responsible
for the hope that the United States historically has represented to
the people around the world.
The cold war, however, confronted our Nation and indeed the
world with the prospect of complete annihilation. The fear and ur-
gency of the time remains with those of us who lived through it.
As we increasingly learn about some of the measures that our gov-
ernment undertook to fight and win the cold war, we realize what
a high price our Nation and the brave citizens in uniform paid to
prevail.
It is also clear that regardless of the fear and urgency of the
time, serious mistakes were made. Today's hearing will examine
some of the tragic lessons and legacies of the cold war. We must
indeed never forget the horrors posed by possible nuclear annihila-
tion of the entire human race and the horror of losing a single indi-
vidual life, regardless of the purpose.
Accordingly, Mr. Chairman, I look forward to hearing from our
witnesses today and hope that they can help us prevent the future
recurrence of the tragic mistakes that we experienced in the past.
Thank you.
Mr. CoNYERS. Thank you very much. Without objection, we have
a statement from Bill Clinger of Pennsylvania that will go into the
record, as will the statements of any other members of this sub-
committee.
[The prepared statement of Mr. Clinger follows:]
WILLIAM F CLINGER, JR.
5th OtSTRICT, PiNHSnVANU
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Statement
of the Honorable William F. dinger, Jr.
Subcommittee on Legislation and National Security
September 28, 1994
Thank you, Mr. Chairman. I certainly concur with my distinguished colleague
from California - the legacies of the Cold War are ones that we should never forget.
Today, we will examine one of the more troubling legacies of the Cold War era -
human experimentation. Certainly, for those citizens and their families who suffered as a
result of these tests, nothing can recoup the precious life that was harmed or lost. As my
colleague has stated so well, the value we Americans place on individual human life sets
us apart from most nations in the world. We should never lose this distinguishing trait
In keeping with our concern for the lives of our citizens, we should go back and
re-examine after every war or armed conflia what we did and why, and what mistakes
were made that cost lives. The Cold War is no exception.
Accordingly, I welcome today's hearing with the hope and expectation that we will
all join together in a constructive effort to understand what happened and what we are
or should be doing today to ensure the same tragedies are not repeated.
###
THIS STATIONERY PftlNTgO ON PAPER MAO€ Of RECYCLED FIBERS
Mr. CoNYERS. One of our great leaders in the Congress, Martin
Sabo, is here. We are delighted that he is with us today. We have
a letter from your Senator, Paul Wellstone, that without objection
we will include in the record. If you have not seen it, I would like
you to have a copy of it as well.
[The prepared statement of Mr. Wellstone follows:]
PAUL D WELLSTONE
( 'Dll NilVhlF
United States ;Dtnatc
AASHiNCToN OC2OS10;303
'\ih,,^ AKO NATUH41 WSCutitf*
Septeinber 27, 1994
The Honorable John Conyers Jr.
United States House of Representatives
Washington, D.C. 20515
Dear Mr. Chairman:
I want to commend you for holding a hearing Wednesday to
shed light on the sad secret of U.S. government experimentation
on its citizens during the Cold War. One aspect of this testing
is of grave concern to many Hinnesotans and other Americans , and
I would like to submit the enclosed pertinent materials for the
record .
During the 1950s and 1960s, the U.S. Army conducted numerous
open-air experiments of biological and chemical warfare methods
in Minneapolis and other areas of greater Minnesota, the United
States and Canada . These tests involved the spraying of varying
quantities of zinc cadmium sulfide, a fluorescent powder, to
simulate dispersion patterns of actual biological or chemical
agents .
At the time, the Army considered zinc cadmium sulfide to be
a harmless stibstance. However, numerous Hinnesotans, including
former students of an elementary school downwind of several tests
conducted in Minneapolis in 1952, now suffer from various adverse
health effects ranging from reproductive difficulties to cancer.
They wonder if their illnesses are linked to the tests to which
they were unwittingly subjected.
The enclosed reports detail the known or probable adverse
htiman health effects of cadmium, the most toxic ingredient in
zinc cadmium sulfide. One of the reports, a paper by Dr. Leon
Prodan published in 1932 — a full two decades before the
Minneapolis sprayings, asserts that inhalation or ingestion of
even small amounts of cadmium or its compounds can pose serious
dangers to human health.
Also enclosed is a 1973 paper that cites potential health
hazards of zinc cadmium sulfide and urges caution in the handling
and use of the fluorescent powder in open atmospheric
experiments. The final report enclosed is the U.S. Agency for
Toxic Substances and Disease Registry's toxicological profile of
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PRINTFD ON RECVCltD PAPER
September 27, 1994
Page 2
cadmium and cadmium compounds .
It Is clear from these documents that zinc cadmium sulfide
is harmful to people who are exposed to it and that further study
is needed. To that end. Congressman Martin 0. Sabo and I have
secured funding in next year's defense budget for an independent
study by the National Academy of Sciences.
Your hearing is an important part in the federal
government's ongoing disclosure of the nature, extent and effects
of Cold War experimentation on U.S. citizens. I appreciate your
consideration of testimony regarding the zinc cadmium sulfide
experiments, and I hope that these documents I have supplied for
the record will be helpful .
Sincerely,
(^uX UjOXaT^^^
Paul David Hells tone
United States Senator
PDW:krb
8
Mr. CohfYERS. Congressman Sabo, we are delighted to begin the
hearing with your testimony.
STATEMENT OF HON. MARTIN OLAV SABO, A REPRESENTA-
TIVE IN CONGRESS FROM THE STATE OF MINNESOTA
Mr. Sabo. Well, thank you, Mr. Chairman.
It is a privilege to be here again. I appreciate your invitation to
testify. It is different being here on a subject other than budget
process. I appreciate this opportunity.
And to Mr. McCandless, let me say I wish him well in his future
endeavors. We are going to miss you in the Congpress. I know you
will enjoy yourself and work on that golf game.
But I want to thguik you for holding this hearing. The broad out-
lines of the Army's biological testing program have been known for
many years. When details emerged earlier this year about spraying
of zinc cadmium sulfide in Minneapolis, however, people in my dis-
trict were stunned.
The idea that the government would use its own citizens as guin-
ea pigs is appalling, and I condemn it in the strongest possible
terms. We need a complete release of all relevant information, and
an independent assessment of the damage the spraying might have
caused. Your hearing will help us achieve these goals.
As we know, the Army conducted extensive spraying of zinc cad-
mium sulfide at several locations in Minneapolis in 1953. Citizens
were not warned of the program. Indeed, I assume the program's
value to the Army would have been eliminated if people had known
about the testing, since many would have left the affected area.
Among the sites was the former Clinton school, where as many as
600 children were exposed to this compound.
In 1953, little was known about the adverse health effects of ex-
posure to cadmium, which was an essential element in this
compound. Now we know that cadmium causes certain types of
cancers, and the substance has been labeled as carcinogenic.
I have two specific goals relating to this spraying. First is the re-
lease of all relevant data. Responding to the encouragement of my
colleague from Minnesota, Senator Paul Wellstone, the Army has
released hundreds of pages of documents. I am not convinced that
everything has been made public, however, and we must push for
continued document searches at Army archives. Along these lines,
I will be writing to the Secretary of the Army Togo West within
the next few weeks on behalf of current and former Minneapolis
residents who have asked the Army to release any individual medi-
cal records it may have.
Second, we need an independent assessment of the possible
health effects from the spraying. The Army has concluded that the
levels of cadmium were so low that no adverse health effects were
possible. However, the residents of Minneapolis would feel more
comfortable with a study conducted by an organization other than
the Army, since it clearly has some institutional incentives to mini-
mize the spraying's impact. Therefore, at my request, the House
Appropriations Committee has added $1 million to the Army's fis-
cal 1995 budget for a health effects study by the National Academy
of Sciences.
The release of all pertinent information coupled with the comple-
tion of an independent health study will shed light on a clouded
part of our cold war history. We owe it to the American people to
investigate the impact of the chemical separation and to share our
findings with those who may have been affected.
Again, Mr. Chairman, thank you for scheduling this hearing. I
look forward to hearing from the remaining witnesses and your
conclusions.
Thank you very much.
Mr. CONYERS. Thank you very much, Mr. Sabo.
Here we are dealing with the spraying of zinc cadmium sulfide,
a poison which enters the body mainly through the respiratory sys-
tem, and second through the gastrointestinal tract. That doesn't
sound like harmless biological testing to me. Have there been citi-
zens from your State that have come forward with complaints that
they tracked to this activity?
Mr. Sabo. There are numerous questions. There clearly are many
residents of that area, including particularly the students who were
at the school, who are very concerned. Many of them have thought
that they have noted over the years different health patterns
emerging from students who were at the school at that point of
time. I am not in a position to make a judgment as to whether that
is accurate or not.
That is one of the reasons we pursued the separate funding for
a separate and independent study of the impact of the spraying in
Minneapolis in 1953 and some other communities around the coun-
try, including St. Louis.
Cadmium, as I imderstand it, has been labeled a carcinogenic in
recent years and clearly has the potential of having had an adverse
impact on people involved.
Mr. CoNYERS. Well, I think that is an important appropriation
that you have added and, of course, we support it completely. I
think that the study goes just beyond Minnesota; it is of national
consequence. We have medical studies going back to the 1930's that
have pointed out that there is a very dangerous potential to this
particular poison. I am amazed that it can be brushed off as some-
thing that is probably not consequential. So we will be looking for-
ward to the medical results of the people that are coming forward
who are probably now, what, in their 40's?
Mr. Sabo. Or older. Probably — could be late 40's, early 50's. I
might indicate, as background to the amount of money and using
the Academy of Sciences, we inquired of our department of health
in Minnesota whether they thought this was an appropriate agency
to do the study and whether the amount of money we had appro-
priated was enough to have a thorough study.
They indicated in both cases they thought the amount of money
and resources involved was approximately right, and that this was
a good agency to do the study.
Mr. CoNYERS. Well, I will be joining with you and Senator
Wellstone to ask the Secretary of the Army, Togo West, to expedi-
tiously release all of the medical records and related papers dealing
with this subject. It is very important.
One thing that we should establish at the outset of this hearing;
we are trying to find out what happened. It is very important that
10
we know what happened. As tragic as it is, the worst thing would
be that we brush past this — to try to conceal it or cover it up in
any way. I am hoping that the entire defense establishment cooper-
ates with this committee and other committees in the Congress
that will be working on this.
I want to commend you for joining us here, and ask Mr. McCand-
less if he has any questions.
Mr. McCandless. I have two very quick ones, Mr. Sabo. First,
have you been able to find out the intended purpose of this experi-
ment at the location using the ingredients we have been talking
about?
Mr. Sabo. I think it involved — it is an urban area, it involved
certain climate, certain wind, and the impact of all of those things.
Mr. McCandless. In going through this material, I keep coming
back to the same question: At what point in the chain of command
does someone have the authority to order this type of an experi-
ment carried out? Have you come across anything that would shed
some light on that?
Mr, Sabo. Who made the decision, that, I do not know. Appar-
ently there were some conversations with some officials in the city
about this spraying, but they clearly had no idea of what its impact
was. And as relates to some of the individual medical records, we
have asked the Army or will be asking the Army to search their
archives to see if they exist. Some of the students recall going
through some medical examinations at school after they didn't
know what those were about, and we are very curious whether any
such records still exist. I must say that the Army has released
many, many documents relating to the study, but we want them
to continue to see if these individual medical records also exist.
Mr. McCandless. What I am trying to put into perspective here
is, obviously, this had medical overtones to it of some nature, so we
would assume that someone in the hierarchy of the medical part
of the Defense Department was the instigator or promoter of this,
and did that person or persons then require the approval of the
Secretary of Army, the Secretary of Defense, or the President?
Mr, Sabo. That I don't know. That information might be in the
records. If it is, I do not know the answer to it.
Mr. McCandless. Thank you.
Mr. CONYERS. Marty, we have 239 cities involved in what hap-
pened to your city. Minneapolis, St. Louis, Detroit, Toledo, Spring-
field, IL — we are trying to make sure that the names of these cities
are declassified so they can be released. If they are not declassified,
I am going to ask that that happen right away.
But through the line of flight, we can determine some of these
cities. If cadmium is as dangerous as we suspect it might be, the
estimated half million people who were involuntarily involved in
testing would rise exponentially. We are talking about a lot of peo-
ple who could be involved. So we will be working very closely with
you and Senator Wellstone.
Mr. Sabo. I appreciate it.
Mr. CoNYERS. We thank vou for joining us today.
I am pleased now to call the Assistant Comptroller General of
the United States, Mr. Frank Conahan, who is accompanied by Mr.
11
Glenn Furbish, senior evaluator at GAO. Mr. Conahan has over-
seen an overview on cold war experimentation.
At the outset I want to commend him for beginning the first
thorough study of the cold war era tests. The revelations of particu-
lar experiments goes back to the Church Committee hearings in
the mid-1970's. GrAO tries to provide a wider understanding of this
matter than that revealed by Secretary O'Leary, when she made
the first stunning release of these materials as they affected her
particular Department.
We would invite you to proceed in your own way.
STATEMENT OF FRANK C. CONAHAN, ASSISTANT COMPTROL-
LER GENERAL, NATIONAL SECURITY AND INTERNAL AF-
FAIRS DIVISION, U.S. GENERAL ACCOUNTING OFFICE,' AC-
COMPANIED BY GLENN D. FURBISH, SENIOR EVALUATOR
Mr. Conahan. Thank you, Mr. Chairman, Mr. McCandless. We
do appreciate the opportunity to be here today at this very impor-
tant undertaking.
Let me start by emphasizing at the outset that precise informa-
tion on the scope and magnitude of government tests and experi-
ments involving human subjects is not available, and exact num-
bers may never be known. I think that is a point we need to under-
stand up front.
There are a number of reasons for this. No. 1, government infor-
mation is incomplete. We have established that, and I can talk
more about why. In addition, some records have been lost or de-
stroyed, and existing documentation is limited in several respects.
One important respect, is that the names of individuals who have
been subject to testing and experimentation is not always included
in the documentation. It may be available with contractors or other
institutions, but government agencies, in many cases, have not
gone after it.
So, I think that there are continuing areas of inquiry, but as
things stand presently, that information is not available. Therefore,
it remains to be seen as to precisely how much will be known at
the conclusion of this terribly difficult situation we find ourselves
in.
Notwithstanding, as you said, hundreds of tests have been con-
ducted over the years involving hundreds of thousands of people.
These tests involve exposing people to hazardous substances, such
as radiation, blister, and nerve agents, biological agents and LSD.
As you also mentioned, various groups of people have been sub-
jected to these tests, both with and without their knowledge and/
or consent.
My prepared statement which you have entered into the record,
describes several of the cases which we think are important for
consideration in this hearing. You cited a number of examples in
your own opening statement and Mr. Sabo talked about one that
is of particular interest to him. Therefore, I am not going to cite
too many additional. But what I would like to do, is talk about the
particulars of two or three which I think are important.
In a series of experiments in the 1940's and 1950's, the Atomic
Energy Commission and the U.S. Public Health Service did re-
searcn on a large number of individuals exposing them to doses of
12
radiation. This involved children as well as adults. It wasn't how-
ever until many years after those experiments that the individuals
realized the nature and risk associated with the exposures. This is
important because long periods of time often expire before people
really become aware of what they have been subjected to in the ra-
diation area.
The subjects of chemical testing have not fared any better. Tests
in the chemical area have been done without the knowledge or con-
sent of individuals, and without their knowing the full risks in-
volved.
One of the problems we face in dealing with those groups is that
in many cases, records were not kept in a manner that readily
identifies the participants. I will talk a little bit later about rec-
ommendations we have made to improve that situation. But we
will have to reserve judgment on how far we can go down that
road.
In addition to in-house tests, there were also a number involving
contractors. The Army Chemical Corps, for example, contracted
with universities, hospitals, and other institutions to research the
destructive influence of psychochemical agents on combat troops.
The Air Force did likewise. I believe you referred to one series of
Air Force experiments in your opening statement where approxi-
mately 100 people received LSD. We can talk further about that,
if necessary, during the Q&A.
You talked about other agencies such as the CIA. Of course, the
record shows those agencies were indeed involved in this kind of
experimentation.
Now, our information on biological tests and experiments is not
as extensive as it is in the other areas. I just need to note that.
I don't know what additional work would show, but as has already
been said here, between 1949 and 1969, several hundred biological
tests were conducted. For the most part, the subjects, unaware pop-
ulations were sprayed with bacterial tracers or simulants.
Mr. Sabo talked about one of particular concern to him. Some of
these were wide area experiments but others were localized, such
as right here at the Washington National Airport, and a similar ex-
periment in the vicinity of the New York City subway system. So
these things went across the board. Although the government has
clearly sponsored extensive research, the effects of tne experiments
and tests were often difficult to determine. At the time of the test,
some people were clearly harmed. In other cases, it took a long pe-
riod of time to determine what the harm, if any, was. As a result,
we have to look at these things individually, and generalizations
should not be made in that regard.
We did a report in February 1993 where we discussed the results
of claimants looking for redress against harm done by chemical
testing. What we found, was that a good number of those people
could not prove their health problems were caused by participation
in tests. One of the big factors, again, was information, although
there were some other problems, too.
Now, let me turn — ^yes, sir.
Mr. CoNYERS. Mr. Conahan, how could a citizen prove to his gov-
ernment that there was a causal connection between a secret ex-
periment and his illness?
13
Mr. CoNAHAN. When the government, one, has the information,
is willing to make that information available, and the individual in-
deed has an illness or ailment that matches up with what the
agent of that experiment would cause, and that match can be
made. Under the current regulations that individual is able to get
redress from the government.
The key here is the information, in the very first place.
Mr. CoNYERS. Exactly. You can see that is one hell of a burden
that we are putting on citizens.
Mr. CoNAHAN. I think that citizens in this case need the help of
government to the extent that government is going to provide that
redress.
Mr. CoNYERS. Right. I know there are problems on both sides,
but I am just thinking of the recently concluded health care de-
bates that got us nowhere. Thirty-eight million people without any
health insurance whatsoever. They can't get contemporary health
care, much less research a problem unless there is a lot of govern-
ment help, and that is what you are pointing out here, is that we
need more resources on the government's side helping to try to
make sense of where we are on this.
Not that every allegation proves the point; but that we have a
mechanism that would facilitate us determining this in an expedi-
tious and hopefully uncostly manner to the people that are in-
volved.
Mr. CoNAHAN. I think we need to describe where the real fault
lies. We do have programs within the Veterans Administration and
within the Department of Labor that provide both medical care and
disability benefits for people who have been harmed by these ex-
periments.
The key is in the individual's ability to prove that fact, and I
think that we need to spend a good bit of time dealing with that
issue. That is the key and it goes to your issue of resources and
greater emphasis.
Now, there have been special efforts since the 1970's to help cer-
tain individuals. But this has been particularly in the area of radio-
logical experimentation, and efforts such as those, are as far along
in the area of chemical and biological experimentation.
Again, our February 1993 report laid out the problems with re-
spect to chemical experimentation, and we made a series of rec-
ommendations. I am happy to report the Department of Defense re-
sponded in a positive way to those recommendations. The Depart-
ment of Defense did set up a Chemical Weapons Exposure Task
Force to identify the information that individuals needed, and
tasked the services to provide that information.
So while the response was positive, I have to report that the ac-
tual implementation has not been as positive. No. 1, the task force
has but one full-time investigator and the Army and the Navy have
not yet designated points of contact. And to date, none of the serv-
ices have really conducted thorough or complete searches of their
data bases.
Without this assistance, the Veterans Administration continues
to have great difficulty in assisting claimants. Earlier this month,
as a matter of fact, the Veterans Administration told us that they
14
still misdirect as many as 100 applications per month because ade-
quate information is not available.
In recognition that the situation with respect to biological experi-
mentation is very, very similar to the chemical area, the Depart-
ment of Defense extended the response to our recommendations to
include the biological area. Also, as Mr. Sabo reported earlier, the
fiscal year 1995 appropriations bill includes $1 million to further
study the possible effects of one of the simulants used in a series
of biological tests, one of which was discussed by Mr. Sabo.
I would like to point out, or perhaps remind, the panel at this
time that because of the difficulty that individuals have had over
the years in pursuing their interests, there has been a need for spe-
cial efforts. We have seen these come through the courts, we have
seen these come through the Congress, and as a matter of fact,
there has been special legislation providing benefits to some people.
Some of these are included in my statement.
Finally, let me say a few words about government efforts to
strengthen the protection of human participants. Guidance in this
regard has been available since right after the Second World War
but it simply was not always followed. We have example after ex-
ample of that.
It was not until the 1970's, that the Congress and the executive
agencies focused on this in any great way whatsoever, at which
time I think we have to take note that there was a rather signifi-
cant event in 1974, when the then — HEW did prescribe regulations
to strengthen informed consent procedures and institutional review
requirements. That was further strengthened by HHS in 1991, and
it was adopted by some 16 other agencies, to include the Depart-
ment of Defense, the CIA. and others.
So those requirements have now been clarified and strengthened.
The consent procedures and the review requirements are fairly ex-
plicit. They have not, as far as I know, been reviewed very well.
And I can report that we are currently reviewing the implementa-
tion of those regulations, and will report to the Congress upon com-
pletion of that work.
I suppose, Mr. Chairman, that is all I need to say for summary
purposes. We are available for your questions.
[The prepared statement of Mr. Conahan follows:!
15
United States General Accounting Office
GAO
Testimony
Before the Legislation and National Security Subcommittee
For Release on Deliveiy
Expected u
lOHWun.EST
Wednesday
September 28, 1994
Human Experimentation
An Overview on Cold War
Era Programs
Statement of Frank C Conahan, Assistant Comptroller General,
National Security and International Affairs Division
GAO/T-NSIAD-94-266
16
Mr. Chairman and Members of the Subcommittee:
We are pleased to be here today to discuss the use of humans In
tests and experiments conducted for national security purposes by
the Department of Defense (DOD) and other agencies between 1940 and
1974. As you requested, we collected information oh the scope of
these experiments ind their possible impact. We obtained
information on (1) the magnitude and scope of human subject
experimentation, (2) the potential effects of the experiments on
human subjects, (3) government efforts to assist those who may have
been injured or suffered adverse health effects as a result of the
tests or experiments, and (4) measures to ensure that informed
consent is secured and that volunteers are protected in government-
sponsored experiments.
BACKGROUND
As you requested^, we focused our work on defense-affiliated
programs that used human test subjects between 1940 and 1974.
The programs included tests and experiments conducted or sponsored
by the Departments of the Army, the Navy, and the Air Force; the
Defense Nuclear Agency; the Central Intelligence Agency (CIA); the
Department of Energy; and the Department of Health and Human
Services. The tests and experiments involved radiological,
chemical, and biological research and were conducted to support
weapon development programs, identify methods to protect the health
17
of military personnel against a variety of diseases and combat
conditions, and analyze U.S. defense vulnerabilities.
RESULTS IN BRIEF
During World War II and the Cold War era, DOD and other national
security agencies conducted or sponsored extensive radiological,
chemical, and biological research programs. Precise Information on
the number of tests, experiments, and participants Is not
available, and the exact numbers may never be known. However, we
have Identified hundreds of radiological, chemical, and biological
tests and experiments In which hundreds of thousands of people were
used as test subjects. These tests and experiments often Involved
hazardous substances such as radiation, blister and nerve agents,
biological agents, and lysergic acid diethylamide (LSD). In some
cases, basic safeguards to protect people were either not in place
or not followed. For example, some tests and experiments were
conducted in secret; others involved the use of people without
their knowledge or consent or their full knowledge of the risks
Involved.
The effects of the tests and experiments are often difficult to
determine. Although some participants suffered immediate acute
injuries, and some died, in other cases adverse health problems
were not discovered until many years later--often 20 to 30 years or
longer .
18
Federal programs provide benefits to former military and federal
civilian employees who suffer from Injuries or adverse health
effects as a result of federal service. However, It has proven
difficult for participants In government tests and experiments
between 1940 and 1974 to pursue claims because little centralized
information Is available to prove participation or determine
whether adverse health effects resulted from the testing. To
address these problems, special efforts have been made by some
Involved agencies to help groups of test participants obtain the
Information necessary to pursue claims. For example, the
Department of Veterans Affairs (VA) relaxed Its requirement that
participants link their health problems to those tests or
experiments. Also, since 1978 DOD has had a program to Identify
and provide information to participants in atmospheric nuclear
tests that were conducted between the 1940s and 1960s. More
recently, in January 1994, the administration established an
advisory committee to identify participants in other government-
sponsored radiation research. We are reviewing the efforts of the
committee at the request of the Senate Committee on Governmental
Affairs.
In other areas, however, special efforts to make information
available on test participants are not as far along. For example,
DOD recently recognized a need to identify and assist participants
in chemical tests conducted prior to 1968, but to date limited
resources have be.en applied. We were told earlier this month that
19
the VA continues to have difficulty processing claims because It
cannot obtain necessary Information from DOD. Some participants or
their survivors have pursed benefits or compensation, outside
existing federal programs, through specific congressional action or
court awards.
Although military regulations In effect as early as 1953 generally
required that volunteers be Informed of the nature and foreseeable
risks of the studies in which they participated, this did not
always occur. Some participants have testified that they were not
informed about the test risks. Government testing and
experimentation with human subjects continues today because of its
importance to national security agencies. For example, the Army's
Medical Research Institute for Infectious Disease uses volunteers
in its tests of new vaccines for malaria, hepatitis, and other
exotic diseases. Since 1974, federal regulations have become more
protective of research subjects and, in general, require (1) the
formation of institutional review boards and procedures and
(2) researchers to obtain Informed consent from human subjects and
ensure that their participation is voluntary and based on knowledge
of the potential risks and benefits. We are in the process of •
reviewing the effectiveness of these measures. A National
Institutes of Health official has stated that no mechanism exists
to ensure implementation of the key federal policies in this area.
20
THE GOVERNMENT HAS SPONSORED EXTENSIVE TESTING. BUT PRECISE
INFORMATION ON TESTS AND PARTICIPANTS IS NOT AVAILABLE
Precise information on the scope and magnitude of government tests
and experiments Involving human subjects Is not available, and
exact numbers may never be known. However, our review of available
documentation and Interviews with agency officials Ident/ fled
hundreds of tests and experiments In which hundreds of thousands of
people were used as subjects. Some of these tests and experiments
Involved the Intentional exposure of people to hazardous substances
such as radiation, blister and nerve agents, biological agents,
LSD, and phencyclidine (PCP) . These tests and experiments were
conducted to support weapon development programs, identify methods
to protect the health of military personnel against a variety of
diseases and combat conditions, and analyze U.S. defense
vulnerabilities. Healthy adults, children, psychiatric patients,
and prison Inmates were used in these tests and experiments.
Documenting the precise number of tests and participants is
difficult because government information is incomplete. Some
records have been lost or destroyed, and existing documentation
contains limited information and often does not identify names of
participants. Moreover, these records are spread throughout the
country at the National Archives, Federal Record Centers, other
government offices, and the military commands or organizational
units that created them. Some of the records measure thousands of
21
linear feet, and the availability and quality of indexes to the
records vary widely.
I will describe a few of the radiological, chemical, and biological
research projects that illustrate the scope and magnitude of
governmental experimentation.
Radiological Tests and Experiments
To date, over 200 radiation tests and experiments have been
identified involving over 210,000 test participants. Although not
involved in a test or experiment, another 199,000 people were
exposed to radiation through work. This latter group is of concern
because the effects of the exposure are the same as those incurred
by test participants. The radiation tests are generally recognized
as involving the largest number of test participants.
The largest known test program was the atmospheric nuclear test
program conducted from 1945 to 1962. The purpose of this program
was to develop weapons and to gain a better understanding of the
tactical effect on troops. Over this 17-year period, approximately
210,000 DOD-af filiated personnel, including civilian employees of
DOD contractors, scientists, technicians, maneuver and training
troops, and support personnel, participated in 235 atmospheric
nuclear tests. We reported on two of these tests, known as
22
Operation Crossroads, In 1985.^ In some tests, participants were
directly exposed to radiation. For example, in one test, five
Individuals were located directly beneath a high-altitude test. In
other tests, 37 Individuals were located in trenches from 2,000 to
2,600 yards from ground zero, and in others, approximately 26,000
individuals occupied trenches, bunkers, and armored vehicles from
2,500 to 5,500 yards from ground zero. According to DOD officials,
as many as 150,000 of the 210,000 participants may have been
exposed to fallout. In addition, 195,000 U.S. service members may
have been exposed to radiation during the occupation of Hiroshima
and Nagasaki, and over 4,000 other service members may have been
exposed during cleanups at Bikini, Enewetak and Johnston Atolls
after nuclear tests were conducted. Some participants have alleged
that they were not fully informed or did not understand the
potential health risks of exposure to radiation.
In a series of experiments conducted between the 1940s and 1960s,
the Atomic Energy Commission and the U.S. Public Health Service
funded research of the potential medical effects on people from
fallout after a nuclear attack or accident. In some of the
experiments, university researchers exposed mentally disabled
children to low doses of radiation. Years after the experiments
were completed, a task force found that researchers failed to
satisfactorily inform the subjects' families about the nature and
^Operation Crossroads; Personnel Radiation Exposure Estimates
Should Be Improved (GAO/RCED-86-15, Nov. 8, 1985).
23
risk of the experiments in order for them to make an informed
decision when they gave their consent. The president of one of the
universities involved in the experiments later apologized for the
use of children and the failure to provide full information about
the nature and risk. We are not aware of what, if any, further
action was taken in this case.
Chemical Tests and Experiments
During World War II and the Cold War era, the Army and the Navy
conducted two major chemical research experiments in which
thousands of service members were used as test subjects. An
unknown number of other chemical tests and experiments were
conducted under contracts with universities, hospitals, and medical
research facilities. In some of the tests and experiments, healthy
adults, psychiatric patients, and prison inmates were used without
their knowledge or consent or their full knowledge of the risks
involved.
During World War II, the Army conducted tests of protective
clothing and equipment in which thousands of people were exposed to
mustard gas and lewisite agents. In addition, the Army developed
and tested offensive chemical weapons and evaluated the
effectiveness and persistency of mustard agents in different
environments. In February 1993, we reported that the Army's
records of its mustard test activities were not kept in a manner
8
24
that readily Identifies the participants.' However, the available
records show that 1,002 soldiers were conunended for their
participation In tests In which they subjected themselves to pain,
discomfort, and possible permanent Injury for the advancement of
research In protection of the armed services .
Similar to the Axmy's tests, the Navy conducted tests of clothing
and equipment that exposed thousands to the effects of mustard gas
and lewisite agents. These experiments Involved (1) gas chamber
tests. In which service members were completely exposed to mustard
and lewisite agents while wearing protective clothing, and (2) skin
tests. In which amounts of mustard agent and antlveslcant ointments
were applied to service members' forearms. The Navy has a list of
the names of approximately 3,200 sailors who participated In
mustard and lewisite agent tests performed by the Naval Research
Laboratory. Additionally, Navy officials told us that between
15,000 and 60,000 Navy recruits had participated In skin tests
conducted by a contractor but that the Navy had no record of the
recruits' names.
From 1952 to 1975, the Army conducted a classified medical research
program to develop incapacitating agents. The program involved
testing nerve agents, nerve agent antidotes, psychochemicals, and
irritants. The chemicals were given to volunteer service members
^Veterans Disabllitv; Information From Military May Help VA
Assess Claims Related to Secret Tests {GAO/NSIAD-93-89, Feb. 18,
1993).
25
at the Edgewood Arsenal, Maryland, and four other locations. Army
documents Identify a total of 7,120 Army and Air Force personnel
who participated in these tests, about half of whom were exposed to
chemicals. The Army's Medical Research and Development Command in
Fort Detrick, Maryland, has the names and service numbers of all
test participants and a list of the chemicals to which the service
members were exposed. Sone service members have testified before
congressional committees that they were not fully informed of the
risks involved.
During the same period, the Army Chemical Corps contracted with
various universities, state hospitals, and medical foundations to
research the disruptive influences that psychochemical agents could
have on combat troops. The Air Force also conducted experiments on
the effects of LSD through contracts at five universities.
According to Air Force officials and records, approximately 100
people received LSD in these experiments. No effort has been made
by the Air Force to determine if the participants' names are
available in the universities' records.
According to a CIA official, from 1953 to about 1964, the CIA
conducted a series of experiments called MKULTRA to test
vulnerabilities to behavior modification drugs. As a part of these
experiments, LSD and other psychochemical drugs were administered
to an undetermined number of people without their knowledge or
consent. According to the official, the names of those involved in
10
26
the tests are not available because names were not recorded or the
records were subsequently destroyed. However, some tests were done
under contract, and no effort has been made by the CIA to determine
if names are available In contractors' records.
Biological Tests and Experiments
The Army conducted a series of biological warfare experiments and
tests between 1949 and 1974. The purpose of these tests was to
determine U.S. vulnerabilities to biological warfare. For example,
between 1949 and 1969, the Army conducted several hundred
biological warfare tests in which unaware populations were sprayed
with bacterial tracers or simulants that the Army thought were
harmless at that time. Some, of the tests involved spraying large
areas, such as the cities of St. Louis and San Francisco, and
others involved spraying more focused areas, such as the New York
City subway system and Washington National Airport.
In another Army experiment conducted between 1959 and 1974,
approximately 2,200 volunteers were exposed to biological
pathogens, such as Venezuelan Equine Encephalitis and Tularemia, as
part of research to develop vaccines and antidotes. A list of all
studies and medical records of all volunteers are located at the
Army's Medical Research Institute of Infectious Diseases in Fort
Detrick, Maryland. It appears that the participants were
adequately Informed.
11
27
EFFECTS OF EXPERIMENTS
ARE OFTEN DIFFICULT TO DETERMINE
The effects of government tests on participants' health have been
difficult to determine. At the time of the tests, some people were
clearly harmed. However, in other cases, possible adverse health
effects related to the substances used were \ nknown or did not
become apparent until years later.
Available records show that people suffered immediate acute
injuries in some tests and that people died in at least two tests.
For example, available records show that some participants in the
Army's and the Navy's mustard and lewisite tests suffered burns and
required hospitalization. Also, in a highly publicized case, an
Army employee died in 1953, a short time after participating in a
CIA experiment using LSD.
However, for some test participants, the test effects were not
readily apparent. In these cases, claimed adverse health problems
did not appear until many years later. For example, in our
February 1993 report on the Army's chemical testing program, we
noted that the first health problems for most of the veterans who
sought assistance appeared many years after their military service
and at a time when these same ailments typically show up in their
general age population. Further, only a few of the veterans
alleged that their health problems were long term in nature, dating
12
28
back to their active military duty. We reported that 97 of 145
veterans seeking assistance could not prove that their health
problems were caused by participation in a test or experiment.
Research studies have also shown that exposure to some of the
substances used in the tests may create health problems that often
will not appear for many years. For example, the National Academy
of Sciences concluded in 1993 that exposure to mustard agents could
cause many serious diseases that would not immediately appear, such
as leukemia, emphysema, respiratory and skin cancers, and eye
diseases, and that lewisite agents could cause some of these same
diseases.
INFORMATION AVAILABLE TO ASSIST
TEST PARTICIPANTS VARIES
Two federal agencies, the VA and the Department of Labor, have
programs to provide medical care and disability benefits to former
military and federal civilian personnel who have experienced health
problems as a result of their participation in government tests or
experiments. However, because there is not complete information on
those who participated and the precise adverse health effects of
their participation, it has often proven difficult for former test
participants to pursue claims. To address these problems, special
efforts have been made by some involved agencies to help groups of
test participants obtain the information necessary to pursue
13
29
claims. Other Involved agencies, however, are not providing the
Information test participants need. Apart from the information
issue, some participants or their survivors have sought
compensation or benefits directly through civil or specific
congressional actions.
The largest special information assistance effort is the Nuclea.:
Test Personnel Review program, established by DOD in 1978. This
program, administered by the Defense Nuclear Agency, has assisted
veterans by compiling data on atmospheric nuclear tests, including
the names of participants, the locations of the tests, and the
amount of radiation administered during the tests. ^ This program
also Involves an extensive outreach program that provides documents
about the tests and informs participants of the availability of VA-
provided health care and disability benefits.
Other special actions have also been taken to help some veterans
pursue health claims related to their participation in testing. In
1988, the Congress directed the VA to relax its claims adjudication
procedures for veterans exposed to radiation resulting from
atmospheric nuclear detonations. For veterans with certain
ailments that may be attributable to radiation exposure, the VA
presumes that the ailments are service connected. In 1992, the VA
^In October 1979, DOD expanded the program to include U.S. service personnel vrfio
had participated in the postwar oco^iation of Hiroshima and Nagasaki.
14
30
amended its regulations so that veterans of mustard testing receive
similar treatment If they develop certain diseases. In 1994, the
regulations were further amended to Include lewisite.
Earlier this year, the administration Initiated a large effort to
gather data on people who participated In experiments Involving
Intentional exposure to Ionizing radiation and Intentional
environmental releases of radiation. The Presidential Advisory
Committee on Human Radiation Experiments, established in January
1994, is conducting this review. We are currently reviewing the
efforts of the advisory committee at the request of the Chairman,
Senate Committee on Governmental Affairs.
Let me describe some areas in which information is still needed.
Our February 1993 report stated that the military services lacked
complete information on their chemical test activities and
recommended that DOD aggregate the information and provide a point
of contact within each service to assist veterans in obtaining
information about their test experiences. DOD, in turn,
established the Chemical Weapons Exposure Task Force to identify
chemical test information and tasked the Secretaries of the Army,
the Navy, and the Air Force to provide Information related to the
tests to the task force. However, to date (1) the task force
employs only one full-time investigator, (2) the Army and the Navy
have not designated points of contact to lead this effort, and (3)
15
31
the services have not conducted a complete and thorough search of
their records. Without this assistance, the VA continues to have
difficulty assisting former test participants. For example, we
were told In September 1994 that VA claims adjudicators misdirect
over 100 test Information requests monthly because they do not know
which agency should receive them.
A similar situation exists with some other groups. For example,
some agencies have made little effort to assist test participants
by Identifying test locations and participants In experiments
conducted by contractors. The CIA, In fact, has not released the
names of 15 of the approximately 80 organizations that conducted
experiments under the previously discussed MKULTRA program because
the organizations do not want to be Identified.
Conclusive Information on the effects of some biological simulants
used In the Army's testing Is not available. Recently, the Army
had the Centers for Disease Control review Its risk assessments for
one simulant used In some of Its biological warfare tests. The
Center determined that adverse health effects from the levels of
exposure to the simulant, zinc cadmium sulfide, at those sites were
very unlikely. However, the Fiscal Year 1995 Defense Appropriation
Bill provides $1 million to further study possible adverse health
effects of exposure to this simulant.
16
32
Finally, In the case of civilian government employees, whose claims
for compensation are processed through the Department of Labor, we
were told that the rules have not been relaxed in the same way as
they have been at the VA. In some cases, civilian employees
participated in the same testing as military service members.
In selected cases, test and experiment participants have received
compensation as a result of a civil action or specific
congressional action. For example, in 1976 the President signed
legislation providing $750,000 to the family of an LSD test
participant who died in 1953 shortly after being administered LSD.*
Also, the Justice Department settled a suit brought by another
group of LSD test participants for $750,000. Another example of a
specific congressional action is the establishment of a $100
million fund to cover claims from individuals who lived downwind
from locations where above-ground nuclear tests were conducted.^
Similarly, another act authorized $184 million for Marshall Islands
citizens who may have been exposed during nuclear testing.^ These
funds are distributed to Individual islands and disbursed by the
local governments .
♦Private Law 94-126.
'The Radiation Exposure Compensation Act (P.L. 101-426).
*The Compact of Free Association Act of 1985 (P.L. 99-239)
17
33
GOVERNMENT EFFORTS TO STRENGTHEN THE
PROTECTION OF HUMAN PARTICIPANTS
Although guidance for protecting human subjects has existed since
the post-World War II Nuremberg trials, the principles were not
always followed by U.S. government researchers. It was not until
the 1970s that the Congress and some agencies became actively
Involved In examining human research ethics and establishing laws
and regulations that became progressively more protective of human
subjects. In 1974, the Department of Health, Education, and
Welfare Issued a regulation strengthening the Department's Informed
consent procedures and Institutional review requirements. In 1991,
the Department of Health and Human Services Issued a revised,
uniform regulation for the protection of human subjects that was
adopted by 16 federal agencies. Including DOD, CIA, and other
national security agencies .
The 1947 Nuremberg Code of Ethics established the fundamental
principles for scientists and physicians Involved In using people
as subjects In experiments and tests. In the Nuremberg Code, the
respect for the human rights of patients. Including their voluntary
consent and their safety from undue physical or psychological harm,
was of paramount consideration. A 1953 memorandum from the
Secretary of Defense to the secretaries of the military services
directed them. In essence, to adopt the Nuremberg Code as a guide
for human experimentation. However, according to defense
18
34
officials, some of the rules. Including those related to the
quality of informed consent and the capability of the subjects to
withdraw without prejudice, were not followed in the 1950s and
1960s.
In 1964, the Declaration of Helsinki emphasized that clinical
research using people as subjects should be (1) based on laboratory
and animal experiments or on scientifically established facts, (2)
conducted by scientifically qualified medical persons, (3) preceded
by a careful assessment of the inherent risks versus benefits, and
(4) generally done with disclosure of the risks to the subjects and
with the subjects' free consent. In November 1966, the American
Medical Association adopted the ethical principles of the Helsinki
Declaration to guide physicians engaged in clinical research and
investigations of new drugs and procedures.
The federal regulation Issued in 1974 by the Department of Health,
Education, and Welfare covers the protection of humans in
experiments and tests and requires all institutions carrying out
research funded by the department to have an Institutional Review
Board. The boards are to review the risks and benefits of the
proposed research, the specific procedures to be followed, and the
process of informing the human subject and obtaining consent. The
regulation also requires institutions to describe the test
procedures and the foreseeable risks or discomforts and explain
that subjects can refuse to participate at any time. In general,
19
35
federal departments incorporated parts or all of this regulation In
their policies on human experimentation.
The Department of Health and Human Services' 1991 regulation
replaced previous federal policies and regulations and clarified
requirements for researchers to obtain informed consent from human
subjects and ensure that their participation is voluntary and based
on knowledge of the potential risks and benefits. The regulation
was subsequently adopted by 16 other federal agencies.
This concludes my prepared statement, Mr. Chairman. I will be
happy to answer any questions.
(709096)
20
36
Mr. CoNYERS. Thank you very much.
First I want to thank Mr. Furbish and the rest of your organiza-
tion that has done a remarkable amount of research in a short time
so that this hearing could be convened before the conclusion of the
103d Congpress. We are indebted to you.
Mr. CoNAHAN. We appreciate that, Mr. Chairman, because it has
been a short time, and we hope that we are able to give you what
you need.
Mr. CoNYERS. Well, it is coming along. Without your organiza-
tion, we would spend all of our efforts just on one subject, and as
you know, we have about two dozen subjects pending in the Grov-
emment Operations Committee.
Could you comment on the Nuremberg Code and the Helsinki
agpreements as they impact upon the protection that citizens have
against improper government research among the countries that
recognize these principles?
Mr. CoNAHAN. I think that we all have been reminded often
enough of the atrocities that were committed by the Nazi regime
during World War II. The Nuremberg Code was intended to in part
redress those atrocities. I think that there are two essential ingre-
dients that people focused in on at that time. One was to ensure
that the individual has the information necessary to know what he
or she is agreeing to be subjected to. Second, that there is a mecha-
nism in place to gain adequate consent. That theory — the fun-
damental right of individuals — was carried through the Nuremberg
Code, the Helsinki Accord, and up through our own regulations
adopted in 1974 and subsequently amended.
I think they are the two key fundamentals that happily have
been recognized and brought along these years.
Mr. CoNYERS. So we have got to make sure first of all that we
are fiilly compljdng with these principles, and that informed con-
sent is commonplace. Now, what about the violations that appear
to have occurred anyway? Do those principles provide any relief to
citizens of any country whose rights may have been violated?
Mr. CONAHAN. I am not aware of specific relief that is covered
under any of those accords. In our own government, I would say
that the Veterans Administration and the Department of Labor
would be in a position to provide appropriate benefits for harm that
was done as a result of the experiments.
Mr, CoNYERS. Do you agree with our analysis that the Presi-
dent's Advisory Committee only includes radiation experiments and
therefore we have got some more work to do in fashioning a relief
mechanism for all of these other experiments — some of which are
combinations and others are completely different from radiation?
Mr. CoNAHAN. Not only, Mr. Chairman, do I agree with that,
that is a fact that the President's Advisory Commission covers only
radiological experimentation and not chemical, biological, and other
medical tests, and therefore let me say a word about that.
I believe we have to wait and see the results of the President's
Advisory Commission as I think it is a step in the right direction.
I think they are going down the right track. I think they have pub-
licized it so that folks who are in a position to help move things
along can come in and help. I understand there will be a hearing
37
later this year, in the other body, at which time the progress of
commission will be explored.
When it comes to chemical and biological, I don't believe we are
near where we need to be in that regard. As I said, the Secretary
of Defense, in response to the recommendation in our 1993 report,
did set up this task force in order to explore the chemical question
and its jurisdiction was later expanded to the biological area. But
it has not received the kind of emphasis, resources, or commitment
that I think are needed. Let me say here, because I think it is very
important, that the individuals who are working in this area right
now are very diligent, and I think that they are trying their vepr,
very best to do a good job. So I am not talking about the individ-
uals that are out there plowing this ground. They are doing a very
good job, it has been our observation, and it has been the observa-
tion of others who have sought out their help. We are talking about
the institutional commitment behind that effort.
Mr. CoNYERS. We will be working toward fashioning rehef mech-
anisms. I am not very enthusiastic about one commission after an-
other— we will have a commission on this and a commission on
that, and a commission on the other. It seems that we may have
to go back to the drawing board to put together something more
universal, so we can really look to one source as we review this un-
happy part of American nistory rather than a variety of commis-
sions. Although I have not consulted with anybody on the commit-
tee about it, we are going to be examining that facet as well. If you
or Mr. Furbish have any recommendations that you would care to
make to us, we would be glad to receive them.
Mr. CoNAHAN. Thank you. We would do that, Mr. Chairman.
I would say at the outset that I fully agree that commissions
seemingly don't do the job. We have seen commissions come and go,
and not much in the way of results.
What we need to do is to institutionalize the mechanisms that
are required in order to, one, provide the information, and two, find
a way to make access to it user friendly for both the claimant, as
well as, the adjudicators in the Veterans Administration and the
Department of Labor. That is what is necessary.
Mr. CoNYERS. I think you are right.
President Clinton may also want to come out and make an ex-
panded statement, now that we have a lot more than was brought
forward initially by Secretary O'Leary, whom I personally called to
commend for her revelations. Obviously, her point of view is from
the Energy Department, but these issues are far wider.
Our Veterans Administration is also deeply involved in this, be-
cause many of those involved in the military experiments are veter-
ans now. It reminds me of Agent Orange, where we fought medi-
cally, legislatively, and administratively to get some understanding
of what seemed to be a fairly obvious causal relationship between
an event and injuries that resulted from it. It still took years. It
seems to me that we ought to be looking very carefully at the Vet-
erans Administration. I have plans for naving public hearings in-
volving them because their role becomes inordinately large, and it
is important that we learn something from these past episodes like
Agent Orange so the government does not go into this fighting and
resisting the obvious.
38
Now, we are not here to judge with finahty the allegations that
are now being brought forward — some of them may not be able to
be medically connected or related. But there are ways that the gov-
ernment goes about redressing the wrongs that have been commit-
ted which show that we are seriously concerned about changing
what used to happen.
It is going to be very important that the VA play a constructive
role in creating the positive outreach that will publicize this matter
and get everyl^dy in front of it that needs to be. I am very worried
about the burden that a private citizen will have to bear to prove
a medical history. I am also troubled by your work showing that
we have only one or two people on these jobs at DOD. I don't know
what the VA situation is, but we have to step it up on the govern-
ment side so that we can solve this problem rather than try to drag
it out. Your work has been very helpful in that regard.
Lastly, let's talk about the CIA. What is this MKULTRA pro-
gram that they had going at one time? Second, what is the basis
for the CIA's reluctance to release the names of the 80 organiza-
tions that conducted experiments under their sponsorship?
Mr. CoNAHAN. The CIA during the 1950's and early 1960's con-
ducted a series of tests to determine vulnerabilities to behavior
modification drugs. LSD and other psychochemical drugs were ad-
ministered to an undetermined number of people. We don't know
the number because that information has never been released, but
there is sufficient information to show that it was done without
their consent or knowledge. Also, the names of the people involved
are not available — primarily because the records have been de-
stroyed. Some of these tests were done under contract with univer-
sities, but the CIA has not moved to determine the names of these
individuals from the universities.
Mr. CoNYERS. Do you get the feeling that this is something like
a science fiction novel in which the unbelievable is being revealed?
I mean, how does this affect us as government representatives who
have the unhappy task of bringing this forward to the American
people?
I know you don't enjoy this. You don't relish this investigations.
But there is something eerie about this. It is beyond most people's
rational anticipation, that their government could have been doing
this after World War II and into the 1960's.
Mr. CONAHAN. I think, Mr. Chairman, we all agree that if our
national security is truly at risk by divulging information, we can
all agree to find an alternative to releasing that precise informa-
tion. It strains me, however, in too many cases dealing with our na-
tional security agencies, to include specifically the Central Intel-
ligence Agency, why they contend that information such as this
needs to be protected for national security purposes.
Mr. CoNYERS. It should be declassified at this point.
Mr. CoNAHAN. I don't know why it hasn't been. As I say, in those
cases where the demonstration has been made, fine. But in the ab-
sence of that demonstration, it should not remain classified.
Mr. CONYERS. Thank you.
The Chair recognizes Mr. Al McCandless.
Mr. McCandless. Thank you, Mr. Chairman.
39
Mr. Conahan, you have given us a pretty thorough overview and
history of the period, particularly 1940 to 1974. To your knowledge,
what tests if any have been continued beyond that point of 1974?
Mr. Conahan. Mr. McCandless, this is not in way of explaining
away why I can't give you a full answer to that question, but it is
important for me to say that in preparing for this hearing, we fo-
cused on the period up through 1974, since that is where the real
problems seem to be.
Beginning in 19 74, we did have government regulation, and con-
tinuing or new involvement and control mechanisms in this area.
So we thought that at least the basic fundamental conditions were
beginning to be corrected. Now, having said that, although we
dicb't focus on a later period, it is clear that medical research con-
tinues, hopefully, it continues under the ground rules of the 1974,
as amended, regulations. We have instruments within the Depart-
ment of Defense, within the military establishment, that have as
a principal objective, the continuation of medical research. For ex-
ample, at Fort Detrick in Fredericksburg, MD, we have a medical
research facility.
While we have not reviewed that facility, it is mv hope, of course,
that they are complying with the current ground rules which re-
quire them to provide adequate information as to what the subjects
are involved in and to gain their consent. But yes, it continues.
Mr. McCandless. The overriding concern here that just boggles
my mind, having in recent years been involved extensively with the
Environmental Protection Agency and the rules and regulations
being promulgated there relative to water quality control, air qual-
ity control, environmental controls of all types, that we find our-
selves in, on a daily basis, on the one hand, and here in this panel
we are talking about all of these things that are taking place with
the full knowledge and consent of the same government that is
bringing about all of these regulations to attempt to clean up the
environment and make a more healthy atmosphere for us to live.
There is a certain contradictory part of that.
So we are saying here, in essence, that the Federal Government,
through whatever authority that they deem that they have in some
size, shape and form, are continuing to conduct what they consider
to be valid experiments relative to our environment and the hu-
mans that live in it?
Mr. Conahan. I think that there is a legitimate basis for some
experimentation. We have to develop new weapons programs to
counter whatever the threat is, at any point in time, to our na-
tional security.
Mr. McCandless. Let me interrupt you here. I am not talking
about an experiment of the nature that is performed within a lab-
oratory environment. I am talking about what we have been talk-
ing about here, subjecting people and locations and geography to
certain experiments without their knowledge or consent.
Mr, Conahan. We do not have information, as I said at the out-
set, on the situation since 1974. As we have gone around and
talked to the people who are working in these areas throughout the
Federal Government, there was a feeling that the 1974, as amend-
ed, regulations are generally being complied with.
40
However, we have not found a mechanism anywhere along the
way to ensure that that is the case. There is not a reporting mecha-
nism to assure that. And a very well-placed individual at the Na-
tional Institutes of Health had that very concern, and shared us,
that as he looks across the horizon, we don't have a mechanism in
place to assure that those things aren't occurring.
Mr. McCandless. Let me conclude by asking, in your investiga-
tory role, have you tracked a particular set of circumstances from
the incident through the process, to the point where an agreement
to proceed became a decision on the part of some level of govern-
ment and/or persons involved?
Mr. CoNAHAN. What we have in the 1993 report is, we have
traced claims made by individuals for benefits in response to their
ailment. And we showed how they went through the process and
what the outcome of that was, yes, sir.
Mr. McCandless. I didn't frame my question correctly. I am
talking about the actual performance of this experiment. Let me be
hypothetical here for purposes of illustration.
A scientist feels that it is essential for his or her project that
they move beyond the laboratory and perform certain exterior-to-
the-laboratory functions relative to the overall subject matter
under investigation or experimentation.
And so this laboratory person goes to someone, and that someone
says, well, I see where you are coming from, yes, to me there would
be a value, let's proceed to explore how we might be able to bring
this about. And so thejr explore on how to bring this about.
And so my question is, who in the echelons above this theoretical
situation, at what level does someone say, that is a great idea, let's
go ahead and involve a neighborhood, a community, a gproup of peo-
ple who have no idea that they are a part of that experiment? This
is the thing that concerns me.
Mr. CoNAHAN. An excellent point, Mr. McCandless, and I think
it is key to what we are talking about here. The HHS regulation
does require independent review groups be established within each
of the agencies to address this very question that you are raising.
We have that work underway right now but I cannot report a con-
clusion as it simply is not completed. It is very, very key, and I
agree with you that it needs to be addressed and as I said we are
addressing it.
Mr. McCandless. One further comment — I thank the chairman
for the time — it boggles my mind going through this that we give
someone who has been sentenced by a court and a judge to death,
13 years of — or whatever number of times, years it may take, to
preserve his or her rights to the msiximum degree possible in a
court of law, and to explore every avenue of the activities that led
up to this sentence, and whether or not the sentence is valid, and
yet we are out here somewhere doing something with what it is we
want to do, with people who have no knowledge of it, and there is
a legal contradiction there somewhere. I dont expect to you re-
spond imless you want to. But this boggles the mind.
Mr. CoNAHAN. Well, I will accept your invitation to respond.
Chairman Conyers talked earlier about the need for some mecha-
nism beyond this commission activity and all the rest of that sort
of stuff. I think that something is absolutely required and would
41
suggest that it include such things as estabhshing milestones for
doing the things that need to get done. Then I think there is a sec-
ond part as well. What you are getting at is accountability. I think
we have to hold people accountable for approval actions when they
sign off on these experiments, because these are signed off on.
Mr. McCandless. Thank you.
Mr. CoNYERS. Thank you. Mr. Bill dinger.
Mr. Clinger. Thank you, Mr. Chairman.
We know all of these issues involve very sensitive, delicate, ethi-
cal, moral questions, and we are reminded of that in this morning's
Post which refers to recommendations with regard to embryo re-
search that are coming forward. The only question I would ask you
is, you have conducted very extensive review on these tests from
1940 to 1974, did you find any evidence that these tests resulted
in positive or beneficial results or scientific discoveries?
Mr. CoNAHAN. I think there are two things that can be said in
that regard. Yes, a series of tests have resulted in advances in nu-
clear medicine in the radiological experimentation area, and there
are individual cases where other experimentation has resulted in
antidotes, vaccines and so on. Not all experiments are to be faulted.
There are experiments that are being done properly, and we came
across a few of those as we did our review.
But I must confess that the scope and magnitude of those of con-
cern really stood out during that earlier period.
Mr. Clinger. So the question always is, do the benefits outweigh
the possible harm, or should you ever engage in it if there is going
to be harm to the individuals being tested? what are the tradeoffs/
Mr. CoNAHAN. Yes, I think there is that tradeoff. If we get in
place the proper sidelines and mechanisms for enforcement, then
we can all deal with that much better than we can today.
Mr. Clinger. Thank you.
Thank you, Mr. Chairman.
Mr. CoNYERS. I have one final observation. Did you mention the
Air Force's LSD tests, which was information that came to the sub-
committee rather late?
Mr. CoNAHAN. I think I made a passing reference to it. It did in-
volve a fairly large number of individuals. As I recall, there were
about a hundred individuals and five universities involved.
LSD was administered. I do have a listing of the universities in-
volved here: Duke University, New York University, Baylor Univer-
sity, and then one principal researcher did work at both the Uni-
versity of Minnesota and the University of Missouri.
The Air Force does not have the names and has not gone to the
contractors to ask them for their names, so I suppose as to the
question as to whether these people actually knew whether they
were subjected to the experiments remains simply to be answered.
In view of everything else we have seen here, I would not hold out
that we would get a very warm answer to that question.
Mr. CoNYERS. Well, I would like to continue to enlist the services
of GAO in this regard. This is more than just a sensational hear-
ing. This really goes to the fundamental nature of a government's
relationship to its citizens.
It is important not only because the rights of so many people
were blatantly disregarded, but also because if there is to be any
42
trust in this system, if there is to be a contract between our citi-
zens and its government, then this has to be diHgently exposed and
finally resolved.
It is in that sense that I again want to thank you, Mr. Conahan,
and you, Mr. Furbish, and the rest of your staff that worked to
help us make this much available to the American people today.
Mr. Conahan. Thank you, Mr. Chairman, Mr. McCandless.
Mr. CONYERS. Thank you very much. The Chair is now pleased
to call Dr. Eric Olson of Frederick, MD, and Ms. Elizabeth Barrett
of New York City, to the witness table. Dr. Olson and Ms. Barrett
are here today to provide testimony about bizarre incidents revolv-
ing around the deaths of their parents during secret experiments
conducted by the government.
First of all, I want to express on behalf of our committee our
deep respect to you for coming forward. This is not just an unhappy
part of American history, but for you and your families, it is a
much deeper, more personal matter. So I understand that it could
have been much simpler for you to have declined to come before
this committee. But you did so voluntarily, both of you, and we are
deeply grateful to you. Without your assistance and work that you
have done for years long before this hearing, we probably wouldn't
have reached this point in revealing what has gone on. So I thank
you very much.
Dr. Olson, I will ask you to begin,
STATEMENT OF ERIC OLSON, Ph.D^ FREDERICK, MD
Dr. Olson. Thank you. Mr. Chairman, members of the commit-
tee, I want to begin by thanking you for inviting me to come here
and speak about my family's experience with U.S. Government
testing on unwitting subjects, which begins more than 40 years
ago.
In November 1953, my father, Dr. Frank Olson, was given a dose
of LSD, without his knowledge and without his consent, in an
after-dinner drink. This bizarre incident occurred during a meeting
of Fort Detrick scientists, organized by Dr. Sidney Gottneb, who at
that time was in the early stages of what became a very long pro-
gram of mind manipulation research at the CIA.
At the time of that strange meeting, which one hesitates to call
scientific even though it was organized by and for a small g^roup
of scientists, my mother was still a young woman. She was 38
years old. I was 9, my sister was 7, and my brother was 5.
Nine days after that meeting at Deep Creek Lake, in the pre-
dawn hours of November 28, 1953, which was the Saturday after
Thanksgiving, I was awakened to be told that my father was dead.
I was told he had died from a fall out of the window of a New York
hotel room.
For me on that predawn morning, it was as if the lights went
out. I could not understand what I had been told. I remember see-
ing my mother sitting on the sofa across from me, motionless, with
a frozen expression on her face. I remember an overwhelming feel-
ing of isolation, a crushing sensation that the world in which I had
been living was suddenly gone forever.
Our family did not know what hit us. We did not know that my
father had been the subject of an experiment. We did not know
43
why he had been suddenly whisked away to New York to get some
kind of psychiatric help, if indeed that was the purpose of his visits
to a CIA consultant named Harold Abramson. We did not learn
these things for 22 years, until 1975, and even then we learned
them by accident.
On Jime 11, 1975, one day after my mother was told by her doc-
tor that she had cancer. The Washington Post reported that an
unnamed scientist had plunged to his death in 1953 after being
drugged with LSD by the CIA. We deduced that this unnamed sci-
entist must be my father, and eventually Vincent Ruwet, one of my
father's colleagues, confirmed for us that this was in fact the case.
But we were never officially notified by either the Rockefeller
Commission, in whose report this story first appeared, or by the
CIA, whose failure to contact us rendered that agency's subsequent
apology rather empty in our ears. It was as if a body long missing
in action had at last been found, but the family were not notified.
Later that summer we were invited to the White House to re-
ceive a formal apology fi-om President Gerald Ford. And we re-
ceived from William Colby a set of heavily censored documents
which he assured us contained everything the CIA had on this
case.
White House attorneys helped our lawyers draft a bill that would
compensate our family financially for my father's death and for the
22-year coverup that followed it. After months of discussion with
participation by the White House, the CIA, the Justice Depart-
ment, the Treasury Department, and the Labor Department, we ar-
rived at an agreement, supported by all these agencies, with which
we were satisfied. White House attorneys assured us that Congress
was overwhelmingly in favor of the bill, and that it would face no
serious opposition.
On the day of the vote, however, we discovered that a single Con-
gressman opposed the bill. We were also informed that private bills
require unanimous support and that due to the opposition of this
Congressman, the bill could not pass. This individual later agreed
to support the bill only if the proposed financial amount, carefully
negotiated over many months, were cut by 40 percent.
We had no choice but to accept the terms dictated by this indi-
vidual, even though the makeshift quality of this emergency com-
promise deprived us of a feeling of integrity in the settlement proc-
ess.
I remember my mother's comment to this Congressman, who had
refused even to meet with us. My mother said, "This bill represents
an apology from the American people for what our family has suf-
fered. If you compromise an apology, you don't have an apology."
And I remember, too, this Congressman's response to my mother,
"Oh, Mrs. Olson, I would never want to compromise your pain or
your suffering."
No one ever did compromise my mother's pain or suffering. She
had it in full measure. She bore her burdens with great dignity,
but she paid a very heavy price.
She never remarried. After my father died, my mother main-
tained her public stance in the community as a woman of great, al-
most incredible strength. But privately she began a 20-year decent
44
into alcoholism from which, after repeated hospitalization, she only
narrowly escaped with her life.
My mothers serious drinking began shortly after my father's
death. At the time of day when my father would normally have
been returning home from work, one of my father's colleagues
began coming to our house to have a drink with my mother. In
1975 we learned from the documents we received from William
Colby that this colleague had been directed by the CIA to, "Tceep
track of the wife." Unfortunately, keeping track did not include tell-
ing my mother the truth.
My brother, sister, and I grew up in a home from which our fa-
ther had inexplicably vanished and in which our mother was
gnradually becoming severely alcoholic. On the surface we lived a re-
markably normal life; most of the pain was hidden from those who
knew us and even from ourselves.
We received financial compensation from the CIA 3 days after
my father's death so that we had at least a moderate income.
My father's death affected each of the members of my family dif-
ferently. For all of us, though, there was a feeling of shame —
shame not only that our father had vanished, had perhaps commit-
ted some inexplicable kind of suicide, but shame especially because
we didn't know how to speak about his death; that we had no idea
what to say to our friends.
My brother, sister, and I used to dread the moment when anyone
would ask us how our father died. We eventually learned to reply
to such questions by saying our father had died of a nervous break-
down, although we had no idea what that might mean.
It is easier for me to speak about my own reactions than about
those of my brother and sister. I was 9 years old when my father
vanished, a delicate age when interruptions to the logic of cause
and effect can have a crushing impact on one's confidence that the
world is a reasonable place and that one can trust people and
events.
My son, who is here with me today, will never know his grand-
father. I have to explain to him why, just as my brother has tried
explain this to his children. My sister, her husband and their 2-
year-old child were all killed in an airplane crash in 1978 while
they were flying to upstate New York to consider an investment of
their share of tne money we received in the settlement of my fa-
ther's case in 1975.
The best way in which I can convey the depth of impact which
the revelations of 1975 and the settlement we made with the gov-
ernment made upon me is that, beginning in the late 1970's, after
finishing my Ph.D. at Harvard, I spent nearly a decade and a half
living outside the United States. I moved to Sweden to live in the
country from which my father's parents had immigprated as opti-
mistic immigrants to the United States in the 1890's.
I relate these things to stress the way in which an incident like
this reverberates for decades through the generations of a family
and its close friends.
During the last year of his life, my father spoke of wanting to
leave his job in bacteriological warfare research and reeducate him-
self as a dentist. Dentistry is in fact the profession my brother has
taken up. I suspect that tne atmosphere of eerie silence in our fam-
45
ily around my father's death strongly influenced my sister's deci-
sion to become a speech therapist and to teach deaf children to
speak. I know that it determined my decision to become a psycholo-
gist as well as the particular path I have followed within that dis-
cipline.
When I started graduate school in psychology in the early 1970's,
I was still strongly motivated by the need to understand what had
happened to my father and the consequences this loss had for the
history of my family. I chose to work with the well-known psychia-
trist Robert Jay Liflon at Yale, the sequence of whose research
comprised a virtual curriculum in the issues raised by my father's
death. Liflon's early work concerned the psychology of brainwash-
ing. Later he studied the psychology of survivors of massive trau-
ma, identity formation without the father, and the psychology of
weapons scientists. In more recent work he has concentrated on the
motivations of Nazi doctors who performed immoral experiments
on human subjects in the Nazi death camps.
After World War II, in a project known as Operation Paper Clip,
many of those Nazi scientists were in fact recruited by the Amer-
ican military to work side by side with American scientists prepar-
ing the experiments whose effects we are considering today. This
fact helps us to understand that, in other circumstances, the per-
petrators of these acts would not be enjoying their retirements.
They would be prosecuted as war criminals.
How did my father die? Sadly, I believe that we still don't know
for sure.
For a brief moment in 1975 I thought the lights had been turned
on again. But, unfortunately, the feeling of illumination did not en-
dure. In the years after 1975 my brother and I became increasingly
convinced that we still did not know the truth about what had hap-
pened to my father.
In fact, I believe we cannot be certain about anything concerning
my father's death, except that he died just outside the Statler Hotel
in New York City — or it was in the hotel room itself? — after falling
some 13 stories from the room he had shared with Dr. Robert
Lashbrook, who was Sydney Gottlieb's associate at the CIA.
The documents we received from the CIA in 1975 are so riddled
with contradictions, omissions, and outright lies that it is difficult
to have any confidence in them at all. The documents that would
have been really informative were almost certainly shredded by
Sydney Gottlieb when he retired from the CLA in 1975. What we
have are remnants of the coverup within the CIA itself, that began
immediately after my father's death, and which included the finan-
cial compensation we received so quickly.
Over the past two decades my brother and I have been increas-
ingly convinced that in fact my father was murdered. In June of
this year, we had his body exhumed so that a full-scale autopsy,
blocked by the CIA in 1953, could now be performed.
For the first time in 41 years my brother and I saw my father's
body, which was remarkably intact. No one in my family had ever
seen my father's body after he died. At the funeral the casket was
closed, because my mother had been told that my father's body was
so maimed that we would not want to see it. Now, in its mum-
46
mified state, we discovered that this had not been true. Even that
bit of consolation had been denied us.
Professor James Starrs of the George Washington University Na-
tional Law Center is now overseeing an exhaustive investigation of
my father's remains. Professor Starrs' findings will be reported in
a press conference to be held in late November, on the anniversary
of my father's death. Professor Starrs's forensic investigation is not
yet complete but its preliminary results, which increasingly point
toward the likelihood of homicide, are tending to confirm our most
dire suspicions.
Meanwhile, I have managed to locate a former CIA employee
who worked in Gottlieb's small group during the years after my fa-
ther's death. This source has confirmed that the members of that
small group all believed that my father was murdered.
My father's case — still unresolved after four decades — illustrates
what can happen when civil liberties are violated in the name of
national security research. Once one starts on the dangerous path
of poisoning one's own citizens in order to develop the weapons al-
legedly needed to protect them, one enters a zone of lunacy where
anjrthing is possible, where sadists can disguise their maliciousness
as patriotic duty. In such a situation, any experiment if it goes
awry can quickly become a risk to the careers of the experimenters
themselves.
The path from experimental mind manipulation to murder may
then be a short one, for how else can one guarantee the security
of an immoral research program in which one's fellow citizens are
used as guinea pigs?
My brother and I can only hope that our father's case, and our
family's experience, remain a lesson in the risks posed to a free so-
ciety by pretentious pseudoscience, self-serving secrecy, and bu-
reaucratic arrogance.
Thank you.
[The prepared statement of Dr. Olson follows:!
47
Eric Wicks Olson, Ph.D.
6919 Holier Vista Drive
Frederick, Maryland 21702-3604
(301) 371-7508
Testimony to the Committee on Government Operations,
United States House of Representatives
September 28, 1994
I.
The unending event.
My family's experience with U.S. government testing on unwitting subjects begins
more than forty years ago. In November 1953 my father, Dr. Frank Olson, was
given a dose of LSD, without his knowledge and without his consent in an after-
dinner drink. This bizarre incident occurred during a meeting of Ft. Detrick
scientists, organized by Dr. Sidney Gottlieb who at that time was in the early
stages of what became a very long program of mind-manipulation research at the
CIA.
At the time of that strange meeting, which one hesitates to call "scientific"
even though it was organized by and for a small group of scientists, my mother
was still a young woman. She was thirty-eight years old. I was nine, my sister was
seven, and my brother was five.
Nine days after that meeting at Deep Creek Lake, in the pre-dawn hours of
November 28, 1953, which was the Saturday after Thanksgiving, I was awakened to
be told that my father was dead. I was told that he died from a fall out of the
window of a New York hotel room.
For me on that pre-dawn morning it was as if the lights went out. I could
not understand what I had been told. I remember seeing my mother sitting on
the sofa across from me, motionless, with a frozen expression on her face. I
remember an overwhelming feeling of isolation, a crushing sensation that the
world in which I had been living was suddenly gone for ever.
Our family did not know what hit us. We did not know that my father had
been the subject of an experiment. We did not know why he had been suddenly
whisked away to New York to get some kind of psychiatric help — if that was
indeed the purpose of his visits to a CIA consultant named Harold Abramson.
48
We did not learn these things for twenty-two years, until 1975; and even
then we learned them by accident. On June 1 1 of 1975 — one day after my mother
was told by her doctor that she had cancer — the Washington Post reported that
an unnamed scientist had plunged to his death in 1953 after being drugged with
LSD by the CIA. We deduced that this unnamed scientist must be my father.
Eventually Vincent Ruwet, one of my father's colleagues, confirmed for us that this
was in faa the case. But we were never officially notified by either the Rockefeller
Commission, in whose report this story first appeared, or by the CIA, whose
failure to contact us, rendered that agency's subsequent apology rather empty in
our ears. It was as if a body long missing in action had at last been found, but the
family were not notified.
Later that summer we were invited to the White House to receive a formal
apology from President Gerald Ford. And we received from William Colby a set
of heavily censored documents which he assured us contained everything the CIA
had on this case.
White House attorneys helped our lawyers draft a bill that would
compensate our family financially for my father's death and for the twenty-two
year cover-up that followed it. After months of discussion, with participation by
the White House, the CIA, the Justice Department, the Treasury Department, and
the Labor Department we arrived at an agreement, supported by all these
agencies, with which we were satisfied. White House attorneys assured us that
Congress was over-whelmingly in favor of the bill, and that it would face no
serious opposition.
On the day of the vote, however, we discovered that a single congressman
opposed the bill. We were also informed that private bills require unanimous
support, and that due to the opposition of this congressman, the bill could not
pass. This individual later agreed to support the bill only if the proposed financial
amount, carefully negotiated over many months, were cut by forty per cent.
We had no choice but to accept the terms dictated by this individual, even
though the make-shift quality of this emergency compromise deprived us of a
feeling of integrity in the settlement process. I remember my mother's comment
to this congressman, who had refused even to meet with us. My mother said, "This
bill represents an apology from the American people for what our family has
suffered. If you compromise an apology you don't have an ajxjlogy." And I
remember too this congressman's response to my mother-. "Oh Mrs. Olson, I
would never want to compromise your pain or your suffering."
49
n.
Widening reverberations.
No one ever did compromise my mother's pain or suffering: she had it in
full measure. She bore her burdens with great dignity, but she paid a heavy price.
She never re-married. After my father died my mother maintained her
public stance in the community as a woman of great, almost incredible strength.
But privately she began a twenty-year descent into alcoholism from which, after
repeated hospitalizations, she only narrowly escaped with her life.
My mother's serious drinking began shortly after my father's death. At the
time of day when my father would normally have been returning home from
work one of my father's colleagues began coming to our house, to have a drink
with my mother. In 1975 we learned from the documents we received from
William Colby that this colleague had been directed by the CIA to "keep track of
the wife." Unfortunately, "keeping track" did not include telling my mother the
truth.
My brother, sister, and I grew up in a home from which our father had
inexplicably vanished, and in which our mother was gradually becoming severely
alcoholic. On the surface we lived a remarkably normal life; most of pain was
hidden from those who knew us and even from our selves.
My father's death affected each of the members of my family differently.
For all of us, though, there was a feeling of shame — shame not only that our
father had vanished, had perhaps committed some inexplicable kind of suicide,
but shame especially because we didn't know how to speak about his death; that
we had no idea what to say to our friends. My brother, sister, and I used to dread
the moment when anyone would ask us how our father died. We eventually
learned to reply to such questions by saying that our father had died of a nervous
breakdown — though we had no idea what that might mean.
It is easier for me to speak about my own reactions than about those of my
brother and sister. I was nine years old when my father vanished — a delicate age
when interruptions to the logic of cause and effect can have a crushing impart on
one's confidence that world is a reasonable place, and that one can trust people
and events.
My son, who is here with me today, will never know his grandfather. I have
to try to explain to him why, just as my brother has to explain this to his children.
My sister, her husband and their two-year old child were all killed in an airplane
50
crash in 1978 while they were flying to upstate New York to consider an
investment of their share of the money we received in the settlement of my
father's case.
The best way in which I can convey the depth of impart which the
revelations of 1975, and the settlement we made with the government, made upon
me is that, beginning in the late 1970's, after finishing my Ph.D. at Harvard, I spent
nearly a decade and a half living outside the United States. I moved to Sweden to
live in the country from which my father's parents had immiagrated as optimistic
immigrants to the United States in the 1890's.
I relate these things to stress the way in which an incident like this
reverberates for decades through the generations of a family and its close friends.
During the last year of his life, my father spoke of wanting to leave his job
in barteriological warfare research, and re-educate himself as a dentist. Dentistry
is, in fact, the profession my brother has taken up. I suspert that the atmosphere
of eerie silence in our family around my father's death strongly influenced my
sister's decision to become a sp>eech therapist, and to teach deaf children to
speak. I know that it determined my decision to become a psychologist, as well as
the particular path I followed within that discipline.
When I started graduate school in psychology in the early 1970's I was still
strongly motivated by the need to understand what had happened to my father
and the consequences this loss for the history of my family. 1 chose to work with
the well-known psychiatrist Robert Jay Lifton at Yale, the sequence of whose
research comprised a virtual curriculum in the issues raised by my father's death.
Lifton's early work concerned the psychology of brain-washing. Later he studied
the psychology of survivors of massive trauma, identity-formation without the
father, and the psychology of weapons scientists. In more recent work he has
concentrated on the motivations of Nazi doctors who performed immoral
experiments on human subjects in the Nazi death camps.
After World War II, in a project known as "Operation Paper Clip," many of
those Nazi scientists were in fart recruited by the American military to work side-
by-side with American scientists preparing the experiments whose effects we are
considering today. This fart helps us to understand that, in other circumstances,
the perpetrators of these acts would not be enjoying their retirements: they
would be prosecuted as war criminals.
51
ni.
Struggling to learn the truth.
How did my father die? Sadly, I believe that we still don't know for sure.
For a brief moment in 1975 I thought the lights had been turned on again.
Unfortunately the feeling of illumination did not endure. In the years after 1975 my
brother and I became increasingly convinced that we still did not know the truth
what about what had happened to my father.
In fact, I believe we cannot be certain about anything concerning my
father's death, except that he died just outside the Statler Hotel in New York City
(or was it in the hotel room itself?), after falling some thirteen stories from the
room he had shared with Dr. Robert Lashbrook, who was Sidney Gottlieb's
associate at the CIA.
The documents we received from the CIA. in 1975 are so riddled with
contradictions, omissions, and outright lies that it is difficult to have any
confidence in them at all. The documents that would have been really informative
were almost certainly shredded by Sidney Gottlieb when he retired from the CIA
in 1975. What we have are remnants of the cover-up within the CIA itself, that
began immediately after my father's death.
Over the past two decades my brother and I have become increasingly
convinced that in faa my father was murdered. In June of this year we had his
body exhumed so that a full-scale autopsy — blocked by the CIA in 1953 — coiild
now be performed. For the first time in forty-one years my brother and I saw my
father's body, which was remarkably intact. No one in my familiy had ever seen
my father's body after he died. At the funeral the casket was closed, because my
mother had been told that my father's body was so maimed that we would not
want to see it. Now, in its mumified state, we discovered that this had not been
true. Even that bit of consolation had been denied us.
Professor James Starrs of the George Washington University National Law
Center is now over-seeing an exhaustive investigation of my father's remains.
Professor Starrs' findings will be reported in a press conference to be held in late
November, on the anniversary of my father's death. Professor Starrs' forensic
investigation is not yet complete, but its preliminary results, which increasingly
point toward the likelihood of homicide, are tending to confirm our most dire
suspicions.
52
Meanwhile I have managed to locate a former CIA employee who worked
in Gottlieb's small group during the years after my father's death. This source has
confirmed that the members of that small group all believed that my father was
murdered.
My father's case — still unresolved after four decades — illustrates what can
happen when civil liberties are violated in the name of national security research.
Once one starts on the dangerous path of poisoning one's own citizens in order
to develop the weapxans allegedly needed to protect them one enters a zone of
lunacy where anything is f>ossible, where sadists can disguise their maliciousness
as patriotic duty.
In such a situation any experiment, if it goes awry, can quickly become a
risk to the careers of the experimenters themselves. The path from experimental
mind-manipulation to murder may then be a short one, for how else can one
guarantee the security of an immoral research program in which one's fellow
citizens are used as guinea pigs?
My brother and I can only hope that our father's case, and our family's
experience, remain a lesson in the risks posed to a free society by pretentious
pseudo-science, self-serving secrecy, and bureaucratic arrogance.
I 53
Mr. CONYERS. Dr. Olson, that is one of the most moving state-
ments I have ever heard in this committee.
I would like now to call Ms. EHzabeth Barrett, a daughter of the
late Mr. Harold Blauer, a psychiatric patient who lost his Ufe in
a secret government experiment.
STATEMENT OF ELIZABETH BARRETT, NEW YORK, NY
Ms. Barrett. Thank you, Mr. Conyers. I am afraid I am not
quite as poised as Dr. Olson.
I am very grateful that you have given me this opportunity, al-
though I am frightened and still quite bitter. Like Dr. Olson, I
don't believe anything like all the facts have been revealed. I won't
go into the details of why I believe that in an oral presentation, but
there are many reasons to believe it.
The only reason I can bring myself to do this is because I have
the hope that you are approaching Walter Lippmann's definition of
an ideal public man. He said, "Those in high places are more than
the administrators of government bureaus, they are more than the
writers of laws. They are the custodians of a nation's ideals, of the
beliefs it cherishes, of its permanent hopes, of the faith which
makes a nation out of a mere aggregation of individuals."
In the hope that you try to live this ideal, let me try to take you
back to 1952. Divorce was much less common than today and a fa-
ther with custody of his daughter was unknown. That was my life.
I adored my father. I went to work with him whenever I didn't
have school. I only remember him leaving me once during that pe-
riod, to join a friend for an evening, and I really had to insist that
he go.
When he died, my world came to an end. My mother moved us
to Mexico, where it was much cheaper to live. Unlike Dr. Olson, we
didn't get any money at all.
She put me in a Mexico City boarding school and went to
Cuemavaca with my sister to live. I was one miserable, lonely 13
year old. I don't think my mother or sister were very happy either.
I loved my father. I think of him every day. But 16 years of deal-
ing with the most horrendous legal and political roadblocks I expe-
rienced every step of the wav haven't made it any easier.
Although this is probably my last opportunity to get things
changed to make all these battles meaningful, I have been de-
pressed and frightened ever since I got your invitation to testify.
I have been afraid ever since the true nature of my father's death
was revealed.
Friends warned me the government considered me a threat and
if I didn't settle the case, something terrible might happen to me.
Columnist Jack Anderson said he had the same concerns with his
safety. He told me to take proper precautions and go on with my
life. But I am still always looking over my shoulder. I am fright-
ened because I don't believe all the facts have been revealed.
For example, I was supposed to have seen all the original docu-
ments, the ones that were in the Edgewood arsenal safe, were sup-
posed to be brought forth at trial. We had seen Xeroxed copies of
them but never the originals. The government refused to provide
them.
54
The absence of my father from my Hfe will always hurt. This is
true for all children. But I also feel I lost my country at the same
time. This is something no American, brought up as I was to be-
lieve in our system almost as a religion, expects.
There doesn't seem to be any wav to understand or heal this
pain. My country destroyed my family, as well as my father, with
grossly negligent and purposeful acts by professionals — doctors and
lawyers who were supposed to protect us from harm, not cause it.
These people are protected by our immunity laws and other legal
precedents that need to be changed.
The potential victims we are talking about could be you, your
wife, husband, daughter, son, mother, or father. It could happen
again. Secrecy, lying, and lack of accountability enable continuation
of criminal activity. You who represent us need to change this.
My father sougnt help from physicians who killed him for chemi-
cal warfare research purposes. How would you feel if you found out
your father died not in Nazi Germany, but in the United States,
8 years after we hanged war criminals for the same events?
My father was forcibly given a chemical tested only on mice. Har-
old Blauer was a civilian. He never ^ave his consent. The hospital
record shows he objected to all four injections given to him in the
last month of his life.
According to the Army's Inspector General's report. Dr. James
Cattel, who gave my fatner the deadly injection, said the chemical
was an Army secret, and "We didn't know whether it was dog piss
or . . ." The Army Chemical Corps provided the untested chemical
to the New York State Psychiatric Institute's Hospital because it
wanted to develop psychotropic substsinces into chemical weapons.
Thev were in a hurry to find answers, without regard for the safety
of their human subjects. My father was told the chemicals were
"therapy."
On January 8, 1953, my father was given a chemical dose more
than 15 times the size of the first experiment. As described in the
book. The Mind Manipulators, "On the morning of January 8, 1953,
tennis pro Harold Blauer was taken from his room at the New
York State Psychiatric Institute to receive an injection. Blauer did
not want it. Four injections he had been given the previous month
had made him ill and he was scheduled to return to his family the
very next day. He was well. He knew it, the doctors knew it, the
staff knew it and his family knew it. Why should he have to take
this last needle? It must have made him very apprehensive because
the last shot had upset him mentally and physically for a week."
The nurse's notes on my father's last day, just very, very briefly,
shows the injection starting at 9:53 in the morning, 9:55, i.v.'s get-
ting me now — restless movements — protesting injection, 9:57, injec-
tion ended, 9:59, very restless — ^has to be restrained by nurse — out
of contact, wild flailing of arms. Sweating profusely; 10:01, patient
pulled up in bed — generalized stiffening of^body. Teeth clenched —
frothing at the mouth." My father's pulse increased enormously and
he finally lapsed into a coma. He died at 12:15 p.m. that day.
The record shows my father suffered from December 11, 1952, to
January 8, 1953. On his last day he did not die instantly. The final
deadly injection took 2 hours and 22 minutes to kill him, a torture
comparable to those inflicted during the inquisition.
55
His death certificate stated that a chemical compound had acti-
vated a previously unknown heart condition. Harold Blauer did not
have a heart condition. He was a tennis teacher, slim, active, all
good things.
My father was not the only victim in this tragedy. My mother
died with a broken heart because she felt her divorce was respon-
sible in some part for his death. She never knew my father was
murdered in an Army chemical warfare experiment.
My daughter. Amy, has been a victim, too. She was 13 when I
found out about the reason for my father's death and its coverup.
The already stressful years for an adolescent daughter of a single
mother were enormously complicated because I took an active role
in pursuing reason and justice.
I gave up my career in health education and became a secretary
so I could spend the time necessary to find law firms to represent
me. I had eight law firms, one law school, and the New York Civil
Liberties Union at various times during those 16 years. I had to
raise money for expenses and attend depositions around the coun-
try to get at the truth.
Now, I don't seem to be able to get my career back or even get
a job. I tried to make my case, Barrett v. the U.SA., a springboard
for new accountability laws and bills to prevent unethical experi-
mentation from happening to others. There were discussions at the
beginning about a settlement with the Justice Department, but I
felt the truth was necessary to prevent more tragedies and would
not a^ee to sweep hidden facts under the rug.
I didn't get much help. My friends and I wrote letters to Con-
gress, getting the usual form-letter response. Marty Teitel, director
of the CS Fund, provided a grant of $10,000 to help me get ac-
countability from those responsible. I will always be grateful to him
and his foundation for that support.
I fought my lawyers as much as the government. My lawyers
wanted to settle or drop important defendants like Warren Burger
and Jacob Javits. Mr. Burger was the Assistant Attorney General
in the U.S. Justice Department in the 1950's. Mr. Javits was a
major in the Army Chemical Corps during World War H, and then
the New York State Attorney General who helped Mr. Burger de-
ceive the court and my mother.
Even the press, which had been very interested in helping, be-
came a problem. When the involvement of Burger and Javits was
revealed, the stories about these horrors which had been on the
front page of many newspapers and on the national television
newscasts stopped. I was told by Lyle Denniston that Mr. Burger's
gress secretary told him that if he wrote another word, he would
e sued.
CBS rushed me into their New York studio for an interview the
day Burger was officially named in the suit, but they didn't run the
story, saying their Washington legal correspondent wanted to check
it first. It never ran.
The New York Times, which had run several firont-page stories,
not only stopped covering the story, but refused to cover the 8-week
trial and never even did a story on the verdict.
As long as there is secrecy and a lack of accountability for one's
actions, tragedies like what happened to my father will continue.
56
Please don't let these outrageous cases of human abuse be contin-
ued.
Now there is no personal accountability for unethical human ex-
periments on humans. Those IRB boards that your previous person
was testifying about are not really available to people that are
doing secret classified experiments. Immunity is given to those offi-
cials who are supposed to be protecting American citizens, not
hurting them.
A lawyer, Robert King, commented, "In the eyes of the law, the
more responsibility that is placed on a government official, the less
liability is associated with his official conduct."
In 1986, when he dismissed David Marcus, the Assistant New
York State Attorney General assigned to defend the hospital in
1985, Judge Walter Mansfield stated that questionable or harmful
conduct during Marcus's representation of the State was, "irrele-
vant. Immunity attaches to his function, not the manner in which
he performed it."
It is this t3T)e of irrationality that needs to be changed. All the
rules on immunity for people who violate the Constitution have
been made by judges, not by Congress.
So my plea is, one, please pass a law to repeal this kind of immu-
nity so the courts cannot continue this sham.
Who would have thought after Nuremberg that experiments like
those of the Nazis would continue in this country? It can happen
again, and we are painfully naive if we don't think so.
Nothing has really changed since the 1950's. Classified research
still has no ethical scrutiny.
Two, Congress must pass laws to hold those people who have the
most power over our lives — doctors, lawyers, government employ-
ees, and contractors — responsible for their actions.
David Rothman, of Columbia University says "Research by mili-
tary or any Federal agency must receive special scrutiny, not just
from their own boards, but from an independent body. This will
help us be certain of the integrity of government research."
Three, everyone should have immediate access to their own med-
ical records. This is illegal in many States. It should be illegal to
deny anyone access to information about themselves. If patients
have access to information, mistakes as well as harmful experimen-
tation will be less likely to occur. If my father had been able to see
his records, he might have had more help from friends when he
protested.
Most legal cases about unethical military experiments have been
settled out of court, without the victims or the general public ever
knowing exactly what happened. How can we rectify the problem
if these acts are still kept secret?
Health care costs, which you talked about earlier, as well as inju-
ries, could be gpreatly reduced if people were aware of the risks of
many of the drugs and other treatments that are prescribed. The
"Physician's Desk Reference" is a best seller which shows that peo-
ple are willing to try and understand.
Taxpayers who have been harmed by experiments are fighting
for justice against a government using their tax dollars against
them. I understand there has already been $50 million spent de-
fending the radiation experiments. The Justice Department has a
57
reputation for dragging things on for years so the victim will run
out of money or time.
Four, I suggest the government pay for the plaintiff's case as it
Pj^s for the defendant— the government — after the courts have de-
cided the case has merit. This would provide more equal access to
justice.
In my case, as mentioned in the letter submitted by Roger
Parloff" of the American Lawyer, "Attorneys suing under the Fed-
eral Tort Claims Act can't apply for reasonable attorney's fees from
the defendant if the plaintiff" wins. Instead, they take their fee —
a contingency fee of 25 percent^-out of the plaintiff's award. But,
because of limits upon damages in Federal Tort Claims Act cases,
the plaintiff's award will seldom fully compensate the plaintiff, and
25 percent of that award will seldom fiilly compensate the lawyer
for the fees and expenses of bringing the suit. Accordingly, most
lawyers will not want to bring the case in the first place. Though
there is a limit on the percentage of the award that can Be
consumed by attorney's fees, there is no limit on the amount of
that award that may be depleted by reimbursement of attorney's
expenses."
Five, discretionary function should be reviewed. Our laws are
made for a sovereign government. I was only allowed to sue for
negligence. I was not allowed to sue for my father's intentional
murder. Individuals working for the government are allowed to kill
citizens for the greater good, and are protected by "intentional tort"
or "discretionary functions" which are immune from suit.
Sovereign immunity is un-American. I thought we fought Eng-
land in the 18th century because the King could do no wrong ac-
cording to England's laws, and royal abuses of power made us want
all people to be equal under the law here.
In the biological warfare case, Nevin v. the U.SA., the court
ruled, "Thus, sovereign immunity is not waived if, as the govern-
ment maintains in this case, the acts being sued upon were under-
taken as part of the government's discretionary function. Specifi-
cally, the government contends the acts in question here con-
stituted the discretionaiy function of providing for national defense
so that they are not actionable under the Federal Tort Claims Act."
So, if you find victims from the wind dispersal experiments that
have been previously described, they will not be able to sue, be-
cause the government just says, *We were doing it for national se-
curity."
Six, no statute of limitations should be in effect if the govern-
ment causes the problem, especially if they try to cover it up.
My case was lost over the statute of limitations issue in the dis-
trict court. I needed to appeal. After finding that fVaud tolled the
statute, the appellate court returned my case to the district court
to be retried. If the statute of limitations is frozen by explicit law
when there is a coverup or fraud, much time will be saved, and jus-
tice will be more likely.
My civil rights actions against Federal officials was blocked be-
cause of the obscure issue of "personal jurisdiction."
Roger Parloff of the American Lawyer comments, "Since many of
the Federal officials responsible for your father's death were geo-
graphically disbursed around the country and had not actually
58
come to New York in order to iniure Harold Blauer, Barrett's fa-
ther, Barrett tried to sue them all in a single forum in New York,
a place where she lived and her father was killed. But, while she
would have been permitted to do just that had she been suing a
defendant for almost any ordinary business injury, the law did not
permit her to do so in a civil rights action against Federal officials.
Instead, she was required to sue each of the individual defendants
in the State where he or she currently lived, which would have
meant filing numerous actions in different States — see Green v.
McCall, 710 F.2d 29 (2d Cir. 1983). This procedural rule seems de-
signed to serve no purpose except to make civil rights actions
against Federal officials prohibitively expensive, regaroless of their
merit." Robert King believes the New York State Assistant Attor-
ney, David Marcus — who participated in the coverup — acted as
agent for these officials within the State and therefore subjected
them to the jurisdiction of the courts in New York. I believe they
were all part of the same action and should be sued one place at
one trial.
Seven, we must make individuals who have no integrity account-
able for their crimes, especially those politicians, scientists, and
doctors who are held in the public trust. If we don't, as we have
seen for ourselves, history will repeat itself.
Eight, punitive damages and prejudgment interest, should be the
rule when individuals in government are so negligent. We can no
longer make laws with the assumption that people are inherently
good. We must create laws to prevent evil people from harming
others.
In Barrett v. United States, Dave Side of Uncle Sam, New York
Law Journal, May 13, 1987, Joseph and Robert Keiny said, "When
an activity is so obviously grossly negligent, wanton or reckless, pu-
nitive damages should be awarded as a deterrent, whether the cul-
prit be an individual or government agent, servant or employee."
And Mr. ParlofF says, ^hat problem was exacerbated — in your
case — ^by the fact that the plaintiff, under the Federal Torts Claim
Act, can't get prejudgment interest either. In your case, the govern-
ment had coverea up the cause of your father s death for 22 years.
The absence of prejudgment interest meant that anjrthing you were
awarded had to be paid in 1953 dollars. Should say: "anything you
were awarded has to be paid in 1953 dollars. Not only were your
father's lost earnings computed solely upon the earnings of a tennis
instructor in 1953, uncorrected to inflation or interest, but even the
award for his pain and suffering before he died was determined in
terms of 1953 dollars."
Nine, in 1987, Judge Constance Baker Motley's opinion "said the
question of prejudg^nent interest should be addressed by Congress."
Well, I am here now, and I hope you will address and correct this
wrong — if not for me, at least for the people who come behind me.
This congressional hearing is a breath of fi*esh air in a country
that has avoided the truth about itself for decades. I hope we can
now take action and make our laws fair to all, not privileges for
the powerful. As Elie Wiesel said in his 1986 Nobel Peace Prize
ceremony, "Action is the only remedy to indifference, the most in-
sidious danger of all. One person of integrity can make a difference,
a difference of life and death."
59
Will at least one of you help?
Ten, I suggest that as a representative victim of the laws as they
are now, I could help you when you draft new laws to correct these
problems. We can learn from our mistakes if we want to.
Eleven, at the very least there should be a public advocate or om-
budsman for a plaintiff suing the government when a coverup or
fraud is discovered. This person should be hired at taxpayers' ex-
pense to get the case on the "fast-track." Justice is not provided
when cases are drawn out over many years. It can approach justice
only if resolution is timely.
Twelve, I hope that you agree that a good symbolic start, other
than your recognition and interest today, would be for my family
to get a Presidential apology for my father^s death.
This is only symbolic. Not one administration. Republican or
Democrat, since 1975, when the truth was revealed, ever said, "I
am sorry." Instead, they, through the Department of Justice and
the Pentagon, continued to lie and kept me in court for 16 years,
wasting taxpayers' money and ruining my life.
It is sadly ironic and unjust that I, the victim's daughter, was
treated as if I were the criminal, an impediment to just govern-
ment rather than a solution.
I believe that in my father's case individuals in government
broke their moral, and I think fiduciary, contract with my father
and his family when they actively pursued him against his will and
killed him.
Thirteen, this apology from the President should be accompanied
by a refund of all taxes paid by my father, his wife, and his chil-
dren, with a recognition that taxes should never be paid by his
children. This is to show that the Government recognizes that
taxes paid incur an obligation of service for those taxes.
I have not filed a tax return since I was told of my father's death.
I am very afraid the Government will use this to put me in jail and
keep me quiet.
I challenge this representative body to make a difference and
help me be a catalyst for change so I can some day hold my head
high when our national anthem is played, not lower it, as I have
done for years, in shame.
Thank you.
Mr. CoNYERS. I didn't know what you were going to say because
you had not submitted a statement. I appreciate very much the ad-
ditional responsibility and the view that you have so particularly
expressed here today. It makes me feel more ashamed than ever
for what you and your family have gone through, and maybe other
people who will never be able to come before the committee or ar-
ticulate their experiences. So I can only commit to you that this is
the first of an inquiry that is so very, very important. We all know
that you could have very easily declined or sent in a statement, but
I think it is very significant that you are here today and made this
magnificent statement.
As a member, additionally, of the Judiciary Committee, I am
pleased to hear of the many legal recommendations that you made,
and I want to sort them out. We will continue to do everything pos-
sible. There are some things that you have said that I don't think
60
we need to spend a lot of time determining whether we agree with
them or not.
You know, nothing would make me feel better about this than to
have the present President of the United States know that both of
you were witnesses here in the Congress today, and that he take
this matter under his personal advisement.
We in the Congress have a lot to do. But what you two have done
to spur and energize those of us who are committed to a true
participatory democracy can never be fully measured. We can't
thank you enough, both of you.
I would like to recognize Mr. Al McCandless now.
Mr. McCandless. Thank you, Mr. Chairman.
I want to thank both of you for taking the time to come before
the committee. We will take what you gave us in the way of sug-
gestions and review those relative to the future legislative process.
You and others in the audience may say, you can't do all of that
between now and October 7 or October 14 or whenever it is that
the 103d Congress recesses. But what the purpose of this hearing
is all about is to build a record upon which then, in the 104th Con-
gress, this and other committees which have become involved will
take this and proceed in a direction that will hopefully solve the
problems that become apparent as a result of reviewing records
that are developed such as we are here today.
And thank you both for your attendance and your participation.
Ms. Barrett. Could I make one more comment? I want to say
if all this information is revealed and nothing is done about it, you
increase the cynicism and the despair. It makes it worse.
I have been offered several opportunities to do a television or
movie docu-drama, and I have refused, because the end result
would be to make people feel worse, would be to make people feel
more despair. Then they would be less likely to fight city hall. We
need to show that it is possible to make things better.
And I think the despair in this country now and the cjmicism,
every place that we go, it just — oh, they will never do anything
about it, don't worry it, they have their own agenda. That is why
I think our country is falling apart. There is no standard set at the
top for responsibility.
So if the President or the Congress or — they don't care, why
should we care?
Mr. McCandless. I understand where you are coming from. I am
in accord. What I was trying to diagram out for you is that you
made a number of points — I think there were something like 13 or
14 — all of which had a direct bearing upon your experience in the
legal system as it relates to your case.
Not being a lawyer, I am not in a position to be able to comment
yes or no, other than that many of these suggestions would go be-
yond the parameter of what it is we are here talking about today,
if applied to other circumstances. So they need to be addressed m
terms of how could we adjust and provide the protection and what
is necessary in the way of justice to those who have experienced,
such as you, and yet not turn the legal system completely upside
down in order to address a particular issue, which then would open
the door for other things which had nothing to do with the subject
matter that we are tallung about here today.
61
I think you probably have been working with lawyers long
enough that you have an idea of what I am talking about.
Ms. Barrett. The lawyers I have had have almost universally
said to me, Elizabeth, we hate working with you because you are
too logical, because whatever you are saying absolutely should be
the case, and unfortunately it is not. To just shrug and say, "Gree,
that is the wav it is," seems to me the way down the path of total
disaster. You have to say, "If this is a problem here, yes, it prob-
ably has a lot of ramifications, and if it turns the justice system
upside down, maybe that is what the justice system needs." I don't
know that there is a lot of people out there that really have a great
deal of faith in the justice system.
Mr. McCandless. I couldn't agree with you more. I am sharing
with you maybe some nostalgia here. After completing 12 years
here m the Congress, I have closets full of frustration, and have
been told by those who are experts that, well, your ideas are good,
what you want to do is fine, but do you realize the ramifications
beyond that area in which you are concentrating. And I was just
trying to share with you that thought.
Thank you both for coming.
Mr. CoNYERS. The Chair recognizes the gentleman fi*om Califor-
nia, subcommittee Chair, Gary Condit.
Mr. Condit. Mr. Chairman, I came in late and didn't have the
privilege to hear all the testimony. I apologize for that.
I just want to commend you for holding this hearing. I think this
is an excellent opportunity for us to get to the truth. And there is
no reason for us not to have this information available so that we
can make some decisions on how we proceed from here. I want to
commend you and the witnesses for being here today.
Mr. CoNYERS. We all want to thank you.
There are some questions that we will want to raise with you,
but I think your statements are so profound that they will become
a part of our history. If we can turn this thing around, if we can
make good on the promise of what really makes a system a democ-
racy, this will be an important point at which we started to do
that.
Ms. Barrett. I hope you let us continue to help you,
Mr. CoNYERS. You have already helped us immeasurably. I know
you can continue to be of great assistance to us. Again, on behalf
of the whole committee, we thank you both very, very much.
I would now like to call the Deputy Under Secretary, the Deputy
Assistant Secretary, the Director of Environment and Life Sciences,
Executive Director of the U.S. Army, Chemical and Biological De-
fense Command, Ms. Jeanne Kites, Dr. Gordon Soper, Dr. Joseph
Osterman, Mr. Michael A. Parker.
Lady and gentlemen, we thank you for joining us today. We have
your prepared statements. Dr. Gordon Soper, would you begin,
please.
STATEMENT OF GORDON K. SOPER, Ph.D^ PRINCIPAL DEPUTY
ASSISTANT SECRETARY OF DEFENSE FOR ATOMIC ENERGY
Dr. Soper. Mr. Chairman, members of the subcommittee, I am
Gordon Soper, representing along with my colleagues the Depart-
ment of Defense. I am the Principal Deputy to the Assistant to the
62
Secretary of Defense for Atomic Energy. We are happy to be here
to support this committee's investigation.
My testimony will focus on radiation experiments. However, I
first would like to introduce the other members of our panel. You
have our prepared statement, which we have submitted for the
record. If you would permit us, we would all like to provide a short
opening statement, after which we would be prepared to take your
questions.
Mr. CONYERS. Quite all right. All of your statements will be en-
tered into the record in their entirety and reproduced.
Dr. SoPER. Thank you, sir.
On my left is Ms. Jeanne Fites. She is the Deputy Under Sec-
retary of Defense for Requirements and Resources. She will rep-
resent the department's efforts to identify individuals involved in
chemical and biological testing.
On my right is Mr. Michael Parker, the Executive Director of the
U.S. Army Chemical Biological Defense Comm£md at the Aberdeen
Proving Groimd in Maryland. He is prepared to address your ques-
tions about the chemical and biological experiments that have come
up, drug testing, and the question you specifically asked in your
letter to Secretary Perry, regarding the operational coverage.
Finally, Dr. Joe Osterman, Director of Environmental and Life
Sciences in the Office of the Director, Defense Research and Engi-
neering in the Pentagon. He is prepared to discuss with you, in
whatever detail you would like, the present rules and regfulations
for human use research, particularly the issue of informed consent.
You spoke
Mr. CoNYERS. We can make this go smoother and faster if those
questions. Dr. Soper and Ms. Fites, Mr. Parker, Dr. Osterman, that
you know we are going to ask, if you would just be forthcoming
rather than to make a courtesy statement, and then we go into the
cross-examination. So let's lay everything on the table that you can.
There is nothing complicated about what we want to know, namely
everything that it is proposed by DOD and relevant to the inquiry.
Dr. Soper. I certainly agree. There was no intent at all not to
provide the committee with all the information we have on this
issue. I am certainly prepared, and I hope you don't think these
statements are merely courtesy statements. They are statements
we thought about carefully. We read your letter carefully. We are
trying to respond as best we can to your questions. If that is agree-
able, I will proceed.
You have made mention of the extensive effort that the adminis-
tration is pursuing in regard to searching for records of human ra-
diation experimentation following Mrs. 0 Leary's comments on this
subject early this year. The DOD, along with other Cabinet agen-
cies, are full partners in the effort to be forthcoming with records
associated with the past radiation testing.
I want to tell you of the extensive effort that the Department of
Defense is conducting in order to respond to that challenge. So far
literally hundreds of people have spent 65 or so thousand man-
hours searching for these records in order to understand the dy-
namics of these past experiments.
I don't know whether you have ever been involved in this kind
of activity, but I will really tell you it is a box-by-box, paper-by-
63
paper, page-by-page endeavor. We are making progress, but we
have a long way to go.
Following your suggestion, I would like to briefly turn to your
specific questions and give you a top line view of where we are. The
Department decided to institute a requirement to err on the side
of inclusion in our record search; that is, to include every document
that could possibly be related to radiation experiments on humans.
The Department of Defense so far has identified over 2,000 possible
DOD-sponsored radiation experiments with over 50,000 partici-
pants.
I would like to tell you, sir, that these numbers do not include
what the GAO representative mentioned earlier and what you have
in your press release. Specifically, soldiers that were involved in
the U.S. Atmospheric Nuclear Testing Program. We would be
happy to answer your questions on that, but I am specifically here
to address the Department of Defense's involvement in ionizing ra-
diation experiments on human subjects.
I would like to add a footnote to the numbers I just gave you.
It appears that most of these experiments were either therapeutic
diagnostic, or they were tracer studies where the radioactive mate-
rials or procedures were used to assist the experimentation but the
effects of the irradiation were not a central part of research.
But let me point out, that the Department of Defense has chosen
not to make a judgment regarding the purpose or intent of the pos-
sible experiment. So what we have done is this; in every record
where we find three key ingredients — ^human beings, ionizing radi-
ation, and experimentation — we call that a record, and we include
that in our data base.
We are assembling those records. Every one of those records is
given to the Advisory Committee on Human Radiation Experi-
ments that you mentioned, for their study and their review.
Now, I would like to respond to your question about what we
have done to notify the people who have participated in the human
radiation experiments. All inquiries come into our command center.
As you might imagine, the Department of Defense established a
command center headed by a Senior Executive Service civilian. In-
quiries come into the command center by several means: the radi-
ation experiment's national help line sponsored by the Department
of Energy; referrals from other agencies, such as Veterans Affairs,
on Health and Human Services; from Congress — we have had some
from your office, I believe, sir; the White House; and direct inquir-
ies from the public.
To date, the command center has been in touch with over 6,000
individuals through letters. We have provided many of them with
questionnaires. We have also been in contact with some of them
personally, through telephone calls.
When the records research process in which we are presently en-
gaged has progressed sufficiently, we expect to undertake a com-
prehensive effort to notify all of the participants in the DOD-spon-
sored human radiation experiments. After the independent Advi-
sory Committee has issued its first report the executive branch can
work closely with the legislative branch to establish any compensa-
tion or medical care programs that are necessary.
64
I would like then to close my brief opening remarks by emphasiz-
ing that the Department of Defense is committed, from Secretary
Perry on down, to a full public accounting of our involvement in
human radiation experimentation, £md I would like to also say we
are equally committed to ensuring that any experiments today, in-
volving human subjects are conducted in accordance with estab-
lished medical research protocols and the highest ethical stand-
ards.
Thank you for this opportunity to briefly tell you a little bit
about our ston^. I would like to now turn it over to Mike Parker
from the Aberaeen Proving Ground.
[The prepared statement of Dr. Soper follows:]
65
TESTIMONY FOR DR. SOPER
BEFORE THE COMMITTEE ON GOVERNMENT OPERATIONS
SUBCOMMITTEE ON LEGISLATION AND NATIONAL SECURITY
28 SEPTEMBER 1994
Good Morning, Mr Chairman and Members of the Subcommittee I am Gordon K.
Soper, the Principal Deputy in the Office of the Assistant to the Secretary of Defense for Atomic
Energy. I am here to support your request of August 1 2th to conduct oversight hearings on Cold
War era human subject experimentation. My testimony will focus on radiation experiments.
With me today to assist in giving you insight into this matter are Mrs. Jeanne Fites,
Deputy Under Secretary of Defense (Requirements & Resources) within the Office of the
Assistant Secretary of Defense (Personnel & Readiness); Mr. Michael Parker, Executive Director,
U.S. Army Chemical Biological Defense Command (CBDCOM), Aberdeen Proving Ground,
Maryland; and Dr. Joseph Osterman, Director of Environmental and Life Sciences in the Office of
the Director, Defense Research and Engineering. Mrs. Fites will address your questions about the
Department's efforts to identify individuals involved in chemical and biological testing. Mr.
Parker will address your questions about chemical and biological experiments, drug testing and
"Operation Large Area Coverage." Finally, Dr. Osterman will address the questions you have
raised relative to informed consent.
Before I address the specific questions you asked in your letter of August 12th, I would
66
like to provide you with some background information that will help put our answers into proper
context. The use of human volunteers in biomedical research programs in the Armed Forces dates
back to the early 1 800s. With the advent of the nuclear age and the following Cold War, this
research began to include human radiation experiments. There has been Congressional oversight
on this topic. For example, in 1972, Senator Edward Kennedy and Senator Mike Gravel held
hearings on the Department of Defense involvement in radiation experiments at the University of
Cincinnati, and in 1986, Representative Edward Markey published a critical report on 31 of 35
Government-sponsored human radiation studies involving 695 individuals.
This issue was given renewed emphasis in December of 1993, when Secretary of Energy
Hazel O'Leary provided to the public some amplifying information about the Government's
participation in human radiation experimentation during the Cold War era. Secretary O'Leary's
statements are a reflection of the Clinton Administration's desire to govern in a more open
manner. In a further demonstration of the Administration's desire to provide a fiill accounting of
the Government's past role in this area. President Clinton instructed the Federal Agencies to
conduct a comprehensive search for all available records related to Government-sponsored human
radiation experimentation and the public release of the pertinent information in those records. Of
note, in compliance with the Privacy Act, great care is being taken to ensure the privacy of the
individuals identified in such records.
In order to facilitate this systematic record search and comprehensive review, the
President established two major activities: an Interagency Working Group on Human Radiation
67
Experiments and the Independent Advisory Committee on Human Radiation Experiments. These
two groups are working closely together and have provided guidance to Agencies on conducting
the Government-wide search.
The first organization, the Government-wide Interagency Working Group, includes key
representatives from the Department of Defense, the Department of Energy, the Central
Intelligence Agency, the Department of Veterans Affairs, the Department of Health and Human
Services, the National Aeronautics and Space Administration, the Department of Justice, and the
OflBce of Management and Budget. This group is responsible for coordinating and overseeing the
Government's search for records of human radiation experirhentation. The strategy for the
Agencies involved in the search process is straightforward and all-inclusive. Radiation
experiments are defined as those:
(1) Experiments on individuals involving intentional exposure to ionizing radiation.
This category does not include common and routine clinical practices, such as established
diagnosis and treatment methods, involving incidental exposures to ionizing radiation.
(2) Experiments involving intentional environmental releases of radiation that (A) were
designed to test human health effects of ionizing radiation; or (B) were designed to test
the extent of human exposure to ionizing radiation.
68
The second activity established by the President, the Independent Advisory Committee, is
an independent group composed of pre-eminent scientists, physicians, legal experts, medical
ethicists, and others. Its purpose is to advise the Interagency Working Group on matters
pertaining to the ethical and scientific standards that were applied in government-sponsored or
conducted research which involved the intentional exposure of humans to ionizing radiation.
Specifically, as stated in the Executive Order issued by President Clinton in January: "The
Advisory Committee shall consider whether (A) there was a clear medical or scientific purpose for
the experiments; (B) appropriate medical foUow-up was conducted; and (C) the experiments'
design and administration adequately met the ethical and scientific standards, including standards
of informed consent, that prevailed at the time of the experiments and that exist today.
Within the Department of Defense, we took fiirther steps to ensure that DoD responded to
the executive order issued by the President. Then-Secretary of Defense, LesAspin, appointed
the Assistant to the Secretary of Defense (Atomic Energy), Dr. Harold P. Smith, Jr. as the official
responsible for this important initiative. Second, to focus the Department's efforts, we set up a
command center structure, initially led by a Flag Officer and now led by a Senior Executive
Service civilian, that serves as the central repository for all documents retrieved as a result of our
record search. The command center is also responsible for reviewing and analyzing documents
found during the search and for responding to public inquiries related to human subject
participation in radiation experiments.
Third, DoD established strict records review procedures for all DoD components to
69
ensure a comprehensive record search. Within these procedures, the need to "err on the side of
inclusion" when searching for records was emphasized to assure the public that the Government
was being open and forthcoming on this issue. We also established guidelines to allow for the
expeditious declassification of documents located during the record search.
Five straightforward principles guide the Department's efforts. First, we want the search
to be thorough. Second, the search will be done as quickly as possible. Third, all due care is to
be exercised to preserve records related to human radiation experiments. Fourth, the integrity of
the process must be preserved to ensure that it retains its credibility in the long term. Fifth, the
process must result in open accounting of the Department's past action in human radiation
experiments.
In keeping with these principles, the Department's response to this issue consists of two
phases. Phase I, which has been completed, identified DoD organizations that conducted or
sponsored human radiation experiments, identified the archives or records center where records
concerning such experiments are stored, and documented the process by which the search was
conducted. Phase n, which is still in progress, will identify each human radiation experiment,
provide details of the experiment, and locate the relevant records. Phase II of the search process
is expected to be completed by April 1995.
The Department has also focused its efforts to respond to requests for records and
information firom the Independent Advisory Committee. The Department has provided
70
information related to Departmental informed consent procedures since the mid-1940's; records
on the development of ethics policies since 1944; and policy directives related to the establishment
and operation of pertinent research and development bodies; and other data.
The DoD record search has been a massive undertaking and is still in progress. It is truly
a box-by-box, page-by-page endeavor. Hundreds of people throughout DoD expended
considerable effort on this research task. Some of the locations where records have been located
include: National Archives, Washington, D.C. and Suitland, Maryland; Washington National
Records Center, Suitland, Maryland; Federal Personnel Records Center, St. Louis, Missouri;
Naval Medical Research Institute, Bethesda, Maryland; Naval Hospital, San Diego, California,
Dugway Proving Ground, Utah; the Army Training and Doctrine Command, Fort Monroe,
Virginia; and Armstrong Laboratory, Brooks Air Force Base, Texas and Wright-Patterson Air
Force Base, Ohio. Since January, we have spent approximately 65,000 man hours on this
process. We are making progress, but we still have a long way to go.
Now I would like to address your specific questions. First, concerning DoD-sponsored
programs involving human subject ionizing radiation experiments during the 1950s, 1960s and
1970s, the Department has categorized these experiments into four categories:
therapeutic/diagnostic, intentional atmospheric releases, total body irradiation, and tracer studies.
To give you the flavor of what I am talking about, the following are examples of experiments
from each category: Therapeutic/diagnostic studies include "The Use of Radioisotopes in
Diagnostic Hematologic Procedures (Simultaneous Cr-51 and Fe-59 Studies)" and "The
71
Significance of Positive Ipsilateral Nodes in Resections of Lung"; intentional atmospheric
releases include "The Green Run Test" conducted in Washington and radiological warfare tests
conducted at Dugway Proving Grounds, Utah from 1949-1952; total body irradiation research
includes the "Metabolic Changes in Humans Following Total Body Irradiation" experiments
conducted at the University of Cincinnati and "Systemic and Clinical Effects Induced in 263
Cancer Patients by Whole-Body X-Irradiation with Nominal Air Doses of 15 to 200 Rads"; and
tracer studies include "The Total Exchangeable Potassium and Chloride and Total Body Water in
Healthy Men of Varying Water and Fat Content" and "Assessment of Platelet Function in Patients
with Coronary Artery Disease."
Most of the experiments identified to date fall into the therapeutic/diagnostic or tracer
study categories, in which radioactive materials or procedures were used to assist the
experimentation, but effects of the irradiation were not a central part of the research. Based on
the present requirements to "err on the side of inclusion," we have identified over 2,000 possible
human radiation experiments with over 52,000 participants that were conducted or sponsored by
DoD. When we locate a record containing three key phrases, viz. ionizing radiation, humans and
experiments, we include it in our data base of possible experiments and v^U submit it to the
Independent Advisory Committee for review and study. Additional experiments are expected to
be identified before Phase II of the search process is completed.
I will now address your question concerning the potential effects of such ionizing radiation
experiments upon human subjects. This is a key focus of the investigation's being conducted by
72
the Independent Advisory Committee, the Interagency Working Group, and the Department of
Defense. Since its creation in February 1994, the DoD command center has been compiling
information about human radiation experimentation. A detailed questionnaire has been developed
and distributed to all individuals under DoD's purview who contact or are referred to the
command center. This questionnaire includes a section concerning medical problems experienced
by these individuals. Responses to these questions are helping to identify individuals who may
have been affected by radiation experiments. This information will ultimately be helpful in any
notification and compensation initiatives. Determining the potential effect of exposure to ionizing
radiation will have to be done on a case-by-case basis. Many factors will influence the answer,
such as the subject's age and the type, duration and fi-equency of exposure.
Let me now respond to your question about what efforts DoD has made to notify the
subjects of these experiments. As I mentioned earlier, one of the responsibilities of the DoD
command center is to respond to public inquiries related to human subjects participation in
radiation experiments. Inquiries come to the command center by several means, the Radiation
Experiments National Helpline, referrals from other agencies, Congressional referrals, White
House referrals, or direct contact. To date, the command center has been in contact with more
than 4,000 individuals. When the records search process has progressed sufficiently, we expect to
undertake a comprehensive effort to notify all participants in DoD-sponsored human radiation
experiments.
You have also inquired about the efforts DoD has made to provide medical care or
73
compensation for the subjects of these experiments. At this time, I believe it is premature to
discuss any remedy the Government should apply in this matter until our research is completed
and the report of the Independent Advisory Committee has been evaluated.
Furthermore, the provision of medical care to veterans as a result of exposure to ionizing
radiation is governed by Public Law 97-72, the "Veterans' Health Care and Small Business Loan
Act of 1981." as amended (novk^ codified at 38 USC 1710 (e)(i)(B)), which authorized the
Department of Veterans Affairs to provide hospital and nursing home care and limited outpatient
services to "veterans who were exposed while serving on active duty to ionizing radiation from
the detonation of a nuclear device in connection with each veteran's participation in the test of
such a device, or with the American occupation of Hiroshima and Nagasaki during the period
beginning September 1 1, 1945 and ending July 1, 1946." This law provides for medical care
related to radiogenic diseases, but does not authorize care for conditions that are found by the
Department of Veterans Affairs to have resulted fi-om other than the exposure to ionizing
radiation.
As you are aware, Congress has not passed legislation to direct the Government to
provide compensation or medical services to the subjects of human radiation experiments.
Several bills are currently before Congress related to compensation and medical care for radiation
experiment subjects, including HR 4292, "Radiation Experimentation Victims Act of 1 994"
introduced by Representative Edward Markey; HR 3743 "Radiation Experimentation
Compensation Act of 1994" introduced by Representative Martin Frost. Congress, in concert
74
with the Executive branch, will need to examine and determine whether there is a need to
establish specific compensation and medical care programs for individual participants in radiation
experiments.
As concerns your question regarding informed consent, formal DoD policy for the
protection of human subjects in research dates back to at least 1953. At that time, a TOP
SECRET Memorandum (declassified August 1975) was sent to the Secretaries of the Services
from Secretary of Defense C.E. Wilson, titled "Use of Human Volunteers in Experimental
Research". This memorandum authorized the voluntary participation of military personnel and
civilian employees in DoD conducted research for atomic, biological and chemical warfare
defense and established specific standards, based on guidelines fi^om the Nuremberg Code for
informed consent and minimization of risk of harm to subjects.
Over the years, more detailed procedures have been established, including incorporation in
1991 of the 1974 Department of Health and Human Services regulations for the Protection of
human subjects, 45 Code of Federal Regulation (CFR) Part 46.
Today, DoD-sponsored research is governed by the so-called "Common Rule"~the
Federal Policy for the Protection of Human Subjects-which is part of DoD regulations at Title
32, CFR, Part 219. A copy of this regulation is attached to my statement. DoD is a fijll partner in
the government's commitment to this standard and has ftirther defined its human use regulation in
DoD Directive 3216.2, "Protection of Human Subjects in DoD Supported Research," January 7,
10
75
1983 and Department of Defense Guidance for Assurance of Compliance with the Federal Policy
for the Protection of Human Subjects, June 10, 1993.
In closing, I would like to reemphasize that the Department of Defense is committed to a
fiill accounting in this matter and is equally committed to ensuring that any experiments involving
human subjects are conducted in accordance with established medical research protocols and the
highest ethical standards. I will be happy to answer any questions you might have on this issue.
11
76
Mr. CONYERS. Thank you. What is that hotUne number?
Dr. SOPER. I have it. The DOE radiation experiments hotline is
1-800-493-2998. I have other help-Une numbers I will provide you
for the record. But that is the national radiation help-line number.
[The information follows:!
77
DOD RADIATION EXPERIMENTS COMMAND
CENTER
TELEPHONE NUMBERS AND ADDRESSES OF RELATED AGENCIES
1. Nuclear Test Personnel Review (NTPR)
6801 Telegraph Road
Alexandria, VA 22310-3398
1-800-462-3683
2. VA Hotline
(For referral from NTPR - connects caller to VA regional office in home state)
1-800-827-1000
3. VA Hotline (General)
ATTN. Mr. Adamczeck
1-800-827-0365
4. DOE Radiation Experiments Helpline
1-800-493-2998
5. Lawrence Livennore Laboratory (DOE)
510-424-6565
6. Los Alamos (DOE)
Human Studies Project
505-667-1948
7. Sandia
Historical Task Force in Human Studies
ATTN. Julie Kesti
Librarian
505-845-8044
78
Mr. CONYERS. Thank you very much. Who heads the team?
Dr. SOPER. In the Department of Defense, my boss, Dr. Harold
P. Smith, the Assistant to the Secretary of Defense for Atomic En-
ergy, is the single Department of Defense point of contact. And I
am his Principal Deputy.
Mr. CoNYERS. All right. He, of course, is not working exclusively
on this matter. He has many other responsibilities?
Dr. SoPER. Implementation of Nunn-Lugar activities, the devel-
opment of a counter proliferation acquisition strategy and nuclear
stockpiles maintenance, for example.
Mr. CoNYERS. And so do you.
Dr. SoPER. Yes, sir.
Mr. CONYERS. All right.
Mr. Parker, welcome to these hearings.
STATEMENT OF MICHAEL A. PARKER, EXECUTIVE DIRECTOR,
U.S. ARMY CHEMICAL AND BIOLOGICAL DEFENSE COM-
MAND, ABERDEEN PROVING GROUND
Mr. Parker, Good morning. Thank you, Mr. Chairman, members
of the subcommittee.
I am Michael Parker, U.S. Army Chemical and Biological De-
fense Command. It is a relatively new command formed out of the
Chemical Research Development and Engineering Center.
I would like to open with an endorsement of Dr. Soper's comment
on the Department being committed to providing full disclosure of
all information related to the individual exposure so that the af-
fected parties can deal appropriately with the VA and Department
of Labor in identifying appropriate compensation.
As was discussed earlier, the historical roots of the chemical and
biological defense efforts resulted in heavy classification. That was
the common practice up until 1977, at which point, after the
Church hearings, which I believe the chairman referenced earlier,
caused the Department of Defense to relook the basis of classifica-
tion. Since that time, many documents have been declassified in an
effort to provide information on individuals, to assist them in pros-
ecuting their claims with the appropriate bodies.
Specific comments on the large area of coverage, experiments or
other tests that were referenced earlier, that whole test series is
going through a declassification review that should be completed in
about the next 30 to 45 days. I might advise that some aspects of
the test appear to specifically address performance of some of the
dissemination systems and vulnerabilities that are still an issue for
national security such that certain elements of the report may have
to remain classified.
However, the information on exposure of the general population
and the nature of the material, the areas covered and all the perti-
nent information from a health effects standpoint will be sanitized
and released.
I might also note that the Department of Defense did outreach
beyond the Department in seeking assistance from the Department
of Health and Human Services, specifically the Center for Disease
Control, to do an independent assessment of the health effects of
the so-called large area coverage test using zinc cadmium sulfide.
79
The Center for Disease Control in their independent judgment de-
termined the health risk to be negligible.
I might also point out that the statement that zinc cadmium sul-
fide is a radiation product or an ionization source is incorrect. It
is a nonradiative-type material, a complex of metals with a sulfur
component. It is in no way a radiation type of material, nor is it
classified as a poison, as described earlier.
The health effects are somewhat documented as a potential car-
cinogen based on the cadmium content. But the acute effects are
fairly well-known and it is a relatively benign material in that re-
gard.
Mr. CONYERS. OK. You told me what it isn't. What is it?
Mr. Parker. It is a complex of zinc metal, cadmium metal, and
sulfur. It is a commercial dye product that has a strong fluores-
cence characteristic, which is why it was used in these particular
tests, when exposed to ultraviolet.
I might note as a common component of a child's chemistry set
that you buy in a toy store. That is the type of material that was
used, and it was believed at the time and still believed to be fairly
innocuous in the concentration and at the exposures that were in-
volved in the test.
Mr. CoNYERS. OK. It is potentially carcinogenic. What is your
background?
Mr. Parker. I am a mechanical engineer by academic trsiining.
Mr. CoNYERS. What is your understanding of the use of that
term?
Mr. Parker. A potential carcinogen is a material that one would
suspect on chronic exposure or acute exposure to produce carcino-
genic effects in excess of those of the normal background.
Mr. CoNYERS. It could be cancer causing.
Mr. Parker. It could be, yes.
Mr. Conyers. Well, let me ask you, and I include the study that
you mentioned that came from Atlanta, do you have other sources
that lead you to an opinion of what the carcinogenic potential is in
terms of the experiments that were conducted?
Mr. Parker. Given the concentration, using these standard avail-
able health safety data sheets as kind of the source document and
then a literature search of what is known of the material, in the
concentrations and the exposure period associated with the test,
both the Army Environmental Health Agency and the Center for
Disease Control assessed it as negligible risk.
Mr. Conyers. It is a negHgible risk?
Mr. Parker. That was ^e judgment of the CDC.
Mr. Conyers. But I was talking about, have you found anybody
else besides them? I concede that that is what they found in At-
lanta.
Mr. Parker. No, sir. I am not aware of any other. As was briefed
earlier, the effort and the look by the National Academv of
Sciences, which is the preeminent body to do this work, should an-
swer the question definitively.
Mr. Conyers. OK. Well, then, we don't need the million-dollar
appropriation that has been put in the budget to further study this
question.
80
Mr. Parker. I think that is a judgment the Congress has to
make.
Mr. CoNYERS. We did. We want to make sure.
Mr. Parker. I don't think there is any disagreement that the Na-
tional Academy of Sciences can look at this thing independently
and render a true third-party judgment. There is no argument on
that.
Mr. CoNYERS. You know, it is funny. I don't hear the tobacco in-
dustry ever making claims like that.
When they receive third-party Judgments, you know what their
advertisers put out? "What do they know about that? They are
wrong, dead wrong."
We have these disputes raging in the medical community, about
what to me are fairly well settled questions as a matter of fact.
So I will accept your view that this ought to be decided, but I
think we ought to go ahead with a little further investigation.
Please continue your statement, sir.
Mr. Parker. One of the specific questions that was raised had
to do with the approximate number of people involved, which post-
World War II or post- 1952 through 1974, in looking across the De-
partment of Defense records, we nave been able to determine there
were approximately 12,000 individuals who have been involved in
chemical agent testing where there was a human exposure.
The testing was terminated in the middle of 1975 by direction of
the Secretary of the Army, and subsequently there has been no
purposeful exposure of human subjects to chemical warfare agents.
In the area of biological warfare testing conducted between ap-
proximately 1950 and 1970, there were tne large area tests that
were discussed earlier, in which biotracers or simulants were used.
There also was a series of tests involving human subjects for the
purpose of developing vaccines and antidotes. Approximately 2,000
volunteers participated in the latter, in the development of vaccines
and antidotes.
This effort was terminated in I am sorry, the offensive aspects
of biological warfare research were terminated in 1969 by Presi-
dential directive, at which time we disposed of our total biological
warfare stocks and capability. At this point in time we continue
only defensive research.
The biomedical component of the research program, which is
clearly the oldest program, has its roots in the 1800's, and it has
produced many broadly beneficial products. Two of those in the
timeframe in question, the cold war years, of special note were test-
ing and development of treatment for malaria and the experimen-
tation with the psychoactive drugs such as LSD, benzoates, BZ,
and related glycolates.
With regard to the medical efforts under the malaria treatment
program, in the 30-year period spanning 1945 to 1975, there were
approximately 7,000 civilian prisoners involved in that research ef-
fort. With regard to the LSD and related psychoactive drug efforts,
there were about 700 personnel involved in that.
The thrust of tne latter was primarily to determine
vulnerabilities and countermeasures that could be taken to protect
U.S. forces in the event that psychoactive compounds were used
against them.
81
That concludes my remarks, Mr. Chairman.
I would like to introduce Ms. Jeanne Fites.
Mr. CoNYERS. Before you introduce her, on page 4 of your state-
ment, did you mean to say that these were volunteers, or do you
disaCTee with the Army IG that found that these volunteers were
not fully informed as required prior to their participation?
Mr. Parker. The testing involved volunteers in the sense that
the individuals knew that they were participating in a voluntary
manner. The IG found that in some cases ana I thmk by anybody s
definition of informed consent, that the individuals were not nec-
essarily provided all the information that would truly allow them
to meet me intent of informed consent. No one was coerced to par-
ticipate in the experiments.
There were occasions when less than adequate information was
provided.
Mr. CoNYERS. All right. Thank you.
[The prepared statement of Mr. Parker follows:]
82
RECORD VERSION
STATEMENT BY
MICHAEL A PARKER
BEFORE THE
SUBCOMMnTEE
ON LEGISLATION AND NATIONAL SECURITY
COMMITTEE ON GOVERNMENT OPERATIONS
UNITED STATES HOUSE OF REPRESENTATIVES
SECOND SESSION, 103RD CONGRESS
CHEMICAL, BIOLOGICAL, AND DRUG TESTING PROGRAMS
28 SEPTEMBER 1994
NOT FOR PUBLICATION
UNTIL RELEASED
BY THE HOUSE
GOVERNMENT OPERATIONS
COMMITTEE
83
U.S. ARMY CHEMICAL, BIOLOGICAL AND DRUG TESTING PROGRAMS
BACKGROUND
Over the past seventeen years. Congress and the public have expressed interest and
concern about the use of humans for chemical, biological and drug testing. Until recently, most
information related to these programs was classified due to its sensitivity and national security
implications. In 1977, the Army began the declassification effort for its testing programs. Even
though quite old, portions of these documents contain technical information that remains critical
to our national security interests. Some information contained in various reports has the potential
for misuse by individuals or groups intending harm against the nation and the general public. For
this reason, complete declassification of all test programs is not in the best interest of national
security. The Department of Army is, however, committed to providing, to the maximum extent
possible, complete and accurate information on our testing programs to the American people.
CHEMICAL WARFARE PROGRAM
On June 28, 1918, the President of the United States directed the organization of the
Chemical Warfare Service (CWS), under the Secretary of War. In October 1922, the CWS
created a Medical Research Division to conduct research directed at providing therapeutic and
prophylactic defense measures against chemical agents.
Prior to World War II, volunteer employees of Edgewood Arsenal were used as lest
subjects in various tests of mustard, phosgene, and other chemical agents. In early 1941, the
threat of war caused greater urgency for the development of protective items, and consequently, a
larger source of volunteers was needed. The first recorded recruiting arrangement was a request
made to all technical and officer personnel at Edgewood Arsenal to participate in various tests.
The documentation from the Worid War II period does not show who explicitly
authorized the use of human volunteers. It is believed, however, that the Acting Secretary of
Army, approved the test in principle and granted implied authorization. Large -scale human
experimentation was thereafter conducted at Edgewood Arsenal, as well as at field laboratories
located at Camp Siebert, Alabama; Bushnell, Florida; Dugway Proving Ground, Utah; and San
Jose Island.
84
The Army's World War 11 mustard agent test program tested protective clothing,
equipment, and antivesicant ointments. In addition, the Army developed and tested offensive
chemical weapons and evaluated the effectiveness and persistency of mustard agents in different
environments. Test documents show that gas chamber tests and skin tests were conducted at
Edgewood Arsenal, .Vlaryland, and that field tests were conducted at Bushnell Field, Flonda; Fort
Pierce, Florida; Dry Tortugas, Florida Keys; San Jose Island, Panama Canal Zone; Camp Sieberi.
Alabama; Dugway Proving Grounds. Utah; Camp Polk, Louisiana; Gulfpon. Mississippi; El
Centro, California; San Carlos, California; Fort Richardson, Alaska; and New Guinea.
The Army's records of mustard agent lest activities do not identify by name soldiers who
participated in World War II chemical tests. However, a Department of Army report titled,
"Medical Research in Chemical Warfare," estimates that the number of panicipants is in the
thousands. Over 1,000 soldiers were commended for their participation in tests. The records do
not indicate, however, what types of tests these soldiers participated in. According to the report,
200 and 300 soldiers were available at Edgewood and Dugway Proving Grounds to participate in
experiments from December 1944 until the end of the war.
In the early 1950's, the Army Chemical Corps began a classified research program for
developing incapacitating agents that continued until 1975. This program involved testing
chemicals including nerve agents, nerve agent antidotes, psycho chemicals, irritants, and vesicant
agents. Human volunteer nerve agent testing with G-agents was conducted during the early
1950's. In the late 1950s, after approval by the Secretary of the Army, testing with V-agent
began. The chemicals were given to volunteer service members at Edgewood Arsenal, Maryland;
Dugway Proving Grounds, Utah; and Forts Benning, Bragg, and McClellan.
The Army conducted an extensive chemical testing program with human subjects at
Edgewood from 1955 to 1975. Human volunteers were exposed to chemical agents to see how
agents might affect humans and how such affected humans might respond to therapy. The
program consisted of a wide variety of tests including: chemical agents, treatment drugs for
chemical agents, personnel protective equipment, skin penetration, irritant agents, and personnel
performance measurements. Approximately 7,000 soldiers took part in this program. The
volunteer hours were broken down according to the following experimental categories:
incapacitating compound - 29.9%, lethal compounds (anticholinesterases, cylinide) - 14.5%, riot
control compounds - 14.2%, protective equipment and clothing (masks and climatic effects) -
13.2%, effects of drugs and environmental stress on human physiological mechanisms - 6.4%,
85
development evaluation and lest procedures (confipounds in body fluids, stress condition) -
12.5%, human factors tests (ability of volunteers to follow instructions) - 2.1%, other (visual
studies, sleep deprivation, incapacitating compounds effect on rifle team) - 7.2%.
Of the 34.500 compounds studied by the Chemical Corps, approximately 150 chemicals
were used in the human volunteer program. Of these, approximately 50 were therapeutic agents
approved by the Food and Drug Administration or are well-known solvents and nutrients. The
Army's Medical Research and Development Command, Fori Detrick, Maryland, maintains records
of the test participants and the chemicals to which they were exposed.
The chemical compounds used in chemical testing program at Edgewood Arsenal from
1955 to 1975 include: Anticholinergic - Scopolamine, BZ, Ditran, "several numbered";
Barbiturates - Amytal. Nembutal, Phenobarbital, Seconal: Diagnostic - Antipyrine,
Sulfobromphthaieim. Indocardio green. Sodium Aminohippurate; Anticholinesterase Agents -
DFP, Physosligmine, Prostigmine, GO, Malathion, GA, GF, VX, GB, G-V; Antidotes - Atropine,
Benactyzine, Homatropine, Sodium Nitrite, Vasoxyl, Methscopolamine, BOL, metatropine, THA,
BTA; Oximes - Protopam chloride, P2S, TMB4, Toxogonin; Irritants - DMHP, DEP, "several
numbered"; Miscellaneous - Adrenalin, Alcohol, Amyl Nitrite, Arlane, Ammonium Chloride,
Benadryl, Caffeine, Compazine, Cogentin, Curare, Dapsone, Dexedrine, Dilantin, Dibenzyline,
Heparin, Inderal, Isuprel, Lanoxin, Lidocaine, Maisilid, Mecholyl Chloride, Meprobamate,
Mylaxin, PABA, Propylene glycol. Prolixin, Pryibenzamine, Reserpine, Ritalin, Sodium
Bicarbonate, Thiamin, Thorazine, Urecholin, Valium, ACTH, Nitrogen Dioxide, Semyl, LSD,
5HTP, Mustard, and N-Oclylamine.
In addition to the testing previously discussed, field testing was also conducted on small
military units to examine the effects of psycho chemical agents on military operations. These tests
were conducted at Forts Benning, Bragg and McClellan and Dugway Proving Ground. The
Army also conducted field testing in the late I950's and early 1960's using a wide range of
chemical compounds at Dugway Proving Ground, Utah; Edgewood Arsenal, Maryland; England;
Hawaii; Horn Island, Mississippi; Marshall Islands; Maryland; San Jose Island, Panama; Arctic
Test Center, Fort Greely, Alaska; Water Island, Virgin Islands; and Yuma Proving Ground,
Arizona. Since that time, limited field testing without human test subjects has been done at
Dugway Proving Ground.
86
A 1975 Department of the Army Inspector General report states that, "the evidence
clearly reflected that every possible medical consideration was observed by the professional
investigators at the Medical Research Laboratories." The report, however, concludes that,
"...(the) volunteers were not fully informed, as required, prior to their participation; and the
methods of procuring their services, in many cases, appeared not to have been in accord with the
mtent of (the) Department of the Army policies governing (the) use of volunteers in research."
On July 28, 1975, Acting Secretary of the Army Norman R. Augustine suspended testing
of chemical compounds on human volunteers at Edgewood Arsenal. To date, the Department of
Defense has identified approximately 12,000 individuals who may have been exposed to chemical
weapons agents as pan of defense research during and after World War II.
BIOLOGICAL TESTING PROGRAM
The United States began a Biological Warfare Program in 1942 that included both
offensive and defensive testing programs. The offensive aspects of the program were stopped by
Presidential Directive in 1969 and by 1973 the U.S. had destroyed all of its BW stockpiles.
Today, only defensive testing work continues.
The policy of the United Slates regarding biological warfare between 1941 and 1969 was
to first deter its use against the United States and its forces, and secondly, to retaliate if
deterrence failed. Fundamental to the development of a deterrent strategy was the need for a
thorough study and analysis of our vulnerability to both overt and covert attacks, and an
examination of the potential range of retaliatory options. From its inception, the program was
characterized by continuing in-depth review and participation by the most eminent scientists,
medical consultants, industrial experts, and government officials.
Prior to 1977, the BW program was classified up to top secret. In 1977, most aspects of
the program were declassified. A congressional hearing was held on this subject on 8 March
1977, and concurrent with the hearing, the Army released an unclassified report titled, "U.S.
Army Activity in the U.S. Biological Warfare Programs." The report contains extensive
information on the dales and locations of tests, types of simulants used, and rationale for the U.S.
biological program.
87
BW testing was conducted to provide infonnation on several issues such as: the agents
likely to be used; the best means of disseminating agents; the sizes of areas that could be attacked;
the environmental effects of agents; and the obstructive effects of buildings and terrain of agents.
Tests were also done to identify areas of the U.S. and forces most vulnerable to attack, and to
devise physical and mathematical models to be used as substitutes for live, open air testing.
The BW testing program was concerned principally with anti-personnel and anti-crop
agents and associated delivery capabilities, and to a lesser degree anti -animal agents. Biological
testing was conducted in laboratories, closed chambers, and open air field (large scale), and used
both simulants and pathogens. The biological testing program also included human volunteers
under a codename "Operation Whitecoat."
Anti-personnel agent research covered a wide range of highly infectious pathogenic
bacteria, rickettsial, viruses, and fungi, and extremely toxic products of biological origin (toxins).
Research efforts were directed toward selecting and preserving the most virulent strains,
establishing human dosages, enhancing storability, and survival when released as an aerosol.
Technology for large scale production of the most promising agents was developed. Efforts were
expended to obtain improved simulants to assist production, development, and testing efforts.
The Department of Defense conducted anti-crop research using BW agents and CW
agents (i.e., chemical herbicides and defoliants). Research on BW agents included strain
selection, evaluation of nutritional requirements, development of optimal growth conditions and
harvesting techniques, and preparation in a form suitable for dissemination. Extensive field testing
was done to assess the effectiveness of agents on crops. Many candidate anti-crop BW agents
were screened resulting in five standardized BW anti-crop agents that included various stem rust
of wheat and rye, and rice blast.
The Department of Defense began conducting open air tests using BW simulants and
certain selected inorganic materials such as fluorescent particles in the 1950s to obtain aerosol
dissemination data. The two most commonly used biological simulants were Serratia marcescens
(SM) and Bacillus subtillis varian niger. normally referred to as Bacillus globigii (BG), and
Aspergillus Fumigatus (AF). The most commonly used fluorescent particle (FP) was an inorganic
complex, zinc cadmium sulfide.
Bacillus globigii is considered ubiquitous in nature. It can be readily cultured from hay,
dust, milk, and water. It was considered by medical authorities to be harmless to man. SM is
88
commonly found in waier, food and sewage and sometimes can be isolated from feces and sputum
of apparently healthy people. It was used as a bacterial marker with little risk because of its
avirulanl nature. In 1969 it was recognized as having limited pathogenic capability and was not
used for study of experimental infection in man because of the assumed role as the opportunist,
producing disease if man is exposed to large doses or when the body's defenses were weakened
for other reasons.
The AF was a fungus simulant used on four occasions from 1950-1953 and abandoned
when antifungal agents were removed from the BW program. AF is ubiquitous in nature and is
considered an opportunist causing aspergillosis in debilitated persons.
The Department of Defense conducted numerous open air tests using zinc cadmium
sulfide in the 1950s and 1960s. This testing, referred to as Fluorescent Particle Atmospheric
Tracer Technique, employed accepted meteorological practices using zinc cadmium sulfide to
determine the possible effectiveness of an adversary dispersing a BW agent over populated areas
of the U.S. The compound is found naturally in the earth's crust and is in numerous products still
in use today. Cadmium can be a carcinogen at high levels.
The U.S. Army Center for Health Promotion and Preventive Medicine (formerly the Anny
Environmental Health Agency) recently completed three Health Risk Assessments for cities
involved with the FP aerosol testing. In all cases, the assessments concluded that the level of risk
experienced by inhabitants in the test areas was below the 1994 Occupational Safety and Health
Administration (OSHA) standards. Additionally, the assessment concluded that the risk of
exposed individuals developing cancer is below the accepted level of risk established by the U.S.
Environmental Protection Agency for the general population. In August 1994, the Center for
Disease Control and Prevention, in an independent study, concluded that zinc cadmium sulfide
tests posed negligible health threats to residents of the test areas.
Human Volunteer Testing. It was determined in 1952 that while tests with simulants had
demonstrated the vulnerability of the U.S. to biological attack, no scientific data was available to
assess human vulnerability to biological agents. The program included several thousand
volunteers and examined the vulnerability of man to biological agents, prevention and treatment of
BW casualties, and identification of biological agents.
The major human testing program. Project Whitecoat, originated in 1954 following a
series of meetings between representatives of the General Conference of the Seventh Day
89
Adventist Church and ihe Surgeon General of the Army. It continued at Fort Detrick, Maryland
until the end of the draft in 1973. Project Whitecoat was originally established to determine the
vulnerability of man to attack with biological weapons using Q fever as a prototype.
Personnel for Project Whitecoat were recruited from military personnel with a 1-A-O
(conscientious objector) classification undergoing Basic and Advanced Individual Training at the
Medical Training Center, Fort Sam Houston. These personnel were given a complete and
comprehensive explanation of the program including discussion of the risks involved. The
following day, they were interviewed individually and offered an additional opportunity to ask
questions and indicate their desire to participate or noL Many more individuals volunteered than
could be accepted.
r
After administrative processing, these volunteers were assigned to various noncombatant
duties at Fort Detrick. Volunteers were again briefed on each individual project and allowed to
reject participation. Those who chose to volunteer signed consent forms. Multiple vaccine and
antibiotic studies were conducted on a wide variety of infectious diseases. The entire program
was initially monitored by the Commission of Epidemiological Survey of the Armed Forces
Epidemiology Board. Project Whitecoat involved 2,200 soldiers between 1954 and 1973.
Information obtained for the BW testing program has proven to be of great value to public
health, agriculture, industry, and the fundamental sciences. Today's defensive program continues
to seek and develop effective warning and detection devices, protective clothing and equipment,
and continues to assess the vulnerability of the U.S. and its force to enemy BW threat
DRUG. DISEASE AND RRSRARCH TRSTTNG PROGRAM
Biomedical research programs are the oldest research programs in the Armed Forces with
their beginnings the early 1800s. From the 1800s leading up to the 1950s, the military was
involved in many programs testing drugs and vaccines in human subjects. These tests have made
a number of valuable contributions to medicine. For example, the military studied and
participated in the development of a safe Venezuelan Equine Encephalitis vaccine and Sulfamylon,
an antibacterial cream for the treatment of pseudomonas infections in bum patients. In the late
60s and earlier 70s, studies validated the use of gamma globulin for prevention of hepatitis.
90
In 1976, military tests validated use of the drug acetazolamide for Acute Mountain
Sickness. During the 1970s, multiple other clinical investigations took place with the rise of
antibiotics (carbenicillin, tetracycline, etc.) and other drugs (antacids and cimetidine for Curling's
ulcer). While there were other drug testing programs, two major cold war drug testing programs
conducted by the Department of Defense deserve discussion:
Malaria
The U.S. government sponsored malaria research involving prisoners from 1945 through
1975. The Committee on Medical Research of the Office of Scientific Research and
Development, National Research Council, organized and sponsored the initial malaria drug
development program. The U.S. Army was one of several cooperating federal agencies.
During World War II and the later 1940s, several sites were involved in testing new
compounds. The U.S. Army was primarily involved with Stateville Penitentiary, Illinois. From
the onset, the use of prison volunteers was open to public scrutiny as evidenced by an editorial in
the new England Journal of Medicine in March 1945 and other public observation of the program.
The volunteers were white male inmates, 21 to 45 years of age and in good physical and mental
health. They were copni^ant ^f .v,e nature of the experiments and were able to remain under
observation for 18 months. This testing succeeded in the discovery of chloroquine, a drug with
rapid and unsurpassed anti-malarial activity.
In the l%Os, chloroquine-resistant malaria surfaced in Southeast Asia, and subsequently
initiated the need for new effective anti-malarial drugs. In 1963 to 1964, studies were initiated
under government contract at Kansas City Jail, University of Missouri and Maryland House of
Correction, University of Maryland.
Two additional facilities were used briefly in the eariy 1970s, Oklahoma State Prison at
McAlester, Oklahoma, and the Florida Correctional Institution, University of Florida College of
Medicine. The U.S. Army Investigational Drug Review Board approved each study and ensured
that the potential volunteers were informed as to the nature and hazards of their participation in
the studies. They were allowed the right to withdraw from participation without prejudice. All of
the U.S. Army prison programs were stopped in 1975. Alternative procedures for continuing
anti-malarial drug testing in free living volunteers were subsequently developed by the Walter
Reed Army Institute of Research and are active today. The U.S. Army worked with approxi-
mately 7,000 prisoners in the malaria drug testing program during the period 1945 to 1975.
8
91
LSD. Benzilate and Scopolamine Studies.
The remaricable hallucinogenic properties of lysergic acid diethyl amide (LSD) were
discovered in 1943. In the 1950s, LSD was thought to possess many properties desirable in
chemical warfare. It was known to be effective in incredibly small amounts and conveniently
colorless, odorless, and tasteless. Because of these properties, the U.S. Army Chemical Corps
and the U.S. Army Intelligence Corps decided to conduct a series of experiments with LSD.
These tests began in 1955 and continued through 1967. Volunteer research subjects were
solicited from the Army in general and from the Chemical Corps.
In some cases, subjects were volunteering for research but were not told they were in drug
research. If they did know they were in drug research, they may not have been told what drugs
they were taking. In most cases, LSD-exposed subjects voluntarily participated in the chemical
warfare testing and were informed ahead of time they would be receiving a psychoactive agent.
Strict medical supervision was provided during the testing and prior to the actual receipt
of the drugs. Almost all subjects received some degree of psychological screening, and 30 to 50
percent of the Army volunteers were turned down during the screening process. The bulk of the
testing was carried out at Edgewood Arsenal, Maryland, although other sites such as Dugway
Proving Ground and Forts Benning, Bragg and McClellan were occasionally used. Projects were
designed to obtain information, not only about the possible usefulness of LSD in operations
against an enemy force, but also about means that might be taken to defend against the use of
LSD to disrupt U.S. forces. By 1967, further LSD research was discontinued. The civilian
community over these same years has tested LSD on a much larger scale. In 1975, Secretary of
the Army Norman R. Augustine suspended testing of chemical compounds on human volunteers
at Edgewood Arsenal.
There are 54 contracts or reports of contracts with universities and chemical companies
from 1950-1971. Twenty-five were awarded for incapacitating agent research. The agent/drugs
used were physical incapacitants such as morphine, demerol, Seconal, scopolamine,
chlorpromazine, and secobarbital. Mental incapacitant studies included LSD, mescaline, atropine,
psilocybin, BZ and glycolate compounds.
Several LSD follow-up medical evaluation studies took place in the 1970s, beginning with
Project 33 in 1974-75. In the meantime, public and congressional interest in chemical warfare
92
testing was stimulated by, among other things, the disclosure of the tragic suicide in 1953 of an
Army mathematician shortly after surreptitiously being given LSD by non-military experimenters.
In 1975, congressional investigators requested that measures be taken to locate an(J evaluate for
possible long-term adverse effects all former participants in Army chemical warfare research with
LSD. Project 28 and Project 50/50 followed with the number indicating the number of
participants in the follow-up study. In 1978, a follow-up office was established. It proceeded to
contact all individuals from a comprehensive roster of 686 individuals believed to have received
LSD. Of those, 320 (47%) individuals electing to participate were provided travel at government
expense to selected Army medical centers for evaluation. A 158 page summary report of this
medical follow-up program was prepared in 1980.
As a group, the LSD testing subjects appeared to be relatively stable socially, unusually
well educated and economically successful. The medical and psychiatric findings for those 220
subjects examined directly, as well as that obtained from the additional 100 subjects examined by
questionnaire, generally appeared to parallel in type and frequency findings that could be expected
in a comparable segment of the general population.
10
93
Mr. CoNYERS. Ms. Files.
STATEMENT OF JEANNE FITES, DEPUTY UNDER SECRETARY
OF DEFENSE FOR REQUIREMENTS AND RESOURCES
Ms. Kites. Thank you.
As the Greneral Accounting Office stated, the Department has
been less aggressive getting information on people who were sub-
jects of chemical or biological weapons experiments. We started in
March 1993. We have not had the resources put against it that
have been put against, for example, the radiation. A lot of the same
people are working on the same things.
We found about 500 sites that are not all test sites. There were
16 test sites for chemicals that we found so far, and the 500 sites
include transport points and everything else. So far we have identi-
fied 12,000 names. Locating these people isn't going to be easy.
We don't have fiill names in most cases. We don't have serial
numbers. Social Securitv numbers. We have people literally sitting
and going through old dusty boxes to find these names and to find
what experiments were conducted and to collect the information on
the experiments.
We have had people contact us, and to the extent we can, we are
matching them up with records on experiments when they can
identify where they thought the experiment occurred, where we
have found any records for that experiment. We have put the indi-
viduals in contact with the VA or the Department of Labor as ap-
propriate.
Last week we got additional names, both from the office of Con-
gressman Goss and from Mr. Nat Schrerman, who is a victim of
mustard gas testing who has testified several times before the Con-
gress. He has been compiling lists of names. We are in the process
of trying to contact these people, get more information, and help
them find records that would help them prove their cases.
I would be pleased to try to answer any questions you have.
And right now. Dr. Osterman will address the Department's com-
pliance with the Nuremberg Code, et cetera.
[The prepared statement of Ms. Fites follows:]
94
TESTIMONY OF JEANNE B. HTES
DEPUTY UNDER SECRETARY OF DEFENSE
(REQUIREMENTS AND RESOURCES)
BEFORE THE HOUSE GOVERNMENT OPERATIONS COMMITTEE
SUBCOMMITTEE ON LEGISLATION AND NATIONAL SECURITY
SEPTEMBER 28, 1994
Not for Publication
Until Released by the Committee
95
Thank you for the opportunity to tell you what the Department of Defense is
doing to identify and support military or civilian persoiuiel who were exposed to
chemical weapons agents as part of Defense research programs during and after World
WarU.
On March 9, 1993, Dr. Perry directed the Department to take immediate steps to
determine the extent of the potential human exposure to chemical weapons agents
through our testing program and to identify the individuals exposed. He immediately
declassified all relevant information concerning chemical weapons testing programs that
were conducted prior to 1968, and directed the Department to begin the declassification
process for all programs since 1968. He also released any individuals who participated in
testing, production, transportation, or storage associated with any chemical weapons
research from any oaths of secrecy or non-disclosure restrictions concerning their
participation in such testing.
Our first efforts focused on two things: first, a definition of the kinds of data we
were seeking on the testing programs and on the individuals exposed; and second,
identification of places where such information would be found. Unfortunately, there is
no central repository for information concerning historical data on our chemical weapons
testing programs. We worked with representatives from Veterans Affairs to ensure that
we would collect information that would support their efforts to appropriately identify
and compensate veterans exposed.
In addition to the National Archives in Suitland and St. Louis, we have identified
five major DoD records holding sites and one Univeniity site where large volumes of
records are stored. They are: Edgewood Arsenal, in Maryland; the Naval Research
Laboratory, in Maryland; Dugway Proving Ground, in Utah; the Army Chemical School
Library, in Alabama; Rocky Mountain Arsenal, in Colorado; and the University of
96
Chicago. We also believe that additional records may be stored at other contractor
facilities and universities that we have not identified.
In general, these records are not indexed or sorted. They consist of thousands of
linear feet of paper in filing cabinets or boxes, and thousands of sets of microfiche. They
are in historical library collections, warehouse holding areas, and technical libraries. The
files also contain weapons schematics, technical drawings, and operational directions as
weU as scientific formulae. Personnel information can sometimes be extracted firom
scientific notebooks, operational orders and plans, administrative correspondence,
technical reports, personnel rosters, or medical records. Because of national security,
foreign diplomacy, and personal privacy issues, review of this information can only be
completed by personnel with appropriate security clearances and technical background,
as well as knowledge of personnel issues. Each piece of paper in every collection must
be reviewed page by page.
The records at the contractor-operated Chemical and Biological Information
Analysis Center at Edgewood are completely automated. We contracted with them to
perform a key words search on their records. The resulting report contains over 2,000
entries for about 500 sites. The sites include locations where chemical and biological
agents were tested, produced, stored, or shipped. We are currently enhancing this report
with additional information from on-site manual searches using contractor and DoD
personnel.
One of our sources of information is correspondence from veterans and others
who participated in or know something about the tests. We follow up on individual
claims forwarded to us from Veterans Affairs and on phone conversations and letters.
These contacts have resulted in identification of additional storage and testing sites.
97
We now have about 12,000 names of individuals who may have been exposed,
including 504 from the Ban Harbor incident. We do not have complete information on
all of them and not all of them are confinned exposures.
The Department is committed to supporting these individuals, and we will
continue to pureue review of records and foUow-up on letters from veterans and personal
conversations with veterans and former DoD employees.
98
Mr. CoNYERS. Welcome, doctor.
STATEMENT OF JOSEPH OSTERMAN, PhJ)^ DIRECTOR, ENVI-
RONMENTAL AND LIFE SCIENCES, OFFICE OF THE DIREC-
TOR, DEFENSE RESEARCH AND ENGINEERING
Dr. OsTERMAN. Thank you, Mr. Chairman.
As mentioned, I am Dr. Osterman, the Director of Environmental
and Life Sciences in the Office of the Director of Defense Research
and Engineering. I will provide an overview of the measures cur-
rently in place to ensure the protection of human subjects in De-
partment of Defense research and development.
The Federal policy for human subjects protection is promulgated
in title 32, part 219, Code of Federal Regulations. This Federal pol-
icy is designed to make uniform the human subjects protection sys-
tem in all applicable Federal agencies and departments, includmg
the Department of Defense, and hence its reference as the Federal
policy or common rule for human subjects protection.
The basic protections contained in the Federal policy for human
subjects protection govern the role of the human subjects review
board, or Institutional Review Board, the informed consent docu-
ment, and the reporting chain of command for overseeing the
human subject protection regulations.
These three concepts are interlinked and serve to ensure the pro-
tection of human subjects throughout the Federal Government. The
informed consent document is a voluntary agreement of the subject
to participate in a research study protocol that is based on a plain
language explanation of the test purpose and all known risks and
benefits associated with participation in the study protocol.
The informed consent document contains a description and expla-
nation of the procedures to be employed, a description of risks and
discomforts associated with study protocol participation, a descrip-
tion of the benefits that are expected from such participation, a dis-
closure of alternative procedures if the research is a clinical, thera-
peutic trial conducted in a hospital, an offer to answer inquiries
about the procedure, and a clear understanding that the individual
is free to withdraw consent and discontinue participation in the
study protocol at any time.
Informed consent requires the participation be free of coercion.
The second key to ensuring human subjects' protection is the Insti-
tutional Review Board, IRB, or human use committee. The IRB
membership serves as reviewers of the study protocol and acts as
human subject advocates to ensure the adequacy of the informed
consent document and the safety of human subiect participation.
Formal IRB meetings are regfularly scheduled, usually on a
monthly basis, to review new protocol submissions and to conduct
an annual review of existing ongoing protocols. The IRB and in-
formed consent documents are parts of the overall program to en-
sure the protection of the rights and well-being of numan subject
participants in research protocols.
Also key to the program is active oversight participation by indi-
vidual facility commanders through a formal submission of assur-
ance statements. The facility commanders and major military com-
ponents state their awareness and intent to protect the rights of
subjects in research under the Federal policy for protection of
99
human subjects and to establish formal chains of command for ac-
countability in execution of the human subjects' research program.
Within the various Service components or agencies, human sub-
jects' protection is conducted at biomedical research and develop-
ment facilities and research programs at various medical treatment
facilities. In general, both facets of this program are under the re-
view of the Service Surgeon General.
There are no significant differences in oversight of extramural
and intramural human subjects' research programs. The Federal
common rule applies to both areas of research activity with regard
to human subjects' protection.
In accordance with the common Federal rule, extramural proto-
cols require the facility performing the research to maintain a cur-
rent National Institutes of Health assurance number issued by the
Office for Protection from Research Risk or a Department of De-
fense assurance number issued by a military service or agency.
In general, a notice of Federal requirements with regard to
human use experimentation is often included in the broad agency
announcement soliciting research proposals from the private sector.
A contractor or grantee must undergo an Institutional Review
Board review and approval of research protocols and informed con-
sent documents prior to the award of any funds from the Depart-
ment of Defense.
Additional protections for vulnerable classes of individuals,
fetuses, pregnant women, children and prisoners can be found in
title 45, Code of Federal Regulations, part 46, subparts B, C and
D. The Department of Defense has adopted these additional guid-
ance policies for vulnerable classes of individuals.
Let me conclude, sir, by saying the Department views the protec-
tion of the human subject as a major responsibility.
This concludes my statement, Mr. Chairman. I would be pleased
to answer any questions from you or other members of the commit-
tee.
[The prepared statement of Dr. Osterman follows:]
100
DRAFT TESTIMONY FOR DR. OSTERMAN
BEFORE THE COMMITTEE ON GOVERNMENT OPERATIONS
SUBCOMMITTEE ON LEGISLATION AND NATIONAL SECURITY
28 SEPTEMBER 1994
Good morning, Mr. Chainnan. I am Dr. Joseph Ostennan, Director of Environmental and
Life Sciences in the office of the Director, Defense Research and Engineering. I will provide an
overview of the measures currently in place to ensure the protection of human subjects in DoD
research and development. I will specifically address the manner in which informed consent is
secured from vohmteers.
The Federal Policy for Human Subjects Protection is promulgated in Title 32 Part 219
Code of Federal Regulations (32 CFR 219). This federal policy is designed to make imiform the
human subjects protection system in all apphcable federal agencies and departments, including the
Department of Defense, and hence its reference as the Federal Policy or Common Rule for Human
Subjects Protection. In addition, the Department adheres to other federal regulations governing
human subjects. These include: the vulnerable classes of himian subjects protected imder 45 CFR
16, and FDA regulations codified in Title 21 of the Code of Federal Regulations. These latter
regulations inchide Parts SO (requirements for informed consent), 56 (provisions for Institutional
Review Boards), and 812 (investigational device exemptions).
The basic protections contained in the Federal Policy for Himian Subjects Protection
101
govern the role of the human subjects review board or institutional review board, the informed
consent document, and the reporting chain of command for overseeing the human subject
protection regulations. These three concepts are interlinked and serve to ensure the protection of
himian subjects.
The informed consent document is a vohintaiy agreement of the subject to participate in a
research study protocol that is based on a plain language explanation of the test purpose and all
known risks and benefits associated with participation in the study protocol. The informed
consent document contains a description and explanation of the procedures to be employed; a
description of risks and discomforts associated with study protocol participation; a description of
the benefits that are expected fi'om such participation, a disclosure of alternative procedures if the
research is a clinical therapeutic trial conducted in a hospital; an offer to answer inquiries about
the procedure; and a clear understanding that the individual is fi'ee to withdraw consent and
discontinue participation in the study protocol at any time. Informed consent requires that
participation be fi'ee of any coercion. Also a clear delineation of any limitations on compensation
for any adverse event resulting fi'om such participation must be described.
The second key to ensuring human subjects protection is the institutional review board
(IRB) or Human Use Committee. The IRB membership serves as reviewers of the study protocol
and act as human subject advocates to ensure the adequacy of the informed consent document and
the safety of human subject participation. Within each service or agency, the oversight of human
subjects protection is an ongoing process conducted daily. Formal IRB meetings are regularly
102
scheduled, usually on a monthly basis, to review new protocol submissions and to conduct annual
reviews of existing protocols.
The IRB and informed consent document are parts of the overall program to ensure the
protection of the rights and well-being of human subject participants in research protocols. Key
to the program is active oversi^ paitic^)ation by the individual facility commanders. Through a
formal submission of an assurance statement, the &cility commanders and major military
components state their awareness and intent to protect the rights of subjects in research under the
Federal Policy for Protection of Human Subjects and to establish formal chains of command for
accountability in execution of the human subjects research program.
Within the Department of Defense, human subjects protection oversight resides with the
Director, Defense Research and Engineoing. Operational oversight has been delegated to the
individual Services or Defense Agencies. Within the various Service Components or Agencies,
human subjects protection is conducted at biomedical research and devdopment facilities and
clinical investigations programs at various medical treatment £u»lities. In general, both facets of
this program are under the review of the Service's Surgeons General.
CLINICAL INVESTIGATIONS PROGRAMS
The primary req>onsibility for oversight of human medical research resides with each
hospital commander whose &cility sponsors a dinicai investigation program. This oversight is
103
exercised at each major teaching medical treatment &cility primarily through the Chief of the
Department of Clinical Investigation. These medical treatment facilities also enjoy the
deliberations and contributions of human-use committees and clinical investigation committees.
Medical monitors are appointed for each study not conducted by a physician, and that involves
more than minimal risk, to assure the ongoing protection of each subject. Review by the human-
use committee is required at least annually in order for studies to continue. A central office is
established within each Service to provide human subjects protection, coordination and quality
assurance among medical treatment facilities performing human subjects research.
ARAIY: Clinical Investigation Regulatory Office (CIRO). CIRO also hosts an annual training
conference on human use and animal use oversight for Army, Navy, and Air Force investigators
and administrators.
NAVY: Health Sciences Education and Training Command.
AIR FORCE: Headquarters Air Force Medical Operations Agency, Office of the Surgeon
General.
BIOMEDICAL RESEARCH AND DEVELOPMENT PROGRAMS
The Commanding Officers of the military medical research laboratories or institutes are
ultimately responsible for local institutional oversight. Commanders utilize several review
104
committees to exercise their responsibilities regarding scientific integrity and protection of human
subjects. The principal committees for protocol reviews are the Scientific Review and the Human
Use Committees. Commanders cannot overrule the Human Use Committee and approve a
protocol which the Human Use Committee does not recommend for approval. Monitoring also is
provided by a locally assigned physician who serves as a medical monitor for each protocol
determined to be greater than minimal risk. This determination is made by a duly convened
Human Use Committee.
Oversight review of intramural and extramural human-use protocob is accomplished by
the following Service offices:
Army: Human Use Review and Regulatory A£fairs Division of the Office of the Deputy Chief of
Staff for Regulatory Compliance and Quality, U.S. Army Medical Research and Material
Command.
Navy: Committee for the Protection of Human Subjects, Navy Medical Research and
Development Command. The Office of Naval Research also support contraaed research
activities, and uader the authority of the Chief of Naval Research, the Head, Personnel
Optimization and Biomolecular Science and Technology Dq)artment, is responsible for human
subjects protection oversight.
Air Force: Headquarters Air Force Medical Operations Agency, Office of the Surgeon General.
105
The functions of these various offices are conducted in accordance with requirements
delineated in Title 32 Code of Federal Regulations Part 219 (32 CFR 219), Federal Policy for the
Protection of Human Subjects, which is the Department of Defense "Federal Common Rule"
document. Headquarters level oversight involves continuous monitoring and audit reviews of the
programs under their cognizance. The various oversight offices described maintain records of all
research protocols (including study design), investigator credentials, approved informed consent
forms, compliance and assurance documentation, progress reports, and minutes of IRB
transactions. In addition, the oversight offices serve as central locations for access to Federal
regulations, and directives and policies pertaining to research involving human subjects.
Furthermore, these offices offer legal consultation and guidance on issues related to regulations.
There are no significant differences in oversight of extramural and intramural human
subjects research programs. The Federal Common Rule ^pUes to both areas of research activity
with regard to human subjects protectioiL All protocob involving the use of human subjects are
handled with the same level ofoversight by the local IRB. In accordance with the "Common
Federal Rule," extramural protocols require the facihty performing the research to maintain a
current National Institute of Health assurance number issued by the Office for Protection fi-om
Research Risk, or a Department of Defense assurance number issued by a MiUtary Service or
Agency. In general, a notice of federal requirements with regard to himian use experimentation is
often included in the Broad Agency Announcement soliciting research proposals. A contractor or
grantee must undergo IRB review and approval of research protocols and informed consent
documents prior to the award of any funds. Furthermore, noncompliance by a contractor or
106
grantee could result in a tennination of the contract or grant.
The authority for oversight of human subjects protection within DoD is established within
the military reporting chain of command. Title 32, Code of Regulations, Part ' 1 9, Federal Policy
for the Protection of Human Subjects and Title 10 United States Code, Section 980 establish the
fundamental regulatory requirements for human subjects protection. Execution of these
regulations and written standards for performance are found in the Service's directives and
instructions:
DoD Directive 3216.2, "Protection of Human Subjects in DoD Supported Research"
DoD Directive 6000.8, "Funding and Administration of Clinical Investigation Programs"
Army Regulation 40-7, "Use of Investigational Drugs and Devices in Humans and the Use
of Schedule I Controlled Drug Substances."
Army Regulation 10-38, "Clinical Investigation Program."
Army Regulation 70-25, "Use of Volunteers as Subjects of Research."
Secretary of the Navy Instruction 3900.39B, "Protection of Human Subjects."
HSETC Instruction 6000.41 A, "Clinical Investigation Program"
Air Force Policy Directive 40-4, "Clinical Investigation and Human Use in Medical
Research."
Air Force Instruction 40-403, "Clinical Investigations in Medical Research, Gmdance and
Procedures."
107
Air Force Instruction 40-402, "Using Human Subjects in Research, Development, Test,
and Evaluation."
Additional protections for vulnerable classes of individuals, fetuses, pregnant women,
prisoners, and children can be found in Title 45, Code of Federal Regulations Part 46, Subparts B,
C, and D. The Department of Defense has adopted these additional guidance policies for
vulnerable classes of individuals. The requirement in those studies using vulnerable populations
(children, prisoners, handicapped persons) is to have an individual knowledgeable about and
experienced in working with these subjects. DoD views the protection of the human subject as a
major responsibility.
This concludes my prepared statement, Mr. Chairman, and I would be pleased to answer
any questions from you or other members of the Committee.
108
Mr. CoNYERS. Thank you.
Mr. McCandless.
Mr. McCandless. Mr. Chairman, we are in a very technical
area, and I would like an opportunity with the unanimous consent
of the committee to submit to the panel questions that we would
have on more specific parts of their disciplines as it relates to the
subject matter here in the hearing.
I want to ask one general question of the panel. I believe you
were all present during the previous testimony, in the audience, if
I remember correctly. I was quite taken aback by the number of
comments about the services and/or the Federal Government par-
ticipating in experiments without the knowledge and consent of
those who are involved, be they individuals or communities.
And I would pose that question to the panel. To your knowledge,
are you as people in your disciplines involved in any of this kind
of activity at the present time, or have you been in the recent past?
Dr. SOPER. Perhaps I will speak first, and then let everyone
else
Mr. McCandless. However you would like.
Dr. SoPER. Thank you, sir. We have been very careful in the ra-
diation review to make sure that the record that we find is as com-
plete as possible, including all of the information— or not, if it is
not there — all of the information associated with ethical medical re-
search, including statements of the consent, et cetera.
If those aren't there, that needs to be reported as well.
Mr. McCandless. I imderstand what you are saying, and I am
not trying to quarrel with you. But mv question is a very simple
one. You used the term "with consent. That would imply the per-
son was aware of what you were doing.
Dr. SoPER. Yes.
Mr. McCandless. So that would not be an issue. The issue
would be, well, let's take the next 12 people coming into sick call,
I mean theoretically, for the purposes of our discussion, and try
this on to see if it is going to help us with the common cold. And
they don't know what they are getting. They came in because they
have got a cold and they can't function, so you give them something
and they walk away and you have conducted an experiment with-
out their knowledge or consent.
I am reaching probably for an example, but is any of that going
on?
Dr. OsTERMAN. Mr. McCandless, sir, if you don't mind, I will re-
spond to that. There is absolutely no chance of that happening
under our current regulations. There is a triad, as I mentioned ear-
lier, of events which fully protect the individual in the cir-
cumstance that you described.
No. 1, no experimentation could be performed on that individual
appearing at sick call without a protocol that had been approved
by an institutional review board.
That individual could not be administered experimental drugs or
vaccines without his written informed consent.
And third, it would have to be done with the knowledge and ap-
proval of the commanding officer of that installation.
So I feel certain in telling you that the scenario you laid out
would not happen in today's world.
109
Mr. McCatidless. Thank you.
In the chemical field, Mr. Parker, are we conducting anything in
the way of activities that would be synonymous with what we were
hearing about previously that had been done at urban, rural, or
suburban areas without the knowledge or consent of those who
were involved?
Mr. Parker. Absolutely not. Any form of testing, and we do con-
tinue to do development and evaluation of chemical and biological
defensive equipment, and I am speaking at the equipment level,
where our procedures are in line with what Dr. Osterman outlined.
When we do even physiological evaluation of, say, a protective
mask, we write a protocol, even though there is no chemical expo-
sure, because we are using human subjects, we write a protocol,
have an independent review panel that is independent of the pri-
mary researchers, subject to review by the Surgeon (Jeneral, the IG
of the Army, and recently the GAO visit us to review what we do
along these lines.
I might note that the GAO had no findings or recommendations,
and the exit interview indicated we were in full compliance with
the most recent 1991 guidance out of HHS.
In the area of any kind of open air testing, most of that would
be done at Dugway Proving Ground. There is a full environmental
disclosure of all activities at Dugway Proving Ground. There is a
citizens advisory board appointed by the Governor of Utah that
oversees all of the activities, and prior to any kind of testing there
is separate environmental documentation prepared and published
in the local newspapers, and a response period for any concerned
citizen to comment.
So that there is a fiill disclosure and a full and aggressive effort
to make sure everybody who is potentially impacted is informed.
Mr. McCandless. Ms. Fites and Dr. Soper, would you agree with
those comments firom your point of view in your area of responsibil-
ity?
Dr. Soper. From my area of responsibility, I agree with those
comments.
Ms. Fites. Absolutely.
Mr. McCandless. Thank you. Again, I will be submitting ques-
tions, with your approval, Mr. Chairman, more of a technical na-
ture.
Thank you.
Mr. CoNYERS. Lady and gentlemen, the difficulty that we have
is this. We have statements that came in from you, starting from
2 days ago, with Dr. Osterman's, to Mr. Parker's, who came in this
morning. None of you have been interviewed by our staff, nor have
we had any opportunity for interchange before so I propose that
after we have had an appropriate time to analyze the materials you
submitted, we meet to discuss these matters — ^not a second hear-
ing, but a discussion that will be built upon the documents, the
statements, and the interchanges that we have had here today.
Would that meet with all of your agreement?
Dr. Soper. Of course.
Mr. Conyers. Thank you very much.
110
Mr. McCandless. If the chairman would yield, obviously these
documents which are their statements are a matter of public
record.
Mr, CONYERS. The next thing I would like to do is to ask each
of you outside of Dr. Soper to identify the chains of command under
which you operate.
Ms. FiTES. I work for the Under Secretary of Defense for Person-
nel and Readiness, Edwin Dom.
Mr. CoNYERS. And you say you work for him.
Ms. FiTES. Right.
Mr. CoNYERS. At what level?
Ms. FiTES. I am a Deputy Under Secretary,
Mr. CoNYERS, So you have a special assignment of duties that
are separate from his, since he is over that entire area?
Ms, FiTES, No, It is not separate, I perform the integrative func-
tion across the three assistant Secretaries that work for him: Force
Management Reserve Affairs, and Health Affairs. I do the pro-
gramming, budgeting, and congressional testimony integration, and
I do any of the projects that are too hard, like support to the Olym-
pics, like these drug-testing programs when they came up.
I worked on Persian Guli mystery illness for a while. So I am
kind of a Jack-of-all-trades.
Mr, CoNYERS. Thank you very much,
Mr, Parker, where does your responsibilities fit in?
Mr, Parker. I am the Deputy to the Commander of the Chemical
and Biological Defense Command, an element of the Army Material
Command, The Army Material Command answers to the Secretary
and the Chief of Staff of the Army,
Mr, CoNYERS. And what is the name of your immediate superior?
Mr, Parker, My immediate boss is Maj. Gren, George Freely.
Mr, CoNYERS, Dr. Osterman.
Dr. Osterman. Yes, sir. I am the Director of Environmental and
Life Sciences, In the latter capacity of life sciences, I have respon-
sibility for both human use and animal use experimentation within
the Department of Defense. I report to Dr, Anita Jones, the Direc-
tor of Defense Research and Engineering, who in turn reports to
the Under Secretary of Defense for Acquisition and Technology,
Mr, CoNYERS, Thank you. Thank you all very much.
The final thing I wanted to find out is if anyone has anjrthing
to add on the most recent information about the Air Force spon-
sored LSD tests at several universities. Do any of you have any in-
formation on that at this point? If you would include that some-
where in your response for the record, because that information
was just made known to us today, and we would like to get a little
bit more on it.
Mr. Parker. Yes, Mr. Conyers, we will take that for the record
to try to get some amplification.
[The information follows:]
Ill
INSERT FOR THE RECORD
Houn
AFfMcmiATioiw eoMNimi
miJuM luti
6 Oct 94
■mfosfmrssnts:
AHiMD tEHVICn COMMTnt
UHnrar
2435
IMIKTMA.
2»*8
Mouir
OTHmQo„,ltt«« on
vnuMttt OpTatlong
is:
HuBCn Uia Ejcp During Cold H«r Era
Undasiified (The information fbllowt:)
From the late 19S05 to the e»rly 1970s . the Air
Force contracted five studies at civilian univenitiei that involved
lyMtgic add diethylamide (LSO). Thoewere: 'Investigation of
the ESectJ and Mode of Action of the Psycho-chemicalt' on
Human State of Conaciouaneu" conducted by Baylor Univenity
Mental Center between April 19S6 and April 1961;
'Psychophysiologicaf Correlatet of Human lofbrmation Processing"
coiiducted by Houston State Psychiatric Institute (Baylor
Utiivetiity CoU^ of Medicine) between July 1964 and July 1968;
"Psydiophysiological Medianisou of Stress Responsivity"
conducted by Duke University Medial Center between April 1958
and July 1966; 'Chemical Chaises in Leatnii^' conducted by the
Utdveraity of Minnesota between October 1964 and September
1969; and 'Aerospace Streu and Human Rdiability' conducted by
theUniversityofMissouribetweenJuly 1969andMay 1971. The
actual reports may be obtained directly from the Air Force OfGce of
Scientific Research (AFOSR), Boiling AFB. DC 29332.
112
Mr. CONYERS. I thank you very much for your cooperation. Any
further statements we need to discuss this afternoon?
Dr. SOPER. No. We are looking forward to following up our writ-
ten testimonies and discussions with vou and your staff.
Mr. CoNYERS. Thank you very mucn.
I would like to now call the director for the Center for the Study
of Society and Medicine, the professor of political science at Rut-
gers University, the professor of history of medicine and preventive
medicine and family medicine. University of Wisconsin, and the
senior associate of the Office of Technology and Assessment — Drs.
David Rothman, Leonard Cole, Vanessa Gamble, and Robyn
Nishimi.
We want to thank all of you for your patience. We have your
statements and they will be included in their entirety in the record.
We would invite your discussion, which we hope will include any
comments about anything that may have come to your attention
during the course of these hearings this morning.
I want to thank you very much for your helpfulness. Unlike some
hearings where the last witnesses are something that was tagged
on at the end, in this instance the last witnesses are very, very
seminal to the work that we are trying to accomplish. So I want
you to know we will be carefully listening to the comments that
you give this committee. I thank you again for your cooperation.
Dr. Rothman, would you please begin.
STATEMENT OF DAVID J. ROTHMAN, Ph.D^ DIRECTOR, CEN-
TER FOR THE STUDY OF SOCIETY AND MEDICINE, COIXEGE
OF PHYSICIANS AND SURGEONS, COLUMBIA UNIVERSITY
Dr. Rothman. First, Mr. Chairman, let me just thank you for the
opportimity to appear before you.
Even before I came down this morning, I was well aware of the
work that the committee had begun in this area, and I must sav,
listening this morning, having the chance to speak with you briefly
before me session, I am just delighted and enthusiastic about your
readiness to take on these issues. They are very, very important.
I will try to make a couple of brief pomts from my testimony. But
your readiness to take on these issues strikes me as absolutely ex-
emplary.
The first point that my testimony covers, and I can do it quite
briefly, is to try to respond to probaoly what is the most frequently
heard line of defense that is often made toward the materials that
we have been dealing with today, and that is that whatever went
wrong in terms of consent or whatever went amiss in terms of vio-
lations of citizens' rights during the 1940's, 1950's and 1960's, real-
ly reflects upon the fact that the standards of consent that we
would apply now were not viable and were not being recognized in
that earlier period.
Those who take this argument forward would make it seem as
though consent was an absolutely new kind of idea born in the
1980 s and really had no impact on the earlier period, and we
should not hold up investigators of the earlier period to that stand-
ard.
I myself think that that position is altogether incorrect, that the
standards of consent in human experimentation had been very well
113
established, and my testimony, as submitted to you in writing, will
take you through some 12 pages, briefly and succinctly presented.
With time and more space, I could go on at much greater length.
So that if at some point as your own work continues you come
up against this notion that we are kind of plajdng Monday morning
quarterback, at least from my perspective, rest assured that that
is not the case, and that the standards were well entrenched and
violated often, yes, but not because the standards themselves were
not particularly clear.
I don't want to go on at length about it, just a couple of little cap-
sule quotes. I can take you back to 1865, the very famous French
physiologist, Claude Bernard. "It is immoral to make an experi-
ment on man when it is dangerous to him, even though the result
may be useful to others."
Andrew Ivy, bringing it into the United States, coming off the
Nuremberg trials. This being written in 1948. "It is a matter of
common understanding that an individual may consent to undergo
medical or surgical treatment or other experiments for the good of
his own body, but you must have the consent of the human subject.
All subjects have been volunteers in the absence of any coercion.
Before volunteering, the subjects have been informed of the haz-
ards, if any, of the experiment."
And the material you are uncovering from the 1950's and 1960's
I think, in a very obvious way, violates those standards.
If you went through the scholarly literature, you would find it
again and again, basic ethical principles for the conduct of human
experimentation, written by the dean of Western Missouri Medical
School in 1950; "The voluntary consent of the human subject must
be obtained. The human subject should be at liberty to terminate
the experiment at any time."
Again, I don't want to keep repeating them. The record is clear,
and I think should be fully understood. Indeed, you can find such
statements as well from within the Armed Forces, memorandums
by Secretary of Defense Wilson, in 1953, making the same points
again.
"The voluntary consent of the human subject is absolutely essen-
tial. This means that the person involved snould have legal capac-
ity to give consent, should be so situated as to be able to exercise
free power of choice, should be able in this sense to be able to make
an understanding and enlightened decision."
The research you heard about this morning violates all of these
dictums and I think your sense that something was amiss and it
was not in the existence of the standard, is most important.
If the ethics of experimentation were so clearly established, why
did American investigators so frequently violate them? Well, I
think the essence of the answer is the war effort, first in 1940 to
1945, then the cold war effort after 1945, fostered what we might
call highly utilitarian judgments.
Investigators made the calculus that the national interest out-
weighed individual rights, that the exigencies of the cold war justi-
fied violations of known ethical practices. For the sake of national
security, investigators wanted to know more about the effects of
mind-altering drugs or the ways that biological material is spread
114
through the atmosphere, whether they were through airports or
through cities.
These investigators Hke so many others might well have mini-
mized the risks of the procedures they carried out. It is not at all
unusual for investigators to maximize the potential benefits of pro-
posed research even as they underestimate the dangers involved.
But again, the self-serving quality of the calculus reflected a be-
lief in the importance of the research in the national interest and
allowed them, I believe, to ignore the existing precepts.
It is only by appreciating this mind set that we can understand
how the distinction between medical experimentation for thera-
peutic purposes became indistinguishable from experiments with
no therapeutic benefited to the subjects themselves, and then slid
over into what was essentially weapons research.
What the American record demonstrates over the period from the
early 1940's through the 1960's is a steady progression from war-
time research into such disease as malaria and dysentery, using
backward, mentally disabled patients for subjects, to mind-altering
drugs on unknowing soldiers, to weapons testing, releasing various
compounds and bacteria into the atmosphere, into public gathering
places, and into public transportation systems.
Indeed, the goal of this research apparently was not only defen-
sive, how to protect against an enemv agent performing this kind
of activity, but offensive, how could the knowledge gained through
this weapons research enable the United States to use these tech-
niques in foreign countries.
The historical record, I think, does have immediate relevance to
what the committee ought to be looking at in terms of where we
go from here. First, I think it is absolutely essential that the full
public record on human experimentation be fully known.
I am pleased, as I know that you are, that radiation has become
the focus of investigation. But I think that the other activities that
went on within the CIA, within the Defense Department, within all
aspects of government, must be explored.
In no other ways can victims be identified and appropriately
compensated. But even more than that, in no other ways will I
think we understand how to adopt fully corrective measures.
I was most impressed this morning with the questioning that
went on about the chain of command. Who was it that allowed or
finally passed off on the experiment? How did it work its way
through? Was it simply, well, that is a fine idea, let's ^o out and
do it/ Was there anything approximate meriting chain of com-
mand? Was there anything approximating signoff?
We do not know the answers to those questions. And if we are
going to set up various kinds of corrective measures, I think that
knowledge is absolutely essential.
Second, I think the committee must spend time thinking, revis-
ing, and strengthening the system of research oversight focusing on
the institutional review board. We just heard read to us what are
essentially the regulations of the IRB that the Defense Department
signed onto later, after the IRBs, I believe, were already in exist-
ence elsewhere.
But to read us the regs is not to tell us how they are functioning.
We need to know who is sitting on those IRBs in defense, what is
115
the nature of outside review, who is auditing the auditors. And to
simply come before us and read the regulations I think does not
take us far enough into the dynamics of tne process.
It may well be. I have no way of knowing that Defense Depart-
ment IF^s at this moment are functioning very well. I can only tell
you that the Office of Protection from Research Risks is very
understaffed — ^maybe one, two full-time employees able to check
into the composition of the IRBs. In essence, the reg^ are very clear
but we know have you little about how these regs are actually
being carried out.
There are certainly difficulties and problems, they occur in the
press periodically with university based IRBs. What is going on in
the intercity cease of various agencies of the Federal &3vemment
I think is even more shrouded.
And so to accept a reading of the regs is fine, but I think we are
duty bound to try to find out much more about the actual imple-
mentation of these regs. And my suspicion at the moment is that
we may well find shortfalls in amninistration.
Are we recapitulating the 1950's? I would certainly hope not. But
the exposes of the 1950's I believe should become the occasion for
us to make certain administratively and in terms of oversight that
those kinds of experiments could not be repeated.
I think medical investigators cannot be allowed to select at will
those who will be martyrs for mankind in terms of conquering dis-
ease. And I think weapons researchers cannot be allowed to select
those who will be martyrs to a sense of national interest or patriot-
ism.
In the end, as the Nuremberg Code makes clear, the ethics of
human experimentation cannot be violated because of a State's
readiness to advance its own military capability.
Thank you.
[The prepared statement of Dr. Rothman follows:]
116
College of Physicians & Surgeons of Columbia University | t^ew York, NY. 10032
0«<4TBB POn THB STUOY *"D ^'>*« '•*" •»»«
O*: SOOSTV * MBOfClNE "*'= Bia 30S-41W
FAX: enX 3(»-«4ie
Taatinksny be£or« Th« Legislatloii and Hational Security
Suboonmltt** e£ th* Coamitta* on Sovaramant Operatlana
Saptaabax 28, 1994 at lOiOO am
David J. Rottamaa. Pb.Q.
Baznazd Sohoanbarg Profaaaer of Social Madloina
Profaaaor of Biatory
Slraotor, Centar for tha Study of Society and Nedlolna
117
Although the r«c«nt disclosures of th« practices of the
Anerlcan medical research coranunity over the 1950s and
'60s have brought to light new eyamplcs of hxinan research performed
without patient consent, the additional information does not alter
the essential ethical context in which these practices should be
understood. Over this period, the ethical principle that
experinentation should not be conducted without the explicit and
Informed consent of the subject was well established; the fact that
the principle was frequently violated (perhaps even more frequently
than has been recognized before 1993} reflects not on the weakness
of the principles but on the readiness of investigators to violate
them. The idea that the "standard of the tines was different" is
not correct. The ethical precepts were cleeurly formulated and well
understood. Vfhat is now the more clearly established is that
investigators transgressed the standards not out of ignorance but
out of a commitment to advancing scientific knowledge and Cold War
strategies. In effect, they were prepared to transgress the
principles to serve these other ends.
Given the frequency with which it is claimed that notions of
informed consent aire a 1970s creation, it is worthwhile to review,
however briefly, the abundance of evidence that suggests a much
earlier recognition and appreciation of the doctrine.
It is not inappropriate to begin with Hippocrates, for the
precept that the physician must first do no harm to the patient
remains a bedrock principle of medicine and is the correct starting
point for an ethical analysis of human experimentation. The
administration of experimental mind-altering drugs and psychiatric
118
2
procedures in th« 1950a (such as "psychic driving") clearly
transgressed this ethic. But beyond the general maxims of
Hippocrates, there is an abundant and much more specific literature
that addresses experimentation directly. And in tone and substance
it makes evident that whatever the practice in post -World War Two
research laboratories, the ethical imperative to inform the human
subject and obtain his or her consent was indisputable.
Perhaps the most explicit l9th century statement of the ethio
was provided by the French physician and investigator, Claude
Bernard, in his famous 1865 treatise, An Introduction to the Study
of Experimental Medicine. Bernard declared:
The principle of medical and surgical morality,
therefore, consists in never performing on man an
experiment which might be harmful to him to any
extent, even though the result might be highly
advantageous to science, i.e., to the health of
others.... If it is Immoral, then, to make an
experiment on man when it is dangerous to him, even
though the result may be useful to others . . .
Bernard's views on experimentation were derived from the work of
still others. Thomas Percival, for example, in his widely read
early 19th Century treatise on medical ethics declared: "Every rash
experiment ... is in the eye of conscience, a crime both against
God and mem" (CD. Leake (ed.), Percival 'a Medical Ethics. 132,
Willieuns & wilkie Co., Baltimore: 1927). And one could also add to
this roster the practices of such physicians as William Beaumont,
119
3
Ubo dr«w up a formal agreement with his subject bsfore carrying out
his research with him.
There can be no disagreement, Z believe, about the fact that
by the 1950s, the voluntary consent requirement was a well-
established medico-legal obligation of physicians. Again, a nunber
of examples establish the point. As stated by Hubert W. smith of
the Harvard Lav and Medical Schools in 1942, ethical and legal
principles required "full disclosure of material facts" and the
securing of the "enlightened consent" of the human subject:
Here the patient is made an involuntary and
unwitting guinea pig for some new -and experimental
treatment not yet recognized by the profession as
proven for general use . . . subjecting a patient to
experimental remedies without disclosure and consent
is contrary to the customs of surgeons and thus
negligent. . . . The surgeon should make a full
disclosure of material facts to the patient,
including risks and alternative treatments, and
obtain his enlightened consent before applying any
novel or experimental treatment.... (Antecedent
Grounds off Liability in the Practice of suraerv. 14
Rocky Ht. L. Rev. 233, 263-65.)
These positions were formally enunciated in medical codes. In
1946, for example, the Judicial Council of the American Kedical
Association adopted the following ethical code recognizing the
voluntary consent requirement in research:
120
4
In order to oonforn to the •thics of the Aaerloan
Medical ABBoclation, thre* requlrcmttnts must be
■atisfled: (1) the voluntary consent of the person
on whom the experiment is to be performed; (2) the
danger of each experiment must be previously
Investigated by animal experimentation, and (3) the
experiment must be performed under proper medical
protection and management. [132 AHA Jour. 1090,
December 26, 1946].
Indeed, were the principles of consent not well embedded in an
ethic of human experimentation, the code set for-Ui at Nuremberg
would be little more than an ex post facte condemnation of Nazi
doctors. Whan the world learned of the experimental atrocities
that they had committed during World War il, the legal and medical
comnunitlee joined to seek justice at the Nuremberg war Crimea
Trials on the basis of the fact that a requirement for voluntary
consent existed In an uncodified form by the medical consnunlty long
before the Nuremberg trials.
Although the Nuremberg Code was not cited with great frequency
in the American medical literature before the mid-1960s, there can
be no doubt that the substantive requirements of the Code were
themselves well luiown. By the late 1940s and early 1950s, the
ethical standards stated in the Nuremberg Code, including the
voluntary consent requirement, were the principles applicable to
medical experimentation. This was the view expressed by Dr. Andrew
121
5
C. Ivy, vhoea teatinony had been pivotal at th* Nuraabarg aedioal
trials:
It is a natter of connon understanding that an
individual may consent to undergo medical or
surgical treatment, or other experimentation, for
the good of his ovn body .... [medical experiments]
have bean conducted according to certain ethical
principles in all countries of the world which
have contributed to the prevention, cure, and
control of disease and suffering. These principles,
which have been in force by connon understanding and
practice, nay be sunmarized as follows: (I) Consent
of the human subject has been obtained. All
subjects have been volunteers in the absence of any
coercion in any form. Before volunteering, the
subjects have been informed of the hazards, if any.
fThe hiatorv and ethics of the Use of Human Subject
in Medical Exparimsnts. 108 Science 3-4, July 2, 1948].
Moreover, the Nuremberg principles were overtly recognized by
a special advisory oonmittee appointed by Illinois Governor Dwight
H. Green in its 1948 report published in the AMA Journal:
The ethical prinoiplas most pertinent to the present
consideration are (1) that all subjects should be
volunteers in the absence of coercion in any form;
(2) before volunteering, thay be adequately informed
of the hazards, if any, and (3) that the choice of
122
6
volunt*«r8 be made on the basis of dstablishcd
criteria. fghhic« Qovernina tha Sarvica of PriaonTB
a« subHapl^a in Madical Exparimenta; RaPOrt
of the ConinHttea Appolntad bv Govarnor Dwjqht H.
Green. 136 AMA Jour. *57 , 458]
Tha athioal raquiraments for obtaining consent prior to
exparinantation were also widely racognizad in scholarly
publications. For example, Louis John Reagan, in the 1949 edition
of Doel:or and Pat i ant and tha Law, enphaeized the obligation of a
physician to obtain a signed consent before initiating experimental
procedures (at 398):
The physician must keep abreast of medical progress,
but he is responeible if he goes beyond the usxial
and standard procedures to the point of
experimentation. If such treatment is considered
indicated, it should not be undertaken »intil
consultation has been had and until the patient has
signed a paper acknowledging and assuming the risk.
And more detailed requirements for tha provision of information to
patients were also announced in professional journals during the
early 1950s. Carl J. Wiggers, Dean of Western Reserve Medical
School, published the following Basic Ethical Principles for the
Conduct of Human Experimentation in 1950:
The voluntary consent of the human subject must be
obtained All unnecessary physical and mental
suffering should be avoided. . . . The human subject
123
7
should b« at liberty to teminate the expftriment at
any ^Ina. [1950 Aliumi Bullotln, School of Madloine,
Hestarn Reaarve University, 60-65, quoted, in
Beecher, R^aarch and the Individual; HVHian ftU^ll^i.
238-39]
Were all this not persuasive enough, the need for obtaining
oonaent was also discussed at professional nedioal associations ,
during the aarly 1950s. Thus, in his Hovwnber 1951 presidential
address to the Central Society for Clinical Research in Chicago,
HilliaB Bennett Bean wam«d that "[in] clinical research we must do
•xpariaenrts on our fellow nan, but they are justifiable only with
freely granted permission, and we must forego them when they
conflict with the interests and rights of our patients" (39 Jotir.
Lab. & Clin. iced. 3, 9, January 1952)
The AHA itself frequently and explicitly brought these points
to the attention of physicians. In 1957, it warned phyBiclans of
their responsibility to "be certain, too, that the patient
understands fully the content of the written consent he is signing"
and stated that if "the patient is being asked to take a calculated
risk In suboiitting to a recommended procedure, the patient is
entitled to know irtiat those risks are so that he will be able to
form an intelligent judgement about the matter." Indeed, it
elaborated on the consent and responsible experimentation
requirements, stating unequivocally: "In the treatment of a
patient, experimentation should be done only with the knowledge and
consent of the patient or those responsible for him, and then only
124
8
If the traatnent doea not vary too radically Crom the accepted
method of practice" (J. Sadusk, AHA Law Department, "Hazardous
Fields of Medicine In Relation to Professional Liability," 163 AMA
Jour. 953, 956 (March 16, 1957)). Its Law Department advised
physicians of their responsibility to obtain informed consents for
experimental procedures in no less certain terms. (AMA Law
Department, "Consent to Operations and other Procedures," 165 AMA
Jour. 65 (Sept. 7, 1957)). Treatment involving an element of
experimentation may properly be administered only with the full
knowledge and consent of the patient or those legally responsible
for hin, and then only if the treatment does not vary too radically
from the accepted methods of medical practice."
The AMA Judicial Council in 1957 set forth these principles to
cover all new drugs or procedures:
In order to conform to the Principles of Medical
Ethics of the American Medical Association, three
requirements must be satisfied:
(1) The voluntary consent of the person on whom the
experiment is to be performed must be obtained;
(2) The danger of each experiment must have been
investigated previously by means of animal
experimentation; and
(3) The experiment must be performed under proper
medical protection and management. [AMA Jour. (March
30, 1957)].
125
9
Critical evidence of the recognition of the importance of
consent is also apparent in the 1953 Memorandum by the Secreteury of
Defense Wilson to the Secretaries of the Army, Navy and Air Force
Regarding Use of Human Volunteers in Experimental Reseeurch. As
suonarized by the Inspector General of the Department of the Amy,
in a March 1976 Report on the Use of Volunteers in Chemical Aaent
Research (33, 61) :
The matter of the use of human volunteers was under
deliberate consideration by the Armed Forces Medical
Policy Council during the first two years of the
1950a. In the fall of 1952, following extensive
study, the Council reported to the Secretary of
Defense that researchers had reached the point
beyond which essential data could not be obtained
unless human volunteers ware utilized. Thus, they
recommended that the Kuremberg Code of 1947 be cited
as the principal guidance to the services.
[T]he Armed Forces Medical Policy Council
established the rules of the Kuremberg Code as an
essential part of future medical research involving
the use of human subjects when in 1952 they
recommended that the Secretary of Defense permit the
use of humans in medical research.
Based thus expressly on the Nuremberg Code, the 1953 Wilson
Memorandum provided:
126
10
Th« voluntary consent of the human subject is
absolutely essential.... This means that the person
involved should have legal capacity to give consent;
should be so situated as to be able to exercise free
power of choice, without the intervention of any
element of force, fraud, deceit, duress, over-
reaching, or other ulterior form of constraint
or coercion; and should have sufficient knowledge and
comprehension of the elements of the subject natter
involved as to enable him to make an understanding
and enlightened decision. This latter element
requires that before the acceptance of an
affirmative decision by the experimental sxibject
there should be made known to him the nature,
duration, and purpose of the experiment; the method
and means by which it is to be conducted; all
inconveniences and hazards reasonable to be
expected; and the effects upon his health or person
which may possibly come from his participation in
the experiment.
The Wilson Memorandum was supplemented by Chief of staff
Memorandum 385, Use of Volunteers in Research, issued on June 30
1953, and Principles. Policies and Rules of the Office of the
Surgeon General governing Dae of Human Volunteers in Medical
Research issued in March 1954. All of these U.S. Government policy
statements provided that the human subject "should have sufficient
127
11
knowledge and comprehension of the alcnents of the subject matter
involved as to enable him to make an understanding and enlightened
decision" (fififi 1976 Army I.G. Rep. 82). Together, these official
policy statements confirm that the "absolute essentiality of
voluntary consent has been the stated policy of the Department of
Defense and the Department of the Army since the inception of
authority to conduct experimental research with human subjects"
(id. at 77).
The acceptance by the United States Government of the
principles of responsible medical experimentation and Informed
consent codified at Nuremberg is confirmed by the adoption in 1958
of a Covenant on Civil and Political Rights by the Third Committee
of the General Assembly of the United Nations, which included both
Canada and the United States. That Covenant provided:
No one shall be subjected to tortvire or to cruel,
inh\iman or degrading treatnent or punishment. In
particular, no one shall be subjected without his
free consent to medical or scientific
experimentation. [See Beecher Research and the
Individual: Human Studies. 247-51].
Finally, there was a recognized obligation on the part of
entities financing, sponsoring or conducting medical
experimentation to adopt ethical standards on human research,
particularly the informed consent requirement; and to make inquiry
and to ascertain the competence and prudence in dealing with
research subjects of those conducting medical experiments on their
128
12
behalf. Theaa obligations Clow«d from the language of the
Nuremberg Code:
The duty and responsibility for ascertaining the
quality of the consent rests upon each individual
who initiates, directs, or engages in the
e^cperinent. It is a personal duty and
responsibility which nay not be delegated to another
with impunity.
If the ethics of experimentation were so clearly established,
why did American Investigators so frequently transgress them? For
one, the war effort, first in 1940-1945, and then in the Cold War
era after 1948, fostered utilitarizm judgments. Investigators made
the calculus that the national interest outweighed individual
rights, that the exigencies of the Cold War justified violations of
standard ethical practices. For the sake of national security,
investigators had to know more about the effects of mind-altering
drugs or the ways that biological materials spread through the
atmosphere or through airports, or through cities. These
investigators, like so many others, may well have minimized the
risks of the procedures that they carried out; it is not unusual
for investigators to maximize the potential benefits of proposed
research even as they underestimate the dangers involved. But
again, the self-serving quality of the calculus reflected a belief
in the importance of the research to the national interest.
129
13
It is only by appreciating this mind-set that we can
understand how the distinction between medical experimentation for
'therapeutic purposes became indistinguishable from experiments with
no therapeutic benefit to the subjects and then, most notably, with
what was essentially weapons research. What the American record
demonstrates over the period from the early 1940s through the 1960s
Is a steady progression from wartime research (1942-44) into cures
for such militarily important diseases as malaria and dysentery
(using backward mentally disabled patients for subjects) , to
"testing mind-altering drugs on unknowing soldiers, to weapons
"testing, by releasing various compounds and bacteria into the
atmosphere, into public gathering places, and into public
transportation syeteme. Indeed, the goal of this research
apparently was not only defensive (how to protect against an enemy
agent performing this kind of activity) but offensive: how could
the knowledge gained through this weapons research enable the
United States to use these techniques on foreign countries.
The lessons that ought to be drawn from this record include:
First, to make certain that the public record on human
experimentation is fully known. The focus on radiation is
certainly important but it should not be an exclusive focus. It is
vital that the activities of other Departments over the period
1945-1970 be fully explored. In no other ways can victims be
identified and appropriately compensated. In no other way, can the
lessons to be learned be altogher understood and necessary
corrective measures adopted.
130
14
Second, to explore the best methods for revising and
strengthening the syatema of oversight of research, focusing on the
Institutional Review Board. This need is clear for IRBs in
university and commerlcal settings; it is even uore important that
the IRB operation within govenunental agencies be overhauled. The
scrutiny over government departmental research must be increased so
that ethical norms do not fall victim to utilitarian calculations.
Just as medical investigators cannot be allowed to select at will
those who will be martyrs to mankind, weapons researchers cannot be
allowed to select those who will be martyrs to a sense of national
interest or patriotism. In the end, as the Nuremberg Code maJces
clear, the ethics of human experimentation cannot be violated
because of a state's readiness to advance its own military
capability.
131
Mr. CoNYERS. Thank you very much.
I must say that for a person who has written so extensively on
these and other related subject matters, your comments were very
lucid and really quite brief. I believe you when you said you could
have gone on and on, because in looking at one of your books, I
know you are an author of at least a half dozen more. We welcome
your collaboration in this operation, £ind I know that all the panel-
ists regard this as a beginning.
This is not a one-time flashy hearing to titillate the American
people, and off to the next whatever it is next week. This is going
to take a long time. We are going to need to marshal the services
of many like yourselves here today as we begin what could be one
of the most important inquiries into the kind of activity and con-
duct that so appalls the Nation. So I am grateful to you for your
testimony.
I am now pleased to recognize Dr. Leonard Cole from Rutgers,
who himself has written extensively, particularly one book, "Clouds
of Secrecy: The Army's Germ Warfare Experiments Over Populated
Areas." That makes you very key to share your views with us this
afternoon. Welcome to the committee.
STATEMENT OF LEONARD A. COLE, Ph.D., PROFESSOR OF
POLITICAL SCIENCE, RUTGERS UNIVERSITY
Dr. Cole. Thank you, Congressman Conyers.
May I say that I think you capsulized in one sentence earlier on
what I think is the essence of what we are after today: The rela-
tionship of an individual to his or her government and the govern-
ment's relationship to that person, and the responsibilities we have
to each other. I thank you for that summary, too.
Well, as you suggested, my expertise is in the area of the open
air biological warfare testing program during the 1950's and 1960's,
although I am in the middle of another enterprise now that goes
beyond that. I am looking at the general question of biological
weapons defense and how we might as a Nation benefit and as a
world benefit from avoiding the use of these weapons ever.
The Army began a program in 1949, as you heard, to assess the
Nation's vulnerability to attack with biological and chemical weap-
ons. During the next 20 years, biological and chemical agents were
released over hundreds of populated areas around the coimtry. And
some of the areas that were mentioned earlier, and beyond, in-
cluded Hawaii, Alaska, San Francisco, St. Louis, Minneapolis,
many, many other cities.
And some tests, as you heard as well, were narrowly focused, as
when bacteria were released in the New York City subway system
and in Washington National Airport, and in the Greyhound termi-
nal in Washington in the early 1950's. The purpose of these tests
was to see how bacteria spread and survived as people went about
their normal activities.
The Pentagon always maintained that the bacteria and chemicals
used in these tests were harmless. They were described as
simulants, intended to mimic more lethal bacteria and chemicals
that might be used in an actual warfare situation.
132
But, and this I emphasize, increases in infections among people
in some of the testing areas were reported as early as 1950, imme-
diately after the testing program began.
In September of that year, San Francisco was blanketed with
bacteria called Serratia marcescens. The bacteria were sprayed
from a boat offshore. Within days, patients at Stanford University
Hospital, then located in San Francisco, began to develop heart and
urinary tract infections caused by Serratia marcescens. One pa-
tient, Edward Nevin, died as a consequence.
When the Army learned about the epidemic of Serratia infec-
tions, it secretly convened a panel to assess the situation. Although
infections from these bacteria had never before been reported at
the hospital, and Stanford University Hospital is one of the pre-
eminent institutions in the world, the panel concluded that the re-
lationship between the test and infections appeared coincidental. It
recommended that the spraying of these bacteria be continued,
"even over populated areas when such studies are necessary for the
advancement of the biological warfare program."
Since the Army never monitored the health of the people exposed
during its experiments, no one knows how many may have suffered
illness or death as a result.
The public first became aware of the biological testing program
in late 1976. A newspaper story revealed that a few experiments
in cities had been conducted years earlier. But at Senate hearings
in 1977, Army witnesses aclmowledged that 239 tests over popu-
lated areas had been conducted between 1949 and 1969.
The breadth of the program to me seemed remarkable. And I
might say for a moment that while we are talking about thousands
and perhaps even hundreds of thousands of people who had been
affected by some of these other tests, particularly the radiology
tests or nuclear tests, when you discuss the biological test program,
we are dealing with millions of people who have been subjects.
Based on my own interest and intrigue with the situation, I
began to develop more information about it through interviews,
through previously classified reports, and from a legal suit against
the government by the family of Edward Nevin, the person who
had died after the 1950 San Francisco test.
The Nevin trial went to Federal court in 1981, 30 years to after
the fact, and one of the witnesses was retired Gen. William Creasy,
formerly the commander of the testing progn"am. His rationale for
testing in cities was that biological agents are, and I quote from his
testimony, "designed to work against people. You have to test them
in the kind of place where people live and work."
On the ethics of the program, he testified: "I would feel it com-
pletely impossible to conduct such a test trying to obtain informed
consent. I could only conduct such a test without informing the citi-
zens it was being conducted."
The general recognized that the citizens under some cir-
cumstances deserved the right of informed consent before being ex-
posed to these materials, although he was obviously willing to cir-
cumvent that understanding.
A document obtained this year through the Freedom of Informa-
tion Act confirms that the Army then was literally using the coun-
try as an experimental laboratory.
133
In 1957 and 1958, a cargo plane criss-crossed the country releas-
ing tons of zinc cadmium sulfide, the chemical you have heard re-
ferred to many times today.
Mr. CONYERS. You say tons.
Dr. Cole. Tons. During that period they would take 5,000
pounds of this material and over a long, slow flight, disperse the
material. In fact, again according to the Army summary of the ex-
periment, "the test area covered the United States from the Rock-
ies to the Atlantic, from Canada to the Gulf of Mexico."
And I think you mentioned. Congressman Conyers, in your open-
ing remarks, that there was a path that was described in the re-
port that ran from Detroit to Springfield, Illinois, then west to
Groodland, Kansas.
Millions and millions of Americans were unwittingly exposed to
the chemical during this series of tests. Unnoted in the Army docu-
ment is the fact that the chemical, especially the cadmium compo-
nent, is toxic and a potential carcinogen. We have heard that dis-
cussed a good deal today.
This I think is important for the record as well. As far back as
1932, a scientific study concluded that
Mr. Conyers. Excuse me, Dr. Cole. But didn't Mr. Parker dis-
pute whether it was toxic or not?
Dr. Cole. Well, I heard him dispute it. I would say that, first,
if I may give this quotation to you from this 1932 study, then I
would make a comment on his remarks.
The comment — this statement that I shall read to you, which is
a quote from a report in the Journal of Industrial Hygiene, May
1932, was based on studies of cadmiumsulfide, part of the ingredi-
ent of the zinc cadmium sulfide composition, which led the sci-
entists doing the work on animals to conclude that "cadmium, no
matter how small the amount taken into the lungs, causes
pathologic changes, and that there is, therefore, no permissible
amount of cadmium."
I have looked at the scientific literature, not all of it, but a good
deal of it having to do with cadmium toxicity, and I can assure you
there is a mixed review about this. It is true that some would sug-
gest that at very, very low concentration, cadmium might not offer
the toxicity that is suggested by this earlier report. But it seems
to me that when you are going to be spreading that material
around millions of people, it would be prudent to err on the side
of caution. One should anticipate the worst possibilities rather than
hope that only the best of the findings might be seen.
Although experiments in heavily populated areas presumably are
no longer taking place, as you have heard this morning, unhappy
consequences of the earlier program persist. Just this year, just a
few months ago, Minneapolis residents ieamed about tests with
zinc cadmium sulfide in their city during 1953. Again, you have
heard about several former students in an elementaiy school tar-
geted during that period who believe they have suffered health
problems as a result.
I understand, as you have heard this morning, that Congressman
Martin Sabo and Senator Paul Wellstone have introduced provi-
sions in the 1995 defense appropriations bill for a study of the
134
health effects of that test. I think that is an absolutely welcome
and desirable result of their efforts.
Biological warfare testing has caused anguish to many citizens
who are put at risk and to their families, and of course you heard
not just about biological testing but several resulting heart-rending
stones. There was a ripple effect, that it is not just the individual
who happens to be in the exposed area or who has been victimized
individually in one of these tests, but the effects on certainly sev-
eral people in the family and perhaps dozens when you count the
extended family and friends who are victims in their own way.
This hearing is in my judgment a very valuable step toward ad-
dressing the question not only of the health effects on these indi-
viduals. Another very important ingredient which has not been
touched upon very much today is the terrible legacy of distrust in
government that these kinds of tests have caused.
While this hearing cannot undo injuries that people may have
suffered, I think bv seeking full disclosure it should help the ag-
grieved parties in their quest for information and for justice. Equal-
ly important, informing the American public about these experi-
ments makes less likely the chance that such activities will take
place again.
And in conclusion I note the Army has not considered people in
testing areas, in these large-scale testing areas, to be research sub-
jects, and that therefore the requirement of informed consent does
not apply.
I suggest enactment of legislation to remedy this, that anyone in
a test area be treated as an experimental subject with the right to
informed consent. No one should ever have to worry while in a sub-
way, an air terminal, or a school that he or she might be an unwit-
ting target in a biological or chemical warfare test.
[The prepared statement of Dr. Cole follows:]
135
THE STATE UNIVERSfTY Of NEW JERSEY
RUTGERS
Campus at Newark
Faculty of Arts and Sciences • Department of Fblltical Science
University Heights • Hill Hall. 7tti Floor • Newark • New Jerse/ 07102 • USA. • 201/648-5105
Contact Address: 381 Crest Road
Ridgewood, NJ 07450
Phone: 201-427-2385
Fax: 201-652-4323
Testinony before the Legislation and National Security
Subcommittee of the Committee on Government Operations
U.S. House of Representatives, September 28, 1994
Biological Warfare Testing "Where People Live and Work"
Leonard A. Cole, Ph.D.
Thank you. Congressman Conyers, for inviting me to discuss
the army's biological warfare tests during the Cold War. While I
teach science emd public policy at Rutgers University in Newark,
I have a particular interest in the subject. As noted in your
letter of invitation, I am the author of Clouds of Secrecy: The
Army ' s Germ Warfare Tests over Populated Areas .
The army began a program in 1949 to assess the nation's
vulneredaility to attack with biological weapons. During the next
20 years, biological and chemical agents were released over
hundreds of populated areas around the country. Tests were
conducted in Hawaii and Alaska, San Francisco, St. Louis,
Minneapolis, and many other cities. Some tests were narrowly
focused, as when bacteria were released in the New York City
subway system and in Washington National Airport. The purpose
was to see how the bacteria spread and survived as people went
about normal activities.
The Pentagon maintained that the bacteria and chemicals used
in these tests were harmless. Described as simulants, they were
intended to mimic more lethal bacteria and chemicals that might
be used in actual warfare. Yet increases in infections among
people in some of the testing eureas were reported from the
outset. As early as 1950, there were indications that the
experiments might be causing harm. In September of that year,
San Francisco was blanketed with bacteria called Serratia
marcescens. The bacteria were sprayed from a boat offshore.
Within days, patients at Stanford University Hospital, then
136
located in San Francisco, began to develop heart and urinary-
tract infections caused by Serratia marcescens. One patient,
Edward Nevin, died as a consequence.
When the army learned ediout the epidemic of serratia
infections, it secretly convened a panel to assess the situation.
Although infections from these bacteria had never before been
reported at the hospital, the panel concluded that the
relationship between the test and the infections appeared
coincidental. It recommended that spraying of Serratia
marcescens be continued "even over populated eireas, when such
studies are necessary for the advancement of the biological
warfeire program." Since the tunny never monitored the health of
the people exposed during its experiments, no one knows how many
may have suffered illness or death as a result.
The public first became aware of the biological testing
program in late 1976. A newspaper story revealed that a few
experiments in cities had been conducted years eaurlier. At
Senate heiurings in 1977, army witnesses acknowledged that 239
tests over populated areas had been conducted between 1949 and
1969. The breadth of the progrcun seemed remarkable. I begem to
develop more information eibout it through interviews, previously
classified reports, fmd from a suit against the government by the
family of Edward Nevin.
The Nevin trial was held in 1981, and one of the witnesses
was retired General William Creasy, formerly the commander of the
testing progrtun. His rationale for testing in cities was that
biological agents are "designed to work against people. You have
to test them in the kind of place where people live euid work."
On the ethics of the program he testified: "I would feel it
completely impossible to conduct such a test trying to obtain
informed consent. I could only conduct such a test without
informing the citizens it was being conducted."
A document obtained this yeeu: through the Freedom of
Information Act confirms that the army was literally using the
country as an experimental laboratory. In 1957 euid 1958, a cargo
plane criss-crossed the country releasing tons of a chemical
called zinc cadmium sulfide. According to an army summary of the
experiment, "the test eurea covered the United States from the
Rockies to the Atlantic, from Cemada to the Gulf of Mexico." I
think. Congressman Conyers, you would be especially interested in
one of the flight paths, which ran "from Detroit to Springfield,
Illinois, then west to Goodlemd, Remsas."
Millions of Americans were unwittingly exposed to the
chemical during this series of tests. Unnoted in the amy
document is the fact that the chemical, especially the cadmium
component, is toxic and a potential carcinogen. As feu: back as
1932, a scientific study concluded that "cadmium, no matter how
137
small the amount taken into the lungs causes pathologic changes,
and that there is, therefore, no permissible eunount of cadmium"
(Leon Prodan, "Cadmium Poisoning," The Journal of Industrial
Hygiene . Vol. 14 [May 1932], 192).
Although experiments in heavily populated eureas presumably
are no longer taking place, unhappy consequences of the earlier
program persist. Just this year, Minneapolis residents leeirned
about tests with zinc cadmium sulfide in their city during the
1950s. Several former students of a targeted elementary school
believe they may have suffered health problems as a result. They
have identified hundreds of classmates who now are seeking
information about the risks posed by the tests. I understand
that Congressman Martin Sabo and Senator Paul Wellstone have
introduced provisions in the 1995 Department of Defense
appropriations bill for a health effects study of the test.
Biological warfare testing has caused anguish to many
citizens who were put at risk, and to their families. Beyond the
health risks, the tests have left a terrible legacy of distrust
in government. This hearing is, in my judgment, a valuaible step
toward addressing both matters. It cannot undo injuries that
people may have suffered, but by seeking full disclosure it
should help aggrieved parties in their quest for information and
justice. Equally i]iq>ortant, informing the American public about
these experiments makes less likely the chance that such
activities will take place again.
This concludes my prepared remarks, but I would be pleased
to answer any questions from the committee.
138
Mr. CoNYERS. Excellent suggestion. I appreciate very deeply your
testimony, and the career of work that has led to your being able
to come here and speak with such authority.
I note also that Ms. Elizabeth Barrett joined with you in finding
that there is the question of one's relationship with their govern-
ment, and that in terms of these secret experiments, the question
goes beyond merely the legal relationship of citizens to their coun-
try— it contributes to the cynicism that almost seems to be continu-
ing, even raging, in certain quarters of our country. It is very im-
portant that our work help turn this around rather than further
contribute to it by having a brief exposure to this problem, and
then we turn away to the next sensational item that will surely
soon come along. So I appreciate your observations in that respect.
Dr. Cole.
We are delighted now to call on Dr. Gamble of the University of
Wisconsin, who works in many areas, medicine, preventive medi-
cine, family medicine, and the history of medicine. We are pleased
you could join us today. Dr. Gamble. Welcome to our hearings.
STATEMENT OF VANESSA NORTHINGTON GAMBLE, MJ)., Ph.D.,
PROFESSOR OF THE HISTORY OF MEDICINE, PREVENTIVE
MEDICINE, AND FAMILY MEDICINE, UNIVERSITY OF WIS-
CONSIN SCHOOL OF MEDICINE
Dr. Gamble. Thank you thank you for inviting me. Chairman
Conyers.
I have been asked here to testify about the use of vulnerable pop-
ulations in cold war experiments. At the outset, I should state that
at present many of the specifics about the use of such populations
in the experiments cannot be answered because the necessary doc-
uments have only recently become declassified. Others remain clas-
sified and must be made available if the questions regarding the
nature of the government's activities in cold war era experimen-
tation are to be answered. So I would like to add my voice to the
voices of other people here today who have urged for the opening
of records.
The other thing that I would like to say at this point is that
there were a couple of comments made this morning that I think
need to be commented upon, and that is that there are some com-
plaints that this is going to take a page-by-page, box-by-box ap-
proach. It will. And that there are some of us who spend our lives
doing work and have the technical expertise of doing page-by-page
and Dox-by-box work. And so I want you not to be swayed by that
argument, that this is going to take a lot of work. It will.
My area of expertise is the historv of race in medicine, specifi-
cally African-Americans. Subsequently, most of my remarks will be
directed toward this group.
After the revelations of the radiation experiments came out, I
think a comment that a patient of mine said to me capsulized the
ideas of many African-Americans when he said, "If they were doing
all that to white folks, you can imagine what they were doing to
us."
In my comments in terms of African-Americans, I don't mean to
s^ that other groups have not been affected. But that focusing on
Amcan-Americans, we see how vulnerable populations have been
139
exploited. We also learn about the ramifications of government
policies and also the legacy of government policies.
With respect to human experimentation, vulnerable populations
are those who are more likely to be used as subjects of experimen-
tation because they belong to groups who are less valued and re-
spected by society, or those who may find themselves in situations
in which the voluntariness of their informed consent should be
questioned, or those who are unable or not given the chance to give
their informed consent.
Examples of vulnerable populations include members of racial
and ethnic minorities, the poor, prisoners, the mentally ill, and the
mentally retarded. However, they also include members of the mili-
tary who might cooperate with an experiment because they fear
they have no choice.
These populations require special scrutiny, and illustrate why
the concept of informed consent must not be examined in isolation,
but within a sociopolitical context.
I also would like to add mv voice to the call to examine the im-
plementation of IRBs and also look at — when we look at the in-
formed consent, what do we actually mean.
It is important to note that the designation of vulnerable popu-
lation, does not carry with it homogeneity. These are many dif-
ferent groups, and safeguards must be established that protect the
particular needs of each group.
Historians, as I said, have not yet had access to the documents
that will fully reveal the government's role in morally questionable
research. Even with the limited records that have been released
and analyzed so far, we already know that members of vulnerable
populations were often singled out. Two examples illustrate how
African-Americans, especially those who are poor and uneducated,
have been exploited.
I want to give a few remarks on the Tuskegee syphilis study,
even though this is not a cold war experiment, because you see a
pattern here. In the whole issue of the relationship of African-
Americans to the government, Tuskegee is often used. Let me brief-
ly talk about the study.
The study was conducted between 1932 and 1972 by the U.S.
Public Health Service to investigate the consequences of untreated
syphilis. The subjects of the investigation were 400 poor black
sharecroppers from Macon County, AL, with latent syphilis, and
200 men without the disease who served as controls.
As part of the project, however, government doctors deliberately
denied treatment to the men who had syphilis, and went to ex-
treme lengths to ensure that they would not receive any.
They also used incentives such as free meals, free burial insur-
ance, and free medical examinations to ensure the participation of
the men. Published medical reports have estimated that between
28 and 100 men died as a result of their syphilis.
I should state that despite historical evidence, many African-
Americans to this day believe that the men were injected with
syphilis, that it was a biological warfare experiment.
Another experiment, this one at the University of Cincinnati Col-
lege of Medicine further illustrates the abuse of vulnerable popu-
lations and government-sponsored research. From 1960 to 1972,
140
with funding from the Department of Defense and the Public
Health Service, investi^tors exposed 88 cancer patients to full and
whole body radiation. The patients, ranging in age from 9 to 84,
were poor. They were recipients of charity care at Cincinnati Gren-
eral Hospital. They were uneducated. They were predominantly
members of minority groups. Sixty percent of the patients were Af-
rican-Americans.
The patients were exposed to radiation, not for therapeutic pur-
poses. At the time, whole body radiation had been largely dis-
counted for all but a few cancers. They were exposed to radiation
for national security purposes.
The obiective of the experiment was to study the influence of
whole body radiations on the combat effectiveness of troops. For ex-
ample, they sought to ascertain, in the event of a nuclear explosion,
how much radiation a soldier could withstand before becoming dis-
abled.
Patients drafted in the study suffered from several side effects,
including nausea, vomiting, mental confusion, and abdominal pain.
It is not yet clear how many patients died as a result of their un-
derlying disease or as a direct result of their participation in the
experiment. There is no evidence that the investigators obtained
consent of the patients in the study.
Even if they had, the issue remains whether poor patients who
were receiving free care from the hospital thought that they had
any choice but to submit to the researchers' investigation, or
whether black patients, especially elderly ones, thought that they
could refuse a solicitation from a white researcher. Which brings
up the point that informed consent has to be looked at in terms of
social context.
The consequences of these experiments go beyond the unwitting
subjects and their families. They have contributed to a legacy of
distrust of many Americans, including African-Americans, toward
many institutions of our society, including the government and
medicine.
As a physician, I see this firsthand with respect to the attitudes
that African-Americans hold toward AIDS. Many believe that AIDS
resulted from government- sponsored biological warfare intended to
destroy gay and black populations.
Given the government's disregard for the lives of many of its citi-
zens as evidenced by the experiments that we have heard about
today, it is very difficult to dislodge such rumors and obtain Afri-
can-American participation in research trials and in HIV/AIDS pre-
vention programs.
As this committee proceeds with its investigation, it is impera-
tive that it concern itself with the members of vulnerable popu-
lations, who so very often do not have access to the resources that
allow their stories to be told.
Thank you very much.
[The prepared statement of Dr. Gamble follows:]
141
Testimony
Legislation and National Security Subcommittee
House of Representatives
Committee on Government Operations
28 September 1994
My name is Vanessa Northington Gamble. I am an associate
professor in the Departments of the History of Medicine and
Family Medicine at the University of Wisconsin School of
Medicine. I am trained both as a physician and as an historian
of medicine. My area of expertise is the history of race and
American medicine, specifically the experiences of African
Americans. Consequently, most of my remarks will be directed
toward this group. I have been asked here today to testify about
the use of vulunerable populations in Cold War experiments. At
the outset, I should state that at present many of the specifics
about the use of such populations in the experiments cannot be
answered because the necessary documents have only recently been
declassified. Others remain classifed and must be made available
if the questions regarding the nature of the government's
activities in Cold War era human experimentation are to be
answered .
With respect to human experimentation, vulnerable
populations are those who are more likely to be used as subjects
of experimentation because they belong to groups who are less
valued and respected by society or those who may find themselves
in situations in which the voluntariness of their informed
consent should be questioned or those who are unable to give
their informed consent. Examples of vulnerable populations
142
2
include members of racial and ethnic minorities, the poor,
prisoners, the mentally ill and the mentally retarded. However,
they also include members of the military who might cooperate
with an experiment because they fear for their jobs. It is
important to note that the designation, vulnerable population,
does not carry with it homogeneity. Safeguards must be
established that protect the particular needs of each group.
Historians have not y^t had access to the documents that
will fully reveal the government's role in morally questionable
research. Even with the limited records that have been released
and analyzed so far, we already know that members of vulnerable
populations were often singled out. Two examples illustrate how
African Americans, especially those who are poor and uneducated
have been exploited.
The foremost example is the Tuskegee Syphilis Study, the
study conducted between 1932 and 1972 by the United States Public
Health Service to investigate the consequences of untreated
syphilis. The subjects of the investigation were 400 poor black
sharecroppers from Macon County, Alabama with latent syphilis and
200 men without the disease who served as controls. As part of
the project, however, government doctors deliberately denied
treatment to the men who had syphilis and went to extreme lengths
to ensure that they would not receive any. They also used
incentives such as free meals, free medical examinations, and
burial insurance to ensure the participation of the men.
Published medical reports have estimated that between 28 and 100
143
3
men died as a result of their syphilis.
Another experiment this one at the University of Cincinnati
College of Medicine further illustrates the abuse of vulnerable
patients in government-sponsored research. From 1960 to 1972,
with funding from the Department of Defense and the Public Health
Service, investigators exposed 88 cancer patients to full and
whole body radiation. The patients, ranging in age from 9 to 84,
were poor - they were recipients of charity care at Cincinnati
General Hospital. They were uneducated - their average length of
education was six years. And they were predominantly members of
minority groups - 60 percent of them were African Americans. The
patients were exposed to radiation, not for therapeutic
purposes - at the time, whole body radiation had been largely
discounted for all but a few cancers. They were exposed to
radiation for national security purposes - the objective of the
experiment was to study the influence of whole-body radiation on
the combat effectiveness of troops. For example, it sought to
ascertain in the event of a nuclear explosion how much radiation
a soldier could withstand before becoming disabled. Patients
drafted in the study suffered from several side effects,
including nausea, vomiting, abdominal pain, and mental confusion.
It is not yet clear how many patients died as a result of their
underlying disease or as a direct result of their participation
in the experiment. There is no evidence that the investigators
obtained the consent of the patients in this study. Even if they
had, the issue remains whether poor patients who were receiving
144
4
free care from the hospital thought that they had any choice but
to submit to the researchers' invitation. Or whether black
patients, especially elderly ones, thought that they could refuse
a solicitation from a white researcher.
The consequences of these experiments go extend beyond the
unwitting subjects and their families. They have contributed to
a legacy of distrust of African Americans toward many
institutions of our society. As a physician, I see this first
hand with respect to the attitudes that African Americans hold
towards AIDS. Many believe that AIDS resulted from government-
sponsored biological warfare intended to destroy gay and black
populations. Given the goverment's disregard for the lives of
many of its citizens - as evidenced by the experiments that I
have discussed today - it is very difficult to dislodge such
rumors and obtain African American participation in research
trials and in HIV/AIDS prevention programs
As this committee proceeds with its investigation it is
imperative that they not forget members of vulnerable
populations, who so very often do not have access to the
resources that allow their stories to be told.
145
A Legacy of Distrust: African
Americans and Medical Research
Vanessa Northington Gamble, MD, PhD
After the abuses of the Tuskegec Syphihs Study were revealed,
the federal government strengthened regulations to protect the
subjects of human experimentation. These increased safeguards,
however, have not erased many African Americans' fear that
they will be abused m the name of medical research. The tcn.ic-
ity of this conviaion is understandable if one examines the
broader history of race and American medicine. The goals of
this short essay are twofold: (1) to place the Tuskegee Syphilis
Study within its historical context and (2) to examine how race
and racism influence contemporary biomedical research.
A historical analysts of racism and American medicine illumi-
nates the ways in which the profession has been used to sup-
port racist social institutions and has, in turn, been influenced
by them. Examination of this history demonstrates why so
many African Americans mistrust the medical profession and its
institutions. As efforts begin to include more African Americans
in clinical trials and to develop community-collaborative
research programs, this legacy of distrust must be addressed,
not dismissed as paranoia or hypersensitivity. The challenge is
to understand and confront the historically based realities
behind these sentiments.
\n understanding of the Tuskegee Syphilis Study and its
impact on African Americans is imperative for medical
researchers. Although the study is not the only case in which
black people have been exploited in the name of medicine, it
has come to symbolize such abuse. The history of the study is
often used to demonstrate why African Americans should not
cooperate with medical researchers. Most recently, its specter
has been raised in connection with human immunodeficiency
virus prevention programs.
Law professor Patricia A. King warns that the Tuskegee Syph-
ilis Study should serve as a caveat to medical researchers when
they analyze racial differences between whites and blacks. She
writes that "in a racist society that incorporates beliefs about
From the Departments of the History of Medicine, Preventive Medicine,
and F.imily Medicine, University of Wisconsin School of Medicine.
Madison, Wisconsin.
Address reprint requests to Dr. Gamble at the University of Wisconsin
School of Medicine. IJIIO University Avenue, Madison. Wl S1706.
the inherent infcrioritv of .'\fric.m .Americans in contrast to the
superior status tit whites, any attention to the question of differ-
ence that may exist is likely to be pursued in a manner that
burdens rather than benefits .\frican Americans."' The premise
underlying King's commcnrs is th.it medicine is nor .i v.iltic-(rec
discipline. Rather, it has reflected and reinforced the beliefs,
values, and power dynamics of the wider society. Accordingly, it
has been influenced by issues of race and racism. History shows
numerous examples of the use of medical beliefs to support the
alleged infetiority of black people.
.Vledical theories, for example, were used to justify the
enslavement of Africans. Antebellum physicians contended that
black people possessed peculiar physiological and anatomical
features that justified their enslavement. This medical dis-
tinctiveness, they argued, made Africans not only inferior but
inherently suited for slavery. For example, the physicians theo-
rized that Africans had thicker skins, which allowed them to
tolerate better the rays of the sun. They also observed, in this
case accurately, that black people seemed to be less susceptible
than white people to some diseases, such as yellow fevet and
malaria. Plantation owners took note of these observations and,
without qualms, worked slaves in environments such as
mosquito-ridden swamps, which they believed detrimental to
white people. -
Medical theories influenced societal attitudes that held that
black people were inferior and inhuman. Such attitudes under-
scored the use of slaves and free black people as subjects for
medical experimentation and demonstration in the antebellum
South. '■'* Although poor whites were also used as subjects,
blacks were used far more often. Harriet Martineau, after an
1834 trip to Baltimore, commented that "the bodies of col-
oured people exclusively are taken for dissection, 'because the
whites do not like it, and the coloured people cannor res-
ist.'"'" In 1839 abolitionist Theodore Dwight Weld asserted.
"'Public opinion' would tolerate surgical experiments, opera-
tions, processes, performed upon [slaves), which it would exe-
crate if performed upon their master or other whites."*
Tv/o antebellum experiments, one carried out in Georgia, the
other m Alabama, confirm Weld's charge. In the first, Georgia
physician Dr. Thomas Hamilton conducted a series of brutal
experiments on a slave to test remedies for heatstroke. The sub-
Made in Unittd States of America
Kcprinlcd from Amcrican Journal of Pbeventivi: Mi •m.-is-h
Supplement to Vol. 9, No 6. Novcmher/DeccinSc Wji
O 199.3 American Journal -.1 Ivcvt-niivc Medicine
Legacy of Distrust JS
146
|cct of these investigations was Fed, who had been In.ined lo
Hamilton as repayment for his owner's debt. Fed was forced to
strip and sit on a stool on n platform placed m a pit that havl
been heated to a high temperature. Only his head was above
ground. Over a period of two or three weeks, the man was
placed in the pit five or six times and given different medica-
tions to determine which enabled him best to withstand the
heat. Each ordeal ended when Fed fainted and had to be
revived. But note that Fed was not the only victim m this exper-
iment; Its whole purpose was to make it possible for masters
to force slaves to work still longer hours on the hottest of
days.'
In the second experiment, Dr. J. Marion Sims, the so-called
father of modern gynecology, used three Alabama slave women
to develop an operation to repair vesico-vaginal fistulas.
Between 1845 and 1849, the three slave women on whom Sims
operated each underwent up to thirty painful operations. The
physician himself described the agony associated with some of
the experiments."* He wrote, "The first patient I operated on
was Lucy. . . . That was before the days of anaesthetics, and the
poor girl, on her knees, bore the operation with great heroism
and bravery." This operation was not successful, and Sims later
attempted to repair the defect by placing a sponge in the blad-
der. This experiment, too, ended in failure. He noted, "The
whole urethra and the neck of the bladder were in a high state
of inflammation, which came from the foreign substance. It had
to come away, and there was nothing to do but to pull it away
by main force. Lucy's agony was extreme. She was much pros-
trated, and I thought that she was going to die; but by irrigat-
ing the parts of the bladder she recovered with great
rapidity. ..." Sims finally did perfect his technique and ulti-
mately repaired the fistulas. Only after his experimentation
with the slave women proved successful did the physician
attempt the procedure on white women volunteers. He found,
however, that they could not, or more accurately, would not.
withstand the pain and discomfort that the procedure entailed.
The black women had no choice but to endure. They, like Fed,
were forced to submit because the state considered them prop-
erty and denied them the legal right to refuse to participate.
This history of medical experimentation on slaves profoundly
influenced African-American attitudes toward the medical pro-
fession even after the Civil War. In the 1920s, for example,
many black people believed that they would be experimented
upon if they entered hospitals.^ Thus, the legacy of distrust pre-
ceded the 1932 initiation of the Tuskegee Syphilis Study.
The influence of racism on medicine did not end at
Appomanox. The medical and public health lournals of the late
nineteenth and early twentieth centuries contain many articles
that discuss the health problems of African Americans. Many ot
the discussions focused on syphilis. White physicians main-
tained that intrinsic racial characteristics such as excessive sex-
ual desire, immorality, and overindulgence caused black people
to have high rates of syphilis. As Dr". Thomas W. Murrcll noted
in 1910, "Morality among these people is almost a }oke and
only assumed as a matter of convenience or when there is a
lack of desire and opportunity for indulgence, and venereal dis-
eases arc well-nigh universal.**'^ Dr. H. H. Hazen echoed this
sentiment: "The negro springs from a southern race, and as
such his sexual appetite is strong; all oi his environments stimu-
late this appetite, and as a general rule his emotional type of
religion certainly docs not decrease it."" Physicians also
pointed to alleged anatomical ditfercncci — large peniics and
small brains — to explain the disease rates. '^
White physKians, in the early twentieth cctitury, bclievid that
syphilis was difficult to treat in black patients because they
could not be convinced to come in for treatment or, if they did,
to follow the treatment regimen. In the words of Dr. Eugene
Corson, "this absolute indifference [to treatment] is a charac-
teristic of the negro, not only as regards syphilis, but oi all dis-
eases. He IS simply concerned with the present moment of
suffering, and not always concerned then."'*
Historian Allan Brandt has argued that these assumptions
regarding black people and venereal disease influenced the phy-
sicians who initiated the Tuskegee Syphilis Study. He writes:
"The premise that blacks, promiscuous and lustful, would not
seek or continue treatment, shaped the study. A test of
untreated syphilis seemed 'natural' because the USPHS pre-
sumed the men would never be treated; the Tuskegee Study
made that a self-fulfilling prophecy."'* The Tuskegee Syphilis
Studv thus did not occur in a vacuum. It represented the con-
tinuing inducnce of racist thought not only on medical theory
but on physicians' perceptions of a group of people and conse-
quently on the treatment, or lack of treatment, individuals
would receive.
The United States Public Health Service {USPHS) initiated the
study in 19J2 to document the natural history of syphilis.'*
The sub)ects of the investigation were 400 poor black share-
croppers from Macon County, Alabama, with latent syphilis
and 200 men without the disease who served as controls. The
physicians conducting the study deceived the men, telling them
they were being treated for "bad blood." The men, for exam-
ple, were informed that lumbar punctures were therapeutic, not
diagnostic.
As part of the project, however, the USPHS deliberately
denied treatment to the men who had syphilis and went to
extreme lengths to ensure that they would not receive any.
When the Tuskegee Syphilis Study began, the standard therapy
for syphilis consisted of painful injections of heavy metal com-
pounds, such as arsenic and bismuth, which had to be adminis-
tered for up to two years. Although this therapy was less
effective than penicillin would later prove to be, in the 1930s
every ma|or textbook on syphilis recommended it for the treat-
ment of the disease at all stages. Published medical reports have
estimated that between 28 and 100 men died as a result of their
syphilis. In exchange for their participation, the men received
free meals, free medical examinations, and burial insurance.
The Tuskegee Syphilis Study continued until 1972. Through-
out Its 40-year history, accounts of the study appeared in prom-
inent medical [ournals. Thus, the experiment was widely known
in medical circles. As late as 1969, a committee from the Cen-
ters for Disease Control examined the study and decided to
continue it. Three years later, a USPHS worker, who was not a
physician, leaked details about it to the press. Media disclosure
and the subsequent public outrage led to the termination of the
study and ultimately to the National Research Act of 1974.
This act, established to protect subjects in human experimenta-
tion, mandates institutional review board approval of all feder-
ally funded projects with human subjects.
After the study had been exposed, many black people
charged that it represented "nothing less than an official, pre-
meditated policy of genocide."'* This was neither the first nor
the last time that the issue of genocide has been raised with
36 Racial Differences in Preterm Delivery
147
regard co the relaiiunship of Africnn Americans and mcdit.il
research. It has been associated with the development ol hirth
control programs and with the sickle cell anemia screening pro-
grams of the 19705."-'"
Most recently, both genocide and Tuskegee have come up rn
connection with acquired immunodeficiency virus (AIDS). In
September 1990, an article entitled "Is it Genocide.'" appeared
in Essence, a black woman's magazine. The author noted: "As
an increasing number of African-Americans continue to sicken
and die and as no cure for AIDS has been found some of us are
beginning to think the unthinkable: Could AIDS be a virus that
was manufactured to erase large numbers of us.* Are they trying
to kill us with this disease?"'*' In other words, some members
of the black community see AIDS as part of a deliberate plot to
exterminate African Americans. The views of James Small, a
black studies instructor at City College of New York exemplify
this position. "Our whole relationship to [whites) has been of
(their) practicing genocidal conspiratorial behavior on us, from
the whole slave encounter up to the Tuskegee Study," Small
contends. "People make it sound nice, by saying the Tuskegee
'study*, but do you know how many thousands and thousands
of our people died because of that?" '**
It would be a mistake co dismiss such ideas as those of a
paranoid extremist. In 1990 a survey conducted by tlu- South-
ern Christian Leadership Conference found that 35% of the
1,056 black church members who responded believed that
AIDS was a form of genocide.^" The legacy of Tuskegee has
also influenced the wariness that many African Americans
maintain toward needle exchange programs.^ '--^^
The Tuskegee Syphilis Study symbolizes for many African
Americans the racism that pervades American institutions,
including the medical profession. A lasting legacy of the study is
African Americans* distrust of medical researchers. Dr. Stephen B.
Thomas, director of the Minority Health Research Laboratory
at the University of Maryland — College Park, laments,
"Although everyone may not know the specifics of the Tuskegee
experiment, they have enough residual knowledge of it so that
they mistrust government-sponsored programs, and this results
in a lack of participation in [AIDS) risk-reduaion efforts."'"
Alpha Thomas, a Dallas health educator. University Hospital,
often confronts the legacy of Tuskegee. She notes that "so many
African American people that I work with do not trust hospi-
tals or any of the other community health care service providers
because of that Tuskegee Experiment. It is like ... if they did it
then they will do it again."-"
The strengthening of safeguards and the reforms in research
standards that followed the public disclosure of the abuses of
the Tuskegee Syphilis Study have been insufficient to change
African Americans' historically based fears of medical research.
These apprehensions contribute to the low enrollment rate of
African Americans in clinical trials.-^ A 1989 study conducted
by pharmacologist Craig K. Svensson demonstrated the under-
representation of African Americans in clinical trials. He
reviewed 50 clinical trials for new drugs that had been pub-
lished in Clinical Pharmacology and Therapeutics for the three-
year penod 1984-1986. He discovered that the percentage of
black subjects was less than their percentage in the cities in
which the research was conducted and less than their percent-
age in the general population of the United States. More recent
studies confirm this underreprcsentation of African Americans
in cimical trials for AIDS drugs.^**"
Why this underreprcsentation of black people? As one phvsi-
ci.iM h.ls pur It. "We're b.utling centuries of mistrust h.isetl on
liistoric.tt .iLtioMs o( the very institutions inviilvcd."-'' Ihe .itti-
tudes and practices of medical researchers towards African
Americans .ilso c.innot be discounted. Once at a |ob mtervievs. I
was told that black people are not included in clinical studies
because "it is ,i well-known tact that they are noncomplianr."
hirthermore, m the past, most clinical researchers base used
white men as the standard or norm from which to extrapoJate
data to the rest of the population. Young white men were pre-
sumed to be a homogenous population that had fewer con-
founding factors. Members of minority groups and women were
frequently excluded from clinical studies. However, federal
guidelines now call for the inclusion of these groups in studies
unless a compelling reason exists for their exclusion.
Does It matter that African Americans have been excluded
from therapeutic drug trials? In the case of the Tuskegee Syph-
ilis Study, clearly the inclusion of the men in a nontherapeutic
experiment was detrimental to their health; today, however,
exclusion trom a therapeutic one may he harmful. For example,
recent studies suggest th.it there are racial and gender differ-
ences III the therapeutic efficacy of some drugs. -*--~-^^ In addi-
tion. It IS crucial to have African Americans participate in
clmic.il atul public he.ilth studies ih.ir cxaiuine disc.lscs .iikI
conditions that disproportionately affect them.
The researchers associated with the innovative research strat-
egy to exaiiiiiie preterm delivery in African-American women
recognize that a historically-based mistrust still influences ,\fri-
can Americans' perceptions of biomedical research. They under-
stand that these attitudes represent a significant research
obstacle. These researchers have chosen not to cavalierlv dismiss
this legacy of distrust but to confront it. They have acknowl-
edged that the voices and experiences of African-American
women are crucial for the proiect's success. In a radical depar-
ture from traditional scientific studies, the investigators have
actively solicited advice about the study from the .African-
American lay community. Their goal is to develop a collabora-
tive research study that is conducted ivith African-.Aiiieric.in
people, not tnt them. The efforts of these researchers are a sig-
nificant step in eroding the legacy of distrust that has so pro-
foundly shaped the relationship of African Americans to
medicine.
REFERENCES
I. Kinj; PA. The il.ingcrs of difference Hastings Center Rep 1 942.22
(no. (i):.iS.
2 Savitt TI.. Medicine and sl.ivery. Urbana: Universirv of Illinois Press;
V Savitt TL, The use of blacks for medical experimentation and
demonstration in the old south. J Southern History 1982;48:33 1— 18.
4. Humphrey DC. Dissecnon and discnmmanon: the social origins of
cadavers in America. I760-191J. Bull NY Acad Med I973;49:819-
27.
5. Martineau H. Retrospea of wcjtem travel. 2 vols. New York
ISIS; I 140.
6. VCtId TD. American slavery as it is: testimony of a thousand
witnesses. New York; 1939:170.
legacy of Distrust 37
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■'. Bonrv FN. Doctor Thomas H.imilloi); two views ti* j j;fiitlcni.ui ot
the old south. Phylon 19«,-,:«::88-92
8. Sims JM. The story ol mv life. New York: Applcton. l88Sr21*-".
9. Gamble VN. Making a place tor ourselves: the black hospit.il
mosement. 1920-1945. New York: Ovtord University Press,
torthcoming.
10. MufTcll TW, Syphilis and the American Negro JAMA
1910:54:847.
11. Hazen, HH. Syphilis in the American Negro. JAMA 1914;63:463
12. Haller JS. The physician versus the Negro: medical and
anthropological concepts of race in the late nineteenth century. Bull
Histors of .Vied 1970;44: lS4-«7
13. Corson ER. Syphilis in the Negro. Am J Dermatol Genito-Urinary
Drs 1906;10:241.
14. Brandt AM. Racism and research: the case of the Tuskegee svphilis
study. In: Leavirt JW. Numbers RL, eds. Sickness and health in
Amenca. 2nd ed. Madison: University of Wisconsin Press; 1985:334.
15. Jones JH. Bad Blood. New York: Kree Press; 1981
16. Weisbord RG. Binh control and the black .^mencan: A matter of
genocide' ncmo|;r.lphy IV !; Ill: 57 I -"().
17. Jones AS. Editorial linking blacks, contraceptives stirs debate at
Philadelphia paper. Arizona Daily Star. 1990 Dec 23:F4.
18. Wilkinson DY. For whose benefit? Politics and sickle cell. The
Black Scholar 1974;5:26-31.
19, Bates kLC;. Is It cenocide- Kssence September I99l):"h
211 ITioni.is Sli. guiiin SC. Ihc luskeyce syphilis siujv. 11(2 to 19-2
implications for HIV education and .\IDS risk education programs in
the bl.ick community. Am J of Pub Health 1991,81:1499.
21. Thomas SB. Quinn SC. Understanding the attitudes of black
Americans. In: Stryker J, Smith .VID, eds. Dimensions of HIV
prevention: needle exchange. Menlo Park: The Henry J Kaiser Familv
Foundation, 1993: 99--)28.
22. Kirp DL. Bayer R. Needles and race. Atlantic. July 1991.38-42.
23. Svcnsson C Representation of American blacks in clinical tnals of
new- drugs. JA.VIA 1989;261:263-5.
24. Steinbrook R. AIDS trials shortchange minorities and drug users.
Los Angeles Times 1989 25 Sept.: 1.19
ZS Smith .MD. Zidovudine: does it work for everyone? (Editonall.
JAMA 1991;266:2750-1.
26. Cotton P. Is there still tixi much extrapohtion from data on
middle-aged white men- JAMA 1990:63:1050.
2". Cotton I*, txaniples abound of gaps in medical knowledge becaust
of srnups excluded from scientific study. JAMA 1990;263; 1051. 1055.
2s. ( iittoii IV K.Ki' jiiMis host of iiii.iii^wtrcd i|iicsnoii\ 1111 c.irK 1 MV
therapy. JA.MA 1991:265:1065-6.
38 Racial Differences in Preterm Delivery
149
Mr, CohfYERS. Thank you very much for your contribution, Dr.
Gamble. I am sure that as these investigations and hearings go on,
the African-American involvement in these tests will be reviewed
and that we will learn more about it, particularly in the institu-
tionalized groups and in the military.
Dr. Nishimi is a Senior Associate, Office of Technology Assess-
ment, and we welcome you here as our final witness for the day.
STATEMENT OF ROBYN Y. NISHIMI, Ph.D., SENIOR ASSOCIATE,
OFFICE OF TECHNOLOGY ASSESSMENT
Dr. Nishimi. Thank you, Mr. Chairman.
I would like to first make three brief points about the Federal
Government's mechanisms to protect human research subjects, and
then summarize possible policy options to address the concerns of
human research subjects.
First, while the Department of Health and Human Services has
had policies or regulations in place since 1953, it was not until
1991 that a uniform policy based on DHHS's regulations was
adopted by the entire Federal Government. Today, 16 Federal
agencies adhere to this common set of reflations.
Second, the Federal system is by design, decentralized and dif-
fuse. It depends, and in fact emphasizes, review by local institu-
tional review boards.
Third, the Federal mechanism to protect human research sub-
jects has changed little, structurallv and in its decentralized ap-
proach, since initially implemented by the then Department of
Health, Education and Welfare. The legal authority, however, has
shifted to recommended, and then required, guidelines and finally
to regulations. No statute, however, governs the general oversight
of research involving Americans.
Moreover, the current system, while changing incrementally, has
fallen short of implementing, or did not implement at all, rec-
ommendations made between 1973 and 1982 by an ad hoc commit-
tee of DHEW, a congressional report, and two congressionally man-
dated commissions.
With respect to policy options, since reports began to accumulate,
it has become clear to OTA that a definitive picture of the govern-
ment's implementation of the regulations is not available, even
though the regulations have been in effect since June 1991. Thus,
a broad spectrum of issues has surfaced.
Regardless of the type of research, three issues that are men-
tioned repeatedly are compensation for research injuries, the ade-
quacy of the current Federal system per se, and oversight of pri-
vately funded research.
The issue of compensation, not surprisingly, is a volatile matter.
Although 12 years old, the 1982 President Commission's report re-
mains the most comprehensive document. It concluded no program
be instituted until DHHS conducted a small experiment to aeter-
mine whether a formal program was needed, and if so, the most
fair and efficient means to administer it. No such studies have
been undertaken. Compensation remains controversial, one with
many opinions, but no data.
Not surprisingly, the renewed interest in Federal protection of
human research subjects is perceived as having created a climate
150
in which some of the bypassed recommendations of the prior bodies
might now be implemented.
First, even if no systemic changes are undertaken, it might be
appropriate to evaluate whether current Federal resources to en-
sure compliance are sufficient. Dr. Rothman alluded to the situa-
tion at the Office for Protection from Research Risks, Over the past
three administrations, NIH has been downsizing the human sub-
jects protection staff despite the significant increases in research
funding.
OPMl currently has a backlog of more than 90 complex cases of
alleged noncompliance, and this is overseen by two investigators.
And you have to keep in mind that OPRR has the most developed
office and system of all the Federal entities. Except for DHHS,
most agencies have one part-time professional, one part-time sec-
retary, and no specified budget for implementing the current regu-
lations.
To say that no problems exist is disingenuous. Agencies will not
be aware of violations unless a rigorous system to monitor compli-
ance is in place. Those departments that are not looking for prob-
lems will not find problems.
The second option that might warrant further scrutiny centers on
the role bioethics commissions have played in U.S. public policy.
For over a decade, the Federal Government has been without an
operational, broad-based forum to address these issues. In contrast,
the governments of at least 27 nations on six continents have es-
tablished national bioethics commissions or currently have legisla-
tion pending. And in fact the option of establishing a new commis-
sion is already being pursued in some quarters. For example, last
month the WTiite House Office of Science and Technology Policy
published a drafl charter for a proposed national bioethics advisory
commission.
A third option would involve a dramatic alteration in the Federal
approach to protecting human research subjects. A national board
could be created to review classes of protocols or even single proto-
cols.
Depending on the nature of such an entity, protocol reviews
could significantly shift to the national level, resulting in uniform
review. It would, however, represent the philosophical antithesis of
the current theory that local review accommodates the prevailing
values and ethics of the community in which the research will be
conducted.
Additionally, the sheer volume of human research currently con-
ducted, especially compared to 20 years ago when this approach
was first contetnplated, might make a national IRB-like entity un-
manageable.
A fourth option could be less drastic philosophically than a na-
tional IRB, but would require legislation to provide statutory force
to the current regulations. Such legislation could inject consistency
in review and implementation of Federal protection of human re-
search subjects. If Congress pursues this option, it would likely face
a decision about whether to create a new independent agency
charged with the responsibility of ensuring the protection of all
human subjects who participate in federally funded protocols. Cur-
rently, each agency polices itself and its own research portfolios, an
151
approach that OTA has already seen results in uneven implemen-
tation compliance and oversight.
In the interests of time, Mr. Chairman, I would just like to con-
clude that to maintain the public trust it is clear tnat we must all
share a vigorous and unwavering commitment to protect the rights
of those who participate in research. These people are our relatives,
our neighbors, our friends and our fellow citizens.
Thank you.
[The prepared statement of Dr. Nishimi follows:]
152
OTA T R S T 1 M O N Y
Statement of
ROBYN Y. NISHIMI, Ph.D.
Senior Associate
Office of Technology Assessment
Before the
Subcommittee on Legislation and National Security
Committee on Government Operations
U.S. House of Representatives
September 28, 1994
THE FEDERAL ROLE IN PROTECTING HUMAN RESEARCH SUBJECTS
Congress o( the United Statss
OffiM of Technology Asswsnwnl
WuMnglon,DC2051M02S
153
Mr. Chairman and members of the Committee, it is a pleasure to appear before you today to
discuss issues related to federal oversight of research involving human subjects There is little doubt
that, over the decades, research involving humans has contributed to improvements in the health,
safety, and well-being of all Americans. Through the participation of few, all benefit Safeguarding
the interests and well-being of individuals who participate in research is of paramount importance. As
you requested, my statement summarizes three broad areas related to the government's experience
with the protection of human research subjects:
• the response of the federal government to past reports of "abuses" of human research
subjects and whether the approach has evolved,
• the mechanisms employed by the federal government to protect human subjects and the
extent to which these have changed over time, and
• possible policy options to address the concerns of human research subjects.
In general, my remarks pertain to the protection of human subjects by the range of federal
agencies that conduct research involving humans. For the first issue, however— the historical response
of the federal government to reports of unethical treatment of human research subjects—I focus
primarily on the Department of Health and Human Services (DHHS) and its predecessors As the
largest fiinder of research involving human subjects, this agency has played a pivotal role in the
development of U.S. policies governing the ethical conduct of research involving humans.
Federal Policies and Human Research Subjects
The U.S. government's policymaking in research ethics lagged behind others' recognition of
the importance of formal codes of conduct about the treatment of human research subjects For
example, in the United States, the American Medical Association adopted a code of research ethics in
December 1946 This code preceded, but included tenets of, the so-called "Nuremberg Code,"— ten
principles that were part of the judgment in the Nuremberg trial of 23 Nazi physicians.
The eariiest, publicly acknowledged, federal guidance for the protection of human research
subjects can be traced to the 1953 National Institutes of Health (NIH) Clinical Center guidelines. In
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1966, the then Department of Health, Education and Welfare (DHEW) enlarged upon this action by
issuing a broad policy—with the inauspicious name, "Policy Procedure Order 129"~goveming all
research supported by the Public Health Service (PHS). Since that time, incremental changes in the
federal government's oversight of research involving humans have occurred. Three events, in
particular, were catalysts for change: 1972 news reports of the Tuskegee Syphilis Study,
congressional hearings in 1973 on an array of controversial experiments involving humans, and a 1981
report by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical
and Behavioral Research.
In 1972, front page news reports brought one of the most notorious abuses of human research
subjects to an end From 1932 to 1972, the PHS and several foundations had conducted a study on
approximately 600 African American males in Tuskegee, Alabama When the study was initiated, the
Tuskegee area had the highest incidence of syphilis in the nation, and more than 400 of these men had
this sexually transmitted disease, for which limited treatment was then available.
The men were lured into participating by the promise of free medical treatment, food, and
burials. Initially, they were treated with mercury and arsenic compounds—then standard therapy—
when the drugs were available. However, they also endured spinal taps without anesthesia and were
denied penicillin long after it became apparent in 1 945 that this antibiotic was the preferred
therapeutic drug To prevent participants from receiving treatment by the US Army, PHS also
instructed draft boards not to induct them. Under congressional scrutiny, PHS officials offered the
excuse that treating the subjects with penicillin would have arrested the disease and made following
the long-term effects of syphilis impossible
Soon after the widespread disclosure of the Tuskegee Syphilis Study, DHEW convened the
Tuskegee Syphihs Study Ad Hoc Advisory Committee. This committee's final report in 1 973
recommended that Congress "establish a permanent body with the authority to regulate at least all
Federally supported research involving human subjects." Such a body, referred to as the National
Human Investigation Board, was not created. In the wake of this report, however, came renewed and
heightened congressional interest in the protection of human research subjects.
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Congress previously had examined the topic of informed consent for participants in clinical
trials during 1962 hearings on investigational studies that involved the use of thalidomide by pregnant
women and had addressed, in a limited fashion, the issue of informed consent with respect to
investigational new drugs and the Food and Drug Administration. It was a series of Senate hearings
in 1973, however, that prompted the U.S. government to respond to concerns about the protection of
human research subjects. In addition to receiving testimony about the Tuskegee Syphilis Study,
witnesses testified about the injection of liver cancer cells into patients at the Jewish Chronic Disease
Hospital in Brooklyn, New York; the intentional infection with hepatitis of residents of the
Willowbrook State School for the Retarded; and on other "abuses" in behavior control research,
research in prisons, and research involving institutionalized individuals.
In response to this information, legislation was proposed to establish a permanent commission
that would not only develop and refine existing DHEW policies governing research involving humans,
but one that also would oversee and enforce their implementation. Congress also recognized that
protecting human research subjects was an issue extending beyond DHEW, and noted "it is important
to establish a single standard to be applied by all agencies ..."
The ultimate outcome, however, was the establishment in 1 974 of a fixed-term advisory
commission— the National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research (hereinafter referred to as the National Commission); enforcement powers were
dropped Congress directed the National Commission to identify the ethical principles necessary for
protecting human subjects involved in research and to use those principles to recommend actions by
the federal government The conference committee report also called for a permanent National
Advisory Council to replace the National Commission after its sunset, but no such entity materialized.
Nor was the issue of a single standard addressed
Still, the work of the National Commission had a significant impact on federal protection of
human research subjects From 1974-78, the National Commission issued ten reports and several
appendices on the general ethical principles and procedures that should govern research involving
humans, as well as reports and recommendations for research on what have been termed "vulnerable
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populations"~pregnant women and fetuses, children, prisoners, and "those institutionalized as
mentally infirm." Today's regulatory framework for the protection of human research subjects owes
its existence in its current form to the work of the National Commission.
I mentioned earlier that my discussion on the evolution of federal policies centers on three
events— media focus on the Tuskegee Syphilis Study, congressional scrutiny of research involving
humans and its creation of the National Commission, and a report by the President's Commission for
the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (hereinafter
referred to as the President's Commission) The President's Commission report, however, differed
from the cases just cited. Nevertheless, it bears mentioning because of its impact in standardizing the
federal approach to protecting human research subjects.
The President's Commission was established by Congress, but not in response to a specific
incident (or set of incidents) involving questions about the protection of human research subjects Its
1981 report, Protecting Human Subjects, systematically documented that 23 federal entities funded
research involving human subjects. It found a lack of conformity among component parts of a
department or agency, inconsistency in the application of regulations or policies to all types of human
research within a single entity, and a lack of uniformity in policy among the 23 federal departments
and agencies who fund research involving humans The President's Commission recommended that all
federally-funded research involving humans should conform to a uniform, core set of regulations and
that DHHS's regulations should serve as the template for such an effort; Ten years' elapsed before 16
federal departments and agencies^ adopted the so-called "common rule"~the regulatory requirements
' And, in fact, 17 years had passed since Congress had recognized the importance of a single standard.
^58 F.R 28002 for the Department of Agriculture, Department of Energy (DOE), National Aeronautics and Space
Administration (NASA), Department of Commerce, Consumer Product Safety Commission, Agency for International
Development, Department of Housing and Uiban Development. Department of Justice, Department of Defense (DOD),
Department of Education, Department of Veterans Affairs (VA), Environmental Protection Agency, Department of
Health and Human Services (DHHS), National Science Foundation, and the Department of Transportation. The action
also notes that the Central Intelligence Agency (CIA) is required by Executive Order 12333 to conform to the guidelines
issued by DHHS.
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that detail the mechanisms used by the federal government to protect human research subjects,' which
is the second area that you requested my testimony address.
Before describing some of the details of these mechanisms, however, I would like to reinforce
what are probably obvious points about the government's responses to past reports of real and/or
perceived "abuses" of human research subjects. First, in many respects the first two examples I cited—
Tuskegee and the series of congressional hearings-represent a "crisis management" model following
increased publicity about research "abuses " In the first instance, the executive branch convened an
advisory committee; in the second, Congress created an advisory commission Second, in each case,
the recommendations of these bodies—as well as that of another congressionally created commission-
advanced federal policies for the protection of human research subjects, but either not to the extent
envisioned by the parties involved or not at all
Not surprisingly, then, when nationwide news reports of Cold War era human radiation
experiments surfaced in December 1 993 and through the eariy months of 1 994, the government's
approach resembled previous responses. Congress and the executive branch again have responded to
perceived needs to strengthen federal policies governing the protection of human research subjects.
During the past nine months. Congress has held a series of hearings on the issues surrounding
the human radiation experiments. And as this hearing demonstrates, congressional interest is not
confined to that set of experiments, but also is concerned with other Cold War era chemical and
biological warfare tests, as well as purely biomedical research during that period And as you know,
the General Accounting Office is conducting several investigations related to human subjects
protection at your request and at the request of other committees. Additionally, President Clinton
chartered the Advisory Committee on Human Radiation Experiments (ACHRE) and appointed a
group of experts to provide advice and recommendations on the ethical and scientific standards
■* The President's Commission issued a second report on human subjects protection in 1983 and reported to Congress
that while some progress had been made by Federal agencies in response to recommendations in the 1981 report, the
overall progress was "disappointing." The Commission identified numerous deficiencies in agencies' mechanisms to
protect human research subjects. It made a series of recommendations to improve Federal oversight, but to date
virtually none has been implemented.
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applicable to human radiation experiments carried out or sponsored by the U.S. government, ACHRE
will deliberate until April 1995. The President also directed all heads of executive departments and
agencies to immediately review their present practices to ensure that the current regulatory framework
is being "strictly enforced " I will discuss the possible implications of these events for federal human
subjects protection policies in the final part of my testimony, which addresses policy options to
address the concerns of human subjects.
Federal Mechanisms to Protect Human Research Subjects
Returning to the issue of how the federal government protects human research subjects,
regulations adopted in June 1991 mean that 16 federal agencies should employ a common mechanism
intended to ensure that research involving humans is conducted ethically. Today, all federally funded
research involving human subjects must conform with a series of core regulatory requirements Each
agency is responsible for ensuring compliance at institutions that receive its funds. For instance, NUTs
Office for Protection from Research Risks (OPRR) oversees implementation of DHHS human
research subjects regulations in all domestic and foreign institutions or sites receiving DHHS funds
The provisions of the common rule, first promulgated as regulations for DHHS in 1974, set
forth the elements, mechanisms, and conditions by which federally funded research involving human
subjects shall be conducted Roughly speaking, there are three key aspects: 1) review of the protocol
and informed consent document by a local Institutional Review Board (IRB), 2) the interaction
^between the volunteer participant and investigator, including the informed consent process; and 3)
federal agencies' oversight of institutions through an assurance of compliance process. 1 will describe
these elements in some detail—though by no means exhaustively-because of their importance to
possible policy options
The mechanisms that the federal government employs to protects human research subjects are,
by design, decentralized and diffuse. The underiying tenents and basic approach of the current system
differ little from those put forth by the 1966 PHS guidelines Then-and now--the U.S. approach
centers on local review, under the belief that a local group of individuals is most desirable because
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they are in the best position to know the prevailing values and ethics of the community and proposed
research subject population.
Thus, under the regulations, the principal responsibility for ensuring that scientists conduct
human subjects research ethically rests with ERBs. The regulations detail minimum IRB membership
requirements, how IRBs shall operate, the scope of authority assigned to IRBs, the criteria by which
IRBs shall approve research, and the documentation required by the federal funding agency. The
regulations also mandate eight specific informed consent requirements:
• "A statement that the study involves research, an explanation of the purposes of the
research and the expected duration of the subject's participation, a description of the
procedures to be followed, and identification of any procedures which are
experimental.
• A description of any reasonably foreseeable risks or discomforts to the subjects.
• A disclosure of any benefits to the subject or to others which may reasonably be
expected fi^om the research.
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject
• A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained
• For research involving more than "minimal risk,"'' an explanation as to whether any
compensation and an explanation as to whether any medical treatments are available if
injury occurs and, if so, what they consist of or where further information may be
obtained.
• An explanation of whom to contact for answers to pertinent questions about the
research and research subjects' rights, and whom to contact in the event of a research-
related injury to the subject.
• A statement that participation is voluntary, refusal to participate will involve no penalty
or loss of benefits to which the subject is otherwise entitled, and the subject may
discontinue participation at any time without penalty or loss of benefits to which the
subject is otherwise entitled"
'' TTie regulations define minimal risk as meaning "that the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those ordinarily encountered m daily life or dunng the
performance of routine physical or psychological examinations or tests."
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IRBs may alter or exclude some or all consent elements—as well as expedite review of a
protocol— if the research exposes subjects to no more than minimal risk. Overall, IRBs are required to
review research involving humans according to the following criteria:
minimization of risk to the subjects,
reasonable risks in relation to anticipated benefits,
equitable selection of subjects,
assurance of informed consent,
adequate provisions for monitoring data,
provisions for protecting patient privacy, and
assurance that decisions to participate in research will not be coerced.
The regulations specifically preclude IRBs fi-om assessing the broad-based societal implications of a
protocol—i.e., IRBs may not assess the "long-range effects of applying knowledge gained in the
research (for example, the possible effects of the research on public policy)."
Additionally, three special provisions govern research funded by DHHS. Referred to as
subparts B, C, and D of 45 CFR 46, the regulations detail additional protections for research involving
pregnant women and fetuses, prisoners, and children, respectively~i.e., those populations deemed
vulnerable by the National Commission.' Thus, DHHS regulations governing human subjects research
are more comprehensive than those that pertain to the other 1 5 signatories to the common rule
Research conducted with funds from an agency other than DHHS is not strictly subject to the
additional protections for vulnerable populations, although any IRB may voluntarily employ them.
However, non-DHHS funded research may be governed by the full regulatory system under
certain circumstances. As I have mentioned, the mechanisms for the protecting human research
subjects include the responsibility of a federal agency to provide assurance that facilities receiving
federal funds that support research involving humans are in regulatory compliance. An assurance is a
' The DHHS regulations that cover research involving pregnant women and fetuses, children, and prisoners resuhed
from specific recommendations in reports by the National Commission. The National Commission also issued a report
and made recommendations for "those institutionalized as mentally infirm." DHHS, in violation of the law, never
promulgated regulations to cover this population.
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formal, detailed written commitment by the receiving institution that it shall abide by the human
research subject regulations DHHS has the oldest and most comprehensive architecture in place, and
among its procedures is a mechanism referred to as a Multiple Project Assurance of Compliance
(MPA).
Because large universities can have tens or hundreds of protocols involving human subjects,
case-by-case submission of protocols would be extremely burdensome for both the institution and
OPRR Thus, OPRR may invite an institution to negotiate with OPRR for one or more MPAs— i e.,
an umbrella assurance that sets forth an institution's approaches and guarantees to safeguard the
interests and welfare of human subjects who participate in DHHS-funded research Institutions
granted an MPA because of their experience and expertise need not submit each case to OPRR for
review for a specified period of time, generally five years About 95 percent of the 420 institutions
holding DHHS MPAs pledge that all research—not just DHHS-fiinded research, and including
privately funded research-will be conducted in accordance with the fiill set of DHHS regulations
Hence, research sponsored by the Department of Energy, or other federal departments covered by the
common rule, would be subject to the additional protections for special populations if it is undertaken
at such institutions. Unless an institution has an MPA with OPRR, responsibility for monitoring and
compliance, however, still remains with the fijnding source— in my example, the Department of Energy
would be obligated to ensure compliance of research it funded.
Thus, to briefly summarize the mechanisms employed by the federal government to protect
human subjects and the extent to which these have evolved:
• Sixteen federal agencies adhere to a common set of regulations that describe elements
of informed consent, requirements for local review of protocols, and the agencies'
responsibilities to assure compliance.
• The federal system to protect human research subjects is by design, decentralized and
depends on review by local Institutional Review Boards;
• Federal mechanisms to protect human research subjects have changed little—
structurally and in approach— since their initial implementation nearly three decades
ago, although the legal authority has shifted from informal policies to recommended,
then required, guidelines, to federal regulations.
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Options to Address Concerns of Human Subjects
Mr Chairman, as you are well aware, the flurry of news reports documenting questionable
research practices involving the exposure of humans to ionizing radiation has evoked a deep and
visceral anger in much of the American populace. The public outrage can, in some respects, be
divided into two distinct concerns. The first looks back in time and asks: How could this have
happened? Why did it happen? What redress is appropriate? And second, a more contemporary and
future concern: Is this happening today? Could this happen tomorrow?
About the first type of concern, much is being done. Congressional hearings and
investigations contribute to the public debate and remind Americans that Congress is committed to as
full an accounting of the human radiation experiments as possible And, in due course, the Advisory
Committee on Human Radiation Experiments will make findings and recommendations in this regard.
Currently at its mid-course stage, it already has uncovered documents that are likely to rewrite the
early history of the awareness and attentiveness of some federal agencies to principles governing the
ethical conduct of research involving human subjects.
The spotlight on human radiation experiments also has provided the opportunity for reflection-
-as in this hearing— about the adequacy of federal protection of all human research subjects in the past,
at present, and in the future. Since reports of the human radiation experiments began to accumulate, it
has become clear to OTA that a definitive picture of current federal implementation and oversight of
existing regulations to protect human research subjects is not available I do not mean to imply that
OTA believes the likelihood of egregiously unethical research practices are anything but remote.
Nevertheless, agencies will not be aware of violations of existing regulations unless a rigorous system
is in place to monitor compliance. Put agnother way, those Departments and agencies that are not
looking for problems will not find any problems.
Currently, information from all agencies on the total number of all research grants or contracts,
total fiinding for all research grants or contracts, total number of research grants involving human
subjects, total funding for research and grants involving human subjects, and number of ftill time
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equivalent personnel devoted to assurance and compliance has not been collected in a coordinated or
centralized fashion. Nor has information been collected about oversight, including whether
unannounced or announced site visits a'^e used to monitor compliance Similarly, a reporting of
compliance investigations is unavailable, although investigations are the means by which violations of
the regulations are determined The types of compliance investigations, the results of such
investigations, and the corrective actions taken, if any were required based on those investigations, has
not been compiled.
For some agencies, information even limited to the number of, funding levels for, and types of
research involved for current grants or contracts using human subjects could not be reported as
recently as March 1994, although the common rule has been effective since June 1991 . Without such
information, ensuring that proper institutional assurances are in place and then overseeing compliance
would appear to be problematic.
Thus, over the past nine months, a broad spectrum of issues related to the U.S. government's
role in overseeing research involving humans has surfaced and been discussed by policymakers,
researchers, and subjects and their families These issues cut across types of research, and I would
like to briefly discuss three that are mentioned repeatedly: compensation for research injuries, the
adequacy of the current Federal system per se, and oversight of privately funded research.
Suffice to say, the issue of compensation is a volatile matter and one with a range of opinions
Current federal regulations make a single reference to this complex issue, requiring that it be
addressed as an element of informed consent That is, the informed consent document must indicate
whether there will be any compensation—or no compensation—if injury occurs as a result of the
research.
Though twelve years old, the 1982 report of the President's Commission, Compensating for
Research Injuries, is the most recent, comprehensive examination of the issue It noted that several
federal panels that preceded it had recommended the establishment of a governmental program of
compensation for injured research subjects. In contrast, the President's Commission concluded that no
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program be instituted until DHHS conducted a small, controlled experiment to determine whether a
formal program was needed and, if so, the most fair and efficient means to administer it. It described
in detail how such an effort could be conducted, but no such project has been undertaken Thus, the
issue of compensation remains controversial and one with many opinions, but no data Thus, to
address the issue of compensation. Congress could direct that DHHS embark on the experiment
recommended by the President's Commission, or it could conclude that the current disclosure
requirement suffices.
Not surprisingly, the renewed interest in and attention to federal protection of human research
subjects has created a climate~or is perceived as having created a climate-in which some of the
bypassed recommendations of the Tuskegee Syphilis Study Committee, National Commission, and
President's Commission might be implemented. In other words, a strong sentiment exists among many
that not only might past harms and redresses be addressed, but incremental or wholesale changes in
current federal oversight of research involving humans, too As with compensation, a broad range of
options have been suggested to modify the overall federal approach to protecting human research
subjects, and I will briefly discuss four of these
First, even if no systemic changes are undertaken, an evaluation of whether the current federal
efforl to ensure compliance is sufficient might address the concerns of some. For example, in
February 1994, Dr Charles R McCarthy, retired director of OPRR, testified before Congress on what
he believes is a decreased commitment across the federal government to oversight of human research
subjects regulations-including oversight by DHHS, the agency with the most experience and most
developed program
Dr. McCarthy reported that over the past decade and across three administrations, NIH* has
been downsizing the human subjects protection staff despite the significant increases in biomedical
research funding OPRR currently has a backlog of more than 90 complex cases of alleged
noncompliance that is overseen by two investigators. OPRR does not conduct unannounced, random
* Although previously housed at the departmental level (under a different name), OPRR's predecessor was moved to
NIH in about 1970.
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site visits, in part due to lack of funds Except for DHHS, most agencies have one part-time
professional, one part-time secretary, and no specified budget for implementing current regulations.
The second option that might warrant further scrutiny centers on the role bioethics
commissions have played in US. public policy, which was reviewed in OTA's recent report.
Biomedical Ethics in U.S. Public Policy. As I mentioned earlier, 20 years ago Congress created the
National Commission to review what were then DHEW policies governing the conduct of research
involving humans. Today, however, no body currently is in place to perform such a review because
for over a decade the federal government has been without a formal, operational forum that addresses
bioethical issues^ This absence is especially noticeable when we look abroad: The governments of at
least 27 nations on 6 continents have established national bioethics commissions of some type or
currently have legislation pending Moreover, the focus of a significant number of these international
commissions is the protection of human research subjects. Thus, two decades after constituting the
National Commission, Congress could consider whether a similar effort is again necessary, or it could
determine that ad hoc committees convened at the initiative of the executive branch— such as the
radiation committee or the Tuskegee committee—are adequate.
In fact, the option of establishing a new commission already has already been adopted by
some Senator Mark Hatfield, one of the requestors of the OTA bioethics report, has introduced
legislation to establish a broad-based commission. And, on August 12, 1994, the White House Office
of Science and Technology Policy (OSTP) published a draft charter for a National Bioethics Advisory
Commission in the Federal Register . The OSTP effort would be a term-limited broad-based advisory
commission, and under the proposed charter, one study it would address "as a first priority" would be
the protection and welfare of research subjects, including current notions of informed consent (eg,
whether multicultural views should be articulated), the adequacy and implementation of Federal
^ Since the National Commission, three other broad-based bioethics entitities h^ve operated: the President's
Commission, as well as the Ethics Advisor>' Board and the congressional Biomedical Ethics Advisory Committee.
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human research subjects mechanisms, and whether the definition of "minimal risk" needs
modification.*
A third option that could be adopted to address the concerns of human research subjects
would involve a dramatic alteration in the Federal approach to protecting human research subjects, but
it is an idea that traces its history, in part, to the 1973 report of the Tuskegee Syphilis Study Ad Hoc
Advisory Committee. The Tuskegee committee advocated that a board should be created to identify
the overarching principles that should govern research involving human subjects; enforce the policies
developed fi-om these principles; interpret and refine the principles and policies as cutting edge
research demands; review classes of protocols, or even single protocols, if novel issues make such a
national review advisable; and investigate and review conflicts that arise between IRBs, subjects, and
investigators.
Depending on the nature of such an entity, protocol reviews could significantly shift to the
national level, which would represent the philosophical antithesis of the current theory that reliance on
local review accommodates the prevailing values and ethics of the community. Others express
concern that the sheer volume of human research currently conducted (especially compared to 20
years ago when this approach was first contemplated) makes a national IRB-like entity unworkable
and unmanageable Such an approach would, however, satisfy those who see the current system as
failing to adequately protect human subjects because it lacks a single, national mandate and authority.
A fourth option to address the concerns of human subjects could be less drastic than a national
IRB, but would require that Congress enact legislation to provide statutory force to the current
regulatory requirements that encompass human subjects protection by the 1 6 common rule agencies
Such legislation could serve to further standardize federal oversight of research involving human
subjects and create a formal system of investigation, sanctions, and penalties, while preserving the
* The OTA report also identified the issue of vulnerable research populations as an area that might merit inquir>. For
example, research involving individuals with dementia and research involving individuals with mental disorders are
potential areas for a new commission to e.xplore should one be formed. Additionally, several experts note that
individuals who are terminally ill might constitute a vulnerable population worthy of special protections; terminally ill
patients might seize any opportimity without regard for weighing risks, no matter how great, against potential benefits,
no matter how small.
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philosophical principles of local review by IRBs that the regulations embody. If Congress were to
pursue this option, however, it likely would face a decision on whether to adopt a decentralized
enforcement mechanism or whether a central authority (e.g., a new independent agency or White
House office) should be vested with the responsibility of ensuring the protection of all human research
subjects who participate in federally funded protocols. Currently, each of the 16 common rule
agencies police themselves and their own research portfolios—clearly, as just described, with uneven
implementation, compliance, and oversight On the other hand, the prospect of a statute for the
protection of human research subjects raises concerns by many about increased federal intervention
and some loss of local review authority, along with the potential loss of flexibility in interpretation that
today's system affords, which many view as a positive feature.
Finally, while many questions have been raised (and options advanced) about the current
system to protect human subjects involved in federally funded research, of growing interest and
concern is privately funded research, which falls wholly outside the purview of federal regulations and
the options just discussed. For example, research conducted by private physicians and flmded by a
pharmaceutical company can be beyond scrutiny of today's system; news reports last month illustrate
this issue A pharmaceutical company was reported to have made research grants to physicians in
private practice to do research (a survey) in schools, in order to identify children of short stature The
federal government has no authority to assure protection of human subjects in such research (which in
this case involved children, who are considered a vulnerable subject population).
Thus, if Congress considers options to modify current federal mechanisms to protect human
research subjects. Congress also could examine the extent (if any) to which privately funded research
should or should not be subject to federal oversight.
Prospectus
Mr Chairman, over the past two decades. Congress has exhibited an enduring interest in
ensuring the ethical treatment of human research subjects In fact, each year Congress explicitly
acknowledges this obligation: We continue to pay the ethical and economic costs of not being
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sufficiently vigilant about the societal ramifications of human subjects research. As OTA Director
Roger Herdman noted last October in his testimony at the release of OTA's report Biomedical Ethics
in U.S. Public Policy:
[T]his year, as in years past. Congress will appropriate fijnds for the ongoing
medical care of survivors of the Tuskegee syphilis study . Let no one doubt that
the compensation is appropriate; it should also serve as an ever present reminder to us
all about the important role of bioethics in [biological and medical research].
Today and in the past, the United States' research enterprise-the envy of the world-
unquestionably has yielded extraordinary advances in health, welfare, and safety. And there is no
dispute that such advances depend on the participation in research of our relatives, neighbors, fiiends,
and fellow citizens. Their participation has served, and continues to serve, as the cornerstone of an
increasing knowledge base that helps us all
Still, incidents such as the Tuskegee syphilis study and revelations of the human radiation
experiments cast a shadow over the U.S. research enterprise, as, perhaps more importantly, do
concerns raised about some current protocols research (eg, research involving people with
schizophrenia or the use of tamoxifen for breast cancer prevention) The length of this shadow is
testament to the need for continued and unwavering federal oversight of human subjects research.
Sound ethical practices must go hand in hand with scientifically valid research involving human
subjects To maintain the public trust, we must all share a vigorous commitment to protect the rights
and welfare of those who participate in research protocols that ultimately benefit everyone
Again, OTA appreciates the invitation to discuss the important issues raised at this hearing,
and I will be happy to answer any questions.
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Mr, CONYERS. I thank you very much.
Dr. Nishimi, because you are from OTA, I would Hke to make
your statement available to the three persons who are at the wit-
ness table with you, because it is going to play a large role in how
we organize ourselves to move forward in this matter.
I would like all of you to feel invited to continue in this inquiry.
I will be in touch witn you, I can assure you.
I just say that this matter is larger than I thought it was. When
I talked to Secretary O'Leary when these matters first broke, I
thought she had done an excellent job, but I failed to appreciate
the mller ramifications of this. Now today I think I see some of
them, and I am sure that there are others that remain to be
hooked up. So I am very pleased to have you all here.
I must say that we have received an incredible number of specific
recommendations, and that the thoughtfulness of them gives us a
very, very large challenge indeed. I will be reading some of your
literature, some of your books.
This committee will continue the kind of work that made us real-
ize that this matter had not been gone into far enough. Indeed, if
there is anybody in the Congress that is going to follow up on this,
it should be the oversight committee of the Congress. That is what
we have tried to do.
So on behalf of many of my colleagues, we want to thank you
very much, and announce that the committee now stands ad-
journed.
[Whereupon, at 1:25 p.m., the subcommittee adjourned, to recon-
vene subject to the call of the Chair.]
APPENDIX
Material Submitted for the Hearing Record
Volume XIV
MAY, 1932
Number 5
THE JOURNAL OF
INDUSTRIAL
HYGIENE
WITH ABSTRACT OF THE LITERATURE ( '
E<£tsr, Uaitnl Scats Hooovr fnninlrini Z&ar EAtar, Great Bdtain
Davn L. FWHT,, JLD, S.D. Sn TBotui M. Lioai. MJ}, D^A E. L. Cous, MJ>, IfJLCS.
On the Effects of Prolonged Exposure to Sulphur ' '^
; Dioxide , -'' ;
Cadmium Poisoning; n. Experimental Cadmium ':'•/:!.''.
'■>'-■' Poisoning ^ ^ '; '"^^
The Reactions of the Organism to Repeated Electric
-i^iC Shocks - -' - ,
.cy
Eatotd aa aeood-daia aiatter, at tha Foat'OSca at BaMaora, MaiTbad, oakt Act of Uan± 3, 1179.
" 7 ■/- ■■ •• /■ . Copjrri^t, 19«, by Hartard MofieaJ School •. ' ■ , ■ ■..X-
.' 'j '\ ,;-/;, ^ ;"' '- itad« in Vie Umted State* of America^ ■''*i.. ' ' ■•■^ ■ " '.'
'■j,-.:y-jZ
(171)
172
CADMroM POISONING: II. EXPERIMENTAL CADMIUM
POISONING*
Leon Prodan, M.D., M.P.H., Dr. P.H.
From tht DepartmtnU of Phynology and Induttrial Byfiene, Harvard School of Publie
Btaltk, BoiUm, iiati.
Genebal Considerations
POISONOUS substances inay en-
ter the body through the respi-
ratory system, the gastro-intes-
tinal tract, the mucous surfaces
(conjunctivae, nasal mucosa, and buc-
cal mucosa), and the slrin (broken
or unbroken). The reactions and
changes produced are dependent on
many factors, the most important of
which are the manner of entrance into
and excretion from the organism, and
the concentration, duration (time of
exposure), and physicochemical proper-
ties of the poison. The ph3rsico-
chemical properties are especially
important and sometimes enable us to
foresee the possible changes which
may occur in the organism as a result
of their action.
Cadmium is classed as a heavy metal
and consequently should have the
same properties as the heavy metals.
Briefly, according to Flury and Zang-
ger (1), the heavy metaJs have the
following pharmacologic characteris-
tics: great atomic weight and conse-
quently great specific gravity or
density; a tendency when in contact
with organic material to form complex
• From a thesis presented to the Harv&rd
School of Public Health as partial fulfilment
of the requirements for the Doctorate in
Public Health.
Received for publication Jan. 22, 1932.
metal albumin compounds; a general
toxic action which may lead to inJ9am-
mation and degeneration of different
organs, and frequently cause injury
to the capillaries. The soluble metal
albumin compovmds are more nox-
ious because they have a more pro-
found action, and because they are
resorbed more rapidly. As a secon-
dary noxious action we have the
elaboration of acids at the moment of
formation of metal albumin com-
pounds.
In the consideration of cadmium as
an industrial health hazard, we have to
deal with a poison whirh Pnt^rs t,hf
body mainly through the respiratory
system, and secondly through the
gastro-intestinal tract. Consequently
observations on poisoning through the
respiratory system are of greater
value. In studying any kind of poi-
soning we are interested not only in
the acute and chronic action of the
poison, and the sequelae, but also in
the fate of the poison after its entrance
into the body — resorption, distribu-
tion, and elimination. The most com-
mon kind of cadmium poisoning is the
acute respiratory form resultiiig from
exposure in manufacturing and han-
dling cadmiimi compounds. Serious
acute poisoning through the gastro-
intestinal tract is improbable for man
174
J. I.E.
173
CADMIUM POISONING
175
owing to the emetic effect of cadmium;
and since cadmium is not absorbed
through the unbroken skin, poisoning
cannot occur in this manner.
The observations here reported were
made on cats poisoned with cadmium
oxide fume, cadmium oxide dust, and
cadmium sulphide dust. These com-
pounds were chosen because of their
frequent use. Cadmium sulphide was
psperiallv included because it ia be-
]jpvp<| in snmp jnHimtripa in Kp
it , „ harmless. In general the experimen-
[a^ ^\M iCSS tal animals were killed by bleeding,
and after specimens were taken for
microscopic study the organs were
analyzed for cadmium. The method
of cadmium analysis described by
Fairhall and Prodan (2) was employed
in all the chemical work and proved
uniformly satisfactory.
PoisoNLVG Br Inhalation
Cadmium Oxide Fume
High Concentrations:
Two cats (Cats 1 and 2), subjected
to very highly concentrated fume,
were exposed separately for thirty
minutes in a wooden box of about 150
liters' capacity. The fume was gen-
erated in a p>Tex glass tube connected
to the box at one end and to an o.xygen
tank at the other. Small pieces of
metallic cadmium were placed in a
bulb blown at the middle of the tube;
this was heated from below by a
Bunsen burner and a gentle stream of
oxygen was blown through. The mol-
ten cadmium was then ignited by
means of a glowing splint and the
combustion of the metal proceeded
evenly, with the abundant production
of cadmium oxide fume. Cat 1 was
killed by bleeding five hours after
exposure; Cat 2 died about twelve
hours after exposure.
Symptoms. — About ten minutes
after exposure was started the cats
showed an abundant salivation, rather
thick in character, and an increased
respiration (panting), .\fter they
were taken out of the box the saliva-
tion continued and they showed great
difficulty in respiration, stretching
out their forefeet so that the accessory
respiratory muscles entered into
action.
Autopsy. — The lungs showed con-
gestion with several emphysematous
patches at the bases, and were more
solid than normally. The mediasti-
num was edematous, and Cat 1 showed
a yellowish pleural effusion. On sec-
tion the lungs e.'cuded a pink-colored,
aerated liquid. The trachea appeared
normal; a few of the bronchioles were
filled with froth. The liver in both
cats had a fatty appearance. The
rest of the organs were very congested.
Microscopic Findings. — The lungs
(see Fig. 1) of both cats showed exten-
sive acute injury, with the following
outstanding changes: edema, injury to
the bronchioles and alveolar ducts
manifested by desquamation of the
epithelium, polj-morphonuclear leuko-
cyte infiltration in the walls, and
edema of the walls. Acute alveolar
emphysema was present and a small
amount of fibrin was found In the
alveolar spaces.
The liver presented different lesions
in the two cats. Cat 1 showed
slightly swollen cells with prominent
marginal borders, and uniformly
vacuolated and granular cytoplasm.
Cat 2 showed extensive fatty infiltra-
tion (about half of the total liver cells
were filled with fat), and polymor-
Vol. u
No. 1
174
176
THK JOURNAL OF INDUSTIUAL HYGIENE
phonuclcar leukocyte infiltration in
some areas.
The kidneys in Cat 1 showed marked
fatty degeneration, mostly in the
convoluted tubules, and badly swollen
Chemical analysis of the organs of
Cat 1 showed that the cadmium con-
tent was highest in the lungs, next in
the liver, and third in the kidneys
(see Table 1 and Fig. 2).
Fig. 1. — Lesions occurring in lungs of cats poisoned with high concentrations of cad
mium o.xide fume. Showing extensive edema and emphysema, and epithelial desquama-
tion and fibrin precipitate in alveoli and bronchinle*. X 301).
cells. Some fat in the form of
medium-sized vacuoles, chiefly in the
convoluted tubules, w:is found in Cat
2. The other organs presented no
pathologic changes.
Low Concenlialions:
After it was observed that high
concentrations of cadmium o.xide fume
were fatal. Cats 3, 4, and 5 were
exposeil in a gas chamber to less
1. 1. H.
175
CADMIUM POISONING
177
concentrated cadmium oxide fume for
twenty-four hours. Samples of the
exact concentration of cadmium during
the experiment. A typical concentra-
TABLE 1.— CADMIUM CONTENT OF TISSUES OF CAT 1, POISONED WITH
HIGHLY CONCENTRATED CADMIUM OXIDE FUME
Blood. .
LuDgs. .
Liver. . .
Kidneys
BUe. . . .
Urine. . .
ToUl.
PERCZNT-
WKOHT
or Tissue
TOTAL
CADMrUV
AOB or
CAOUIVU
IN 100 CM.
TOTAL
rOCND
or TISSUE
CAMOmt
rOUND
ffm.
mg.
mg.
127.0
traces
69.0
2.50
3.62
46.30
112.0
1.90
1.70
35.20
64.0
0.60
1.11
11.10
1.8
0.25
13.90
4.62
2.5
0.15
6.00
2.78
5.40
100.00
MJOt
LungilinerkidnySik Urine Oho^
Fia. 2. — Distribution and concentrations of cadmium in tissues of Cat 1.
Solid black columns represent percentages of total cadmium found by analysis in dif-
ferent organs. Croas-hatcned columns represent milligrama of cadmium per 100 gm. of fresh
tissue.
^ in the chamber were taken from
time to time in order to determine the
tion curve (or settling curve) is given
in Figure 3. The first sample was
VoLU
N«.|
176
178
THE JOURNAL OF INDUSTRIAL HYGIENE
taken two hours after setting up the
fume; the initial concentration was
therefore estimated from this concen-
tration curve and was found to be 18
mg. per cubic meter of air. The
fume was generated in the same man-
ner as for Cats 1 and 2, by burning
cadmium in a pyrex glass tube with
oxygen. »,
Symptoms. — After about twelve
hours of exposure the cats began to
salivate and showed an increased rate
respiration was difBcult and they
refused to eat. Cat 4 was killed by
bleeding on the fifth day aft«r exposure,
and Cat 5 on the ninth day.
Autopsy. — In Cat 3 the lungs ap-
peared very congested and of dark
reddish-brown color, more solid than
usual and with emphysematous
patches. On section a very little
aerated, reddish-brown liquid escaped
from them. The trachea was slightly
reddened. The liver had a fatty
0 £
4- 6 a /O /£ 14 /6
Time in Houm
/s ^o ^^. £4-
Fio. 3. — ^Typical settling curve of cadmium oxide fume.
of respiration. They refused to eat or
drink and became very depressed. At
the end of the exposure all three cats
were salivating and showed difficulty
in breathing. Cat 3, which had the
symptoms in most accentuated form,
was killed by bleeding. The blood
count before e.Tposure was 7,432,000
for red cells, and 16,500 for white
cells; after exposure it was 8,824,000
for red cells, and 29,600 for white
cells.
Cats 4 and 5 appeared very sick on
the days following exposure. Their
appearance. The rest of the organs
were normal, except for congestion.
Cat 4 showed changes very similar
to those obsen'ed in Cat 3. The
lungs in Cat 5 were extremely con-
gested and of very dark-brown color,
with emphysematous patches. On
section, after the blood content had
been expressed, they did not collapse.
Microscopic Findings. — Cat 3
showed a moderate thickening of the
alveolar walls in the lungs as the most
striking change, with interstitial and
perivascular edema and early poly-
J. LB.
u*y.ua
177
CADMIUM POISONING
179
morphonuclear leukocyte infiltration.
Other findings included extensive
hemorrhage; atelectatic regions and
acute emphysema; desquamation of
the epithelium and hemorrhage in
the bronchioles; and polymorphonu-
TABLE 2.— CADMIUM CONTENT OF TISSUES OF CAT 4, POISONED WITH T,F*SS
CONCENTRATED CADMIUM OXIDE FUME
nsscB
WZIORT
orTzssuz
TOTAL
CABiaUM
FOUND
IN 100 OM.
orTTsauB
PERCBNT-
Aoa or
TOTAL
CADtora
FOUND
Blood
36.0
27.5
57.0
12.6
2.5
1.0
10.0
3.5
3.5
10.5
mg.
trace*
0.39
0.35
0.20
0.12
0.10
0.15
0.07
0.07
0.35
mg.
1.42
0.61
1.59
5.00
10.00
1.50
2.14
2.14
6.67
Lungs .•
Jjvgf
21.67
19.44
TTifinevi
11.11
Bile
6.67
5.56
Heart
8.33
Spleen
3.89
3.89
Feces
19.44
Total
1.80
100.00
O?
51
0
^.^
7
<i:
6
30
*>
^5
41'^
<o
?i:
?o
iS -
no-
if
t
Cat A/a S-
o<s/s.o / 2 a < s 6 7 e
Fia. 4.— Blood variation* of Cats 4 and 5. (Tbe first sample was taken before exposure.)
VoLM
No. I
178
180
THE JOURNAL OF INDUSTRIAL HYGIENE
clear leukocytes in the walla of the
bronchioles.
The Uver showed numerous granu-
lar vacuolated cells, especially around
the central vein, and here and there
the nucleus was destroyed. The archi-
tecture was not disturbed and the
sinusoids were empty. The cells were
slightly swollen and the epithelial
border was prominent. The kidneys
showed a moderate amount of fat in
the tubular epithelium.
The changes in Cat 4 were very
similar to those in Cat 3. The most
prominent change in the lungs of Cat
5 was the marked thickening of the
alveolar walls, which showed extensive
hemorrhage, marked fibroblastic prolif-
eration, and a moderate degree of
inflammatory cell infiltration. The
liver and kidneys showed changes
similar to those found in Cats 3 and 4.
The other organs were negative.
The chemical analysis of the tissues
of Cat 4 is presented in Table 2.
Blood Changes. — The blood changes
in Cats 4 and 5 are shown in Fig\ire 4.
There we see a tendency toward in-
crease in the red cells; the white cell
count increases abruptly on the day
immediately following exposure, but
drops back on the third day, and sub-
sequently fluctuates around the nor-
mal point. The polymorphonuclear
leukocytes, however, maintain a defi-
nite tendency to increase — in Cat 4
from 51 per cent, to 94 per cent, in
four days, and in Cat 5 from 50 per
cent, to 80 per cent, in eight days,
with shght fluctuations during this
period. The microscopic study of the
blood smears showed more or less
normal appearance with no abnormal
cells except in Cat 4 which showed one
normoblast in a whole slide on each of
the last two days before it was killed.
Discussion:
The problem of how much cadmium
was inhaled by the cats and how much
was retained in the lungs is most
important. Although these questions
cannot be answered with accuracy, they
may be answered approximately.
Saito (3), in his experiments on dogs
and on one rabbit, obtained from 4 to
24 per cent, dust (white lead) retention
in the lungs. Cecil K. Drinker and
his coworkers (4) observed that the
natural protection of the lungs of cats,
rabbits, and rats against the inhalation
of dust was very great and was influ-
enced by different factors, such as
quiescence and light breathing.
Philip Drinker and his coworkers (5),
in a study of the retention of dust and
fume by man, found that for zinc oxide
powder it averaged 56 per cent, and
for zinc oxide fume 57 pe: cent.
Brown (6) points out different factors
that influence the dust retention —
inspired dust concentration, particu-
late size, density, wettability, and rate
of respiration. He concluded that
with a respiration rate over 20 per
minute the dust retention is effected
only by impingement and is about 40
per cent, for man.
Normal cats breathe about seventy
times per minute. In the present
research, after about twelve hours of
exposure the breathing of the cats
increased to approximately 100 times
per minute, an unfavorable condition
for the retention of fume or dust.
The volume of air inspired is known
to be about 300 c.c. per minute per kilo
of cat. From these figures and from
J. I. H.
Utr, 1933
179
CADMIUM POISONING
181
the concentration curve (Fig. 3) it was
possible to calculate the theoretical
cadmium content in the inspired air.
The percentage retention was calcu-
lated from the results of the chemical
analysis.
From Table 3 it may be concluded
that the cats had inhaled from 6 t^ 12
mg. of cadmium — the maximum possi-
ble amount under the conditions of the
experiments. Certainly all the cad-
mium retained could not be recovered
by analysis since some must have been
excreted. Even if we assume that 50
tube connected with a blower inter-
rupted about forty times per min.ute.
This air blast maintained a fairly con-
stant concentration of cadmium oxide
dust in the air. Two cats were used
for the experiment: Cat 6, which was
exposed for twenty minutes and was
killed by ether and bleeding one
month later; and Cat 7, which was
exposed three times — for eleven min-
utes on the same day as Cat 6, for
fifteen minutes one month later, and
for thirty minutes on the following
day — and was killed by ether and
TABLE 3.— THEORETICAL AMOUNT OF CADMIUM INSPIRED AND PERCENT-
AGE RETENTION IN CATS POISONED WITH LESS CONCENTRATED
CADMIUM OXIDE FUME
THSOSXnCAl.
CAT NO.
WEIGHT
AMOUNT OF
TOTAL CASUIinC
PERCENTAGE
or CAT
CAOXrUM
Fouxn
RETENTION
INSPIRED
kg.
mj.
»IV7
3
2.45
8.75
1.49
17.03
4
1.70
6.05
1.80
29.75
5
3.53
12.60
2.79
22.14
per cent, of the inspired cadmium was
retained, which represents a very small
amount (3 to 6 mg.), this waa {niffinVnt
to cause considerable damage to
important organs in these animals,
namely, the lungs, liver, and kidneys.
Cadmium Oxide Dust
For the purpose of poisoning cats with
commercial cadmium oxide dust, a
modification of the apparatus de-
scribed by Jotten and Amoldi (7) was
used (see Fig. 5). The cats were put
in the lateral branch boxes of this
apparatus. The cadmium oxide was
placed below in a glass tube, with a
sieve at the bottom, and the glass
bleeding six hours after the last
exposure.
Symptoms. — Cat 6 had abundant
salivation when removed from the
box, appeared very depressed, refused
to eat, and did not react to normal
stimuli. Respiration was increased.
During the following days the cat
was very sick, had noisy respiration,
and refused to eat. Seven days after
exposure it showed signs of recovery,
and on the eighth day began eating.
During this period its weight dropped
from 4.9 kg. to 2.05 kg. The symp-
toms shown after this exposure were
similar to those following exposure to
cadmium oxide fumes; therefore the
Val. u
.Vo. (
180
182
THE JOURNAL OF INDUSTRIAL HYGIENE
cat was left to recover, and on the
following days it improved steadily
although the rate of respiration con-
tinued to be higher than before the
exposure. In two weeks there was an
increase in weight of 0.6 kg., but this
was followed by a loss during the next
two weeks, so that one month after
exposure, when the cat wa^ killed, it
weighed 2.3 kg.
Cat 7 showed very few symptoms
vomiting. Respiration was very diffi-
cult and the animal was in the same
serious condition as the two cats
exposed to high concentrations of
cadmium oxide fume.
Autopsy. — In Cat 6 the lungs were of
a light pink color, with a gray alveolar
design. The trachea was normal in
appearance. The liver was yellowish
brown, friable on section, and had a
fatty appearance. The other organs
Fia. 5. — Cross section of appar&tus used for poisoning cats with cadmium oxide dust
and cadmium sulphide dust.
following the first exposure — chiefly
slight loss of appetite on the day of
exposure. On the next day its appear-
ance was absolutely normal. During
the following month it gained 0.5 kg.
in weight, and at the end of that time
was again exposed for fifteen minutes.
This second exposure apparently dis-
turbed the cat very little, and on the
following day it was again exposed for
thirty minutes. After the third expo-
sure there was abundant salivation and
were normaL In Cat 7 the lungs were
very congested, and on section exuded
an aerated liquid. The trachea and
other organs were normal.
Microscopic Findings. — Cat 6
showed most pronounced changes in
the limgs: chronic and subacute inter-
stitial pneumonia, and marked thick-
ening and fibrosis of the alveolar
walls. Some hemorrhage, as well as
foci of lymphoid cell infiltration, was
seen. Scattering of polymorphonu-
J. I. H.
lOy, mi
181
CADMIUM POISONING
183
clear leukocytes, hyperplastic alveolar regions were also observed. The liver
epithelium, and emphysematous re- showed a marked, central fatty infil-
gions alternating with atelectatic tration, with an occasional tiny nee-
TABLE 4.— CADMIUM CONTENT OF TISSUES OF CAT 6, EXPOSED TO CADM IUM
OXIDE DUST FOR TWENTY MINUTES AND KILLED ONE MONTH LATER
nsstis
Blood
Lunga
Liver
Kidnejn
BQe
Urine ,
Heart
Spleen
Pancreas
Brain
Muscle
Bone (2 femurs)
Total
WEIGHT
or nssvz
ffrn.
80.5
24.0
72.0
11. 0
2.0
4.0
no
2.5
6.6
19.5
56.0
18.0
TOTAL
CADMIUSI
rOOND
Trig.
O.OO
0.25
0.50
0.55
0.05
0.06
0.04
0.05
0.08
0.05
0.10
0.40
CAOMK7V
IN 100 Oli.
or TISSUE
2.13
mg.
0.00
1.04
0.69
5.00
2.50
1.50
0.36
2.00
1.21
0.26
0.18
2.21
PERCENT-
AGE or
TOTAL
CASMTCm
rOTTKD
0.00
11.74
23.47
25.82
2.35
2.82
1.88
2.35
3.75
2.35
4.70
18.77
100.00
TABLE 5.-C.VDMIUM CONTENT OF TISSUES OF CAT 7, EXPOSED TO CADMIUM
OXIDE DUST FOR ELEVEN M1^'UTES, AND AGAIN FOR FIFTEEN
AND THIRTY MINUTES, RESPECTIVELY, ON TWO SUCCES-
SIVE DAYS ONE MONTH LATER
TISSTTE
WEIGHT
or TISStJE
TOTAL
CAOUITni
rOUND
CAS SCUM
IN 100 GM.
or TISSUE
PEHCE NT-
AGE or
TOTAL
CASIOUU
TOTTSO
Blood
gyn.
73.0
23.0
74.0
20.0
2.0
1.5 ,
8.5
4.0
9.0
mg.
traces
2.00
0.75
O.SO
0.30
0.25
0.10
0.12
0.15
mg.
8.70
1.11
2.50
1.50
16.65
1.12
3.00
1.67
Lungs
47.96
Liver
17.99
Kidneys
11.99
Bile
7.19
Urine
5.99
Heart
2.40
Spleen
2.88
Pancreas
3.60
Total
4.17
100.00
Vol It
N«.i
182
184
THE JOURNAL OF INDUSTRIAL HYGIENE
rotic area, and some yellow-brown
material (bile or blood) in the phago-
cytic cells. The kidneys showed fatty
infiltration, especially in the convo-
luted tubules. The other organs were
negative. The chemical analysis of
Cat 6 is given in Table 4.
The lungs of Cat 7 showed acute
edema and generalized bronchopneu-
monia, polymorphonuclear leukocytes
in the alveolar walls and alveolar
lymphatics, interstitial edema, blood
in some of the larger bronchioles, and
acute alveolar emphysema. As was
stated before, Cat 7 appeared abso-
lutely normal following the first
exposure, but lesions were found in the
lungs which showed that this first
exposure had had a damaging effect.
Reparative reaction was found around
and in the lining of the alveolar ducts.
Here and there were small scars with
lymphoid infiltration. The kidneys
showed a moderate fatty infiltration
in the tubules. The spleen showed
abnormal congestion and many poly-
morphonuclear leukocytes. The Uver
and other organs were negative. The
results of the chemical analysis of this
cat are given in Table 5.
Discussion:
From these observations we may
conclude that cadmium oxide dust is
harmful, and that the toxicity resem-
bles that of cadmium oxide fume.'
Further, it is apparent that owing to
fibrotic process, the pneumonia and
' Id the case of both cadmium oxide fume
and cadmium oxide dust the amounts in-
haled were very large, larger probably than
would ever be encountered industrially.
.1 \ The experimentH show that nnHmiiim i< ^
VV dLV**."^- dangerous substance and that the type of
damage to be expected is of such critical
nature' a3~to indicate the avoidance~oT the
■'nhaJatiOQ or ingestion pi exstt small
amoonts of cadmium.
bronchopneumonia produced by cad-
mium oxide (fume or dust) perma-
nently damage the lungs by thickening
the alveolar walls. It is important
that very small amotints of cadmium
oxide were capable of producing scars
in the lungs, thoiiftb lb*? ftniTrml^waq
very little disturbed bv the exposure.
The effect of cadmium oxide dust on
the liver and kidneys was similar to
that of cadmium oxide fume. One
month after exposure there was a
large quantity of cadmium in the body,
the largest amounts being retained in
the kidneys, liver, and bones.
The cadmium oxide dust concentra-
tion to which the cats were exposed,
was determined and was found to be
0.4 mg. per liter of air (or 400 mg. per
cubic meter of air). Taking the
quantity of air inspired as 300 c.c. per
kilo of cat, we have the results shown
in Table 6.
Cadmium Sulphide
The same ^ppaialus wSsUsed as for
the experiments with cadmium oxide
fume. The total number of cats
exposed was four: Cat 8, which was
exposed for two hours and killed by
ether four hours later; Cat 9, which
was exposed for one hour and died
one week later; Cat 10, which was
exposed for two hours and twenty
minutes and died on the sixth day after
exposure; and Cat 11, exposed for
twenty minutes and killed one week
later.
Symptoms.— C&t 8 did not show the
least disturbance after exposure to
cadmium sulphide dust, and immedi-
ately started to eat. Cat 9 presented
a normal appearance and ate well at
the end of exposure and on the day
following. On the third day it had
J. I.H.
u*y, ina
183
CADMIUM POISONING
185
very little appetite, appeared de-
pressed, and had diarrhea. During
the following four days, until its death,
it refused to eat and was very sick,
showing definite pulmonary symp-
toms: increased rate of respiration,
dyspnea, and noisy respiration. Cat
10 displayed similar symptoms, foK
lowed by death on the sixth day. In
took only a very little milk and salmon.
These conditions continued for several
days but the cat was not so seriously
sick as Cats 9 and 10.
AuUypsy. — The lungs of Cat 8 were
normal in appearance except for
numerous dark spots denoting areas of
atelectasis. The lungs of Cat 11 were
nearly normal, having little conges-
T.\BLE 6.— THEORETICAL AMOUNT OF CADMIUM INSPIRED AND PERCENT-
AGE RETENTION IN CATS POISONED WITH CADMIUM OXIDE DUST
THEO-
CASWCK
RETICAI.
TOTAL
CAT NO.
WTIOHT
0»CXT
TIME
EXPOSED
CONTENT
or AIR
AMOUNT 0»
CADICTJM
INSPTSED
CASIO VU
rooNB
PERCENTAGE
RETENTION
iff.
mt'n.
rng./l.
mj.
mg.
6
4.9
20
0.4
11.76
2.13
18.11
7
2.0
u
0.4
2.64
15
0.4
3.60
4.17
31.03
30
0.4
7.20
ToUl 13.44
TABLE 7.— CADMIUM CONTENT OF LUNGS -AND LIVER OF CAT 8, POISONED
BY INHALATION OF CADMIUM SULPHIDE
nsscE
WEIGHT
0? TISSUE
—
TOTAL
CADMIUM
FOUND
CADMIUM
IN 100 GM.
OP TISSUE
PERCENT-
AGE OP
TOTAL
CADMIUM
POUND
Lann
16.0
62.0
1.95
0.15
mg.
11.86
0.32
92.86
Liver
7.14
Total
2.10
100.00
Cat 11 no symptoms were manifested
following exposure. On the next day,
however, the animal refused salmon
and drank only milk, after which
salivation appeared. On the third
day salivation continued and vomiting
occurred in the afternoon after drink-
ing milk. On the fourth day the cat
appeared depressed, was dyspneic, and
tion. Cats 9 and 10 showed con-
siderable congestion. In the rest of
the organs nothing abnormal was
observed.
MicTotcvpie Findings. — In Cat 8
the lungs showed extensive emphy-
sema, some alveolar edema, extenaiTe
interstitial and alveolar hemorrhage,
and early pouring out of polymor-
Vol 14
Mo i
184
186
THE JOURNAL OF INDUSTRIAL HYGIENE
phonuclear leukocytes. The observa-
tion gave the impression that the
extensive acute emphysema might be
due to the obstruction of the small
bronchioles and alveolar ducts by the
cadmium sulphide dust. Chemical
analysis is given in Table 7.
The lungs of Cat 9 showed marked
engorgement of the blood vessels and
capillaries, with hemorrhage in the
interstitial tissue and alveoli. There
was extensive emphysema, some ate-
lectasis, but relatively little inflamma-
tory cell infiltration and edema. The
liver and kidneys were very Uttle
involved.
Examination of the lungs of Cat 11
showed moderate congestion, quite
extensive interstitial and alveolar
hemorrhage, and early pouring out
of the polj-morphonuclear leukocytes.
There was moderate emphysema and
atelectasis.
Discussion:
1^5./ From these observations we may
/conclude that cadmium sulphide is far
/ from being harmless. Its noxious
action is different from that of cad-
mium oxide. The subjective symp-
toms, usually appearing from twenty-
four to thirty-six hours after exposure,
are vomiting and diarrhea, occasion-
ally salivation, dyspnea, and noisy
respiration. The pathologic changes
referable to cadmium itself take place
slowly. The first change in the lungs
is an extensive emphysema, which
cannot be other than mechanical,
resulting from the filling of the small
bronchioles and alveolar ducts with
cadnoium sulphide dust. This effect is
of course not specific for cadmium.
After thirty-sLx to forty-eight hours
the animah develop generalized pneu-
monia, and bronchopneumonia with
edema, and after about a week they
die. Very small amounts of cadmium
sulphide are capable of prnHnning
congested inflarmaatorv gQptj'^'O"?. i"
the lungs, and this can occur without
antecedent atelectasis or emphysema.
The fact that even one week after
exposxire to cadmium sulphide dust
over 70 per cent, of the total cadmium
found was in the lungs, explains why
the other organs were affected very
Uttle, if at all. The difference in the
action of cadmium sulphide and cad-
mium oxide is due to the difference
in physicochemical properties. Cad-
mium sulphide, being very insoluble,
is resorbed slowly; therefore the sub-
jective symptoms are retarded and its
distribution in the body is limited.
Because of its lower density, it requires
a greater volumetric amount than
cadmium oxide, and consequently the
tendency to emphysema production is
greater.
Poisoning bt Feeding
Cadmium poisoning through the
gastro-intestinal tract, as has already
been mentioned, is of no great practical
importance for man. The aim was
especially to investigate microscopi-
cally the pathologic changes which
were observed macroscopically in
poisoning by feeding, and also to
determine the distribution of cadmium
in the body.
For this purpose two cadmium com-
pounds were used, namely, cadmium
carbonate and cadmium phosphate.
We had three groups of cats, with two
in each group, for each salt, and two
cats as control animals, making a
total of fourteen. The cadmium salts
were suspended in a 2 per cent, solu-
J. I. H.
185
CADMIUM POISONING
187
tioa of gum acacia, of which 1 c.c. was
equivalent to 10 mg. of metallic
cadmium. The cats were fed with
salmon and milk to which the cad-
mium was added in different doses for
each group. Feedings were given
daily except Sundays for the first
month, and every day including Sun-
days during the second month, witb
the exception of Christmas day.
much was vomited. As there was no
difference between the effects of the
two cadmium salts, the observations
will be described together.
Table S shows the grouping of the
cats according to the amount and the
duration of cadmium feeding: Group
A, fed 100 mg. daily for one month;
Group B, 10 mg. for two months; and
Group C, 2 mg. for two months.
TABLE 8.— GROUPING OF CATS FED DIFFERENT AMOUNTS OF C.VDMIUM
CARBONATE AND
CADMIUM PHOSPHATE
EILLEO
ULLEO AT
1 MO. ATTEa
QBOOP
CAT NO.
COMPOUND FED
DOSE DAILT
DURATION
OP FEEOINO
END OP
rCEOINO
PEEDINO
DISCON-
TINUED
mg.
mot.
A
1
CdCO,
100
1
yes
2
C<1,(P0.),
100
1
yes
3
CdCO,
100
1
yes
4
Cd,(PO.).
100
1
yes
B
5
CdCO,
10
2
yes
6
Cd,(PO.),
10
2
yes
7
CdCO,
10
2
yes
8
Cd.(PO.).
10
2
yes
C
9
CdCO,
2
2
yes
10
Cd,{P04).
2
2
yes
U
CdCO,
2
2
yes
12
Cd,(PO.),
2
2
yes
The cats were weighed, and blood
samples were taken, before the experi-
ment was started and every two weeks
afterwards. At the end of the obser-
vations the animalg were killed by
bleeding; specimens were then taken
for microscopy, and the body was
analyzed for cadmium. The aim was
to make the cats eat all the cadmium
destined for them, and this was
accomplished for the most part except
in the case of the highest doses. An
estimate was made of the consumed
food containing cadmium, but no
attempt was made to determine how
Group A
Of the four cats in this group, two
(Cats 1 and 2) were killed by bleeding
after one month of cadmium feeding,
and two (Cats 3 and 4) were allowed
to live for one month following the
feeding experiment, during which time
they were given only salmon and milk.
Symptoms. — During the entire feed-
ing period there was always vomiting
when the cats ate food containing 25
per cent, or more of cadmium. At the
beginning of the experiment the vomit-
ing occurred within from two to four
VoL M
No.J-
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188
THE JOURNAL OF INDUSTRIAL HYGIENE
hours after the meal; later it was
delayed so that at the end of about a
month it occurred from eighteen to
twenty-four hours after eating. In
these cases of delayed vomiting the
food was very little digested, having
almost the same appearance as in the
period of early vomiting. This is
perhaps explained by the tcxic effect of
the cadmium salts on the gastric
ferments. At the beginning of the
the animals ate better and partly
regained their lost weight.
Autopsy. — In Cat 1 the kidneys had
the aspect of the so-called "big white
kidney." The lungs, Uver, and other
organs were normal in appearance.
Cats 3 and 4 showed nothing abnor-
mal, and Cat 2 nothing except possibly
a fatty liver and large kidneys.
Microscopic Findings. — Cat 1
showed very slight congestion of the
TABLE 9.— CADMIUM CONTENT OF TISSUES OF CAT 1, FED 100 MG. OF CAD-
MIUM CARBONATE DAILY FOR ONE MONTH AND KILLED AT END OF
CADMIUM FEEDING
•nssms
WIIOHT
0? TISSUE
TOTAL
CATMrUK
rOUKD
CADMnjJI
FEB
100 GK.
OF TISSUE
PERCENT-
AGE or
TOTAL
CADMIUM
FOUND
Blood
gm.
97.5
21.5
67.5
44.0
2.0
8.0
14.0
7.5
7.0
22.0
67.0
28.5
mf.
0.00
0.10
6.75
4.00
0.12
0.10
0.10
0.05
0.05
0.07
0.12
0.60
mg.
0.00
0.46
10.00
9.10
6.00
1.25
0.71
0.67
0.71
0.32
0.18
2.10
0.00
0.S3
55.97
KidnpvB
33.17
Bile
1.00
Urine
0.83
Heart ...
0.83
0.41
Pancreas
0.41
Brain
0.57
1.00
4.98
Total
12.06
100.00
feeding the vomiting was preceded by
abundant salivation, and this still
persisted after the vomiting. The
cats, sls would be expected, lost con-
siderable body weight during the
cadmium feeding. This may be ex-
plained by the inanition due to vom-
iting, loss of appetite, and deficient
digestion of the retained food, and
also to the toxic effect of cadmium.
When the cadmium was discontinued
lungs, a few polymorphonuclear cells
in the alveolar walls, and some emphy-
sema. The liver was essentially nega-
tive. The kidneys showed a varying
degree of degeneration of the tubular
epithelium, involving principally the
proximal convoluted tubules, and to
a slight extent the collecting tubules.
The glomeruli showed no change.
The gastro-intestinal tract, the trachea,
and other organs, including the heart,
J.I.H.
187
CADMIUM POISONING
189
spleen, pancreas, brain, bone marrow,
and muscle, were all negative. The
chemical analysis of this cat is given
in Table 9. The analysis of 11 gm. of
feces (found in the rectum) yielded 60
mg. of cadmium.
The lungs of Cat 2 showed very few
polymorphonuclear cells. In the liver
there was a general granulation of the
ceUs, which was more prominent in the
central areas. The kidneys presented
the same tubular fatty degeneration as
those of Cat 1, but to a lesser extent.
Blood Changes. — The blood was not
affected in this group of feeding
experiments.
Group B
The cats in this group were fed 10
mg. of cadmium daily for two months,
after which two (Cats 5 and 6) were
killed and two (Cats 7 and 8) were put
on a plain diet for a month.
Symptoms. — During the first ten
or twelve days vomiting occurred
from four to six times, accompanied
TABLE 10.— CADMIUM CONTENT OF TISSUES OF CAT 3, FED 100 MG. OF CAD-
MIUM CARBONATE DAILY FOR ONE MONTH AND KILLED ONE MONTH
AFTER DISCONTINU.OfCE OF CADMIUM FEEDING
nsscs
Blood
Liver
Kidneys
BUe
Urine
Bone (1 femur)
Tot»l
WWOHT
OFTIMCE
fftn.
117.0
103.0
38.0
0.8
34.0
16.0
TOTAL
CASMTUM
FOUND
0.00
4.00
2.00
0.05
O.IS
0.80
7.00
CADMIUV
FEB
100 GM.
OFTISSUX
mg.
0.00
3.88
5.26
6.25
0.44
5.00
FERCENT-
Aox or
TOTAL
CAfiuruv
FOOND
0.00
57.14
28.57
0.72
2.14
11.43
100.00
In Cat 3 the lungs were negative;
the hver showed a general granulation
of the cells, and large vacuoles of fat.
The fat accumulation was not so
prominent in the central areas, but
seemed to be more generalized. If
there was any repair it was very slow.
The kidneys showed a pronounced
fatty degeneration of the tubules.
Chemical analysis of the tissues is
given in Table 10.
The changes observed in Cat 4
were much the same as those in the
other cats in this group.
by salivation. During the vomiting
period the appetite was decreased.
After vomiting ceased, all the cats
started to eat well, and continued to
do so until about the end of the second
month when, with the e.Tception of Cat
5, they all showed a marked decrease
in appetite. Cat 5 refused to eat on
the forty-second day of the cadmium
feeding, and was killed the next day.
The variations in body weight were
definite only for Cat 5, in which there
was a steady decrease.
Autopsy.— Except for a very fatty
Vol. u
Xo.J
188
190
THE JOURNAL OF INDUSTRIAL HYGIENE
liver in Cat 5, nothing abnormal was
found.
Microscopic Findings. — In Cat 5 the
liver showed a strikingly profound
alteration, so that the central and
midzonal areas of lobules stood out
prominently as lightly stained vacuo-
lated areas. In the periphery of the
lobules of the hver the tissue was
relatively normal in all respects.
The portal blood vessels and biliary
out the liver tissue, but especially
near the periphery of the lobules, a
yellow-brown pigmented material was
noticed in the form of droplets and
granules, often enclosed within phago-
cytic cells. Occasional scattered
Uver cells could be seen which were
necrotic and were invaded by poly-
morphonuclear leukocjrtes. The kid-
neys showed a moderate degree of fat
in the tubxiles; the other organs were
TABLE 11.— CADMIUM CONTENT OF TISSUES OF CAT 5, FED 10 MG. OF CAD-
MIUM CARBONATE DAILY FOR TWO MONTHS AND KILLED AT END OF
CADMIUM FEEDING
Blood
Lungs
Liver
Kidneys
BUe
Urine
Heart
Pancreas
Spleen
Brain
Muscle
Bone (2 femurs)
Total
WIIQHT
OTTisain
TOTAL
CASMIUU
FOUND
CASiauii
PEB
100 OX.
OFTISaTTE
Qin.
62.0
14.0
44.5
21.5
1.5
11.0
9.0
5.0
4.5
23.0
99.0
20.0
mg.
0.00
0.10
2.50
1.00
0.07
0.15
0.05
0.04
0.05
0.06
0.10
0.50
mg.
0.00
0.79
5.62
4.65
4.66
1.36
0.56
0.80
1.11
0.26
0.10
2.50
....
4.62
....
PERCENT-
AGE OF
TOTAL
CADMItTM
POUND
0.00
2.16
54.11
21.65
1.52
3.25
1.08
0.87
1.08
1.30
2.16
10.82
100.00
ducts presented no abnormalities.
The central veins were engorged. A
more detailed study of the central
areas mentioned above revealed that
practically every liver cell contained
many small or single large, clear
vacuoles of fat. This fat accumula-
tion caused distortion of the columns
of liver cells so that the sinusoidal
spaces were di£5cult to recognize
and appeared compressed. Through-
negative. The chemical analysis of
Cat 5 is given in Table 1 1 . The analy-
sis of the feces showed 10 mg. of
cadmium in 6 gm. of feces.
The changes observed in the other
cats in this group consisted chiefly in
granulation of the Uver cells and
pronounced fatty degeneration of the
renal tubules.
Blood Changes. — No marked blood
changes were noted except in Cat 5,
J. I. H.
189
CADMIUM POISONING
191
which showed an increase in the
number of red cells and in the hemo-
globin content.
Group C
The experiments in this group, in
which cats were fed 2 mg. of cadmjum
daily for two months, proved to be
simple variants of those with large
doses, and they will therefore not be
considered separately.
Discussion:
Cats fed with large doses (100 mg.)
of cadmium vomited during the entire
period of cadmium feeding. At the
beginning of the period the vomiting
occurred within two or three hours
after eating, but it became progres-
sively delayed until at the end it
occurred from eighteen to twenty-four
hours after eating. The cats showed
a marked loss of appetite and a pro-
gressive loss of weight. The loss of
weight was so pronounced in one
instance (Cat 1) that the muscles were
reduced to a TniniTniiTn and the cat
could hardly walk. The cats which
were fed an intermediate dose (10 mg.)
vomited only at the beginning of the
period. They lost less weight than
the animals fed larger doses, and had
fairly good appetites except during the
vomiting period and at the end of the
second month. The vomiting in both
groups of cats was accompanied by
salivation. The cats fed with small
doses (2 mg.) did not vomit, and in
general maintained their body weight.
Their appetites were good except at
the end of the second month, when
there was a marked loss of appetite.
During the feeding period no other
symptoms were observed.
At autopsy, in general no pathologic
changes were found except occasionally
very marked fatty hver and large
kidne>-s. The urine from these cats
gave a typical Gmelin test, and was
negative for albumin when tried in
a few cases (four in all). Microscopic
changes occurred chiefly in the liver
and the kidneys, and in such a manner
that either one or the other was more
affected, and only seldom were both
affected profoundly. For the most
part, the cats with less appetite, or
those that refused more often to eat,
had badly affected livers; in those that
ate well, the kidneys were more
affected. The changes in the liver
ranged from general granulation of the
liver cells, aa the minimum, to a
generalized fatty infiltration as the
most profound change, predominant
in the central areas of liver lobules.
The cats which were put on a plain diet
for one month after the cadmium feed-
ing was discontinued did not show any
sign of repair; if there was any it was
very slow. The changes in the liver
were accompanied by a biliary stasis.
The kidneys presented only one t3rpe
of lesion, namely, fatty infiltration,
which was more predominant in the
convoluted tubules and occurred very
little in the collecting tubules; the
remainder of the kidneys was more or
less normal in appearance.* No casts
were observed in the tubules, such as
were described by Severi (8) after
intravenous injection of cadmium
chloride. Neither was mflammation
of the upper respiratory tract observed
during the period of cadmium feeding,
as described by Schwarz and Otto (9),
and the microscopy of the trachea
was always negative. The gastro-
intestinal tract also appeared normal
Vol 14
No. I
190
192
THE JOURNAL OF INDUSTRIAL HYGIENE
in all instances, both macroscopically
and microscopically.
The cadmium was stored principally
in the liver; in the majority of cases
the kidneys contained the g^^atest
relative amount (t.e., the quantity per
100 gm. of tissue), and in a few cases
the greatest absolute amount. The
excretion was effected through the
gastro-intestinal tract and the kidneys,
and was very slow as is seen from the
analysis of the organs of the cats
remaining on a plain diet for one month
after cadmium feeding was discon-
tinued. The blood did not change in
any definite way.
The observations concerning vomit-
ing and distribution of cadmium in
the body are in accordance with
Schwartze and Als berg's (10) findings,
and the distribution of cadmium is
also in accordance with Hessel's (11)
work, except that in neither instance
(10) (11) was cadmium found in the
bones.
PKEVEjmON OF POISONINO
It has been shown that cadmium
poisoning as an industrial hazard
occurs through the respiratory tract,
and that very small amounts of cad-
piium oxide fume or dust, as well as
of cadmium sulphide, may produce
serious damae;e in the lungs. On the
basis of these observations one may
conclude that cadmium, no matter how
small the amount taken into the lungs,
and that
permissible
-'A / causes pathologic changes
therelore7
no
there is.
ftTTiount of cadmium.
There are two possible methods for
protection against cadmium fume or
dust: adequate ventilation at the
source of the fume or dust, which is of
course the more important; and the
provision of masks or respirators for
use in emergencies or for short periods
of time. The type of ventilation
which should be provided will not be
discussed here, but the protective
value of one type of mask and one type
of respirator will be presented, to-
gether with suggestions as to when
each should be used.
The Burrell dust mask and the
Willson bag respirator were tested for
cadmium oxide fume and for cadmium
chloride fume mixed with hydrochloric
acid. The procedure was as follows:
Cadmium was burned in an electric
furnace in a large dust cabinet. After
there was sufiBcient cadmium oxide
fume, samples were taken with two
impingers in series (12) for the deter-
mination of the cadmium concentra-
tion in the cabinet. Air was then
extracted from the cabinet through
the respirator or the mask, and con-
ducted through the double impinger,
in order to determine the cadmium
content. Finally, from the cadmium
concentration in the cabinet and the
quantity of cadmium passed through
the mask or the respirator, the per-
centage efficiency of each device was
calculated. For the tests with cad-
mium chloride fume, cadmium chloride
was burned in an electric furnace, and
in order to simulate industrial con-
ditions hydrochlonc acid vapor was
introduced, the concentration of which
was not determined since cadmium
chloride and hydrochloric acid in var>'-
ing amounts sometimes occur together
in industry. The determination of
the cadmium content of the cabinet
and the test for the masks were carried
out in the same way as for cadmium
oxide.
The results of these tests, presented
J. I. H.
U*y, in]
191
CADMIUM POISONING
193
in Table 12, show that the Burrell dust
mask retained a greater percentage of
cadmium than the Willson bag respira-
tor. A respirator of the efficiency of
the Willson bag seems suitable for
protection against low concentrations,
have once been exposed to cadmium in
any form and have developed pul-
monarj- symptoms, however mild,
should not suffer a second exposure.
In the smelting of zinc ores containing
cadmium, particular precaution should
T.\BLE 12.— EFFICIENCY OF BURRELL DUST M.\SK AND WILLSON BAG
RESPIR.\TOR IN CADMIUM OXIDE FUME AND IN CADMIOI CHLORIDE
FUME MIXED WITH H'i'DROCHLORIC ACID
COMPOrHD
TADMIUM
COSXKN-
THATION IN
CABINET
MASK OR
RESPIRATOR
TESTED
PERCENTAGE
EPFinENCT
Cadmium oxide
Cadmium chloride
rttg./cu. Jn.
134 00
55 00
26 00
19 30
11 00
8.84
Burrell mask
Willson bag
Willson bag
Willson bag
Burrell mask
Willson bag plus
soda lime car-
tridge'
96 2
79 0
82 6
73 3
82.5
87 0
' The soda lime cartridge is for protection against the hydrochloric acid vapors.
/"•/7>
•vy. • *, •♦ ....... .1
-«.:»----
Fia. 0. — Particles of cadmium oxide fume. X 1,285.
while the Burrell mask is advisable
when high concentrations are encoun-
tered. It should be emphasized again,
however, that adequate ventilation is
the chief consideration in protective
measures. Furthermore, persons who
be taken during the first two hours
when cadmium fume in high concen-
tration is given off. The possibility
of cadmium poisoning in zinc smelters
was asserted by Tracinski (13) and
Sigel (14), and more recently by
VoLU
No. i
192
194
THE JOURNAL OF INDUSTRIAL HYGIENE
Stephens (15). Stephens based his
conclusions on chemical analyses made
on the livers of persons working in
zinc smelting.
The fact that the efficiency of the
mask and the respirator is not nearer
100 per cent, is probably explained by
the smallness of the cadmium o.\ide
fume particles. A measurement of
these particles after the fume had been
set up eight hours showed that 83.5
per cent, were under 1 micron. The
sample was taken with the electric
precipitator, and the floccules were left
out of the measurement. The appear-
ance of the cadmium oxide fume is
given in Figure 6. The size of parti-
cles reported by Legge (16) shows 96
per cent, under 2 microns. The
smallness of the particles is an addi-
tional argument for adequate ventila-
tion.
Summary and CoxcLrsiONS
A thorough review of the literature
showed that the work done on cad-
mium was considerably varied, but
unsatisfactory from the standpoint
of the industrial hygienist (17). Al-
though industrial cadmium poisoning
occurs practically entirely through
the respiratory system, the least work
was done in this direction. Even in
feeding experiments the pathologic
changes were not precisely determined
since they were not verified by micro-
scopic examination. . Much has been
achieved, therefore, in the present
study which presents valuable infor-
mation for the industrial hygienist.
Poianning by Inhalation
Cadmium poisonin.c; was produced
in cats through the respiratory system
with cadmium o.xide fume, cadmium
oxide dust, and cadmium sulphide
dust. From these experiments the
following conclusions may be drawn:
Cadmium Oxide Fume and Dust. —
' Cadmium oxide fume or dust when
inhaled produces an increase in the
rate of respiration and abundant sali-
vation, which appears during the
exposure or immediately after. Later
, the respiration becomes more d>-spneic
', and noisy. The animals refuse en-
tirely to eat or drink.
In high concentrations cadmium
o.xide induces the development of
edema of the lungs which results in the
death of the animals. In smaller
; amounts it produces generalized pneu-
monia and bronchopneumonia, emphy-
sema, and atelectasis. The develop-
ment of the pneumonia is accompanied
by a progressive thickening of the
alveolar walls constituting a perma-
nent damage due to fibrotic tissue and
indicated by the subjective sj-mptom
of increased rate of respiration. The
emph>-sema at best is partly mechani-
cal, being formed by filling of the small
bronchioles and alveolar ducts with
cadmium oxide. In verj- small
amounts cadmium oxide produces
scars in the lungs, though there are no
subjective sjinptoms following such
exposures.
Cadmium oxide produces changes
in the liver varying from a general
granulation of the cells, as a minimum
lesion, to a pronounced fatty infiltra-
tion of the cells from the central areas
of the lobules, as a maximum lesion.
The kidneys are affected by a fatty
infiltration of the cells which is more
pronounced in the convoluted tubules.
The other organs in general are not
affected.
Cadmium is found mainly in the
J. I. H.
]Uy. lasi
i
193
CADMIUM POISONING
195
lungs, liver, and kidneys shortly after
the exposure; later it becomes stored
up chiefly in the Uver, kidneys, and
bones.
Cadmium Sulphide Dust. — The ani-
mals exposed to cadmium sulphide
dust manifested symptoms only after
>- twenty-four to thirty-six hours follow-
ing the exposure. These consisted in
vomiting, diarrhea, occasional saliva-
tion, and increased rat« of respiration,
which was dyspneic and noisy.
Cadmium sulphide causes general-
ized pneumonia and bronchopneu-
monia accompanied by edema, and
extensive emphy^ma and atelectasis
of a mechanical nature. The limgs are
usually the only organs affected.
Cadmium is found mainly in the
/ lungs, with a small percentage in the
/ liver and kidneys. The difference in
[ the distribution of cadmium sulphide
and cadmium oxide is explained by
the greater insolubihty of the former
compound.
With both cadmium sulphide and
cadmium oxide the excretion is af-
fected very slowly through the kid-
neys and the gastro-intestinal tract.
No definite blood changes are found.
Poisoning by Feeding
Cadmium poisoning was produced
by feeding cats cadmium carbonate
and cadmium phosphate. Since no
difference was noted in the action of
these two salts, the same conclusions
may be drawn from both groups of
experiments:
Cadmium fed in large doses induces
vomiting, with salivation and loss of
appetite. Vomiting also occurs for
a short period following medium
doses, but is absent with small doses.
The vomiting and loss of appetite
are followed by loss of Body weight.
Irrespective of the dose of cadmium
fed, the liver and kidneys are affected,
with more pronounced lesions in one
or the other. The liver presents
^changes varying from a general granu-
lation of the cells to a pronounced
fatty infiltration, especially around the
central vein. The kidneys show a
fatty infiltration, which is more promi-
nent in the convoluted tubules. The
other organs are not usually affected.
Cadmium is retained in the liver in
greater absolute quantity, and in the
kidneys in greater relative quantity.
The bones also retain a high per-
centage.
Cadmium is excreted very slowly
through the kidneys and the gastro-
intestinal tract.
No definite blood changes are found.
Prevenlion of Poisoning
One type of mask and one type of
respirator were tested against cad-
mium oxide and against cadmium
chloride mixed with hydrochloric acid
vapor. The use of the respirator is
recommended where the percentage of
cadmium contained in the material
handled is small. A soda lime car-
tridge should be attached to the
respirator when acid fume is also
present in the atmosphere. The mask
should be used in all cases where the
cadmium content is high. Adequate
ventilation is the most important
consideration in the prevention of
cadmium poisoning.
VoLlI
Ne.i
194
196
THE JOURNAL OF INDUSTRIAL HYGIENE
BIBLIOGRAPHY
1. FLrRT, F., AKD Zangger, H.: Lehr-
buch der Toxikologie fOr Studium
und Praxis. Berlin, Julius Springer,
1928.
2. Fairhau., L. T., and Prodan, L.:
The Colorimetric Determination of
Minute .^mounts of Cadmium. Jour.
Am. Chem. Soc, 1931, 55, 1321.
3. Saito, Y. : ExperimeQteUe Untersuch-
ungen Qber die quantitative Absorp-
tion von Staub durch Tiere bei genau
bekanntem Staubgehalt der Luft.
Arch. f. Hyg., 1912, 75, 134.
4. Drinxer, C. K., Drinseb, P., Ain>
Drinker, K. R.: An Effective
Method for Conducting Experiment*
on Dust Inhalation. This Joub.,
1925, 7, 440.
5. Drixser, p., Thomson', R. M., akd
Finn, J. L.: Quantitative Measure-
ments of the Inhalation, Retention,
and Exhalation of Dusts and Fumes
by Man: I. Concentrations of 50 to
450 Mg. per Cubic Meter. Ibid., 1928,
10, 13.
6. Brown, C. E.: Quantitative Measure-
ments of the Inhalation, Retention,
and Exhalation of Dusts and Fumes
by Man: II. Concentrations below
50 Mg. per Cubic Meter. Ibid., 1931,
tS, 285.
Brown, C. E.: Studies in Dust Reten-
tion: III. Factors Involved in the
Retention of Inhaled Dusts and
Fumes by Man. Ibid., p. 293.
7. JOtten, K. W., ajtd Arnoldi, W. :
Gewerbestaub und Lungentuberku-
lose (Stahl-, Porzellan-, Kohle-, Kalk-
staub und Russ). Schrift. a. d.
Gesamtgeb. d. Gewerbehyg., No. 16.
Berlin, Julius Springer, 1927, p. 107.
8. Severi, a.: Le alterazioni del rene nel
veneficio pel cloniro di cadmio. y
Arch, per le sc. med., 18§6, 10, 293. '
9. ScHWARZ, L., AND Otto, A.: Ist Cad-
mium ein gewerblicbes Gift? Ztschr.
f. Hyg. u. InfektioDskrankh., 1925,
lOi, 364.
10. SCHWABTZE, E. W., AND AlSBERO, C.
L.: Studies on the Pharmacology of
Cadmium and Zinc with Particular —
Reference to Emesis. Jour. Phar-
macol, and Ezper. Therap., 1923,
f/,1.
11. Hessel, G.: Uotersuchungen Qber das
Schicksal des Cadmiums nach paren-
tender Einverleibung. Biochem.
Ztschr., 1928, i77, 146.
12. Kati, S. H., Swth; G. W., Mtxhs, W.
M., Trostel, L. J., Ingels, M., a.nd
Greenburo, L. : Comparative Tests
of Instruments for Determining .at-
mospheric Dusts. U. S. Pub. Health
BuU. No. 144, 1925.
13. Tracinski: Die oberschlesische Zink-
industrie und ihr Einfluss auf die
Gesundheit der .Arbeiter. Deutsch.
Vrtljschr. f. Cffentl. Gsndhtspflg.,
18S8, 20, 59.
14. SiccL, J.: Das Giessfieber und seine
Bekampfung mit besonderer BerUck-
sichtigung der Verhfiitnisse in Wurt-
temberg. Vrtljschr. f. gerichtl. Med.,
1906, St, 174, 384.
15. Stephens, G. A.: Cadmium Poisoning.
This Jour., 1920-1921, *, 129.
16. LcGGE, T. M.: Cadmium Poisoning.
Ann. Rep. Chief Inspect. Factories
for 1923. H. M. Stationery Office,
1924, p. 74.
17. Prodan, L. : Cadmium Poisoning: I.
The History of Cadmium Poisoning
and Uses of Cadmium. This Jocr.,
1932, H, 132.
J. I. H.
Hay. mi
195
W'
T^Av^ 4^^ C- Sce-H-
ATMOSPHERIC
ENVIRONMENT
AN INTERNATIVNAL JOURNAL
Tofanne 7
«
il//? POLLUTION ^cJ^
Sdf-
.2
[Aruary 1973 ■ mouSTBIAL AERODYNAMICS
ges 145-240
kl^lS i MICROMETEOROLOGY
AEROSOLS |v); r - , .,. /
frr-
PERGAMON PRESS Oxford New York Braunschweig
196
jtintosphaic Eminnment Pergamon Press 1973. Vol. 7, pp. 353-355. Printed in Great Britain.
FLUORESCENT PARTICLE ATMOSPHERIC TRACER:
TOXICITY HAZARD
L. Arthur Spomer
College of Agriculture, University of Illinois, Urbana, Illinois 61801, U.SA.
{First received 1 June 1972 and in final form 12 October 1972)
Abstract — Fluorescent particle atmospheric tracer (FP) is conunonly used in atmospheric
diffusion and air pollution studies. FP is a finely powdered mixture of zinc sulfide and cadmium
sulfide which fluoresces a characteristic color when exposed to ultra-violet radiation. Cadmium
and cadmium compounds are highly toxic and the use of FP in open atmospheric experiments
- presents a potential human health hazard.
INTRODUCTION
Atmospheric tracers are distinctive materials released into or formed natxirally in
the atmosphere which are useful as indicators of atmospheric flow or of the transport
and diffusion of materials in the atmosphere. Fluorescent particle atmospheric tracer
(FP) has found wide application in atmospheric studies (Leighton, 1964; Lhghton
et al., 1965). FP is a dry, finely powdered mixture of zinc sulfide and cadmium sulfide
which radiates a characteristic ultra-violet-stimulated fluorescence distinct from that
of common atmospheric materials.
Cadmium (Cd) and Cd compounds are highly toxic to humans (American Con-
ference OF Governmental Industrial Hygienists, 1971; Anon., 1970; Athanas-
siADis, 1969; Barrett et al., 1947 a, b; Dunphy, 1967; Friberg, 1959; Friberg
etai, 1971; Kendrey et al., 1969; Prodan, 1932 a, b; Sax, 1963). Cd can be
absorbed into the body by inhalation, ingestion, injection, or epidermal contact and
is accumulated in tissues without regard to existing body concentrations. Cd is
apparently not essential for growth and its exact physiological action is not com-
pletely understood. It is known to be toxic to almost all physiological systems and
may be toxic in acute or chronic exposure. Recovery from Cd poisoning is variable
and depends on the nature, intensity, and duration of exposure.
Although Cd toxicity is well-established and FP is commonly used as a tracer in
atmospheric studies, no case of Cd poisoning resulting from the use of FP has been
reported in the literature. This may be because none has occiured; however, it is
more likely that such poisoning has been of a low-level chronic nature and its symp-
toms are less dramatic and more difficult to recognize than in the case of acute Cd
poisoning. A general ignorance of the toxicity of FP and of the symptoms of Cd
poisoning also contribute to the failure to recognize FP poisoning. No information
directly concerned with FP toxicity and the potential health hazard associated with
its use has been pubUshed. This paper presents a brief general review of the symptoms
of acute and chronic Cd poisoning by inhalation and ingestion and a brief discussion
of the potential health hazard associated with its use in atmospheric studies.
SYMPTOMS OF Cd POISONING*
Symptoms of Cd poisoning range from very mild to very severe depending on the
kind and degree of exposure and the time elapsed since exposure.
* Over 150 papers describing case histories and experimental observations of Cd poisoning were
assimilated into this review of symptoms. The author felt that this was too great a nimiber to cite
and refers the reader to the papers cited in the Introduction for greater detail on Cd poisoning
symptoms.
AA7/3— H 353
197
354 L. Arthur Spomer
Acute poisoning can result in pulmonary edema, pneumonitis, alevolur cellular
proliferation and metaplasia, arterial thrombi, renal bilateral cortical necrosis, renal
tubular degeneration, renal glomeryal infaraction, and death. Inhalation of dust or
fumes initially affects the respiratory tract. Immediate symptoms include throat
dryness, nasopharyngeal irritation, cough, dyspnea, chest pain, chills, weakness,
headache, nausea, vomiting, and diarrhea. More severe exposure causes marked
lung changes with persistent cough, severe chest pain, severe dyspnea, and prostration
which may terminate fatally. Even brief exposure to high concentrations may result
in pulmonary edema and death.
Delayed symptoms include lung damage similar to that from bronchopneumonia,
acute kidney inflammation, dark urine, and fatty degeneration of the liver. These
symptoms may be delayed several hours after exposure and fatal concentrations can
be breathed without sufficient discomfort to warrant avoiding further exposure.
Ingestion of Cd causes gastro-intestinal poisoning similar to food poisoning in symp-
tomology. Nausea, salivation, vomiting, diarrhea, and severe abdominal pain begin
almost inmiediately. Long term effects of eigher acute or chronic Cd inhalation or
ingestion include proteinuria, emphysema, anemia, hypertension, kidney stones,
testicular damage, bone lesions, teratogenic damage, growth retardation, anosmia,
yellowing of dental necks, lumbar and lower extremity pain, and death.
The accumulation of Cd in body tissues has been surveyed experimentally and in
autopsy specimens. The greatest accumulation was observed in the kidneys and liver
with large amounts also in the spleen, pancreas, thyroid, adrenals, and testes.
Inhaled Cd accumulates mainly in the kidneys, pancreas, and thyroid.
FP HEALTH HAZARD
A lack of pubUshed information about FP or CdS toxicity necessitates estimation
of the FP health hazard from general Cd toxicology and the physical and chemical
properties of FP. Many factors contribute to an individual's tolerance to Cd exposure
including his physiological character and previous exposure from pollution, occupa-
tion, food, cigarettes and other Cd sources. Human threshold limit values (TLV) of
Cd toxicity have been estimated from experimental and occupational exposure to
CdO Dust and fumes to be 0.05-0.10 mg Cd m"' (Prodan, 1934 a, b). These
levels have been adopted by the American Conference of Governmental Industrial
Hygienists (1971) as their recommended legal TLV. Barrett et al. (t947 a, b)
estimated the acute lethal dosage to be 2500 min mg Cd m"' (5.2 mg m~^ for 8 h).
A review of recent studies by Friberg et al. (1971) indicates that chronic exposure to
concentrations as much as 100 times less than the legal TLV can also be hazardous.
A total accumulated body burden from all sources of about 120 mg results in per-
manent serious kidney damage.
FP is a finely powdered (1-5 /ira dia.) mixture of approximately 20% CdS and
80% ZnS or about 0.16 g Cd g"* FP. CdS is insoluble in water but soluble in weak
acid. Since the recommended TLV is based primarily on CdO which is also insoluble
in water, the TLV is assumed to apply directly to CdS and FP toxicity. Both the zinc
and sulfur in FP are generally nontoxic. Experimental evidence indicates that zinc
may even prevent or reduce the effects of Cd poisoning (Gltnn et al., 1968 ; Schroeder
et al., 1968). The body regulates tissue zinc concentrations at relatively constant levels
whereas Cd is accumulated without regard to existing tissue concentrations (Lucis
198
Fluorescent Particle Atmospheric Tracier: Toxicity Hazard 355
et al., 1970) and the protective effect of zinc, if it even occurs in the case of FP, may
not be valid over a long period of chronic exposure to FP. In this discussion, the
possible protective effects are therefore ignored. Assuming 1.5 x 10*" particles of
FP g~* (Lhghton et al, 1965), any atmospheric FP concentration greater than 10'
particles m"' exceeds the recommended TLV and any exposure greater than 2500
X 10' particle min FP m~ ' exceeds the acute lethal dosage. A typical FP dissemination
rate from a point source during an atmospheric diffusion study is about 10 g min~*
(Leighton, 1964; Leighton et al., 1965). Under neutral conditions (wind 4 m sec"',
overcast), the TLV would be exceeded closer than 160 m downwind and the minimum
chimney height required to avoid a TLV concentration at ground level woxild be about
100 m (Turner, 1969). The use of FP must be evaluated in relation to total atmos-
pheric Cd concentrations in many urban areas where existing Cd levels are high
(Carroll, 1966).
In conclusion, FP does present a potential health hazard to experimenters and other
humans exposed to it and precautions should be exercised to avoid or minimize
exposure during its storage, handling, and experimental tise. The accumulation of
Cd in the body presents a special hazard to ejcperimenters who are repeatedly exposed
toFP.
REFERENCES
American Conference of Governmental Industrial Hyoienists (1971) Committee on threshold
limit values. Documentation of TLV for substances in workroom air (3rd edn). Cincinnati, Ohio.
ANONYMOin (1970) Further advances in cadmium toxicology. Fd Cosmet. Toxicol. 8, 317-319.
Athanassiadis Y. C. (1969) Preliminary air pollution survey of cadmium and its compounds, 81 pp.
■ Pub. APT D 69-32. U.S. Dept. H.E.W., Raleigh. N.C., U.S.A.
Barrett H. M., Irwin D. A. and Semmons E. (1947a) Studies of inhaled cadmium. I — ^The acute
toxicity of cadmium oxide by inhalation. J. ind. Hyg. Toxicol. 29, 279-285.
Barrett H. M. and Card B. Y. (1947b) Studies on the toxicity of inhaled cadmium, n — The acute
lethal dose of cadmium oxide for man. /. ind. Hyg. Toxicol. 29, 286-293.
Carroll R. E. (1966) The relationship of cadmium in the air to cardiovascular disease death rates.
J. Am. Med. Assoc. 198, 177-183.
DuNPHY B. (1967) Acute occupational cadmium poisoning. /. Occup. Med. 9, 22-26.
Friberc L. (1959) Chronic cadmium poisoning. AMA Arch. Indust. Hlth 20, 401-407.
Friberc L., Piscator M. and Nordbero G. (1971) Cadmium in The Environment, 166 pp. Chemical
Rubber Co., Qevcland, Ohio.
GiWN S. A., Gould T. C. and Anderson W. A. D. (1968) Mechanisms of zinc, cysteine, and selenium
protection against cadmium induced vascular injury to mouse testis. /. Reprod. Fert. 15, 65-70.
Kendrey G. and Roe F. J. C. (1969) Cadmium toxicology. The Lancet 2, 1206-1207.
Leighton P. A. (1964) The fluorescent particle atmospheric tracer, 51 pp. Tech. Report No. 104.
Metronics Assoc.. Inc., Palo Alto, California, U.S;A.
Leighton P. A., Perklns W. A., Grinnell S. W. and Webster F. X. (1965) The fluorescent particle
atmospheric tracer. /. appl. Met. 4, 334-348.
Luas O. J., Shiakh Z. A. and Embil J. A.. Jr. (1970) Cadmium as a trace element and cadmium bind-
ing components in human cells. Experentia 26, 1109-1110.
Prodan L. (1932a) Cadmium poisoning: I — The history of cadmium poisoning and uses of cadmium.
/. ind. Hyg. Toxicol. 14, 132-155.
Prodan L. (1932b) Cadmium poisoning: II — Experimental cadmium poisoning. /. ind. Hyg, Toxicol.
14, 174-196.
Sax N. I. (Editor) (1963) Dangerous Properties of Industrial Materials, pp. 558-562. Reinhold, New
York.
Schroeder H. a.. Nason A. P. and Mttchener M. (1968) Action of a chelate of zinc on trace
metals in hypertensive rats. Am. J. Physiol. 214, 796-800.
Turner D. B. (1969) Workbook of Atmospheric Dispersion Estimates, 84 pp. U.S. Dept. H.E.W.,
Public Health Service Pub. No. 999-AP-26. National Air Pollution Control Administration,
Cincinnati, Ohio.
199
RICANJmWYER
September 26, 1994
I am a senior reporter for The American Lawyer magazine
in New York. I wrote an article about Elizabeth Barrett's
suits against the government which was published in the Sep-
tember 1990 issue ("Elizabeth Barrett's Bad Trip").
I came away from the experience having reached the fol-
lowing conclusions.
If someone has been injured by actions of federal
government officials, there are two main ways to sue--
bringing a Federal Tort Claims Act suit against the govern-
ment, or bringing a so-called Bivens-style civil rights ac-
tion against the individual officials. Barrett tried each of
these methods. But each path was blocked by bizarre, nearly
insuperable obstacles, all of which could easily be swept
away by legislative reform.
Her Federal Tort Claims Act claim was blocked by an ar-
ray of seemingly senseless barriers. The strangest was the
600 THIRD AVEhOJE. NEW YORK. NY 10016
(212) 973-2800 • FAX: (212) 972-6258
200
fact that the Barrett couldn't sue at all for either inten-
tional torts by the government, or for injuries caused by a
government official carrying out a "discretionary function .
. . whether or not the discretion involved is abused." As a
result of these exceedingly broad exemptions, the award Bar-
rett ultimately won was not really for the crux of the out-
rage the government committed upon her father. She was suing
because government officials chose to test chemical weapons
on her father without explaining to him that that's what
they were doing; those chemicals caused him great pain and
anguish, and then killed him. Yet her lawyers informed her
that she probably couldn't succeed on that theory, because
the army's decision to use her father as a guinea pig was
either an "intentional tort" or a "discretionary function,"
both of which were immune from suit. Instead, the lawyers
figured out a theory that was peripheral to the real out-
rage, but one that seemed to thread its way through the nar-
row passage permitted for Federal Tort Claims Act suits.
Barrett finally won money from the government on the theory
that the U.S. Army negligently tested the fatal drug on mice
before its officials chose to feed that drug to her father.
She could sue over the fact that officials were negligent in
testing this chemical weapon on mice. But Barrett couldn't
sue over the fact that a government official chose to test
that weapon on her father. That's bizarre and offensive.
201
The other obstacle any plaintiff faces in using the
Federal Tort Claims Act is finding an attorney willing to
take the case. Barrett relied upon essentially pro bono
attorneys- -attorneys who knew they were unlikely ever to
recover fully either their costs or their fees. Unlike cases
brought under the civil rights act, attorneys suing under
the Federal Tort Claims Act cannot apply for reasonable at-
torneys fees from the defendant if the plaintiff wins. In-
stead, they take their fee- -a contingency fee of 25
percent- -out of the plaintiff's award. But, because of
limits upon damages in Federal Tort Claims Act cases, the
plaintiff's awa'rd will seldom fully compensate the
plaintiff, and 25 percent of that award will seldom fully
compensate the lawyer for the fees and expenses of bringing
the suit. Accordingly, most lawyers will not want to bring
the case in the first place. (Though there is a limit upon
the percentage of the award that can be consumed by at-
torneys fees, there is no limit on the amount of that award
that may be depleted by the reimbursement of attorneys ex-
penses. Had several of Barrett's lawyers not waived their
right to recover their expenses, Barrett would have been
left with nothing whatsoever from her roughly $700,000 award
in this case . ) -
First, the Federal Tort Claims Act doesn't allow puni-
tive damages awards. Without punitive damages, only wealthy
victims or their estates will attract attorneys to represent
202
them, because only high-earners are capable of suffering
large pecuniary injuries when government action puts them
out of work or kills them. In Barrett's case, where her fa-
ther was a tennis instructor, the compensatory damages from
killing him were going to be low.
That problem was exacerbated in Barrett's case by the
fact that the plaintiff, under the Federal Tort Claims Act,
cannot get pre-judgment interest either. Cases of government
wrongdoing on this scale will often be accompanied by a
lengthy coverup, since government officials could otherwise
never expect to get away with such conduct. In Barrett's
case, the government had covered up the cause of her fa-
ther's death for 22 years. The absence of prejudgment inter-
est meant that anything Barrett was awarded had to be paid
in 1953 dollars. Not only were her father's lost earnings
computed based solely upon the earnings of a tennis in-
structor in 1953, uncorrected for inflation or interest, but
even the award for his pain and suffering before he died was
determined in terms of 1953 dollars.
The civil rights accion Barrett brought against federal
officials was likewise beset with its own strange procedural
obstacles. It was. for instance, virtually impossible to
bring such an action because of a Second Circuit Court of
Appeals ruling concerning the obscure issue of "personal
jurisdiction." Since many of the federal officials
203
responsible for her father's death were geographically dis-
persed around the country and had not actually come to New
York in order to injure Harold Blauer, Barrett's father,
Barrett tried to sue them all in a single forum in New York,
the place where she lived and her father was killed. But,
while she would have been permitted to do just that had she
been suing a defendant for almost any ordinary business in-
jury, the law did not permit her to do so in a civil rights
action against federal officials. Instead, she was required
to sue each of the individual defendants in the state where
he or she currently lived, which would have meant filing
numerous actions in different states. See Green v. McCall.
710 F.2d 29 (2nd Cir. 1983) . This procedural rule seems
designed to serve no legitimate purpose except to make civil
rights actions against federal officials prohibitively ex-
pensive and unworkable, regardless of their merit.
Roger Parloff
212-973-2866
204
Testimony of Elizabeth Barrett
House of Representatives
Committee on Government Operations
Legislation and National Security Subcommittee
September 28, 1994
Mr. Chaimian, distinguished members of Congress, and Mr. Turner, thank you
for the opportunity to testify about the death of my father, Harold Blauer, who
was a victim of a government sponsored chemical warfare experiment when he
was a civilian patient 41 years ago.
Walter Lippman's definition of the ideal public man: "Those in high places are
more than the administrators of government bureaus. They are more than the
writers of laws. They are the custodians of a Nation's ideals, of the beliefs it
cherishes, of its permanent hopes, of the faith which makes a Nation out of a
mere aggregation of individuals."
In the hope that you try to live this ideal, let me take you back to 1952.
Divorce was made less common than today, and a father with custody of his
daughter was unknown. This was my life. I adored my father, went to woik
with him whenever I didn't have school. I only remember him leaving me once
to join a friend for an evening, and I had to insist he go.
When he died, my world came to an end. My mother moved us to Mexico,
where it was much cheaper to live. She put me in a Mexico City boarding
school and went to Cuemavaca with my sister to live. I was one miserable
lonely 13 year old. I don't think my mother or sister were very happy either.
I loved my father. I think of him every day. Sixteen years of dealing with the
many horrendous legal and political roadblocks I experienced every step of the
way haven't made it easier. Although this is probably my last opportunity to
get things changed, to make all these battles meaningful, I've been. depressed
and frightened ever since I got your invitation to testify.
205
Testimony of Elizabeth Barrett
September 28, 1994
page two
I have been afraid ever since the true nature of my father's death was revealed.
Friends warned me that the government considered me a threat and if I didn't
settle the case; something terrible might happen to me. Columnist Jack Ander-
son told me he had the same concerns for his safety. I took his advice to take
proper precautions and get on with life, but I'm always looking over my
shoulder. I'm still frightened because I don't believe all the facts have been
revealed. (At the least, I was to have seen all the original documents at trial,
which the government refused to provide.)
The absence of my father from my life will always hurt. That is true for all
children who lose their parents. But, I feel I also lost my country at the same
time. This is something no American, brought up as I was to believe in our
system almost as a religion, expects. There doesn't seem to be any way to
understand or heal this pain. My coimtry destroyed my family, as well as my
father with grossly negligent and purposeful acts by professionals- doctors and
lawyers— who are supposed to protect us from harm, not cause it. These people
are protected by our immunity laws and other legal precedents that need to be
changed. The potential victims we are talking about could be you, your wife,
husband, daughter, son, mother, or father. It could happen again. Secrecy,
lying, and lack of accountability enable the continuation of criminal activity.
You, who represent us, need to change this.
My father sought lielp from physicians who killed him for chemical warfare
research purposes. How would you feel if you found out your father died, not
in Nazi Germany, but in the United States eight years after we hanged war
criminals for the same offense? My father was forcibly given a chemical tested
only on mice. Harold Blauer was a civilian. He never gave his consent. The
hospital record shows he objected to all four injections that were given to him in
the last month of his life. According to the Army Inspector General's report.
Dr. James Cattell, who gave my father the deadly injection, said the chemical
was an Army secret, "and we didn't know whether it was dog piss or ~."
The Army Chemical Corps provided the untested chemical to a New York
hospital because it wanted to develop psychotropic substances into military
weapons. They were in a hurry to find answers, without regard for the safety of
their human subjects. My father was told the chemicals were "therapy."
On January 8, 1953, my father was given a chemical dose more than 15 times
the size of the first experiment.
206
Testimony of Elizabeth Barrett
September 28, 1994
page three
As described in the book, The Mind Manipulators (Sheflin and Opton) "On the
moming of January 8, 1953, tennis pro Harold Blauer was taken from his room
at the New York State Psychiatric Institute to receive an injection. Blauer did
not want it. Four injections he had been given the previous month had made
him ill and he was scheduled to retum to his family the very next day. He was
well. He knew it, the doctors knew it, the staff knew it and his family knew it.
Why should he have to take this last needle? It must have made him very
apprehensive because the last shot had upset him, mentally and physically, for a
week."
From the nurses notes on my father's last day:
9:53 A.M. injection started - Legs being moved
9:55 "i.v.'s getting me now" - restless movements -
protesting injection.
9:57 injection ended.
9:59 very restless - has to be restrained by nurse -
out of contact wild flailing of arms. Sweating profiisely
10:01 patient pulled up in bed - generalized stiffening
of body.
teeth clenched - frothing at mouth.
My father's pulse increased enormously and he finally lapsed into a coma. He
died at 12:15pm that day. The record shows my father suffered from December
11, 1952 to January 8, 1953. On his last day he did not die instantly. The final
deadly injection took two hours and twenty-two minutes to kill him, a torture
comparable to those inflicted during the "Inquisition."
His death certificate stated that a chemical compound had activated a previously
unknown heart condition, causing a fatal heart anack. Harold Blauer did not
have a heart condition.
My father was not the only victim in this tragedy. My mother died with a
broken heart because she felt her divorce was responsible in some part for his
death. She never knew my father was murdered in a chemical warJFare experi-
ment.
My daughter. Amy, has been a victim too. She was 13 when I found out about
the reason for my father's death and its cover-up. The already stressful years
for an adolescent daughter of a single mother were enomiously complicated
because I took an active role in pursuing reason and justice. I gave up my
207
Testimony of Elizabeth Barren
September 28, 1994
page four
career in health education and became a secretary so I could spend the time
necessary to fmd law firms to represent me (I had eight law firms, one law
school and the New York Civil Liberties Union), raise money for expenses, and
attend depositions around the country to get at the truth. Now, I don't seem to
be able to get my career back, or even get a job.
I tried to make my case, Barrett vs U.S.A.. a springboard for new accountability
laws and bills to prevent unethical experimentation from happening to others.
There were discussions at the beginning about a settlement, but I felt the truth
was necessary to prevent more tragedies and would not agree to sweep hidden
facts under the mg.
I didn't get much help. My friends and I wrote letters to Congress, getting the
usual form letter resp>onse. Marty Teitel, Director of the CS Fund, provided me
with a grant of $10,000 to help me get accountability from those responsible. I
will always be grateful to him and his foundation for that support.
I fought my lawyers as much as the government. My lawyers wanted to settle
or drop important defendants like Warren Burger and Jacob Javits. Mr. Burger
was the Assistant Attorney General in the U.S. Justice Department in the 1950s.
Mr. Javits was a Major in the Army Chemical Corps during World War II and
then the New Yoric State Attorney General who helped Mr. Burger deceive the
Court and my mother.
Even the press, which had been very interested in helping, became a problem.
When the involvement of Burger and Javits was revealed, the stories about these
horrors which had been on the front page of many newspapers and on the
national television newscasts stopped. I was told by Lyle Denniston that Mr.
Burger's press secretary told him that if he wrote another word, he would be
sued. CBS rushed me into their New York studio for an interview the day
Burger was officially named, but didn't run the story, saying their Washington
legal correspondent wanted to check it first. It never ran. The New York
Times, which had run several front page stories, not only stopped covering the
story, but refused to cover the eight-week trial and never even did a story on the
verdict!
As long as there is secrecy, and a lack of accountability for one's actions,
tragedies like what happened to my father will continue. Please don't let these
outrageous cases of human abuse be repeated.
208
Testimony of Elizabeth Barrett
September 28, 1994
page five
Now there is no personal accountability for unethical military experiments on
humans. Imnninity is given to those officials who are supposed to be protecting
American citizens, not hurting them. A lawyer. Robert King of Debevoise &
Plimpton, commented, "In the eyes of the law, the more responsibility that is
placed on a government official, the less liability is associated with his official
conduct."
In 1986, when he dismissed David Marcus, the Assistant New Yoric State
Attorney General assigned to defend the hospital in 1955, Judge Walter Mans-
field (U.S. Court of Appeals for the Second Circuit) stated that questionable or
harmful conduct during his (Marcus') representation of the State was "irrelevant.
. . . Immunity attaches to his function, not the manner in which he performed
it." It is this type of irrationality that needs to be changed. All the rules on
immunity for people who violate the constitution, have been made by judges.
1) Please pass a law to repeal this kind of immunity so the courts cannot
continue this sham.
Who would have thought after Nuremberg that experiments like those of the
Nazis would continue in this country? It can happen again, and we are painful-
ly naive if we don't think so. Nothing has really changed since the 1950s:
classified research still has no ethical scrutiny.
2) Congress must pass laws to hold those people who have the most power
over our lives (doctors, lawyers, government employees and contractors)
responsible for their actions.
David Rothman of Columbia University says, "Research by military or any
Federal agency must receive special scrutiny not just from their own boards but
from an independent body. This will help us be certain of the integrity of
government research."
3) Everyone should have immediate access to their own medical records.
This is illegal in many states: it should be illegal to deny anyone access to
information about themselves. If patients have access to information, mistakes
as well as harmful experimentation will be less likely to occur. If my father had
been able to see his records, he might have had more help from friends when he
protested.
209
Testimony of Elizabeth Barren
September 28, 1994
page six
Most legal cases about unethical military experiments have been settled out of
court without the victims or the general public ever knowing exactly what
happened. How can we rectify the problem if these acts are kept secret?
Health care costs, as well as injuries, could be greatly reduced if people were
aware of the "risks" of many of the drugs and other treatments that are pre-
scribed. The Physicians Desk Reference, a reference for prescription drugs, is a
best seller which shows people are willing to try and understand.
Taxpayers who have been harmed by experiments are fighting for justice against
a government using their tax dollars against them (over $50 million to defend
radiation experiments so far). The Justice Department has a reputation for
dragging things on for years so the victim will run out of money or time.
4) I suggest the government pay for the plaintiffs case, as it pays for die
defendant (the government) after the courts have decided the case has merit
This would provide more equal access to justice.
In my case, as mentioned in the letter submitted by Roger Parloff of The
American Lawyer, "attomeys suing under the Federal Tort Claims Act can't
apply for reasonable attomeys fees firom the defendant if the plaintiff wins.
Instead, they take their fee - a contingency fee of 25 percent - out of the
plaintiffs award. But, because of limits upon damages in Federal Tort Claims
Act cases, the plaintiffs award will seldom fully compensate the plaintiff, and
25 percent of that award will seldom fully compensate the lawyer for the fees
and expenses of bringing the suit. Accordingly, most lawyers will not want to
bring the case in the first place. (Though there is a limit upon the percentage of
the award that can be consimied by attomeys fees, there is no limit on the
amount of that award that may be depleted by the reimbursement of attomeys
expenses.)"
5) Discretionary function should be reviewed.
Our laws are made for a sovereign government. I was only allowed to sue for
negligence. I was not allowed to sue for my father's intentional murder.
Individuals working for the government are allowed to kill citizens for the
greater good, and are protected by "intentional tort" or "discretionary functions,"
which are immune from suit.
210
Testimony of Elizabeth Barrett
September 28, 1994
page seven
Sovereign immunity is un-American! I thought we fought England in the 18th
century because the King could do no wrong according to England's laws.
Royal abuses of power made us want all people to be equal under the law here.
In the biological warfare case, Nevin vs U.S.A., the Court ruled, "Thus sover-
eign immunity is not waived if, as the govemment maintains in this case, the
acts being sued upon were undertaken as part of the government's 'discretionary
function.' Specifically, the govemment contends that the acts in question here
constituted the discretionary ftmction of providing for the national defense, so
that they are not actionable under the Federal Tort Claim Act."
ril say it again: sovereign immimity is un-American. I believe this govemment
has a fiduciary responsibility to its citizens, who pay taxes to be protected by
their govemment, not murdered. Too often we are told "national security"
forces us to have secrecy, lying and cover-ups. I don't believe it. Secrecy,
lying, and cover-ups create cynicism and despair, which makes "national
security" most precarious. In most cases the records show that embarrassment
was the reason for a cover-up, not national security.
6) No Statute of Limitations should be in effect if the Govemment causes the
problem, especially if they try to cover it up.
My case was lost over the Statute of Limitations issue in the District court. I
had to appeal. After fmding that fraud tolled the Statute, the Appellate court
renimed my case to the District court to be tried. If the Stamte of Limitations is
frozen by explicit law when there is a cover-up or fraud, much time will be
saved, and justice will be more likely.
My civil rights action against Federal officials was blocked because of the
obscure issue of "personal jurisdiction." Roger Parloff of The American Lawver
comments, "Since many of the Federal officials responsible for your father's
death were geographically dispersed around the country and had not actually
come to New York in order to injure Harold Blauer. Barrett's father, Barrett
tried to sue them all in a single forum in New York, a place where she lived
and her father was killed. But, while she would have been permitted to do just
that had she been suing a defendant for almost any ordinary business injury, the
law did not permit her to do so in a civil rights action against federal officials.
Instead, she was required to sue each of the individual defendants in the state
where he or she currently lived, which would have meant filing numerous
actions in different states. See Green v. McCall. 710 F.2d 29 (2nd Cir. 1983).
211
Testimony of Elizabeth Barrett
September 28, 1994
page eight
This procedural rule seems designed to serve no legitimate purpose except to
make civil rights actions against federal officials prohibitively expensive and
unworkable, regardless of their merit.
Robert King believes the New York State Assistant Attorney, David Marcus
(who participated in the cover-up) acted as agent for these officials within the
State and therefore subjected them to the jurisdiction of the courts in New York.
I believe they were all part of the same action and should be sued in one place,
at one trial.
7) We must make individuals who have no integrity accountable for their
crimes, especially those politicians, scientists, and doctors who are held in the
public trust. If we don't, as we have seen for ourselves, history will repeat
itself.
8) Punitive damages and pre-judgment interest should be the rule when
individuals in government are so negligent. We can no longer make laws with
the assumption that people are inherently good: we must create laws to prevent
evil people from harming others.
In "Barrett v. United States: Dark Side of Uncle Sam," Joseph and Robert
Kelner said (New York Law Journal, May 13, 1987) "... when an activity is so
obviously, grossly negligent, wanton or reckless, punitive damages should be
awarded as a deterrent, whether the culprit be an individual or government
agent, servant or employee."
Without punitive damages, as Mr. Parloff says, "only the wealthy victims or
their estates will attract attomeys to represent them "
Mr. Parloff continued, "That problem was exacerbated (in your case) by the fact
that the plaintiff, under the Federal Tort Claims Act, can't get pre-judgment
interest either. In your case, the government had covered up the cause of your
father's death for 22 years. The absence of pre-judgment interest meant that
anything you were awarded had to be paid in 1953 dollars. Not only were your
father's lost earnings computed solely upon the earnings of a tennis instructor in
1953, uncorrected for inflation or interest, but even the award for his pain and
suffering before he died was determined in terms of 1953 dollars."
212
Testimony of Elizabeth Barrett
September 28, 1994
page nine
9) In 1987, Judge Constance Baker Motley's opinion said the question of
pre-judgment interest should be addressed by Congress. Well, I'm here now
and I hope yoU will correct this wrong.
This Congressional hearing is a breath of fresh air in a country that has avoided
the truth about itself for decades. I hope we can now take action and make our
laws fair to all, not privileges for the powerful. As Elie Wiesel said at his 1986
Nobel Peace Prize ceremony, ". . action is the only remedy to indifference: the
most insidious danger of all .... One person of integrity can make a difference, a
difference of life and death." Will at least one of you help?
10) I suggest that as a representative victim of the laws as they are now, I
could help when you draft new laws to correct these problems. We can learn
from our mistakes if we want to.
11) At the very least there should be a public advocate or Ombudsman for a
plaintiff suing the government when a cover-up or fraud is discovered. This
person should be hired at taxpayer's expense to get the case on the "fast track."
Justice is not provided when cases are drawn out over many years. It can
approach justice only if resolution is timely.
Wiesel: "I swore never to be silent whenever and wherever human beings
endure suffering and humiliation. We must always take sides. Neutrality helps
the oppressor, never the victim. Silence encourages the tormentor, never the
tormented."
12) I hope you agree that a good symbolic start, other than your recognition
and interest today, would be for my family to get a Presidential apology for my
father's death.
Not one administration. Republican or Democrat, since 1975 (when the truth
was revealed) ever said "I'm sorry." Instead, they, through the Department of
Justice and the Pentagon, continued to lie and kept me in court for sixteen years,
wasting taxpayers' money and mining my life. It is sadly ironic and unjust that
I, the victim's daughter, was treated as if I was the criminal, an impediment to
just government rather than a solution.
I believe that in my father's case, individuals in government broke their moral,
and I think, fiduciary contract with my father and his family when they actively
pursued him against his will and killed him.
213
Testiinony of Elizabeth Barrett
September 28. 1994
page ten
13) This apology should be accoo^anied by a refund of all taxes paid by my
father, his wife and his children, and a recognition that taxes should never be
paid by his children. This is to show that the Government recognizes that taxes
paid incur an obligation of service for those taxes. I have not filed a tax return
since I was told of my father's death. I am very afraid the government wiU use
this to put me in jail and keep me quiet.
I challenge this representative body to make a difference and help me be a
catalyst for change so I can some day hold my head high when our National
Anthem plays, not lower it, as I have done for years, in shame.
Elizabeth Barrett
180 West End Avenue
Apartment 3C
New York City 10023
Backup material has been provided to the Committee.
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