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Full text of "Report of the Presidential Commission on the Human Immunodeficiency Virus Epidemic : submitted to the President of the United States"

\ 




Report of 
THE PRESIDENTIAL COMMISSION 



on the 

HUMAN IMMUNODEFICIENCY 

VIRUS EPIDEMIC 



*3m 



»S! 



■ 




Report of 



LIBRARY 

FEB 81989 
Rational Institutes of Health 



THE PRESIDENTIAL COMMISSION 

ii 

on the 

HUMAN IMMUNODEFICIENCY 
VIRUS EPIDEMIC 




Submitted to 
The President of the United States 



June 24, 1988 



(1* 



"No man is an Hand, intire of itself e . 
Any man 's death diminishes me, 
because I am involved in Mankinde. 



— John Donne 
(1573-1631) 



n 



LETTER OF TRANSMITTAL 



PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY VIRUS EPIDEMIC 

655 15th Street NW, Suite 901, Washington, D.C. 20005 (202) 245-2437 



CHAIRMAN 

Admiral James D. Watkins (Retired) 



MEMBERS 

Colleen Conway-Welch, Ph.D. 

John J. Creedon 

Theresa L. Crenshaw, M.D. 

Richard M. DeVos 

Krisline M. Cebbie. R.N.. M.S. 

Burton James Lee III, M.D. 

Frank Lilly. Ph.D. 

John Cardinal O'Connor 

Beny J. Primm, M.D. 

Penny Pulten 

Cory SerVaas, M.D. 

William B. Walsh, M.D. 



June 24, 1988 



The President 
The White House 
Washington, D.C. 20500 

Dear Mr. President: 



On behalf of all members of the Presidential Commission 
on the Human Immunodeficiency Virus (HIV) Epidemic, I 
submit our final report. 

One year ago, by Executive Order, you created an advisory 
commission to investigate the spread of the HIV and the 
resultant acquired immune deficiency syndrome (AIDS). 
In so doing, you tasked the Commission to advise you on 
the public health dangers, including the medical, legal, 
ethical, social, and economic impact, of the epidemic. 
You also asked the Commission to recommend measures that 
Federal, State, and local officials could take to protect 
the public from contracting the HIV, assist in finding 
a cure for AIDS, and care for those who already have the 
disease. You asked that the final report be submitted 
no later than June 24, 1988. By unanimous agreement of 
all its members, this report is believed to have 
fulfilled the requirements outlined in your Executive 
Order . 

Your decision to take one year to develop a comprehensive 
national strategy to deal with the incredible complexity 
of the HIV epidemic was sound. In retrospect, it 
could not have been effectively developed in less 
time. In more than 40 hearings, the Commission listened 
to testimony from over 600 of the most knowledgeable 
witnesses that could be assembled on the HIV epidemic. 
The complexity of issues surrounding the HIV is 
exemplified by the nearly daily development of new 
scientific information about the virus which will 
continue to demand frequent review by officials in 
the public and private sectors . 



Mr. President, you afforded the Commission an unusual 
opportunity to view contemporary American society through 
the lens of the HIV. We saw firsthand: the frightening 
specter of drug abuse and its relation to the spread 
of the virus; an overly burdened and unnecessarily 
costly health care system; a drug development system 
unresponsive to the fast-changing unknowns surrounding 
this epidemic; absence of integrated health education and 
health promotion programs in our schools; an increasingly 
litigious and adversarial relationship between providers 
and consumers of health care; and a society in which some 
members were still too quick to reject, deny, condemn, 
and discriminate, resulting in a situation that neither 
bodes well for the individual nor the public health 
when dealing with this epidemic. 

But what we also saw firsthand was the spark of human 
spirit which rises high when faced with the gravest of 
human tragedies. We saw incredible goodness across 
the nation and a fundamental compassion, expressed by 
thousands of Americans, from health care professionals 
to hospice volunteers to local firemen, police, and 
emergency workers . We heard from young people who 
daily demonstrate personal bravery and integrity in 
standing up for their HIV-infected classmates who have 
been victims of the vilest of attacks by bullies inside 
and outside their schools. We heard from business 
leaders, community-based organizations, church and 
other humanitarian groups who have refused to succumb 
to the overload of work placed on them or the same old 
tired bureaucratic obstacles thrown in their way at 
every turn as they move to meet daily living needs of 
HIV-infected persons . 

We found the HIV epidemic, then, to be much more than 
a medical crisis or a public health threat. While we 
found it a grave tragedy, we also saw the HIV epidemic 
as an opportunity to confront and begin to solve many 
of the problems our society faces . We saw an opportunity 
to begin to eliminate flaws in our health care system 
resulting in a better life for all Americans; we saw 
an opportunity to begin to educate our young people 
about their own human biology so that they can better 
appreciate the unique worth and dignity of themselves 
and others; we saw an opportunity to begin to eliminate 
discrimination against persons with HIV infection, as 
well as persons with other disabilities and illnesses, 
and embrace them as part of the mainstream of American 
life; we saw an opportunity to begin to turn the goodness 
that is out there, just waiting to be harnessed into 
an unbeatable army against this viral enemy that has 
captured early ground. 



VI 



It is our hope, Mr. President, that you will: use 
our report as your national strategy; harness the 
goodness that awaits your effective leadership; continue 
to advance the nation in conguering the virus; and lead 
us to take advantage of waiting opportunities for more 
healthy and wholesome lives . 



Sincerely, 

7> sJa^Ari^ 




:au — 

ames D. Watkins 



Admiral, U.S. Navy (Retired) 
Chairman 



VII 



TABLE OF CONTENTS 



Page 

Executive Summary XVII 

Chapter One: Incidence and Prevalence 1 

Section I. National, State, and Community Leadership 3 

Section II. Public Health System 4 

Section III. Data Analysis and Distribution 4 

Section IV. Mathematical Modeling and Analysis 5 

Chapter Two: Patient Care 7 

Section I. The Patient Spectrum 7 

Section II. The Health Care Delivery System 16 

Chapter Three: Health Care Providers 23 

Section I. Developing a Broader Provider Base 23 

Section II. Health Care Worker Education 29 

Section III. Health Care Worker Safety 30 

Chapter Four: Basic Research, Vaccine, and Drug Development 37 

Section I. Basic Research: The National Institutes of Health 38 

Section II. Vaccine Development 47 

Section III. Drug Development: The Food and Drug Administration 48 

Section IV. Clinical Trials: Testing Drugs in People 54 

Section V. Additional Research Needs 59 

Chapter Five: The Public Health System 65 

Section I. The Federal Role 65 

Section II. The CDC Budget 66 

Section HI. CDC Management 67 

Section IV. National AIDS Information and Education Program :. 67 

Section V. CDC Personnel and Infrastructure 68 

Section VI. The Role of the State and Local Departments of Public Health 69 

Chapter Six: Prevention 73 

Section I. Testing and Counseling 73 

IX 



Page 

Section II. Partner Notification 75 

Section III. Restrictive Measures 77 

Section IV. Safety of the Blood Supply and Donated Tissue 78 

Section V. Laboratory Quality : 80 

Section VI. Therapists' Role in Prevention 81 

Chapter Seven: Education 83 

Section I. General Public Education 84 

Section II. Distinct Population Targeting 86 

Section III. School-Based Education 88 

Chapter Eight: Societal Issues 93 

Section I. Drug Abuse and the HIV Epidemic 94 

Section II. Homeless Persons with HIV Infection 104 

Section III. Infants and Children with HIV Infection 108 

Section IV. Community-Based Organizations 110 

Section V. The Workplace and HIV Infection Ill 

Section VI. Religious Institutions and Organizations 114 

Section VII. Philanthropy 115 

Chapter Nine: Legal and Ethical Issues 119 

Section I. Discrimination 119 

Section II. Confidentiality 126 

Section III. Health Care Provider Notification of Sexual Partners 128 

Section IV. Criminalization of HIV Transmission 130 

Section V. Sexual Assault and HIV Transmission 131 

Section VI. Correctional Facilities 134 

Section VII. Ethical Issues 136 

Chapter Ten: Financing Health Care.... 141 

Section I. Financing Comprehensive Care 141 

Section II. Financing Health Insurance Coverage 145 

Chapter Eleven: The International Response 149 

Section I. World Health Organization/Global Programme on AIDS 150 

Section II. Other Multilateral and Bilateral Programs 152 

Section III. Department of Defense 155 

Section IV. Freedom of Movement 156 

Section V. Refugees 156 

Chapter Twelve: Guidance for the Future 157 

Appendices 159 

Appendix A A History of the United States' Response to Epidemics 161 

Appendix B Budget Estimates for Final Report Recommendations 171 

Appendix C Walter Reed HTV-l Staging Criteria 173 

Appendix D Office of Personnel Management: Guidelines for AIDS Information and 

Education and for Personnel Management Issues 175 

X 



Page 

Appendix E Public Hearing Schedule 181 

Appendix F Biographical Information 183 

Appendix G Physician Review Group 187 

Appendix H Executive Orders 189 

Appendix I Charter 193 

Appendix J Glossary 197 



XI 



PRESIDENTIAL COMMISSION ON THE HUMAN IMMUNODEFICIENCY 

VIRUS EPIDEMIC 



COMMISSIONERS 

ADMIRAL JAMES D. WATKINS, CHAIRMAN 
UNITED STATES NAVY (RETIRED) 

COLLEEN CONWAY-WELCH, PH.D. 

JOHN J. CREEDON 

THERESA L. CRENSHAW, M.D. 

RICHARD M. DEVOS 

KRISTINE M. GEBBIE, R.N., M.N. 

BURTON JAMES LEE III, M.D. 

FRANK LILLY, PH.D. 

HIS EMINENCE JOHN CARDINAL O'CONNOR 

BENY J. PRIMM, M.D. 

REPRESENTATIVE PENNY PULLEN 

CORY SERVAAS, M.D. 

WILLIAM B. WALSH, M.D. 



COMMISSION STAFF 



EXECUTIVE DIRECTOR 

POLLY L. GAULT 



ADMINISTRATIVE OFFICER 

GLORIA B. SMITH 



SENIOR POLICY ANALYSTS 



PEGGY DUFOUR 
JACKIE KNOX 



JANE WEST, Ph.D. 
NANCY WOLICKI, J.D. 



PROFESSIONAL STAFF 



ADRIENNE ALLISON 
LEO L. ARNAIZ, J.D. 
JAMES L. BAKER, M.D. 
AMANDA J. BENEDICT 
EMILY COOKE, J.D. 
ROSEMARY DILIBERTO, R.N. 
CHRISTINE GRADY, R.N. 
SHELLEY B. GORDON 
SHERRY KAIMAN 



ALBERTO G. MATA, Ph.D. 
ROBERT MATHIAS 
JERRY MCCLELLAND, R.N. 
EILEEN T. NICOSIA 
PATRICIA A. RYE 
JOHN SONNEGA 
BERT H. SWIFT, Ph. D. 
DANIEL WARTONICK 
SUSAN L. WINSTON 



COMMUNICATIONS & MEDIA RELATIONS 

THOMAS D. BRANDT 
DIRECTOR 

FRANK J. HAGAN 
PHILIP L. STROBEL 



LOGISTICS & SCHEDULING 
VICTORIA L. THORNTON 



EDITORIAL STAFF 

LARRY J. TOMAYKO 
MANAGING EDITOR 



CHRISTOPHER J. HANUS 
ELIZABETH A. PAUL 



BRIAN K. SUTTON 
WAYNE M. WELCH 



ADMINISTRATIVE STAFF 

MACY MOY 
EXECUTIVE ASSISTANT 



CHRISTIAN BUTLER 
CYNTHIA B. FLYNN 
ANN-MARIE FORREST 
THU-HUANG HOANG 



PATRICIA D. JONES 
MARCO PAYNE 
PHYLLIS B. ROGERS 
L. KRISTI SCHWEIKER 



XV 



EXECUTIVE SUMMARY 



The Human Immunodeficiency Virus (HIV) 
epidemic will be a challenging factor in Ameri- 
can life for years to come and should be a 
concern to all Americans. Recent estimates sug- 
gest that almost 500,000 Americans will have 
died or progressed to later stages of the dis- 
ease by 1992. 

Even this incredible number, however, does 
not reflect the current gravity of the problem. 
One to 1.5 million Americans are believed to 
be infected with the human immunodeficiency 
virus but are not yet ill enough to realize it. 

The recommendations of the Commission 
seek to strike a proper balance between our 
obligation as a society toward those members 
of society who have HIV and those members of 
society who do not have the virus. To slow or 
stop the spread of the virus, to provide proper 
medical care for those who have contracted the 
virus, and to protect the rights of both infected 
and non-infected persons requires a careful 
balancing of interests in a highly complex soci- 
ety. 

Knowledge is a critical weapon against HIV 
— knowledge about the virus and how it is 
transmitted, knowledge of how to maintain 
one's health, knowledge of one's own infection 
status. It is critical too that knowledge lead to 
responsibility toward oneself and others. It is 
the responsibility of all Americans to become 
educated about HIV. It is the responsibility of 
those infected not to infect others. It is the 
responsibility of all citizens to treat those in- 
fected with HIV with respect and compassion. 
All individuals should be responsible for their 
actions and the consequences of those actions. 

Developed in the full Commission report are 
nearly 600 recommendations to prevent further 
spread of the virus, manage care of those in- 



fected with HIV, and enhance our efforts to 
discover a cure. 

The urgency and breadth of the nation's HIV 
research effort is without precedent in the his- 
tory of the federal government's response to an 
infectious disease crisis. However, we are a 
long way from all the answers. The directing of 
more resources toward managing this epidemic 
is critical; equally important is the judicious use 
of those resources. 

For the reader who does not have the time to 
review all the material which follows, the Com- 
mission has prepared a list of its 20 most im- 
portant findings and recommendations, no one 
of which can stand alone or be ignored. These 
will be detailed in the body of the report, and 
together comprise a comprehensive national 
strategy for effectively managing the HIV epi- 
demic. 

• The term "AIDS" is obsolete. "HIV infection" 
more correctly defines the problem. The medi- 
cal, public health, political, and community lead- 
ership must focus on the full course of HIV in- 
fection rather than concentrating on later stages 
of the disease (ARC and AIDS). Continual focus 
on AIDS rather than the entire spectrum of HIV 
disease has left our nation unable to deal ade- 
quately with the epidemic. Federal and state data 
collection efforts must now be focused on early 
HIV reports, while still collecting data on symp- 
tomatic disease. 

• Early diagnosis of HIV infection is essential, not 
only for proper medical treatment and counsel- 
ing of the infected person but also for proper 
follow-up by the public health authorities. HIV 
infection, like other chronic conditions — heart 
disease, high blood pressure, diabetes, cancer — 
can be treated more effectively when detected 
early. Therefore, HIV tests should be offered 
regularly by health care providers in order to in- 
crease the currently small percentage of those in- 
fected who are aware of the fact and under ap- 



XVII 



propriate care. Since many manifestations of HIV 
are treatable, those infected should have ready 
access to treatment for the opportunistic infec- 
tions which often prove fatal for those with HIV. 

Better understanding of the true incidence and 
prevalence of HIV infection is critical and can be 
developed only through careful accumulation of 
data from greatly increased testing. Quality as- 
sured testing should be easily accessible, confi- 
dential, voluntary, and associated with appropri- 
ate counseling and care services. At the present 
time, a relatively small percentage of those in- 
fected with HIV are aware of their infected 
status. For their own protection and for the pro- 
tection of those not infected, strong efforts 
should be made to provide easily accessible vol- 
untary testing. Many of the detailed suggestions 
in the report with respect to testing are directed 
toward increasing this percentage. 

HIV infection is a disability and should be treat- 
ed as such under federal and state law in the 
public and private sectors. Fear has led to dis- 
crimination against persons known to be infect- 
ed. This reaction is inappropriate. Infected per- 
sons should be encouraged to continue normal 
activities, such as work or school, and live in 
their own homes as long as they are able. The 
average time between infection and clinical 
symptoms is now thought to be seven to eight 
years — years which should be productive. 

Stronger protection is needed in federal and 
state law to protect the privacy of those with 
HIV, with significant penalties for violation of 
confidentiality standards, yet with a list of neces- 
sary exceptions clearly defined in the statutes. 
These exceptions are listed in detail in Chapter 
Nine of our report, in the section on Confiden- 
tiality. 

Some preventive measures must be undertaken 

immediately. 

— Public health authorities across the United 
States must begin immediately to institute con- 
fidential partner notification, the system by 
which intimate contacts of persons carrying 
sexually transmitted diseases, including HIV, 
are warned of their exposure. 

— Agencies which license and certify health care 
facilities must move immediately to require 
every facility to notify all persons who received 
blood transfusions since 1977 that they may 
have been exposed to HIV and may need test- 
ing and counseling. 

Prevention and treatment of intravenous drug 
abuse, an important facilitator of the HIV epi- 
demic, must become a top national priority. In- 
creased law enforcement efforts to interrupt the 
supply of drugs must be coupled with greatly ex- 
panded treatment capacity, with the goal of treat- 



ment on demand, to restore addicted individuals 
to healthful living. 

Use of other illegal drugs, as well as abuse of al- 
cohol, are facilitators in the spread of HIV by im- 
pairing judgment and depressing the immune 
system. Federal and state efforts to limit HIV 
spread must contain major components in these 
areas. Drug and alcohol abuse education is es- 
sential for all school children, adolescents, and 
minorities as well as for all other Americans. 

New federal and state nursing scholarship and 
loan programs need to be enacted immediately 
to encourage nurses to serve in areas of high 
HIV impact, as well as to address the nursing 
shortage which impedes efficient health care de- 
livery in all other areas. Nurses will provide the 
major portion of care, both inside and outside 
the hospital setting, to those with HIV. There is 
currently a severe nursing shortage, which is only 
projected to grow worse over the next decade. 

The National Health Service Corps, which places 
health care professionals in medically under- 
served areas, is currently slated for termination, 
but should be extended and greatly expanded. 
The health care industry should give special con- 
sideration to recruiting minority health profes- 
sionals. 

Aggressive biomedical research is the key to un- 
locking the mysteries that surround finding a 
vaccine and cure for HIV. Greater administrative 
flexibility must be given to the National Insti- 
tutes of Health to pursue its research goals. Li- 
ability obstacles must be removed, and clinical 
trials greatly expanded to include a broader 
spectrum of the infected population. 

More equitable and cost-effective financing of 
care for persons with HIV needs to be examined 
through a series of new or expanded demonstra- 
tion programs involving federal and state gov- 
ernment subsidy of private insurance premiums 
for needy patients and greater contribution to 
risk pools. It is important to move toward an or- 
ganized system of care, with case management as 
a principal tool to control costs and provide 
quality care. 

Concerns of health care workers need to be 
better addressed by all levels of government as 
well as the private sector. All of those in the 
health care delivery system, ranging from the 
ambulance driver and other emergency "first re- 
sponders," to physicians, nurses, dentists, lab 
technicians, social workers, chaplains, and allied 
health care workers, to obstetricians and sur- 
geons performing invasive procedures, should be 
provided with complete information about HIV, 
adequate protective materials, and a safe working 
environment in which to provide comprehensive 
and compassionate care. 



XVIII 



• Safety of the blood supply needs to be continual- 
ly assured by the federal government. High pri- 
ority should be placed on the Food and Drug 
Administration (FDA) test approval for new, less 
time-consuming HIV detection tests. Additional- 
ly, a restructured blood products advisory com- 
mittee needs to work with FDA to continuously 
examine mechanisms that will protect our blood 
supply. 

• In health care facilities, all reasonable strategies 
to avoid a transfusion of someone else's blood 
(homologous transfusion) should be implement- 
ed by substituting, whenever possible, transfu- 
sion with one's own blood (autologous transfu- 
sion). Currendy available techniques of autolo- 
gous transfusion include predonation of one's 
own blood, recirculation of one's own blood 
during surgery (intraoperative autologous trans- 
fusion), blood dilution techniques (hemo-dilu- 
tion), and post-operative collection for retransfu- 
sion (post-operative salvage). Health care facili- 
ties should offer aggressive in-service training to 
their staff on these procedures, and informed 
consent for the transfusion of blood or its com- 
ponents should include an explanation of the risk 
involved with transfusion as well as the alterna- 
tives to homologous transfusion. 

• Education programs must continue to be devel- 
oped and implemented for the near term, and 
for the greatest possible positive impact on the 
next generation. Age appropriate, comprehensive 
health education programs in our nation's 
schools, in kindergarten through grade twelve, 
should be a national priority. 

• The problem of HIV-infected "boarder babies" 
is one of the most heartrending the Commission 
has encountered. These children live their entire 
brief and tragic lives in hospital wards, with only 
doctors and nurses as family. The expected 



10,000 to 20,000 HIV-infected births by 1991 
also call attention to the critical need for foster 
homes. Unless the problems of the disadvan- 
taged are addressed, the HD7 epidemic will con- 
tinue to make inroads into these populations and 
we will see large increases in both pediatric and 
drug-related HIV disease. 

• The problems of teenagers, and especially run- 
away youth, that place them at increased risk for 
HIV exposure must be aggressively addressed. 
The spread of HIV within the heterosexual pop- 
ulation should be better defined and accurate in- 
formation communicated to the general public. 
Inaccurate and misleading statements suggesting 
that HIV cannot be spread through heterosexual 
activity are unwarranted. 

• The HIV epidemic has highlighted several ethical 
considerations and responsibilities, including: 

— the responsibility of those who are HIV-infect- 
ed not to infect others; 

— the responsibility of the health care community 
to offer comprehensive and compassionate 
care to all HIV-infected persons; and 

— the responsibility of all citizens to treat HIV- 
infected persons with respect and compassion. 

• International efforts to combat the spread of 
HIV infection should be encouraged and assisted 
by the United States, through our research com- 
munity and our national contribution to the 
World Health Organization and the Global Pro- 
gramme on AIDS. 

The Commission believes that if the recom- 
mendations in this report are fully implement- 
ed, we will have achieved the delicate balance 
between the complex needs and responsibilities 
encountered throughout our society when re- 
sponding to the HIV epidemic. 



XIX 



CHAPTER ONE: INCIDENCE AND 

PREVALENCE 



Late in 1980, small numbers of patients in 
several widely separated locations sought treat- 
ment for an unusual pattern of disease symp- 
toms. In all cases their physicians found that 
even the most aggressive treatment proved in- 
effective in controlling the unusually virulent 
infections. When conferring with colleagues 
across the country, the physicians treating these 
persons found that similar patients were ap- 
pearing elsewhere, often in small patient clus- 
ters, with identical patterns of disease and pa- 
tient histories. Many patients had Kaposi's sar- 
coma, a skin lesion usually benign, but in these 
patients aggressively malignant. Others had 
Pneumocystis carinii pneumonia, a rare lung infec- 
tion. Many patients had both, and all were un- 
responsive to treatment and rapidly died. 

Because so many of these patients also had 
sexually transmitted diseases, including parasit- 
ic and fungal infections, and had histories of 
multiple other conditions, such as hepatitis or 
drug use, it was difficult to isolate what was 
making them critically ill. As time passed and 
the patient population increased, medical re- 
searchers suggested that the cause was a specif- 
ic combination of several infectious diseases. 
Those who thought the cause was a single 
agent suggested cytomegalovirus, a new form 
of syphilis, or a rarely seen parasite that irre- 
versibly damaged the immune system. Still 
others felt that this disease might be the result 
of an organism never before seen: a new virus. 

Modeling AIDS 

As the first cases of acquired immune defi- 
ciency syndrome (AIDS) were identified, na- 
tionwide surveillance activities were initiated to 
monitor the spread of the disease. Through 
surveillance activities, public health officials are 
able to monitor disease trends and determine 
what preventive mechanisms will be most effec- 



tive to alter the spread of infection. For surveil- 
lance data to be valuable, physicians, laborato- 
ries, and other members of the health care 
system must uniformly report disease informa- 
tion for centralized collection. In this way, inci- 
dence (the number of new cases and the rate at 
which disease is increasing over time), and 
prevalence (the total number of existing cases) 
can be calculated. Both incidence and preva- 
lence are usually stated as rates per 1,000, 
10,000 or 100,000 of the population being 
studied. The prevalence rate is the percent of 
the population affected. By 1982, a case defini- 
tion had been developed to identify the range 
of manifestations of AIDS and physicians were 
urged to report any cases to the Centers for 
Disease Control (CDC) through their local or 
state health departments. Nationwide reporting 
allowed for the collection of extensive data on 
individuals with the disease. A major portion of 
the surveillance activities and the epidemiologic 
study was conducted by the Epidemic Intelli- 
gence Service (EIS), a specialized branch of 
CDC, in conjunction with state and local health 
departments and the regular CDC program 
staff. These public health officials began exten- 
sive patient interviews, which: 

• led to identification of probable routes of infec- 
tion, assisting in the eventual determination of 
cause. 

• facilitated monitoring the distribution of cases 
throughout the population. 

• alerted the medical and public health communi- 
ties to the presence of an emerging crisis. 

The case definition of AIDS has undergone 
revisions, and in September 1987, the new defi- 
nition was expanded to include wasting syn- 
drome and central nervous system manifesta- 
tions, increasing the number of reportable 



1 



cases. As of June 6, 1988, 64,506 cases of AIDS 
have been reported to CDC. CDC epidemiolo- 
gists aggregate the total number of cases and 
categorize them by the presumed or implicated 
mode of transmission, sex, age, racial or ethnic 
group, state, and in some cases, city of resi- 
dence. This information is published in CDC's 
AIDS Morbidity and Mortality Weekly Report 
(MMWR). 

Modeling HIV Infection 

Disease surveillance began early in the epi- 
demic, before the human immunodeficiency 
virus (HIV) had been identified or isolated, and 
before it was known that there could be a 
lengthy period of infection prior to illness. Be- 
cause at that time it was possible to identify 
only those individuals in whom disease was far 
enough advanced to be symptomatic, monitor- 
ing the epidemic meant monitoring disease, 
rather than monitoring infection. The early 
concentration on the clinical manifestation of 
AIDS has had the unintended effect of mislead- 
ing the public as to the extent of the infection 
in the population, from initial infection to sero- 
conversion, to an antibody positive asympto- 
matic stage to initial indicative symptoms to 
full-blown AIDS. Continued emphasis on AIDS 
has also impeded long-term planning efforts 
necessary to effectively allocate resources for 
prevention and health care. Decisions on who 
will receive care, and whose costs will be cov- 
ered, focused only on those most seriously ill. 
Continuing to use only the term "AIDS" to 
make treatment, reimbursement, or prevention 
program decisions is anachronistic and a policy 
we can no longer afford. 

While it is of value to continue monitoring 
diagnosed AIDS cases, public policy and pre- 
vention efforts should be based on an under- 
standing of the extent and distribution of HIV 
in the population and on the rate at which new 
infections occur. This is especially critical in 
dealing with HIV, for which the average length 
of time between infection and diagnosis is at 
least eight years, according to the Institute of 
Medicine. 

In 1986, during a Public Health Service con- 
ference in Coolfont, West Virginia, public 
health experts, using limited data, estimated 
the number of persons in the United States 
infected with HIV from one million to 1.5 mil- 
lion. Since that time, additional data have 
become available, particularly on the size of 



certain population groups and the HIV preva- 
lence in populations at higher risk of infection. 

Current knowledge of HIV prevalence is lim- 
ited by the relatively small proportion of the 
potentially infected population who have been 
tested, either as part of specially organized re- 
search/surveillance studies or as individuals 
concerned about their own possible infection. 
It is also limited by a lack of uniformity in 
reporting procedures, specifically, from physi- 
cians and laboratories to states, and from states 
to CDC. It is critical that CDC begin now to 
collect HIV infection data from the states, not 
just case reports. 

Based on the accuracy of the data and the 
validity of assumptions made in mathematical 
modeling, the estimates being published by the 
Public Health Service may be very close to the 
truth, or an over- or underestimate. The sci- 
ence of mathematical modeling and its use in 
the HIV epidemic is discussed by the Institute 
of Medicine in its recently updated report, Con- 
fronting AIDS. 

The success of any disease or infection sur- 
veillance effort is dependent upon coordination 
at the national, state, and local levels and the 
sharing of resources and expenses. Radically 
differing estimates of incidence and prevalence 
have led to public confusion and distrust. Fur- 
ther, it requires public confidence in the gov- 
ernment's goals and intentions and in efforts 
made to protect privacy and maintain confiden- 
tiality. The public health profession has a long 
tradition of respectful, confidential handling of 
sensitive data and of affected persons; those 
currently holding public health posts should be 
striving to build public confidence by stressing 
the profession's traditional adherence to this 
standard. 

A further problem has been public concern 
about test accuracy and reliability. These have 
been addressed, and experts agree that the cur- 
rent sequence of tests used to detect antibody 
against HIV, when performed under well con- 
trolled conditions in good laboratories, yield 
both a sensitivity and specificity of greater than 
99.8 percent. 

All states are currently gathering some HIV 
prevalence information. At public and private 
HIV testing sites, sexually transmitted disease 
clinics, drug rehabilitation programs and vari- 
ous other health care delivery settings, individ- 
uals have the opportunity to be tested. Data on 
infection rates among those who use the serv- 



ices at these sites are being collected and in 
some cases reported to a central point. A 
number of states require the reporting of any 
identified case of HIV infection, and others are 
considering such a requirement. Until CDC 
changes the focus of data collection from diag- 
nosed AIDS cases to HIV infections, effective- 
ness of planning and intervention will be limit- 
ed. 

At President Reagan's persistent direction, 
CDC has undertaken a massive project of HD7 
surveillance and data collection. The family of 
surveys and studies that are components of this 
project are urgently needed and are designed 
to gather a variety of data from a cross section 
of geographical locations and population 
groups. These surveys include testing of volun- 
tary participants from specified settings either 
on a confidential or anonymous basis and, in a 
sentinel hospital survey, testing of unidentified 
blood samples from groups of interest. Pilot 
studies for a proposed nationwide household 
infection prevalence survey are a major part of 
this project. However, the complete results of 
these studies will not be available until 1991. 
Apart from this extraordinary effort, much will 
be learned from ongoing state, local, and pri- 
vate testing when CDC institutes HIV infection 
data collection from the states instead of limit- 
ing its surveillance to diagnosed AIDS cases. 

As of March 1988, CDC acknowledged that a 
precise statement of the prevalence and rate of 
spread of HIV infection in the general popula- 
tion is still not available. Most analysts concur 
with CDC that, based on presently available 
data, the best estimate of seroprevalence is one 
million, with a range of up to 1.5 million. Re- 
peatedly, witnesses before the Commission 
agreed that every reasonable effort should be 
made to increase the precision of this number, 
and of the rate of infection within specific pop- 
ulation groups. 

Section I. National, State, and 
Community Leadership 

Obstacles to Progress 

The Commission has identified the following 
obstacles to a nationwide effort to improve the 
public's response to and participation in pro- 
grams designed to quantify the HIV epidemic 
at the federal, state and local levels: 

• Continued focus on the label "AIDS," contribut- 
ing to lack of understanding of the importance of 



HIV infection as the more significant element for 
taking control of the epidemic. 

• Lack of strong CDC leadership in the public 
health community for obtaining and coordinating 
HIV infection data. 

• Lack of uniform and strong anti-discrimination 
laws protecting those infected with HIV. 

• Excessive concern about potential problems with 
testing programs and reporting systems. 

• Inadequate counseling resources to assist those 
tested makes many support and interest groups 
reluctant to recommend widespread HIV testing. 

RECOMMENDATIONS 

To respond to these obstacles, the Commis- 
sion recommends the following: 

1-1 Appropriate federal, state, and local 

agencies must enact, execute, and en- 
force anti-discrimination laws within the 
context of HIV as a handicap. 

1-2 The Centers for Disease Control must 

provide clear direction for expanded and 
improved surveillance, including en- 
dorsement and support by national lead- 
ers, other federal agencies, and state and 
local leaders. 

1-3 States should require reporting of HIV 

infections. This information should be 
given to the Centers for Disease Control 
in appropriate form for statistical analy- 
sis, without identifiers. 

1-4 National, state, and local leadership must 

work cooperatively to make any HIV 
testing programs useful as data sources 
for surveillance. 

1-5 All public health agencies must select 

and use terminology carefully to make 
the public more aware of the importance 
of the entire spectrum and implications 
of HIV infection. 

1-6 In all federal agencies all relevant job 

and program titles should clearly reflect 
HIV infection as the target of concern. 

1-7 Public health officials should provide 

education, training, and funding re- 
sources to expand greatly the use of 
counseling directly linked to any testing 
program. 



Section II. Public Health System 

The HIV epidemic has had a considerable 
impact on the federal and state public health 
systems. There is not adequate staff at any level 
to respond to this crisis. Both accuracy and 
reliability of the data collected through the 
public health system, and upon which research- 
ers, health care planners and communities rely 
and base decisions, are crucial. Diligence in the 
reporting of each case of AIDS is needed, 
along with immediate development of a mecha- 
nism for overall HIV infection reporting. 

Obstacles to Progress 

The following are specific obstacles to devel- 
oping an efficient public health reporting 
system around this epidemic: 

• Not all jurisdictions have made HIV test results 
reportable, as is the custom with laboratory re- 
ports regarding other conditions of public health 
concern. 

• Underreporting and delayed reporting of data to 
local and state public health departments and 
from them to CDC are detrimental to surveil- 
lance efforts. These delays contribute to a public 
perception that information is deliberately being 
withheld by the federal and state governments. 

• Not all practitioners and health care institutions 
fully understand their roles or procedures for the 
timely reporting of data or participation in sur- 
veillance efforts. 

• Staff shortages and lack of ability to recruit qual- 
ity staff inhibit the responsiveness of the various 
agencies. 

• Funds are lacking to carry out surveillance pro- 
grams in many areas of the country. 

RECOMMENDATIONS 

In response to the public health system ob- 
stacles, the Commission recommends the fol- 
lowing: 

1-8 Widespread, voluntary testing should be 

strongly encouraged at the federal, state, 
and local levels to improve the monitor- 
ing of incidence and prevalence, to 
enable those with HIV to protect them- 
selves, and to help protect against the 
spread of the disease. 

1-9 State public health departments should 

be fully supported in their role of co- 
ordinating the various federal programs 
and resources that are targeted for HIV, 



AIDS, and AIDS-related issues within 
their states. 

1-10 All state health agencies not now doing 

so should move to require reporting and 
use this information to augment special 
studies to better understand HIV inci- 
dence and prevalence. 

1-11 The Centers for Disease Control should 

accumulate HIV testing reports from all 
federal agencies conducting testing, 
without identifiers, for inclusion in na- 
tional incidence and prevalence calcula- 
tions. 

1-12 The Department of Health and Human 

Services should explore a federal pro- 
gram to attract and recruit scientific and 
medical experts to serve as consultants 
and advisers to federal and state public 
health departments during a health 
crisis. 

1-13 Where the data produced are needed for 

surveillance, programs of HIV testing 
sponsored by a state or local public 
health agency should be coordinated 
with the Centers for Disease Control and 
the methodology made consistent with 
the national effort. 

1-14 State and local public health depart- 

ments not eligible to participate in the 
specially designed prevalence studies 
conducted by the Centers for Disease 
Control should be given incentives to be 
involved in alternative data gathering ac- 
tivities. 

1-15 All health care practitioners and institu- 

tions should be educated on procedures 
for reporting HIV infection and encour- 
aged to provide requested HIV-related 
data in a timely manner, as required 
under public health reporting laws or re- 
quested in conjunction with special stud- 
ies. 

Section III. Data Analysis and 
Distribution 

The results of data collection efforts are 
useful to many researchers attempting to study 
the epidemic and to public health officials and 
community-based groups trying to cope with its 
impact. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to maximizing data analysis activities: 



• Many users of AIDS and HIV surveillance data 
have no official forum to communicate their 
needs and recommendations to those who are re- 
sponsible for compiling and disseminating the 
data. 

• National data currently provided to community- 
based and ethnic or minority organizations, par- 
ticularly Hispanic organizations, have been ag- 
gregated in a manner that is not useful for plan- 
ning or response purposes. 

• The development of data bases on HIV infection 
trends is important in addressing this epidemic. 
The scope of ongoing surveillance activities has 
not been able to encompass all groups and 
issues. 

• Information regarding the rate of transmission of 
HIV in heterosexuals has not been forthcoming, 
and its lack has led to complacency and continu- 
ing high-risk behavior. 

RECOMMENDATIONS 

In response to obstacles in this area, the fol- 
lowing recommendations are made: 

1-16 Without delaying day-to-day responses 

to requests for data, the Centers for Dis- 
ease Control (CDC) should establish a 
review group composed of representa- 
tives from state health organizations, the 
research community, community-based 
organizations, and members of the CDC 
staff, which can evaluate requests for 
data, review the methods of processing 
requests, and make recommendations on 
improving the provision and presenta- 
tion of data pursuant to requests. 

1-17 The Centers for Disease Control should 

break down data by sex, race, age, mari- 
tal status, geographical location, and 
presumed mode of transmission, as well 
as combinations thereof, to the degree 
possible without potential compromise 
of identities. Age at diagnosis should be 
broken down into smaller groups so that 
researchers can better interpret the esti- 
mated age of infection from the date of 
diagnosis. The CDC should develop an 
improved method of identifying multiple 
risk factors present in any one case. 

1-18 The Centers for Disease Control should 

oversee the collection and reporting of 
additional statistical data needed on spe- 
cific groups, such as women, teenagers 
(10 to 13 years old and 14 to 19 years 
old), younger men (20 to 24 years old 
and 25 to 29 years old), intravenous 
drug users, and bisexual men and 
women. 



1-19 The Centers for Disease Control should 

be responsible for quickly communicat- 
ing to the research community the need 
for appropriate studies where statistical 
analysis is hampered by lack of other 
needed information, such as size of pop- 
ulation subgroups (e.g., homosexual 
men, heterosexuals, sexually active 
teens). 

1-20 Extensive research should be conducted 

and continually updated, and results 
should be widely disseminated to pro- 
vide more accurate information on the 
spread of HIV into the heterosexual 
population. 

1-21 The Secretary of Health and Human 

Services should coordinate data collected 
by the various entities involved with 
monitoring the HIV epidemic so that it 
is as compatible as possible, relating to 
Census Bureau geographic and demo- 
graphic data and data from other stand- 
ard sources, for comparative research 
purposes and to facilitate the appropri- 
ate targeting of prevention and care re- 
sources. 

1-22 State and local public health agencies 

should make available local data directly 
to community-based organizations and 
other interested parties with regional or 
national needs in order to reduce the re- 
quests to the Centers for Disease Con- 
trol. 

Section IV. Mathematical Modeling 
and Analysis 

Most epidemiological models are too simple 
to describe adequately a population as complex 
as that of the United States, and are based on 
classic epidemics (those with short, well defined 
periods when a person may transmit the dis- 
ease and short, well defined periods of illness) 
which HIV is not. 

There are a number of models that could be 
used to estimate prevalence of HIV infection. It 
is important to note that, while models are ex- 
tremely useful in predicting the size and the 
shape of an epidemic, they are not designed to 
give precise information about the future. 

Several models used by investigators to esti- 
mate the HIV-infected population are based on 
AIDS case surveillance data. This method of 
analyzing data is limited, however, by what is 
known about certain dynamics in the spread of 
the disease, transmission modes, behaviors and 



the natural history of the virus, as well as alter- 
native combinations of the assumptions used. 

Obstacles to Progress 

The major obstacles to improving the predic- 
tive value of mathematical modeling are: 

• Insufficient data. 

• Insufficient models. 

RECOMMENDATIONS 

In response to these obstacles, the following 
recommendations are made: 

1-23 The federal research agenda should in- 

clude demographic studies necessary to 
better estimate the size of the various 
population groups in the United States. 



1-24 The research being conducted on infec- 

tivity, the possible delay between infec- 
tion and infectivity, the efficiency of HIV 
transmission, and progression from in- 
fection to death should be quickly com- 
municated to those modeling the epi- 
demic. 

1-25 The public health system should expand 

the amount of available sentinel data 
from various high- and low-risk popula- 
tions (e.g., hospital patients, penitentiary 
inmates, high school students, runaway 
youths, newborns) to improve the esti- 
mates of incidence and prevalence. 

1-26 The research community should be ac- 

tively engaged in developing innovative 
models that better describe and explain 
the transmission of HIV within the pop- 
ulation. 



CHAPTER TWO: PATIENT CARE 



The health care needs of persons infected 
with HIV are varied and complex and present 
new difficulties for many segments of the cur- 
rently overburdened United States health care 
delivery system. The Commission's examina- 
tion of health care for persons with HlV-relat- 
ed illnesses has revealed several areas in urgent 
need of attention which, if given, will not only 
benefit HIV-infected persons, but will also pro- 
mote better delivery of care to persons with 
other chronic illnesses. 

Section I. The Patient Spectrum 

Human Immunodeficiency Virus (HIV), the 
retrovirus which causes AIDS, is actually re- 
sponsible for human infection with a wide 
range of consequences. In discussing and plan- 
ning for appropriate patient care, it is critical to 
identify the range of patients who will need 
health care services. A complete patient spec- 
trum starts with persons who are at risk for 
infection with HIV, ends with those who die of 
AIDS, and includes everyone in between. Pa- 
tients enter the health care system at various 
points along the spectrum. 

At the beginning of the spectrum are found 
the "worried well," those individuals who may 
have in the past or are currently participating 
in behaviors that put them at risk of acquiring 
HIV infection. Some of them may be infected 
but not yet symptomatic. They are all con- 
cerned about the possibility of infection and 
suffer from anxiety. The care of these patients 
includes diagnosis, counseling, education, and 
appropriate medical and psychological follow- 
up. 

The Commission believes that doctors and 
all primary care providers should regularly in- 
corporate HIV antibody testing and counseling 



as part of the normal range of medical services 
offered to well patients. 

The Spectrum of HIV Infection: Stages of 
Disease 

Recognition of the range of clinical manifes- 
tations associated with HIV prompted both the 
Centers for Disease Control (CDC) and the 
Walter Reed Army Institute of Research to de- 
velop HIV classification schemes in 1986. Clas- 
sification divides HIV-infected persons into 
groups, which is useful for diagnosis, therapy, 
research, and public health planning and pro- 
gramming. The Walter Reed staging system in- 
cludes immunologic criteria such as T4 cell 
count and cutaneous anergy (lack of detectable 
response to skin tests), as well as clinical as- 
sessment. (A chart and explanation of the 
Walter Reed system can be found in the Ap- 
pendix.) The CDC system divides HIV into 
four mutually exclusive groups based on a pre- 
sumptive chronology of infection and the pres- 
ence of clinical findings. A single system may 
not be useful for all purposes. 

As more information about the natural histo- 
ry of HIV infection is available and the range 
of disease manifestations become more fully 
understood, it may be possible to develop a 
classification system which could be used uni- 
versally. In this section of the report, we will 
use the CDC classification scheme in discussing 
patient care and related issues, because the 
Walter Reed system requires more sophisticat- 
ed assessment of the immune system through 
expensive blood tests which may not be avail- 
able in all treatment settings. Complete de- 
scriptions of the range of HIV-related illnesses, 
pathogenesis, and the development and pro- 
gression of signs and symptoms of disease have 
been expertly documented in the medical liter- 



ature. The limited discussion presented here is 
for the purpose of defining who needs services, 
and what those services are. 

CDC I 

Often within three weeks of exposure to 
HIV, many people experience the symptoms of 
acute infection. Characterized by fever, lymph- 
adenopathy (swollen lymph glands), fatigue, 
other mononucleosis-like symptoms, and less 
commonly aseptic meningitis or rash, this syn- 
drome is usually self-limiting and often associ- 
ated with seroconversion (the appearance of 
antibodies to HIV). 

CDC II 

Following the initial infection period and 
after seroconversion, most HIV-infected per- 
sons remain asymptomatic (without symptoms) 
for varying lengths of time. It is not yet known 
whether some of the persons in this category 
will remain symptom-free forever or whether 
with sufficient time all will go on to develop 
symptoms. Although, current data shows that 
approximately 35 percent of infected persons 
will develop AIDS within six years, some be- 
lieve that with time it may approach 100 per- 
cent. 

CDC III 

A proportion of HIV-infected persons with 
no other symptoms do have a generalized 
lymphadenopathy which persists over time 
(often called PGL, persistent generalized 
lymphadenopathy) . 

CDC IV 

HIV-infected persons with clinical symptoms 
can be divided into several groups based on 
the type and degree of symptoms experienced. 
Some infected persons suffer from constitution- 
al symptoms, such as fever, weight loss, and 
diarrhea, which persist and are not associated 
with an identifiable cause other than HIV infec- 
tion. This has been sometimes referred to as 
AIDS-Related Complex (ARC), but this termi- 
nology can be confusing. Because the term 
"ARC" is non-specific and tends to obscure the 
life-threatening aspects of this stage of illness, 
experts favor, and we concur, deemphasizing 
its use in favor of CDC IV-A and other classifi- 
cations. 

Other patients suffer from neurologic mani- 
festations (CDC IV-B), which can include cog- 
nitive (thinking), affective (emotional), and sen- 
sory changes due to dementia, myelopathy 



(spinal cord disease), and peripheral neuro- 
pathies (nerve disease) without any concurrent 
illness to explain these symptoms other than 
HIV infection. Still other HIV-infected persons 
suffer from one or more of the classic oppor- 
tunistic infections or malignancies that are di- 
agnostic of AIDS. (CDC IV-C,D,E.) The com- 
monly used term "persons with AIDS" (PWAs) 
is understood as encompassing any of the CDC 
IV subgroups. The Commission will refer to 
this group as "persons with symptomatic HIV 
infection." 

Persons with HIV infection require a wide 
variety of care during the course of their illness 
— in acute care hospitals, in outpatient clinics, 
in minimal care residential settings, in chronic 
care nursing homes and hospitals, in their 
homes, and in hospices. They meet many types 
of providers in the health care system during 
their illness: doctors, nurses, aides, and den- 
tists; a wide variety of paramedical profession- 
als; social workers; a spectrum of psychiatric 
workers; and workers and volunteers in com- 
munity health programs who help them live at 
home for as long as possible. There is a short- 
age of these care givers today, and, as the HrV 
epidemic progresses, this shortage will become 
more acute. 

It is important to stress that persons with 
HIV infection try to live with their disease. Ap- 
proximately 10 percent of HIV-infected per- 
sons with symptoms diagnostic of AIDS do live 
for at least five years, and we are hopeful that 
life expectancy will increase as treatments im- 
prove. 

Treatment Needs 

Just as the spectrum of HIV infection and 
associated clinical manifestations covers a wide 
range, so do the treatment needs of persons at 
different points on the spectrum. Infected indi- 
viduals at any stage should have access to a full 
range of quality services, including advice on 
nutrition and the spectrum of "wellness" pro- 
grams. These services should be provided in a 
cost-effective and compassionate manner by 
adequately trained health care providers, and 
careful attention must be paid to continuity of 
care. Currently many obstacles prevent this 
from happening. 

HIV-infected persons who are asymptomatic 
(CDC-II) need access to counseling and educa- 
tion services, regular follow-up by primary care 



8 



providers, psychosocial services, and informa- 
tion about nutrition and other health behaviors 
that reduce the risk of secondary infection and 
prolong wellness and that help reduce their 
risk of spreading the infection to loved ones. 
Anticipatory planning and counseling about 
more advanced stages of the disease may also 
be helpful. 

Although HIV infection is not curable at this 
time, many of its manifestations are treatable. 
Early diagnosis of both HIV and its clinical 
consequences results in more appropriate and 
effective care and management. A careful histo- 
ry, physical examination, and laboratory diag- 
nosis are critical and should be regularly em- 
ployed in diagnosing HIV infection and related 
diseases. 

Early diagnosis of HIV infection can also 
assist the infected person to take precautions 
because of his or her suppressed immune 
system. The HIV-infected person must strive to 
avoid becoming infected with other diseases, 
both opportunistic infections and secondary in- 
fections, in order to lengthen life and enhance 
its quality. Definitive early diagnosis can assist 
in motivating the adoption of healthful behav- 
iors. 

HIV-infected persons with lymphadenopathy 
or constitutional symptoms (CDC III and IV-A) 
also have a need for counseling and education 
and for regular medical follow-up by a primary 
care provider who can manage the patient's 
symptoms. These patients need psychological 
support services, some need financial counsel- 
ing and assistance, and linkage to other social 
services. The person with constitutional symp- 
toms may need periodic hospitalization usually 
for diagnostic purposes or for symptom man- 
agement, and in some cases may need support 
in the home to carry out activities of daily 
living. 

Persons who, by virtue of clinical symptoms, 
fit into CDC IV- B, C, D are diagnosed as 
having AIDS and vary greatly in the type and 
degree of symptoms they exhibit. Persons with 
HIV infection need a broad range of health 
care services including diagnostic, prophylactic 
(preventive), and treatment services. Patients 
may have overlapping conditions, and treat- 
ment for one condition may worsen another. 
For example, chemotherapy for Kaposi's sarco- 
ma may induce further suppression of the 
immune system. Pneumocystis carinii pneumonia 
may develop which, with aggressive and appro- 
priate treatment, resolves over the course of a 



few weeks; Kaposi's sarcoma may exist with 
mild associated morbidity and no other symp- 
toms for months or even years; chronic demen- 
tia, chronic candidiasis, chronic cytomegalo- 
virus infection with sporadic episodes of more 
acute symptoms or infections all may occur 
singly or in combination. The appropriate 
health care delivery setting may vary from an 
intensive care unit to ambulatory outpatient 
care or care delivered in the home. 

Two types of treatment interventions have 
significant potential to prolong and improve 
the quality of life of an HIV-infected person 
who is diagnosed early: prophylactic (preventa- 
tive), such as the administration of drugs to 
prevent the onset of opportunistic infections; 
and curative, such as early treatment of Pneumo- 
cystis carinii pneumonia. 

Treatment of Underlying HIV Infection 

Persons at any stage of HIV infection or ill- 
ness may wish to participate in experimental 
treatment protocols (clinical trials), and this op- 
portunity should be available for as many as 
possible. Currently there is one antiviral drug, 
AZT (Zidovudine), approved for patients with 
AIDS after Pneumocystis carinii pneumonia or for 
HIV-infected persons with T4 cell counts lower 
than 200. There are many other drugs, includ- 
ing antivirals and immunomodulators, being 
used experimentally. AZT was shown to pro- 
long life when tested in a multicenter, double 
blind trial. Some patients have suffered severe 
side effects prohibiting the continued use of 
AZT. Participation in an experimental treat- 
ment protocol requires health care services to 
administer the therapy, monitor tolerance and 
side effects, treat complications, and collect and 
analyze data. 

Malignancies 

Persons with HIV infection are more suscep- 
tible than the general population to a wide 
range of malignancies. Approximately one-third 
of AIDS patients die from cancer. The cancers 
that are most common are Kaposi's sarcoma 
and the lymphomas, both Hodgkin's disease, 
and the entire variety of lymphocytic malignan- 
cies. These are frequently referred to as "op- 
portunistic cancers" because they occur more 
quickly and commonly in patients who have 
depressed immunologic host defense mecha- 
nisms. An underlying assumption is that these 
lymphomas and Kaposi's sarcoma may have a 



9 



viral cause, and that the viral infection and sub- 
sequent cellular alteration to malignancy occurs 
more easily because lymphocyte function and 
host defenses have been damaged by the retro- 
virus that causes AIDS. 

When one treats an AIDS patient who also 
has an underlying cancer, one walks a tight- 
rope. Chemotherapy and radiation, both of 
which are effective cancer therapies, also attack 
the lymphocyte system. In a patient without 
AIDS, this is one of the major problems of 
cancer therapy, if not the major problem (i.e., 
giving optimal and maximal treatment of the 
cancer without obliterating the patient's 
immune system). In a patient with AIDS this 
problem is greatly magnified and becomes a 
more difficult problem as AIDS progresses. 
Thus, successful cancer therapy, producing a 
result that lasts for more than a few months, 
almost invariably occurs in a patient who has 
mild morbidity from AIDS, or mild morbidity 
from cancer, or both. Aggressive cancer treat- 
ment with advanced AIDS almost invariably 
produces short-lived results, and may eventual- 
ly contribute to the patient's death. 

It is important to remember that the clinical 
pattern of AIDS represents a wide spectrum of 
disease. When one superimposes upon the 
AIDS syndrome a broad spectrum of cancers, 
each one of which presents itself with a broad 
spectrum of activity from patient to patient, 
one can see that there can be no "standard" 
therapy, no "cookbook" solution, no easy 
therapeutic answer for the person with HIV 
infection who also gets cancer. For optimal 
management, most persons with HIV infection 
and cancer at one time or another have to be 
seen by specialists, in specialist services, in hos- 
pitals that have the required sophisticated staff, 
equipment, and laboratories to deal with their 
care. All of this clearly has both care system 
and financial implications. 

Opportunistic Infections 

Infections seen in AIDS parallel infections 
seen in other immunosuppressed patients, such 
as those with cancer. When people in the 
United States with normal immune systems die 
of infection, their deaths are caused by the 
usual spectrum of bacterial and viral diseases 
that have killed mankind for ages (i.e., infec- 
tions with staphylococci, pneumococci, gram 
negative bacteria, and common viruses such as 
influenza, among others). Although as suscepti- 
ble to these infections as any other person, 



immunosuppressed patients also suffer from in- 
fections — "opportunistic infections" ~ only 
rarely seen in people with normal host re- 
sponses. They get critical and fatal infections 
from organisms that much of the normal popu- 
lation carries more or less with impunity, such 
as Pneumocystis, toxoplasmosis and other para- 
sites, cytomegalovirus, progressive systemic 
herpes and other viruses, cryptococcosis and 
other fungi, and unusual forms of tuberculosis 
that tend to be drug resistant. These are very 
difficult infections to treat, particularly in the 
immunosuppressed patient. They strike the pa- 
tient suddenly and progress rapidly. Early and 
accurate therapy is essential, sometimes with 
drugs not immediately familiar or available to 
the general physician. This treatment usually 
has to be started by vein, and within hours of 
the recognition of infection. Thus, like cancer, 
these infections are best handled by specialists, 
in specialist settings or in hospitals where the 
proper staff is available with the appropriate 
equipment. 

It should be added that the antibiotics used 
for these unusual infections are frequently very 
expensive and, as noted, not readily available. 
It is common for the person with symptomatic 
HIV infection to lack insurance or the funds to 
pay several hundred dollars a day for these 
drugs. Financial considerations are serious and 
are particularly critical for our hospital system, 
both public and private. The hospitals are 
rarely adequately reimbursed for this level of 
care, especially for indigents. Many voluntary 
hospitals attempt to divert these patients into 
the local municipal hospital system. This is be- 
coming a fiscal challenge for our cities, where 
most of these patients are found. 

Central Nervous System Manifestations 

It is now clear that in addition to the various 
infectious and malignant manifestations of HIV 
in the central nervous system (CNS), there is a 
high prevalence of neurologic manifestations of 
HIV infection itself. The retrovirus causes cel- 
lular damage within the CNS. Although some 
have raised concern about the possibility of pa- 
tients presenting with early cognitive changes 
associated with HIV infection, testimony pre- 
sented to this Commission and recent scientific 
studies point to the observation that percepti- 
ble changes in mental activity usually occur in 
later stages of the disease. Further research on 
this point is being carried out. HIV infection in 



10 



the CNS can result in vague symptoms, such as 
apathy and forgetfulness or can progress to 
full-blown dementia. Many providers of mental 
health or primary care may remain unaware of 
HIV infection as a possible organic etiology in 
the differential diagnosis of mental dysfunction. 
Because certain of the CNS problems associat- 
ed with HIV infection, such as secondary infec- 
tions of the brain, are treatable, attention to 
this feature of HIV infection is of increasing 
importance. 

Psychosocial Needs 

As in other fatal diseases, persons with HIV 
infection and their loved ones suffer high levels 
of distress, depression, and anxiety due to the 
great degree of uncertainty associated with the 
diagnosis. Often, there is an overwhelming task 
of sorting through changing medical and scien- 
tific information in order to make accurate de- 
cisions regarding health care and life planning. 
Much anxiety is created by the many questions 
about HIV infection which remain unanswered. 
In addition, many people with HIV infection 
and its various manifestations feel the need to 
hide their condition from friends, co-workers, 
employers, and even family members in order 
to prevent social isolation and ostracism. This 
contributes greatly to their psychological stress 
at a time when they are coping with a devastat- 
ing illness. 

Many people with HIV infection, especially 
those who are active intravenous drug users, 
are unemployed and without adequate financial 
resources. Other persons with HIV infection 
may lose their jobs because of discrimination 
or inability to work, also becoming financially 
needy. Some people with HIV infection are 
without homes or lose their homes. All of these 
factors contribute to the stress and anxiety ex- 
perienced by someone who is seriously ill. 

For the family of the person with HIV infec- 
tion who is being cared for at home, there is 
considerable stress since at least one member 
of the family often must be available for full- 
time nursing care. A significant proportion of 
people with HIV infection do not have the sup- 
port of family or close friends. For all of these 
reasons, the person with HIV and his support- 
ing care givers require access to sensitive psy- 
chosocial support services. These include train- 
ing in the bedside care of the patients, counsel- 
ing, support groups, differential diagnosis, anti- 
depressant medications, financial assistance, 
and social support services. 



Special Populations 

Certain groups of HIV-infected patients may 
have specific needs which differ from those of 
other population groups. For example, an HIV- 
infected woman of childbearing age has special 
needs for counseling about the morbidity and 
mortality risks to herself and a child she may 
conceive; a person who was infected as the 
result of a previous blood transfusion may ex- 
hibit a significant amount of anger requiring 
sensitive psychological services; children with 
HrV infection may have absent or ill parents 
creating unique needs for social and supportive 
services; homeless people with HIV infection 
need active assistance in finding a home in 
order to contend with this difficult illness. In 
another sense, a person with HIV infection and 
Pneumocystis pneumonia, for example, needs di- 
agnostic services, acute treatment, nursing care, 
counseling, prophylaxis, follow-up, and sup- 
portive care whether that person is a hemophil- 
iac, a homosexual, a drug user, black or His- 
panic, a woman, a child, or a transfusion recipi- 
ent. 

All people with HIV infection have specific 
cultural and individual needs which must be 
respected and considered in the provision of 
health care. Health care providers should make 
every effort to elicit and respect patient prefer- 
ences regarding care and treatment. Compre- 
hensive health care services should be available 
and provided with compassion regardless of the 
patient's sex, age, ethnicity, financial status, or 
route of viral transmission. In addition, health 
care services, especially education, counseling 
and support, and respite care should be avail- 
able to the families and loved ones of HIV- 
infected persons. 

HIV-infected Children 

A population which poses unique challenges 
to the health care system are children with HIV 
infection. According to a report by the National 
Commission on Infant Mortality, by 1991, there 
will be an estimated 10,000 to 20,000 cases of 
symptomatic HIV infection in children in the 
United States. Most cases of AIDS in children 
(77 percent) are a result of perinatal transmis- 
sion from infected mothers. These infants can 
be infected either through maternal blood in 
utero, by exposure to maternal blood and other 
body fluids during birth, or through breast 
milk. 



11 



In a newborn, a positive antibody test may 
indicate the presence of maternal antibodies, 
and the child is not necessarily HIV-infected. 
Maternal antibodies will disappear in 12 to 18 
months, showing the child to be antibody nega- 
tive and uninfected. Because HIV infection in 
asymptomatic newborns may not be diagnosed 
accurately for 10 to 18 months, all seropositive 
infants must be followed carefully for at least 
this length of time. Most infants with true HIV 
infection will be symptomatic very early in life. 

Infants born with HIV infection are frequent- 
ly the first member of their family to be diag- 
nosed. An HIV-infected mother, usually a drug 
user or the sex partner of an HIV-infected indi- 
vidual, will transmit the virus to her newborn in 
20 percent to 60 percent of pregnancies. Four 
to five percent of pregnant women in some 
inner city clinics are currently infected. As 
many as 4,000 babies will be born with HIV 
infection in the United States in 1988. Current- 
ly, one in every 61 babies born in New York 
City is seropositive at birth. 

A special problem unique to many children 
with HIV infection is the unavailability of one 
or both parents due to AIDS or drug addiction, 
necessitating long-term or permanent hospitali- 
zation in the absence of any other available 
care setting. Infected mothers and newborns 
are typically from poor, drug-abusing, frag- 
mented families. They rely heavily on Medicaid 
and on care and services provided by public 
hospitals and community agencies. HIV-infect- 
ed babies, born to mothers who may be unable 
or unwilling to care for them, often live their 
brief, tragic lives in the ward of a hospital. 
Drug-addicted seropositive babies are also 
often born to mothers who had no prenatal 
care and they are often of low birth weight, 
frequently requiring prolonged hospital stays 
and possibly needing neonatal intensive care. 
HIV-infected babies can also be born with 
other sexually transmitted diseases, such as 
congenital syphilis. 

Most of these children die of HIV-related 
diseases before the age of three. A few children 
have lived as long as nine years. The course of 
their illness is often stormy, with multiple and 
severe infections, presenting problems not usu- 
ally seen on general pediatric wards. Because 
so many of these infants are born in the inner 
cities of New York, Newark, and Miami, those 
areas have seen the development of special pe- 
diatric units in hospitals serving their popula- 
tions. The Commission has heard expert wit- 



nesses from each of these areas and made site 
visits to the specialized pediatric care delivery 
units of Harlem Hospital in New York and 
Jackson Memorial in Miami. 

The care given the infants and children in 
these hospitals is exemplary and takes into ac- 
count not only their medical needs, but their 
need to interact with other children and adults, 
develop normally educationally and socially, 
and be loved as any other child. However, as 
many pediatric care providers have testified, 
the hospital setting is less than optimal for 
long-term care for any child. 

Pediatric patients require treatment for the 
broad spectrum of infections associated with 
HIV immunosuppression. Intravenous immune 
serum globulin given to symptomatic children 
has been shown to reduce recurrent bacterial 
infections in the study population. Clinical 
trials of AZT (Zidovudine) in children are cur- 
rently ongoing. In addition, children require 
the whole range of acute, chronic, supportive, 
and terminal care services, specially tailored to 
the pediatric population. Health care providers 
who work with adults do not necessarily have 
the specific skills required to deal with new- 
borns or children. 

Experimental therapies for pediatric patients 
have lagged behind trials for adults due to the 
small number of patients available for study, 
and the cultural and ethical issues surrounding 
such treatment. Funds for additional pediatric 
trials are not currently available at NIH. 

Thirteen percent of the children with HIV 
infection in the United States acquired the 
virus by means of transfusion, and six percent 
are hemophiliacs. These children are subject to 
the same range of secondary infections as per- 
inatally exposed children, but are sometimes 
older, and therefore suffer the additional 
burden of having their otherwise normal lives 
severely altered by this new disease and the 
discrimination that often attends it. Parents of 
these children, while not necessarily indigent, 
may require financial assistance to care for 
their children, as costs can be catastrophic. Par- 
ents of all HIV-infected children may also have 
to deal with problems of their child's isolation 
or sense of abandonment, if relationships with 
friends and schoolmates change. 

Adolescents and Teenagers 

Though adolescents and teenagers comprise 
approximately one percent of all reported 



12 



AIDS cases, the degree to which this popula- 
tion is infected — and infectious — is clearly the 
more significant question. Prevalence data for 
adolescents are sketchy; however, preliminary 
data from a Baltimore study show that the 
prevalence of HIV infection in adolescents 
using Baltimore city health clinics is 1.5 to 2.0 
percent. Data derived from the Department of 
Defense (DoD) screening of applicants for mili- 
tary service showed teen prevalence in some 
urban areas at greater than one in 400 (in the 
District of Columbia, the rate is one in 200). 
Limited DoD data indicate that the HIV preva- 
lence rate is equal among female teen military 
applicants aged 17 to 19. However, data ana- 
lyzed by gender and specific age show HIV 
prevalence rates in 17 year old female military 
applicants as twice that of 17 year old male 
applicants. Caution should be used in interpret- 
ing DoD data since teens seeking entrance to 
the military are not necessarily characteristic of 
the general population of teenagers. 

The defining and publication of infection 
prevalence among teenagers is especially criti- 
cal to prevention education in this age group 
because of the traditional tendency of teens to 
view their lives as permanent and because of 
the slow-acting nature of HIV, which causes 
symptoms to be rare in the teen population. 

There are several important differences be- 
tween adults and adolescents regarding HIV 
infection. Some of these are the following: a 
higher rate of heterosexual transmission; a 
higher percentage than adults of adolescents 
who are asymptomatic (who will become symp- 
tomatic in adulthood); a higher percentage of 
black and Hispanic AIDS cases; special legal 
and ethical issues around testing and provision 
of care to adolescents who are minors; and a 
lack of health services and programs that are 
appropriate to youths. 

Adolescents are most likely to receive health 
care in their pediatrician's office, in school 
health clinics, and in STD and/or family plan- 
ning clinics. When discussing a problem related 
to sexual behavior, especially homosexual be- 
havior, adolescents are most likely to seek care 
from those service agencies offering confiden- 
tiality protection. 

One ethical problem involves parental con- 
sent for testing and treatment. In many states 
where HIV is classified as a sexually transmit- 
ted disease, a minor may obtain testing and 
treatment without parental permission. This is 
not true of all states, and directly impacts on 



the delivery of care. In the absence of parental 
consent or knowledge a problem may result of 
having to reveal the diagnosis of an infection 
which is potentially fatal to a very young pa- 
tient. Without the ability to also discuss his 
diagnosis with a parent or responsible family 
member, the physician is left to tell the child, 
and suggest appropriate counseling and medi- 
cal follow-up. It is difficult if not impossible to 
give an adolescent a potentially fatal diagnosis 
without involving the parent or guardian in 
some way. Rarely, if ever, in our society, would 
a physician tell an adolescent that he or she has 
leukemia without also telling the parents. 

Health care providers must be sensitive to 
the fact that HIV transmission in adolescents 
may occur through a range of situations and 
behaviors, including child sexual abuse, male 
homosexual or bisexual activity (which accounts 
for 50 percent of all diagnosed cases of AIDS 
in adolescents), and intravenous drug abuse. 

Women with HIV Infection 

With little exception, HIV research and pro- 
grams have focused exclusively on homosexual 
men and intravenous drug users. As a result, 
there is limited information about the course of 
HIV infection in women. Diagnosis of AIDS in 
women may be late or less accurate because the 
natural history of infection in women is so 
poorly understood to date. There is some evi- 
dence to suggest that it differs from men. The 
problem of women with HIV infection is par- 
ticularly important because it is directly linked 
to the rapid growth of the pediatric AIDS pop- 
ulation. 

The greatest number of AIDS cases among 
women occur in the black and Hispanic popula- 
tions. Of all cases of AIDS in women, 51 per- 
cent are black, and 20 percent are Hispanic. 
The routes of viral transmission are the same 
for women as for men, but in women, HIV 
infection occurring directly from intravenous 
drug use, and through heterosexual contact 
with an infected man rank first and second, 
respectively. 

One of the most serious problems facing the 
HIV-infected mother is the guilt she may feel 
after giving birth to an infected child, her de- 
spair as she watches that child die, or her an- 
guish, knowing that after her own imminent 
death, she will leave children behind. Every 
member of the health care system providing 
service to HIV-infected mothers must recognize 



13 



214-701 0-88-2 



OL 3 



the desperation these women face and be pre- 
pared to encompass terminal care planning and 
child care considerations when delivering tradi- 
tional health care. 

Obstacles to health care access for poor 
women and their children may include lack of 
readily available clinics or physicians, inad- 
equate transportation to the care setting, lack 
of child care arrangements while there, inability 
to obtain time off from a job if employed, and 
not least of all, some means to pay for care 
both for themselves and their children. More 
appropriate care providers and counselors are 
needed when dealing with minority women. For 
example, a black female patient may be more 
likely to seek treatment for a sexually transmit- 
ted disease or discuss sex-related problems if 
she could do so with a black female physician. 

Hemophiliacs 

Individuals with hemophilia (especially hemo- 
philia A, a deficiency of Factor VIII) have been 
a group at very high risk of developing AIDS 
due to exposure to HIV through contaminated 
factor concentrate prior to heat treatment of 
Factor VIII. As of May 1988, CDC reported 
597 cases of AIDS in adult hemophiliacs (plus 
55 cases in children under 13 years old). Ac- 
cording to the National Hemophilia Founda- 
tion, approximately 12,000 hemophiliacs have 
been infected with HIV, and five to 20 percent 
of their spouses are infected. 

Men with hemophilia A are from many walks 
of life and geographic areas. They have lived 
dependent on medical care and the regular ad- 
ministration of factor VIII, the very substance 
which has turned out to be implicated in their 
infection with HIV. Approximately 75 percent 
of hemophiliacs are served by 214 federally 
funded regional Comprehensive Hemophiliac 
Diagnostic and Treatment Centers. These cen- 
ters offer multi-disciplinary services including 
medical and preventive treatment, physical 
therapy, psychosocial support, dental services, 
and financial, vocational, and genetic counsel- 
ing. Data compiled on the use of these centers 
have shown substantial savings by decreasing 
hospitalizations and clinic and emergency room 
visits. 

Homosexual Men 

When the health care provider approaches 
the homosexual or bisexual man who may or 
may not be HIV-infected, the concerns are 
much the same as with a heterosexual (i.e., the 



risks of exposure, number and identity of 
sexual partners, medical history/background, 
and information that may supply co-factor in- 
formation). If it is established that the patient is 
infected, then the same problems of counseling 
about subsequent sexual activity, confidentiality 
of information, and contact notification 
emerge, but are compounded by fears of social 
isolation and provider attitudes towards homo- 
sexuality. 

The health care provider must care for the 
homosexual man with awareness and sensitivi- 
ty. A careful sexual, psychological, and family 
history must be obtained in an effective and 
non-judgmental manner. The provider should 
look for and evaluate Kaposi's sarcoma, which 
in HIV infection occurs almost exclusively in 
homosexual men. There should be a careful 
examination for bowel infections, bowel 
trauma, STDs, and other co-factors. 

Some homosexual men experience societal 
and personal rejection, loneliness, guilt, self- 
hatred, and a loss of self-worth. Family aban- 
donment is not uncommon. Meaningful rela- 
tionships that exist with friends and the non- 
traditional family of the homosexual man must 
be recognized, so that these individuals may be 
included in care decisions if the patient so re- 
quests. Friction with relatives can occur and 
must be handled with care. 

Heterosexual Adults 

Although at present, the incidence of HIV 
infection is believed to be low in the general 
heterosexual population, there are distinct seg- 
ments with much higher incidence of infection. 
Drug addicts and their sexual partners are at 
high risk and represent the principal mode of 
spread into the non-homosexual, non-intrave- 
nous drug-using population. Another risk is a 
history of prior blood transfusion. The risk of 
spread from bisexual men to their unsuspecting 
female partners is particularly worrisome be- 
cause the magnitude of the risk is unknown. 
The estimated number of men who have had 
more than one casual homosexual experience, 
varies from 10 to 30 percent. An accurate as- 
sessment of this problem is currently lacking, 
but if 10 percent of the men in the United 
States are active bisexuals, this would represent 
the very distinct possibility of a large number 
of potentially HIV-infected women, many of 
whom have no knowledge at all about their 
sexual partner's homosexual activity. Almost by 



14 



definition, the homosexual lives of bisexuals, 
especially those who are married, are clandes- 
tine, with transient, and possibly anonymous 
contacts, thereby exposing them to greater risk 
of HIV infection. 

As is true for all sexually transmitted dis- 
eases, an increased number of partners repre- 
sents increased risk and any person with multi- 
ple partners must be advised to reduce the 
number of sexual partners. Any health care 
provider must underline to everyone he or she 
counsels that the "window" between infection 
and a positive antibody test, although usually 
between six weeks and three months, may be as 
long as three years or more, and therefore an 
initial negative test may be misleading. (Testing 
methods currently under development are ex- 
pected to greatly reduce this problem.) For 
freedom from exposure to HIV, long-term 
mutual monogamy remains the best prevention 
short of abstinence. 

Because the epidemic has predominantly 
been confined to people participating in behav- 
iors such as homosexual sex and intravenous 
drug abuse, health care practitioners are less 
likely to consider a diagnosis of HIV positivity 
or AIDS in an individual apparently not at high 
risk, such as a white heterosexual non-intrave- 
nous drug-using female who is not aware that 
her sole male partner is infected. In the past, 
this situation has extended the length of time 
from onset of symptoms to diagnosis of such 
individuals. One compelling witness before the 
Commission revealed that she had gone to doc- 
tors for nearly two years with mild to severe 
problems before anyone thought to do an anti- 
body test. Because no one associated her with 
high-risk behaviors, no one suspected that she 
might be HIV-infected. She now has AIDS. 

Minorities 

The Task Force on Black and Minority 
Health (1985) for the Secretary of Health and 
Human Services described the problem of mi- 
nority access to health care and documented a 
wide range of inadequacies in the provision of 
health information and health care to blacks, 
Hispanics, Asians, and Native Americans. 
These groups were repeatedly the least likely 
to be the target of health education or service 
programs even though their health condition 
suggests their needs are great. 

The impact of HIV infection on black and 
Hispanic communities has been felt very 
strongly; individuals from these groups com- 



prise about 40 percent of all persons with 
symptomatic HIV infection. Similar to the non- 
Hispanic white population, the major category 
of transmission for blacks and Hispanics is ho- 
mosexual/bisexual behavior. However, blacks 
and Hispanics who engage in these behaviors 
are less likely to obtain services from organiza- 
tions which are perceived as homosexually-re- 
lated and more likely to seek information and 
guidance from those community-based organi- 
zations which have traditionally served their re- 
spective communities. Of great concern is that 
intravenous drug use is a much greater method 
of transmission for blacks and Hispanics than it 
is for non-Hispanic whites. The incidence of 
HIV infection among inner city drug users is 
growing more rapidly than the incidence in the 
homosexual population. Most of these patients 
have no private health insurance and must rely 
on Medicaid. It is only recently that black and 
Hispanic community-based organizations have 
been able to obtain funds so that they could 
also use their diverse expertise and credibility 
to address the HIV epidemic. Openly homosex- 
ual support groups encourage early diagnosis, 
treatment, and education in their respective 
communities. Homosexual support groups are 
only now emerging in a few black and Hispanic 
communities, and can make significant contri- 
butions. Leadership is critically needed from 
major national minority organizations and from 
churches in minority communities. 

Overall, the provision of health care services 
to blacks and Hispanics has been hampered by 
the large number of uninsured persons, i.e., 
persons with neither public nor private health 
insurance, including significant numbers who 
are employed. Moreover, the great variability in 
Medicaid coverage by states creates totally dif- 
ferent service pictures in states such as Texas, 
Florida, Mississippi, and Alabama as compared 
to New York or California. 

Large numbers of minorities are uninsured 
or underinsured and, consequently, turn to 
public health care systems, creating high levels 
of demand for services from public clinics and 
hospitals, community health centers, and mi- 
grant health centers. The demand is also felt by 
the National Health Service Corps, which pro- 
vides, in part, personnel for public facilities. 
Ensuring the ability of public facilities to pro- 
vide care and treatment to black, Hispanic, and 
other poor HIV-infected persons is difficult in 
the absence of significantly higher levels of 



15 



funding. The goal of such funding is not only 
to provide the best possible AIDS services but 
also to continue the unfinished job of expand- 
ing minority and indigent access to health care. 

The other major public system, the Indian 
Health Service, must also be brought fully into 
the battle against HIV. Despite the fact that the 
incidence and prevalence among Native Ameri- 
cans remain relatively low, the opportunities 
for primary prevention and early intervention 
should not be lost. The prevalence of HIV in- 
fection in this population is not well document- 
ed, but anecdotal reports make it clear that 
both reservation and urban residents are re- 
porting positive test results and are in need of 
services. Currently, the incidence of AIDS 
among Asian/Pacific Islanders is not high. 
However, with large numbers of these individ- 
uals residing in high-incidence areas, the likeli- 
hood of increasing levels of HIV-related health 
problems cannot be discounted. As in the case 
of blacks, Hispanics, and Native Americans, tra- 
ditional problems of access to care must be 
considered and overcome. 

The much needed attention to low-income 
and uninsured blacks and Hispanics should not 
obscure the fact that many in these two minori- 
ty populations seek health care services from 
private physicians. Thus strategies for assuring 
appropriate high-quality care and treatment 
must look also to the private sector. Unfortu- 
nately, blacks and Hispanics are underrepre- 
sented in the health care professions — as are 
Native Americans and Asian/Pacific Islanders. 
The lack of such personnel has long been rec- 
ognized as a barrier to health care. While the 
response to HIV should add impetus to the 
recruitment and training of minority providers, 
interim solutions are demanded as well. HIV- 
related training can be focused on providers in 
predominantly minority communities. Because 
non-minority providers play a significant role in 
many of these communities, there is a need to 
extend such education and training beyond 
AIDS-specific protocols to matters of values, 
culture, and language in order to improve utili- 
zation and provider/patient relationships and 
patient outcomes. Further, the role of the 
family as caretakers and survivors cannot be 
sufficiently emphasized, and training must be 
made available to families of infected persons. 
Minority providers, already knowledgeable and 
having the trust and support of their communi- 
ties, should be viewed as a resource to contrib- 
ute to this larger educational effort. 



In the course of the epidemic, many myths 
about blacks and Hispanics have developed. It 
has been said that families will not provide 
support and care for patients. Lack of motiva- 
tion to participate in clinical trials has been 
suggested. Those working with the populations 
know otherwise. These populations have suf- 
fered as a result of such myths, but an even 
more serious problem is the isolation from the 
message of hope — the growing availability of 
experimental treatments and the importance of 
early diagnosis and care. Black and Hispanic 
populations must be reoriented to this perspec- 
tive, and the systems must be in place to ag- 
gressively and effectively respond. 

Drug Abusers 

Patient care for active drug abusers is princi- 
pally complicated by the non-compliance and 
unreliability of this patient group. There is no 
certainty that medications are taken, and 
follow-up is frequently poor. There are usually 
many other conditions present which make 
their prognosis particularly poor (e.g., other 
venereal diseases, poor general health, dam- 
aged immune systems independent of HIV in- 
fection, and unstable and frequently violent 
lifestyles). Treatment settings are often emer- 
gency rooms, and opportunities for long-term 
care intervention are limited. In this context, 
treatment may be less than aggressive or com- 
plete, contributing to shorter survival. HIV 
intervention, diagnosis, and counseling for 
drug abusers should be incorporated into drug 
treatment centers. 

Section II. The Health Care 
Delivery System 

Health care in the United States is delivered 
through hospitals (public and private), outpa- 
tient clinics and doctors' offices, home care 
agencies, nursing services, long-term care facili- 
ties, hospices, counseling services, social and 
psychological support services, and community- 
based organizations. Services available vary 
widely from community to community. To date, 
the HIV epidemic has had an uneven impact on 
the United States health care delivery system. 
In low prevalence areas, the care system has 
been much less challenged than high preva- 
lence areas such as New York, California, or 
New Jersey. As a result, most of the country 
has not yet experienced the extraordinary de- 



16 



mands on health care delivery systems as are 
now being experienced in these states. As the 
epidemic continues, however, more areas 
should anticipate a measurable impact. 

The HIV epidemic is placing an increasing 
strain on segments of our health care system, 
particularly our municipal and voluntary hospi- 
tals. This strain is illuminating many of the 
flaws in our health care system that have been 
present for a long time. As we try to address 
these flaws and the variety of possible solu- 
tions, we hopefully will end up with a better 
system which will be more responsive, more 
humane, and more able to direct its manifest 
strengths quickly and efficiently to where they 
are most needed. 

Inpatient Hospitalization 

To date, hospitals are the primary providers 
of care for persons with symptomatic HIV in- 
fection through inpatient hospital admissions. 
A number of acute care hospitals in the United 
States, including San Francisco General, St. 
Clare's and St. Vincent's Hospitals in New 
York, Johns Hopkins in Baltimore and others 
have developed discrete, dedicated inpatient 
and outpatient units as the core of their AIDS 
program, and serve as models for care. Persons 
advocating these structures assert that quality 
patient care can be provided in a more efficient 
and effective manner when delivered by a 
multi-disciplinary team of health care providers 
dedicated to the care of persons with sympto- 
matic HIV infection. St. Clare's AIDS unit, for 
example, provides complete dental services. 

In many areas, specialized AIDS health care 
teams or units do not exist and persons with 
symptomatic HIV infection are placed on gen- 
eral medical/surgical units of hospitals (so 
called "scattered placement") and cared for by 
a variety of practitioners with differing levels of 
experience in caring for persons with HIV in- 
fection. This is especially true in low-incidence 
areas. 

The costs of caring for persons with HIV 
infection are extremely high. Estimates from 
recent studies calculate the AIDS-related hospi- 
tal bill for 1985 at $380 million, and econo- 
mists project costs greater than $8.5 billion for 
AIDS-related medical care by 1991. Financing 
of care is complex, coming primarily from pri- 
vate insurance, Medicaid, and other state, local, 
and private monies. Increasingly, the cost 
burden of providing care to persons with symp- 
tomatic HIV infection is falling to the public 



hospitals, the state and local public assistance 
programs, and Medicaid. 

Comprehensive Services 

Witnesses before the Commission, in agree- 
ment with most experts in this field, noted the 
importance of establishing comprehensive and 
coordinated service delivery systems for people 
affected by the spectrum of HIV infection in 
order to reduce both service fragmentation and 
cost. San Francisco, largely through the inten- 
sive efforts of its homosexual community, de- 
veloped an integrated community-based system 
of comprehensive services for people with HIV 
infection. This case management model was 
centrally coordinated primarily through San 
Francisco General Hospital, and was developed 
at a time when the city was in a budget surplus, 
and experimentation with new and innovative 
care approaches was possible. Outpatient sup- 
port services were provided through the Shanti 
Project and other organizations supported in 
part by the San Francisco AIDS Foundation. 
Efforts were made to ensure that a patient 
transferred from one care setting to another 
did not get "lost in the system" but experi- 
enced care managed with continuity. The result 
was comprehensive and well delivered care, de- 
livered in the treatment setting of the patient's 
choice, and costing less than inpatient care. 
Several other communities are currently devel- 
oping similar service networks emulating the 
San Francisco model. 

Currently there are 22 AIDS Service Delivery 
Demonstration projects being conducted in the 
United States. These projects are being funded 
by the United States Public Health Service, 
Health Resources and Services Administration 
(13 projects), and by the Robert Wood Johnson 
Foundation (nine projects). These projects are 
attempting to develop and demonstrate an ef- 
fective comprehensive model or network of 
out-of-hospital community-based care for 
people with HIV infection. This model is to be 
coordinated, efficient, cost-effective, and 
humane. Recognizing the specific needs and 
existing resources of its own community or 
region, each program has, or is developing, a 
coordinated network of services, including: 

• outpatient care (diagnostic, treatment, follow-up, 
and psychosocial care services); 

• in-home care (such as high-tech home therapies, 
hospice care, homemaker and attendant care); 

• long-term care not in the home; and 



17 



• patient care services, including services provided 
by Visiting Nurses Services, and many other 
home health care organizations. 

Each project includes linkages with acute 
care hospital facilities which provide care to 
people with HIV infection, and some projects 
include services to children. To assure continu- 
ity, a case management model is utilized in 
each project. Evaluation of these projects will 
allow the development of service delivery 
models which will be available for replication 
by other communities and regions. 

Out-of-Hospital Care 

In addition to the work of the San Francisco 
community, the Commission recognizes the 
tireless efforts of many religious and communi- 
ty-based organizations nationwide in providing 
compassionate care for persons with HIV infec- 
tion, particularly for those who are most indi- 
gent. The availability of care settings staffed by 
practitioners knowledgeable in the care of HIV- 
infected persons is an essential alternative to 
hospital-based care. There is a vital need for 
replicating the coordinated system developed 
in San Francisco, and for reimbursement sys- 
tems to respond by supporting high quality and 
cost-effective care in out-of-hospital settings. 

Home care should be made available, par- 
ticularly for the indigent, covering the range 
from high-tech intravenous therapies to chronic 
care by attendants. The average cost of home 
health care is $15,000 per year, while the aver- 
age year cost for nursing homes ranges from 
$24,000 to $60,000, depending on geographic 
location. Hospice care shpuld be available, as 
well as nursing home beds or residential facili- 
ties for those who cannot be adequately cared 
for in their homes. Currently, there are few 
nursing homes that will accept patients with 
advanced HIV illness; this situation must be 
resolved, and additional alternative settings 
sought. In some areas, small group homes and 
nursing services may be a feasible approach. 
Reimbursement and funding for these services 
should be available from a variety of sources. 
Homeless persons with AIDS often remain in 
the hospital because they have no home ad- 
dress to which they can be discharged. No- 
where is this more evident than with the hospi- 
talized infants and children with HIV infection, 
the so-called "boarder babies." The cost of 
maintaining a child in a municipal hospital pe- 
diatric ward for one year is in excess of 
$250,000. Congregate living facilities have 



been identified as a potential alternative to hos- 
pital-based care, and are often able to provide 
a quality home environment for $60 to $100 
per day, versus $500 to $1,000 per hospital 
day. Some private sector institutions have 
begun to provide high quality, cost-effective, 
and compassionate care for homeless persons 
with AIDS and their families. Notable models 
among these include Bailey House, a unique 
public-private partnership between New York 
City and a public foundation, the hospices run 
by Mother Teresa, and many other local efforts 
by religious organizations. 

Community-based organizations (CBOs) have 
played an enormous role in providing health 
care and psychosocial services for persons with 
HIV infection. The prototypes for these organi- 
zations were developed within homosexual 
communities nationwide and illustrate, through 
their diversity and numbers, a self-reliant and 
vigorous response in coping with the HrV epi- 
demic. CBOs often provide services not other- 
wise available through the health care delivery 
system. They are not-for-profit, indigenous to 
the locale, and rely heavily on volunteers. Many 
CBOs serve a large percentage of poverty level 
income, minority, and other underserved cli- 
ents. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in health care delivery to 
persons infected with HIV: 



• Witnesses before the Commission and other ex- 
perts expressed concern that our health care de- 
livery system currently is structurally and finan- 
cially unprepared to deal with the diverse needs 
of people with HIV infection, as well as those 
with other chronic illnesses. 

• Much of the newly emerging HIV patient popula- 
tion is dependent on already overburdened mu- 
nicipal hospital systems. 

• In many areas of the country, services and spe- 
cialists are not adequately available to individuals 
in need, especially to those who are HIV-infected 
but who do not experience the symptoms of 
AIDS. 

• Currently, the vast array of services required for 
people with HIV infection are uncoordinated or 
may be available only in pieces. A person with 
HlV infection is confronted by a complex system 
of fragmented and expensive services. Out-of- 
hospital care is generally inadequate. Indeed, a 



18 



large and growing number of HIV-infected per- 
sons are poor and medically underserved, are 
covered by Medicaid and other forms of public 
assistance. If a wider range of coordinated out- 
of-hospital services were available, hospitaliza- 
tions could presumably be decreased. 

The range of services is inadequate to meet the 
diverse and often complex needs of HIV-infected 
families, including mothers and children. Avail- 
able services, such as day care, home care, res- 
pite care, and psychosocial services, would de- 
crease the number of hospitalizations of children 
with AIDS, possibly improve their quality of life, 
and help maintain the intactness of the natural 
family. 

Although hemophilia treatment centers are 
models of comprehensive care for hemophiliacs, 
there are unique needs of HIV-infected hemo- 
philiacs and their families for which these centers 
are not adequately funded or prepared. 

In many areas, zoning restrictions prevent use of 
facilities which might otherwise provide a site for 
cost-effective care to persons with AIDS. 

Minority and indigent populations often have no 
access to health care and/or are often medically 
underserved. 

The range of health care needs for HIV-infected 
persons is complex, and infected individuals 
often do not have a primary health care provider 
to provide appropriate medical care selection or 
follow-up. 

Health care service resources to date have pri- 
marily been directed toward meeting the acute 
care needs of persons diagnosed with AIDS and 
have not been available to others in the HIV pa- 
tient spectrum for diagnosis, early intervention, 
or support. 

Psychosocial services are frequently unavailable 
to persons needing this type of care. 

Care settings are inadequately used as points of 
intervention to test and counsel patients about 
modes of transmission and behavior modifica- 
tion. 

Support and assistance with activities of daily 
living is generally not available to ill persons 
except on a limited basis by volunteers. 

Much remains to be learned about the most ef- 
fective and efficient way to manage the care and 
associated needs of HIV-infected persons without 
compromising the availability or quality of the 
care they receive. 



RECOMMENDATIONS 

In addressing these obstacles to progress in 
making the needed services available to HIV- 
infected persons, the Commission recommends 
the following: 

2-1 All members of the health care provider 

community should treat patients with 
HIV infection with professionalism, and 
every effort should be made to maintain 
an individual's autonomy, sense of self- 
worth, and personal dignity. 

2-2 Health care facilities should provide or 

arrange for a case manager or some 
equivalent mechanism for assuring conti- 
nuity of care for HIV-infected persons 
who use their facilities. 

2-3 All physicians and primary care provid- 

ers should regularly utilize the HIV anti- 
body test as a diagnostic tool, and incor- 
porate the test and counseling into the 
normal range of services offered to pa- 
tients. 

2-4 The Community Health Center Program 

should be increased in high incidence 
areas to allow for the provision of addi- 
tional services to persons infected with 
HIV. The federal allocation would pro- 
vide primary medical and dental care for 
patients and would also allow for the 
training of current and new staff. 

2-5 The federal government, through the 

Department of Health and Human Serv- 
ices, and the states should provide funds 
for home health care services for under- 
insured persons with HIV infection. 
Each state's federal allocation for home 
health care would be based on the ratio 
of the number of persons with HTV in- 
fection in the state to the total number 
of persons with HIV infection in the 
United States. States should have the 
option to utilize this allocation for grants 
to home health care agencies for the 
provision of care to eligible individuals, 
for compensation for the planners and 
providers of care, and for education and 
training of home health care providers. 

2-6 Facilities which currently care for per- 

sons infected with HIV should be en- 
couraged to make available psychosocial 
care as needed, within the limitations of 
each facility's resources. Care may be 
provided by psychiatrists, psychologists, 
psychiatric nurses, social workers, mar- 
riage counselors, sex counselors and 
therapists, family counselors, or religious 
counselors, as appropriate. All providers 



19 



of psychosocial services should be enlist- 2-12 
ed in efforts to prevent HIV transmis- 
sion. 

2-7 Federally funded community mental 

health centers should develop programs 
targeted for persons infected with HIV 
and their loved ones. To ensure the 
availability of these services, the Alcohol, 
Drug Abuse, and Mental Health Services 
Block Grant funding should be in- 
creased. 

2-8 The Health Resources and Services Ad- 2-13 

ministration should evaluate health care 
provider attrition from municipal hospi- 
tals in high prevalence cities, to deter- 
mine means by which incentives can be 
developed to retain nurses, physicians, 
and other direct health care providers. 

2-9 The Health Resources and Services Ad- 2-14 

10-10 ministration, through the Maternal and 

Child Health Program, should provide 
funding for demonstration grants for Re- 
gional HIV Comprehensive Family Care 
Centers in areas where inadequate pedi- 
atric services exist and the prevalence of 
HIV infection is high. These centers 
would provide a full range of services to 
HIV-infected children, adolescents, and 
their families including: diagnostic, treat- 2-15 
ment, and follow-up services, prenatal 
and well-baby care, testing, counseling, 
psychosocial support services, day care, 
respite care, education, and linkages with 
home care and acute hospital care. 

2-10 Where pediatric infection rates are high, 

based on pediatric seroprevalence infor- 
mation, obstetricians and pediatricians 2-16 
should counsel patients and advise test- 
ing as appropriate. 

2-11 The Health Resources and Services Ad- 

10-11 ministration (HRSA) should widely dis- 

seminate findings from the AIDS Service 
Demonstration Projects so that other 
communities can select and develop the 
most appropriate and feasible model. 
The Public Health Service through 
HRSA and in collaboration with the 2-17 
states should provide initial funding and 
technical assistance to communities in 
order to establish services to fill existing 
gaps and to develop coordinated net- 
works of service. Systems created should 
include a continuum of services, empha- 2-18 
size alternatives to hospitalization, and 
utilize a case-management approach. 



The National Center for Health Services 
Research should compile data from hos- 
pitals using dedicated AIDS units and 
those using scattered placement in order 
to compare their effectiveness with re- 
spect to quality of care, patient satisfac- 
tion, and the effect on staff (i.e., on re- 
cruitment, retention, turnover rate, and 
satisfaction). Findings should be dissemi- 
nated to hospitals nationwide to help 
them plan and design the most appropri- 
ate structure for service delivery to 
people with HIV infection. 

In areas where availability of intermittent 
or chronic care services is encumbered 
by local restrictions or zoning require- 
ments, such as number of exits required 
for a building or allowable number of 
occupants of a facility, local governments 
should provide reasonable variances to 
permit such care to be available. 

Current funding to the Comprehensive 
Hemophiliac Diagnostic and Treatment 
Centers should be increased to cover the 
costs of HIV testing, counseling, evalua- 
tion of immune system function, and 
supportive services for the patient and 
family. Funding of immune system eval- 
uation will enhance the use of the Cen- 
ters for clinical research. 

The Department of Health and Human 
Services should take steps to ensure that 
all Comprehensive Hemophiliac Diag- 
nostic and Treatment Centers are fully 
prepared to offer HIV-related care to 
any patients, and to extend the network 
of centers to the remaining 25 percent 
of the hemophiliac population not now 
being served. 

Municipal hospital systems in high prev- 
alence cities should assess their current 
and five-year anticipated demand for 
HIV-related services and forward these 
projections to the Secretaries of the 
United States Departments of Health 
and Human Services and Housing and 
Urban Development for incorporation 
into a plan for increased funding for pa- 
tient care in community and long-term 
care settings. 

The Department of Health and Human 
Services should make the development 
of new strategies for diagnosing, educat- 
ing, and caring for adolescents at risk for 
HIV infection a high priority. 

The Pediatric AIDS Health Care Demon- 
stration Projects grants announced by 
the Health Resources and Services Ad- 



20 



ministration should be funded through 
1991. Grants should be awarded to pro- 
grams which are family-focused and 
community-based, include a coordinated, 



comprehensive network of services, and 
should utilize a family case management 
approach. 



21 



CHAPTER THREE: HEALTH CARE 

PROVIDERS 



Health care in the various settings previously 
described is provided by an array of profession- 
al and non-professional care givers. These in- 
clude: physicians, both generalists and special- 
ists; nurses and auxiliary nursing personnel; 
dentists; social workers; psychologists and 
other mental health workers; volunteers; emer- 
gency care providers and other "first respond- 
ers," including fire fighters and police. Ade- 
quate numbers of appropriately skilled and pre- 
pared providers are essential to the provision 
of needed services for persons with HIV infec- 
tion. 

A well-educated, skilled, and concerned 
health care community is not only vital to the 
task of caring for those who are ill, but during 
this critical time when fear and misunderstand- 
ing about the HIV epidemic exist within our 
population, the leadership established by pro- 
viders of health care to persons with HIV infec- 
tion is crucial to fostering a sense of compas- 
sion and rationality among all our citizens. 
When health care professionals care for all pa- 
tients who need their help, regardless of HIV 
infection status, and do so without reservation 
or trepidation using time-tested infection con- 
trol methods, they communicate to all people 
that calmness and reason can prevail over panic 
and anxiety as we confront this epidemic. 

There is clearly a need for more knowledge 
about HIV among many health care providers 
— an issue that was repeatedly raised by expert 
witnesses at the hearings on care. An assess- 
ment is currently underway to collect compre- 
hensive data from medical college accreditation 
bodies and elsewhere, on how health profes- 
sions schools have adapted their curricula to 
assure that students are being prepared to di- 
agnose and treat or prevent HIV-related ill- 
ness. There is a need for an effective, coordi- 



nated response within the health care commu- 
nity to promote adequate education for every 
provider about modes of transmission, preven- 
tion, recognition, and management of HIV in- 
fection. 

Section I. Developing a Broader 
Provider Base 

Physicians, Dentists, and Paramedical 
Professionals 

Some of the issues that have been presented 
in testimony regarding health care providers 
are: 

• that the health care system has been faced with a 
sudden increased demand for certain HIV-relat- 
ed medical specialties, e.g., infectious disease 
specialists, immunologists, and dermatologists. 
Currently, these specialties are underenrolled in 
many medical schools. 

• that there is still considerable anxiety on the part 
of some health care workers about risk of work- 
place exposure, and that there is a migration 
away from those health care settings and prac- 
tices that may include risk. 

• that with the evolution of the case management 
model many of the patient care decisions have 
been appropriately vested with nurses at a time 
when the country is facing a severe shortage of 
nurses. 

Obstacles to Progress 

• The acuity of disease of persons with HIV infec- 
tion, the complexity of their physical and psycho- 
social needs, the high fatality rate, and the fear 
of exposure to HIV, along with low salaries and 
understafling in many facilities, create a potential 
for considerable stress, burn-out, turnover, and 
dramatic projected shortages for the delivery of 
HIV patient care in the near future. 



23 



There is underenrollment in many of the physi- 
cian specialties associated with HIV treatment, 
and future shortages are projected. 

In many cities and counties, whether formally 
identified as health manpower shortage areas or 
not, the full continuum of health services re- 
quired for the intensive treatment of symptomat- 
ic HIV-infected patients is unavailable. 

As the number of HIV cases increases, finding 
adequate numbers of physicians, dentists, and 
other primary care personnel in high prevalence 
areas, where recruitment of physicians is already 
difficult, will be a serious problem. 

Complete and up-to-date information about HIV 
is not readily accessible to front-line providers, 
persons with HIV, or the general public except 
through certain limited commercial enterprises 
or medical libraries at academic institutions. The 
attempts to create centrally coordinated access 
have not been successful. 

Minorities are severely underrepresented in the 
health professions. 

The professional medical education system has 
not moved synchronously with the HIV epidem- 
ic. As a result, there are significant gaps in 
knowledge among many providers about man- 
agement of this illness. 

There are currently no comprehensive data, 
within medical college accreditation bodies or 
elsewhere, on how health professions schools 
have adapted their curricula to assure that stu- 
dents are being prepared to treat or prevent 
HIV-related illness. 

The average age of both nursing and medical 
students is rising; a large number of the students 
already face adult responsibilities. The way in 
which financial scholarship need is calculated can 
penalize adult learners by disallowing deductions 
for adult financial obligations such as dependents 
and home mortgages — thereby limiting the stu- 
dent's ability to obtain grants or loans. 

Education for graduate physicians in specialty 
training and continuing education for practicing 
physicians may or may not address HIV preven- 
tion and treatment. As a result, many physicians 
are severely lacking in knowledge about HIV. 

Dental professional education, according to den- 
tists themselves, has been lacking in providing 
education about management of persons infected 
with HIV. This has contributed to limiting access 
to dental care for persons with HIV. 

Pre-hospital emergency care providers (paramed- 
ics, firefighters, and police) have an immediate 
and continuing need for more education about 
infection control, because their frequent expo- 



sure to blood and body fluids in their handling 
of all types of persons in uncontrolled settings 
places them at increased risk of exposure to the 
virus. 

• Providers of allied health care (including social 
workers, therapists, aides, laboratory personnel, 
and many others) are also in need of more com- 
plete education about HIV because their educa- 
tional background may not have provided suffi- 
cient information about infection control and 
other aspects of providing care to persons with 
HIV infection. 

• Availability of trained personnel qualified to pro- 
vide psychosocial services for persons infected 
with HIV or their loved ones varies across the 
country. In many areas, an insufficient number of 
staff are available to respond to current needs, 
and this shortage will deepen as the number of 
persons with HIV increases. 

• The psychological burden on health care provid- 
ers who care for persons with HIV is severe, and 
many providers may leave the profession if they 
have difficulty coping with these stresses. They 
may also face suspicion or intolerance from 
members of the general public who may fear that 
the providers themselves have become infected 
through their work. 

RECOMMENDATIONS 

In addressing these obstacles to progress in 
preparing adequate numbers of health care 
providers for the care of HIV-infected persons, 
the Commission recommends the following: 

3-1 The Department of Health and Human 

Services should administer a competitive 
grant or contract program, or organize 
consensus conferences, to construct HIV 
treatment guidelines for practitioners in 
differing practice environments encom- 
passing a range of medical specialties 
and including other disciplines. The 
guidelines developed should then be 
made available to all practitioners who 
request them. 

3-2 Health care professions schools should 

assure that all students are educated 
about HIV infection and those related 
subjects most needed in providing care 
to HIV-infected patients and their fami- 
lies, including: death and dying, pain 
control, palliative care, human sexuality, 
substance abuse counseling, ethics, and 
infection control. 

3-3 Health care professions schools should 

be given incentives to recruit medical 
students into specialties that are under- 



24 



represented but needed due to the HIV 
epidemic. 

3-4 Eligibility for financial scholarships and 

grants should include evaluation mecha- 
nisms that take into account the adult fi- 
nancial responsibilities of adult students. 

3-5 The Health Resources and Services Ad- 

ministration should develop a model 
program to create innovative techniques 
to recruit, train, and retain nonprofes- 
sional health care providers. 

3-6 The federal government, through the 

National Institute of Mental Health, 
should continue to provide funding for 
development of psychosocial and neur- 
opsychiatric provider education and 
training programs to ensure continued 
availability to those who need such care 
in the future. 

3-7 Institutions which employ health care 

providers serving persons infected with 
HIV should provide psychosocial sup- 
port to their ~staff on a proactive and 
continuing basis. 

Nursing 

The role of nursing in providing care to 
people with HIV infection cannot be addressed 
without acknowledging a deepening shortage of 
nurses in the workforce. In addition, the 
stresses associated with providing care for 
chronically ill patients in need of long-term and 
terminal care, combined with a potential, albeit 
small, risk of exposure to infectious agents may 
be negatively influencing the choice of nursing 
as a career for some people. 

Nurses have a foundation of biophysical and 
psychosocial knowledge which enables them to 
provide quality care to HIV-infected persons in 
a safe and effective manner. This knowledge 
enables nurses to function in the role of case 
manager at its fullest potential. Nurses are edu- 
cated to provide for the physical, psychological, 
emotional, social, and spiritual needs of their 
clients. Nurses have the responsibility, as do all 
health care professionals, to equip themselves 
with accurate information about HIV and the 
care of HIV-infected persons. 

Nurses are currently providing care in a vari- 
ety of health care settings such as hospitals, 
clinics, home care, hospices, nursing homes, 
schools, occupational sites, and others. Howev- 
er, in the hospital setting alone, the vacancy 
rates for registered nurses exceed 13 percent. 
Recommendations to ensure an adequate 



supply of appropriately prepared nurses for 
care of the HIV-infected patient will be made 
in this report within the context of a general 
nursing shortage. The issues of salary compres- 
sion (the narrow range of salaries in which 
nurses top out early in their careers) and re- 
strictions of full use of judgment are major 
causes of nurses leaving the field for other ca- 
reers. Planning must also include strategies for 
retaining nurses already in the workforce. 

The professional nurse educated at the BSN 
(Bachelor of Science in Nursing) level and 
above is educated to care for patients and their 
families in a variety of complex settings, both 
in the hospital and in the community. This pro- 
fessional nurse is educated additionally in dis- 
ease prevention and health promotion for a 
variety of patients and their families in the hos- 
pital and in the community. In contrast, the 
technical nurse is educated to care for such 
patients in hospitals who have well-defined pa- 
tient care problems. 

The demand exceeds the supply of highly 
educated nurses to manage the sophisticated 
health care needs of tomorrow. The projected 
supply of BSN nurses for the year 2000 is 
596,000 full-time equivalents, while the need is 
set at 853,800. The supply of masters and doc- 
torally prepared nurses is projected to be 
174,900 while the requirement is projected to 
be 377,100. The most acute shortage in nurs- 
ing generally — that of nurses with higher edu- 
cation — is made more acute by the intensive 
training needed to care for patients affected by 
HIV. The number of nurses trained to the as- 
sociate degree or diploma level is projected to 
be more than adequate for the nursing posi- 
tions which can be filled by those at these 
lower educational levels. However, consider- 
able testimony has indicated that some inner 
city hospitals are facing a shortage at this level, 
too, primarily due to low hourly wages at mu- 
nicipal institutions. 

Obstacles to Progress 

• The demand exceeds the supply of highly edu- 
cated nurses to manage the sophisticated health 
care needs of tomorrow. 

• Preliminary projections by the Department of 
Health and Human Services for the year 2000 in- 
dicate the need for 38 percent more nurses than 
were required in 1985. Simultaneously, enroll- 
ment in schools of nursing continues to decline, 
necessitating clear, deliberate action on the part 



25 



of the health care industry and the state and fed- 
eral governments to promote the profession of 
nursing. 

• The level of compensation provided to nurses is 
markedly lower than necessary to attract and 
retain adequate numbers of individuals to the 
field. Differing levels of education, skills, and ex- 
pertise, as well as the personal sacrifice requisite 
in a nursing career are reportedly rewarded inad- 
equately at current compensation levels. 

• Federal funding for nursing training and educa- 
tion has remained constant and, in fact, de- 
creased in some programs over the last several 
years, rather than being increased to meet the in- 
creased need. 

• The traditional mechanisms available for stu- 
dents to finance nursing education consist of a 
patchwork combination of scholarships, loans, 
workstudy programs, work payback programs, 
and traineeships. Sources of these funds for LPN 
(licensed practical nurse), Diploma, AD (Associ- 
ate Degree), BSN (Bachelor of Science in Nurs- 
ing), MSN (Master of Science in Nursing), and 
doctoral nursing students have been cut or lost. 

• As with medical students, the average age of 
nursing students is rising, creating a large 
number of non-traditional students with adult re- 
sponsibilities. Current methods of calculating fi- 
nancial need can penalize adult learners by disal- 
lowing deductions for adult financial obligations. 

• The nursing profession also has need for more 
education about HIV. While curriculum changes 
relating to HIV educational programs at Ameri- 
can colleges of nursing have been considered, 
and while there have been several initiatives to 
educate practicing nurses, the response is still in- 
adequate to meet current and projected needs 
for more education. 

• Traineeship funds from the United States Public 
Health Service's Division of Nursing are available 
only to RNs who seek to continue their profes- 
sional education by pursuing a higher degree. 
Non-RNs pursuing nursing as their first profes- 
sional degree are not currently eligible for train- 
eeships. 

• The nursing care of persons with HIV infection 
is complex and intensive, and consumes a dispro- 
portionate amount of nursing time and hospital 
resources. 

RECOMMENDATIONS 

3-8 The Public Health Service's Division of 

Nursing should fund demonstration 
projects to evaluate models of nurse- 
managed care for persons with HIV in- 
fection or other chronic illnesses. Includ- 
ed should be an evaluation of the Com- 



munity Nursing Organization concept (as 
described in the Community Nursing 
and Ambulatory Care Act of 1987) ap- 
plied to the care of HIV-infected per- 
sons. In addition, models of differentiat- 
ed nursing practice, employing nurses in 
differing job descriptions based on vary- 
ing levels of education, should be evalu- 
ated. 

3-9 The Public Health Service's Division of 

Nursing should alleviate restrictions for 
nurse traineeships and provide funding 
for stipends for full-time and part-time 
nursing students. Traineeships should be 
available for RNs pursuing higher de- 
grees as well as for those students who 
are not yet registered nurses but are 
pursuing nursing higher education. Spe- 
cial emphasis should be given to nurses 
pursuing advanced degrees in communi- 
ty health nursing, school health nursing, 
and occupational nursing. 

3-10 The National Institute of Mental Health 

should reinstate funding for traineeships 
to educate psych-mental health nurses at 
the masters and doctoral levels who will 
be needed for counseling efforts. 

3-11 Funding for the current Nursing Student 

Loan Program should be increased, and 
eligibility requirements for low interest 
loans should be modified. 

3-12 Nursing work payback programs should 

be established by the federal govern- 
ment to provide tuition support for edu- 
cation and living expenses. Such pro- 
grams would have a greater forgiveness 
clause for students working in facilities 
which provide care to persons who are 
infected with HIV, including hospitals, 
long-term care facilities, community- 
based organizations, drug treatment fa- 
cilities, and others that meet the expand- 
ed definitions of medically underserved 
areas. 

3-13 Hospitals, other employers of nurses, 

and schools of nursing should be en- 
couraged, in conjunction with the federal 
government, to provide both financial 
and scheduling incentives for nurses to 
pursue advanced degrees in nursing. 

3-14 Nursing organizations in conjunction 

with the Division of Nursing in the 
Health Resources and Services Adminis- 
tration should establish guidelines for 
health care institutions for the imple- 
mentation of counseling and support 
services for nurses caring for HIV-infect- 



26 



ed persons with appropriate mechanisms 
for assuring their implementation. 

3-15 Additional funding should be provided 

through the Public Health Service's Divi- 
sion of Nursing Special Project grants in 
collaboration with the American Hospital 
Association, the Association of Nurse Ex- 
ecutives, and other professional organi- 
zations for the development of innova- 
tive strategies designed to increase re- 
tention of nurses in practice. 

3-16 The Department of Health and Human 

Services should fund grants to Schools 
of Nursing that seek collaborative rela- 
tionships with agencies to demonstrate 
the cost-effectiveness and quality of uti- 
lizing the nurse as a case manager who: 

• assesses the patient and family needs 
for short-term and long-term care; 

• mitigates medical costs by facilitating 
the patient's optimal level of inde- 
pendence through access to appropri- 
ate levels of care both in the hospital 
and in out-of-hospital settings; 

• organizes and sequences those serv- 
ices and resources needed to ade- 
quately respond to patient's health 
care needs by: working with the at- 
tending physician to assess the pa- 
tient's medical needs; and functioning 
as a liaison between the patient and 
specialized facilities and other provid- 
ers. 



3-17 The Department of Health and Human 

Services (HHS) should fund tuition and 
stipend grants for students in innovative 
nursing education programs, which offer 
advanced degrees in nursing as a first 
professional degree in nursing in order 
to: 

• meet future health care provider 
needs as defined by HHS. 

• address the shortage issue by stimu- 
lating interest in nursing careers 
among those in a non-traditional, 
older population, who may seek pro- 
fessional nursing as a second career. 

3-18 The Health Care Financing Administra- 

tion should restructure the Medicare and 
Medicaid reimbursement systems to 
allow for direct reimbursement to pro- 
fessional nurses caring for persons with 
HIV-related illnesses and other chron- 
ically ill patients in acute and community 
care settings. 



3-19 The Public Health Service's Office of Mi- 

nority Health should identify funding for 
recruitment of minorities into advanced 
levels of nursing education programs. 

3-20 Congress should amend the Nurse 

Training Act to include the provision: 
that up to 85 percent of a borrower's 
loan plus interest would be canceled at 
the rate of 15 percent for each complete 
year of full-time employment as a profes- 
sional nurse. 

National Health Service Corps 

It is estimated that 34 million persons in the 
United States live in areas or in groups desig- 
nated as health care shortage areas or groups. 
To meet the needs of these underserved areas, 
the services provided through the National 
Health Service Corps (NHSC) have been of ex- 
traordinary value over the last 18 years. NHSC 
has helped communities obtain qualified health 
care providers by providing scholarships (tui- 
tion abatement) in return for a commitment to 
work longer in a medically underserved area. 
This placement effort was begun to comple- 
ment federal, state and private programs which 
were aimed at expanding student enrollment in 
medical schools. This expansion was an answer 
in part to resolving the severe national short- 
age of health care workers. The primary mis- 
sion of NHSC since its inception in 1970 has 
been to provide primary care services to isolat- 
ed or underserved areas and to populations 
which for a variety of reasons, such as econom- 
ic or geographic barriers, minority status, lan- 
guage, cultural, or other constraints, are unable 
to obtain basic health care. 

The majority of personnel serving in NHSC 
have been physicians though it also includes 
dentists, pharmacists and podiatrists. In 1986, 
the program reached its peak field strength of 
approximately 3,200 individuals. Its current en- 
rollment of 2,800 is serving in federally funded 
Community Health Centers (CHCs) and Mi- 
grant Health Centers (MHCs) as well as facili- 
ties operated by the Indian Health Service 
(IHS), the Bureau of Prisons (BOP), and 
through private practice arrangements. As of 
November 30, 1987, 508 NHSC physicians and 
27 NHSC dentists were serving in facilities 
within the 30 standard metropolitan statistical 
areas (SMSAs) with the highest incidence of 
AIDS cases. However, due to the elimination of 
scholarships since 1981, the number of obligat- 
ed physicians will be decreasing to fewer than 



27 



100 NHSC providers available for assignments 
by 1994, at a point when service needs for 
these underserved populations will be extreme- 
ly high. 

Persons with HIV are now underserved in 
many parts of the country and the increasing 
caseload will create further strains in the na- 
tion's health care system. During the Commis- 
sion's site visit to Belle Glade, Florida, the 
need for NHSC was strikingly evident. A single 
NHSC physician provided the main health care 
services available to the entire community of 
HIV-infected residents and their families, as 
well as the area's migrant population. This area 
and other areas like it will face a health care 
crisis when NHSC physicians complete their 
obligation and leave without being replaced. 

On December 1, 1987, Public Law 100-177 
was signed which provides for the establish- 
ment of a new federal loan repayment pro- 
gram, a state repayment loan program, and in- 
cludes special repayment provisions for previ- 
ous NHSC scholarship recipients who have 
failed to comply with their service obligations. 
The scholarship program provides tuition fees 
and stipend support to enable medical and 
dental students to complete their professional 
education. However, it is expected that these 
programs will make loans available to only 40 
persons and return to service a limited number 
of earlier scholarship recipients. This is inad- 
equate to meet projected needs. 

Obstacles to Progress 

• As the National Health Service Corps (NHSC) 
personnel currently serving populations in un- 
derserved areas are withdrawn, a severe health 
care shortage will occur. 

• NHSC physicians and dentists are often the only 
source of health and dental care in the communi- 
ty. 

• Health care availability through the Indian 
Health Service and the Bureau of Prisons, al- 
ready limited, may worsen as the number of HIV 
infection cases increases. 

• The decrease in available NHSC scholarships will 
make the number of health professionals avail- 
able to underserved areas woefully inadequate. 

RECOMMENDATIONS 

3-21 The National Health Service Corps 

scholarship funds program should be re- 
instated to enlist an additional 400 pri- 
mary care physicians in training per year, 



and provide loan forgiveness to 100 ad- 
ditional practicing primary care physi- 
cians per year to staff facilities in under- 
served areas, including HIV-endemic 
areas. 

3-22 The National Health Service Corps 

should establish scholarships, loans, and 
workstudy opportunities to recruit, train, 
place, and retain 200 nurses per year to 
staff facilities in underserved areas, in- 
cluding HIV-endemic areas. 

3-23 Individuals who received National 

Health Service Corps funding for all or 
part of their professional education and 
who have defaulted on their subsequent 
service obligations, should be offered 
the option of serving in HIV-endemic 
areas to meet their outstanding obliga- 
tions. 

3-24 The National Health Service Corps 

should establish scholarships, loans, and 
workstudy opportunities to recruit, train, 
place, and retain 100 master's degree 
level social workers per year to staff fa- 
cilities in underserved areas, including 
HIV-endemic areas. 

3-25 The National Health Service Corps 

(NHSC) should permit specialist physi- 
cians who have not as yet met their 
NHSC scholarship service obligations to 
fulfill these obligations in an under- 
served, HIV-endemic area. Those spe- 
cialties most appropriate to HIV-related 
care, such as infectious disease or inter- 
nal medicine, should receive priority. 

3-26 The National Health Service Corps 

should ensure that all its professional 
staff are provided with education and 
training in the diagnosis, treatment, and 
prevention of HIV infection, particularly 
in HIV-endemic areas. 

3-27 The National Health Service Corps 

should provide scholarship funds at the 
undergraduate level to minority students 
to allow more minorities to continue 
their education through the professional 
degree level, with repayment of these 
scholarships through service in under- 
served, HIV-endemic areas. 

3-28 The Secretary of Health and Human 

Services should ensure that minorities 
are represented on federal decision- 
making bodies in order that cultural 
characteristics are recognized appropri- 
ately. All new federally funded HIV 
treatment service programs should in- 



28 



elude local advisory boards with appro- 
priate minority representation. 

Section II. Health Care Worker 
Education 

Numerous privately and publicly funded or- 
ganizations are developing training resources 
for health care providers, distributing health 
education pamphlets, and research mono- 
graphs, and publishing books, articles, and 
newsletters in an attempt to share information 
about HIV throughout the health profession 
community. 

Agencies and organizations which are at- 
tempting to coordinate or develop HIV infor- 
mation exchange include: 

• The Centers for Disease Control AIDS Clearing- 
house; 

• The Centers for Disease Control AIDS Hotline; 

• The Health Resources and Services Administra- 
tion AIDS Education and Training Centers Pro- 
gram; 

• The Health Resources and Services Administra- 
tion Area Health Education Centers Program; 

• The National Library of Medicine; 

• Medical societies, specialty organizations and 
professional associations; 

• HIV advocacy and support groups; and 

• several commercial ventures. 

Community planners and administrators who 
are in the position of designing treatment sys- 
tems to meet significant anticipated increases in 
their patient populations need access to re- 
search findings which suggest the most humane 
and cost-effective approach to HIV-related 
care. 

Information about the National Institutes of 
Health (NIH) experimental treatment protocols 
is currently disseminated through a private 
contractor. Information about experimental 
drug trials funded outside NIH is generally not 
centrally collated for retrieval by practicing 
providers, researchers, or the public. 

Obstacles to Progress 

• Many health care providers have not received 
adequate education about the psychosocial needs 
associated with death and dying, and also have 
not received sufficient education about the psy- 
chosocial aspects of human sexuality. As a result, 
some providers are limited in their ability to 
meet these specific needs in HIV-infected per- 
sons or their loved ones. 

• In communities where the prevalence of HIV in- 
fection has been relatively low, primary care phy- 



sicians who encounter HIV-infected patients in 
their practice may have no awareness of central 
sources of information about the disease. Be- 
cause they do not know where to direct their 
questions concerning treatment modalities, eval- 
uation and management may be suboptimal and 
unnecessarily expensive. 

• Information about experimental HIV treatment 
protocols is not adequately communicated to 
those who need it. Information about existing 
treatment protocols is being compiled by a pri- 
vate organization, the American Foundation for 
AIDS Research, with support through a National 
Institute of Allergy and Infectious Disease sub- 
contract. However, many practitioners and per- 
sons with HIV infection are not aware of this. In- 
formation about experimental protocols not 
funded by NIH is more difficult to acquire and at 
this point appears incomplete. 

RECOMMENDATIONS 

3-29 The federal government through a cen- 

tral database/hotline should provide: 

• treatment information for those with 
HIV and for health care profession- 
als. 

• experimental treatment protocol in- 
formation to practitioners and the 
public. 

• linkages with international databases. 

• clearinghouse for health services. 

3-30 The Liaison Committee on Medical Edu- 

cation of the Association of American 
Medical Colleges and the American 
Medical Association, which accredits 
medical colleges, should immediately de- 
termine how medical colleges are modi- 
fying curricula to assure adequate educa- 
tion about prevention, diagnosis, and 
treatment of HIV infection. 

3-31 The American Association of Medical 

Colleges should develop and circulate to 
member institutions a model plan for 
curriculum structure, which medical 
schools can adapt to develop individual- 
ized programs best meeting local needs 
and circumstances. The Health Re- 
sources and Services Administration's 
Multidisciplinary Curriculum Develop- 
ment Conference on HIV Infection, in 
November 1987, produced consensus 
recommendations which may be useful 
for this purpose. 

3-32 The Special Initiative Funding of the 

Area Health Education Centers (AHEC) 
Program should be increased to include 



29 



funds to establish communication chan- 
nels and outreach programs to reach 
nurses and other health care providers 
in all settings within the region to dis- 
seminate updated information concern- 
ing the care of HIV-infected persons. 
AHECs should establish appropriate 
training strategies for care providers 
within their region to learn about HIV, 
including train the trainer and clinical 
hands-on experience strategies. 

3-33 The state regulatory agencies that issue 

licenses for health care providers should 
strongly urge completion of comprehen- 
sive continuing education programs 
about HIV, with particular attention to 
prevention, diagnosis, treatment, and in- 
fection control. Those states that require 
continuing education of health care pro- 
viders for licensure should include HIV 
infection. Professional societies should 
assume the responsibility for seeing that 
every health professional is educated 
concerning HIV infection. 

3-34 Health professions schools should pro- 

vide faculty development programs to 
assure that faculty are adequately pre- 
pared to educate students about aspects 
of HIV. Faculty development grants 
should be provided by the federal gov- 
ernment, to be administered by the 
Health Resources and Services Adminis- 
tration's Bureau of Health Professions, 
with matching state funds. 

3-35 The Department of Health and Human 

Services should require any HIV educa- 
tional programs which receive federal 
funds for both professional and non-pro- 
fessional health care providers to include 
culturally relevant and sensitive curricu- 
lum and instruction. 

3-36 Health professional organizations and 

societies should immediately develop 
plans for assessment of their members' 
HIV-related educational needs, design 
ongoing educational programs to over- 
come identified deficiencies, and periodi- 
cally evaluate effectiveness of these pro- 
grams. Where possible, educational of- 
ferings should be multidisciplinary and 
incorporate hands-on experience. 

[See also (3-53), (3-54), and (3-55) in 
following section.] 

Section III. Health Care Worker 
Safety 

The American health care system is based on 
the work of the fine women and men who daily 



provide quality care for sick people, many 
times in difficult circumstances. The Commis- 
sion appreciates that their dedication and sacri- 
fice contributes greatly to the health of all our 
people. 

The nature of health care providers' work 
puts them at risk of exposure to a number of 
infectious diseases, therefore efforts to mini- 
mize that risk should be a high priority on this 
nation's health care agenda. According to the 
Centers for Disease Control (CDC), there are 
several routes through which a health care 
worker is considered to have an "exposure" to 
blood or blood-contaminated body fluids, and 
possibly to HIV infection. They include: 

• parenteral (e.g. needlestick, cuts); 

• mucous membrane (e.g. splash to the eye or 
mouth); 

• cutaneous, involving large amounts of blood or 
prolonged contact with blood, especially if the 
exposed skin is chapped, abraded, or afflicted 
with dermatitis. 

Health care workers have responded to the 
HIV epidemic in a responsible and compas- 
sionate manner even in the absence of compre- 
hensive research and established guidelines and 
procedures for HIV infection control. Many of 
their concerns have been treated casually by 
those responsible for providing for their gener- 
al safety and health in the workplace setting, 
including administrators, regulators and gov- 
ernment officials at the federal, state and local 
level. 

The health care professional is often thought 
of as being confined to the physician, the 
nurse, and perhaps the laboratory personnel. 
CDC considers a health care worker as any 
person, including students and trainees, whose 
activities involve contact with patients or with 
blood or other body fluids from patients in a 
health care setting. The full range of health 
care workers — including nurses' aides, home 
care workers, the chaplain, volunteers, laundry 
workers and other hospital housekeeping per- 
sonnel — needs to be considered when devel- 
oping infectious disease control procedures and 
training programs. 

In particular, those who provide pre-hospital 
emergency care ~ police, fire fighters, emer- 
gency medical technicians, paramedics 
should be considered as health care workers 
who may require particular methods of precau- 



30 



tion that reflect their relative risk when deliver- 
ing emergency health care. 

The Commission heard considerable testimo- 
ny regarding the quality and availability of the 
equipment used and the garments worn by 
health care providers. We heard that in some 
facilities gowns, goggles and shoe covers often 
are not inspected and that procurement proce- 
dures are often designed to purchase the least 
expensive equipment without consideration for 
effectiveness. In other facilities, equipment and 
required supplies are not available in the quan- 
tities needed. Virtually nothing has been done 
to address the concerns of emergency response 
workers who must perform life-saving functions 
in the most unaccommodating environments. 

Health care workers expressed considerable 
concern that infectious disease control efforts 
in general have not been very effective in this 
country. This is evidenced by CDC data which 
reveal that between 12,000 and 15,000 health 
care workers a year become infected with hepa- 
titis B, leading to over 200 deaths a year. 

Because HIV is in some ways similar to hepa- 
titis B, a number of studies were undertaken to 
assess the risk of HIV infection to health care 
workers. Additional information regarding the 
extent of actual occupational exposure has 
been gathered by other sources such as the 
CDC AIDS surveillance system and case reports 
published in medical literature. 

Most hospitals are not funded to do the nec- 
essary research on the full extent of risk to 
health care workers. Therefore, the studies that 
are being reported are limited in scope, leading 
sometimes to contradictory information about 
the extent of risk and the safeguards that need 
to be implemented. 

Among health care workers, however, there 
is a general consensus that more, and larger, 
studies of the extent of risk of HIV infection 
need to be undertaken in order to resolve the 
persistent questions and build a level of confi- 
dence in those on the front line of providing 
health care to the nation's sick, especially those 
with infectious diseases. 

Early studies and reports have indicated that 
the risk for occupational transmission of HIV in 
the health care setting is less than one percent; 
that is, of all possible exposures, fewer than 
one percent actually lead to seroconversion. If 
this pattern continues, the level of risk for oc- 
cupational exposure to HIV infection is compa- 
rable to or lower than other workplace risks 



that health care workers have been taking for 
years. 

For over 18 years various governmental 
agencies, particularly CDC, have been active in 
developing guidelines and recommendations to 
prevent patient-to-patient, health care worker- 
to-patient and patient-to-health care worker 
transmission of infections. A variety of health 
professional organizations have also been in- 
volved in health education and promotion, as 
well as infection control and prevention for 
their members. 

There is a great need for administrative and 
employment policies instituted by health care 
employers and administrators that provide ef- 
fective approaches to the complex problem of 
exposure to blood-borne infectious diseases 
among health care and support workers. Struc- 
tured infection control training, and strict re- 
quirements for compliance in the health care 
setting cannot be overemphasized. 

A multifaceted program that includes ongo- 
ing research and innovative educational and 
training techniques could provide valuable in- 
formation on how best to accomplish the goals 
of ensuring that workers at significant risk are 
provided with appropriate protection and are 
trained in the need for safe work practices. 

Public Health and Safety Workers 

There is great concern about possible on- 
the-job exposure to HIV among certain public 
health and safety workers, particularly ambu- 
lance personnel, police, fire fighters, correc- 
tional officers, sanitation workers, and custo- 
dians. 

Many of these workers come in direct contact 
with the blood of individuals on a regular basis, 
either when providing emergency medical care 
or in confrontational or violent situations. 
Others deal regularly with waste products, 
blood contaminated body fluids and used hypo- 
dermic needles. 

Development of precautions against HIV for 
these workers has been less than adequate. Pre- 
cautionary measures issued by various govern- 
mental agencies for all workers who may come 
in contact with HIV and other blood-borne dis- 
eases are generally considered to apply to 
emergency response workers as well, but have 
not been presented to those workers in a sys- 
tematic fashion. 

Emergency response personnel are particu- 
larly concerned about their inability to deter- 



31 



mine whether they have been exposed to HIV 
through contact with asymptomatic infected in- 
dividuals. In some states, confidentiality laws 
prohibit hospitals from releasing information 
about a patient's HIV status, leaving these 
workers to wait several months until their own 
blood tests confirm whether or not they have 
contracted the virus. This long delay in notifi- 
cation causes great anxiety and has a devastat- 
ing effect on personal relationships with family 
members. 

Extent of Risk 

CDC and other experts have determined that 
the primary risk of HIV transmission to health 
care workers in the health care setting is by 
blood and blood-contaminated body fluids, and 
the major mode of transmission is percutan- 
eous needlestick exposure. Other studies con- 
firmed that needlestick exposure is the main 
route of HIV transmission to health care work- 
ers. 

Some current studies conclude the risk of 
infection from a single needlestick exposure to 
HIV infected blood is 0.5 percent (one in 200). 
The risk of HIV infection over a lifetime of 
needlesticks could be substantial. However, to 
put this level of risk in perspective, the rate of 
infection following a single needlestick expo- 
sure to blood infected with hepatitis B virus is 
10 to 15 percent, approximately 10 to 30 times 
greater than the risk of HIV. Further studies to 
reassess HIV risk to health care workers are 
urgently needed in light of recently released 
research. Fortunately, most needlestick injuries 
are preventable in the opinion of most practi- 
tioners. 

Health care workers, themselves, admit that 
all too often the risk of exposure to HIV or 
other infectious diseases is caused by the cava- 
lier approach taken by some workers as they 
perform their duties, particularly when they are 
not properly using infection control proce- 
dures. 

Risk of other HIV-related infections is also of 
significant concern to health care workers. Pa- 
tients whose immune systems are compromised 
by HIV excrete in relatively high concentra- 
tions many other agents, including cytomegalo- 
virus (CMV), hepatitis B virus (HBV), herpes 
simplex virus type 2 (HSV-2), and Epstein-Barr 
virus (EBV). Tuberculosis is also a frequent 
infection in HIV-infected individuals. Even 
though current studies indicate that there is no 
difference in the prevalence of these secondary 



infections in health care workers with high ex- 
posure to AIDS patients and those with low or 
no exposure, the Commission continues to be 
concerned about the effect of such exposure on 
health care workers, particularly those who are 
pregnant. 

Policies for Prevention of Transmission 
of HIV 

CDC has developed basic policy recommen- 
dations for prevention of HIV transmission in 
the health care setting. These recommenda- 
tions, which call for the use of Universal Pre- 
cautions, are designed to emphasize the need 
for all health care workers to consider the 
blood and blood-contaminated body fluids of 
all patients as potentially infected with HIV 
and/or other blood-borne pathogens and to 
adhere rigorously to infection control precau- 
tions for minimizing the risk of exposure to 
blood and body fluids of all patients. 

This represents a major difference in the way 
body substance precautions were taken in the 
past. Under the old system the health care 
worker was required to identify the patient and 
the specific infection in order to implement ap- 
propriate infection control procedures. 

It is generally felt at this time that depend- 
ence on HIV blood testing as an infection con- 
trol procedure or to screen all patients for the 
purpose of preventing occupational transmis- 
sion of HIV is not effective and in fact may 
interfere with other means of preventing occu- 
pational transmission. However, the use of test- 
ing for the early diagnosis, medical manage- 
ment, care, and understanding of the patient is 
appropriate. 

There continue to be certain physical bar- 
riers, engineering barriers, financial and behav- 
ioral barriers to compliance with Universal Pre- 
cautions and other infection control proce- 
dures. Development of an enforceable infection 
control standard to protect health care workers 
from all blood-borne diseases is greatly 
needed. CDC does not have the authority to 
enforce hospital compliance with its recommen- 
dations. 

The Occupational Safety and Health Admin- 
istration (OSHA) in the Department of Labor 
(DOL) is generally responsible for the develop- 
ment and promulgation of occupational safety 
and health standards and for the effective en- 
forcement of such standards. In conjunction 
with the Department of Health and Human 



32 



Services, DOL issued a Joint Advisory Notice to 
over 600,000 employers designed to provide 
some basic recommendations for protection 
against occupational exposure to HIV and 
HBV. OSHA has also begun inspections in re- 
sponse to formal worker complaints and gener- 
al schedule inspections to examine actual work 
practices in health care settings, especially the 
extent of compliance with existing protective 
guidelines. Enforcement is also within the au- 
thority of the Health Care Financing Adminis- 
tration through its certification standards for 
federal reimbursement and through the accred- 
itation process of the Joint Commission on Ac- 
creditation of Hospitals. 

In addition, DOL is completing the rulemak- 
ing process on the development of an enforcea- 
ble standard to protect health care workers 
from the threat of infectious blood-borne dis- 
eases. 

The National Institute for Occupational 
Safety and Health, a division of CDC, is re- 
sponsible for conducting research, experi- 
ments, and demonstrations relating to occupa- 
tional safety and health and for making recom- 
mendations concerning new or improved occu- 
pational safety and health standards. This 
agency would be responsible for doing research 
on the efficacy and adequacy of personal pro- 
tective equipment, yet very little progress has 
been achieved to date. 

Expeditious and coordinated consideration of 
these efforts at the federal level should set the 
tone for state, local, and personal responsive- 
ness. 

Policies for Infected Health Care 
Workers 

Health care facilities should have policies for 
their HIV-infected employees. It is important 
that institutional policies protect the employ- 
ment status of the worker, while balancing the 
responsibility to provide safe care to patients. 
Without such protections, infected workers will 
be reluctant to identify themselves. 

In general, policies that govern any other 
HD7-infected worker could apply to the health 
care worker. The clear exception is when the 
health care worker poses the risk of transmis- 
sion to a patient during the performance of an 
invasive procedure. Also of concern is the time 
period when the risk of transmitting a second- 
ary infection exists. Some health care institu- 
tions prohibit HIV-infected health care workers 



from participating in direct patient care, and 
assign them to other duties instead. 

The consensus of witnesses is that infected 
health care workers should be evaluated in con- 
junction with their family health care providers, 
and any changes in work assignment or respon- 
sibilities should be done in a manner appropri- 
ate to each one's medical condition. In consid- 
ering any job reassignment, an infected work- 
er's health should be protected against expo- 
sure to secondary infections wherever possible. 

Obstacles to Progress 

Some obstacles to progress are: 

• Data are lacking which could be obtained from 
large-scale studies to determine the risk of trans- 
mitting HIV and other infectious diseases in the 
health care setting. 

• Training and tradition, tend to stand in the way 
of health care workers assimilation of and com- 
pliance with infection control procedures. 

• Pre-hospital emergency care providers (paramed- 
ics, fire fighters, and police) have an immediate 
and continuing need for more education about 
infection control because their frequent exposure 
to blood and body fluids in their handling of all 
types of patients in uncontrolled settings places 
them at elevated risk of exposure to the virus. 

• There is a lack of current, high-quality education 
and training materials. 

• Health care workers who have not had recent 
formal educational training about AIDS/HIV 
have gaps in their clinical knowledge. 

• Health care professionals who have significant 
fears, phobias and other psychological blocks are 
inhibited in their care of HIV-infected patients, 
and tend not to use appropriate infection control 
practices. 

• Certain state laws prohibit hospitals from divulg- 
ing information about a patient's HIV status, 
even to emergency response personnel who have 
had an exposure to the blood or blood-contami- 
nated body fluid of the patient. 

• Costs of implementing precautions can be signifi- 
cant, such as training costs, costs of better qual- 
ity supplies, engineering modifications, and up- 
dated and current educational materials. 

• Current technology for equipment design is defi- 
cient. Some equipment may increase the risks of 
occupational exposure. 



33 



RECOMMENDATIONS 

3-37 



The federal government should provide 
incentives and funding for the develop- 
ment of systematic, large scale studies of 
the occupational risk of HIV and other 
blood-borne agents in the health care 
setting and the efficacy of Universal Pre- 
cautions. 



3-38 The National Institute for Occupational 

Safety and Health should facilitate coop- 
erative arrangements among health care 3-45 
employers and federal and state agencies 9-102 
to standardize requirements for research 
efforts in order to maximize the useful- 
ness of the results. Flexibility should be 
maintained wherever possible. 

3-39 The National Institute for Occupational 

Safety and Health, in cooperation with 
other concerned bodies, should support 
and conduct studies that document the 
level and particular types of exposure 
risks that are taken by emergency and 
other non-institutional personnel and 
how they can be prevented. 

3-40 The Department of Labor should move 3-46 

expeditiously to develop a permanent 
and enforceable standard covering 
blood-borne diseases, with penalties for 
noncompliance, to protect health care 
and other workers whose jobs involve 
exposure to blood and blood-contami- 
nated body fluids. 

3-41 All health care professionals should be 3-47 

required to be certified in infection con- 
trol knowledge and to participate in an 
appropriate education program. 

3-42 All institutions and agencies employing 

health care workers should require ad- 
herence to Universal Precautions or 
other infection control procedures in 
performance standards and in workers' 
evaluations. 

3-43 The Department of Labor, through the 

Occupational Safety and Health Admin- 
istration, or the Joint Commission on 
Accreditation of Hospitals should re- 
quire that all health care facilities make 
infection control devices and supplies 
available in all patient care areas. Institu- 
tions should be required to document 
that adequate stocks and timely disposal 
of filled infectious waste containers are 
accomplished. 

3-44 Legislation is needed in some states to 

permit hospitals to notify health care 3-49 
workers, who in the process of providing 
health care have had an exposure, as de- 



3-48 



fined by the Centers for Disease Control, 
to the blood or blood-contaminated 
body fluids of any patient, of that pa- 
tient's infection status. Notification 
should be made in such a way to protect 
the confidentiality of the patient while 
ensuring prompt notification to the 
health care worker. All future laws de- 
signed to protect confidentiality should 
include this exception to absolute confi- 
dentiality. 

If, in the process of providing health 
care, a health care worker is exposed to 
the blood or body fluids of any patient, 
the health care worker has the right to 
know the infection status of that individ- 
ual. Consent agreements obtained in the 
traditional health care provider/patient 
context will normally provide for this. In 
the unusual case of denial of consent, 
competent medical authorities should 
make the determination whether testing 
should be done and, if done, should 
note the rationale in the medical record. 

The Department of Health and Human 
Services should provide increased fund- 
ing for the timely development of cur- 
riculum changes and new training mate- 
rials tailored to address the needs of 
management, health care personnel, and 
others who are involved in providing 
care to HIV-infected and AIDS patients. 

The National Institute for Occupational 
Safety and Health should provide re- 
search funds for developing new tech- 
niques to decrease risk to health care 
workers, particularly through equipment 
design modification. This research 
should be integrated and should empha- 
size utilization with Universal Precau- 
tions. It should be coordinated in a way 
to help the entire range of health care 
providers, including volunteers. The re- 
sults of such research should be commu- 
nicated to practitioners in a coherent 
and timely fashion. 

All employers of health care workers 
should have prospective personnel poli- 
cies for employees who may have occu- 
pational exposure to blood and bodily 
fluids in order to ensure equitable treat- 
ment, appropriate medical surveillance, 
care and monitoring should the employ- 
ee become infected. 

All employers should ensure that em- 
ployees infected with HIV have access to 
the same sick, disability, and vacation 



34 



leave as employees with other medical 
conditions. 

3-50 Research institutions should give health 

care workers who become infected on 
the job priority in treatment programs as 
new drugs become available and other 
medical interventions are developed. 

3-51 The Centers for Disease Control should 

encourage voluntary HIV screening pro- 
grams to monitor and better understand 
events that cause infection and to pro- 
vide maximum support and assistance to 
workers who become infected. 

3-52 The National Institute of Mental Health 

should offer research grants for the pur- 
pose of studying the complex psychoso- 
cial issues which preclude assimilation 
of, and compliance with, infection con- 
trol guidelines by health care profession- 
als. 

3-53 The Department of Transportation 

should expand the section of the Nation- 
al Standard Curriculum for the First Re- 
sponder Course, the Emergency Medical 



Technician-Ambulance Course, and the 
Paramedic Course that pertains to com- 
municable diseases so that appropriate 
infection control techniques, including 
those that protect against HIV infection 
are included. States should adopt at least 
that portion of the National Standard 
Curriculum which pertains to communi- 
cable diseases. 

3-54 The certification process of pre-hospital 

care providers should confirm a suffi- 
cient knowledge base about infection 
control and HIV. In addition, states 
should incorporate a section on commu- 
nicable diseases and infection control 
into their continuing education require- 
ments for emergency care providers, 
(i.e., first responders, emergency medical 
technicians, paramedics, police, and fire- 
fighters). 

3-55 Institutions which benefit from the serv- 

ices of health care volunteers should 
assume responsibility for assuring that 
they are educated about HIV, including 
epidemiology, modes of transmission, 
and methods of infection control. 



35 



CHAPTER FOUR: BASIC RESEARCH, 
VACCINE, AND DRUG DEVELOPMENT 



Basic biomedical research continues to make 
vast and unprecedented advances in key scien- 
tific areas directly applicable to the HIV epi- 
demic. However, significant obstacles confront 
both the scientist seeking a cure, and the indi- 
vidual with HIV infection seeking treatment. 
Our national system of research programming 
and funding is not equipped to reorganize rap- 
idly in response to an emergency. The process 
of individual initiatives by scientists, followed 
by peer review, while essential, produces re- 
sults at a rate too slow to be understood or 
accepted by a country at risk. Innovative initia- 
tives are urgendy needed that will both main- 
tain scientific integrity and shorten the time 
from discovery to trial, and from trial to safe 
and effective treatment use. 

In its hearings on research issues, the Com- 
mission identified several areas of serious con- 
cern. Foremost among these is the need for 
broader basic research activity to more rapidly 
model and develop a broad range of anti-viral 
and immune modulating drugs and the need 
for immediate implementation of broadly acces- 
sible clinical trials of all potentially therapeutic 
agents. 

In the area of basic research, other problems 
identified were: 

• the need to free federally sponsored research 
from many of the bureaucratic restrictions that 
delay progress and constrain exploration. 

• the need to create new ways of thinking about 
basic biomedical research and science education 
and to establish them as much higher funding 
priorities. 

• the need for greater collaborative research, both 
nationally and internationally. 

• the need to upgrade many of America's aging re- 
search facilities and properly equip them for HIV 
research. 



• the need for an even greater emphasis on basic 
biology, virology, and immunology. 

• the urgent need for the establishment of a data 
base that would provide a description of the nat- 
ural course of the disease from which "historic 
controls" might be derived for research on the 
full spectrum of HIV-related illness. 

• the need for greater communication of research 
results, both within the research community and 
to the general public. 

In the areas of drug and vaccine develop- 
ment, problems include: 

• the need for increased access by a broader spec- 
trum of the infected population to a greater vari- 
ety of experimental treatments. 

• the need to eliminate whenever possible the use 
of placebo-controlled trials in patients whose dis- 
ease is immediately life-threatening. 

• the need for a public information system that 
would collect and make available current infor- 
mation on drug development and open clinical 
trials. 

• the need for direct federal support of quality-as- 
sured community-based drug trials. 

• the need to set aside counterproductive competi- 
tion as much as possible in favor of greater col- 
laboration among pharmaceutical industry mem- 
bers, and between industry and government, es- 
pecially in times of medical emergencies. 

• the need for additional Food and Drug Adminis- 
tration (FDA) resources to process more rapidly 
all HIV-related applications without compromis- 
ing standards of safety or efficacy or causing 
delays in the review of promising drugs for other 
diseases. 

Hearings on these and many additional re- 
search problems yielded the following informa- 
tion and recommendations. 



37 



Section I. Basic Research — The 
National Institutes of Health 

AIDS is a complex and aggressive biomedical 
syndrome which was initially recognized in this 
country at a time when there was no knowledge 
of what caused the disease, how it was trans- 
mitted, or how it could be stopped. There were 
no therapeutic drugs with known effectiveness, 
no vaccines, and no hope for early intervention 
in what seemed to be an endlessly escalating 
process. When an etiologic (causative) agent 
was identified by Dr. Robert Gallo at the Na- 
tional Cancer Institute (NCI) and Dr. Luc Mon- 
tagnier at the Pasteur Institute in Paris, it was 
found to be a retrovirus, a type of virus about 
which comparatively little was known. 

Within a short time, however, the research 
community responded to the challenge posed 
by the new disease by attacking it on many 
fronts. Even before the virus was isolated and 
the etiology of the disease established, many of 
the complexities of the syndrome had been de- 
lineated, and information had been gathered 
on transmission and possible co-factors. As 
soon as HIV was identified, intensive laborato- 
ry work began with "off the shelf drugs to 
find agents that might be viricidal or interfere 
with viral replication. Trials of promising drugs 
and vaccines are underway. That these success- 
es were achieved relatively rapidly was due to 
the presence of a major research infrastructure 
that worked ~ one that was built upon several 
decades of serious research commitment at the 
National Institutes of Health (NIH). 

America's investment in basic research can 
be broadly categorized as an investment in re- 
search and an investment in researchers. The 
former includes direct federal, state, and local 
funding for materials, facilities, and programs. 
The latter includes investment in training and 
support mechanisms which enable investigators 
to pursue innovative ideas. This research takes 
place on university campuses, in medical insti- 
tutions, and in independently sponsored re- 
search centers. Although other federal sources 
exist, the distribution of federal funding for 
research programs in these varied sites is cen- 
tralized in NIH. The largest proportion (87 
percent) of HIV research funding provided by 
NIH is given to institutions and individuals by 
means of direct grants or contracts. 

The advances made to date in research rest 
on a foundation of research excellence estab- 
lished many years ago at NIH and accelerated 



in the 1970's by the "War on Cancer," primari- 
ly within NCI. During this period, funding was 
increased in the areas of epidemiology, molecu- 
lar biology, microbiology, virology, immunolo- 
gy, genetics, and pharmacology, in an effort to 
find a "magic bullet" that would cure malig- 
nancies. 

In the early years of the HIV epidemic, NIH 
scientists answered the challenge by turning 
their research efforts to the new disease even 
though technically they were funded to do 
other work. As knowledge of the severity of the 
problem increased, funding followed so that re- 
search at NIH, the universities, and medical 
centers could continue and broaden in order to 
explore the disease more aggressively. 

Initial NIH funding for AIDS research was 
authorized by Congress in 1982 at $3.5 million. 
During FY 1988, NIH funding for HrV-related 
research is expected to reach almost $468 mil- 
lion, an 80 percent increase over the previous 
year, over 13,000 percent higher than in 1982. 
Of these funds, $407 million will be given in 
grants to support programs in universities, 
medical centers, and other extramural institu- 
tions, as well as to individuals. The remaining 
$61 million (13 percent of the total) will sup- 
port intramural research at the National Insti- 
tute of Allergy and Infectious Diseases 
(NIAID). 

While the federal government has allocated 
large sums of money to meet the research re- 
quirements of the epidemic, and while a great 
deal has been learned in a relatively short time, 
pressing research needs still exist. 

HIV-related basic research is expected to 
have high yield benefits to Americans who 
suffer from cancer, viral diseases, and immune 
diseases, which collectively kill an estimated 
650,000 individuals each year. Research areas 
that require additional long-range funding in- 
clude: 

Virology and molecular biology: What more 
can we learn about viral activity and structure 
so that vaccines and anti-viral drugs can be 
rapidly and efficiently modeled and developed? 
Until recently, very little was known about re- 
troviruses and lentiviruses, and though we are 
still only on the threshold, our knowledge is 
increasing rapidly. 

Immunology: How does HD7 damage the 
immune system? Why do some individuals 
remain healthy for so long after acquiring the 
virus, while others rapidly decline? What can 



38 



be done to stimulate or support the immune 
system of the infected individual so that he or 
she will remain healthy? 

Cell biology and host genetics: What viral 
mechanisms function in infected cells during 
the viral replication cycle, and how can we 
interfere with these mechanisms? What genetic 
co-factors, present in some individuals and not 
others, influence susceptibility and resistance to 
infection with HIV and the occurrence and ra- 
pidity of progression from a symptom-free state 
to overt disease? 

Pathogenesis: What are the mechanisms by 
which HIV spreads from cell to cell within the 
body, kills certain cells and interferes with the 
normal function of others, and undermines the 
host immune response to many serious oppor- 
tunistic infections? 

Reagents, Animal Models, and Research 
Information Exchange 

For information obtained in different re- 
search laboratories to be comparable, certain 
common resources must exist. Biologic materi- 
als such as viral strains, genetic probes, poly- 
clonal and monoclonal antibodies must be 
standardized and made widely available. 

To date, adequate animal models have not 
been developed for human HIV-related re- 
search. An appropriate model is one in which 
the animal can be infected with HIV and can 
develop disease similar to that produced by 
HIV infection in humans. In this way, experi- 
ments critical to our understanding of the 
virus, and of disease progression can be con- 
ducted without the use of human subjects. Dif- 
ficulties with animal models for HIV research 
persist. Chimpanzees, for example, can be in- 
fected with HIV, but, to date, have not devel- 
oped AIDS. In addition, chimpanzees, the only 
primates that can be infected with HIV, are an 
endangered species. Their breeding, care, and 
use in experiments must be carefully monitored 
by strict application of ethics and peer review, 
and they should be used only when there is no 
other alternative. It is important to ensure that 
experimental animals are treated humanely and 
used as sparingly as possible. Progress against 
HIV would be achieved much more slowly, at 
best, if animal studies were not permitted. 

Simian Immunodeficiency Viruses (SIV) are a 
group of viruses very similar to HIV-2 which 
infect rhesus macaques, a possible animal 
model candidate. In addition, SIV and HIV are 
lentiviruses, a virus characterized by a long la- 



tency period and slow progression of disease. 
Animal studies in lentiviruses are well docu- 
mented, and use of these models may prove 
valuable correlates to HIV. In addition to SIV, 
candidate viruses include visna-maedi (sheep), 
caprine arthritis encephalitis virus (goats), and 
equine infectious anemia (horses). Ideal animal 
model HIV research would use small animals 
that can be relatively easily and inexpensively 
maintained (e.g., mice). As these animals may 
be infected using genetically altered materials, 
issues such as biocontainment and liability 
would require serious attention. 

Work with virus-infected animals requires the 
strictest application of proper biocontainment 
procedures to protect research workers. Addi- 
tional obstacles to developing an appropriate 
animal model for HIV infection and AIDS in- 
clude criticism from organizations concerned 
with animal rights, and a decrease in the animal 
population overseas, resulting in ethical and 
legal restrictions against both animal importa- 
tion and conducting research in the animals' 
native setting. Researchers foresee long delays 
in the development of HIV drugs and vaccines, 
especially for use by pregnant women, if animal 
research is precluded. 

Witnesses before the Commission indicated a 
need for better mechanisms of information ex- 
change and communication about work in 
progress, especially in basic research, but noted 
that competition often precludes such ex- 
change. Within the federal government, the im- 
portance of interdepartmental communication 
on research programs is underlined by the 
HIV-related research being conducted at the 
Department of Defense. Research from the 
Strategic Defense Initiative (SDI) has, as a side 
benefit, produced valuable medical advances 
that may be useful in the fight against the HIV 
epidemic. One project under study is a dye 
laser system, which has been found capable of 
destroying certain viruses within the blood. An- 
other spinoff of the SDI applied technology 
program is the development of a virtually im- 
penetrable yet pliable material which will be 
used to make protective gloves that could be 
worn when conducting surgery or other medi- 
cal procedures. 

Several research witnesses testified that re- 
search liability problems should be addressed 
by the Commission because they create serious 
obstacles to research. Witnesses indicated that 
some institutions have been reluctant to under- 



39 



take HIV research until such liability problems 
have been resolved, fearing the cost of liability 
protection or liability actions would be 
unaffordable. Basic research liability issues 
relate primarily to worker safety, and are of 
special concern to those individuals working 
with live virus or virus-infected animals. 

Facilities 

HIV has added an increased burden to our 
already overstrained research facilities. Many 
scientists believe that our research efforts have 
been slowed because of outdated and antiquat- 
ed facilities. Work with viruses, viral concentra- 
tions, genetically altered and virus-infected ani- 
mals must be done in highly controlled set- 
tings. The model developed for expanding 
such research includes construction of contain- 
ment laboratories with a P-3 level of biosafety 
or modification of existing labs. At the begin- 
ning of the epidemic, very few of these facilities 
were in existence. 

In the research community outside NIH, few 
universities and research institutions have 
funds immediately available to create or con- 
vert facilities for HIV-related work. The cost of 
upgrading existing laboratories to P-3 level is 
approximately $250,000 per laboratory. Many 
laboratories now exist around the country that 
could be upgraded in this manner, providing 
space for additional HIV-related research. This 
diverse pluralistic distribution of research space 
was highly recommended by several witnesses 
as offering the greatest potential for discovery. 

Testimony suggested to the Commission that 
federal funding be supplied to establish region- 
al centers for basic and applied research in 
retroviral diseases. These centers would be lo- 
cated in a university or a research institute 
where a critical mass of expertise already exists, 
and the existing research team would be orga- 
nized and expanded for maximum interaction 
under the leadership of an appropriate investi- 
gator. The enlarged facility would be optimally 
equipped for this work. It would provide an 
appropriate environment for training of gradu- 
ate students and postdoctoral fellows, and 
would ideally be able to share a portion of its 
facilities with qualified visiting researchers from 
outside the parent institution who lacked facili- 
ties to advance their own research. Such cen- 
ters would have a great impact by providing 
opportunity to young researchers. 

A highly specialized type of facility that is in 
very short supply is a laboratory equipped for 



advanced research on the structure of protein 
constituents of viruses such as HIV. These 
studies involve the art of making crystals of 
these proteins and mapping the internal struc- 
ture of the protein molecule by the study of 
their X-ray diffraction patterns. Knowing these 
structures will greatly facilitate the develop- 
ment of antagonists to the functioning of these 
molecules in the course of disease develop- 
ment. 

In order to conduct rapidly expanded re- 
search on HIV that is safe and scientifically 
expedient, facilities and instrumentation must 
be brought up to date. Funds for this type of 
upgrading come primarily from the federal 
government. 

NIH last received major construction appro- 
priations in the late 1960's. Much of the con- 
struction authorization for the research insti- 
tutes has since expired. Institutes within NIH 
used to have independent construction author- 
ity but only three institutes are currently able 
to authorize and grant funds for construction. 
NIAID, the lead agency on HIV research, is not 
one of them. This has created an obstacle to 
NIH funding of extramural university construc- 
tion and reinstrumentation, as well as prevent- 
ed NIH from answering its own intramural con- 
struction needs. A new AIDS research building 
has been planned for the NIH campus at a cost 
of $30 million. After two years, this building is 
still in the early planning stages. 

The seriousness of this obstacle is exempli- 
fied by the lack of progress on the NIAID Con- 
solidated Office Building. Currently, NIAID 
personnel work in leased office spaces scattered 
over an area of several square miles, some dis- 
tance away from the Clinical Center at NIH, 
where patients are seen. The proposed build- 
ing would be constructed under a lease-pur- 
chase agreement and would enable all HIV- 
related NIAID personnel to work closely to- 
gether, in close proximity to the patients. 

Space on the NIH campus has been set aside 
for the building, architectural plans drawn, and 
funds approved by Congress; yet the General 
Services Administration (GSA) has not given 
final approval for construction. NIH cost esti- 
mates indicate that operating costs of current 
leased properties exceed those of the new 
building. At this point in time it would require 
no new dollars, and may in fact save money if 
construction were expedited. Documents, spe- 
cially requested by the Commission and sup- 



40 



plied by NIH, indicate that calculations of net 
present value have been carried out for three 
alternatives, with the following results: 

• Continue present leases — $147.2 million 

• Lease-purchase on NIH campus — $95.0 million 

• Federal construction on NIH campus — $97.5 mil- 
lion 

Delay in the construction of this building is 
one of the most serious research administrative 
obstacles the Commission has encountered. 

Administrative Processes 

HIV was isolated in 1983 and because the 
disease known as AIDS was then determined to 
be a virus-induced infectious disease, NIH des- 
ignated NIAID as the administrator for HIV- 
related federal research management. Much of 
the pre- 1983 HD7 research was done at NCI, 
and work continues at that institute. Senior 
leadership within NIH, especially in NIAID and 
NCI, responded to the challenge of the epi- 
demic by establishing a system for organizing 
and funding research priorities that required 
almost simultaneous development and execu- 
tion. Within a brief time, a new research and 
clinical trial structure had been conceived and 
implemented at NIAID that structurally paral- 
leled that of NCI, which had been established 
over a period of years. The urgency and 
breadth of this effort is without precedent in 
the history of the federal government's re- 
sponse to an infectious disease crisis. 

Witnesses critical of the NIAID response 
have testified that little funding was received by 
outside institutions until late in 1984. They be- 
lieved that this was due to the lack of a pre- 
existing administrative structure similar to that 
of NCI for clinical trials, and also due to the 
complexity of the grant funding process. 

The NIAID clinical trials program has cur- 
rendy enrolled nearly 4,000 patients and is ex- 
panding into additional research institutions, as 
well as into community- and physician-oriented 
programs. The funding and grant making proc- 
ess has recently been reviewed and the 'ASAP" 
(Accelerated - Solicitation - to - Award Program) 
enacted. This should cut grant review and turn- 
around time to less than six months. Both the 
accelerated grant review and community in- 
volvement in clinical trials are significant breaks 
with research and funding tradition. They rep- 
resent an effort on the part of NIAID to re- 
spond to the urgency of the HIV epidemic and 
the needs of the research and patient commu- 



nities. However, as stated in the Commission's 
interim report, a greater sense of urgency 
throughout the government is needed to imple- 
ment the increased funds already approved by 
Congress and to supplement improvements al- 
ready underway by NIH. 

The diversity and multiplicity of HIV re- 
search projects at NIH requires management at 
the level of the Office of the Director. NIH 
recently announced the initiation of the Office 
for AIDS Research, which was established in 
April of 1988, and will eventually have 12 to 15 
full-time equivalent positions (FTEs). It is oper- 
ating under a current budget of $400,000 
which is expected to double in the following 
fiscal year. The Commission endorses the Di- 
rector's establishment of this office and encour- 
ages its full staffing and support. 

The Commission's examination of HD/ re- 
search programs has revealed that despite 
NIAID's commitment to rapid response, limita- 
tions in the federal system must be addressed if 
this nation's goal of controlling the epidemic is 
to be realized. One of the greatest obstacles 
cited by NIH administrators is the inflexibility 
of Office of Management and Budget (OMB) 
regulation of internal resource allocation and 
program development. Currently, OMB acts as 
a surrogate Secretary of HHS, in effect, micro- 
managing research on the institute level within 
NIH. The Commission favors allocating pools 
of resources (funds and personnel) to NIH and 
allowing the Director greater discretionary 
powers to make subsequent personnel and 
funding allocations to each institute. NIH wit- 
nesses have repeatedly indicated their desire to 
be held accountable for results and asked for 
greater flexibility to employ innovative methods 
through which to achieve those results. 

The mandate of science is exploration and 
discovery, and this requires flexible manage- 
ment to allow for the creative application of 
ideas. Such flexibility is often difficult to 
achieve in a bureaucracy as massive as that of 
the federal government. NIH is an organization 
much like the National Science Foundation 
(NSF) in that its mission is broad scientific ex- 
ploration, often in uncharted territory. Howev- 
er, there is a significant difference between the 
two in that NSF is less encumbered by layers of 
bureaucracy. Therefore, to allow NIH the 
greatest potential for discovery in HIV re- 
search, as well as in research on cancer and 
other diseases, the Director should have full 



41 



authority and responsibility to manage the re- 
sources appropriated by Congress as needed. 

Personnel and Recruitment 

From FY 1984 to FY 1988, a total of 371 
new FTEs were added to NIH for HIV-related 
activities. Over the same period, the total 
number of NIH personnel positions dropped 
from 13,493 to 12,461. This represents an 
overall loss of 1,032 positions, even though 
HIV positions have been increased. The Com- 
mission is deeply concerned that the much 
needed increases in HIV research personnel 
are being implemented to the detriment of re- 
search on other diseases. Although research on 
HIV must be expanded, we cannot afford to 
cut back on cancer or heart disease research to 
achieve this goal. 

One serious obstacle, discussed in the Com- 
mission's interim report, is presented by FTE 
ceilings imposed by OMB that prohibit the re- 
cruiting of individuals above those ceilings, 
even in short-term emergency conditions. This 
contributed to both NIAID's inability to put its 
own programs into motion, and to the public's 
perception that NIAID was slow to respond. 
FTE ceilings are designed to limit the size of 
the federal government, i.e., the number of in- 
dividuals working for the government who will 
at some point be eligible for ongoing benefits 
such as retirement. The approval system has 
entrenched inflexibilities intended to guard 
against such growth, but can in fact leave gov- 
ernment agencies funded but unable to hire in 
response to a crisis. The National Cancer Act 
of 1972 created NIH short-term personnel slots 
that were to be filled by visiting scientists, or 
"cancer experts," who were not counted in 
FTE ceilings, as they were not likely to retire 
on government payroll. Four years ago, howev- 
er, OMB regulations for such appointments 
changed, and currently these and other tempo- 
rary positions count against personnel limits. 

NIH administrators also indicated that, given 
funds and personnel positions, they are still 
unable to complete hiring of some individuals 
because of "business as usual" paperwork 
delays in other agencies. Although the Office of 
Personnel Management (OPM) has begun dis- 
cussion with NIH to streamline personnel re- 
cruitment, no practical change has been noted 
since the Commission's interim report. The 
Commission favors greater flexibility on the 
part of OMB and OPM to allow the NIH Direc- 
tor the ability to more rapidly hire greater 



numbers of technically specialized research per- 
sonnel. 

Witnesses before the Commission testified 
that modest salaries and the lack of other in- 
centives deter many talented individuals from 
working at NIH. NIH recently proposed the 
creation of the "Senior Biomedical Research 
Service," a career track similar to the federal 
Senior Executive Service, which would enable 
NIH to recruit scientists at salary levels similar 
to those in the private sector. The model cited 
for this proposal is that used by the Uniformed 
Services University of the Health Sciences. Leg- 
islation creating these University pay scales ex- 
empted them from standard government levels, 
and enabled the University to attract personnel 
with salaries similar to those of other medical 
schools. To date, the proposed Senior Biomed- 
ical Research Service has not been approved. 

Additional research hiring difficulties involve 
a zero tolerance for poor technique, which, 
when working with live virus, could prove fatal. 
This, coupled with the long hours, close quar- 
ters, and poor salaries, also contributes to per- 
sonnel hiring delays. 

Grant Processing and Research Funding 

Traditionally, NIH has sponsored grants for 
projects that were initiated by researchers and 
proposed by them for funding. In response to 
the HIV crisis, NIH took a more centralized 
approach, funding a large number of specific 
contracts and issuing specific requests for grant 
applications for areas of needed research in 
which there was a lack of scientific interest or 
of readily apparent benefit. This approach has 
been criticized by some witnesses who felt 
unable to receive funds for work they thought 
beneficial. What is seen within NIAID as a 
process of taking control and targeting federal 
resources to underexplored areas of science is 
seen by some on the outside as overly restric- 
tive and limiting research options. 

Two of the most significant hindrances of 
NIH have been restricted spending authority 
and the lack of significant pools of discretion- 
ary funds that can be used in medical and sci- 
entific emergencies or immediately to imple- 
ment promising programs. 

Administering taxpayer money for varied yet 
targeted exploration in a multifocal medical 
and scientific crisis requires great skill and bal- 
ance. Given a limited amount of total funds, 
and if spending is so broad that all possibilities 



42 



are touched, there may not be enough money 
in each grant to permit a thorough exploration. 
If funded research is too highly focused in one 
area, an answer lying outside that area will not 
be found. Advisory councils within NIAID and 
NCI and the NIH Director's Advisory Council 
offer advice on funding direction, but some 
witnesses cited too few grants to younger inves- 
tigators and inadequate funding for new or 
"unpopular" ideas. In response, NIAID has 
created seats on its advisory councils for com- 
munity representatives and younger scientists 
and is considering appointing a similarly quali- 
fied person with HIV infection. 

Many researchers testifying before the Com- 
mission indicated a preference for investigator- 
initiated research, citing its ability to offer mul- 
tivaried exploration of any given topic. Many 
also considered highly controlled directed 
funding to be an appropriate response by 
NIAID that should be reserved for short-term 
emergency situations. As HIV research has 
been stimulated, investigators have returned to 
NIH with new ideas and proposals in previous- 
ly underexplored areas. 

Primary to all recommendations for the ad- 
vancement of basic biomedical research is the 
concept that these funds must be new monies 
and not subtracted from other programs. 

Basic Science Education and Research 
Training Grants 

Testimony before the Commission cited the 
belief that the federal government funds the 
best scientists, provides access to the most so- 
phisticated technology, and regulates to the 
highest standard of excellence in the world. Yet 
concern was expressed by members of the sci- 
entific community that the next generation will 
not produce adequate numbers of capable sci- 
entists willing to work in federally funded lab- 
oratories. 

Current NIH training grant programs in- 
clude: 

• university/medical center grants, given to ten re- 
search centers; 

• individual research scientist grants, to support 
ongoing work; 

• Career Development Awards ("K Awards"), to 
allow a specialist in one field to acquire technical 
knowledge in another; and 

• Research Scientist Awards, for achievement in 
one research area. 



In the categories above, there are 200 awards 
of approximately $50,000 each. In addition, 
there are program slots for 250 summer stu- 
dents, each with a stipend of $1,500. 

The dollar amounts listed above are the 
yearly maximum for these programs, although 
in recent years they have not always been 
funded at this level. Some, in fact, have been 
eliminated. Additional appropriations for great- 
ly increased numbers of awards as well as the 
authority to execute these programs are 
needed. 

A serious obstacle exists in that summer stu- 
dents studying on the NIH campus for three 
months are counted against the NIH FTE ceil- 
ing. This means that if NIAID wants to create 
research opportunities for 40 summer students, 
it must eliminate ten full-time positions from 
its staff. The summer student program repre- 
sents a unique opportunity for youth, especially 
minority youth, to participate in government 
research training and to work with recognized 
research leaders. 

Many more research personnel are needed 
now and will be needed in the future, as tech- 
nology expands research potential. A greatly 
upscaled investment must be made now to 
guarantee the availability of researchers in the 
year 2000. 

Obstacles to Progress 

Basic research 

• A lack of standardized reagents makes informa- 
tion coming from separate experiments difficult 
to assess. 

• The lack of appropriate animal models for HIV 
research makes the application of animal re- 
search results to humans uncertain. 

• Information exchange between individual re- 
searchers could be improved, as could research 
information exchange between federal depart- 
ments and agencies. 

Facilities, Administration, Personnel, and Grants 

• OMB micromanagement and FTE ceilings pre- 
vent the deployment of a sufficient number of re- 
searchers to deal with pressing problems. 

• The current structure of NIH management over- 
sight by OMB and HHS means external staff are 
allowed to set personnel allocations at the unit 
program level, and to block fund shifts within 
categories which would contribute to the achieve- 
ment of its intended goal. 



43 



• There is an inadequate number of laboratories 
equipped to carry out HIV work — both at NIH 
and at research institutions around the country. 

• A more rapid response by all elements of gov- 
ernment is needed in order to speed NIH re- 
search efforts. 

• Funds for basic research are inadequate to meet 
the new research priorities of the HIV epidemic. 

• De-emphasis of investigator-initiated grants may 
threaten or constrain broad exploration in HIV 
research. 

• Grants for HIV research projects are not made 
quickly enough, and funds for these projects do 
not allow for longer-term investigation. 

• Scientists and health care professionals are not 
attracted to work at NIH because salary and ben- 
efit levels are not comparable to private sector 
institutions. 

Basic science education and training 

• The lack of basic science education programs in 
elementary and secondary education could lead 
to a shortage of research personnel in the future. 

• There are not enough training programs in exist- 
ence to supply the necessary number of future 
researchers. 

RECOMMENDATIONS 

To facilitate basic biomedical HIV-related re- 
search, the Commission offers recommenda- 
tions in the following categories: 

Reagents, Animal Models, and Research 
Information Exchange 

4-1 Escalate existing efforts of the National 

Institutes of Health to establish a reposi- 
tory for reagents to be used in HIV re- 
search. 

4-2 Investigate a fee-for-use basis for rea- 

gent distribution that would assist in 
supporting this program in private 
sector collaboration. 

4-3 Make the development of appropriate 

animal models for HIV-related research 
an immediate and high priority, and 
make additional funds available to en- 
hance primate center development. 

4-4 Establish a federally funded central reg- 

istry of animal model resources for HIV 
and other diseases. 

4-5 The National Institutes of Health should 

develop a computerized network of all 
HIV-related research activities to pro- 



mote greater exchange of information 
and data between researchers. 

4-6 Increase funds to the National Institutes 

of Health Divisions of Research Services 
and Research Resources for additional 
animal model, reagent, and database 
program support. 

Facilities 

4-7 The National Institutes of Health intra- 

mural construction and reinstrumenta- 
tion needs should be assessed and the 
information forwarded to the Office of 
the Secretary for inclusion as a high pri- 
ority in future budget requests. 

4-8 Construction of the National Institutes 

of Health Consolidated Office Building 
should be made a high priority and Gen- 
eral Services Administration's approval 
be expedited. 

4-9 The National Institutes of Health (NIH) 

construction authority should be rein- 
stated during the Congressional reau- 
thorization of NIH in 1988 to provide 
for the expeditious granting of funds to 
universities or medical centers for con- 
struction or renovation of research facili- 
ties. Construction funds should be made 
available in FY 1989. 

4-10 Funds for construction and modification 

of university facilities, as well as upgrad- 
ing of instrumentation, should be pro- 
vided through federal matching grants. 

4-11 Funds should be made available to the 

National Institutes of Health Division of 
Research Resources to upgrade or ren- 
ovate 20 existing laboratories to P-3 
level. 

4-12 Funds should be made available for the 

construction of four regional structural 
biology centers, equipped for X-ray crys- 
tallography. 

4-13 The National Institutes of Health should 

implement a plan for the development of 
regional retroviral research centers and 
provide renovation of construction funds 
for two such centers. 

Administration 

4-14 To better meet the research mission of 

the National Institutes of Health (NIH) 
through a facilitated management proc- 
ess, the Secretary of Health and Human 
Services and appropriate authority as re- 
quired by law should mandate that the 
Director of NIH report directly to the 
Secretary for a period of two years. The 



44 



Director will receive the NIH budget di- 
rectly from the Secretary, and will have 
discretionary authority over all subse- 
quent allocations of personnel and re- 
sources within NIH. For the two-year 
period, Congress, in conjunction with 
the Secretary, should exempt NIH from 
OMB regulation of personnel and re- 
source allocations within all of NIH. 
During this two-year period, NIH will 
continue to operate within all remaining 
confines of law. 

Following the two-year period, Congress 
should authorize an independent audit 
to measure the effectiveness of this 
change. The Director and the Secretary 
will report to Congress, and if the 
change in procedure has resulted in 
greater flexibility for NIH to achieve its 
scientific mandate, it shall become per- 
manent. If it has not, Congress should 
consider giving NIH a more independent 
funding status, similar to that of the Na- 
tional Science Foundation. 

4-15 In order to discourage a "business as 

usual" response to HIV-related requests 
from the Department of Health and 
Human Services, representatives of the 
Office of Personnel Management, Gener- 
al Services Administration, and Office of 
Management and Budget should partici- 
pate as active members of the Public 
Health Service (PHS) Executive Task 
Force on AIDS in order to assist in rapid 
implementation of high priority requests 
from PHS. 

4-16 The Office of Personnel Management 

and the General Services Administration 
should respond within 21 days to HIV- 
related priority requests from the Direc- 
tors of the National Institute for Allergy 
and Infectious Diseases, National Cancer 
Institute, and the Centers for Disease 
Control, or any additional director desig- 
nated by the Secretary of Health and 
Human Services. Since the Commission's 
interim report, no identifiable change 
has occurred regarding this problem. 

Personnel and Recruitment 

4-17 To alleviate personnel delays resulting 

from current procedures, the Director of 
the National Institutes of Health should 
continue to work with the Office of Per- 
sonnel Management to develop an im- 
proved package of incentives to facilitate 
recruiting of scientific talent. 

4-18 The Director of the National Institutes 

of Health (NIH) should be given greater 
flexibility in both hiring and personnel 
(FTE) allocation within NIH. All new 



HIV-related FTEs must be new and not 
diverted from other programs. 

4-19 The proposed "Senior Biomedical Re- 

search Service" should be enacted, with 
the necessary legislation to provide for 
the recruitment of scientists at salary and 
benefit levels competitive with private 
sector research institutions and medical 
centers. 

4-20 Basic research FTE needs should be 

given high priority review by the Secre- 
tary of Health and Human Services and 
a minimum of 100 new positions should 
be approved for HrV-related basic re- 
search. 

4-21 The Secretary of Health and Human 

Services should evaluate the current FTE 
ceilings at the National Institutes of 
Health in terms of the Institutes' overall 
ability to respond to a national medical 
crisis and should work with the Office of 
Management and Budget to determine 
ways to add flexibility as needed. 

4-22 The Director of the National Institutes 

of Health (NIH) should immediately 
assess the incremental loss of personnel 
from other NIH research areas, who 
have been reassigned to HIV research. 
As these individuals are not fully ac- 
counted for in personnel allocation fig- 
ures, a detailed assessment must be 
made of the actual impact HIV research 
is having on other research areas. Re- 
sults of this assessment should be for- 
warded to the Secretary of Health and 
Human Services for evaluation of future 
resource allocation. 

4-23 Research initiatives at the National 

Center for Nursing Research (NCNR) 
should be expanded. Priority should be 
given to areas already identified by 
NCNR and the National Institutes of 
Health, and the grant funding process 
for HIV-related research should be expe- 
dited. Nurses should be encouraged to 
submit proposals for HIV-related re- 
search to the appropriate institutes at 
NIH. 

4-24 Fast-track recruitment programs to bring 

more nurses and patient care support 
personnel into the Clinical Center 
should be immediately implemented. Ap- 
propriate incentive and retention pack- 
ages should be designed. 

4-25 The National Institutes of Health Clini- 

cal Center should assure that the salaries 



214-701 



3 : OL 3 



45 



of registered nurses and support person- 
nel are competitive with local standards. 

4-26 The National Institutes of Health Clini- 

cal Center should assure that an ade- 
quate ratio of support personnel to each 
registered nurse should be maintained. 

4-27 The National Institutes of Health Clini- 

cal Center should utilize innovative nurs- 
ing practice strategies to make the work 
environment more attractive to nurses. 

Research Funding and Grants 

4-28 All funds appropriated for HIV-related 

basic research must be new "add-on" 
monies and should not be transferred 
from existing programs. 

Continue and expand support for basic 
science research, including virology, mo- 
lecular biology, genetics, immunology, 
pharmacology, and pathogenesis. 

To encourage the greatest possible 
breadth of HIV-related research explora- 
tion, place greater emphasis on investi- 
gator initiated grants. 

Increase funds for "Director's Awards" 
at the National Institutes of Health for 
rapid start-up of projects to pursue new 
basic research ideas, and increase the 
upper funding limit of these awards from 
$50,000 to $100,000. 

A discretionary fund should be created 
to make available to the Office of AIDS 
Research funds for rapid implementation 
of HIV-related project grants. 

Implement within all of NIH the Accel- 
erated-Solicitation - to - Award Program 
(ASAP) for HIV-related grant proposals. 

Establish longer-term funding mecha- 
nisms for grants, expanding three-year 
grants to five- and seven-year terms 
whenever appropriate. 



4-29 



4-30 



4-31 



4-32 



4-33 



4-34 



4-35 



Maintain the HIV-related 
grams in existence at 



4-36 



research pro- 
the National 
Cancer Institute in order to allow the 
National Institutes of Health the greatest 
possible variety and breadth of research 
efforts, and maximize the use of existing 
talent. 

Publicize the rules and procedures for 
negotiation and implementation of coop- 
erative agreements between the National 
Institutes of Health and private industry. 



Basic Science Education and Training 

4-37 Expand and fund the National Institutes 

of Health training programs to levels 
adequate to enable qualified student re- 
searchers to continue advanced study; 
minimum funding levels should include: 

• 350 M.D. or M.D./Ph.D. postdoctoral 
fellowships; 

• 150 special postdoctoral fellowships 
for M.D.s; 

• 350 graduate fellowships for Ph.D. or 
M.D. students; and 

• 400 undergraduate or graduate health 
science non-Ph.D. fellowships. 

4-38 Eliminate the regulation that counts 

short-term "expert" appointments and 
students participating in summer train- 
ing programs against the National Insti- 
tutes of Health FTE ceilings. 

4-39 Enlarge the scope of training grants to 

include interdisciplinary programs spe- 
cially tailored for HIV-related research 
(e.g., psychobiology and immunology). 

4-40 Shift priorities in elementary and sec- 

ondary education to provide greater 
education in biology and other sciences 
to young people earlier. 

4-41 Develop a prestigious and highly visible 

set of awards to recognize both out- 
standing young talent and excellence in 
teaching in areas relating to human biol- 
ogy. These could include: 

• Junior Science Corps Awards for ele- 
mentary school students that include 
small monetary awards, but are pri- 
marily for recognition; 

• National Bioscience Awards for high 
school students, that include the op- 
portunity to work with leading scien- 
tists; 

• National Science Teachers Awards to 
recognize professional excellence and 
enable teachers to spend time with 
leading researchers; and 

• Programs should also be developed 
that bring researchers into the class- 
room, so that they can personally 
convey the excitement of their work. 

This program could be rapidly estab- 
lished and funded at relatively low levels, 
patterned after the proposed Thomas 
Edison Awards for student work in areas 
of science that may have commercial ap- 
plication. One feature of the program 
could be a national awards ceremony 
that would include the President. The 
administrative center for the proposed 



46 



bioscience awards would be the National 
Institutes of Health, as on-campus train- 
ing programs have been in place there 
for many years. 

Section II. Vaccine Development 

Obstacles to Progress 

Testimony before the Commission reported 
results of the Institute of Medicine's (IOM) 
"Conference on the Development of Vaccines 
against HIV and AIDS" on December 14 and 
15, 1987. 

A great deal has already been learned about 
a virus only recently discovered and vaccine 
models have been developed that target not 
only surface proteins, but also core proteins, 
whole virus, and virus function (as in the case 
of reverse transcriptase). 

Despite these advances, the following obsta- 
cles were cited: 

• There is a lack of basic knowledge about which 
cells become infected by HIV, and how to stimu- 
late the immune system to eliminate infected 
cells. 

• There is also a lack of adequate animal models 
for vaccine development. 

• There will be problems with testing any vaccine 
that is developed. 

• Research ethics are complex and undefined. 

• Civil liability may slow vaccine development and 
evaluation. 

The IOM conference presented a variety of 
methods currently under exploration for vac- 
cine development and gave an overall status 
report. The tenor of the conference indicated 
that it may be many years before a vaccine that 
is proven safe and effective is developed. Major 
difficulties with binding sites were noted, as 
was the fact that in animal vaccine trials, al- 
though antibodies were raised, they lacked pro- 
tective ability when challenged. The lack of ap- 
propriate animal models for vaccine develop- 
ment and the length of time projected for trials 
present daunting obstacles to vaccine availabil- 
ity in the near future. The conference conclud- 
ed that prevention remains the greatest single 
means by which to curtail extension of the epi- 
demic. 

Ethics 

Vaccine trials pose exceptionally difficult eth- 
ical questions for both researchers and partici- 



pants. Essential to any blinded trial is the equal 
exposure to risk of disease by both the vacci- 
nated group and the placebo group, yet medi- 
cal ethics mandate counseling all patient par- 
ticipants to avoid the very behaviors that may 
put them at risk. Successfully avoiding risk 
delays confirmatory trial results. Vaccination 
causes an individual to produce antibodies to 
the virus, and the presence of these antibodies 
is currently the basis for a diagnosis of active 
HIV infection, thus potentially subjecting the 
vaccinated person to discrimination or stigma. 
To achieve results most rapidly, trials would be 
done in populations in which HIV is endemic. 
These are often third world or minority popu- 
lations, or intravenous drug users in certain 
cities, raising the issue of exploitation. Because 
of the "window" of antibody response, an indi- 
vidual who tests negative at the beginning of a 
trial may in fact be infected, and vaccination 
could conceivably be injurious to his health. 
Vaccine trials in pediatric populations are even 
more ethically and emotionally complicated. All 
of these issues present the research and patient 
communities with as yet unresolved obstacles. 

Liability 

One of the few obstacles to vaccine develop- 
ment which may be more easily answered is 
liability, which could be addressed by legisla- 
tion. Testimony before the Commission indi- 
cated substantial differences of opinion on the 
need for liability protection. One witness stated 
that only 25 to 30 vaccine liability cases have 
actually come to court in the past 20 years, and 
that the manufacturers won the majority of 
those cases. However, it was noted by another 
witness that for every case that actually reaches 
trial stage, there may be dozens or hundreds 
that are resolved earlier but that require sub- 
stantial litigation time and investment on the 
part of manufacturers. Testimony indicated 
that several manufacturers were currently work- 
ing on HIV vaccines, and that the threat of 
liability did not seem to be a great deterrent. A 
spokesman for one manufacturer, however, 
stated that unless the liability problem, real or 
perceived, was resolved, few if any of the man- 
ufacturers now developing HIV vaccines would 
be eager to bring them to market. 

Several examples were presented in which a 
small company had initially produced a vaccine, 
but was unable or unwilling to market it be- 
cause of liability concerns. These small compa- 



47 



nies licensed their products to larger compa- 
nies that possibly had hundreds of products on 
the market and could therefore spread the li- 
ability risk. 

The question was raised as to whether, given 
the cost of development, production, and trial, 
it would be possible to produce a vaccine that 
was affordable in developing nations. It was 
suggested that if manufacturers could or would 
not be willing to make the long-term invest- 
ment, the government should. Having the sci- 
ence and technology to produce a vaccine that 
would save lives, and declining to do so, would 
seem to be ethically unacceptable. 

The issue of liability protection for the physi- 
cians, nurses, and public health workers who 
routinely administer vaccines was also dis- 
cussed. Some states have enacted protections 
for these health care workers, not only for strict 
liability, but also for simple negligence because 
it was ruled that not to do so would endanger 
the public health beyond tolerable limits. 

Several models have been proposed for new 
legislation that would offer liability protection 
to manufacturers, including: 

• establishment of dispute resolution mechanisms 
that provide compensation for vaccine injuries 
more quickly and cheaply than litigation, but that 
tie the plaintiff to a schedule of limited damages. 
This solution was adopted by Congress for cer- 
tain pediatric vaccines. 

• elimination of manufacturer liability entirely, 
with recourse for injuries limited to claims 
against the government. This was the model 
chosen by Congress for injuries resulting from 
the swine flu vaccine in the early 1980's. 

The National Childhood Vaccine Injury Act 
was cited as a possible model for legislation. 
Other potential models were those states that 
had assumed control of production of pediatric 
vaccines, invoking, as in Michigan, for example, 
the state's sovereign immunity to such liability, 
and yielding the public benefit of a protected 
population. While it was not suggested that 
states begin indemnifying vaccine producers, 
because to do so might create a patchwork pro- 
tection nationwide, state programs could be 
looked at as models for potential federal 
action. 

RECOMMENDATIONS 

To develop most rapidly a vaccine for HIV, 
the Commission recommends that: 

4-42 All approaches to vaccine development 

should continue to be explored and de- 



veloped until one or more are success- 
ful. 

4-43 The basic scientific information neces- 

sary for this development should contin- 
ue to be a high federal priority. 

4-44 The Commission believes that any obsta- 

cle to the acquisition of an effective vac- 
cine should be addressed and, if at all 
possible, removed. The Commission 
feels that appropriate protection from 
excessive legal liability should be made 
available to vaccine manufacturers to en- 
courage research and development. 

4-45 The National Institutes of Health, in co- 

operation with the Institute of Medicine, 
the American Medical Association, the 
American Bar Association, the National 
Medical Association, and the Justice De- 
partment, should convene a conference 
on liability related to vaccine and drug 
development. The conference should de- 
termine whether there is sufficient pri- 
vate sector interest in continued vaccine 
development. If not, then recommenda- 
tions should be made as to how best to 
implement a full-scale government 
effort. A similar conference should be 
convened with appropriate agencies and 
spokespersons to investigate the ethical 
questions surrounding vaccine develop- 
ment. 

4-46 The federal government should fund 

these conferences in partnership with the 
private sector. 

4-47 The results of the liability conference 

should be submitted to Congress for the 
drafting of liability legislation. 

Section III. Drug Development 

Using a process known as rational drug mod- 
eling, it is theoretically possible to design new 
drugs that will have HIV-specific activity, such 
as interfering with viral replication. In theory, it 
should also be possible to design a drug that is 
easy to take (oral) and can cross the "blood- 
brain" barrier and eliminate virus in the central 
nervous system. This process, however, can be 
slow. 

Within NIH, NCI has a long established his- 
tory of research excellence associated with drug 
development. Faced with this new medical 
emergency, NCI geared up its off-the-shelf 
drug screening program, and made it available 
to all pharmaceutical companies, biotechnology 
firms, and universities for products they had 



48 



already produced and had in stock. Com- 
pounds that universities or corporations felt 
might be effective against HIV were submitted 
to NCI for in vitro (test tube) screening. This 
effort resulted in the demonstration of the anti- 
viral properties of azidothymidine (AZT), a 
compound submitted for screening to NCI by 
the Burroughs Wellcome Co. 

The high level of anti-HIV activity discovered 
in AZT indicated that a product might be 
quickly developed that had the potential to 
stop the progression of disease in people who 
were already infected. When it appeared that 
Burroughs Wellcome lacked sufficient amounts 
of a key ingredient to produce enough AZT for 
trials, NCI, in the belief that AZT represented 
an extraordinary opportunity in HIV treatment, 
provided the ingredient at no cost. 

Because no product-patent application could 
be filed by NIH, Burroughs Wellcome retained 
full market control of the compound. Many wit- 
nesses have criticized Burroughs Wellcome for 
the high price of the drug and NIH for contrib- 
uting so greatly without retaining some control 
over the final cost to patients. The company 
indicated that its development costs were sub- 
stantial, but lowered the wholesale price by 20 
percent. Procedures have been instituted at 
NIH so that patent applications are routinely 
filed for all new compounds that NIH origi- 
nates, as well as filing use-patents when appro- 
priate. 

By understanding how the virus works, what 
its physical properties are, and how virus-in- 
fected cells behave, drugs can be developed 
that interact with the virus at various points in 
its life cycle. Some witnesses indicated that 
enough has been learned through basic re- 
search to re-emphasize drug development 
through rational drug modeling, the traditional 
approach. 

Private Sector Collaborative Research and 
Development 

The pharmaceutical industry is playing a sig- 
nificant role in the development of vaccines 
and therapeutic agents. Hundreds of millions 
of dollars have been committed to such re- 
search. The private sector has a long tradition 
of excellent drug and vaccine development. 

In times of serious medical emergency, the 
competition that normally fuels progress in the 
private sector can actually slow down the pro- 
duction and marketing of potentially beneficial 
substances. If several companies are working 



separately on a potential therapy that is costly 
and difficult to develop, they may all relinquish 
their efforts if the ultimate return on invest- 
ment will be too low. In theory, had private 
companies been able and willing to pool re- 
sources and collaborate on the project, they 
would have eliminated the duplicated efforts, 
reduced cost and development time, and been 
able to share profits. In reality, a complex set 
of antitrust laws prohibit this type of collabora- 
tion. 

RECOMMENDATIONS 

NIH Drug Research and Development 

Successful rational drug development re- 
quires additional basic research funding, and 
the Commission therefore recommends that: 

4-48 As a near-term drug discovery measure, 

the National Institutes of Health should 
continue screening off-the-shelf com- 
pounds for antiviral and immunomodu- 
lating activity. 

4-49 Research funding should be increased 

for the development of rational drug 
models for both immunomodulators and 
antivirals, at both the National Institute 
of Allergy and Infectious Diseases and 
the National Cancer Institute, and 
through their grants to universities and 
medical centers. 

Collaborative Research and Development 

4-50 The Food and Drug Administration, in 

partnership with the private sector, and 
appropriate federal agencies, should 
hold a conference on the subject of col- 
laborative Research and Development in 
drug and vaccine development, outlining 
the potential benefits, risks, and legal 
obstacles. Participation in this confer- 
ence should be sought throughout the 
pharmaceutical and biotechnology indus- 
tries, as well as the university research 
community, community-based clinical 
trial organizations, and the National In- 
stitutes of Health. 

4-51 Fund new multi-center studies where 

possible, to encourage collaborative re- 
search. 

4-52 To encourage and reward cooperative 

investigation, a Nobel prize for collabo- 
rative research, both national and inter- 
national, should be established. 



49 



The Food and Drug Administration 

The Food and Drug Administration (FDA) is 
the principal consumer protection agency of 
the federal government. Its primary responsi- 
bility with respect to HIV is to ensure that 
drugs, biological products (such as vaccines 
and blood components), and medical devices 
are safe and effective. 

FDA's role in the new drug approval process 
is to review data from the drug's sponsor and 
then based on information from animal and 
laboratory studies, FDA will grant or reject an 
Investigational New Drug (IND) application 
which allows human studies to begin; and FDA 
will review data from these clinical studies in 
order to grant or reject a New Drug Applica- 
tion (NDA) which permits marketing of the 
drug. On the date FDA receives an NDA, a 
"review clock" is started. By law, FDA has 180 
days to approve or reject the application. 
During the approval process, all data from two 
to ten years of clinical trials are reviewed by an 
interdisciplinary team of scientists, as in the 
IND application. Some applications must be re- 
turned to the sponsors to correct errors or to 
provide additional data; the applications are 
then resubmitted to the FDA. The average ap- 
proval time for an NDA is 24 months. 

The order in which applications are looked at 
is determined with the aid of a classification 
system based on therapeutic importance and 
availability of alternative therapies. Currently, 
all HIV-related therapies are rated 1-AA, FDA's 
highest priority. 

NDA Review 

Witness criticism of the drug approval proc- 
ess dealt mainly with the length of time in- 
volved from start to finish. The problem is 
compounded by the fact that, currently, almost 
all aspects of all NDA reviews are submitted on 
paper. Interaction between FDA and drug 
sponsors during NDA review is rarely facilitat- 
ed by using electronic transfer of information 
prepared and formatted for computer analysis. 

Another obstacle cited was that a new drug 
approval is not always "tracked" through the 
FDA system by the same group of reviewers, 
causing delays as sponsors sought information 
on the status of their applications. 

Treatment INDs 

In spite of the best efforts of the Commis- 
sioner of FDA, with respect to newly developed 
anti-viral drugs or immunomodulators, the 



treatment IND program is not meeting the 
needs of persons with AIDS or advanced HIV- 
related illness. Treatment INDs were designed 
to offer some hope of access to experimental 
drugs to those with life-threatening disease. 
They allow the release of the drug on a non- 
clinical-trial use basis even before the end of 
Phase II efficacy testing, based on the FDA 
Commissioner's recommendation, and after 
safety and some degree of efficacy have been 
demonstrated. Although the program is well- 
intentioned, and does work for antibiotics and 
other types of drugs for HIV-infected persons, 
and for persons needing drugs for other dis- 
eases, the fact remains that for anti-virals and 
immunomodulators for HIV, the system is not 
working. Reasons for its failure to date include 
the following: 

• some pharmaceutical companies are unwilling to 
allow their drugs to be used in this program, 
even when they are sought after by physicians 
and desperately ill patients; 

• there is no information system that allows the pa- 
tient or physician population to know what is 
available; 

• methods of obtaining drugs that are available 
through this program are poorly understood and 
seem unnecessarily complicated; and 

• some physicians are reluctant to prescribe treat- 
ment IND drugs because liability limits are not 
clearly defined. 

Since the adoption of the new rules last year, 
only one sponsor has applied and been ap- 
proved for a treatment IND for an HIV-related 
product. The status of this program has not 
changed since the Commission's interim report 
in March. 

At present, while some pharmaceuticals par- 
ticipate in the treatment IND program with ex- 
perimental antibiotics, the program is not well 
used for other drug types. Some representa- 
tives expressed concern that if they did apply 
for a treatment IND, their subsequent NDA 
would not be favorably reviewed. Others indi- 
cated that some form of liability protection 
would be necessary. Proposed solutions to the 
problem of liability in drug trials are similar to 
those discussed in connection with vaccine de- 
velopment. Still others indicated that wide use 
of treatment INDs would limit the number of 
individuals willing to enroll in controlled trials 
and thereby further delay drug approval. 

Physicians indicated an unwillingness to 
order the drugs even if they were available be- 



50 



cause they feared that their patients would be 
receiving inadequately tested therapies and be- 
cause of potential malpractice litigation. 

The underutilization of this program is of 
concern to the Commission. We have received 
many calls and letters from concerned patients, 
their friends, and families seeking help. They 
were unable to find answers to the simplest 
questions about the availability of drugs. There 
was no centralized information network, and no 
one to help them through the FDA maze. If 
and when they did reach the right individual at 
FDA, they were referred to the drug compa- 
nies, who, in some cases, just said no. Individ- 
uals who qualify for this program are by defini- 
tion desperately or terminally ill, and it is unac- 
ceptable that this situation has languished this 
long without resolution. 

Orphan Products 

Recognition of the lack of incentives for in- 
dustry to develop some products with limited 
commercial appeal led to the development of 
the Orphan Drug Act in 1983. Qualifying prod- 
ucts must be used by fewer than 200,000 per- 
sons per year or be products for which there is 
no reasonable prospect of recovering R&D 
costs by United States sales. The central fea- 
tures of the Act include seven years of exclu- 
sive use, tax credits for up to 63 percent of the 
clinical studies, and the ability of FDA to grant 
special review status and development grants to 
these drugs. 

Deterrents cited by industry in utilizing 
orphan drug status for HIV-related drugs in- 
clude the perceived lack of adequate incentives. 
If the product is not expected to ever be profit- 
able, the tax incentives in the law may not be 
great enough to stimulate larger numbers of 
companies to invest. If the sponsor seeks a 
patent, the market exclusivity offered to orphan 
drugs is not considered significant enough to 
be attractive. In addition, since orphan drugs 
are those limited to a population of 200,000 or 
less, immunomodulators and other drugs that 
can be used by a broad spectrum of HIV-infect- 
ed individuals would not qualify, as there are 
currently projected to be 1.5 million such indi- 
viduals who would be potential recipients. 

Orphan drugs have traditionally been devel- 
oped by pharmaceutical companies as a public 
service. Although industry representatives indi- 
cated a willingness to pursue areas of research 
for which there is limited market application, 
they also indicated the need to meet the con- 



cerns of stockholders, who require a reasonable 
return on their investment. 

The Commission recognizes the need for the 
development of drugs for rare diseases and the 
assistance that has been provided by the 
Orphan Drug Act. Perhaps new legislation is 
necessary to address the question of develop- 
ing drugs which can delay progression of dis- 
ease or reduce infectivity but will be usable in 
populations over 200,000. 

FDA Personnel 

Current advances in basic research, both 
within NIH and in the private sector, have re- 
sulted in a greatly increased number of new 
applications for drug approvals. The number of 
new IND applications for HIV-related products 
has doubled every two years for the past four 
years. In addition, there are currently a large 
number of drugs undergoing clinical trials that 
will be presented for NDA review within the 
next two to three years. 

Each of these applications requires intensive 
effort on the part of a consulting and review 
team. HIV-related drugs and products should 
retain their fast-track approval status without 
compromising the approval process of other 
products. Current personnel levels are inad- 
equate to handle this load. An estimated addi- 
tional 50 FTEs are required. 

Training time for a medical reviewer is ap- 
proximately 10 to 12 months. Currently, there 
is no program in place by which FDA can bring 
in younger personnel and train them for such 
work. 

Medical Devices and Diagnostics 

Reliability of HIV screening tests for both 
patient diagnosis and protection of the blood 
supply is essential. The approval process is 
slowed by the limited review staff of FDA. The 
staff size is constrained by both budget and a 
lack of a pool of qualified individuals from 
which to recruit. 

An accurate, effective HIV antigen test, 
which tests for the presence of the virus itself 
rather than antibodies, will help eliminate false 
negative results of blood tests taken during the 
"window" period following infection, when 
antibodies have not yet developed. Antigen 
tests for HIV have been developed and await 
FDA approval, as do tests for HTLV-1, another 
sexually transmitted, blood-borne lentivirus, 
which can cause leukemia or lymphoma dec- 



51 



ades after infection. Blood bankers have almost 
unanimously indicated they should be doing 
this screening test on all blood donated for 
transfusions, to eliminate the possibility of in- 
fected blood entering the blood supply. Excel- 
lent technology is available to eliminate inaccu- 
rate test results, both at blood banks and test- 
ing sites. 

Condoms and surgical gloves must be effica- 
cious if they are to be of any practical value in 
prevention programs. At present, several man- 
ufacturers make these products with varying 
levels of quality control. FDA regulates condom 
and surgical glove safety, and samples batches 
of these products under a variety of stress tests 
in order to determine their integrity. The cur- 
rent standards of acceptability for condoms is a 
failure rate of 4/1,000 or less. The Commission 
believes that standards should be increased, 
and additional studies performed to determine 
effectiveness under a variety of conditions. 

FDA Facilities 

FDA facilities are currently scattered among 
several locations. Although the FY 1989 budget 
for FDA included $25 million for a new build- 
ing, current projections are that at least one 
more building will be required to house the 
needed number of new full-time employees. 
Suggested sites include the NIH campus and 
the Naval Hospital Campus in Bethesda. 

Working conditions at FDA are below accept- 
able standards. Inadequate space and underde- 
veloped information processing resources are 
two areas of serious concern, as they impact 
negatively on FDA's ability to respond to the 
epidemic. They also present a recruiting prob- 
lem for FDA, as qualified individuals could 
work elsewhere under much better conditions. 
This has had a negative effect of both morale 
and working relations with the private sector. 

FDA Image 

FDA needs to educate the public about its 
role in setting high standards for seeking to 
ensure public safety and requiring efficacy of 
all licensed medical products. Misperceptions 
about FDA's work have contributed to the dis- 
trust and lack of coordination which have hin- 
dered efforts to respond to the HIV epidemic. 

Obstacles to Progress 

• Insufficient funding is slowing the important 
work of rational drug development. 



• Laws that prohibit collaborative research and de- 
velopment among private companies may be 
slowing the speed of drug development. 

• FDA needs to speed up its NDA process. Cur- 
rently, the process is slowed by the submission of 
a large amount of material on paper, which 
means all information must be manipulated by 
hand. The process is also slowed by having dif- 
ferent groups working on the IND and NDA ap- 
plications for the same drug. 

• FDA does not have enough reviewers to expedite 
the processing of HIV-related drug applications 
without slowing the processing of drugs for 
other diseases. 

• Currently, the disincentives for using the treat- 
ment IND program are greater than the incen- 
tives, for both the prescriber and the manufac- 
turer. 

• Adequate information is lacking about what 
drugs are available under treatment IND rules. 

• "Second generation" diagnostic tests which test 
directly for the presence of the virus, namely 
HIV antigen tests and those based on recombi- 
nant DNA, need to be put on the fast track for 
licensure. The use of such tests by blood banks 
and other testing facilities would discount the 
"window" period during which antibodies have 
not yet appeared after a recent infection. Ongo- 
ing research into the further development, ap- 
proval, and implementation of highly accurate 
and low cost HIV diagnostic tests needs to be 
prioritized. 

• Those who manufacture and prescribe experi- 
mental drugs utilized under Treatment IND reg- 
ulations are not protected from liability actions 
that may result from adverse drug reactions. 

RECOMMENDATIONS 

4-53 The team assigned to review the Investi- 

gational New Drug application should 
become involved with the product as 
early as possible and remain with the 
product through the New Drug Applica- 
tion approval. Their work should remain 
subject to independent Food and Drug 
Administration review. 

4-54 The Food and Drug Administration 

should work with the National Institutes 
of Health and private drug companies to 
develop a software package which can be 
used to report and review data from pre- 
clinical and clinical trials, modified for 
each specific use, to shorten review time. 

4-55 Information about which drugs are avail- 

able under a treatment IND must be 
more widely disseminated. An informa- 



52 



tion database must be created which 
should also offer information about po- 
tential toxicity as well as information 
about results of any clinical trials involv- 
ing the drug. 

4-56 If use of treatment INDs increases, the 

Food and Drug Administration's Com- 
missioner should be given authority to 
monitor those drugs in Phase IV, after li- 
censing is complete. 

4-57 Treatment INDs should be used primari- 

ly by those patients who do not have 
access to experimental drug trials. 

4-58 The Food and Drug Administration 

should fund an independent scientific 
organization to conduct an independent 
review of safety regulations dictated by 
the 1962 Kefauver Amendments to de- 
termine whether they should be relaxed 
for drugs used under Treatment IND 
regulations that are intended for termi- 
nally ill patients who have given in- 
formed consent. 

4-59 In order to encourage the administration 

of drugs under treatment IND regula- 
tions, Congress should review current li- 
ability laws regarding these drugs and 
take appropriate action to extend liabil- 
ity protection to cover the manufacture 
and administration of these drugs. 

4-60 The Food and Drug Administration 

should meet with industry representa- 
tives and the Commission on Rare Dis- 
eases to determine the most attractive 
package by which to both encourage ad- 
ditional research and development, and 
allow companies to provide orphan 
drugs at reasonable cost to patients. 

4-61 Cost-effective methods, such as exten- 

sion of market exclusivity, should be fa- 
vored over those that require additional 
investment. 

4-62 Professional pharmaceutical associations 

should survey members to determine 
what package of incentives would be 
most attractive to the producers. 

4-63 Special track approval for medical foods, 

such as lipids, and especially those with 
long use in other diseases, should be 
considered. 

4-64 Congress should immediately authorize 

and fund an additional 50 FTEs for the 
Food and Drug Administration's review 
of new drugs and vaccines. 



4-65 The FTE level for reviewers should be 

tied to increases in the number of new 
IND applications. 

4-66 Office and other support for these indi- 

viduals should be given commensurate 
funding. 

4-67 The Commissioner of the Food and 

Drug Administration (FDA) should de- 
velop a plan by which medical and other 
graduate education loans can be repaid 
through FDA service. Congress and the 
Administration should provide funds for 
this training program in FY 1989. 

4-68 We urge the Food and Drug Administra- 

tion to use deliberate haste in approving 
or rejecting the diagnostic products 
before them currently and in the devel- 
opmental pipeline. Particular attention 
must be given to HIV antigen tests and 
any other new technology which tests di- 
recdy for the virus. Consideration by 
FDA should be given to whether the 
review process could be expedited by 
moving regulatory control of HIV diag- 
nostic tests from the Division of Blood 
and Blood Products to the Division of 
Medical Devices. We recommend in- 
creasing the pool of qualified individuals 
to staff the approval process by creating 
training grants in relevant departments 
of colleges and universities. 

4-69 The Commission recommends the timely 

completion and release of ongoing Food 
and Drug Administration (FDA) studies 
on the efficacy and safety of condoms 
and surgical gloves in blocking transmis- 
sion of HIV and recommends that these 
results be publicized by FDA. In addi- 
tion, standards for condom safety should 
be increased, and studies should be con- 
ducted to determine the effects of sper- 
micides, solvents, and other lubricants 
on latex. Studies to determine the shelf 
life of latex condoms, with or without lu- 
bricants or spermicides, should be per- 
formed, and packaging dated according- 

iy. 

4-70 The federal government should provide 

funds for an additional office and labora- 
tory building for the Food and Drug Ad- 
ministration's drug and vaccine applica- 
tion review personnel. 

4-71 To inspire pride in the Food and Drug 

Administration (FDA), an annual Presi- 
dential Award for Excellence could be 
bestowed on dedicated FDA scientists 
who creatively and expeditiously approve 
life-saving products and discover ways to 
protect society from unforeseen health 
hazards. 



53 



Section IV. Clinical Trials: Testing 
Drugs in People 

In HIV research, clinical trials (trials in 
humans) usually take place in medical centers 
or at the National Institutes of Health Clinical 
Center, and are funded by either the sponsor- 
ing pharmaceutical company, the federal gov- 
ernment, or the two in combination. 

The purpose of clinical trials is to determine 
the safety and effectiveness of a particular drug 
or vaccine with the greatest degree of certainty 
while testing the drug in the fewest number of 
people necessary to achieve this goal. This is 
because the drugs are experimental, and there 
is no guarantee that they will help the patient, 
and may in fact cause harm. Given the urgency 
of the HIV epidemic, there is the additional 
pressure to determine safety and efficacy as 
rapidly as possible. 

Within the next few years, it is projected that 
there will be several hundred thousand persons 
with symptomatic HIV infection who will need 
treatment. The primary goal of current clinical 
trial programs is to develop drugs that can be 
safely used in these individuals, that will be 
effective in alleviating symptoms and, it is 
hoped, be effective in killing the virus and re- 
storing proper immune function. In addition, 
trials in asymptomatic patients are also under- 
way at NIH, to determine the effectiveness of 
drugs in delaying or preventing the onset of a 
symptomatic state. 

In order to produce the quantities of drugs 
that are expected to be needed both now and 
in the coming years, more trials must be con- 
ducted immediately and conducted as efficient- 
ly as possible, to gain as much information as 
possible while conserving both time and human 
resources. The Commission endorses all efforts 
to ascertain that the participation of every indi- 
vidual in any clinical trial is valued and proper- 
ly utilized, and that all trials be as beneficial as 
possible to both the participants and to the 
advancement of medical research. 

Clinical trials are carried out in three phases, 
involving progressively larger numbers of 
people: 

• Phase I trials are concerned primarily with learn- 
ing more about the safety of the drug, though 
they may also provide information about effec- 
tiveness. They provide information on: how the 
drug is absorbed, metabolized, and excreted; 
what effect it has on various organs and tissues; 
and what side effects it has as doses are in- 



creased. Phase I testing is generally done on a 
small number of healthy volunteers. They are 
usually paid for their services, which essentially 
consist of submitting to a variety of tests to learn 
what happens to the drug in the human body. 
One of the chief causes of failure in this phase is 
evidence that the drug is toxic at doses too small 
to produce any beneficial effect. 

• Phase II trials are designed to show whether the 
drug is effective in treating the condition for 
which it is intended. They also attempt to dis- 
close short-term side effects and risks in people 
whose health is impaired. Most phase II trials are 
randomized controlled studies. Placebos are used 
when there is no historic or positive control 
available. 

• Phase III testing is geared to developing infor- 
mation that will allow the drug to be marketed 
and used safely. Optimum dose rates and sched- 
ules are determined and, hopefully, any long- 
term side effects are revealed. 



Study Design 

Protocols must be designed to effectively 
gather large quantities of valuable information 
efficiently, to determine whether drugs work 
and are safe. The issue of placebo controls in 
clinical trials was raised by several witnesses. 
Currently, no new NIAID clinical trials in pa- 
tients with life-threatening disease will be pla- 
cebo-controlled, and, as more drugs show ef- 
fectiveness, they may be added as positive con- 
trols to new drugs under study. 

There are two classification systems currently 
in use 10 determine a patient's stage of disease: 
the CDC system (described in the Patient Care 
chapter), based on clinically apparent criteria, 
and the Walter Reed system, which additionally 
uses immune response parameters. Using a 
clinical staging system in research protocols en- 
courages the use of clinical endpoints in trials, 
and this should be replaced by the use of im- 
munologic criteria which can more precisely 
determine disease progression. 

NIAID-funded HIV Trials 

Clinical trials can be sponsored by private 
sector drug companies, or the federal govern- 
ment. Much of the drug development research 
done in the United States is conducted entirely 
in the private sector, and the pharmaceutical 
industry has a substantial history of developing 
and expertly managing clinical trials. 

Federal funding for clinical trials for HIV- 
related illness is distributed through NIAID. In 



54 



1987, AIDS Treatment Evaluation Units 
(ATEUs) were established at the universities or 
medical centers originally designated to oper- 
ate NIAID-sponsored HIV-related research. 
These centers have been renamed the AIDS 
Clinical Trials Group (ACTG). The recently re- 
designed program currently sponsors clinical 
trials throughout the country, with a total en- 
rollment of nearly 4,000 patients, 800 on the 
NIH campus (intramural) and the remainder in 
participating clinical trial centers (extramural). 
To date, there are 35 funded institutions, 17 
drugs in trial, 28 active protocols, and many 
new agents under study. 

Initially, there was criticism that NIAID trials 
too often used AZT. When AZT was the only 
drug available with demonstrated efficacy, it 
was used in multiple trials in patients with a 
variety of disease manifestations in order to 
determine its range of usefulness. At present, 
AZT is being used in combination with other 
drugs, as well as singly with special patient 
populations. 

Trials are underway with a large (1500) and 
increasing number of asymptomatic patients to 
determine if early treatment delays the onset of 
symptoms. 

NIAID has convened an AIDS Program Advi- 
sory Committee which includes or will include 
representatives of affected minority communi- 
ties, women, community health care providers, 
and social workers. Among its functions will be 
to determine whether the full range of the af- 
fected communities are represented in the clini- 
cal trial patient population, whether additional 
provisions need to be made to permit the sus- 
tained participation of these population groups 
in the clinical trial process (e.g., child care, 
transportation, additional primary medical 
care), and to assure that the data collected will 
be used to ensure that each patient's participa- 
tion contributes to a scientifically valid and ex- 
pertly managed trial. NIAID administrators 
have indicated a willingness to also include a 
qualified individual with HIV infection on this 
committee. 

The Commission is concerned that with the 
number of new drugs under development, the 
number of additional clinical trials will soon 
escalate sharply, and the needed additional per- 
sonnel will be unavailable. New personnel 
should be added and trained today. One wit- 
ness suggested that in a national medical emer- 
gency, the NIAID clinical trials system could be 
supplemented by forming a consortium of 



smaller hospitals that could provide clinical 
trials resources. One principal investigator 
from one such smaller hospital, however, testi- 
fied that internal difficulties within his institu- 
tion had delayed start-up time of his trial by 
several months, which would slow overall 
progress for NIAID considerably. Another wit- 
ness, a principal investigator in one of the ear- 
liest ATEU programs, suggested that to rapidly 
expand clinical trials, the Surgeon General 
could reassign commissioned officers in the 
Public Health Service to areas of the country in 
greatest need. 

Research personnel also indicated that low 
salaries were a hindrance to hiring adequate 
numbers of trained nurses to staff the Clinical 
Center. On one ward, 100 personnel slots were 
authorized, approximately one-half of which 
were nursing slots. To date, only 1 1 of these 
positions have been filled. This has caused 
delays in implementation of clinical trial proto- 
cols. Salary structures for nurses have recently 
been modified, and similar modifications must 
be made for allied health care workers. 

In the extramural trials funded by NIAID, an 
interesting working relationship has developed 
between centers funded to do studies, and 
some inner city hospitals with large HIV pa- 
tient populations, which has led to complaints 
from these hospitals. Many municipal institu- 
tions lack a research infrastructure to support 
clinical trials at their hospital, but are asked to 
"lend" patients to medical centers funded for 
trials and then not included in either the ad- 
ministration of the study or reimbursed for 
their expenses. Equitable means of sharing the 
"intermediate cost recovery" (overhead pay- 
ments) must be developed to encourage fair 
cooperation between institutions. 

Pediatric Trials 

One of the most pressing clinical trials needs 
is trials for pediatric patients. There are many 
unanswered questions in perinatology (the 
study of infants) that relate to HIV disease. 
What factors favor transmission from mothers 
to infants? What is the role of the placenta in 
viral transmission? Why do infants have earlier 
and more severe HIV infection? What is the 
role of breast feeding in transmission? How can 
transmission to fetus be identified early? Is 
treatment of pregnant mothers or newborn in- 
fants feasible? 



55 



The effects of HIV on the brain and, there- 
fore, on the entire neurologic and neurodeve- 
lopmental systems of HIV-infected children are 
detrimental and profound. Of 30 symptomatic 
HIV-infected children under 15 months of age 
at the State University of New York (SUNY) 
Pediatric AIDS Clinic in Brooklyn, only 10 per- 
cent have normal mental and motor develop- 
ment. 

There are no treatments for children with 
symptomatic HIV infection, and several obsta- 
cles prevent broad implementation of clinical 
trials. AZT, a drug that crosses the blood-brain 
barrier, and the primary drug proven effective 
against HIV, is not widely available to HIV- 
infected children. A placebo-controlled trial 
testing intravenous immunoglobulin recently 
opened that is expected to enroll 400 children. 
But this drug, which is not an anti-viral, does 
not address underlying HIV infection. In addi- 
tion, many perinatally infected infants and chil- 
dren are "boarder babies" or wards of the 
state, and there are legal restrictions against 
their being entered into trials. Many of the 
metropolitan hospitals that have large pediatric 
populations with HIV infection have no re- 
search capability or staff to conduct trials. 

Community-based Trials 

Many witnesses before the Commission testi- 
fied that there was a need for greater access by 
a broader spectrum of the infected population 
to clinical trials, specifically women, hemophili- 
acs, children, and transfusion-exposed individ- 
uals. Concern was expressed by many of these 
witnesses that drugs were being tested on one 
segment of the population and may be licensed 
for use in other segments without having been 
intensively tested in them. As these populations 
may represent the future of the epidemic (e.g., 
children and intravenous drug abusers), the im- 
mediate implementation of more broadly avail- 
able therapeutic protocols is essential. 

The Community Research Initiative (CRI) 
offers the possibility to combine the technical 
expertise of the research community with the 
outreach potential of community health clinics 
and physicians in community practice. This 
outreach effort to minority populations, drug 
users, and women may increase the access of 
these populations to experimental treatment. 
The Commission is hopeful that greater access 
by a broader based community will also in- 
crease the information gathered on co-factors 
and increase knowledge of disease manifesta- 



tion and progression. In addition, as many "un- 
derground" drugs are being used by the HIV- 
infected population, community-based efforts 
may offer the added possibility of increasing 
our knowledge of the effectiveness of these 
substances, and how they interact with other 
medications. Such "observational trials" can 
also provide valuable information about "pat- 
terns of care" in community settings. 

All protocols developed by CRI and other 
similar organizations that would follow, are 
prepared and screened by an Institutional 
Review Board (IRB), following the same proce- 
dure adhered to in medical research institu- 
tions. Individuals who are on the staff of such 
medical institutions are members of these 
boards and offer advice on scientific matters. 
All protocols offered to NIAID for funding will 
be passed by the IRB prior to submission, and 
ways are being studied to better link the work 
of CRI with the research establishment at NIH. 
NIAID has indicated a new clinical trial devel- 
opment strategy that will incorporate greater 
community participation. 

A model community physician training pro- 
gram was developed by NCI in the 1970's, and 
could be useful in developing a similar one for 
HIV clinical trials. The program, known as the 
Community Clinical Oncology Program, pro- 
vides a training base for physicians in commu- 
nity practice, who come to major research cen- 
ters to acquire the latest research information 
and clinical trial management skills. A similar 
program could be developed within the infec- 
tious disease departments of major centers al- 
ready in the ACTG program, to train physi- 
cians who work with currently underserved 
populations. 

Obstacles to Progress 

• As the number of new drugs developed in- 
creases, the number of clinical trials will increase, 
and more staff will be needed at NIAID to 
manage them. 

• Community-based physicians are not currently 
involved enough in the clinical trial system. This 
is an underutilization of valuable resources. 

• A broader spectrum of individuals needs to 
become involved in clinical trials in order to 
ensure safety and efficacy of approved drugs in 
all patient populations. 



56 



• Those who need clinical trial information most — 
doctors and patients ~ usually do not know how 
to get it or are unable to do so. 

• Therapeutic trials for infected infants and chil- 
dren do not exist in adequate numbers, and 
there are not enough actual or planned NIAID 
Clinical Trials Centers for pediatric trials. 

• Personnel shortages at the NIH Clinical Center 
are slowing the implementation of drug trials. 

• There is no program similar to the Community 
Clinical Oncology Program to train community- 
based investigators in HIV clinical research. 

RECOMMENDATIONS 

NIAID Clinical Trials and Studies 

4-72 Membership in the National Institute of 

Allergy and Infectious Diseases' AIDS 
Program Advisory Committee should in- 
clude at least one qualified individual 
with HIV infection. Members should also 
include representative minorities, par- 
ents of HPT-infected children, women, 
and hemophiliacs. 

4-73 The National Institute of Allergy and In- 

fectious Diseases should develop means 
by which clinical trials can be made 
available to individuals in all geographic 
areas of the country. 

4-74 To better understand the natural history 

of HIV-infection in women, the National 
Institute of Allergy and Infectious Dis- 
eases should fund female cohort studies 
and enroll women in different stages of 
HIV-related illness. 

Clinical Trial Information Registry 

4-75 Registration of all HIV-related clinical 

trials information, and information on 
approved substances and INDs should 
be made available in one central loca- 
tion. If it is modeled after the Physician's 
Data Query System in the National Li- 
brary of Medicine, software must be de- 
veloped to make the retrieval of hard 
copy information possible. 

4-76 Information regarding the nature and 

status of clinical trials should be readily 
accessible to all interested parties in this 
country and to central health agencies in 
other countries. 

4-77 The NIH Office for AIDS Research 

should assume responsibility for devel- 
oping an appropriate, quality-assured 
database for collection and distribution 
of this information, and should have it 



operational no later than December 31, 
1988. 

4-78 All trials should be registered by the 

sponsor within seven days of approval by 
the Food and Drug Administration. The 
sponsor should furnish complete proto- 
col information including but not limited 
to the drug(s) being tested, inclusion 
and exclusion criteria, pertinent drug- 
taking restrictions, trial site(s), the 
names of principal investigators with 
contact information, and trial com- 
mencement and termination dates. 

4-79 The clinical trials database must be con- 

stantly updated and must include infor- 
mation on trials conducted by the Na- 
tional Institutes of Health, and by pri- 
vate pharmaceutical companies, and 
must, as soon as possible, include trials 
conducted in other countries. Patient en- 
rollment information must also be up- 
dated. 

4-80 If the Physician Data Query System is se- 

lected and used in conjunction with the 
Centers for Disease Control (CDC) 
Clearinghouse, a public information 
campaign should be authorized. Health 
and science editors of all major media 
should be made aware of existence of 
the system to make it more widely un- 
derstood by physicians and patients 
alike. This should be done by coopera- 
tive agreement between CDC, the Na- 
tional Cancer Institute, and the National 
Institute of Allergy and Infectious Dis- 
eases, with additional funds made avail- 
able. 

Study Design and Implementation 

4-81 Use placebo-controlled studies only for 

patients without immediately life-threat- 
ening disease, and positive control stud- 
ies in patients with symptomatic HIV in- 
fection. 

4-82 In the process of giving informed con- 

sent for participation in a clinical trial, 
the participant should fully understand 
all aspects of the study and commit to 
faithful adherence to the protocols. 

4-83 To more effectively analyze information 

across multiple trials, standardize staging 
criteria and utilize the Walter Reed stag- 
ing system to establish disease stage and 
clinical trial endpoints. 

4-84 In order to accelerate evaluation of effi- 

cacy of a new drug, reevaluate the end- 
points of current clinical trials to deter- 
mine whether markers other than clinical 



57 



morbidity or mortality (e.g., laboratory 
markers) can be used. 

4-85 Develop means of shortening the time 

frame of Phase II trials, perhaps by in- 
creasing sample size or changing the 
endpoints. 

4-86 Establish as a high priority the develop- 

ment of trials with sufficient numbers of 
women (including pregnant women), in- 
fants and children, hemophiliacs, trans- 
fusion-infected individuals, and intrave- 
nous drug users to both serve these pop- 
ulations and be statistically evaluable. 

4-87 Prior to the initiation of all new HlV-re- 

lated trials, the National Institute of Al- 
lergy and Infectious Diseases should re- 
quire a commitment on the part of par- 
ticipating institutions to rapid and active 
facilitation by their Institutional Review 
Boards and other internal regulatory 
mechanisms so that protocols are rapidly 
implemented. 

Data Collection 

4-88 The federal government should immedi- 

ately fund a pilot study for the develop- 
ment of computer software that could be 
used across all HIV clinical trials to 
standardize clinical data input and facili- 
tate the rapid evaluation of those trials 
by the Food and Drug Administration 
(FDA). This pilot study should include 
experts from the computer support divi- 
sions of FDA and the National Institutes 
of Health, as well as clinical and review 
experts. 

4-89 This software should be immediately 

used to begin collecting co-factor infor- 
mation on ongoing clinical trial partici- 
pants. 

4-90 Information gathered on placebo recipi- 

ents should be used to formulate the 
equivalent of a "historic control" for 
HIV so that future studies can be de- 
signed with decreased reliance on place- 
bos as controls. 

Pediatric Trials 

4-91 National Institute of Allergy and Infec- 

tious Diseases Clinical Trials Centers for 
children should be expanded from the 
presently planned three to six to 20 
throughout the United States. 

4-92 All clinical trials developed for adults at 

the National Institutes of Health should 
also address the possibility of being uti- 
lized in pediatric populations, wherever 



possible in the form of a "concept pro- 
posal." 

4-93 Because of the high percentage of HIV- 

infected children who suffer severe neu- 
ropathy, drugs that cross the blood-brain 
barrier should be given highest priority 
in the design and implementation of 
clinical trials for this population. Proto- 
cols for every trial should include neuro- 
logic and neurodevelopmental tests to 
determine the neurologic efficacy or tox- 
icity of the drug. 

4-94 In order to facilitate patient accrual in 

pediatric trials and deliver experimental 
treatment and superior care where it is 
most needed, clinical facilities in areas 
with high prevalence of pediatric infec- 
tion must be upgraded so they can con- 
duct more demanding Phase I and Phase 
II trials; these facilities must be given the 
means to recruit the personnel necessary 
to conduct these trials. 

4-95 Wherever legal restrictions bar the entry 

of "boarder babies" and other foster 
children into clinical trials, these restric- 
tions must be examined and challenged 
as appropriate, to make certain that 
these children are not being denied 
access to palliative or possibly curative 
therapies. 

Community-Based Trials 

4-96 Activities already in progress at the Na- 

tional Institute of Allergy and Infectious 
Diseases should be encouraged to incor- 
porate greater participation of industry 
and community physicians in protocol 
development and implementation. 

4-97 A direct grant program should be 

funded immediately to assist community- 
based trial sponsors to develop and im- 
plement clinical trial protocols, and to 
encourage increased access to these pro- 
tocols by any underserved populations. 

4-98 The National Institutes of Health Office 

for AIDS Research should develop a 
training program for community practice 
physicians whereby physicians can ac- 
quire both the latest HIV research infor- 
mation and clinical trial management 
skills. This program could be patterned 
after the Community Clinical Oncology 
Program, should be funded through ex- 
isting AIDS Clinical Trials Group cen- 
ters, and should be designed to develop 
a broader base of clinical expertise for 
administering HrV-related clinical proto- 
cols as they become available. Funds for 



58 



this program should be made available 
in FY 1989. 

4-99 Community-based organizations and 

community health centers should be 
consulted in the design and should be 
used in the execution of clinical trials. 

4-100 Community-based trial investigators 

should be encouraged to work closely 
with leading clinical researchers and 
basic scientists at medical institutions in 
their community to establish better re- 
search relationships and provide the best 
service to their patients. 

Section V: Additional Research 
Needs 

Behavioral and Social Science Research 

HIV transmission is linked to specific and 
potentially changeable patterns of behavior. 
For individuals currently engaging in those be- 
haviors, prevention of transmission depends on 
implementing effective behavioral change pro- 
grams which seek to reduce or eliminate expo- 
sure to the virus. Research on sexual and drug- 
abusing behavior must, therefore, be an inte- 
gral part of all HIV intervention efforts. 

The study of human behavior is a complex 
endeavor which includes a variety of disciplines 
with numerous methodologies. The need to 
change individual behavior and to sustain that 
change will be paramount indefinitely. Given 
the central role of behavioral and social proc- 
esses in the HIV epidemic, it is essential that 
the social and behavioral sciences be given pri- 
ority in the funding portfolios of the appropri- 
ate Public Health Service agencies (Alcohol, 
Drug Abuse and Mental Health Administration 
and the National Institutes of Health). 

Evaluative components must be built into any 
intervention program to determine which ele- 
ments of the program were successful and 
which were not. The incorporation of evalua- 
tion into such programs is often far from ideal, 
not only for financial reasons. The forging of a 
relationship between researchers and members 
of community projects who may be suspicious 
of the intentions of researchers is difficult at 
best. Yet evaluation of programs by trained re- 
searchers remains the only way to determine 
program success. 

To date, most of the efforts used to stop the 
spread of HIV have been informational mass 
communications, such as pamphlets, public 
service announcements, advertisements in mag- 



azines, and — to a limited extent ~ television 
commercials. However, some behavioral re- 
search indicates that simply providing informa- 
tion may increase awareness about HIV, but 
does not necessarily lead to change in risk be- 
havior. 

Sexual Behavior 

Transmission of HIV can occur in any sexual 
behavior (from female to male, from male to 
female, and between two partners of the same 
sex) in which there is an exposure of HIV- 
infected body fluids to cells which can be in-^_ 
fected. For this reason, research on sexual be- 
havior is particularly relevant for designing and 
implementing appropriate and effective preven- 
tion programs. In addition, research indicates 
that sexual behavior and attitude vary some- 
what as a function of ethnicity and culture. In 
order to be effective, educational efforts must 
be sensitive to these differences. 

A behavioral model that has been tested in 
terms of sexual behavior change in response to 
the HIV epidemic is the Health Belief Model 
which states that risk reduction depends on 
knowledge about HIV, a sense of perceived 
risk, a sense of personal efficacy (i.e., a feeling 
of having the mechanical and social skills nec- 
essary to make changes), and a perception that 
community norms support HIV risk reduction. 

One area of concern in behavior change, il- 
lustrated by the study of human sexuality, is 
rekpse__preyention. Maintenance of behavior 
change is often perceived to be more difficult 
than the original change itself. Among other 
areas of concern are: the seeming inability of 
some individuals to enjoy and maintain exclu- 
sive sexual relationships, and those individuals 
whose behaviors may pose an increased risk of 
HIV transmission — including those diagnosed 
by sex therapists as sexually compulsive, hyper- 
sexual, or sexually addicted. 

Currently, researchers in the field of adult 
sexual behavior must continue to refer to data 
collected by Kinsey over 40 years ago. There is 
an urgent need to update the information base. 
Data collected in the future should include not 
only prevalence of behaviors, but also attitudes 
and beliefs about sex. 

Research areas which need attention are not 
limited to the behavioral area. Some are inter- 
personal in nature (e.g., developing assertive- 
ness to resist coercion by partners to engage in 
high-risk sex and developing social skills to 



59 



maintain stable relationships). Therefore, it is 
important to support a variety of programs that 
reflect different approaches to behavior change 
(e.g., programs that emphasize acquisition of 
skills, the changing of norms, and intensive 
counseling). 

Behavior Studies in Homosexual and Bisexual 
Men 

There is reason to be optimistic about 
projects aimed at reducing high-risk behaviors. 
Results from a behavioral research study in San 
Francisco shows that the incidence of detected 
HIV infection in a group of over 800 homosex- 
ual and bisexual men is approaching zero. 
From 1984 through 1986, the prevalence of 
HIV-infection in this group of homosexual and 
bisexual men was stable at approximately 50 
percent. Not surprisingly, this is concomitant 
with substantial reductions in self-reported 
high-risk activities. The study results may show 
effectiveness in both behavior modification ef- 
forts and community-based HIV educational 
programs. 

There are some researchers who believe that 
the San Francisco study sample is not repre- 
sentative of all homosexual and bisexual men. 
Therefore, further studies must be targeted on 
this population. 

Behavior Studies in Women 

In general, HIV service programs and educa- 
tional efforts have not taken into account 
women's social roles, childbearing and child 
care responsibilities, or their economic position 
relative to men. There is considerable interest 
in women in HIV research as vectors of trans- 
mission as mothers or prostitutes. However, 
there is a general lack of information in HIV 
literature on the psychosocial problems of 
women as they cope with illness. 

The greatest number of diagnosed AIDS 
cases among women occur in the black and 
Hispanic population. Approximately 51 percent 
of all AIDS cases in women are among black 
women and 20 percent are among Hispanic 
women. Thus, there are ethnic and cultural 
issues that are important areas of research for 
women with HIV infection. Qualitative research 
is also needed on why women may choose to 
get pregnant and bear children even though 
they know they are infected with HIV and have 
approximately a 50 percent chance of infecting 
their child. 



Adolescents 

The Commission believes there should be 
more extensive behavioral research on adoles- 
cents. Although adolescents currently represent 
a relatively small percentage of all reported 
AIDS cases (approximately one percent), the 
potential exists for a significant increase in this 
percentage. As of January 1988, over 700 cases 
of AIDS were reported to the Centers for Dis- 
ease Control in the 13 to 21 year old age 
group, and this number is doubling each year. 
Estimates show that about 20 percent of all 
persons with AIDS are in their twenties. How- 
ever, because of the long latency from infection 
to onset of disease symptoms, many of the 
cases of AIDS detected in young adults devel- 
oped in all likelihood from infection with HIV 
in adolescence. According to preliminary Army 
data, during the first two years of the military 
screening program, 673,031 teenage youths, 
ages 17 to 19, were tested. Overall, 226 teen- 
age applicants were found to be seropositive 
(0.034 percent). However, this preliminary data 
showed the prevalence rate among female mili- 
tary applicants age 17 was 0.032 percent, twice 
that of male applicants age 17 (0.015 percent). 

Estimates vary widely on the proportion of 
adolescents who are sexually active, ranging 
anywhere from 50 to 70 percent. Evidence sug- 
gests there is a greater number of adolescents 
engaging in sexual activity at progressively 
younger ages. 

But the threat of HIV transmission in adoles- 
cents is not limited to sexual activity. The 
urgent necessity of addressing the special 
needs of adolescents is nowhere more poignant 
than on the streets of America's major cities 
where runaways often migrate. Many runaway 
and homeless adolescents are caught at the 
juncture of risks that include sex and drugs. 
Both male and female adolescents often use 
prostitution as a means of supporting them- 
selves and possibly a drug habit. For example, 
in a small study conducted at the Covenant 
House, a shelter for runaway youth in New 
York City, approximately 40 percent of the 
adolescents were HIV-infected. 

But activities that increase the risk of HIV 
infection are not limited to runaway and home- 
less adolescents. For example, one percent of 
high school seniors surveyed reported having 
used heroin intravenously. 

Several studies in the San Francisco area 
have brought to light misperceptions among 



60 



adolescents concerning routes of transmission, 
modes of effective prevention, and information 
about HIV. These misperceptions significantly 
contribute to their behavioral risk of HIV infec- 
tion. For example, one study showed that ado- 
lescents tend to overestimate the risk of con- 
tracting HIV through casual contact, but more 
importantly they tend to significantly underesti- 
mate their risk of contracting the virus through 
sexual contact. Another study revealed that 
white high school adolescents were more 
knowledgeable than black adolescents about all 
aspects of HIV. In the same study, less knowl- 
edge was associated with an increased per- 
ceived risk of contracting HIV. Prevention pro- 
grams for adolescents should promote changes 
in attitudes toward risk behavior as well as in- 
creasing awareness about risk and emphasize 
the benefits of behavior change. 

Educators, or those who counsel or provide 
information to adolescents, must appear credi- 
ble. Research on adolescents shows that peers 
tend to be a predominant source of informa- 
tion about sexuality and have a strong influ- 
ence on sexual behavior. Education in non-tra- 
ditional, peer settings has been found effective. 

Federal Research Efforts 

The National Institute for Mental Health 
(NIMH), within the Alcohol, Drug Abuse, and 
Mental Health Administration (ADAMHA), is 
the focal point within the federal government 
for research on behavior and its psychological 
and psychosocial determinants. NIMH supports 
research and research training in the biological, 
psychological, epidemiological, and social sci- 
ence aspects of mental health and illness. 

The National Institute on Drug Abuse 
(NIDA), another ADAMHA institute, conducts 
research to improve the effectiveness of drug 
abuse treatments and behavior change strate- 
gies in order to prevent drug use and to pre- 
vent the progression from non-intravenous to 
intravenous drug use. 

The National Institute on Alcohol Abuse and 
Alcoholism (NIAAA) will be funding research 
on the relationship of alcohol-related behaviors 
that increase the risk of transmission of HIV 
and strategies to prevent that risk. 

The National Institute of Child Health and 
Human Development (NICHD), within NIH, 
currently has a smaller behavioral research pro- 
gram involved in developing and testing inter- 
ventions to prevent the spread of HIV among 
sexually active adolescents and other high-risk 



populations. In addition, NICHD will be con- 
ducting research on general sexual attitudes 
and behaviors and on pediatric and adolescent 
HIV issues. 

CDC collaborated on some of the earliest 
behavior research related to the HIV epidemic 
with its cohort studies of homosexual men in 
San Francisco. It currently funds several dem- 
onstration projects focusing on the effects of 
community-based interventions to stimulate 
changes in knowledge, attitudes, and behaviors 
and is contributing to the Public Health Service 
(PHS) survey research efforts. 

Much of this work is complemented by a 
foundation of health-related behavioral re- 
search conducted through other PHS agencies. 
For example, principles of behavior change 
(such as those used in research sponsored by 
the National Cancer Institute in smoking cessa- 
tion programs and the National Heart, Lung, 
and Blood Institute in its cardiovascular com- 
munity intervention trials) are directly applica- 
ble to changing risk behaviors associated with 
HIV transmission. 

Federal funding for behavioral research flows 
primarily through NIMH. However, behavioral 
change research has received inadequate priori- 
ty in funding in the past decade. The National 
Academy of Sciences has stated in Confronting 
AIDS that "the knowledge base in the behavior- 
al and social sciences needed to design ap- 
proaches to encourage behavioral change is 
more rudimentary because of chronic inad- 
equate funding." 

Research must continue into determinants of 
high-risk behaviors and the development, im- 
plementation, and evaluation of culturally spe- 
cific risk reduction and risk elimination pro- 
grams designed to prevent further spread of 
HIV. 

The success of preventive intervention pro- 
grams depends upon an informed understand- 
ing of health behaviors and the determinants of 
behavioral change. HIV research requires a 
multidisciplinary perspective. Experts of differ- 
ent disciplines within the behavioral and social 
sciences do not always sufficiently collaborate 
among themselves as well as with other disci- 
plines in the biomedical sciences, though there 
are current efforts to increase collaboration, 
such as the Committee on Behavioral, Social, 
and Statistical Sciences of the National Acade- 
my of Sciences. Social and behavioral research 
in HIV must be long-term, collaborative efforts 



61 



such as that found in the NIMH Centers Pro- 
gram grant mechanism. 

The NIMH Centers are multidisciplinary and 
multi-institutional operations. They support 
basic, clinical and applied research, and preven- 
tion and educational research. All Centers con- 
tain information dissemination components, 
and each maintains contacts with community 
groups for access to high-risk populations. It is 
imperative that this mechanism for funding re- 
search be maintained and funding expanded, 
particularly for behavioral and social sciences 
research. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in the behavioral and 
social science research area: 

• Social and behavioral research has been under- 
funded and undervalued as a tool for developing 
effective prevention programs. 

• Better coordination and collaboration are needed 
among PHS agencies regarding their behavioral 
research activities. 

• Significant data are lacking on the sexual behav- 
ior patterns of adults and young people of vary- 
ing ages and cultural backgrounds. 

• Often, prevention programs are not successful 
because of insufficient collaboration among serv- 
ice providers and behavioral researchers. 

• Researchers are not given enough time to evalu- 
ate the effectiveness of programs and once a 
strategy is found effective, the means are lacking 
for widespread dissemination of that finding. 

• Parents and educators often disagree on the con- 
text and format of school-based sex education. 
Some fear that sex education will encourage 
sexual experimentation in adolescents while 
others believe sex education is essential to pre- 
vention. 

• HIV prevention programs are not sufficiently 
comprehensive, lacking research-proven behavior 
modification components in providing options 
for individuals attempting change. 

RECOMMENDATIONS 

In response to these obstacles, the Commis- 
sion recommends the following: 

4-101 The Department of Health and Human 

Services, through the Alcohol, Drug 
Abuse, and Mental Health Administra- 
tion, the National Institutes of Health, 
and the Centers for Disease Control 



should continue and expand the funding 
of research on adults and adolescents 
that identify: determinants of risk behav- 
ior; models of behavior change interven- 
tions (in laboratory, field, and communi- 
ty-based settings); social factors and 
strategies to affect behavior change; and 
evaluation and other methodologies. 

4-102 All HIV-related research funded by the 

National Institute of Allergy and Infec- 
tious Diseases and the National Institute 
of Mental Health should be reported to 
a central information gathering source. 
In the HIV crisis, data sharing should be 
the rule. 

4-103 Funds should be made available through 

the National Institute of Mental Health 
and the Centers for Disease Control to 
sponsor training programs for graduate 
and post-graduate HIV researchers in 
the field of behavioral research. 

4-104 Funds should be allocated for training 

grants for pre- and post-doctoral stu- 
dents in academic settings for research 
in the disciplines related to HIV research 
such as psychoimmunology, social psy- 
chology, human sexuality (including bi- 
sexuality), and behavioral sciences. 

4-105 Social and behavioral research in HIV 

must be long-term, collaborative efforts 
such as that found in the National Insti- 
tute of Mental Health Centers Program 
grant mechanism. It is imperative that 
this mechanism for funding research be 
maintained and increased in behavioral 
and social sciences research and that the 
Centers continue to play a significant 
role in behavioral and social research. 

4-106 The Department of Health and Human 

Services, through the National Institutes 
of Health, the Centers for Disease Con- 
trol (CDC), and the Alcohol, Drug 
Abuse and Mental Health Administration 
should take advantage of work already 
begun by the National Institute of Child 
Health and Human Development, in col- 
laboration with CDC, and continue to 
fund national baseline data collection ac- 
tivities with longitudinal components, 
that would permit a better understand- 
ing of sexual practices (including bisex- 
ual behavior), attitudes, and risk behav- 
iors of adults and adolescents of differing 
ages and cultural backgrounds in order 
to assess risks and guide intervention ac- 
tivities. Survey research should include 
proportionate sampling of ethnic, racial, 
and cultural groups, and regional vari- 
ations. 



62 



4-107 The Department of Health and Human 

Services, through the National Institutes 
of Health, the Centers for Disease Con- 
trol, and the Alcohol, Drug Abuse and 
Mental Health Administration, should 
fund small-scale surveys and studies in 
targeted groups to identify attitudes and 
behaviors that should be modified or re- 
inforced prior to development of educa- 
tion programs or other interventions 
that will be effective in those target 
groups and the cost-effectiveness and ef- 
ficacy of various channels for reaching 
such groups. 

4-108 The National Institute of Mental 

Health's review panels ("study sections") 
which determine which grants are ap- 
proved and given priority scores for 
funding should maintain a sufficient bal- 
ance and expertise in the area of behav- 
ior change research. 

4-109 The National Institute of Mental Health 

in collaboration with other Public Health 
Service agencies should continue to fund 
research to assess the impact of learning 
the diagnosis of HIV infection on indi- 
vidual behavior, and whether the impact 
varies by risk group. 

4-110 A working group on HIV infection and 

adolescents should be established 
through expansion of the mission of the 
Department of Health and Human Serv- 
ices' Pediatric AIDS Working Group. 

4-111 The National Institute of Mental Health, 

in collaboration with the National Insti- 
tute on Drug Abuse, should conduct 
studies of the determinants of the point 
of entry that puts an individual at risk 
and patterns of drug use and sexual 
practices (particularly, bisexual prac- 
tices). 

4-112 Researchers must be given sufficient 

time to evaluate the effectiveness of pro- 
grams, and once found effective, be 
given the means for widespread dissemi- 
nation of those findings. 

Co-Factors 

Co-factors are those conditions or influences 
which, when present or absent, influence indi- 
vidual susceptibility to infection and disease 
progression. 

Biomedical researchers interested in the 
study of co-factors in HIV infection have in- 
cluded the following in their study: presence 
and history of other sexually transmitted dis- 
eases; presence of other infections; pregnancy; 
behavioral factors; nutritional factors; and psy- 



chosocial factors (such as stress) that influence 
the immune system. 

In addition to these, co-factors which influ- 
ence risk behavior need to be considered. Such 
factors are individual perception of risk, belief 
in the efficacy of behavioral change, and the 
norms which either support or sanction risk 
behavior. 

Alcohol and substance use represents both a 
risk for initial infection and a possible co-factor 
in disease progression. The disinhibitory (judg- 
ment impairing) effect on behavior of alcohol 
and drugs makes use of these substances a po- 
tential risk factor for HIV infection. There is 
also some evidence to suggest that alcohol and 
certain drugs may have an immunosuppressive 
effect, possibly hastening progression of dis- 
ease. 

Research investigating co-factors is being 
conducted under the auspices of various PHS 
agencies along a continuum of intervention ef- 
forts. Research in these areas can be used to 
design programs which may prevent initial HIV 
infection, prevent the onset of symptoms in 
HIV-infected individuals, and ameliorate symp- 
toms in persons already symptomatic. There is 
some concern over a lack of coordination 
among these agencies. Because of the multidis- 
ciplinary nature of HIV research, close commu- 
nication is needed across federal agencies and 
disciplines, both intramurally and extramurally. 

Obstacles to Progress 

• Co-factor studies, which examine the effects of 
previous histories of other sexually transmitted 
diseases, the presence of other infections, preg- 
nancy, nutritional, behavioral, and psychosocial 
factors, have been underfunded. 

• Other co-factor research on factors influencing 
behavioral risk has also been underfunded. 

• A lack of coordination among appropriate PHS 
agencies may act to slow the progress of research 
in this area. 

RECOMMENDATIONS 

In response to these obstacles to co-factor 
research, the Commission recommends the fol- 
lowing: 

4-113 The National Institutes of Health and 

the Alcohol, Drug Abuse, and Mental 
Health Administration should ensure 
that there is sufficient coordination and 
collaboration in research in the areas of 
neurosciences and neurobiology to avoid 



63 



duplication of research efforts. This rec- 
ommendation is not intended to reduce 
funding of confirmatory studies. 

4-114 The Department of Health and Human 

Services, through the National Institute 
of Child Health and Human Develop- 
ment, the National Institute of Mental 
Health, and the National Institute on 
Drug Abuse, should fund a cohort study 
to determine the natural history of HIV 
infection in women and special social 
factors related to women at risk for HIV 
infection. 

4-115 Funds should be made available through 

the National Institute of Mental Health 
and the Centers for Disease Control to 
sponsor training programs for graduate 
and post-graduate HIV researchers in 
the area of co-factors associated with 
onset and progression of HIV-related 
diseases. 

4-116 The National Institute of Mental Health 

should continue to support research on 
the neurobiological and psychobiological 
processes, and the behavioral, psychoso- 
cial, and psychiatric factors thought to 
be associated with both the transmission 
of HIV infection and the progression of 
disease. 

4-117 The National Institute of Mental Health 

(NIMH) should issue a competitive re- 
quest for proposal to establish a center 
where researchers from various disci- 
plines could convene to exchange infor- 
mation formally and offer training in 
their discipline to researchers interested 
in integrating ideas. As the study of HIV 
co-factors is multidisciplinary, there 
should be cooperation between NIMH 
and appropriate agencies whose work is 
also devoted to concerns surrounding in- 
travenous and other drug abuse. 

4-118 The appropriate Public Health Service 

agencies should continue to fund neu- 
ropsychiatric research on symptomatic 
and asymptomatic HIV-infected patients. 
Research is needed to improve current 
testing instruments and methods of 
neuropsychiatric diagnostic testing for 
central nervous system involvement. 

4-119 The National Institute of Mental Health 

should continue to conduct research 
with the National Institute on Drug 
Abuse and the National Institute of Al- 
cohol Abuse and Alcoholism to better 
understand the impact of affective states, 



social isolation, and disinhibitors, such 
as alcohol and drugs on risk behaviors. 

Transmission 

Continued and expanded research is needed 
in the area of HIV transmission. The Multi- 
Center AIDS Cohort Study (MACS), funded by 
NIAID, is currently studying homosexual and 
bisexual men over time to gather transmission 
and other data. 

While the MACS project must continue, simi- 
lar studies must be funded to determine these 
factors in other populations at risk, especially 
female partners of infected men, intravenous 
drug abusers, and both heterosexual and ho- 
mosexual adolescents. Data are needed on the 
efficiency of transmission from male to female, 
female to male, and between two partners of 
the same sex in which there is an exchange of 
HIV-infected body fluids. 

Perinatal transmission is not well understood. 
It is still unclear why some babies of HIV- 
infected mothers develop HIV infection and 
some do not. Possible routes of perinatal trans- 
mission include transplacentally, during the 
birth process, and after birth through breast 
feeding. 

Obstacle to Progress 

• There is a lack of sufficient information regard- 
ing the effectiveness of transmission through dif- 
ferent routes. This not only makes risk assess- 
ment difficult, but makes it more difficult to de- 
termine which programs would be most effective 
in halting the spread of the virus. 

RECOMMENDATIONS 

In order to further efforts in this area, the 
Commission recommends: 

4-120 Funds should be made available through 

the National Institute of Mental Health, 
the National Institute of Child Health 
and Human Development, and the Cen- 
ters for Disease Control to sponsor 
training programs for graduate and post- 
graduate HIV researchers in the area of 
HIV transmission and maternal, perina- 
tal, and neonatal HIV infection. 

4-121 Research should be expanded to include 

studies to determine the effectiveness of 
viral transmission through various routes 
such as intravenous drug abuse, various 
modes of sexual activity, and perinatal 
transmission. 



64 



CHAPTER FIVE: THE PUBLIC HEALTH 

SYSTEM 



The HIV epidemic has presented a tremen- 
dous challenge to this nation's public health 
and education systems. The preventive re- 
sponse to the epidemic must be multidiscipli- 
nary, involving the public health community, 
the traditional education community, private 
and public health care providers, and substan- 
tial involvement of private, voluntary initiatives. 
The response must also be flexible and cre- 
ative, not bound to a single approach. 

The public health system, a system which has 
been fighting disease and promoting the gener- 
al health of our nation's population for more 
than a century, has the primary responsibility 
to provide leadership in the design and imple- 
mentation of strategies intended to halt the 
spread of HIV. The public health system 
cannot, however, lead in a vacuum. It must 
actively seek participation and cooperation 
from individuals who have in the past been 
considered outside that system. Prevention and 
education strategies that are not coordinated 
and that do not include input from all sectors 
of society will not succeed. 

The basic legal framework of the public 
health system is the public health laws of the 
states and territories which give authority for 
the protection, preservation, and promotion of 
the health of the population. The federal gov- 
ernment, through the Public Health Service 
(PHS), has the responsibility for protecting the 
nation as a whole and for coordinating among 
and providing technical assistance to the state 
and local agencies. Local public health agencies 
(city and county) act under local ordinance or a 
delegation of state law to serve a more limited 
geographic area. National efforts, such as the 
universal reporting of syphilis and rabies, are 
carried out by the voluntary coordination of the 
states and territories working through local 



agencies and in collaboration with the key fed- 
eral agency, the Centers for Disease Control 
(CDC). 

Section I. The Federal Role 

While many branches of PHS contribute to 
prevention, CDC is the lead agency in this en- 
deavor. The Epidemic Intelligence Service was 
created within CDC in the 1950s to provide a 
highly trained and mobile work force which 
could be quickly deployed to investigate a 
public health emergency. CDC is charged with: 
preventing and controlling infectious and 
chronic diseases; preventing disease, disability, 
and death associated with the environment and 
the workplace; and reducing health risks 
through education and information. All of 
these are done in partnership with state and 
local health agencies. 

CDC began its AIDS efforts in the spring of 
1981 by conducting epidemiologic and labora- 
tory investigations to determine the cause and 
document the epidemiologic trends. The use of 
a nationwide communications network alerted 
all states to the epidemic in 1981 and encour- 
aged state and local interest in the new condi- 
tion. Some members of the Epidemic Intelli- 
gence Service as well as other CDC employees 
were diverted from their regular duties into a 
variety of special projects designed to better 
understand this new disease. The following 
year, CDC provided New York City with federal 
funds for its surveillance program. In 1983, 
additional funds were provided by CDC to 
states and cities that had the largest number of 
AIDS cases. 1983 also marked the year that 
CDC, in conjunction with state epidemiologists, 
determined that AIDS should become a report- 
able condition, and appropriate instructions 
were issued by every state. In 1985, CDC 



65 



began allocating funds to state and local public 
health departments for AIDS information and 
education initiatives. Counseling and testing 
programs became part of CDC's funding 
agenda in 1986. No funds for overall program 
management were included. CDC's education 
plan further expanded in 1987 with the estab- 
lishment of the National Aids Information and 
Education Program Office, whose purpose is to 
provide mechanisms that will educate and 
inform the public. CDC's planned HIV activi- 
ties for 1988 include an AIDS information 
mailer that was sent to every American house- 
hold in May and June, the establishment of a 
clearinghouse that will serve as a reference 
center where the public may obtain information 
concerning the HIV epidemic, and further ex- 
pansion of surveillance activities. 

A critical role of CDC is its leadership for 
state policy design and its collaboration with 
state public health agencies in surveillance. Al- 
though CDC's definition of AIDS originally de- 
fined the problem well as it was early under- 
stood and assisted scientific and public under- 
standing as well as originally possible, CDC has 
lagged behind scientific understanding by not 
moving to an HIV infection-based data collec- 
tion system when the antibody test was devel- 
oped in 1985 to detect infection in asympto- 
matic persons. It is critical that CDC work with 
the states to collect HIV infection data and end 
its focus on symptomatic disease. 

CDC's HIV efforts have illustrated the agen- 
cy's strengths and weaknesses that must be dis- 
cussed in defining CDC's role in combating the 
HIV epidemic. The areas to be examined in- 
clude: CDC's budget; its structural organiza- 
tion; its personnel; its location; and its AIDS 
education and information programs. 

Section II. The CDC Budget 

Since 1981, CDC's AIDS budget has signifi- 
cantly increased from $200,000 to approxi- 
mately $305 million in FY 1988. Today, AIDS 
represents 40 percent of the CDC budget. 
During this same time period, very few CDC 
programs have realized as much growth as its 
AIDS activities. 

Obstacles to Progress 

In order for CDC to expand its prevention 
efforts, the following obstacles must be over- 
come: 



• Prevention programs are budgeted via annual ap- 
propriations, while federal illness treatment pro- 
grams are entitlements that allow continued 
access to funds. This limits the ability to plan 
programs over long periods of time, though 
most prevention efforts must be multi-year and 
will not have "pay-off' in reduced mortality or 
morbidity during the first 12 to 24 months of 
program activity. For example, there are no enti- 
tlements for immunization for all children in the 
United States. There are just year-to-year dollars 
eroded by inflation. On the other hand, annual 
appropriations maintain the opportunity for 
oversight and accountability. 

• There is a lack of sufficient funds for many CDC 
programs. CDC's overall budget has received 
only slight increases in recent years. For the 
most part, these increases occurred within the 
HIV budget, while the other CDC programs have 
basically remained level funded or have been 
tapped to augment HIV needs. A key example 
that illustrates CDC's budgeting constraints is its 
funding allocation for sexually transmitted dis- 
eases (STDs) other than HIV. For FY 1988, the 
federal government has allocated $65 million for 
STDs (this does not include funding for HIV). 
For FY 1989, the President's budget request in- 
cludes less than a $300,000 increase for the STD 
program. While the budget request accounts for 
little more than inflation in funding STD activi- 
ties, a resurgence in STDs is apparent in many 
parts of the nation. From 1986 to 1987, infec- 
tious syphilis cases rose 30 percent. The HIV 
epidemic has had an adverse impact on the avail- 
ability of senior scientists and public health ad- 
visers for STD investigation and control. 

RECOMMENDATIONS 

5-1 The Department of Health and Human 

Services should propose and Congress 
should support mechanisms to sustain 
longer term commitments to prevention 
programming than are now the case. 
Such mechanisms must include annual 
accountability for programs and regular 
evaluation of the effects of prevention 
services. 

5-2 Without reducing funds for other pre- 

vention activities under the Centers for 
Disease Control's (CDC) jurisdiction, ap- 
propriations to CDC should include not 
only funds for direct activities and pass- 
through allocations to state and local 
governments, but also funds for the 
management and evaluation of HlV-re- 
lated activities. 

5-3 Sexually transmitted diseases (STDs) are 

believed to be a significant co-factor of 
HIV infection. Recognizing this relation- 



66 



ship, the Centers for Disease Control 
should significantly increase its FY 1989 
funding for STD programs. 

Section III. CDC Management 

HIV prevention activities in CDC are distrib- 
uted through eight entities. These are: the 
Office of the Deputy Director for AIDS, which 
supervises all of CDC's HIV activities; the Na- 
tional AIDS Information and Education Pro- 
gram, which disseminates information to the 
public; the Center for Infectious Diseases, 
which is in charge of surveillance, epidemiolo- 
gy, and laboratory science; the Center for Pre- 
vention Services, which handles target groups, 
health education, and risk reduction; the 
Center for Health Promotion and Education, 
which administers the school health education 
program; the National Institute for Occupation- 
al Safety and Health, which examines HIV in 
the workplace; the Training and Laboratory 
Program Office, which handles laboratory eval- 
uation and training; and the National Center 
for Health Statistics, which conducts health 
interview surveys. In order for CDC's HIV pro- 
grams to succeed, it is crucial that the eight 
offices involved with HIV programs interact 
frequently and coordinate their efforts and that 
the agency shift focus to include the full spec- 
trum of HIV disease. 

Obstacles to Progress 

• The "matrix management" model, which has 
most HIV personnel reporting their activities in a 
line to both a major subunit of CDC and to the 
Deputy Director for AIDS, is confusing. Persons 
seeking information and assistance from CDC 
may not find it quickly. Activities in one area may 
not be coordinated with related activities in an- 
other center. 

• Continued use of the term "AIDS" rather than 
"HIV" in program titles and written materials 
contributes to the national confusion regarding 
this disease. 

• The continued CDC focus on AIDS case report- 
ing is blocking efforts to track the epidemic and 
to plan, target, and implement prevention strate- 
gies and is misleading the public as to the urgen- 
cy of the problem. 

RECOMMENDATIONS 

5-4 The Centers for Disease Control (CDC) 

should design and immediately imple- 
ment an internal plan for coordinating 
all of their HIV-related efforts. This task 
should be completed by September 30, 



1988. Such a plan should specifically 
state the responsibilities of all CDC units 
that are involved in HIV programs. It 
should also outline the coordination and 
communication processes between all 
participating CDC entities. 

5-5 The Centers for Disease Control (CDC) 

should establish by August 1, 1988, a 
clear and comprehensive mission state- 
ment for the Office of the Deputy Direc- 
tor for AIDS. This statement should in- 
clude the specific duties for that office as 
well as how that office will relate to all 
divisions of CDC. 

5-6 The Centers for Disease Control should 

immediately emphasize its focus on the 
HIV disease, collecting data beginning at 
infection. 

Section IV. National AIDS 
Information and Education 
Program 

The National AIDS Information and Educa- 
tion Program (NAIEP) was established in April 
1987. Its purpose is to provide a focus for 
CDC's public information and education en- 
deavors related to the HIV epidemic. NAIEP is 
intended to serve as a link to national and 
community-based organizations that are essen- 
tial in providing comprehensive HIV informa- 
tion and education. 

For its first year of operation, NAIEP operat- 
ed on a budget of $23.6 million. Its budget for 
1988 is slightly over $41 million. NAIEP's ac- 
tivities include: 

• direction of the National AIDS Information Cam- 
paign. The information campaign is a media- 
based public information effort intended to relay 
to the public facts about HIV. The contract for 
the campaign was awarded to a large public rela- 
tions firm. Some of the campaign's activities in- 
clude public service announcements and a na- 
tional mailing to every American household re- 
garding HIV. The campaign's goal is to positive- 
ly influence the public's knowledge and attitudes 
concerning HIV. The contract is presently 
funded at $7.9 million with several outstanding 
change orders. The estimated cost of these modi- 
fications is $1.4 million. 

• direction of the National AIDS Clearinghouse. 
The clearinghouse is also operated through a 
contract with a private organization. It is intend- 
ed to serve as a resource center for materials dis- 
cussing AIDS and HIV infection. For FY 1988, 
the clearinghouse is funded at $2.2 million. 



67 



• direction of the National AIDS Hotline. The hot- 
line is also operated through a contract. Since 
the awarding of the contract in 1986, the hotline 
has been funded at $8.5 million. 

• funding of minority outreach programs. Current- 
ly NAIEP administers the Minority Outreach Pro- 
gram which, through grants and contracts, is in- 
tended to assist national and regional organiza- 
tions in developing minority initiatives that will 
target HIV information to minority populations. 
Funding for minority initiatives for FY 1988 is 
$19.5 million. 

The NAIEP office must not only serve as a 
facilitator, but also as a coordinator for infor- 
mation and education programs. After one year 
of existence, it appears that there are several 
obstacles blocking NAIEP's path to functioning 
effectively. 

Obstacles to Progress 

• After more than one year of existence, this office 
has yet to determine its goals. A cohesive plan of 
action and sense of mission is lacking. NAIEP 
has contracted with a private organization for the 
purpose of developing its own goals and objec- 
tives. 

• There is an absence of communication among 
the various CDC entities regarding CDC's HIV 
activities and programs. This has resulted in a 
lack of coordination regarding a national HIV 
prevention and education plan. 

• NAIEP has contracted out the majority of its sig- 
nificant activities. Because of the limited number 
of full-time equivalent staff positions (FTEs) and 
the lack of direction and coordination within 
NAIEP, there has been limited and sometimes in- 
consistent guidance from CDC regarding con- 
tract implementation and oversight. 

RECOMMENDATIONS 

5-7 The Centers for Disease Control should 

devise its own program goals and objec- 
tives, and should not enter into contracts 
with outside consultants for this pur- 
pose. 

5-8 The Centers for Disease Control should 

move the National AIDS Information 
and Education Program (NAIEP) to the 
Center for Prevention Services by Sep- 
tember 30, 1988. This will avoid any du- 
plication of activities that is presently oc- 
curring between NAIEP and the Center 
for Prevention Services. 

Section V. CDC Personnel and 
Infrastructure 

From FY 1981 through FY 1988, a total of 
165 new personnel positions (FTEs) were 



added to CDC for HIV activities. For FY 1988, 
CDC has 416 FTEs assigned to HIV initiatives. 
Of this total, 251 FTEs have been diverted 
from other CDC efforts. Thus, the HrV epi- 
demic has placed a severe strain on CDC per- 
sonnel and functions. Additional personnel are 
urgently needed at CDC to expand both CDC's 
HIV programs and other CDC activities. In 
order to accommodate additional personnel, 
additional facilities will be necessary. 

Obstacles to Progress 

• Past FTE ceiling restrictions on hiring middle to 
upper grade levels of personnel have resulted in 
a decreasing number of these workers in the fed- 
eral government. It has become common practice 
within the federal government that positions va- 
cated by reassignment, promotion, or retirement 
are eliminated by attrition. 

• The federal government's salaries and benefits 
packages often hamper the recruitment of quality 
personnel by CDC. Many qualified scientists and 
physicians who are interested in working for 
CDC will not do so because salaries are signifi- 
cantly lower in the public sector than in the pri- 
vate sector. 

• The diversion of personnel from other programs 
within CDC to staff HIV programs has resulted 
in delays in other important public health pro- 
grams. Specific health initiatives that have been 
delayed or not fully implemented because of per- 
sonnel diversions include: expansion of efforts to 
control sexually transmitted diseases — especially 
revising and updating training courses for STD 
control; development of programs to reduce and 
prevent injuries that result in chronic disabilities; 
building CDC's behavioral science capacity, an 
area essential to understanding which are the 
most effective prevention programs for injuries 
and disabilities and the best control programs for 
infectious and chronic diseases; implementing an 
intensive review of the prevalence of hepatitis A 
in the United States; and implementation of pro- 
grams to prevent or reduce smoking during 
pregnancy. 

• CDC is confined to a small and outmoded facili- 
ty. The Office of Management and Budget 
(OMB) has thwarted recent attempts by CDC to 
expand and modernize this facility. Being housed 
in an antiquated facility has severely hampered 
CDC's ability to respond effectively to the HrV 
epidemic. In March 1988, OMB sent a memoran- 
dum to the President describing CDC's request 
for the construction of additional facilities as 
"wasteful." In contrast, in a November 1987 
letter to Dr. James Mason, Director of CDC, 
from the General Services Administration (GSA), 
the GSA stated, "It is our commitment to sup- 
port the Centers for Disease Control in your ef- 



68 



forts to upgrade and replace your aging physical 
plant at Chamblee, Georgia." 

RECOMMENDATIONS 

5-9 The Centers for Disease Control (CDC) 

must be adequately staffed at all times in 
order to successfully meet its public 
health mission, including HIV program- 
ming. The Commission's analysis of cur- 
rent and proposed HIV programs at 
CDC indicates that a total of 523 full- 
time equivalents will be required to be 
permanendy assigned to HIV activities 
for FY 1989. CDC should be allowed to 
hire new staff in sufficient numbers to 
replace those personnel who have been 
diverted from other programs, and staff 
HrV-related programs with a full compli- 
ment of 523 full-time equivalents for FY 
1989. 

5-10 Congress, in conjunction with the Office 

of Personnel Management, should ana- 
lyze the recruitment of personnel to the 
Centers for Disease Control (CDC). Fed- 
eral salaries and benefits should be as- 
sessed. Following such an analysis, Con- 
gress should make every effort to enact 
legislation that will attract first-rate per- 
sonnel to CDC. 

5-11 The Office of Management and Budget 

(OMB) should follow both the General 
Services Administration and congres- 
sional mandates regarding the construc- 
tion of facilities at the Centers for Dis- 
ease Control. OMB should not under- 
mine congressional intent. 

Section VI. The Role of the State 
and Local Departments of Public 
Health 

The state and local components of the public 
health system consist of state or territorial 
health departments, thousands of county and 
city health departments, as well as private, vol- 
untary organizations such as community-based 
service organizations or community and mi- 
grant health centers. The structure and operat- 
ing procedures for each of these organizations 
vary from locality to locality depending on a 
number of variables, including state or local 
law, the size of population served, and available 
financial resources. In some areas, city and 
county health departments operate only under 
state law, but receive local as well as state and 
federal funds. Other city and county health de- 
partments follow mandates established by their 
local governments that augment state law. In 



areas where local health departments are in 
place, the state health department often guides 
policy and functions in the important role of a 
coordinating body and the supplier of technical 
assistance. Many smaller cities and counties 
have no local health departments and receive 
public health services only from the state 
agency. 

State and local public health agencies have 
several general responsibilities for any condi- 
tion that affects the health of the general popu- 
lation. First, components of the local public 
health system collect and interpret surveillance 
data about a specific condition through the im- 
plementation of epidemiological studies and re- 
porting of selected conditions by physicians, 
laboratories, and other elements of the health 
care system. Second, using the information 
gathered from such studies, local public health 
agencies then plan and implement programs to 
interrupt the spread of disease. Such programs 
may include public education campaigns, iden- 
tification of infected people through the use of 
testing and partner notification mechanisms, or 
any other intervention designed to change be- 
haviors in people who are at risk of becoming 
infected with the disease. Third, local public 
health agencies have the responsibility to pro- 
vide selected treatment services for those mem- 
bers of society who cannot pay or who lack 
access to the health care system. Fourth, as a 
last resort, local public health agencies can use 
restrictive measures such as isolation to control 
the spread of disease. Fifth, local public health 
agencies evaluate the effectiveness of their ef- 
forts in controlling the spread of disease, iden- 
tifying those strategies that have been success- 
ful and those that have failed. The sixth and 
final general responsibility of local public 
health agencies is to support appropriate com- 
munity systems which contribute to the above. 
All of these are applicable to the HIV epidem- 
ic; however, there are obstacles to their full 
implementation. 

Obstacles to Progress 

• Funding for most HIV education and prevention 
programs occurs through grants. Due to the bu- 
reaucracy surrounding grant applications, valua- 
ble staff hours are continually used for filling out 
grant applications and not for direct delivery of 
prevention services. 

• There is a lack of effective evaluation models and 
tools that can be applied to HIV prevention and 



69 



education programs in order to measure their 
success. Evaluation of HIV prevention and edu- 
cation is difficult because it is a complex task to 
determine accurately whether behavior has 
changed as the result of any specific intervention. 
Long-term community-wide patterns of sexual 
and drug abuse behavior, and knowledge and at- 
titudes pertaining to the HIV epidemic need to 
be measured in order to determine the effective- 
ness of a particular strategy. Lack of baseline in- 
fection prevalence data also hinders evaluation. 

• Many personnel have been diverted from other 
programs to work in a crisis mobilization against 
the spread of HIV. The result of such diversion 
is that other programs such as the delivery of 
services for other sexually transmitted disease 
are being shortchanged, while there are still in- 
sufficient resources for HIV programs. 

• The Commission is concerned that some individ- 
uals found to be HIV-infected through the mili- 
tary, Job Corps, State Department (including 
Peace Corps), and any other federal agency's 
screening processes are not being properly coun- 
seled and referred to the appropriate support 
agencies. This raises the possibility that the high- 
risk behavior of these individuals will not change 
and the opportunity to provide counseling will 
be lost. 

RECOMMENDATIONS 

5-12 The budgeting process needs to be 

streamlined to ensure that valuable staff 
time is used in the actual delivery of pre- 
vention programs. Funds should be 
made available to states for prevention 
services, such as counseling and testing, 
partner notification, education, and 
other services as a block grant adminis- 
tered by the Centers for Disease Control 
and delivered on a formula basis. That 
formula should be based on the follow- 
ing principles: 

• Thirty-five percent of the funds 
should be distributed to the states 
providing: 

— a base amount to each state for the 
establishment of basic programmat- 
ic efforts as core support. 

— the balance of the amount to be 
distributed on a per capita basis 
and utilized by the state in accord- 
ance with a plan which incorporates 
the funding needs of local health 
departments, community health 
centers, community-based organiza- 
tions, and other appropriate institu- 
tions. 

• Fifty percent of the funds should be 
distributed among states on the basis 
of a formula reflecting the reported 



and the estimated HIV prevalence. 
Funding for FY 1991 should be 
awarded on the basis of reported 
prevalence only. 
• Fifteen percent of the funds should 
be retained by the Centers for Dis- 
ease Control for use in capacity build- 
ing among states, technical assistance 
to states, federal demonstration and 
special projects, and research and 
training, including support for data 
collection. 

5-13 Rational staffing strategies need to be 

developed at the state and local levels 
that identify HIV programs as separate 
entities or that fully incorporate them 
into existing structures. The end result, 
however, must be the full delivery of 
HIV prevention services and other im- 
portant public health initiatives. 

5-14 If not already in place, state and local 

departments of health should form an 
advisory committee that consists of 
health care professionals, community- 
based service organizations, community 
leaders, and others to advise on the 
most appropriate strategy to control the 
HIV epidemic, including methods to ini- 
tiate and/or expand and maintain a 
counseling, testing, and partner notifica- 
tion program within the state. An official 
from the state department of health 
should be the designated chair of such a 
committee and should convene meetings 
at regular intervals. 

5-15 State departments of health should co- 

ordinate the prevention and education 
activities of local health departments and 
community-based service organizations 
to ensure that there is neither the need- 
less duplication of services nor an ab- 
sence of needed services within a state. 
In so doing, state departments of health 
should assign one individual or office to 
meet regularly and work directly with 
local health departments, community- 
based service organizations, and profes- 
sional medical and health care associa- 
tions on HIV prevention and education 
activities. 

5-16 Public health organizations should con- 

duct studies that will enable public 
health professionals to determine the 
most valid ways to evaluate HIV preven- 
tion and education programs. 

5-17 Experienced and well-credentialed spe- 

cialists in human sexuality should be in- 
corporated into the full-time staff and 
consulting staff of state and local public 



70 



health departments and the Centers for 
Disease Control. 

5-18 Department of Defense officials should 

meet with organizations representing 
state and local public health authorities 
to ensure that the policy for referral and 
follow-up for those found to be HIV-in- 
fected is implemented. Implementation 
should be made a part of the normal 
Military Entrance Processing Command's 
mission statement. 

5-19 Officials from the Job Corps, the State 

Department (including the Peace Corps), 



5-20 



and any other federal agencies conduct- 
ing HIV screening should meet with or- 
ganizations representing state and local 
public health authorities to ensure that a 
policy for referral and follow-up for 
those found to be HIV-infected is imple- 
mented. Implementation policies and 
procedures should be a part of agencies' 
mission statements. 

All state and local health authorities 
should have systems for channeling HIV- 
infected applicants into appropriate 
counseling programs and partner notifi- 
cation and available medical services. 



71 



CHAPTER SIX: PREVENTION 



Although the HIV epidemic has presented 
the public health system with a new set of chal- 
lenges, the prevention of disease has been the 
primary mission of that system since its incep- 
tion. Prevention refers to any action that inter- 
rupts or halts the progressive path of a disease. 
Effective preventive interventions which can be 
applied to the HIV epidemic include the imple- 
mentation of widespread testing and counsel- 
ing, partner notification, the pre-donation 
screening of potential blood and semen 
donors, the testing of donated blood and 
organs, restrictive measures, and the imple- 
mentation of general and targeted education 
programs. Education is addressed in its own 
chapter. This chapter will address the other 
preventive measures mentioned above. 

Section I. Testing and Counseling 

The HIV antibody test is used for several 
reasons. First, it can determine an early clinical 
diagnosis of HIV infection which should imme- 
diately establish a strong link between an in- 
fected individual and a primary health care pro- 
vider. Second, it is used to screen donated 
blood, organs, breast milk, and semen to pro- 
tect the eventual recipient. Third, test results 
are used to establish incidence and prevalence 
data, critical to monitoring the epidemic. 
Fourth, test results can be used to initiate a 
process whereby partners are warned of their 
exposure to the virus. Finally, testing and coun- 
seling are a vital component in encouraging 
positive behavior change in an individual. The 
first four uses of the HIV antibody test are 
discussed elsewhere in the report. Here, we will 
focus on testing and counseling programs used 
as a vital component of an overall prevention 
strategy to promote behavior change in order 
to stem the spread of HIV infection. 



Only a limited number of individuals poten- 
tially infected with HIV have been counseled 
and tested, and only a limited percentage (ap- 
proximately five percent) of those infected with 
HIV have laboratory confirmation of their in- 
fection due to a lack of information, fears of 
testing, or limited access to voluntary testing 
and counseling services. 

Testing provides an opportunity for effective 
education and counseling and, for some, the 
initiation of behavior modification. When a 
person has volunteered to be tested, or when 
his or her physician has determined with the 
individual's consent that an HIV antibody test 
is appropriate, the tested person's interest is 
elevated; in short, he or she is more likely at 
this point to pay attention than in merely re- 
ceiving impersonal educational messages. The 
type and intensity of education and counseling 
linked to testing ought to be guided by two 
factors - the test result and the reason the 
person offers for being tested. If the test result 
is negative, a simple brochure accompanying 
the result could, in some cases, suffice. 

If a person expresses concern that his or her 
own behavior has led to the test or appears 
agitated at the time the blood is drawn, person- 
to-person counseling is appropriate both 
before and after the administration of the test. 
Particularly, counseling should be available for 
these persons between the time the test is ad- 
ministered and the result is known. The person 
who has participated in high-risk behavior but 
has a negative test result should receive coun- 
seling in an effort to ensure that he or she 
remains uninfected. 

If the test result is confirmed positive, inten- 
sive counseling at the time the result is given is 
needed. Because of the significance of that 
result and the natural tendency for the infected 



73 



person to block out much of the information 
given at the initial session while concentrating 
on the result itself, it is imperative that the 
initial counseling session include the presenta- 
tion in writing of the implications of the test 
result and of the opportunity for further testing 
and for further counseling, which may be by 
referral. An effort should be made at the initial 
counseling session to link the infected individ- 
ual with a primary care provider if that link 
does not already exist. Consideration should be 
given to providing take-home materials, such as 
brochures or audiotapes, so that the infected 
person can review the information at home if 
he or she so chooses. 

Counseling of infected persons should also 
include the means to and the responsibility to 
avoid transmitting the virus to others, the re- 
sponsibility and benefits of telling one's sexual 
or drug-using contacts about the test result, 
and the availability of public health services to 
inform those partners should the person be 
unable or unwilling to do so. 

Many have suggested that testing should not 
be done in any circumstance without interper- 
sonal counseling. This appears to be current 
public health policy, except in blood donating 
settings. While still using the testing process to 
promote education, however, it would be more 
prudent to differentiate the handling of those 
whose need for counseling is apparent from 
those for whom a simple brochure will suffice. 
Additionally, pre-test counseling can burden 
those who decide to seek an HIV test if done 
inappropriately. In some jurisdictions, pre-test 
counseling includes commentary which might 
discourage the person who has considered long 
and hard whether to seek the test. Pre-test 
counseling should support the decision for the 
test, should provide the person with basic in- 
formation about the medical implications of the 
test, including the fact that diagnosis can lead 
to treatment and care, and should attempt to 
elicit the reasons the person is seeking to be 
tested without passing judgment on the deci- 
sion. 

Testing and pre- and post-test counseling for 
HIV should be available in a timely fashion for 
any individual who wishes these services. An 
adequate number of testing facilities must be 
made available for those individuals who have 
no personal physician or who will not seek test- 
ing services from their physicians so that any 
individual can determine whether he or she has 



been infected and can receive counseling, if 
needed, about healthy behavior. 

Obstacles to Progress 

• The perception that confidentiality may be 
breached is keeping people who believe that they 
may have been exposed to the virus from seeking 
testing and counseling services. 

• The Commission heard from numerous witnesses 
who had been the target of discrimination as a 
result of a positive HIV antibody test. Some per- 
sons who fear such discrimination because of a 
positive test result or even admission that such a 
test is desired are choosing not to be tested. 

• Access to voluntary testing is limited; long wait- 
ing periods in densely populated areas and lack 
of testing facilities in rural areas are impeding 
the ability of individuals to determine whether or 
not they are infected. 

• State and local departments of health do not 
have adequate funding available to provide test- 
ing and counseling services on the scale that is 
needed for those who either cannot or will not 
get those services in the private sector. 

• Many private physicians do not regularly offer 
HIV antibody tests to their patients, resulting in 
increased demands on public testing and coun- 
seling centers. 

• Demand for service exceeds capacity at existing 
testing sites, both anonymous and confidential, 
in many areas. This results in unreasonably long 
waiting periods to receive both the administra- 
tion of a test, as well as the communication of 
the result together with its appropriate counsel- 
ing. 

RECOMMENDATIONS 

6-1 States should adopt statutes that ensure 

confidentiality in testing and in reporting 
to public health authorities. 

6-2 People who fall into any of the following 

categories should seek testing and coun- 
seling services from their physician or 
public health agency, regardless of the 
presence or absence of symptoms: 

• recipients of blood, blood products, 
donated semen, or organs since 1977. 

• intravenous drug abusers. 

• men who have engaged in sexual ac- 
tivities with other men. 

• persons who have engaged in sexual 
activities with more than one partner 
since 1977. 

• any person who believes his or her 
sexual partner, either current or past, 
is any of the above. 



74 



6-4 



6-3 Voluntary testing for HIV infection on a 

nationwide basis should be widely en- 
couraged by government at all levels, 
and physicians and other health care 
professionals should promote voluntary 
testing for their potentially exposed pa- 
tients. To facilitate the performance of 
such tests, a variety of facilities such as 
mobile vans should be made widely 
available by funding through public 
health agencies and by the private 
sector. 

Each state, through the local public 
health system, should increase the 
number and availability of anonymous 
and/or confidential testing and counsel- 
ing sites. 

6-5 State departments of health should make 

new funds available that will ensure that 
HIV testing and counseling services are 
a part of the services offered by sexually 
transmitted disease clinics, family plan- 
ning centers, drug treatment clinics, and 
community health centers. 

6-6 Private physicians should regularly offer 

their patients the opportunity for an HIV 
antibody test. 

6-7 State and local departments of health 

should aggressively advocate the use of 
HIV testing and counseling services 
through public health education cam- 
paigns. These should highlight the as- 
surance of confidentiality in order to 
induce more individuals to use the 
public health system. Special efforts 
should be focused on those geographic 
areas or members of groups in which 
there is evidence of high seroprevalence. 

6-8 An incentive grant program should be 

created to support voluntary testing in 
counties or other well-defined geograph- 
ic areas where the incidence of HIV in- 
fection rises above a designated level. 
These funds should be made available 
by the Centers for Disease Control on an 
expedited basis to applicants, who can 
be public or private non-profit agencies. 
Applicants must show that their program 
is consistent with the overall state HIV 
plan, and that those tested will be re-, 
ferred to appropriate community serv- 
ices. Funds may be used for both the 
testing itself and for aggressive outreach 
and advertising of the program in the 
target population. 

6-9 Where anonymous testing services are 

offered, the appropriate state or local 
health authorities should assure that the 
services are consistent with those offered 



6-10 



at other sites, including full access to 
partner notification assistance and re- 
porting data generated into seropreva- 
lence monitoring systems. 

State laws should not prohibit private 
laboratories from performing HIV analy- 
sis. 



Section II. Partner Notification 

Both public health practice and case law 
makes clear that persons put at risk of expo- 
sure to an infectious disease should be alerted 
to their exposure. The Commission believes 
that there should be a process in place in every 
state by which the official state health agency is 
responsible for assuring that those persons put 
unsuspectingly at risk for HIV infection are no- 
tified of that exposure. Such a process will 
enable that agency to work with the infected 
individual and the patient's primary health care 
provider to assure that contacts are notified of 
their exposure and urged to take advantage of 
the opportunity for testing and counseling. 

When interviewed appropriately, any person 
infected should be able to identify one or more 
persons from whom the infection may have 
come or to whom it may have been given. 
There are options for contacting those persons 
and ensuring that they, too, are aware of their 
risks. Those options include patient-managed 
referral and professional-assisted referral (with 
notification by an individual's health care pro- 
vider or with notification by the health depart- 
ment). 

Though the ideal would be to attempt to 
locate every sexual partner of every individual 
who tested HIV antibody positive, this is not 
realistic for most partner notification programs. 
Some states have already instituted partner no- 
tification, which is labor-intensive in nature. In 
light of limited public resources, they have es- 
tablished a priority list for partner notification. 
As an example, consider the woman who has 
been married for 30 years to a man who, un- 
known to her, is a bisexual, or the person who 
believes he or she is involved in a completely 
monogamous marriage when, in fact, his or her 
spouse has been having sex with others. These 
people are completely ignorant of their expo- 
sure to the virus and would probably remain so 
until either their spouse, their child, or they, 
themselves, developed the clinical symptoms of 
AIDS. The Commission firmly believes in these 
individuals' right to be notified of their possi- 



75 



ble exposure so that they can seek prompt 
medical attention and avoid potentially expos- 
ing others. 

Those states which decide to fully fund part- 
ner notification as a major initiative to inter- 
vene in the HIV epidemic should consider also 
efforts to notify paraphernalia-sharing partners 
of intravenous drug abusers, preferably 
through training drug abuse treatment provid- 
ers in partner notification procedures and then 
through increased funding for the purpose. 
Such an effort, however, should be considered 
only in addition to intensive efforts to notify 
sexual partners. 

In keeping with the long tradition of the 
public health profession in respecting, in a con- 
fidential manner, both data and affected per- 
sons, the need to report identities should not 
be a bar to partner notification or to persons 
coming forward for testing. It is critical, howev- 
er, that in proposing and implementing partner 
notification, the public health authorities in- 
volved must stress the confidential nature of 
the process and build confidence in those af- 
fected. Furthermore, there would be no pur- 
pose in public health authorities informing the 
notified partner of the identity of the person 
who disclosed the partner's name; this standard 
operating policy of traditional partner notifica- 
tion procedures should be followed also with 
respect to HIV. 

Obstacles to Progress 

• Difficulty exists in appropriately reconciling con- 
flicts between rights of partners to notification 
and codes of medical ethics which have long and 
appropriately asserted that communications be- 
tween doctors and patients are privileged and 
that doctors must maintain the privacy of patient 
communications . 

• Many health care providers are neither skilled 
nor trained in providing the necessary counseling 
that is an integral part of partner notification. 

• The application of traditional partner notification 
practices to this epidemic has been slow for a 
number of reasons, including: the lack of a cure 
which could be offered to the infected partner, 
unlike the case with other sexually transmitted 
diseases; the extreme fear of subsequent dis- 
criminatory retaliation; the limited resources 
available for HIV prevention services; and the 
perceived high cost per case for partner notifica- 
tion programs. 



RECOMMENDATIONS 

6-11 Any HIV-related confidentiality law 

should provide for confidentially report- 
ing identity-linked test results to public 
health authorities. 

6-12 Each state public health law should pro- 

tect the confidentiality of an individual's 
reported infection status but allow for 
partner notification without informing 
the contacted partner of the identity of 
the infected person. 

6-13 All state and local health agencies 

should initiate and be funded adequately 
to develop HIV partner notification pro- 
grams without diverting resources from 
other sexually transmitted disease part- 
ner notification programs. These pro- 
grams should include counseling, test- 
ing, and supportive follow-up for those 
individuals who are notified of their pos- 
sible exposure. 

6-14 To assure maximum use of resources, 

partner notification programs should be 
prioritized. Partner notification should 
begin with the partners of the following 
persons: 

• hemophiliacs. 

• persons who have received contami- 
nated blood or blood products identi- 
fied through "look-back" notification 
programs and other means. 

• rejected military applicants. 

• bisexual males. 

• intravenous drug abusers. 

• persons with multiple sex partners. 

• persons with anonymous sex part- 
ners. 

• infected prison inmates. 

6-15 The public health department has an ob- 

ligation to ensure that any partners are 
aware of their exposure to the virus. The 
public health authority and the primary 
provider should determine the priority 
of follow-up, the nature of verification 
that warning occurred, and the role of 
the identified individual in notification 
by considering such factors as: 

• the patient's own statements, includ- 
ing commitment to provide notifica- 
tion directly. 

• the patient's relationship with the 
party. 

• the potential additional risk presented 
by a delayed notification. 

• evidence that the third party is aware 
of the risk. 



76 



• the strength of the physician-patient 
relationship. 

• other relevant factors. 

6-16 Continuing education programs and the 

policies and programs of professional or- 
ganizations should emphasize and rein- 
force the role of the public health au- 
thority and the ethical obligation of each 
health care provider to participate in the 
reporting process and partner notifica- 
tion programs, as well as include the sci- 
entific and behavioral information about 
the transmission of the virus. 

Section III. Restrictive Measures 

The primary focus in developing a compre- 
hensive public health strategy to control HIV 
infection should be placed on those public 
health measures that are based on voluntary 
cooperation in risk-reducing behavior change: 
focused education; voluntary testing; counsel- 
ing; partner notification; and treatment for 
drug abuse. However, these prevention meas- 
ures even vigorously applied will be unsuccess- 
ful in persuading some small number of indi- 
viduals to alter their behavior. When an indi- 
vidual poses a health risk to others by remain- 
ing noncompliant with recommended behavior 
change, appropriate control measures should 
be employed to achieve the public health objec- 
tive of controlling the spread of HIV. 

Compulsory control measures are usually au- 
thorized in state public health laws and could 
include limited isolation or supervised living 
arrangements. Such measures restricting the 
activities of individuals are appropriate to clear- 
ly culpable conduct that poses a significant risk 
of transmission when narrowly applied with 
adequate procedural safeguards. While a few 
states have amended their public health laws to 
permit some form of isolation with respect to 
HIV-infected individuals, the absence of a 
range of less restrictive compulsory measures 
and procedural deficiencies in many state 
public health statutes make it essential that 
states update these laws before employing them 
as a response to recalcitrant individuals. 

Obstacles to Progress 

• Traditional public health quarantine is not well 
suited to the limiting of HIV transmission. 

• Many state public health statutes are deficient 
because of: basic structural problems caused by 
artificial boundaries erected between venereal 
and communicable diseases; the absence of clear- 



ly stated, objective criteria to guide public health 
officials in the exercise of their powers; the ab- 
sence of procedures necessary for fair and impar- 
tial public health decision-making; and the ab- 
sence of a range of less restrictive powers suffi- 
ciently flexible to allow supervision in the com- 
munity. 

• Public health officials and other interested 
groups fear that excessive attention to personal 
control measures may undermine public health 
goals by diverting attention and resources from 
effective prevention policies such as education, 
testing, counseling, and partner notification. 

• Many people confuse public health restrictions 
designed to stop further spread with punitive 
measures intended to retaliate for past exposure 
of others. 

RECOMMENDATIONS 

6-17 States should immediately reform exist- 

ing public health statutes designed to 
control the spread of communicable dis- 
eases according to the following guide- 
lines: 

• Rigid distinctions between venereal 
and communicable diseases should be 
removed. 

• The public health statute should 
specify that use of personal control 
measures must be based upon a find- 
ing that the person is in an infectious 
state and is reasonably likely to trans- 
mit the infectious agent, posing a se- 
rious risk to the public health. 

• The public health statute should 
allow for a range of control measures, 
imposing on the infected individuals 
requirements such as: to report all 
changes of address to the public 
health department; to attend sessions 
at appropriate places and times for 
the purposes of education, counsel- 
ing, testing, medical examination or 
treatment; and if necessary, to be ad- 
mitted to a hospital, detoxification 
center, or a clinic for treatment of 
drug dependency or sexually trans- 
mitted disease on an out-patient or 
day-patient or in-patient basis. Con- 
trol measures should have the same 
procedural safeguards and enforce- 
ment should be for a specified period 
of duration. 

• The statute must provide procedural 
safeguards of written notice, counsel, 
presentation of evidence and cross- 
examination, a clear and convincing 
standard of proof, and a verbatim 
transcript for appeal (the procedural 
safeguards required in civil commit- 



77 



214-701 



- U 



OL 3 



merit of the mentally ill). An impartial 
decision-maker should hear the case 
prior to, or in cases of urgent necessi- 
ty, immediately after the imposition 
of personal control measures. A proc- 
ess for review of the decision must be 
authorized. Due process must be ac- 
corded. 
• State public health statutes should in- 
clude strong uniform confidentiality 
protection. 

6-18 Quarantine or isolation of HIV-infected 

individuals based only on HIV status 
without consideration of an individual's 
behavior is not appropriate and should 
not be adopted. 

6-19 Less restrictive measures under public 

health laws should be exhausted before 
more restrictive measures, such as limit- 
ed isolation, are taken. 

6-20 In exercising powers of isolation under 

public health laws, there should be a 
heavy burden on the public health offi- 
cial to determine that these are neces- 
sary and appropriate and that a factual 
basis exists for making a determination 
to isolate. 

Section IV. Safety of the Blood 
Supply and Donated Tissue 

As of June 6, 1988, 2,399 of the people diag- 
nosed with AIDS had acquired the infection 
through transfusions of blood, blood products, 
or the clotting factors used to treat hemophilia. 
The initial response of the nation's blood bank- 
ing industry to the possibility of contamination 
of the nation's blood by a new infectious agent 
was unnecessarily slow. However, important 
lessons were learned from this chapter of our 
blood banking history which cannot be dis- 
missed as we face future problems. The Com- 
mission believes strongly that the blood banks 
should not delay any longer the screening for 
another blood-borne virus, HTLV-1, which is 
believed to be the cause of adult T-cell leuke- 
mia/lymphoma and a severe neurological dis- 
ease known as tropical spastic paraparesis 
(TSP). 

Technological advances in blood screening 
tests and the purification process of the clotting 
factor have rendered the nation's blood supply 
as safe as it ever has been; however, this does 
not imply that it is completely free of risk. 
Transfusions of blood can be lifesaving, but it 
must be remembered that their side effects can 
cause serious illness or death. 



The most significant complications of blood 
transfusions are immunologic reactions and the 
transmission of infectious disease agents, in- 
cluding the transmission of HIV. While donor 
screening procedures combined with pre-trans- 
fusion laboratory tests can reduce the incidence 
of the transmission of diseases such as hepati- 
tis, syphilis, malaria, and HIV, they cannot 
eliminate the risk. 

It is for these reasons that the Commission 
supports aggressive screening of the nation's 
blood donors along with thorough testing of 
the blood that is donated. However, the surest 
preventive measure with regard to the blood 
supply is to eliminate the exposure of a patient 
to the blood of others, whenever possible. 

The same principles apply to donated organs 
and semen. An organ or semen that has been 
infected with HIV can transmit that infection to 
the recipient. The same type of infection con- 
trol that is practiced with the blood supply 
needs to be applied equally to organ trans- 
plants and artificial insemination. 

Obstacles to Progress 

• Many physicians and hospitals do not have an 
adequate understanding of and, therefore, have 
not adequately informed their patient population 
about the availability of alternatives to traditional 
transfusion therapy. 

• Because a majority of the fresh blood supply is 
derived from voluntary donations, the blood 
banking industry must actively recruit numerous 
donors into the system. As many donors as pos- 
sible are accepted. 

• The Food and Drug Administration (FDA) has 
the responsibility to set the standards for the 
blood industry; however, it relies heavily on that 
industry for advice on what standards to set — a 
relationship that presents a significant opportuni- 
ty for conflicts of interest to arise. 

• Health care financing plans that are applied to 
traditional homologous transfusion therapy often 
cannot be applied to autologous transfusion ther- 
apy. 

• Some regional blood centers have been hesitant 
to promote strategies that minimize the use of 
transfusion therapies, since their operating 
income is derived from the sale of blood and 
blood products. 

• Not all facilities have instituted notification pro- 
cedures for those persons transfused with blood 
or its components since 1977. Not only persons 



78 



transfused but also their sexual partners may 
have been exposed to infection. 

• Blood banks are currently using a self-deferral 
system whereby those individuals who have prac- 
ticed behaviors that put them at greater risk of 
becoming infected with HIV are encouraged not 
to donate blood. Because this is an entirely vol- 
untary process, some individuals who are at 
greater risk of HIV infection continue to donate 
blood despite attempts to exclude these individ- 
uals from the donor pool. 

• Because of the significantly increased workload 
that the HIV epidemic has presented and the 
lack of human and financial resources, manufac- 
turers of blood screening tests have an extremely 
limited access to FDA review staff. This slows the 
introduction of useful new screening products to 
the market. 

• Recent advances in technology have made clot- 
ting factors safer. However, the application of 
such technology has resulted in a four- to eight- 
fold increase in cost to the patient. This substan- 
tial rise in cost has resulted in considerable con- 
cern that third-party payments could be jeopard- 
ized and access to such products denied. 

RECOMMENDATIONS 

6-21 As soon as is practically possible, but no 

later than July 1, 1989, agencies which li- 
cense and certify health care facilities 
should make a condition for licensure, a 
program to notify all recipients of blood 
or blood products since 1977 of their 
possible exposure to HIV. Such "look- 
back" notification should include a state- 
ment about the benefits of receiving 
counseling and testing services and pro- 
vide information about where such serv- 
ices are delivered. This may be done in 
conjunction with local or regional blood 
banks or the state or local health depart- 
ment. Notification of partners of these 
persons is the responsibility of public 
health agencies. If licensing agencies do 
not take such immediate steps, Congress 
should then enact a law that requires it. 

6-22 Informed consent for transfusion of 

blood or its components should include 
an explanation of the risks involved with 
the transfusion of blood and its compo- 
nents, including the possibility of HIV 
infection, and information about appro- 
priate alternatives to homologous blood 
transfusion therapy. These specifically 
include pre-deposit autologous blood, 
intra-operative autologous transfusion, 
hemodilution techniques, and post-oper- 
ative collection. 



6-23 The Food and Drug Administration, in 

an effort to ensure that the nation's 
blood supply is never contaminated, 
should define a mechanism that quickly 
identifies a new threat to the safety of 
the blood supply and implements proce- 
dures that will abrogate that threat. 

6-24 The Food and Drug Administration, in 

collaboration with the Blood Products 
Advisory Committee, should identify 
principles on which to base the introduc- 
tion of new testing requirements and ac- 
tively assess additional direct or surro- 
gate tests in order to consider their in- 
troduction. Surrogate tests, such as se- 
rology for syphilis, should be required. 

6-25 The Food and Drug Administration 

(FDA) should restructure the member- 
ship of its Blood Products Advisory 
Committee so that it reflects the entire 
blood products community, the plasma 
industry, and members of the related 
academic community, as well as one or 
more public members. In its capacity as 
an advisory body to FDA, this Commit- 
tee should actively monitor advances in 
research and development and recom- 
mend changes in policy and practice that 
should be implemented by the blood in- 
dustry which will promote the further 
safety of the blood supply. 

6-26 In health care facilities, all reasonable 

strategies to avoid homologous transfu- 
sion (blood from others) should be im- 
plemented including pre-deposit autolo- 
gous transfusions, hemodilution tech- 
niques, intra-operative autologous trans- 
fusions, and post-operative collection. 
Health care facilities should offer aggres- 
sive in-service training to their staff, par- 
ticularly blood banking and transfusion 
services personnel, to bring them up-to- 
date on current autologous transfusion 
therapy techniques. 

6-27 The Health Care Financing Administra- 

tion and the Health Resources Services 
Administration working with the Nation- 
al Hemophilia Foundation should devel- 
op alternative payment mechanisms to 
make clotting factor treatment affordable 
for patients. 

6-28 The Centers for Disease Control should 

make grants available to Comprehensive 
Hemophilia Treatment Centers to be 
used for the design and implementation 
of risk-reduction and psychosocial sup- 
port programs. The objectives of such 
programs should be to educate HIV-in- 
fected hemophiliacs about techniques to 



79 



avoid the further transmission of the 
virus either sexually, perinatally, or 
through the sharing of needles. 

6-29 All blood banking facilities should imple- 

ment screening procedures to identify 
the presence of HTLV-1 in the homolo- 
gous blood supply. 

6-30 The Food and Drug Administration 

(FDA) should fund an independent sci- 
entific organization to initiate a six- 
month study of the extent, purpose, and 
effectiveness of existing blood donor 
registries and the effect that expansion 
and/or requirement of donor registries 
would have on the safety of the blood 
supply. The independent organization 
should report the results of such a study 
to both FDA and the Congress. 

6-31 Health care financing plans should treat 

autologous transfusion therapy no differ- 
ently than homologous transfusion ther- 
apy. Coverage should apply to both. 

6-32 All states should immediately enact legis- 

lation requiring the registration of facili- 
ties for the collection, storage, and trans- 
fusion or administration of blood, 
organs, other tissues, semen, and breast 
milk, in order to facilitate enforcement 
of regulations requiring screening for 
HIV. 

Section V. Laboratory Quality 

The HIV antibody tests now available are 
reliable when performed under well-supervised 
conditions in excellent laboratories. The conse- 
quences of poor quality control in the laborato- 
ries that perform diagnostic tests can have dev- 
astating effects on people's lives. This problem 
is brought into especially sharp focus by the 
consequences of a misdiagnosis of HIV infec- 
tion due to disorganized laboratories. This ap- 
plies to all laboratory tests, not just those for 
HIV. 

Continued public awareness of this situation 
discourages individuals from seeking HIV test- 
ing and community groups from recommend- 
ing testing. Currently, there are 98,000 unregu- 
lated physician laboratories in the United 
States. Only 16 states regulate these physician 
laboratories. There are 37 states that regulate 
independent laboratories and 40 states that 
regulate the labs in hospitals. There is no 
standard regulation policy among even these. 
FDA regulates laboratories that engage in 
interstate commerce and the Health Care Fi- 



nancing Administration regulates laboratories 
that bill Medicare or Medicaid for services. 

The initial screening test for HIV, known as 
the Enzyme-Linked Immunosorbent Assay 
(ELISA), is a relatively simple test to perform 
and interpret. Because the ELISA is more sen- 
sitive than it is specific, however, any positive 
results from an ELISA screen need to be con- 
firmed by a more specific test before they can 
be trusted. The most commonly used confirma- 
tory test is a Western Blot Assay (WBA), a 
more complex — and expensive — test whose 
performance is currently limited to a relatively 
few laboratories. 

It is critical that laboratories performing 
WBAs and/or other sophisticated confirmatory 
tests employ highly skilled technicians and 
stringent quality standards, since it is the con- 
firmatory test result that is definitive to diagno- 
sis. The HIV antibody tests are extremely accu- 
rate, and false positives are no longer a prob- 
lem when repeatedly positive ELISA screening 
tests are followed with the confirmatory West- 
ern blot tests done in qualified laboratories. 
Therefore, we suggest that FDA and CDC in 
cooperation with other government agencies 
consider capabilities for the confirmatory HIV 
antibody testing. 

This could be done by sending "known" 
tests to certified confirmatory HIV antibody 
testing laboratories at intervals to check their 
personnel for accuracy. Any laboratories having 
unacceptable clerical mistakes or other person- 
nel errors could face a problem in maintaining 
their continued certification. 

Obstacles to Progress 

• Many labs in the United States have no outside 
review of quality. 

• The Health Care Financing Administration has 
reduced the number of its laboratory inspectors 
by 30 percent. 

RECOMMENDATIONS 

6-33 The Health Care Financing Administra- 

tion, the Centers for Disease Control, 
the Food and Drug Administration, the 
National Governors Association, and the 
Association of State and Territorial 
Health Officials should develop a model 
state laboratory licensing law that ad- 
dresses: types and levels of tests per- 
formed; personnel standards; use of pro- 
ficiency tests; on-site inspections; and 
participation in education programs. 



80 



6-34 The Public Health Service should pro- 

vide funds that will enable states to im- 
plement the above model law. 

6-35 The Food and Drug Administration 

should impose criteria at least as strin- 
gent as the model state law on laborato- 
ries involved in interstate commerce. 

6-36 The FY 1989 allocation for the Health 

Care Financing Administration should be 
increased so that it can expand its labo- 
ratory inspection efforts. 

6-37 Medical professionals and laboratories 

should immediately adopt the policy of 
not reporting positive initial screening 
test results (such as ELISA) to the tested 
individual or to public health authorities 
without first having confirmed such posi- 
tive results by a Western Blot Assay or 
other approved test. 

6-38 Performance of the Western Blot Assay 

or other confirmatory tests should be re- 
stricted immediately to laboratories 
which currently meet high quality stand- 
ards, and priority should be given to as- 
sessing labs currently doing such tests 
for possible certification to continue 
their practice. 

6-39 Consideration should be given to con- 

tracting out laboratory assessment activi- 
ties to professional organizations experi- 
enced in evaluating laboratory quality. 

Section VI. Therapists' Role in 
Prevention 

Professional therapists and counselors (such 
as marriage, family, and sex therapists, psychia- 
trists, psychologists, pastoral counselors, social 
workers) are an underutilized resource in the 
HIV epidemic. They play four major roles in 
prevention: 

• counseling those who are infected on how to 
avoid spreading the disease to others; 



• counseling their general patient population, most 
of whom are not infected, on how to avoid be- 
coming infected; 

• encouraging self responsibility and social respon- 
sibility; and 

• test-linked counseling. 

Obstacles to Progress 

• The therapists' role in prevention has been gen- 
erally overlooked. 

• Many professional associations have not recog- 
nized or encouraged their memberships to serve 
this function. 

• Qualified counselors to perform post-test coun- 
seling are in short supply. 

• Funding for post-test counseling is not adequate. 

RECOMMENDATIONS 

6-40 Therapists and counselors should coun- 

sel their patients/clients who are partici- 
pating in behaviors that make them vul- 
nerable to infection with HrV with the 
purpose of behavior modification. 

6-41 Therapists and counselors treating HIV- 

infected patients/clients should encour- 
age sexual and social responsibility. 

6-42 Therapists and counselors should be en- 

couraged to become well-informed and 
up-to-date on HIV infection. Profession- 
al associations should be encouraged to 
provide this education. 

6-43 Incentive programs and grants should be 

developed to create and attract more 
qualified counselors to perform test- 
linked counseling. 

6-44 Therapy and counseling associations 

should cooperate in establishing an 
interdisciplinary advisory committee to 
develop guidelines for therapists on ad- 
vising their patients about protecting 
themselves, their partners, and their 
unborn children from infection. 



81 



CHAPTER SEVEN: EDUCATION 



It is critical that the term "education," when 
used in conjunction with the HIV epidemic, is 
not associated only with a formal setting such 
as the classroom. HIV-related education needs 
to take place in all locations, both within and 
outside of society's mainstream. Education 
about HIV needs to occur both inside and out- 
side of our nation's schools and workplaces. No 
corner of society can be neglected as educa- 
tional programs about the HIV epidemic are 
developed and implemented. The Commission 
recognizes the vital role that health care work- 
ers occupy in meeting the educational needs of 
our society as a whole. Their own, unique edu- 
cational needs are addressed in the chapter on 
patient care. The responsibility of employers to 
provide the nation's work force with general 
health information, including information 
about HIV, is addressed with other workplace 
issues in the chapter on societal concerns. This 
chapter will address those educational strate- 
gies that can be implemented for the rest of 
society. 

During the last year, there has been a great 
deal of sometimes acrimonious debate over the 
content of HIV education. The Commission is 
concerned that, in the promotion of the per- 
sonal moral and political values of those from 
both ends of the political spectrum, the consist- 
ent distribution of clear, factual information 
about HIV transmission has suffered. HIV edu- 
cation programs for example, should discour- 
age promiscuous sexual activity and recognize 
the benefits of abstinence and monogamy; how- 
ever, they need to be explicit in nature so that 
there is no confusion about how to avoid ac- 
quiring or transmitting the virus. The Commis- 
sion firmly believes that it is possible to devel- 
op educational materials and programs that 
clearly convey an explicit message without pro- 



moting high-risk behaviors. All HD7 education 
programs should emphasize personal responsi- 
bility for one's actions. Actions have conse- 
quences. 

No citizen of our nation is exempt from the 
need to be educated about the HD7 epidemic. 
The real challenge lies in matching the appro- 
priate educational approach with the people to 
be educated. It is not the role of the federal 
government to dictate to local communities 
their values, and too much time has been 
wasted on this debate when educational materi- 
als are needed which clearly present the facts 
about AIDS and HD7 transmission. In a similar 
vein, those who seek to use HIV education pro- 
grams to further their own ideology of which- 
ever stripe cannot expect federal funds for this 
purpose. In short, the federal, state, and local 
governments should convey the current medi- 
cal and scientific facts to the American public 
and they, in turn, will build curricula suited to 
their own community value systems. When 
these curricula are constructed well, with all 
responsible local entities working in a collabo- 
rative way to help ensure their efficacy, the 
educational response of one region of the 
country can be expected to differ from that of 
another. Both responses should be applauded. 

The Commission believes that several educa- 
tion initiatives are of such vital importance to 
the effective preventive management of the 
HIV epidemic that they must be implemented 
immediately. These include: general public 
education, distinct population targeting, and 
school-based education. 

Obstacle to Progress 

• The educational response to the epidemic in 
many areas can best be described as haphazard. 
There is often a lack of statewide planning that 



83 



involves input from local health departments, 
community-based AIDS service organizations, 
schools, philanthropic organizations, religious in- 
stitutions, and other appropriate voluntary initia- 
tives. 

RECOMMENDATIONS 

7-1 All HIV programs should emphasize per- 

sonal responsibility for one's actions. Ac- 
tions have consequences. 

7-2 State departments of health should 

assume the lead responsibility for co- 
ordinating HIV-related educational ini- 
tiatives within each state. State depart- 
ments of health should develop a one- 
year plan and a five-year plan that clearly 
define the state's educational response 
to the HIV epidemic. Such a plan must 
include the input and identify the roles 
and responsibilities of local health de- 
partments, professional health care asso- 
ciations, community-based AIDS service 
organizations, state and local education 
agencies, philanthropic organizations, re- 
ligious institutions, and other appropri- 
ate voluntary initiatives. The one-year 
plan should be developed by September 
1, 1988 and the five-year plan by January 
1, 1989. 



by providing constant, accurate information 
about the epidemic. 

Obstacles to Progress 

• Inaccurate or incomplete information about the 
HIV epidemic is, at times, presented by the 
media, both in their entertainment and news ac- 
tivities. 

• Public service announcements are often broad- 
cast at times when a majority of the population 
are not watching television or listening to the 
radio. 

• Media events, such as a special program about 
the HIV epidemic, public service announce- 
ments, or a news story, often are not coordinated 
with state or local health departments or commu- 
nity-based organizations, resulting in an unex- 
pected high demand for services or information 
which cannot be met because of lack of notice. 

• The entertainment industry often portrays pro- 
miscuous sexual activity and drug use in a glam- 
orous light and fails to mention the frequent 
negative consequences of such activity. 

• Geographically specific HIV infection data and 
other related information are not available to the 
media in all parts of the country. 



Section I. General Public Education RECOMMENDATIONS 



In a national response to an epidemic, there 
is some information which every citizen should 
receive regardless of race, sex, age, geographic 
location, literacy level, or degree of risk for 
infection. This information sets the tone for 
more specific education and prevention pro- 
grams and helps sustain our community effort 
as a whole. General information about the HIV 
epidemic should include basic facts about HIV 
infection and AIDS, the ethical obligation to be 
both non-discriminatory and caring, and re- 
sources where a person can obtain more de- 
tailed information. 

The Role of the Media 

The media, both electronic and print, have a 
tremendous opportunity to enhance the pub- 
lic's knowledge and attitudes about the HIV 
epidemic through the information that it choos- 
es to present. There have been many examples 
of responsible — and unfortunately some exam- 
ples of irresponsible — reporting and program- 
ming on the HIV epidemic. The Commission 
realizes that media activity alone cannot bring 
about positive behavior change; however, it can 
support the education activities of a community 



7-3 The electronic media should schedule a 

majority of its HIV-related public service 
announcements at times when they will 
receive high visibility. 

7-4 The Centers for Disease Control should 

create a weekly newsletter targeted spe- 
cifically to the media that provides accu- 
rate, current information about the HIV 
epidemic, including data as geographi- 
cally specific as possible. Such a newslet- 
ter should include a telephone number 
that can be called during regular busi- 
ness hours to receive the most up-to- 
date information about the HIV epidem- 
ic. Such a newsletter should be widely 
advertised through trade journals, con- 
ferences, and other appropriate avenues, 
and should be offered on a subscription 
basis at reasonable cost. 

7-5 State and local health departments and 

community-based AIDS service organiza- 
tions should sponsor seminars for mem- 
bers of the local news and entertainment 
media. The seminars should help coordi- 
nate activities, provide current and accu- 
rate information about the HIV epidem- 
ic, and explain HIV-related services that 
are being offered throughout a commu- 
nity or state. 



84 



7-6 The entertainment industry should por- 

tray irresponsible sexual and drug-relat- 
ed activity in a manner that reflects the 
potentially detrimental emotional and 
physical consequences of such behavior 
and should shift focus to presenting the 
appeal of healthy behavior. 

7-7 The Centers for Disease Control (CDC) 

should conduct a 90-day study on the ef- 
fectiveness of purchasing paid advertis- 
ing, in addition to requesting advertising 
at no cost, to present information about 
the HIV epidemic to the general public. 
If the study concludes that such a pur- 
chase would be effective, CDC should 
purchase paid advertising. 

The National AIDS Hotline 

The National AIDS Hotline operated by the 
Centers for Disease Control (CDC) serves an 
important function in providing the general 
public with a toll-free telephone number that 
can be called 24 hours a day. The Hotline 
counselors can provide the caller with general 
information about the HIV epidemic, answer 
specific questions, provide information about 
HD7-related services that are available within a 
specific community, and take requests for pub- 
lications offered by the National AIDS Clear- 
inghouse. The Hotline offers one of the great- 
est opportunities to provide educational infor- 
mation in a professional, confidential, direct 
manner to any member of the public. 

Obstacle to Progress 

• Many citizens, including those most at risk of 
HD7 infection, are not aware of the National 
AIDS Hotline and the services it offers. 

RECOMMENDATIONS 

7-8 The Centers for Disease Control (CDC) 

should aggressively market the National 
AIDS Hotline through its ongoing HIV 
education and information campaign. 
The toll-free number, along with a de- 
scription of services offered, should be 
widely publicized in informational pam- 
phlets and public service announcements 
that are sponsored by CDC. 

7-9 The National AIDS Hotline should con- 

tinue to offer 24-hour counseling to re- 
spond to the needs of any caller. The 
Centers for Disease Control should 
ensure that there are sufficient operators 
on duty at all times to meet demand. 

7-10 The Centers for Disease Control should 

equip the National AIDS Hotline with 



communications capability for the hear- 
ing impaired by August 1, 1988. 

7-1 1 The National AIDS Hotline should serve 

as a referral center for the following 
services: community-based service orga- 
nizations, advocacy and protection pro- 
grams and services, availability of drug 
and vaccine trials, counseling and testing 
centers, and federal, state, and local 
agencies that deliver HIV-related serv- 
ices. 

The National AIDS Clearinghouse 

The National AIDS Clearinghouse operated 
by CDC is intended to tell the public where 
pertinent information about the HIV epidemic 
can be obtained. It has also been described as a 
resource for public health officials and health 
care providers. 

Obstacles to Progress 

• The only general information publications that 
the National AIDS Clearinghouse currently offers 
are those documents produced, either directly or 
under contract, by the federal government. 

• The National AIDS Clearinghouse has not been 
connected with the existing electronic network 
that serves state and local public health depart- 
ments. 

RECOMMENDATIONS 

7-12 The National AIDS Clearinghouse 

should continue to make available free 
of charge those documents pertaining to 
the HIV epidemic produced by the fed- 
eral government. 

7-13 The Centers for Disease Control (CDC) 

should conduct a potential user survey 
of state and local departments of health, 
community-based service organizations, 
and individual practitioners to determine 
their information requirements. At the 
conclusion of the survey, CDC should 
then ensure that the clearinghouse has 
the necessary funding and direction to 
meet those requirements. 

7-14 The National AIDS Clearinghouse 

should collect and disseminate educa- 
tional materials, including curricula and 
methods of instruction related to both 
the medical and the societal aspects of 
the HIV epidemic that are produced by 
federal, state, or local agencies or com- 
munity-based service organizations. The 
Clearinghouse should make a catalog of 
these materials available free of charge, 
and provide copies of such material on a 
fee-for-service basis. 



85 



7-15 The National AIDS Clearinghouse 

should collect and actively disseminate 
to education associations, chief state 
school officers, school districts, and 
others school-based educational materi- 
als, including sample curricula and meth- 
ods of instruction concerning the HIV 
epidemic. The Clearinghouse should 
make a catalog of these materials avail- 
able free of charge, and provide hard 
copy of such material on a fee-for-service 
basis. 

7-16 The National AIDS Clearinghouse 

should make federally produced docu- 
ments available in braille and on audio 
_ cassette. 

7-17 The National AIDS Clearinghouse 

should become connected with the elec- 
tronic information networks that serve 
state and local departments of health. 

Section II. Distinct Population 
Targeting 

While the HIV epidemic affects all segments 
of society, it is important to recognize that each 
distinct segment has its own unique educational 
needs. The Commission recognizes that it is 
behavior, not membership in any particular 
group or population, that places a person at 
greater risk for HIV infection. However, the 
educational response to the epidemic needs to 
acknowledge the eclectic nature of our society 
and effectively match the proper educational 
approach with a receptive target population. 

The Commission has heard testimony from 
members of many different distinct popula- 
tions, including homosexual men, blacks, His- 
panics, students, advocates for runaway and 
homeless youths, the hearing-impaired, and ad- 
vocates for the developmentally disabled. But 
for all these groups, or for any other distinct 
population, the principles involved in the de- 
velopment of curricula and methods of presen- 
tation are the same. The design and implemen- 
tation of educational programs must have sig- 
nificant input from members of the targeted 
population so that each program will be rele- 
vant, appropriate in language, and effectively 
reach the intended audience. 

State and local public health departments, in 
conjunction with community-based AIDS serv- 
ice organizations and other community leaders, 
are in the best position to understand the cul- 
tural, language, lifestyle, educational, and be- 
havioral components of their communities. It is 



because of this understanding that the assess- 
ment of the education needs of a community 
must occur at the local level, reflecting local 
community values. 

Following that assessment, local communities 
must develop and implement comprehensive 
HIV education strategies that will meet the 
community's specialized needs. However, local 
communities will not be able to meet their pre- 
vention and education needs without significant 
financial and technical support from both the 
state and federal governments and the private 
sector. 

Obstacles to Progress 

• Comprehensive, integrated strategies developed 
by state and local departments of health in con- 
junction with community-based organizations 
often do not exist, resulting in the duplication of 
some services and the absence of others. 

• Community-based organizations often lack exper- 
tise in program development, management, and 
grant writing. 

• National information and education campaigns 
implemented to date have not been significandy 
targeted to — and therefore do not reach — dis- 
tinct populations, such as minority communities. 

• The basic health care needs, including education 
and prevention programs, of minority popula- 
tions have not been met in the past, a situation 
that is being compounded by the HIV epidemic. 

• Federal, state and local funding of community- 
based initiatives has been scarce and uncoordi- 
nated. As a result, communities have been 
unable to develop and implement adequate long- 
term prevention and education services. 

• Funding patterns have not enabled community- 
based education initiatives to be adequately eval- 
uated by their sponsors, making it difficult to 
design further programs with any certainty that 
they will be effective. 

RECOMMENDATIONS 

7-18 The Centers for Disease Control (CDC), 

in conjunction with the Public Health 
Service Office of Minority Health, should 
increase its information and education 
programs targeted toward minority com- 
munities. In so doing, CDC should con- 
tract directly with minority advertising 
agencies and community-based service 
organizations to develop a media-based 
information and education campaign in- 
cluding the input from the community- 
based service organizations targeted 
toward specific minority populations in 



86 



7-23 



10 metropolitan areas that have signifi- 7-22 
cant minority populations. CDC and the 
Office of Minority Health should choose 
those 10 cities. The content of such a 
campaign should be clear and unequivo- 
cable and culturally relevant to the com- 
munities. CDC should be responsible for 
the content of such a campaign and the 
advertising agencies should be responsi- 
ble for determining the most effective 
way to package and deliver that informa- 
tion. The major objective of such a 
media campaign should be to inform 
people about activities that place them at 
risk of becoming infected with the virus 
and to identify HIV-related services that 
are available within a specific communi- 
ty. The result of this media-based minor- 7_24 
ity information and education initiative 
should be the creation of model media- 
based public information programs that 
can be easily replicated in other parts of 
the country. Consideration should be 
given to use of extended presentations, 
not just spot announcements. 



7-19 Once such a media-based campaign has 

been developed, the Centers for Disease 
Control should make funds available to 
state and local departments of health so 
that targeted paid advertising can be 
purchased in media outlets specific to 
minorities and other distinct popula- 
tions. Such funding should reflect the 
need to present paid programs, not just 
spot announcements. 

7-20 When federal money is used to finance 

all or a part of an educational program, 
the Centers for Disease Control should 
ensure that all program sponsors have a 
detailed evaluation component included 
in the program that measures, among 
other indicators, changes in behavior, 
knowledge, and attitudes pertaining to 
the HIV epidemic. 



7-25 



7-26 



7-21 State and local departments of health 

should recognize the disproportionate 
way in which the HIV epidemic has af- 
fected minority populations. They 
should, at a minimum, allocate a per- 
centage of their HIV prevention and 
education budgets directly proportional 
to the minority populations within their 
jurisdiction for the delivery of preven- 
tion and education programs to those 
minority populations. State and local de- 7-27 
partments of health should ensure that 
all educational programming produced is 
linguistically relevant to the targeted au- 
dience. 



State and local departments of health 
should ensure that easily accessible HIV- 
related services, including public health 
education programs, peer counseling, 
and other risk reduction interventions, 
are being offered within their jurisdic- 
tions. 

The Centers for Disease Control, states, 
and localities should increase funds to 
state and local health departments to ini- 
tiate and/or increase HIV prevention 
and education activities. These activities 
should include public health education 
campaigns, peer counseling, outreach 
education, and other risk reduction 
interventions. 

The Centers for Disease Control (CDC) 
in conjunction with states should in- 
crease funds and technical assistance in 
program development, management, and 
fundraising (including grant writing) to 
community-based service organizations 
so they can develop appropriate preven- 
tion programs. These programs should 
include public health education cam- 
paigns, peer counseling, outreach educa- 
tion, and other risk-reduction interven- 
tions. Where federal money is involved, 
CDC should require that all grant appli- 
cants include detailed evidence of their 
ongoing coordination with state and 
local departments of health. 

Because community-based organizations 
have successfully used their credibility 
with hard-to-reach populations to bring 
their educational messages to a broad 
audience, state and local health depart- 
ments should provide support to respon- 
sible community-based organizations 
providing such services. 

All citizens and philanthropic groups 
should be challenged to target at least a 
portion of their activities over the next 
10 years to programs and services which 
will further reduce the risk of HIV trans- 
mission. Economic and political realities 
make it impossible for public funds to 
support all possible activities related to 
control of HIV infection. Public funds 
will only sustain basic services and may 
not be able to provide the specificity 
needed by some groups. Private support 
can extend the services and can experi- 
ment creatively with new approaches. 

The Department of Health and Human 
Services (HHS), the Department of 
Housing and Urban Development 
(HUD), and states should increase funds 
to national and local organizations that 



87 



provide services to homeless and run- 
away youth. The funds should be used 
to initiate and/or expand programs de- 
signed to provide appropriate education 
strategies for runaway and homeless 
youth. When federal money is involved, 
HHS and HUD should require that all 
recipients provide detailed evidence of 
ongoing coordination with state and 
local departments of health and other 
social service agencies. Funding should 
be based on an established history of 
positive interventions with homeless and 
runaway youth and innovative program 
design. 

7-28 The Centers for Disease Control should 

make funds available to organizations 
representing persons with disabilities 
and special education professionals to 
develop materials and disseminate infor- 
mation about HIV infection. Such mate- 
rials should be targeted to the unique 
needs of individuals with mental retarda- 
tion, mental illness, hearing impair- 
ments, visual impairments and other 
learning and physical impairments. 

7-29 The Centers for Disease Control should 

make evaluation grants to state depart- 
ments of health to conduct special stud- 
ies to determine what programmatic 
interventions are most effective in reduc- 
ing transmission of the virus in various 
communities. Detailed information about 
those programs, including program con- 
tent and implementation strategies, 
should be provided to other state and 
local departments of health, as well as 
national and community-based AIDS 
service organizations, so that those pro- 
grams can be replicated in other parts of 
the nation. 

Section III. School-Based 
Education 

The Near-Term Response: Immediate 
HIV Education 

A two-part response to the epidemic is re- 
quired from the nation's elementary and sec- 
ondary school system. The first part must 
happen in the short term. It is the opinion of 
the Commission that the provision of HIV edu- 
cation in our schools is of vital importance and 
must be introduced across the nation immedi- 
ately. Some states have already ensured that 
this is happening; the rest must follow their 
lead. The decisions about appropriate content 
and methods of instruction should be deter- 
mined at the local level; however, both elemen- 



tary and secondary school students should re- 
ceive such education. Students must be provid- 
ed with current and accurate information about 
the HIV epidemic that is appropriate for age so 
that they can make informed decisions about 
their behavior and avoid those actions that put 
them at risk for HIV infection. School-based 
education should highlight the benefits of char- 
acter development, abstinence, and monogamy. 
By ensuring that appropriate education about 
the virus is provided in the elementary and 
secondary school system, we can help our 
younger generation avoid the tragedy we are 
witnessing today. 

The second part is the long-term response, 
which will have a far greater pay-off when fully 
implemented; that is the introduction of a com- 
prehensive health education curriculum for all 
grades K through 12. This broader topic is 
discussed later in this chapter. 

Obstacles to Progress 

• The HIV epidemic involves some of our most 
personal behaviors, and many find it difficult to 
incorporate information about the epidemic and 
those behaviors into a classroom program. 

• Many communities still do not believe that the 
HIV epidemic is something that will ever affect 
them and, therefore, see no need to provide 
HIV-related education to their children. 

• Funding that will allow HIV education programs 
to be delivered is not in place. 

RECOMMENDATIONS 

7-30 State boards of education should man- 

date that an HIV education curriculum 
with appropriate content for age be of- 
fered to all students at each schooling 
level (e.g., elementary, middle, and high 
school) throughout the state. 

7-31 If such a system is not already in place, 

the state director of health and the chief 
state school officer in every state should 
establish a formal mechanism to ex- 
change information about the HIV epi- 
demic, including current technical infor- 
mation and model education programs. 

7-32 School staff who deliver HIV education 

should receive extensive in-service edu- 
cation before they begin instruction. The 
content of the in-service education 
should be designed in conjunction with 
state education and health agencies. No 
member of the school staff should be 
forced to deliver education about HIV if 



88 



he or she is not comfortable with the 
subject. 

7-33 Local school boards should establish an 

advisory committee, consisting of school 
board members, professionals from the 
state and/or local public health depart- 
ment, parents, teachers and students, to 
develop an HIV education curriculum. 
The committee should meet at frequent 
intervals until the curriculum is enacted 
and thereafter at least annually to moni- 
tor and evaluate HIV school-based edu- 
cation. 

7-34 The Department of Education, the Cen- 

ters for Disease Control, states and lo- 
calities should increase funds to national 
education organizations, school districts, 
and other educational entities to design 
and implement HIV education curricula. 

7-35 The Centers for Disease Control should 

increase funds to colleges and universi- 
ties for creation and/or expansion of 
HIV prevention and education programs 
on campus. The schools should use 
these funds to educate their students 
about the medical aspects, including ap- 
propriate risk-reduction techniques, and 
the societal aspects of the epidemic. 

7-36 State and local health departments 

should conduct conferences to provide 
current technical information about the 
HIV epidemic to state and local school 
boards, principals, and teachers. Such 
conferences should be held regularly, 
based on the amount of new information 
available or requests for updated infor- 
mation. 

7-37 State and local health departments, in 

conjunction with state and local school 
boards, should conduct conferences to 
provide current and accurate informa- 
tion about the HIV epidemic and school- 
based education initiatives, including the 
description of model programs, for par- 
ents of school-age children. Such confer- 
ences should be made available free of 
charge to all parents of school-age chil- 
dren, and should be held regularly, 
based on the amount of new information 
available, turnover in the student popu- 
lation, or requests for updated informa- 
tion. 

The Long-Term Response: 
Comprehensive Health Education 

The Commission strongly believes that the 
introduction of an age-appropriate comprehen- 
sive health education curriculum that encom- 



passes grades K through 12 is long overdue. 
Providing our nation's school children with 
education about HIV transmission, as recom- 
mended in the near-term response section, is a 
significant step. However, it represents only a 
stop-gap measure to correct a larger problem. 
The expert witnesses who testified before the 
Commission clearly demonstrated that the 
problems that are afflicting youth today — such 
as sexually transmitted diseases including HIV 
infection, drug abuse, school-aged pregnancy, 
and decisions to drop-out or run away — are all 
inseparably intertwined. The HIV epidemic 
provides a unique impetus to address these 
problems in total rather than continue the 
piecemeal, fractured, and largely ineffective ap- 
proach that is being undertaken today. 

The heaviest burden of illness in the techni- 
cally advanced countries today is related to in- 
dividual behavior, especially the long-term pat- 
terns of behavior often referred to as "life- 
style." In the United States, it is reliably esti- 
mated that 50 percent of mortality from the 10 
leading causes of death can be traced to life- 
style — health-damaging behaviors such as 
smoking, drinking, eating too many calories 
and too much fat, and inactivity. Other behav- 
iors highly relevant to health and disease — 
both mental and physical — are responses to 
the stresses of events in life. 

What we do early in life lays the foundation 
for all the rest. The early years can provide the 
basis for a long, healthy life span. Early preven- 
tive intervention tends to be exceptionally cost- 
effective. Health and education are closely 
linked in the development of vigorous, skillful, 
adaptable young people. Investments in health 
and education can be guided by research in 
biomedical and behavioral sciences in ways 
likely to prevent much of the damage now 
being done to children and adolescents. 

The onset of adolescence is a critical period 
of biological and psychological change for the 
individual. Puberty is one of the most far- 
reaching biological upheavals in the life-span. 
For many, it involves drastic changes in the 
social environment as well: the transition from 
elementary to secondary school. These years 
(ages 10 to 15) are highly formative for health- 
relevant behavior patterns such as the smoking 
of cigarettes or avoidance, the use of alcohol or 
other drugs or abstaining, the driving of auto- 
mobiles and motorcycles, habits of food intake 
and exercise, and patterns of human relation- 



89 



ships, including pre-marital sexual activity lead- 
ing to high-risk pregnancy and sexually trans- 
mitted disease or abstinence. Before health- 
damaging patterns are firmly established, there 
is a crucial opportunity for preventive interven- 
tion and affirmation of healthful living and self- 
respect. 

Despite the drastic biological, social, and 
technological changes surrounding adolescence 
that have taken place during this century, there 
appear to be fundamental human needs that 
are enduring and crucial to survival and healthy 
development: 

• The need to find a place in a group that provides 
a sense of belonging. 

• The need to identify tasks that are generally rec- 
ognized in the group as having adaptive value 
and that thereby earn respect when skill is ac- 
quired for coping with the task. 

• The need to feel a sense of worth as a person. 

• The need for reliable and predictable relation- 
ships with other people, especially a few relative- 
ly close relationships. 

The experience of industrialized nations sug- 
gests that rapid social changes, the breakdown 
of family supports, and prolongation of adoles- 
cence are associated with an increase in behav- 
ior-related problems such as substance abuse, 
school-age pregnancy, and education failure. 
The opportunities for prevention rest heavily 
on finding constructive ways to meet the basic 
aspirations of adolescent development in a new 
social context. 

The Commission believes that comprehen- 
sive health education, taught through a life sci- 
ences curriculum, offer a distinct opportunity 
to stimulate early interest in science and to 
learn how to deal more effectively with matters 
of deep human concern. The life sciences, by 
stimulating children's interest in understanding 
nature, can also lead the way to a deeper study 
of other scientific disciplines such as chemistry 
and physics. 

In this context, then, health education in- 
cludes at least three components in a system: 
(1) education in terms of classroom instruction 
and curriculum; (2) school policies that support 
the knowledge and skills that are developed 
through such education; and (3) governmental 
policies and regulations that reinforce both of 
the above. But it is the school health program 
that is "comprehensive" in taking into account 
different levels of a total system from the indi- 
vidual, organization, community and govern- 



ment, and not the curriculum that is so often 
referred to as "comprehensive". A truly "com- 
prehensive" health education program is one 
that integrates basic concepts in biological and 
behavioral sciences, and opportunities to apply 
problem-solving and decision-making skills in 
the context of real-life individual and social 
issues. 

An important goal in understanding human 
biology will be to permit better solutions ~ 
with less strife and more informed public par- 
ticipation — to biological aspects of social prob- 
lems, such as environmental hazards. Knowl- 
edge of human biology is particularly important 
for decisions that relate to health — decisions 
on whether to use alcohol, cigarettes, or drugs; 
to understand what constitutes healthy diet and 
exercise; decisions about sexuality — as well as 
decisions on when and how to seek health care. 
Thus, education for health is a potentially pow- 
erful offshoot of education in the life sciences. 

The objectives of teaching life sciences to all 
students is to provide a major stimulus to the 
biology curriculum for young adolescents. An 
age-appropriate comprehensive health educa- 
tion program (K through 12) would teach stu- 
dents essential concepts in biology and then 
relate these concepts to problems that students 
encounter in their daily lives. These programs 
should emphasize personal responsibility for 
one's actions. Actions have consequences. It 
would promote healthy behaviors, through the 
knowledge they will gain about themselves — 
and what they can do to their own bodies and 
their own lives. 

The Commission believes it is time to allow 
our children to become part of the solution to 
all health threats they face, and to do this by 
engendering in them a fundamental knowledge 
of their own biological uniqueness as part of a 
comprehensive health education program. A 
life sciences/health education curriculum must 
be reinforced by consistent school climate and 
policies, family and community support, con- 
structive messages from the media, and favor- 
able governmental policies ~ a far better alter- 
native than continuing the counterproductive 
practice of allowing society to consistently criti- 
cize youth as being the problem itself. 

RECOMMENDATIONS 

7-38 The President should direct the Secre- 

tary of Health and Human Services and 
the Secretary of Education to co-chair a 



90 



task force on comprehensive school- 
based health programs. The task force 
should articulate concepts which will 
drive development of a truly comprehen- 
sive health education program at the 
local level. Strategies for funding should 
also be produced. Additionally, the task 
force should explore the development of 
incentives for school systems to incorpo- 
rate these concepts into their programs. 
The Elementary and Secondary Educa- 
tion Act Amendments of 1988 (the Haw- 
kins-Stafford bill), which provides funds 



for school systems to develop coordinat- 
ed health and physical education pro- 
grams, is an example of such an incen- 
tive. 

7-39 All schools, both public and private, 

should have comprehensive health edu- 
cation programs for grades K through 
12 fully implemented by the year 2000. 

7-40 School boards and parents should devel- 

op means to incorporate values empha- 
sizing personal responsibility in the gen- 
eral education curriculum. 



91 



CHAPTER EIGHT: SOCIETAL ISSUES 



As the Commission looked at patterns of 
HIV infection and particularly their correlation 
to intravenous drug abuse, the relationship be- 
tween the spread of HIV and longstanding so- 
cietal problems became apparent. It is impera- 
tive that this nation recognize and address the 
context in which the epidemic is occurring. It is 
occurring disproportionately within the under- 
class, the largely minority population of the 
inner city poor. (For discussion of the "under- 
class," see William Julius Wilson, The Truly Dis- 
advantaged — the Inner City, the Underclass and 
Public Policy, the University of Chicago Press, 
1987.) 

Witnesses before the Commission presented 
considerable evidence that the occurrence of 
drug abuse, particularly intravenous heroin 
abuse, is frequently found in communities 
where poverty and crime are endemic. It has 
been noted that persistent poverty in the midst 
of an affluent society engenders hopelessness 
and despair which can lead to heroin abuse and 
related high rates of crime. 

In HIV prevalence studies of homosexual 
men, intravenous drug users, and patients at 
sexually transmitted disease clinics, inner city 
areas consistently report the highest prevalence 
rates, with minorities overrepresented among 
this population. In addition, witnesses testified 
that neighborhoods characterized by high rates 
of teenage pregnancy, high school dropouts, 
crime (particularly drug- related crime), welfare 
dependency, males who are jobless, and 
female-headed households (which represent 
over 90 percent of households in some urban 
housing projects) have suffered a high rate of 
heterosexual transmission. 

Heterosexual transmission is occurring par- 
ticularly in communities where prostitution and 
drug abuse are prevalent, and where HIV infec- 



tion is correspondingly high (as high as 70 per- 
cent among intravenous heroin users in some 
areas). In this setting, the disease has dispersed 
rapidly into . the heterosexual community 
through the sexual partners of those infected. 
As many as five percent of mothers delivering 
babies in some inner city hospitals are now 
infected, a frightening statistic, especially when 
we consider the social and financial ramifica- 
tions of a rapidly increasing incidence of pedi- 
atric HIV infection. Some of our public city 
hospitals are already overwhelmed, and we 
have only seen the beginning of the accelera- 
tion of this pediatric HIV crisis. 

In addition to intravenous heroin use, crack 
and cocaine use are likely avenues for the 
spread of HIV. Witnesses testified that drug 
users tend to use any available drug and 
method in pursuit of a "high," underscoring 
the interconnection of drug-using sub-popula- 
tions. Evidence from a small number of studies 
suggests that crack and cocaine users may be at 
considerable risk for contracting and spreading 
HIV because they tend to be involved in fre- 
quent, indiscriminate sexual activity and prosti- 
tution. 

A Johns Hopkins University study estimated 
that unemployment, declines in income, and 
high school dropout rates are significant na- 
tional predictors of narcotics arrest rates. Wit- 
nesses testified that there is a correlation be- 
tween inner-city unemployment rates and nar- 
cotics arrests. Thus, when the employment rate 
rises, it could be inferred that drug use and the 
high-risk behavior which accompanies that drug 
use, decreases. The connection with HIV infec- 
tion is apparent. 

For those with few skills to offer, the drug 
economy promotes an alternative model of 
achievement. If the attraction of the drug econ- 



93 



omy is to be decreased, then productive alter- 
natives for developing earning potential are 
necessary. 

Intensive efforts are needed to train and 
place unskilled workers, including rehabilitated 
drug addicts, and to build their self-respect, 
confidence, and hope. The employment of 
these workers is paramount to remedying un- 
derclass societal and family problems. Jobs, al- 
ternatives to the drug world, and motivation 
for further education are all needed. A statistic 
often quoted is that one job provided to a head 
of household takes four people off welfare and 
an unknown number out of the prison system. 
Witnesses before this Commission have repeat- 
edly testified to the cost-effectiveness in both 
human and financial terms of employment and 
job training programs. 

Lacking health insurance typically provided 
through employment, individuals living in pov- 
erty also suffer from too little medical care and 
high rates of acute and chronic illness. Al- 
though the Medicaid program was designed to 
be the nation's health insurance program for 
the poor, Medicaid currently provides health 
care coverage for only about 40 percent of 
those with incomes below the poverty line. 
Management of the HIV epidemic presents ad- 
ditional new problems in prevention and care 
for a population already receiving inadequate 
health services. 

In addition to inner-city poverty-stricken 
communities, the 1980's have witnessed an ex- 
plosion of homelessness in our nation. Between 
400,000 and 3 million persons are currently 
estimated to be homeless. While the HIV infec- 
tion rate in homeless persons is unknown, wit- 
nesses report that many HIV-infected persons 
may have become homeless because of discrim- 
ination as a result of being infected. 

It has often been said that a society is judged 
by how it responds to those in greatest need. A 
tragedy such as the HIV epidemic brings a so- 
ciety face to face with the core of its established 
values, and offers an opportunity for the reaf- 
firmation of compassion, justice, and dignity. 
Many individuals and groups in our society 
have responded to the HIV epidemic so as to 
reaffirm these basic values. The development 
and growth of community-based organizations, 
particularly in the homosexual community, has 
been remarkable. The response of many em- 
ployers, corporations, philanthropies, and reli- 
gious organizations and institutions has also 
been exemplary. A further commitment by our 



society to a response to the HIV epidemic char- 
acterized by compassion, justice, and dignity is 
imperative. 

It has been shown that improvements in 
health and mental health and increased longev- 
ity are related to increased per capita income 
and decreased unemployment rates. Lower 
crime rates are also positively correlated with 
increased employment and a higher socioeco- 
nomic status. 

In a recent study conducted by the Council 
on Economic Development, leading business 
leaders recognized that the productive capacity 
of the nation depends on its people and con- 
cluded that unless the needs of children in pov- 
erty are addressed, the nation would suffer eco- 
nomic decline and perhaps even social disarray. 
The study concluded that "the single most im- 
portant investment the nation can make ... is 
to provide comprehensive pre-school prepara- 
tion for every educationally and economically 
disadvantaged child in the nation, beginning at 
conception if not well before." 

The Commission endorses this statement and 
points out that the presence of the HIV epi- 
demic only increases the urgent need to ad- 
dress the problems of poverty, unemployment, 
teenage pregnancy, drug abuse, and homeless- 
ness, and the human suffering and social costs 
that they generate. 

Section I. Drug Abuse and the HIV 
Epidemic 

Our nation's ability to control the course of 
the HIV epidemic depends greatly on our abili- 
ty to control the problem of intravenous drug 
abuse. Intravenous and other drug abuse is a 
substantial carrier for infection, a major port of 
entry for the virus into the larger population. 
Although intravenous drug abusers constitute 
only 25 percent of AIDS cases in the United 
States, 70 percent of all heterosexually trans- 
mitted cases in native-born citizens comes from 
contact with this group. In addition, 70 percent 
of perinatally transmitted AIDS cases are the 
children of those who abuse intravenous drugs 
or whose sexual partners abuse intravenous 
drugs. And the situation is rapidly worsening as 
the number of infected drug abusers grows 
daily. 

Among the more tragic manifestations of this 
epidemic are the infected infants of intravenous 
drug abusers. Most of these children die in 



94 



their first few years of life. Many never leave 
the hospital. Their time on this earth begins 
with a few months of drug withdrawal in an 
isolation unit and ends after a series of painful 
illnesses. Because few have visitors in the hos- 
pital, the nurses, physicians, social workers, and 
volunteers who staff our pediatric acute care 
units become father, mother, and friend to 
these children. By 1991 there are expected to 
be 10,000 to 20,000 cases of AIDS among in- 
fants and children. 

But they represent only the beginning of the 
tragedy if this nation does not move to address 
its entire drug abuse problem. The Commis- 
sion recognizes that alcohol and drug abuse in 
all their manifestations represent a threat since 
the use of alcohol or any drug which impairs 
judgment may lead to the sexual transmission 
of HIV. The United States continues to have 
the highest rate of illicit drug use among young 
people of any country in the industrialized 
world. Our drug problem pervades all elements 
of society. A recent study has demonstrated 
that drug abuse is a problem for both suburbs 
and inner cities, for all races, and at all income 
levels. Without a coordinated and sustained re- 
sponse, America as a whole faces a bleak 
future. 

In addition to the devastation that drug 
abuse represents for the individual, the family, 
and the community, the purely financial cost of 
drug abuse — in terms of providing health care, 
reduced productivity, law enforcement, plus 
theft and destruction of property - is estimated 
at $60 billion annually. This remarkable figure 
does not include the staggering costs of provid- 
ing health care for drug abusers with HIV in- 
fection. 

A number of efforts to curb drug abuse have 
been initiated. The First Lady's highly visible 
"Just Say 'No' " campaign, for example, has 
successfully drawn our nation's attention to the 
devastation of drug abuse and called on Ameri- 
ca's youth to reject drugs. Such efforts need to 
be strengthened and increased. In addition, 
more needs to be done in providing treatment 
for those already addicted. 

But curbing drug abuse will require major 
commitments from many sources. It will re- 
quire, first, that individual drug abusers take 
personal responsibility for their own well- 
being. Treatment systems to be effective re- 
quire the commitment of individual drug abus- 
ers to the treatment regimen. It will also re- 
quire a major commitment from federal, state, 



and local governments, as well as parents, edu- 
cators, and community leaders to work togeth- 
er to initiate new prevention and education 
programs and to build community support for 
eliminating drug abuse and drug trafficking. 

The Commission's recommendations are de- 
signed to develop a comprehensive, ten-year 
strategy to deal with the nation's intravenous 
and other drug abuse problems. This will be 
accomplished by increasing treatment capacity, 
increasing research into treatment modes, 
strengthening primary prevention and early 
intervention programs, and conducting aggres- 
sive outreach programs in HIV-related educa- 
tion and prevention. The Commission recom- 
mends a system which can accommodate a 
treatment-on-demand response for intravenous 
drug abusers. 

Provision of Treatment Services 

The Commission believes it is imperative to 
curb drug abuse, especially intravenous drug 
abuse, by means of treatment in order to slow 
the HIV epidemic. Because a clear federal, 
state, and local government policy is needed, 
the Commission recommends a national policy 
of providing "treatment on demand" for intra- 
venous drug abusers. 

This policy would need to be a long-term 
commitment, and the funding should come 
from a 50 percent federal and 50 percent state- 
and-local matching program. The spending 
should be accompanied by the institution of a 
national campaign to promote community ac- 
ceptance of treatment programs. 

Given the fact that temporarily alleviating the 
health effects of symptomatic HIV infection can 
cost as much as $100,000 per person and that 
imprisonment costs an average of $14,500 per 
person per year, and even without considering 
the previously cited astronomical costs of drug 
abuse to the nation, the investment necessary 
to provide for intravenous drug abuse "treat- 
ment on demand" is sound public policy. Cur- 
rent treatment modes for intravenous drug 
abusers, including methadone maintenance and 
drug-free residential communities, reduce illicit 
drug use, improve employment among addicts, 
reduce crime rates, and improve social func- 
tioning. 



95 



Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in providing drug treat- 
ment services nationwide: 

• The National Institute on Drug Abuse (NIDA) 
estimates that 6.5 million people are now using 
drugs in a manner which significantly impairs 
their health and ability to function. Of these, 1 .2 
to 1.3 million are intravenous drug abusers. At 
any given time there are probably not more than 
250,000 drug abusers in treatment, of whom 
148,000 are intravenous drug abusers. The lack 
of treatment capacity has produced long waiting 
lists for treatment, in some cases up to six 
months, in three out of four cities in the United 
States. During this waiting period many intrave- 
nous drug abusers continue to use drugs intrave- 
nously several times each day, increasing their 
risk of contracting and spreading HIV, and in 
many cases diminishing their resolve to enter 
treatment. 

• Treatment capacity in most parts of the country 
can be increased by approximately 20 percent 
with the addition of treatment funds. But further 
expansion could exceed the capacity of the na- 
tion's existing infrastructure and may require an 
increase in "brick and mortar" funds and a con- 
certed effort to recruit and train more personnel. 

• A substantial commitment of funds by federal, 
state, and local governments, plus private care 
providers, is needed to expand expeditiously the 
quantity and improve the quality of the treatment 
system. Further, collaboration among all these 
sources is needed to design innovative plans for 
reducing barriers to expansion. This expansion 
should incorporate treatment models which have 
been demonstrated to be cost-effective. As an in- 
terim emergency measure, it may be necessary to 
establish minimal service or "holding" clinics, 
but as soon as possible patients must be admit- 
ted to programs with full services, including psy- 
chological counseling and medical care. 

• Rates of effectiveness of treatment are directly 
related to retention in treatment. Attention must 
be paid to improving the quality of treatment to 
retain clients until they are rehabilitated. 

• The presence of HIV infection in the drug-abus- 
ing population has generated a decline in the 
overall health of this population, with dramatic 
increases in deaths from bacterial pneumonia, tu- 
berculosis, endocarditis, nephritis, and a variety 
of other infections. 

• Establishment of community-based treatment 
programs has been hampered by the "not-in-my- 
neighborhood" syndrome. 



• Many community services which could give much 
needed support to clients in drug treatment pro- 
grams are not well coordinated. 

• The treatment field needs more trained staff and 
in-service training. HIV infection has increased 
the already heavy burdens on those in this field. 
In addition to their regular duties, they now face 
the need to educate their clients on HIV-related 
issues, risk reduction activities, and, in many 
cases, the psychosocial needs of dying clients. 

• The special needs of women of childbearing age 
have become more pronounced, emphasizing the 
need for programs for addicted women, addicted 
pregnant women, and their children. 

RECOMMENDATIONS 

In response to these obstacles, the Commis- 
sion recommends the following improvements 
in providing drug abuse treatment, with em- 
phasis in every instance on appropriate HIV- 
related education and prevention: 

8-1 In the near term, the National Institute 

on Drug Abuse, in conjunction with state 
agencies, local drug abuse officials, and 
representatives of drug treatment pro- 
viders, should develop a plan for in- 
creasing the capacity of the drug treat- 
ment system so that the goal of treat- 
ment-on-demand can be met. The plan 
should designate an implementing office 
with the staff and technical capacity to 
guide implementation of the plan. The 
plan should provide for matching fund- 
ing on a 50 percent federal and 50 per- 
cent state-and-local basis. It should have 
elements for a phased, targeted increase 
in programs insuring the quality of care 
and mechanisms to evaluate progress 
and make appropriate adjustments. 

8-2 The Alcohol, Drug Abuse, and Mental 

Health Block Grant program should con- 
tinue to be the mechanism for disbursing 
treatment funds. However, provisions 
must be made for expediting disburse- 
ments and targeting the money to those 
areas with the largest numbers of intra- 
venous drug abusers. If using the block 
grant mechanism would cause undue 
delays in accomplishing this, consider- 
ation should be given to such methods 
as state and citywide contracts that could 
later be folded into the block grants. 

8-3 The Alcohol, Drug Abuse, and Mental 

Health Block Grant funds should be di- 
rected to activities that stimulate and 
help patients to enter the treatment 
system. These activities should include, 
but not be limited to: aggressive out- 



96 



reach services to drug abusers; tele- 
phone hotlines that provide treatment 
information and initial access to treat- 
ment programs; centralized assessment, 
referral, or intake units; linkages be- 
tween drug abuse programs and commu- 
nity service agencies, criminal justice and 
correctional systems, employers, schools, 
churches, clinics for treatment of sexual- 
ly transmitted diseases, prenatal clinics, 
mental health professionals, marriage, 
family, and sexual counselors and thera- 
pists, hospice care, HIV crisis networks 
and coalitions; and mechanisms for iden- 
tifying, developing, and cataloguing 
treatment resources within the communi- 
ty- 

8-4 Federal constraints on funds for con- 

structing, expanding, and renovating fa- 
cilities for intravenous drug treatment 
should be made more flexible in re- 
sponse to increased treatment needs. In 
addition, a wide range of federal and 
local financing arrangements for commu- 
nity-based treatment programs should be 
considered. 

8-5 Since an estimated 1.2 million intrave- 

nous drug abusers are concentrated in 
24 cities in the United States, treatment 
should be quickly expanded in those 
cities by having state, city, local, and 
community officials identify facilities 
which could be used for treatment cen- 
ters. These should include hospitals, 
clinics, and other health-related sites. 
Approximately 2,500 new facilities may 
need to be developed this way. 

8-6 As an interim step until new treatment 

facilities can be developed, state drug 
abuse agencies should consider contract- 
ing with allied health professionals and 
social workers or organizations to serve 
as case managers for drug abuse clients. 
Case managers, who need not be affili- 
ated with traditional drug abuse facili- 
ties, could procure medical, educational, 
job training and social services, and 
other necessary services, from existing 
community resources. They could assess 
client needs, develop individualized 
treatment plans, procure services, and 
monitor service delivery. The federal 
government should provide demonstra- 
tion funds for projects that use the case 
management approach to bring external 
community resources into treatment 
plans. 

8-7 The National Institute on Drug Abuse 

should develop model demonstration 
programs that are community-based. 



These should focus on ethnic and mi- 
nority populations that have been dis- 
proportionately affected by the HIV epi- 
demic, and on the treatment needs of 
teenaged intravenous drug abusers. In 
addition, grants should be made to com- 
munities which are designing and imple- 
menting treatment programs that inte- 
grate community services and have the 
support of community leaders. 

8-8 More emphasis needs to be placed on 

matching treatment with the specific 
needs of clients. Drug addiction is a dis- 
ease of the whole person involving mul- 
tiple areas of function. To be effective, 
any treatment approaches must ultimate- 
ly address many dimensions of the 
client. Those who fund and administer 
treatment programs should become 
more flexible, focusing not only on drug 
abuse behaviors, but also on other di- 
mensions of the client's life (e.g., educa- 
tional and vocational deficiencies and 
family problems) that may contribute to 
drug abuse. Services should not be limit- 
ed to those that can be provided within a 
program's own facilities or by its own 
staff. There should be more extensive 
use of services available in local commu- 
nities which can help to rehabilitate the 
drug abuser. This will require a focus on 
continuity of care, whether services are 
provided in one facility or in a number 
of community facilities. Community care 
facilities which receive public funds 
should be required to coordinate serv- 
ices with drug treatment programs and 
should be monitored by appropriate au- 
thorities. 

8-9 Treatment programs should try different 

strategies to encourage patients to par- 
ticipate. These should include: extended 
hours of operation, operation during un- 
usual hours, mobile treatment units, 24- 
hour satellite clinics in medical facilities, 
and storefronts in communities. Results 
of these efforts should be carefully eval- 
uated. 

8-10 Effective drug treatment, especially in 

this HIV epidemic, includes dealing not 
only with the health care needs of pa- 
tients but also of their families. Treat- 
ment should include on-site primary 
services or referrals to community health 
centers, mental health centers, and other 
accessible community-based resources. 

8-11 Comprehensive programs should be 

made available for women who are intra- 
venous drug abusers and are of child- 
bearing age, pregnant, or mothers. 



97 



These programs should provide treat- 
ment as well as prenatal and postnatal 
care, day care facilities, family planning, 
HIV testing, counseling, and child wel- 
fare services. It is essential that these 
services be provided during extended 
hours. 

8-12 Drug treatment programs must aggres- 

sively provide HIV prevention and risk 
reduction education to clients and their 
sexual partners. Information must be 
provided on the dangers of needle and 
paraphernalia sharing, the immunosup- 
pressive effect of drugs (including non- 
intravenous drugs and alcohol), sexual 
transmission, and risks to the unborn. 
Voluntary HIV testing should be strong- 
ly encouraged for clients, their sexual 
partners, children of intravenous drug- 
abusing mothers, and children of sexual 
partners of intravenous drug abusers. 
Any such testing must be accompanied 
by a counseling program. Collaborative 
efforts should be established to routinely 
refer released prisoners to drug treat- 
ment programs near their homes, for 
HIV services as well as drug interven- 
tion, if such prisoners are known to have 
a history of drug use. 

8-13 Political and community leadership 

should be exerted to reduce barriers to 
the establishment of community treat- 
ment facilities in appropriate locations. 
In communities where there are high 
rates of drug abuse and a proven need 
for drug abuse rehabilitation programs, 
but continued resistance to their estab- 
lishment, health commissioners should 
review the possibility of invoking emer- 
gency health measures to overcome this 
inertia and resistance. 

8-14 Quality assurance in drug abuse treat- 

ment programs needs to be reexamined. 
Quality of care needs to be better de- 
fined by the drug abuse treatment field 
and standards for programs and practi- 
tioners need to be established or re- 
fined. States should reexamine their li- 
censing procedures for drug abuse treat- 
ment programs. The federal government 
should support studies of treatment out- 
come and the development of scientifi- 
cally based quality assurance mecha- 
nisms. 

8-15 A significant increase in trained person- 

nel will be needed to implement new 
programs. Approximately 59,000 per- 
sons will be needed to join the ranks of 
drug abuse workers. New staff training 
programs should be developed at univer- 



sities, community colleges, vocational 
and technical schools, and through in- 
ternships in existing drug programs and 
the training of ex-addicts. Curricula 
dealing with education, prevention, and 
treatment of substance abuse and HIV 
should be developed throughout the 
educational systems for physicians, 
nurses, and social service workers. Fed- 
eral leadership is needed to foster and 
identify model curricula for training pro- 
grams as well as establishing the fields of 
drug abuse prevention, treatment, and 
research as viable and rewarding profes- 
sions. 

8-16 Staff development and training for drug 

abuse treatment providers must include 
education and skill development related 
to HIV, such as education in the modes 
of HIV transmission and prevention. 

8-17 State judicial and correctional systems 

should consider assigning individuals to 
drug treatment programs as a sentence 
or in connection with sentencing. For 
persons convicted of drug-related of- 
fenses or those convicted on non-drug- 
related offenses but found to be drug 
abusers, the convicted person should be 
placed in a drug treatment program in 
those instances where probation authori- 
ties recommend alternatives to imprison- 
ment. To assure program compliance, 
the convicted person should serve a 
prison sentence for violating the terms 
of the drug treatment program. Those 
who are incarcerated should be referred 
upon release to drug treatment facilities 
near their homes. 

Treatment Research 

The Commission's research has led us to 
conclude that improved and expanded research 
focusing on intravenous and other forms of 
drug abuse and HIV will require a long-term 
commitment. Funding priorities should follow 
guidelines set forth below. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in treatment research: 

• Intravenous cocaine use has been increasing in 
the United States and, while there are pharmaco- 
logical treatments for intravenous heroin use, 
there are no such proven pharmacological agents 
for intravenous cocaine use. 

• Efforts to be innovative in treatment have not 
been aggressive. There have not been enough 



98 



experiments with new procedures and model 
treatment program development. 

• Due to inconsistent funding, treatment research- 
ers have often sought other more stable fields in 
which to work. 

• Grant and contract cycles are often too drawn 
out to cope with the urgency of the HIV epidem- 
ic. 

• Data on drug abusers are not being collected in 
the uniform way that might provide the basis for 
responsive policy decisions. 

RECOMMENDATIONS 

In response to these obstacles in treatment 
research, the Commission recommends the fol- 
lowing: 

8-18 The National Institute on Drug Abuse 

should expand its comprehensive re- 
search program. It should particularly 
emphasize strategies for the treatment of 
intravenous cocaine use. 

8-19 The National Institute on Drug Abuse 

should sponsor additional research to 
determine which clients will most likely 
succeed in a particular treatment pro- 
gram. 

8-20 The National Institute on Drug Abuse 

should sponsor additional research in 
improved pharmacological agents for 
drug abuse treatment, including narcotic 
antagonists, mixed agonist-antagonists, 
non-pharmacological strategies and 
more effective delivery systems. 

8-21 The National Institute on Drug Abuse 

should fund research to improve service 
delivery, treatment methods, and innova- 
tive types of treatment. Results should 
be disseminated to the field. 

8-22 Federally sponsored research should be 

conducted on the effects of drug abuse 
on the immune system in order to deter- 
mine the efficiency of HIV transmission 
to and from drug abusers and to prevent 
asymptomatic HIV-infected individuals 
from progressing to symptomatic dis- 
ease. 

8-23 The grant processing cycle must be 

shortened throughout government to 
provide quicker review and approval of 
applications for grants related to HIV re- 
search in general, and in particular as it 
relates to drug abuse research in data 
collection, demonstration programs, pre- 
vention and treatment research. 



8-24 Studies funded by the National Institute 

on Drug Abuse should be undertaken 
expeditiously to provide adequate data 
on the number of drug abusers, the 
number in treatment, the HIV rates 
among drug abusers, and baseline re- 
search into the sexual patterns of drug 
abusers. The data can be used to pro- 
mote detailed planning by the federal 
government, states, cities, and communi- 
ties. Also needed is research that exam- 
ines the characteristics of addicts which 
lead them to respond to various social 
and environmental pressures. Since suc- 
cess rates in treatment are related to 
length of stay in treatment, research 
should continue on ways to improve re- 
tention in treatment. 

Drug Abuse Prevention 

Primary or overall drug abuse prevention re- 
quires the sustained efforts of parents, educa- 
tors, community leaders, and all levels of gov- 
ernment, collaborating to develop effective new 
prevention approaches and expand existing 
prevention programs. Community organiza- 
tions, religious institutions, and schools should 
be encouraged to design value-oriented educa- 
tional programs to discourage drug abuse and 
to encourage rehabilitation. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in implementing drug 
abuse prevention: 

• Prevention strategies need to be evaluated over 
long periods of time. Such a process is compli- 
cated by the many factors influencing human be- 
havior, which slow analysis of the effectiveness of 
various strategies and slow even more the dis- 
semination of model programs. 

• Funding for prevention research has not always 
been consistent, leading researchers to migrate 
out of the field and leading to uneven productivi- 
ty of the research effort. 

• Presenting a consistent message is fundamental 
to eliminating confusion about drug abuse 
among children. It is essential to coordinate ef- 
forts linking school to community to religious in- 
stitutions to family to individual; yet such coordi- 
nation is sporadic at best. 

• Not enough attention is being paid to providing 
effective model programs and training communi- 
ty groups in effective prevention programming. 



99 



RECOMMENDATIONS 

In response to these obstacles, the Commis- 
sion recommends the following: 

8-25 The Alcohol, Drug Abuse, and Mental 

Health Administration's Office of Sub- 
stance Abuse Prevention should sponsor 
more research into the root cause of 
drug abuse, determination of those at 
greatest risk, and the most effective 
means of preventing drug abuse. 

8-26 The federal effort should emphasize the 

development, implementation, and eval- 
uation of model prevention programs 
with aggressive dissemination of effective 
models. Current knowledge of effective 
prevention and intervention strategies, 
such as those based on the significant in- 
fluence of family and peers, should be 
used in developing additional prevention 
programs. 

8-27 To the extent that current research pro- 

vides the tools necessary to identify 
young people at risk for drug abuse 
through their behaviors, the Office of 
Substance Abuse Prevention should 
make this information, as well as proven 
intervention techniques, widely available 
through publications, conferences, train- 
ing sessions, and a national clearing- 
house. 

8-28 Educators should design and offer train- 

ing courses on drug abuse prevention 
and intervention at both the undergrad- 
uate and graduate levels as well as pro- 
grams to train specialists with the exper- 
tise needed to develop and implement 
drug abuse and HIV prevention efforts 
in ethnic minority communities. Special 
training should be designed for health 
professionals and alcohol and drug 
counselors, and should include the latest 
information on prevention of high-risk 
behaviors. 

8-29 State and local drug agencies should 

support community plans to identify and 
develop human resources within minori- 
ty communities for the drug abuse and 
HIV intervention effort and implement 
them on an urgent basis. 

8-30 The federal government should support 

regional workshops to provide educa- 
tors, parent groups, voluntary organiza- 
tions, and community leaders with skills 
to conduct effective prevention pro- 
grams to meet local needs. 

8-31 Community and parental involvement 

should be sought in community-wide 



drug abuse programs. Developing public 
commitment to the elimination of drug 
trafficking should be an integral part of 
this effort. 

8-32 Innovative community-based prevention 

programs should be implemented, such 
as culturally significant and current 
modes of communication, like "Rap" 
contests on preventing drug abuse and 
HIV, and peer youth training aimed at 
preventing initiation into the drug cul- 
ture. 

8-33 Current information and prevention 

strategies should be used widely within 
our education systems and communities 
to create an atmosphere which promotes 
drug-free lifestyles. Educational materi- 
als and prevention strategies must be 
age-appropriate and culturally relevant. 

8-34 The media should be urged to donate 

air time for appropriate messages on 
drug abuse and HIV. Additionally, pro- 
gramming should include accurate mes- 
sages on the consequences of drug 
abuse. 

8-35 The Department of Housing and Urban 

Development, in conjunction with state 
drug abuse agencies, should give special 
attention to public and other low income 
housing in creating a drug-free environ- 
ment for youth. Communities in public 
housing that want to establish drug 
abuse prevention programs should be 
offered the organizational support of 
drug abuse prevention specialists and 
funding to support drug abuse education 
and prevention campaigns. 

8-36 Schools, churches, and religious institu- 

tions should be encouraged to design 
appropriate value-oriented educational 
programs to discourage drug abuse and 
to encourage rehabilitation. 

Outreach Education 

Although education is one component of an 
outreach effort that should be an ongoing and 
persistent process, it alone cannot necessarily 
change behavior. Targeted information, cou- 
pled with intervention and treatment, is more 
likely to produce the desired behavior change. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in providing outreach 
education: 



100 



Because drug abusers are engaged in illegal ac- 
tivity, they are frequently alienated from society 
and therefore more difficult to reach through the 
usual education channels. However, contrary to 
common belief that intravenous and other types 
of drug users do not care about their health, out- 
reach efforts thus far have identified concern 
among drug users about HIV infection and a 
willingness to change behavior in order to 
reduce the risk of infection. 

Currently, much needed outreach is being con- 
ducted in high-incidence areas; as that work con- 
tinues and is expanded, low-incidence communi- 
ties must not feel any sense of complacency. 
There is little time from the introduction of HIV 
into a drug-abusing population to the increase of 
the prevalence of the infection in that communi- 
ty. Action must be taken in advance to prevent 
the spread of the virus. 

In reaching drug users, the most effective tech- 
nique demonstrated so far has been the use of 
indigenous street outreach workers, often ex-ad- 
dicts, who are recruited and given intensive 
training on HIV and its spread. Many more of 
these trained outreach workers are needed. They 
should be provided with written material to dis- 
tribute and should initiate conversations with 
drug users near shooting galleries and other 
places frequented by drug users, engaging in 
one-on-one communication and education. 

Outreach workers who meet with drug abusers 
and discuss risk reduction report that the drug 
users ask for treatment. Unfortunately, with na- 
tionwide waiting lists, outreach workers too often 
do not have treatment to offer. This leaves ad- 
dicts who are ready to receive help with virtually 
no options. 

With 70 percent of the perinatally transmitted 
pediatric HIV patients being the children of in- 
travenous drug-abusing women or women whose 
sex partners are intravenous drug abusers, these 
women are at increased risk and need many spe- 
cialized services, which today are in extremely 
limited supply. 

Many minority communities face disproportion- 
ate rates of HIV infection; too few targeted out- 
reach programs are currently being designed and 
implemented for these communities. 

Verbal, one-on-one communication within the 
minority communities appears to be the most ef- 
fective way to communicate health messages. We 
solicit the help of religious institutions to reach 
this population. Television and radio can also be 
effective if appropriate assessments are made of 
peak viewing and listening times. 



RECOMMENDATIONS 

In response to these obstacles in outreach 
education, the Commission recommends the 
following: 

8-37 The National Institute on Drug Abuse 

should sponsor additional research to 
determine which techniques are effective 
in producing behavior change among in- 
travenous drug abusers. Particularly 
needed is research examining the most 
effective ways of educating ethnically and 
culturally diverse groups. Since time is 
critical, research must take place in con- 
junction with the institution of pro- 
grams. 

8-38 While drug-using populations in high 

HIV-prevalence regions are targeted, 
those communities in low-incidence 
areas should recognize the threat of HIV 
spread and encourage drug users to seek 
treatment. While treatment has proven 
effective in reducing the rate of spread 
of the HIV, the spread will not be 
stemmed without intervention in both 
low- and high-incidence communities. 
Outreach programs to the drug-abusing 
population should therefore be expand- 
ed in both high- and low-incidence 
areas. In addition, communities with low 
HIV prevalence rates in their intrave- 
nous drug-using population should 
engage in prevention and education 
campaigns to keep those rates low. 

8-39 State and local drug abuse agencies 

should expand the treatment system and 
outreach efforts together. Outreach 
workers must have treatment programs 
available to offer drug users who are 
willing to take action. Education without 
treatment is empty. 

8-40 Programs aimed at prevention, interven- 

tion, and rehabilitation among intrave- 
nous drug users should include outreach 
to their sexual partners. All providers of 
care in substance abuse programs should 
be enlisted in efforts to prevent sexual 
transmission of HIV. 

8-41 Creative outreach programs should be 

implemented to reach drug users and 
adolescent runaways in homeless shel- 
ters, shooting galleries, hospitals, and 
other places where addicts congregate. 
Innovative outreach techniques should 
be used, including such ideas as the dis- 
tribution of coupons to be redeemed for 
drug treatment and the use of mobile 
vans. One-on-one communication should 
be supplemented by flyers, posters, and 



101 



other creative means of presenting infor- 
mation. 

8-42 Outreach efforts should have an HIV 

prevention and risk reduction emphasis, 
focusing on the risks associated with 
needle- and paraphernalia-sharing as 
well as sexual and perinatal transmission. 

8-43 Training of street outreach workers and 

of staff should be continued and expand- 
ed. Ex-addict street educators should be 
integrated with community-based treat- 
ment staffs who are familiar with the 
communities where they work and reflect 
the ethnic composition of the communi- 
ties. 

8-44 Prevention programs for minorities 

should be established at the grass roots 
level and on a one-to-one basis with 
peer contact, in shooting galleries and in 
neighborhoods. The information pre- 
sented must be understandable, cultural- 
ly sensitive, and direct. Ethnic minorities 
should be included in the planning, de- 
veloping, and implementation of such ef- 
forts. 

8-45 Outreach efforts should be targeted at 

female intravenous drug users and fe- 
males of childbearing age who are sexual 
partners of intravenous drug users. All 
providers of women's health care should 
be enlisted in efforts to prevent sexual 
transmission of HIV. Most women who 
visit a women's health care provider, 
whether it be for family planning or a 
routine checkup, have no other health 
contact annually. 

8-46 All women's health care providers, in 

providing pregnancy and maternity serv- 
ices, should make maximum effort to 
avoid increasing the risk of infection of 
neonates by infected pregnant women. 



Supply of Illegal Drugs to the United 
States 

The dangers and costs of drug abuse have 
taken on a new dimension, a greater horror, 
because of the relationship between HIV infec- 
tion and drug use. Recent efforts to control the 
use of illegal drugs have demonstrated the im- 
portance of addressing both the demand for 
drugs and the readily available supply of drugs 
in our society. Along with many others, the 
President's Commission on Organized Crime 
has pointed out the "... dual nature of the 
drug phenomenon: drug supply and drug 



demand are mutually dependent aspects of a 
single global problem." 

Our young people are lured into drug abuse 
by the ready availability of illicit drugs. For 
those who have few alternatives in life, dealing 
in drugs offers "easy" money and a luxurious 
lifestyle, leading to drug trafficking and other 
crimes. It is imperative that we break that chain 
by reducing simultaneously both the supply of 
drugs and the demand for drugs. 

Illegal drugs are readily available on our 
streets for those who want to buy, from both 
domestic and imported sources. Marijuana is a 
leading cash crop in some areas of this country, 
undermining our efforts to persuade foreign 
governments to eradicate crops in their coun- 
tries. An estimated 3,000 shipments of illegal 
drugs enter this country each day. Despite a 
record number of seizures, more cocaine is 
coming into this country each year (in 1987 the 
Drug Enforcement Agency seized almost 
79,200 pounds), its price is decreasing, and co- 
caine use is increasing. Stopping the flow of 
drugs into this country must be addressed at 
both the source in foreign countries and at our 
borders. The Commission supports current ef- 
forts to strengthen international narcotics con- 
trol through bilateral and multilateral agree- 
ments, development assistance, and collabora- 
tion with foreign governments on training pro- 
grams for foreign officials, crop eradication, 
and law enforcement activities. At the same 
time, detection of drug smugglers must be aug- 
mented by increased surveillance of ships and 
planes carrying drugs into the United States 
and strengthened law enforcement by federal 
agencies. The unique capacity of the military 
and National Guard should be appropriately 
utilized in partnership with domestic drug en- 
forcement agencies. 

In conjunction with the fight against drug 
smuggling, a strong effort to reduce the do- 
mestic drug supply must also be launched. Cul- 
tivation of marijuana crops and laboratory pro- 
duction of dangerous drugs such as PCP must 
be curbed. To create a realistic deterrent to 
drug abuse, harsher penalties should be im- 
posed both on those who sell drugs and those 
who buy and use drugs. Enforcement of drug 
laws at the state and local levels should be 
increased with stiffer sentences, larger fines, 
and forfeiture of assets derived from drug traf- 
ficking. Judges must recognize their obligation 
to support responsible law enforcement. 



102 



Strengthening law enforcement against illicit 
drug trafficking and drug use will create new 
needs in an already overburdened criminal jus- 
tice system, and require additional courtroom 
personnel and facilities and more jails and pris- 
ons. 

The Commission recognizes that the task of 
formulating strategic drug control planning and 
policies falls principally on others whose focus 
is directed toward those ends. However, nu- 
merous experts at the federal, state and local 
levels testifying before the Commission empha- 
sized repeatedly the multiple complexities of 
the drug problem and the strong correlation 
between the demand for and the supply of 
drugs. The fight to end drug abuse in America 
calls for the integration of education, preven- 
tion, treatment, enforcement, prosecution, and 
corrections. This Commission must act to en- 
hance efforts in all these areas. The magnitude 
of the threat for the spread of HIV infection 
posed by the current levels of drug abuse is too 
great for this Commission not to take some 
responsibility for finding solutions to the 
supply aspect of the drug problem. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to reducing the supply of illicit drugs 
in this country: 

• Exorbitant demand for drugs by Americans from 
diverse economic backgrounds. 

• Inadequate deterrence in existing drug laws. 

• Huge profits in marketing of illegal drugs which 
eases recruitment of youngsters into peddling 
drugs and leads to drug-related crime. 

• Reported rivalries and lack of cooperation 
among law enforcement agencies at the federal, 
state, and local levels which sometimes hampers 
coordinated, broad-based action against drug 
traffickers. 

• Limited resources in the criminal justice system 
leading to lack of trained and experienced per- 
sonnel, both investigative and prosecutorial; in- 
adequate jail space; and overcrowded prisons. 

• Tolerant attitude toward drugs by courts, legisla- 
tures, and the community in general; lenient sen- 
tencing by judges. 

• Resource constraints of drug supply countries. 

• Lack of alternative lifestyles for those in poverty. 



• Very extensive and open movement of people 
across United States borders. Approximately 6.5 
million people per year apply for tourist visas in 
the United States, with approximately 300 mil- 
lion border crossings between the United States, 
Mexico, and Canada. 

• Casual attitude about the serious repercussions 
of breaking the law. 

RECOMMENDATIONS 

The Commission believes we should perse- 
vere in our efforts to develop a comprehensive 
approach to eliminating the traffic in illicit 
drugs. Specifically, the Commission recom- 
mends: 

8-47 State and local governments should 

make illicit drug control a high priority 
and provide adequate funds for drug-re- 
lated programs. Increased funding 
should be provided for additional law 
enforcement personnel, prosecutors, ju- 
dicial resources, and prisons. 

8-48 State and local governments must 

strengthen their drug abuse laws and 
regulations and increase their enforce- 
ment. In addition to strengthening pro- 
grams to reduce the supply of illicit 
drugs, individuals and community orga- 
nizations should establish strong anti- 
drug policies aimed at reducing the 
demand for drugs. For example, schools 
and colleges and universities must estab- 
lish and enforce strict anti-drug policies 
and procedures for students, teachers, 
administrators, and staff. All private and 
public employers, including transporta- 
tion organizations, should have a strong 
anti-drug work policy applicable to all 
employees. 

8-49 States should enact stronger penalties 

for those convicted of selling, possess- 
ing, and/or using drugs, including, 
where appropriate, minimum mandatory 
sentences. Individuals on probation or 
parole from drug sentences should have 
probation or parole revoked upon viola- 
tion of the conditions of their release, 
especially where those violations are 
drug-related. 

8-50 State and local governments should de- 

velop programs aimed at parents of 
minors convicted of drug-related of- 
fenses, including elements such as train- 
ing courses and community service re- 
quirements. 



103 



8-51 The process for confiscating, liquidating, 

and distributing the assets of drug sell- 
ers and users must be enhanced: 

• The Federal Bureau of Investigation 
and the Drug Enforcement Adminis- 
tration must hire and train more for- 
feiture specialists to ensure more ex- 
peditious review of seizures. 

• All states should enact asset seizure 
and forfeiture statutes. 

• Greater effort must be made to pro- 
tect seized assets in custody to ensure 
that assets retain their maximum 
value. 

• Consideration should be given to per- 
mitting, under certain circumstances, 
asset forfeiture funds to be disbursed 
for capital expenditures related to 
drug control operations. 

• With respect to the sharing of funds 
generated by forfeited property pur- 
suant to statutory provisions, consid- 
eration should be given to expanding 
the scope of such equitable sharing 
provisions to permit sharing by for- 
eign government law enforcement au- 
thorities assisting in United States 
government drug control operations. 

In addition to the above recommendations, 
the Commission strongly endorses other drug 
control efforts, many of which are currently 
underway. In endorsing these programs we rec- 
ognize that some may have significant cost im- 
plications. However, we will leave the cost ben- 
efit analysis of these programs to those more 
directly involved in the process of implement- 
ing the programs. Accordingly, the Commis- 
sion strongly endorses the following: 

• The National Drug Policy Board should continue 
its efforts to coordinate the programs of federal 
agencies involved in the enforcement of drug 
control laws. The budget, resources, and oper- 
ations of the involved agencies should be coordi- 
nated to the fullest extent possible to achieve the 
most efficient use of available resources and 
avoid duplication and waste. 

• Consistent with both established worldwide com- 
mitments of United States military forces and tar- 
geted appropriated funding, the Department of 
Defense (DoD) should continue to provide, and 
on a sustained basis for the foreseeable future, 
military support to the national effort to stem the 
supply of drugs. DoD should regularly advise law 
enforcement officers of DoD capabilities to assist 
in the drug supply effort and facilitate the proc- 
ess for responding to requests for assistance. 

• The Drug Enforcement Agency (DEA) should 
strengthen the coordination of all state, local, 
and federal eradication initiatives. DEA should 



continue working with the states to develop new 
programs to eradicate illicit crops and laborato- 
ries and through the State Department to expand 
efforts to convince governments in countries 
where drugs are grown to develop and enhance 
eradication programs. 

• The Customs Service and the Coast Guard 
should have access to the most sophisticated de- 
tection equipment and boats and airplanes to 
carry out maritime and air interdiction missions. 

• Aggressive enforcement of the criminal justice 
provisions and international narcotics control 
provisions of the Anti-Drug Abuse Act of 1986, 
and full funding of the provisions relating to 
drug law enforcement should be continued and 
strengthened. 

• Collaboration between federal, state, and local 
law enforcement agencies in carrying out drug 
control policies to maximize the impact of the 
federal plan within every jurisdiction in the coun- 
try should be continued and strengthened. Drug 
control policies need to be comprehensive and 
need to emphasize the importance of sustained 
efforts by interdiction and law enforcement agen- 
cies. 

• Expansion is needed of Department of Justice 
(DOJ) assistance to state and local narcotics en- 
forcement programs, including technical assist- 
ance in drafting of state legislation on money 
laundering, drug conspiracy based on the Feder- 
al Racketeer Influenced and Corrupt Organiza- 
tions provisions (RICO), electronic surveillance, 
forfeiture, enhanced penalties, and grand jury 
powers. Also, enhancement of DOJ training pro- 
grams for state and local investigators and pros- 
ecutors should be undertaken. In addition, DOJ 
sharing of intelligence information, technical and 
laboratory facilities, and non-English language 
support teams with state and local governments 
should continue. 

• Federal, state, and local prosecution authorities 
should develop programs to provide incentives 
to recruit, retain, and, where necessary, relocate 
experienced prosecutors to handle drug-related 
cases. 

• Leadership by district attorneys is needed in the 
development and implementation of comprehen- 
sive community wide anti-drug programs in addi- 
tion to aggressive prosecution policies and prac- 
tices. 

Section II. Homeless Persons with 
HIV Infection 

The increasing number of homeless persons 
with HIV infection ~ and homelessness in gen- 
eral — is a serious problem for which there are 
few simple solutions. Estimates of the size of 
America's total homeless population vary 
widely, from 400,000 (National Bureau of Eco- 
nomic Research) to three million (National Co- 



104 



alition for the Homeless). Reasons for home- 
lessness also vary, but common causes include 
rising housing costs, falling wages, cuts in serv- 
ices to the mentally ill, and, most significantly 
for persons with HIV infection, discrimination. 

In general, the homeless in America can be 
divided into three groups, all vulnerable to the 
spread of the HIV epidemic. Approximately 40 
percent are chronically and severely mentally 
ill, receive no treatment while they live on the 
streets, and are subject to total health care dep- 
rivation, multiple infections, alcohol and drug 
addiction, and physical abuse. The fastest 
growing segment are poor families, whose prin- 
cipal wage earner has become jobless or has 
low-paying work. These families now account 
for one-third of the homeless population. The 
largest homeless group is comprised of single 
men, of whom approximately 30 percent are 
veterans. Many have been on the streets for 
several years, have become desocialized, and 
have drug habits or criminal histories. These 
are all difficult populations to reach, and per- 
sons with HIV infection in each of these groups 
require a stable environment in which to live, 
access to medical care, and education about 
transmission. 

Two types of housing for homeless persons 
with HIV infection currently exist and both are 
in critically short supply: temporary overnight 
shelters and congregate living facilities that 
provide a permanent residence. An increasing 
number of HIV-infected persons stay in munic- 
ipal shelters on a night-to-night basis and are 
required to leave during the day. For these 
persons in particular, access to medical care is 
almost non-existent. Individuals often hide 
their illness because discovery may mean physi- 
cal and psychological abuse, or because once 
diagnosed, they are no longer eligible for shel- 
ter residency. In many instances, once admitted 
to a hospital, a homeless person cannot be re- 
leased until he has a permanent address, and 
shelters do not qualify as official residences. 
Testimony before the Commission indicated 
that too often homeless persons with AIDS and 
HIV-related diseases die in the streets, having 
found the health care system too difficult to 
enter or too unresponsive to their special 
needs. 

Persons with HIV infection may become 
homeless when job discrimination or the debili- 
tating effects of the disease result in inability to 
work and inability to continue paying medical 
insurance premiums, medical bills, or rent. Wit- 



nesses before the Commission have told of 
being unable to obtain rental assistance and 
being abruptly evicted by landlords, primary 
tenants, or, in some instances, relatives and 
roommates. Testimony stated that one woman 
had returned from a stay in the hospital only to 
find herself locked out of her apartment and 
her belongings on the sidewalk. 

Housing for homeless persons with sympto- 
matic HIV infection is even more limited than 
for the general homeless population. The 
person with HIV infection and a damaged 
immune system cannot survive for very long 
living on streets, in subways, or city parks. 
Even in shelters, he or she may be exposed to 
infectious diseases that could prove life-threat- 
ening. Among the general New York City shel- 
ter population, for example, tuberculosis has 
risen at an alarming rate. The housing pros- 
pects for homeless HIV-infected women with 
children are even more bleak. 

Adolescents who live on the streets are an- 
other homeless problem directly tied to the 
spread of the HIV epidemic. Many of these 
children work on the streets as prostitutes in 
order to pay for food or to support a drug 
addiction. Organizations that assist runaway 
youth provide much needed protection for 
these adolescents, but the problem is greater 
than the supply of help, and prevention mes- 
sages are often too late. Dr. James T. Kennedy, 
Medical Director of Covenant House in New 
York, testified before the Commission that in a 
recent study of his adolescent clients, 40 per- 
cent were already HIV-infected. 

The housing crisis for homeless persons with 
symptomatic HIV infection is greatest in our 
large cities, which are unable to deal with their 
general homeless population, and are unpre- 
pared, in terms of resources, to respond to the 
new problem of homeless persons with HIV- 
related diseases. While it is difficult to establish 
concrete estimates of the size of the population 
of homeless persons with HIV, one study esti- 
mated that as many as 1,000 to 2,000 HIV- 
infected people reside nightly in New York City 
shelters. Mr. Peter Smith, President of the Part- 
nership for the Homeless Inc., testified before 
the Commission that: New York City has no 
separate emergency housing shelter facilities 
for persons with HIV-related illnesses; the 
rental assistance program is inadequate; only 
18 scatter-site apartments are now available for 
persons with AIDS; the only specialized home- 



105 



less facility for persons with HIV-related ill- 
nesses, Bailey House, has 44 units; and plans 
for renovating city-owned abandoned buildings 
have not been pursued. 

Federal Housing Programs 

The United States Department of Housing 
and Urban Development (HUD), the primary 
source of federal funds for developing such 
housing, provides funds for both permanent 
and temporary housing. In 1987, Congress en- 
acted the Stewart McKinney Homeless Assist- 
ance Act, and provided five programs to be 
administered through HUD for homeless relief. 
Of most direct potential benefit to homeless 
persons with HIV-related illnesses is the Tran- 
sitional Housing Demonstration Program, 
funded at $70 million last year and $49 million 
this year. This program is intended to fund 
innovative approaches to develop housing serv- 
ices for homeless persons who are capable of 
making a transition to independent living. 

Another program, entitled the Section Eight 
Moderate Rehabilitation Program, assists com- 
munities in the rehabilitation of single-room 
occupancy dwellings. Under this program, pri- 
vate funds pay for renovation work, and HUD 
funds are used to provide rental assistance to 
low-income households so that the property 
owner can repay the loan for rehabilitation 
work. In December 1987, HUD awarded $35 
million to 19 public housing agencies to devel- 
op over 1,000 units of this housing through the 
rent collected. A representative from HUD, tes- 
tifying before the Commission indicated that 
one project recipient is the Phillips Hotel in 
San Francisco, which will provide 33 single- 
room occupancy units in a structured living en- 
vironment for people with various stages of 
HIV infection. This project will also provide 
concentrated support, counseling, and health 
services. 

Community Development Block Grant funds 
can also be used by states and localities for 
housing programs. HUD distributes nearly $3 
billion a year on a formula basis in this pro- 
gram, with approximately $165 million being 
used for homeless shelters over the last few 
years. 

Housing assistance was provided to a total of 
four million households nationwide last year. 
Central to HUD's current housing assistance 
program for permanent housing is the distribu- 
tion of rent certificates and vouchers. This as- 
sistance is currently given to one million house- 



holds. Single non-elderly persons are usually 
given a low priority for such vouchers, but 
handicapped persons are given a higher priori- 
ty. Persons with HIV infection may or may not 
qualify for a higher priority rating, based on 
local regulations. 

Mortgage insurance for the development or 
renovation of intermediate or long-term care 
facilities is available under the National Hous- 
ing Act through provisions in Section 232. To 
date, HUD has not received any quantity of 
applications oriented to HIV-related services, 
and there is serious doubt that such applica- 
tions would be funded since a key consider- 
ation is whether or not there will be adequate 
income to pay off the mortgage. Only four 
states have Medicaid payment levels for per- 
sons with HIV that approach the level of reim- 
bursement necessary to make the development 
of boarding homes or intermediate care facili- 
ties for persons with HIV-related illnesses fi- 
nancially feasible. 

Medical Care for the Homeless 

The Health Resources and Services Adminis- 
tration (HRSA), in the Department of Health 
and Human Services (HHS), provides medical 
assistance to homeless persons with HIV-relat- 
ed illnesses through the following programs: 

• The Bureau of Health Care Delivery and Assist- 
ance (BHCDA) is responsible for implementing 
the health care provisions of the Stewart McKin- 
ney Homeless Assistance Act. This Act calls for 
the provision of primary care, substance abuse 
and mental health services to the homeless popu- 
lation. BHCDA granted a total of over $44 mil- 
lion to 108 organizations, primarily Community 
Health Centers, to provide such care. Any provi- 
sion of care for substance abuse also implies HIV 
educational and prevention activities. 

• The Bureau of Maternal and Child Health and 
Resources Development (BMCHRD) is responsi- 
ble for the educational and prevention activities 
as well as grant support to communities for HIV 
services. The budget for these efforts for FY 
1988 is approximately $25 million. All AIDS 
demonstration projects include intravenous drug 
user program components. Since a large propor- 
tion of the homeless use intravenous drugs, this 
linkage ties together the homeless and HIV inter- 
vention activities. 

• BHCDA has awarded grants to 43 community 
and migrant health centers totaling $2 million 
for the integration of substance abuse recogni- 
tion, diagnosis, referral and follow-up activities. 
While no direct linkage was mandated with HIV 



106 



initiatives, the drug abuse/HIV relationship and 
the homeless/drug abuse relationships are clear. 

• A joint project between HRSA and the National 
Institute of Mental Health (NIMH) is just begin- 
ning to get underway. This $400,000 project will 
fund: 

• training programs for homeless youth shelter 
staff; 

• an ethnographic study of what is currendy 
being done in adolescent HIV prevention 
projects; 

• development of model policy guidelines for 
adolescent facilities; 

• regional meetings to address assistance of 
street youth who become infected or are 
symptomatic with HIV disease; and 

• technical assistance to communities. 

Obstacles to Progress 

• An accurate estimate of the size of the homeless 
population of persons with HIV infection is lack- 
ing. 

• Seroprevalence studies have not been done on 
this difficult-to-track population. An adequate as- 
sessment of the size and scope of the problem of 
homelessness of persons with HIV infection is 
necessary to target future resources. 

• Individuals with HIV infection may receive low 
priority ratings for housing subsidies due to local 
regulations. 

• Construction of shelters or group residences for 
persons with symptomatic HIV infection has not 
kept pace with demand in many cities. 

• Municipal shelters are unable to diagnose HIV 
infection or target medical resources to HIV-in- 
fected persons in shelters. 

• Hospitals are often unable to discharge medically 
stable homeless patients because they have no 
permanent street address. 

• Service needs of special populations, such as 
adolescents and women with children, have not 
been defined or estimated. 

RECOMMENDATIONS 



8-52 



Federal anti-discrimination protection 
for persons with disabilities, including 
persons with HIV infection, should be 
expanded to cover housing that does not 
receive federal funds. The Department 
of Housing and Urban Development 
(HUD) should clarify that Section 504 of 
the Rehabilitation Act currently prohibits 
discrimination against persons with HIV 
infection if federal funds are involved. 
HUD should actively enforce Section 
504. 



8-53 The Department of Housing and Urban 

Development funding for homeless as- 
sistance programs should be increased, 
and funds should be made more easily 
available to cities and private sector or- 
ganizations to build both temporary 
shelters and permanent residences for 
homeless persons with HIV infection. 

8-54 Operators of all homeless shelters and 

residences must treat those clients who 
are HIV-infected in an anti-discrimina- 
tory manner, protect them from abuse, 
and help them seek medical assistance as 
needed. 

8-55 The Centers for Disease Control should 

fund and coordinate targeted seropreva- 
lence studies (e.g., on adolescents, 
women, and adult men) to be conducted 
by city agencies in high prevalence cities 
to establish the size of the homeless 
population of persons with symptomatic 
HIV infection and to help cities deter- 
mine the need for services. In addition 
to HIV antibody status, these studies 
should gather information on concurrent 
medical problems, such as tuberculosis 
and drug addiction, to both collect co- 
factor information, and determine the 
need for greater medical intervention in 
municipal shelters. Study results includ- 
ing geographic breakdowns should be 
made available to national mayors' asso- 
ciations, to the Association of State and 
Territorial Health Officials, and to state 
and local officials, as appropriate. 

8-56 The joint project between the National 

Institute of Mental Health and the 
Health Resources and Services Adminis- 
tration on adolescent homeless youth 
and HIV infection should be expanded 
and funding increased. More programs 
on homeless youth should be funded. 

8-57 The Department of Housing and Urban 

Development should provide renovation 
grants to public hospitals to convert un- 
derutilized acute care beds into long- 
term care beds for HIV-infected individ- 
uals requiring hospice or other long- 
term care. 

8-58 The use of the Department of Housing 

and Urban Development funds to help 
finance construction and improvement of 
nursing homes and related facilities 
should be encouraged to make addition- 
al long-term care and hospice care beds 
available. 

8-59 The Veterans' Administration should 

conduct a short-term study to determine 



107 



the extent of homelessness among veter- 
ans, and HIV infection in this popula- 
tion. The results of this study should be 
forwarded to the Secretaries of Housing 
and Urban Development and Health and 
Human Services for future resource allo- 
cation. 

Section III. Infants and Children 
with HIV Infection 

There has been a recent, disturbing rise in 
pediatric AIDS cases, with 85 percent of the 
total cases reported since 1985. Through June 
6, 1988, of the total of 64,506 cases of AIDS 
reported to CDC, 1,013 have been infants and 
children under the age of 13 at the time of 
diagnosis. According to the Report of the Sur- 
geon General's Workshop on Children with 
HIV Infection and Their Families, over 75 per- 
cent of babies born with AIDS are black or 
Hispanic. Public health experts predict a sub- 
stantial increase in pediatric AIDS cases by 
1991, ranging from 3,000 cases estimated by 
the Public Health Service to 10,000 to 20,000 
AIDS cases predicted by the National Commis- 
sion to Prevent Infant Mortality. 

CDC categorizes pediatric AIDS cases as chil- 
dren of a parent with or at risk of AIDS, hemo- 
philiacs, or children who became infected 
through a blood transfusion. For a large major- 
ity, epidemiologic data suggests perinatal trans- 
mission from a mother who uses intravenous 
drugs or is the sexual partner of an intravenous 
drug user. Most pediatric AIDS cases that are 
being diagnosed now fall within this category, 
as transmission to hemophiliacs and through 
blood transfusions have been largely prevented 
with new blood screening methods. 

Hospitals serving pediatric HIV cases, espe- 
cially urban hospitals in areas with a high inci- 
dence of drug abusers, report a growing prob- 
lem with children with HIV infection who must 
remain in the hospital when it is no longer 
medically necessary for them to be there simply 
because there is no one to care for them at 
home. In some cases the parents are drug ad- 
dicts, are themselves ill with HIV infection, or 
have previously died from HIV-related diseases 
and the child has been abandoned. In other 
cases, the family may be homeless, or the par- 
ents are ill and there is no extended family able 
to take care of the child. 

As a result, these children must live in a 
hospital setting, receiving intermittent attention 
from a variety of attendants, rather than experi- 



encing the stimulation and bonding with a con- 
stant care giver that occurs in a home atmos- 
phere. In addition, they unnecessarily occupy 
costly hospital beds and stretch hospital budg- 
ets when a less expensive, community-based 
setting would better meet their needs. 

While hospitals and service agencies are 
stretched to their limits in some areas with a 
high incidence of pediatric HIV infection, other 
areas have yet to face the problem. While a 
serious problem now, care of an increasing 
number of HIV-infected children may over- 
whelm hospital budgets in the future unless a 
plan is developed to place these children in 
more appropriate settings, either with their 
own families or, where that is not possible, in a 
foster home or small group home. 

Obstacles to Progress 

The Commission has identified the following 
obstacles that must be overcome in order to 
provide proper care for these children: 

• Parental drug abuse. 

• Medicaid coverage for HIV-infected children 
which does not extend to home or community- 
based health care. 

• The overburdened and underfinanced foster care 
system, characterized by a scarcity of foster 
homes for all children, especially those with HIV 
infection. 

• Lack of collaboration and cooperation at the fed- 
eral, state, and local levels to provide a continu- 
um of services for these children. 

The Commission has heard testimony from 
individuals and groups who are working to pro- 
vide homes for infants and children with HIV 
infection. Although the societal problems 
giving rise to children boarding in hospitals 
encompass some of the most difficult issues to 
resolve, such as drug abuse, unemployment, 
school drop-outs, teen pregnancy, sexual 
abuse, prostitution, crime, homelessness, and 
poverty, the Commission believes that home 
settings can be found for these children. The 
first option should be to provide supportive 
services to nuclear and extended families. In 
addition, utilizing special training and support 
services and special foster care rates, foster 
families should be found for children with HIV 
infection who cannot return to their biological 
families. 



108 



Because of the scarcity of individual foster 
homes, group homes must also be developed 
for HIV-infected children. The Commission has 
heard testimony about outstanding model 
homes which are small, humane, and tailored 
to the needs of small children. Group homes 
like these should be developed to provide tran- 
sitional homes while the child is waiting to 
return to his or her biological family or for an 
individual foster home to be found. Group 
homes should also be developed as intermedi- 
ate care facilities for those children who do not 
need the services and technology of an acute 
care hospital, but do need medical services 
(such as oxygen, catheters, or physical rehabili- 
tation services) which cannot be supplied in 
custodial foster homes. 

Supporting these families and providing 
foster care will be cost-effective. For example, 
according to an informal survey by the Child 
Welfare League of America and the National 
Association of Children's Hospitals and Related 
Institutions, the cost of hospital care for these 
children ranges about $1,200 per day com- 
pared with specialized foster care which aver- 
ages about $100 per day. Providing support 
services needed to keep families intact and de- 
veloping foster homes and foster group homes 
will improve the overall well-being of these 
children, while reducing the costs of maintain- 
ing them in expensive, acute care hospitals. 

RECOMMENDATIONS 

The Commission has the following recom- 
mendations, especially for areas with a high 
incidence of pediatric HIV infection: 

8-60 State and local social service agencies 

should establish a special HIV unit 
charged with development of a compre- 
hensive care program for biological and 
foster families with children with HIV in- 
fection. Children with HIV infection 
should be assigned to case managers 
who will be responsible for developing 
networks to provide supportive services, 
including visiting ijiurse and other medi- 
cal services, counseling and mental 
health services, nutritional programs, 
day care, and housing. 

8-61 State and local social service agencies 

should train special caseworkers to be 
assigned to cases involving HIV infec- 
tion. Case loads should be small so that 
the caseworker will be readily available 
to support the family in time of crisis. 



8-62 All social service agencies working with 

HIV-infected children should encourage 
kinship foster care, which has been a fre- 
quent solution in minority families espe- 
cially. In particular, the grandmothers of 
children with HIV infection have come 
forward to care for them and should re- 
ceive appropriate support services to 
enable them to provide homes for these 
children. Through local community and 
church groups, agencies should develop 
outreach programs for grandmothers 
and other relatives of children with HIV 
infection. 

8-63 Social service agencies should undertake 

aggressive recruitment of foster families, 
including contacting existing networks of 
foster parents in the community and em- 
ploying publicity to focus public atten- 
tion on these children and the need for 
foster homes. Agencies should consider 
non-traditional foster parents, including 
single and handicapped individuals, 
older parents, and senior citizens for 
children with HIV infection. 

8-64 Agencies funding foster care should give 

foster parents of children with HIV in- 
fection special incentives such as access 
to day care and respite care and an in- 
creased foster care stipend. Day care 
centers, with specially trained personnel, 
should be established to make foster 
care possible for a larger number of par- 
ents. Grandmothers and other relatives 
of children with HIV infection should be 
made eligible for foster care stipends. 

8-65 The Health Care Financing Administra- 

tion, in conjunction with state Medicaid 
agencies, should re-evaluate the eligibil- 
ity of infants with HIV infection for 
Medicaid through the Supplemental Se- 
curity Income and Aid to Families with 
Dependent Children programs. The re- 
lease of these children from hospitals 
should not be delayed simply because of 
the need for confirmatory testing and di- 
agnosis at 15 months to provide Medic- 
aid eligibility. 

8-66 The Health Care Financing Administra- 

tion (HCFA) should encourage and sup- 
port state social service agencies and 
Medicaid agencies to collaborate in ap- 
plying for and using any available waiv- 
ers to assure coverage for the full range 
of in-home and community-based serv- 
ices needed by HIV-infected eligible 
children. The state and local agencies in- 
volved should closely monitor the serv- 
ices provided under these waivers and 



109 



214-701 0-88 



0L 3 



request new waiver provisions from 
HCFA if necessary. 

8-67 The Department of Health and Human 

Services should provide adequate fund- 
ing for demonstration programs provid- 
ing residential care for babies who are 
abandoned in hospitals and temporary 
non-medical care for children with seri- 
ous illness. Programs should include 
both foster family care and innovative 
community-based alternatives to hospi- 
talization along with provision of day 
care, respite care, and other support 
services for care givers. Model programs 
should be developed in conjunction with 
local public social service and health 
agencies, religious organizations, child 
welfare agencies, community service, and 
voluntary organizations. Dissemination 
and replication of models should be en- 
couraged. Where appropriate, foster and 
respite care provided through not-for- 
profit sectarian and non-sectarian orga- 
nizations should be supported through 
federal and state funds. 

8-68 The Department of Housing and Urban 

Development should make available to 
states and localities matching funds for 
the construction or renovation of small 
group homes for HIV-infected children. 
These funds should be available for fa- 
cilities for day care and respite care for 
families of HIV-infected children as well 
as for group homes. 

Section IV. Community-Based 
Organizations 

Community-based organizations (CBOs) are 
private, non-profit, volunteer-based entities 
that provide a variety of services to the local 
community and occasionally to a wider domain, 
such as the state in which they are located. 
CBOs are, in every sense of the word, commu- 
nity-based. Their very survival is dependent 
upon local funding and the credibility they 
have established in the particular community 
they serve. 

CBOs have led the response to the HIV epi- 
demic in this country. AIDS-oriented CBOs 
began appearing as early as 1981 in areas of 
greatest infection, and they now appear 
throughout the country. The development and 
response of CBOs is an example of how even 
the worst of times can bring out the best in 
people. As stated in previous Commission re- 
ports, the work of these organizations, particu- 
larly at the beginning of the HIV epidemic, has 
been outstanding. Organizations in the homo- 



sexual community provided the leadership and 
subsequently developed most of the care deliv- 
ery models followed by others today. There 
now exists throughout many areas of the coun- 
try a network of organizations providing serv- 
ices. Most HlV-oriented CBOs have few paid 
staff, but rather make use of a large pool of 
volunteers from a variety of professions within 
the community. These organizations range in 
size from extremely small (one or two volun- 
teers) to very sizable (thousands of volunteers) 
serving thousands of HIV-infected persons. 

There has been a major increase in the 
number of CBOs in the black and Hispanic 
communities who have either expanded their 
services to include HIV, formed black or His- 
panic specific HIV organizations, or who have 
formed coalitions with other institutions in 
their communities to address the epidemic. 

CBOs vary greatly in their expertise and can 
provide a broad range of services such as 
health education, mental health services, health 
services, social services, medical assistance, case 
management, support groups, counseling, test- 
ing, food programs, clothing banks, and assist- 
ance with legal issues, housing, transportation, 
and utilities. CBOs have successfully used their 
credibility with hard-to-reach populations to 
bring education messages to a broad audience 
and to conduct research. Sources of funding 
for CBOs vary greatly. According to a Commis- 
sion survey, funding in general for HIV-orient- 
ed CBOs is largely private. However, other 
data indicate that CBOs which serve blacks and 
Hispanics have few private dollars. In fact, only 
one percent of all foundation funds are award- 
ed to Hispanic organizations. Government 
funds available for HIV-oriented CBOs have 
been extremely limited and are often channeled 
through local health departments. This ar- 
rangement can be problematic as local health 
departments have not had longstanding rela- 
tionships with CBOs. This is especially true for 
HIV-oriented CBOs and CBOs in black and 
Hispanic communities. 

Obstacles to Progress 

• There is currently minimal funding and no clear 
funding system that provides funds directly to 
CBOs for either program development and im- 
plementation or technical assistance. 

• Frequently, the services CBOs provide are to the 
indigent or those with little or no money to pay 



110 



for services. This adds to the already overwhelm- 
ing financial burden of the organizations. 

• Funding periods for grants are often for only a 
year at a time. This puts CBOs in a constant 
search for funding and a tenuous financial situa- 
tion year to year. 

• Individual CBOs have been growing at a phe- 
nomenal rate to keep up with the demand for 
services that the growing epidemic requires. 
Management capabilities within CBOs are often 
strained, and individuals with litde or no man- 
agement experience often are promoted rapidly 
to fill the growing needs. 

RECOMMENDATIONS 

8-69 Funds should be provided by the De- 

partment of Health and Human Services 
for a national technical assistance pro- 
gram for community-based organiza- 
tions. Technical assistance should in- 
clude training in general management 
practices, fund raising, and program de- 
velopment. 

8-70 A clear funding system, with increased 

funds, which provides money directly to 
community-based organizations, should 
be established by the Department of 
Health and Human Services. The grants 
should be used to provide a variety of 
services including counseling, prevention 
and education programs, assistance with 
housing, food, clothing, transportation, 
and securing needed medical and social 
services. Grant applicants should provide 
evidence of their ongoing coordination 
with state and local departments of 
health. 

Section V. The Workplace and HIV 
Infection 

Policies concerning the HIV-infected worker 
involve critical issues for the United States 
workplace. The impact of HIV will be felt both 
in terms of the personal suffering of the HIV- 
infected individual, especially as an employee 
becomes too ill to work, as well as the reaction 
of coworkers and members of the public with 
whom the individual comes in contact. Educa- 
tion about HIV infection and employment poli- 
cies for infected workers is imperative to enable 
employers to minimize disruptions in worker 
productivity, maintain employee morale, and 
avoid litigation for noncompliance with worker 
safety procedures or discrimination against 
HIV-infected employees. 

Some employers in both the public and pri- 
vate sectors have established exemplary HIV- 



related workplace programs and should be 
commended for their participation in national, 
state, and local coalitions which have brought 
issues related to HIV and HIV disease to the 
attention of the business community. A few em- 
ployee unions have also been active in both 
protecting the rights of employees with HIV 
infection and protecting the health and safety 
of workers, especially those in occupations 
where workers might be exposed directly to the 
blood of individuals infected with HIV. 

Corporate Response to the HIV Epidemic 

Notable among corporate leaders responding 
to the HIV challenge are: a group of San Fran- 
cisco-based companies which formed a Busi- 
ness Leadership Task Force in 1984; the Na- 
tional Leadership Coalition on AIDS, estab- 
lished in 1987, and now numbering over 100 
members from businesses, corporations, labor 
and voluntary groups, and religious bodies; and 
the Allstate Insurance Company, which spon- 
sored a 1987 conference on AIDS in the work- 
place, resulting in the report, "AIDS: Corpo- 
rate America Responds," a resource for both 
public and private sector employers preparing 
to establish HIV policies or guidelines. 

The "Ten Principles for the Workplace," de- 
veloped by the Citizens Commission on AIDS 
for the New York/New Jersey region, is an- 
other helpful guide for those involved in set- 
ting up HIV-related policies in the workplace. 

Workplace Policy 

Several federal agencies have developed 
policy statements covering the management of 
HrV-infected personnel in the workplace. 
Among the first to issue such guidelines was 
the General Accounting Office (GAO). In De- 
cember 1986, the Comptroller General estab- 
lished a GAO Task Force to determine how the 
growing incidence of AIDS could be expected 
to affect GAO and to identify any policy clarifi- 
cations or changes needed to respond appro- 
priately to the HIV epidemic. The report of the 
Task Force was published in December 1987 
and includes comprehensive workplace policies 
which meet four objectives: 

• Maintain a safe and healthful work environment 
for all employees. 

• Treat an employee with AIDS fairly and humane- 

iy. 

• Avoid disruptions to GAO productivity. 



Ill 



• Help managers deal efficiently and sensitively 
with HIV-related illness in the workplace. 

In March 1988, the Office of Personnel Man- 
agement (OPM) issued comprehensive guide- 
lines which outline employment policies for 
federal workers who are HIV-infected. The 
Commission commends OPM for developing 
these guidelines, which offer a compassionate 
approach to a delicate human situation and 
provide excellent advice based on open com- 
munication, comprehensive education, and 
sound legal principles. Employers should refer 
to these guidelines when developing policies 
for their employees with HIV. 

However, the majority of employers in both 
the public and private sectors have yet to devel- 
op programs or guidelines to address this 
issue. Small businesses in particular remain un- 
aware, for the most part, of the challenges of 
HIV, although they may be significantly affect- 
ed because of the size of their work forces, 
their small profit margins, and their inability to 
absorb major increases in health insurance 
costs for an employee with HIV-related dis- 
eases. 

Regardless of the size of the business, it is 
the responsibility of every employer to provide 
a safe environment for his or her work force. 
Employers should implement HIV-related poli- 
cies or guidelines before a case occurs to give 
everyone sufficient time to understand the pro- 
cedures and to demonstrate management's sup- 
port for protecting the rights of all their em- 
ployees. 

Obstacles to Progress 

• Many employers are reluctant to consider poli- 
cies regarding HIV-infected workers because the 
epidemic has not yet affected their work forces. 
They fear publicity associating their business 
with HIV infection will cause disruption among 
their work forces and drive customers away. 

• The lack of low-cost information about employ- 
ment policies for HIV-infected workers has de- 
terred many employers, especially small business 
owners, from implementing HIV policies and 
procedures. 

• Continued leadership is needed in the private 
sector to help employers, especially those in 
small- and medium-sized businesses, who may 
need assistance developing HIV-related policies. 

• For federal workers, each individual federal 
agency has the authority to determine the extent 
to which it implements the OPM guidelines. 



OPM does not have the authority to enforce 
compliance with these guidelines. 

RECOMMENDATIONS 

8-71 All public and private employers should 

ensure that their workplace policies pro- 
vide HIV-infected employees with the 
same rights and benefits offered other 
employees with other illnesses and dis- 
abilities. Employers are encouraged to 
use the Office of Personnel Management 
guidelines as a reference when planning 
their HIV policies and programs. (These 
guidelines appear in the Appendix). 

8-72 All federal agencies should serve as a 

role model for the private sector by im- 
mediately adopting and implementing 
the employment policies for HIV-infect- 
ed workers described in the Office of 
Personnel Management guidelines. 
These guidelines establish a policy for 
employers of responding to HIV-infect- 
ed individuals just as employers should 
with an individual with any other disease 
or disability (i.e., in a compassionate, 
humane, and fair manner). 

8-73 The President should consider requiring 

all federal agencies to comply with the 
Office of Personnel Management guide- 
lines and report annually to him on com- 
pliance. 

8-74 All employers are encouraged to take 

active roles in the community response 
to the HIV epidemic by supporting re- 
search, education, health care coalitions, 
and local HIV support groups. 

8-75 Large corporations are encouraged to 

work with other area businesses to help 
employers develop appropriate HIV-re- 
lated policies and to develop, print, and 
distribute education materials appropri- 
ate to the workplace. 

8-76 Low-cost or free information about 

model HIV policies and programs for 
the workplace should be made more 
readily available through the support of 
the private sector, non-profit organiza- 
tions, business and health coalitions, 
local Chambers of Commerce, and local, 
state, and federal governments. 

8-77 The Centers for Disease Control's Na- 

tional Clearinghouse on AIDS and the 
General Service Administration's Con- 
sumer Information Center should dis- 
seminate exemplary publications on HIV 
infection in the workplace produced by 
both the public and private sectors. 



112 



Employer-Employee Concerns 

The Commission believes that HIV-infected 
individuals, including those with symptomatic 
HIV infection, should continue their self-suffi- 
ciency through employment as long as possible. 
Every effort should be made to keep disabled 
individuals, including those with HIV infection, 
gainfully employed. 

Employers are encouraged to provide the 
same reasonable accommodations, including al- 
ternative work schedules and job modifications 
for employees with HIV-related problems that 
are offered employees with other illnesses or 
disabilities. Because HIV is not transmitted in 
the type of casual contact that generally takes 
place in the workplace, there is no justification 
for fear of transmission of the virus in the vast 
majority of workplace and public settings. In 
occupations where there is a risk of exposure 
to HIV, such as police officers, fire fighters, 
sanitation workers, and hospital workers, it is 
the employer's responsibility to provide health 
and safety protection and training for the work- 
ers, as was discussed in the chapter on health 
care providers. 

Some controversy exists about the extent of 
central nervous system impairment experienced 
by persons with HIV infection and the impact 
of such impairment on work performance. This 
question has been of particular concern to 
those employing persons in stressful and/or 
high performance occupations, such as airline 
pilots. 

HIV-related dementia was the subject of a 
World Health Organization (WHO) meeting 
earlier this year. A statement released by WHO 
on March 18, 1988 notes that available scientif- 
ic evidence does not show that the presence of 
HIV infection in itself implies a likelihood of 
impaired occupational performance. It states 
that HIV testing of employees is not useful in 
predicting the onset of functional impairment 
in persons who are otherwise healthy. 

The Commission concurs with this conclu- 
sion and supports the use of more sophisticat- 
ed measures for assessing the ability of individ- 
uals to work in positions requiring top neuro- 
logical functioning, regardless of whether the 
persons are infected with HIV. Based on testi- 
mony presented before the Commission, it 
would be misleading to assume that a positive 
HIV test is an accurate indicator of the physical 
or mental skills of the person tested. Likewise, 
a negative HIV test tells very little about an 



individual's ability to function in a particular 
job requiring significant manual and mental 
dexterity. 

The question of possible transmission of sec- 
ondary infections to coworkers by employees 
with HIV infection has been raised. HIV-infect- 
ed individuals are susceptible to infections such 
as Pneumocystis carinii, cytomegalovirus, and My- 
cobacterium tuberculosis. Most of these infections 
are "opportunistic" and occur only in people 
with lowered resistance because of immunode- 
ficiencies. Organisms such as Pneumocystis carinii 
are present everywhere and only cause an in- 
fection in individuals who are immunodeficient. 
Organisms such as cytomegalovirus are trans- 
mitted through intimate contact with infected 
body fluids and not by the type of casual con- 
tact which generally takes place in the work 
setting. 

Tuberculosis in HIV-infected individuals 
often occurs in organs other than the lungs and 
in these cases is less easily transmittable than 
pulmonary tuberculosis. Pulmonary tuberculo- 
sis in an HIV-infected individual is no more 
infectious than pulmonary tuberculosis in any 
other person. A common tuberculin skin test is 
not conclusive if a person's immune response is 
diminished. Therefore, additional diagnostic 
measures are required to confirm suspected tu- 
berculosis in an HIV-infected person, even rel- 
atively early in the course of the HIV infection. 
The Commission is concerned that no one be 
unnecessarily exposed to any tuberculosis or 
other infectious diseases while the disease is in 
an infectious stage. 

It is for this reason that the Commission 
strongly supports the reasoning in the Arline 
case relating to employment of an individual 
with a contagious disease, as described in detail 
in the discrimination section of this report. In 
Arline, the Supreme Court noted that under 
Section 504 of the Rehabilitation Act of 1973, 
such individuals would not be "otherwise quali- 
fied" for an employment position if they posed 
a significant risk of communicating the infec- 
tious disease to others in the workplace and 
reasonable accommodation could not eliminate 
that risk. 

The court in Arline delineated guidelines for 
determining whether an individual with a hand- 
icap is "otherwise qualified" for employment in 
terms of the contagious disease. These guide- 
lines include the examination of medical evi- 
dence to determine "a) the nature of the risk 



113 



(how the disease is transmitted), b) the dura- 
tion of the risk (how long is the carrier infec- 
tious), c) the severity of the risk (what is the 
potential harm to third parties) and d) the 
probabilities the disease will be transmitted and 
will cause varying degrees of harm." 

As with other contagious diseases, the Com- 
mission believes that this reasoning should be 
applied to the HIV infection and secondary in- 
fections from which the individual is actually 
suffering when an employer is faced with deter- 
mining whether or not an employee with HIV 
infection is "otherwise qualified." 

With regard to the personal safety of the 
HIV-infected worker in some occupations, spe- 
cial precautions may be necessary for certain 
circumstances, such as overseas travel to areas 
of poor sanitation or disease outbreak, or 
where there may be an increased risk of trans- 
mission of certain infectious organisms, such as 
in school situations when there is an outbreak 
of chicken pox, or in large animal veterinary 
work. HIV-infected individuals need access to 
information about the type of situations they 
should avoid to protect their health. 

Obstacles to Progress 

• Confusion surrounding methods of transmitting 
HIV has generated understandable but unwar- 
ranted fear among employers, causing unneces- 
sary termination of HIV-infected workers. 

• Fear of the effects of HIV-related dementia on 
work performance has prompted employers to 
request employee blood testing to determine eli- 
gibility for employment. 

RECOMMENDATIONS 

8-78 Employees with any disease or disability, 

including HIV infection, should be treat- 
ed with compassion and understanding 
and allowed to continue working as long 
as they are able to perform their job. 
The "otherwise qualified" standards ar- 
ticulated by Arline should be applied and 
reasonable accommodation should be 
made for the employee. 

8-79 Employers should, where indicated to 

protect the public safety, provide per- 
formance testing and evaluation, includ- 
ing neurological assessment, to detect 
functional impairment. The Commission 
does not recommend HIV blood screen- 
ing for this purpose. 

8-80 The Centers for Disease Control should 

classify the transmission modes of orga- 
nisms which cause secondary infections 



in HIV-infected individuals. This infor- 
mation should be written in easy-to-un- 
derstand terms and made available to 
employers and the general public 
through brochures or other appropriate 
means. 

Education and Information About HIV 

Fear and misunderstanding about HIV infec- 
tion has been the underlying cause of much of 
the anxiety, hostility, and discrimination shown 
towards HIV-infected individuals in the work- 
place. Education is one of the most formidable 
weapons for attacking this fear and ignorance 
and for maintaining a calm work environment, 
as well as stopping the spread of HIV. Employ- 
ers should take the initiative to educate their 
work force about the transmission and preven- 
tion of HIV infection and the laws prohibiting 
discrimination. In so doing, they will become 
an important part of the solution by educating 
the nation with the facts about HIV. In addi- 
tion, the widespread education of adults creates 
the necessary foundation for educating youth 
about this disease. 

Obstacles to Progress 

• The lack of information about HIV infection has 
prevented implementation of rational solutions 
to many HIV-related workplace issues and prob- 
lems. 

• Education programs that are not tailored to the 
concerns of the employees and which do not re- 
flect the culture of the business environment 
have little chance of success. 

RECOMMENDATIONS 

8-81 Employers should take a personal and 

active role in providing both manage- 
ment and employees with information 
about HIV and its transmission. 

8-82 Employers should work with employee 

representatives as well as area HIV edu- 
cation and health experts to tailor the 
HIV information program to the needs 
of the work force. 

Section VI. Religious Institutions 
and Organizations 

The Presidential Commission is well aware 
that the problems associated with HIV and its 
transmission must be addressed not only by the 
medical and scientific communities, but also by 
every sector of society including churches and 
other religious institutions. The Commission is 



114 



sensitive to the complexities of discussing 
moral values in a pluralistic society and recog- 
nizes its limitations in this regard. It does not 
hesitate to note, however, that religious organi- 
zations have done a great deal of effective work 
in the area of HIV, have contributed from an 
educational perspective in many important 
ways, and have encouraged others to approach 
HIV-infected persons and their families with 
compassion and understanding. 

We are aware that many religious-sponsored 
health care systems have provided medical as- 
sistance, hospital care, and residential facilities 
to all in need, without discrimination on reli- 
gious or any other grounds. They have been 
particularly effective in the care of the indigent. 
We see the religious institutions carrying out a 
critical role on a continuing basis, and encour- 
age them all to join with medical, scientific, and 
educational communities to help the broader 
community recognize the moral, ethical, and 
spiritual dimensions of the HIV crisis. We be- 
lieve that religious organizations can be of spe- 
cial assistance in continuing to emphasize the 
worth and dignity of every human being in 
providing care and offering hope to those af- 
flicted. Fully aware of the reality that ours is a 
diverse society, we believe, nonetheless, that it 
would do a grave disservice to individuals and 
their families were no recognition given to 
moral and spiritual guidance. 

Treatment of persons with HIV infection re- 
quires attention to the total care of the individ- 
ual as a unique person. All care should there- 
fore be rendered in the context of uncondition- 
al human dignity. Compassionate care coupled 
with clinical research to reduce despair and suf- 
fering are not exclusive but intermingled. 

Religious institutions have made unique and 
generous contributions in the area of patient 
care. Their financial liabilities in this regard are 
already formidable, particularly when they are 
supporting the care of the indigent in hospital 
systems. 

The religious community establishes two 
basic tenets: first, HIV is a treatable illness, 
early diagnosis and early treatment should be 
the standard; second, HIV is a preventable ill- 
ness. We have to look beyond quick fixes that 
only lead to a false sense of security, and actu- 
ally lead to a greater spread of the disease. 

Religious institutions are a powerful force 
within society against all forms of substance 
abuse and sexual promiscuity, the risk behav- 
iors that most continue to spread the epidemic. 



The Commission endorses their efforts and 
also urges religious institutions to use their sig- 
nificant social presence to continue the struggle 
against all forms of discrimination. 

RECOMMENDATIONS 

8-83 The Department of Health and Human 

Services should study reimbursement 
regulations and practices with regard to 
those voluntary organizations which 
serve indigent populations to ensure that 
regulations are not unnecessarily restric- 
tive. 

8-84 Convocations of religious and lay leaders 

of the country should be convened in 
conjunction with health care providers to 
develop policy guidelines regarding pro- 
vision of care and education about high- 
risk behavior. Increased coordination of 
effort along these lines could be ex- 
tremely helpful in bringing to fruition so 
many of the care and education objec- 
tives we all share. 

8-85 Religious institutions should address 

their congregations concerning compas- 
sionate treatment of persons with HIV 
disease and should continue to educate 
their congregations about scientifically 
substantiated modes of transmission of 
HIV. This education should allay unwar- 
ranted fears and attempt to put an end 
to discriminatory practices in their com- 
munities. 

8-86 Religious educators themselves should 

be provided with a thorough education 
about HIV so that they, in turn, can pro- 
vide accurate and consistent information 
to the laity. 

Section VII. Philanthropy 

It has very often been the case in American 
history that in times of crisis or great social 
change, groups of individuals in the private 
sector have mobilized quickly to provide assist- 
ance. Individual donors and foundations are 
relatively flexible, and can often respond more 
rapidly than large government agencies which 
are tied to funding cycles and long-range pro- 
gram commitments. Especially in the area of 
social need, foundation funding has traditional- 
ly led government efforts. 

The HIV epidemic exemplifies this tradition 
of private sector response. In the earliest days 
of emerging awareness of the epidemic, it was 
philanthropy from foundations and individuals 
that took the lead in funding much of the edu- 



115 



cation and relief efforts that began in major 
urban centers. While local, state, and federal 
governments seemed glacially slow to develop 
policies to effectively deal with the health crisis, 
CBOs formed to provide desperately needed 
services. Start-up funds for these much needed 
efforts came largely from individual contribu- 
tions and from private and corporate founda- 
tions. 

Since 1983, private sector funding has grown 
from an initial five foundation grants totaling 
$216,000, to over 130 grants in 1986 totaling 
an estimated $14 million. It is estimated that 
grants made in 1987 total $25 million. The first 
funding ventures began in some of the areas 
hardest hit by the HIV epidemic. In 1983, mu- 
nicipal foundations in San Francisco and New 
York City funded groups that provided care- 
related services for HIV-infected persons and 
organizations that provided community educa- 
tion. Corporate foundations also funded educa- 
tional programs and developed guidelines for 
employees and volunteers engaged in epidem- 
ic-related work. Also at this time, the private 
funding for AIDS research began at a grass 
roots level and grew into the highly regarded 
American Foundation for AIDS Research 
(AmFAR), the only national HIV-related re- 
search foundation. 

Since November 1986, the Robert Wood 
Johnson Foundation has awarded grants total- 
ing $22.1 million, funding such projects as a 
four-year national effort providing comprehen- 
sive and coordinated care for persons with 
AIDS as well as research and technical assist- 
ance efforts on the HIV epidemic. Proposals 
currently under consideration total more than 
$4 million. The Ford Foundation recently an- 
nounced a partnership forged from among a 
number of national foundations and corpora- 
tions to fund a $4.5 million program of care 
and education in United States communities 
and abroad. The American Council of Life In- 
surance has been very active, and the Metro- 
politan Life Foundation has taken a leadership 
role in promoting educational efforts, spending 
over $5 million for national television HIV edu- 
cation programming on commercial stations in 
addition to education campaigns and program 
grants. 

This commitment, however, is only a small 
part of the actual potential for private sector 
involvement. Private foundations in the United 
States committed only a small percent of avail- 
able funds for epidemic-related programs last 



year. Corporations engage in philanthropy in 
part to maintain a positive corporate image, 
and controversy associated with some aspects 
of the epidemic may have deterred initial re- 
sponse. However, positive steps currently being 
taken by philanthropies reflect a greater will- 
ingness to fund socially complex issues. Philan- 
thropies were also presented with obstacles 
such as the rapidly changing base of knowl- 
edge, uncertainties as to the size of the prob- 
lem or length of funding commitment, and an 
inability to respond because applications did 
not meet existing guidelines. The Robert 
Wood Johnson Foundation, thus far the leader 
in foundation funding, rewrote their guidelines 
for grant awards so that AIDS is a major area 
included in the foundation's overall mission, 
and initiated a program of funding HIV pre- 
vention and services projects at the community 
level throughout the United States. 

Individual philanthropic events associated 
with the HIV epidemic represent the efforts of 
many who worked together to create an event 
that would both raise money and heighten the 
public's awareness of the need for support. 
The many benefit events produced by the arts 
community, in particular, not only paid tribute 
to those in that community who had been lost 
to the epidemic, but also provided a unique 
opportunity for the general public to see well- 
known individuals calling for an end to discrim- 
ination, highlighting the need for more re- 
search, and supporting community-based orga- 
nizations. The design industry created a unique 
approach to bringing continuity to many such 
single events by creating the Design Industries 
Foundation for AIDS (DIFFA), the first indus- 
try-wide foundation that serves as a central de- 
pository for proceeds, as well as organizes tech- 
nical assistance contributions of industry mem- 
bers. On an individual basis, film stars and 
other well-known media personalities donated 
their services for public service announcements 
that carried prevention education messages na- 
tionwide. In so doing, they heightened aware- 
ness that the epidemic is a universal problem 
and that help and compassion should be the 
universal response. 

In combination, the philanthropic efforts of 
many segments of society have contributed to 
educating the American public about preven- 
tion, have provided a better standard of care 
and care-related services for HIV-infected per- 
sons, and have done a great deal to lead gov- 



116 



ernment funding into more innovative ap- 
proaches to care planning and care delivery in 
non-hospital-based settings. Much needs to be 
done to bring what has been learned through 
private sector philanthropy to the awareness of 
government agencies responsible for care and 
education so that government programs can be 
modified when necessary to incorporate the 
successes created by the private sector. 

Obstacles to Progress 

• The perceived risks of funding HIV-related 
projects such as a constantly changing knowledge 
base, explicit messages needed in education cam- 
paigns, high visibility and strong association with 
controversial messages, and long-term commit- 
ment needed for funding, have prevented many 
private and corporate foundations from becom- 
ing involved. 

• The slow emergence of highly visible corporate 
and private foundation support for HIV-related 
projects and a lack of involvement by recogniz- 
able corporate spokespersons has contributed to 
keeping such philanthropic efforts minimal. 

• Corporate, foundation, and individual donor re- 
luctance to be associated with the controversial 
issues of the HIV epidemic has slowed the 
progress of private sector participation. 

• The epidemic was perceived as affecting only 
one small segment of the population, a commu- 
nity that was perceived as being well organized, 
successful, and not needing assistance and one 
with which it was difficult for the broad base of 
individual donors to identify. 

• Organizations working on HIV-related projects 
and most in need of funding were not likely to 
approach large national foundations because so 
few foundations have funded any HIV-related 
projects by new, small, community-oriented orga- 
nizations. 

• When philanthropic funding is granted, it is usu- 
ally to larger, more established, "safer" organiza- 
tions, rather than to small local efforts, whose 
survival is more in jeopardy. 

RECOMMENDATIONS 

8-87 The nation's business leadership should 

convene a highly visible conference, 
bringing together national corporate and 
foundation leaders and leaders of re- 
gional and community philanthropic or- 
ganizations. The conference should in- 
clude organizations such as the National 
Leadership Coalition, the National Busi- 
ness Council, and others likely to repre- 
sent broad coordinated leadership. Key 



government officials should be invited to 
provide a briefing on the epidemic and 
rationale for corporate and foundation 
involvement in all aspects of the epidem- 
ic. 

8-88 Philanthropies should more actively par- 

ticipate in local community involvement 
by meeting with local HIV-related orga- 
nizations to determine needs and share 
information and resources. 

8-89 Corporations should focus grant award 

efforts on areas most underserved by 
federal and state funding (e.g., housing 
and food for the homeless, foster care 
for HIV-infected children, and provision 
of services for the homebound person 
with HIV-related illnesses). 

8-90 Both the federal government and the 

private sector funding organizations 
should more frequently employ chal- 
lenge or matching grant programs to en- 
courage a wider participation in funding 
for epidemic relief and education by a 
broader base of business, foundation, 
and individual donors. 

8-91 National trade associations and their net- 

works should encourage medium and 
small businesses, as well as those outside 
major cities on the East and West 
Coasts, to become more actively in- 
volved in funding programs, and should 
encourage their membership to support 
local efforts. 

8-92 Recipient agencies should make every 

effort to become enrolled in employee 
"matching gift" programs, by which a 
corporation will contribute to a non- 
profit organization an amount equal to 
the employee's contribution. 

8-93 Corporations and foundations should 

develop ways to provide technical sup- 
port to newly emerging community- 
based organizations by loaning middle 
level managers, accounting services, 
printing and design services, and other 
practical contributions that will help the 
new organizations develop technical ex- 
pertise and increase funding eligibility. 

8-94 Government agencies responsible for de- 

signing prevention messages targeted to 
special populations, such as minorities or 
adolescents, should utilize the services of 
well-known personalities in the creative 
arts, film, and television industries to 
present those messages through well- 
known role models. 



117 



CHAPTER NINE: LEGAL AND ETHICAL 

ISSUES 



Section I. Discrimination 

Throughout our investigation of the spread 
of HIV in the United States, the Commission 
has been confronted with the problem of dis- 
crimination against individuals with HIV sero- 
positivity and all stages of HIV infection, in- 
cluding AIDS. At virtually every Commission 
hearing, witnesses have attested to discrimina- 
tion's occurrence and its serious repercussions 
for both the individual who experiences it and 
for this nation's efforts to control the epidemic. 
Many witnesses have indicated that addressing 
discrimination is the first critical step in the 
nation's response to the epidemic. 

HIV-related discrimination is impairing this 
nation's ability to limit the spread of the epi- 
demic. Crucial to this effort are epidemiological 
studies to track the epidemic as well as the 
education, testing, and counseling of those who 
have been exposed to the virus. Public health 
officials will not be able to gain the confidence 
and cooperation of infected individuals or 
those at high risk for infection if such individ- 
uals fear that they will be unable to retain their 
jobs and their housing, and that they will be 
unable to obtain the medical and support serv- 
ices they need because of discrimination based 
on a positive HIV antibody test. 

As long as discrimination occurs, and no 
strong national policy with rapid and effective 
remedies against discrimination is established, 
individuals who are infected with HIV will be 
reluctant to come forward for testing, counsel- 
ing, and care. This fear of potential discrimina- 
tion will limit the public's willingness to comply 
with the collection of epidemiological data and 
other public health strategies, will undermine 
our efforts to contain the HIV epidemic, and 
will leave HIV-infected individuals isolated and 
alone. 



On the other hand, the Commission has also 
received testimony about situations in which 
HIV-infected individuals have been treated with 
compassion and understanding by employers, 
coworkers, fellow students, and members of 
their local community. From these contrasting 
experiences, it is clear that the key to an en- 
lightened and compassionate response is edu- 
cation and the planning and development of 
HIV programs and policies well in advance of 
the occurrence of the first case of HIV infec- 
tion. The Commission believes that every em- 
ployer, school system, and community should 
start that education and planning process now. 

In general, because HIV is blood-borne and 
sexually transmitted, there is no need to treat 
those infected with HIV in a manner different 
from those not infected in such settings as the 
workplace, housing, and the schools. In the 
vast majority of workplace and public settings 
there is virtually no risk of the direct exposure 
to body fluids which could result in HIV trans- 
mission. Detailed Centers for Disease Control 
(CDC) guidelines have been issued for dealing 
with HIV infection in those cases which require 
special handling, such as health care workers 
and other workers who might be exposed to 
blood or those schoolchildren who lack control 
of their body secretions. 

Therefore, discrimination against persons 
with HIV infection in the workplace setting, or 
in the areas of housing, schools, and public 
accommodations, is unwarranted because it has 
no public health basis. Nor is there any basis to 
discriminate against those who care for or asso- 
ciate with such individuals. 

It is illegal to discriminate against persons 
with AIDS in those local jurisdictions with 
AIDS-specific anti-discrimination statutes, in 
those states which include AIDS as a protected 



119 



handicap under their disability anti-discrimina- 
tion laws, and in programs which receive feder- 
al funds. Section 504 of the Rehabilitation Act 
of 1973 is the federal anti-discrimination stat- 
ute which prohibits discrimination against oth- 
erwise qualified persons with disabilities (in- 
cluding persons subject to a range of AIDS- 
related discrimination) in any program or activ- 
ity receiving federal funds. 

Nevertheless, complaints of HIV-related dis- 
crimination persist and their number is increas- 
ing. For example, HIV-related cases handled by 
the New York City Commission on Human 
Rights have risen from three in 1983, to more 
than 300 in 1986, to almost 600 in 1987. Simi- 
larly, the Office of Civil Rights which enforces 
federal disability discrimination law in pro- 
grams funded by the Department of Health and 
Human Services reports a rise in complaints 
related to HIV infection in the past few years. 
AIDS advocacy groups and civil rights organi- 
zations nationwide also are experiencing an in- 
crease in HIV-related discrimination cases. 

As a witness at the Commission's hearing on 
discrimination explained, individuals infected 
with HIV face two fights: the fight against the 
virus and the fight against discrimination. Just 
as the HIV-infected must have society's support 
in their fight against the virus, these individuals 
must have society's support in their fight 
against discrimination and must have assur- 
ances that policies will be implemented to pre- 
vent discrimination from occurring in the 
future. 

One of the primary causes of discriminatory 
responses to an individual with HIV infection is 
fear, based on ignorance or misinformation 
about the transmission of the virus. We cannot 
afford to let such ignorance and misinforma- 
tion persist. Each publicized incidence of dis- 
crimination, such as the picketing of a school 
that has admitted a child with HIV infection, 
perpetuates this ignorance and sows doubts in 
the minds of those who hear of it. This under- 
mines current and future HIV education pro- 
grams as well as rational HIV policies. 

Furthermore, each act of discrimination, 
whether publicized or not, diminishes our soci- 
ety's adherence to the principles of justice and 
equality. Our leaders at all levels — national, 
state, and local — should speak out against igno- 
rance and injustice, and make clear to the 
American people that discrimination against 
persons with HIV infection will not be tolerat- 
ed. 



Just as our society has taken a definitive 
stand on discrimination against persons with 
other handicapping conditions and illnesses — 
such as cerebral palsy, mental retardation, and 
cancer — society must take a stand on discrimi- 
nation against persons with HIV infection. The 
United States has been an international leader 
in affirming and promoting the civil rights of 
persons with disabilities. While much remains 
to be done, as a nation we can take great pride 
in the progress we have made in embracing 
persons with disabilities as a part of the main- 
stream of society. Persons with HIV infection 
must be clearly and definitively guaranteed 
their civil rights and be protected against dis- 
crimination just as persons with other disabil- 
ities are. Such protection enables the HIV-in- 
fected person to become a partner with social 
institutions in limiting further spread of the 
infection and supporting effective care-giving 
systems. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in combating discrimina- 
tion against persons with HIV infection: 

• There is not a societal standard or national 
policy statement clearly and unequivocally stating 
that discrimination against persons with HIV in- 
fection is wrong. 

• There is no comprehensive, national legislation 
clearly prohibiting discrimination against persons 
with HIV infection as a handicapping condition. 

• There is a lack of coordinated leadership from 
our public and private institutions on the issue of 
discrimination against persons with HIV infec- 
tion. 

• A patchwork of federal, state, and local laws is 
both confusing and, ultimately, ineffective in pre- 
venting discrimination or providing remedies. 



• Enforcement of existing anti-discrimination laws 
is slow and ineffective. 

• Education about transmission of the virus and 
about the laws banning HIV-related discrimina- 
tion is insufficient. This results in ignorance, mis- 
information, acts of discrimination, and, in some 
persons, an irrational fear of association with 
those who are HIV-infected. 

The Commission believes that removing 
these obstacles and eliminating HIV-related 
discrimination will require coordinated action 
by all Americans — by individuals and organiza- 



120 



tions at the federal, state, and community 
levels, and in both the private and public sec- 
tors. Strong anti-discrimination laws are 
needed to establish a standard of behavior and 
to provide remedies in individual cases. In ad- 
dition, because discrimination occurs in person- 
to-person interactions, eradicating it from our 
society will require programs and policies to 
educate people in order to change their atti- 
tudes. Through a combination of laws and edu- 
cation we can promote this change and create a 
society in which discrimination against those 
infected with HIV as well as those with other 
handicapping conditions is unacceptable. En- 
actment of strong confidentiality laws should 
also help to alleviate discrimination. The Com- 
mission has the following specific recommenda- 
tions at the federal, state, and community 
levels. 

RECOMMENDATIONS 

The Commission believes that persons with 
HIV infection should be considered members 
of the group of persons with disabilities, not as 
a separate group unto themselves. Persons with 
HIV infection deserve the same protections as 
all other persons with disabilities, including 
those with cancer, cerebral palsy and epilepsy. 
The Commission rejected the notion of provid- 
ing anti-discrimination protection only for per- 
sons with HIV infection, outside of the context 
of other disabilities. 

For the long term, federal legislation which 
clearly provides comprehensive anti-discrimina- 
tion protection for all persons with disabilities, 
including those with HIV infection, is needed. 
As a critical first step towards passage and en- 
forcement of such federal legislation, the Com- 
mission recommends that the federal govern- 
ment take the following immediate, affirmative 
steps to articulate a strong national policy 
against discrimination and thereby lay the 
groundwork for such legislation: 

9-1 The President should issue an executive 

order banning discrimination on the 
basis of handicap, with HIV infection in- 
cluded as a handicapping condition. This 
executive order would reinforce existing 
Section 504 regulations and clarify that 
all persons with HIV infection are cov- 
ered by Section 504. Such an executive 
order would reaffirm existing federal 
anti-discrimination law which prohibits 
discrimination on the basis of handicap 
and would be a powerful message from 
the leadership of the nation. One basis 



for this directive could be the excellent 
policy guidance on "AIDS in the Work- 
place" recently issued by the Office of 
Personnel Management. 



9-2 A strong anti-discrimination message, 

clarifying that HIV infection, like other 
disabilities, cannot be a basis for discrim- 
ination, should be a part of all national 
HIV education and information materials 
and activities, including the Centers' for 
Disease Control National AIDS Informa- 
tion and Education Program. In addition 
to providing the facts about transmission 
of the virus, national education efforts 
should emphasize that HIV-related dis- 
crimination is both irrational and illegal. 
The federal government should provide 
leadership in asserting that HIV-related 
discrimination will not be tolerated. 

9-3 Special incentives or awards for positive, 

innovative HIV policies and programs in 
workplaces and schools should be high- 
lighted and promoted by a high-level 
federal government office, such as the 
Office of the Surgeon General. 

Section 504 and the "Arline" Decision 

The Commission heard from numerous wit- 
nesses that the anti-discrimination protections 
afforded persons with HIV infection under fed- 
eral and state disability laws represent impor- 
tant first steps toward the enactment of neces- 
sary, broader legislation. Section 504 of the 
Rehabilitation Act of 1973 currently prohibits 
discrimination against persons with disabilities 
by entities receiving federal financial assistance. 
Section 504 states that no "otherwise qualified 
individual with handicaps . . . shall . . . solely 
by reason of his handicap, be excluded from 
the participation in, be denied the benefits of, 
or be subjected to discrimination under any 
program or activity receiving federal financial 
assistance or under any program or activity 
conducted by any Executive agency or by the 
United States Postal Service." 

On March 3, 1987, the Supreme Court 
handed down its decision in the case of School 
Board of Nassau County v. Arline, 107 S.Ct. 1123 
(1987). In Arline, the Court held that a person 
with a contagious disease (in that case, tubercu- 
losis) could be protected by Section 504 since 
the individual was covered under the definition 
of a handicapped individual. The Supreme 
Court indicated that the basic purpose of Sec- 
tion 504 is "to ensure that handicapped indi- 
viduals are not denied jobs or other benefits 
because of the prejudiced attitudes or the igno- 



121 



ranee of others." The Court emphasized, how- 
ever, that having a contagious disease does not 
automatically ensure that a plaintiff will prevail 
on his or her Section 504 claim. Rather, the 
individual with the contagious disease must 
also meet the criteria for being otherwise quali- 
fied. 

The concept of "otherwise qualified" means 
that an individual with handicaps must meet 
the qualification standards of the program or 
activity from which that individual is seeking 
benefits or services. In the case of an individual 
with a contagious disease, the Court in Arline 
noted that such an individual would not be 
"otherwise qualified" for an employment posi- 
tion if the individual posed a significant risk of 
communicating the infectious disease to others 
in the workplace and reasonable accommoda- 
tion could not eliminate that risk. The court 
delineated guidelines for determining whether 
an individual with a handicap is "otherwise 
qualified" in terms of the contagious disease. 
These guidelines include the examination of 
medical evidence to determine "a) the nature 
of the risk (how the disease is transmitted), b) 
the duration of the risk (how long is the carrier 
infectious), c) the severity of the risk (what is 
the potential harm to third parties) and d) the 
probabilities the disease will be transmitted and 
will cause varying degrees of harm." This four- 
part test was recommended to the Court by the 
American Medical Association. 

In other words, the Court enunciated a two- 
step approach. First, a determination must be 
made as to whether the individual is an individ- 
ual with a handicap. Second, the determination 
must be made as to whether the individual is 
"otherwise qualified." Only persons who are 
both handicapped and "otherwise qualified" 
are protected by Section 504. 

The Court in Arline also noted that enforce- 
ment of Section 504 would not interfere with 
the appropriate exercise of authority by public 
health officials. State public health laws gener- 
ally provide authority for restrictions of individ- 
uals with infectious conditions during periods 
when they may infect others or from activities 
which may put others at significant risk. This 
authority is not hampered by the proper appli- 
cation of the Section 504 standard to conta- 
gious diseases. 

Thus, under Section 504, as recently inter- 
preted by the Supreme Court in the Arline deci- 
sion, individuals with contagious diseases are 
covered by the statute's anti-discrimination pro- 



visions so long as the individual with the conta- 
gious disease does not pose a significant risk of 
infecting others in the work place. The Com- 
mission supports the reasoning in the Arline 
decision and believes that it offers a balanced 
approach which secures the rights of infected 
individuals while not jeopardizing the health of 
those who are not infected. 

A recently enacted provision of law (the 
Harkin-Humphrey amendment to the Civil 
Rights Restoration Act) was intended to clarify 
the application of Section 504 in the employ- 
ment context in terms of persons with conta- 
gious diseases. It states that: 

"for the purposes of Sections 503 and 504, as 
such sections relate to employment, such term 
does not include an individual who has a cur- 
rently contagious disease or infection and who, 
by reason of such disease or infection, would 
constitute a direct threat to the health or safety 
of other individuals or who, by reason of the 
currently contagious disease or infection, is 
unable to perform the duties of the job." 

It appears that this amendment is in concert 
with the Arline decision and codifies the existing 
standards applicable to Section 504. 

The Arline decision has been critical in ensur- 
ing the continued importance of Section 504 in 
providing protection against a range of HIV- 
related discriminatory action. Both preceding 
and following the Supreme Court's affirmation 
in Arline that Congress intended Section 504 to 
cover contagious diseases, the lower courts 
have applied Section 504 to claims of discrimi- 
nation based on AIDS and HIV infection. 

Thus, for example, although the Court in 
Arline did not address the question whether 
asymptomatic carriers of HIV were covered 
under Section 504 (because the facts of the 
Arline case did not require the Court to exam- 
ine that specific question), the lower courts 
have consistently held that the range of HIV- 
related impairments, including asymptomatic 
HIV infection, are covered under Section 504. 
[See, e.g., Local 1812, American Federation of Gov- 
ernment Employees v. U. S. Department of State, 662 
F.Supp. 50, 54 (D.D.C. 1987); Ray v. School 
District of DeSoto County, 666 F.Supp. 1524 (M.D. 
Fla. 1987); District 27 Community School Board v. 
Board of Education of the City of New York, 502 
N.Y.S. 2d 325, 336 (Sup. 1986)]. Parties in 
these cases, including the Department of Jus- 
tice in the case of 1812, took the position that 
HIV-infected asymptomatic persons are cov- 



122 



ered under Section 504. The Commission sup- 
ports the position that Section 504 coverage 
applies to persons who are HIV positive yet 
asymptomatic. 

Section 504's prohibition against discrimina- 
tion extends, however, only to federally funded 
programs and activities. Thus, large segments 
of the population in the private sector do not 
fall within its jurisdiction. There is no existing 
federal anti-discrimination protection for per- 
sons with disabilities facing discrimination in 
the workplace, housing, or public accommoda- 
tions which do not receive federal funds. 

RECOMMENDATIONS 

The Commission believes that federal dis- 
ability anti-discrimination law should be ex- 
panded to cover the private as well as the 
public sector. Specifically, the Commission rec- 
ommends: 

9-4 Comprehensive federal anti-discrimina- 

tion legislation which prohibits discrimi- 
nation against persons with disabilities in 
the public and private sectors, including 
employment, housing, public accommo- 
dations, and participation in government 
programs, should be enacted. All per- 
sons with symptomatic or asymptomatic 
HIV infection should be clearly included 
as persons with disabilities who are cov- 
ered by the anti-discrimination protec- 
tions of this legislation. 

The National Council on the Handicapped, 
an independent federal agency comprised of 15 
members appointed by the President to make 
recommendations on public policy issues affect- 
ing people with disabilities, included a proposal 
for a comprehensive federal law of this kind in 
their January 1988 report to the President. 
Their proposal, the Americans with Disabilities 
Act of 1988, was recently introduced in the 
United States Congress. The Commission be- 
lieves that this type of comprehensive, disability 
anti-discrimination legislation should serve as a 
model for federal legislation in this area. 

The Commission does not intend for anti- 
discrimination legislation to invoke affirmative 
action for persons with HIV infection. In other 
words, no one would be required to hire an 
individual with HIV infection based on that 
status. 

The Commission recognizes that particular 
attention will need to be paid to the impact of 
such legislation on small employers, as has 
been done in other civil rights laws. Any dis- 



ability anti-discrimination law passed should be 
consistent with, and not go beyond, the reach 
of existing civil rights laws for other groups 
such as minorities and women. In carrying out 
provisions of the new legislation, all persons 
with disabilities should have access to the same 
support services as those covered under other 
comprehensive federal anti-discrimination laws. 

The Commission recognizes that passage of 
more comprehensive disability discrimination 
legislation by Congress may take time. There- 
fore, the Commission believes that it is impera- 
tive for the federal government to take immedi- 
ate steps to inform the public regarding exist- 
ing federal anti-discrimination law and regard- 
ing the remedies which are available for those 
who experience HIV-related discrimination by 
entities that receive federal financial assistance. 
Enforcement of existing law must be strength- 
ened. 

In 1986, the Department of Justice issued a 
memorandum which concluded that although 
federal disability law prohibits discrimination 
based on the disabling effects of AIDS, discrim- 
ination based on fear of contagion was not cov- 
ered. The absence of any further statement 
from the Department of Justice has created 
confusion and uncertainty about its position, 
particularly since Arline rejected the fear of con- 
tagion argument. Specifically, the Arline deci- 
sion stated: 

We do not agree with petitioners that, in defin- 
ing a handicapped individual under Section 
504, the contagious effects of a disease can be 
meaningfully distinguished from the disease's 
physical effects on a claimant in a case such as 
this. 

To eliminate uncertainty and clarify the appli- 
cability of federal disability law to HIV-related 
conditions, the Commission recommends: 

9-5 The Department of Justice, which has 

been designated to coordinate the en- 
forcement of disability discrimination law 
for all federal agencies, should issue a 
follow-up memorandum expressing sup- 
port for the Arline decision and with- 
drawing its earlier opinion that fear of 
contagion is not a basis for Section 504 
coverage. In addition, the Department of 
Justice memorandum should take the 
lead in endorsing lower court rulings by 
clarifying that persons who are HIV-in- 
fected yet asymptomatic, as well as per- 
sons with symptomatic HIV infection, 
are covered by Section 504. 



123 



9-6 The Office of Civil Rights within each 

agency should develop policy guidelines 
stating that all HIV-infected persons, in- 
cluding those who are asymptomatic, are 
subject to the jurisdiction of the Office. 
The agencies should publicize the avail- 
ability of the services of their Offices of 
Civil Rights to those who have experi- 
enced HIV-related discrimination and 
should publish their intent to investigate 
actively all complaints. The agencies 
should distribute these policy guidelines 
to all contractors and grantees. 

9-7 All agency Offices of Civil Rights should 

establish a system of aggressive investi- 
gation of violations of Section 504 in 
HIV infection-related cases, including 
expedited procedures for review of com- 
plaints and regular monitoring of those 
procedures. 

9-8 Supplemental funds should be allocated 

to all agency Offices of Civil Rights to 
increase staff and resources for the en- 
forcement of Section 504. 

State and Local Government Response 

In addition to strong federal anti-discrimina- 
tion legislation, state and local legislation is 
needed to provide the local administrative pro- 
cedures and courts as an alternative to federal 
litigation for enforcement of the rights of the 
HIV-infected. Local government officials are 
able to intervene quickly and utilize ongoing 
relationships in the community for rapid reso- 
lution of discrimination complaints. Rapid reso- 
lution is needed as the infected individual may 
well die in the time interval that a typical case 
is processed. 

RECOMMENDATIONS 

For state and local governments, the Com- 
mission recommends: 

9-9 If not now the case, states should amend 

their disability laws to prohibit discrimi- 
nation against persons with disabilities, 
including persons with HIV infection 
who are asymptomatic or symptomatic, 
and persons with AIDS, in public and 
private settings including employment, 
housing, public accommodations, and 
governmental services. 

9-10 State-sponsored HIV education cam- 

paigns should include anti-discrimination 
components. 

9-11 Arbitration, mediation, and accelerated 

settlement procedures and programs 
should be developed and utilized to 



assist in the speedy resolution of HIV-re- 
lated discrimination complaints. Media- 
tors and arbitrators should be trained to 
deal with the special circumstances sur- 
rounding HIV-related discrimination 
cases. 

Community Response 

One of the primary barriers between those 
infected with HIV and those not infected is the 
widespread belief that HIV infection is some- 
one else's problem — there is no need to 
become educated about it. Individuals in large 
and small communities across the country are 
discovering that this is not the case, as they 
have learned to accommodate individuals with 
HIV infection living in their midst. In those 
communities which have developed HIV-relat- 
ed policies and guidelines for health care set- 
tings, the workplace, and the schools, and had 
their programs in place before the first case of 
HIV infection appeared, fears were reduced 
and individuals with HIV infection have been 
accepted. In some cases, where community 
leaders have not educated the community and 
not developed policies in advance, the result 
has been discrimination fueled by fear and ig- 
norance, leading to divisiveness in the commu- 
nity and suffering for the family and friends of 
the infected individual. 

To prevent discrimination, the primary tools 
at the local level are comprehensive, participa- 
tory educational programs, advance planning, 
and preparation. Educational programs about 
the transmission of the virus, the laws against 
discrimination, and the reasons for compliance 
should be developed by employers, school sys- 
tems, and health care providers. Education 
should be provided in simple language for the 
layman and it should come from a person who 
has the confidence of those being offered the 
information. Local officials in government, 
business, public health, schools, and religious 
and community organizations should assume a 
leadership role in this effort. 

RECOMMENDATIONS 

Specifically, the Commission recommends: 

9-12 Organizations representing health pro- 

fessionals should adopt a public policy 
stating that their members have an ethi- 
cal obligation to treat patients with HIV 
infection in a non-discriminatory fashion. 
These organizations should develop edu- 
cation programs for their members 



124 



which include education on non-discrim- 
ination. 

9-13 Religious leaders should take an active 

role in the anti-discrimination education 
effort with members of their parish or 
congregation. In addition, religious insti- 
tutions should develop outreach pro- 
grams for individuals in their community 
with HIV infection and should involve 
the congregation or parish members in 
volunteer activities. 

9-14 Employers should develop an HIV edu- 

cation program for all employees. Edu- 
cation programs to combat discrimina- 
tion should emphasize two goals: infor- 
mation about transmission to prevent 
the further spread of HIV infection and 
education about legal issues — such as 
how to ensure confidentiality and pre- 
vent discrimination. This approach 
should be used in all workplace settings. 

9-15 Employers should have each department 

or office review and revise policies and 
procedures in light of medical and legal 
information related to HIV infection, 
and, where applicable, interact with the 
community to further public education 
about HIV infection. This last step may 
be most applicable to the public sector. 

HIV and the Schools 

The Commission has heard testimony about 
the experiences, both good and bad, of a 
number of HIV-infected schoolchildren. Impor- 
tant lessons can be learned from those model 
communities which have policies in place re- 
garding HIV infection in advance of the first 
case, and have been able to accept the HIV- 
infected individual in their schools without fear 
and discrimination. In some school districts, a 
well-coordinated system of educational pro- 
grams has produced an enhanced sense of 
community pride and satisfaction from having 
worked together to fashion an enlightened, ra- 
tional policy on HIV infection for the schools. 
The Commission has been impressed with the 
courage and compassion which school and 
public health officials have displayed in plan- 
ning and preparing for a positive outcome. A 
number of common principles emerge from the 
experiences of these model communities. The 
recommendations in this section should be im- 
plemented in conjunction with the school- 
based education recommendations in the edu- 
cation chapter of this report. 



RECOMMENDATIONS 

Specifically, the Commission recommends: 

9-16 Each school system should establish a 

board-developed policy, with accompa- 
nying guidelines, for dealing with an in- 
dividual with HIV infection in the school 
before it is confronted with the first case. 
The Centers for Disease Control or 
other public health guidelines should be 
utilized but the policy should be flexible 
and allow each case to be dealt with on 
an individual basis, based on medical 
facts. 

9-17 Educational materials about the trans- 

mission of the disease and the anti-dis- 
crimination laws should be developed 
and disseminated and, where necessary, 
explained fully by legal and medical ex- 
perts. Age-appropriate materials on 
these topics should be developed for stu- 
dents. 

9-18 School officials should identify a deci- 

sion-making structure to review all HIV 
policies and procedures and to deal with 
each individual case. Legal, medical, and 
public health consultants from the com- 
munity should be involved. 

9-19 Open public meetings should be sched- 

uled, featuring school officials, medical 
and legal consultants, and community of- 
ficials, to discuss the board's policies and 
the rationale for its decisions. School of- 
ficials must be prepared to educate the 
entire community, including parents, 
public officials, clergy, pediatricians, stu- 
dents, and media representatives, about 
the reasons for the board's decisions. 
Support and counseling should be of- 
fered to employees, parents, or children 
who are troubled by the board's deci- 
sion. 

9-20 In any communications about specific 

HIV-infected individuals, the confiden- 
tiality of the schoolchild or staff member 
should be maintained to minimize the 
opportunity for discriminatory behavior. 

9-21 A team should be formed with responsi- 

bility for reviewing all aspects of the case 
on an ongoing basis and monitoring 
medical or legal developments that 
might affect school district decisions. 

9-22 School officials should actively partici- 

pate in community education efforts so 
that they support acceptance of HIV-in- 
fected individuals in the schools in a 
non-discriminatory manner. 



125 



9-23 Educational associations should dissemi- 

nate information to their members on 
the policies and procedures used by 
those communities which have accepted 
an HIV-infected individual in their 
schools without fear and discrimination. 

HIV and Health Care Settings 

The Commission has heard testimony that 
some hospitals and some health care workers in 
hospitals have been unwilling to care for HIV- 
infected persons or have provided inappropri- 
ate care because of fear. Steps must be taken to 
eradicate this fear because these institutions are 
critical sources of care and are leaders in com- 
munity attitudes. 

Over the next five to 10 years, even more 
community-based health care facilities, such as 
group homes, nursing homes, hospices, and 
mental health facilities, will be needed in many 
communities to care for patients with HIV in- 
fection. Long-range planning for these facilities 
must be undertaken now in order to avoid fear- 
ful and discriminatory reactions from the com- 
munity. 

RECOMMENDATIONS 

Specifically, the Commission recommends: 

9-24 Hospitals and providers of health care to 

HIV-infected patients should establish a 
mandatory education program for all 
hospital employees, including an anti- 
discrimination component and profes- 
sional, confidential counseling for all 
employees. Health care workers need to 
be reminded about the social context of 
HIV infection and the need for confiden- 
tiality and protection of private medical 
information. 

9-25 Health care providers dealing with pa- 

tients with HIV should make available a 
patient care advocate, if one does not yet 
exist, to regularly contact individuals 
with HIV, so that patients could confi- 
dentially report treatment problems. 
Health care professionals who have re- 
peated, substantiated complaints made 
against them, and who resist education, 
should be formally reprimanded and 
placed on probation. In general, the 
Commission feels that remedies such as 
this should be short-term in nature and 
could gradually be phased out. 

9-26 State and local governments and health 

care providers should develop long- 
range plans now to anticipate the need 
for community-based health care facili- 
ties, and should develop a strategy to 



educate community members to accept 
facilities and prevent discriminatory re- 
sponses. 

9-27 Those working to educate a community 

in preparation for acceptance of patients 
with HIV infection should develop a 
strategy to prevent discrimination. Some 
important points to include are: allowing 
time for education; knowing the legal 
issues involved; mobilizing political, 
community, and religious leaders for 
support; bringing in legal and public 
health experts; meeting with people who 
have concerns and listening to their con- 
cerns. 

Section II. Confidentiality 

Rigorous maintenance of confidentiality is 
considered critical to the success of the public 
health endeavor to prevent the transmission 
and spread of HIV infection. Current public 
health strategies for fighting the spread of HIV 
infection are entirely dependent on voluntary 
cooperation. To encourage individuals to come 
forward voluntarily for necessary testing, coun- 
seling, and treatment, our health care system 
must be viewed with confidence and trust by 
those in need of its services. Individuals enter- 
ing the system must be convinced that informa- 
tion about their health will be kept confidential 
by those in the system. Aside from the illness 
itself, it is discrimination that is most feared by 
the HIV-infected. An effective guarantee of 
confidentiality is the major bulwark against that 
fear. A federal statute that carefully balances 
the need for confidentiality of HIV information 
against the protection of the public health is a 
necessary and appropriate response to confi- 
dentiality concerns. 

To confirm our commitment to the principle 
of confidentiality in this epidemic and to 
ensure national uniformity in confidentiality 
protection policies, it is important for the fed- 
eral government through legislation to take a 
leadership role in assuring the confidentiality 
of HIV-related records, while defining those 
situations in which information must be shared. 
In addition, state model confidentiality legisla- 
tion must be developed and passed as rein- 
forcement to federal confidentiality protection. 

The federal government and the states, how- 
ever, cannot alone carry out a successful strate- 
gy for safeguarding against breaches of confi- 
dentiality. In addition to legislative initiatives 
by the government, there must also be a con- 



126 



current commitment on the part of the public 
health and health care communities to reaffirm 
their time-honored standards for confidentiality 
and emphasize to all constituents that viola- 
tions of confidentiality will not be tolerated. 
In addition, the role of the individual with 
HIV infection and his or her family is impor- 
tant in ensuring confidentiality, as their need to 
communicate with others often leads to indis- 
creet violations of confidentiality. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in confidentiality protec- 
tion: 

• There is considerable variance in the way indi- 
vidual states currently provide for confidentiality 
of HIV information. This lack of uniformity 
causes confusion and arbitrary consequences, 
and bars the establishment of an effective nation- 
al confidentiality policy. 

• There appears to be a lack of confidence that the 
confidentiality of HIV-related information will be 
maintained regardless of the law. Many perceive 
confidentiality protection as lacking, even when 
adequate safeguards exist. One particular area of 
concern is the confidentiality of HIV information 
held by insurance companies. 

• Many state confidentiality statutes leave "holes" 
in substantive areas, such as blood donor HIV 
information held by hospitals, blood banks, and 
court disclosures. 

• Health care systems have not been inclined to 
define narrowly "need to know" of identifier- 
linked information, resulting in a system where 
safeguards against disclosure are difficult to 
maintain. 

• There is a need for clear and comprehensive 
policies on the confidentiality of HlV informa- 
tion held by the federal government, including 
the military. 

• Many persons do not understand that it is possi- 
ble to warn someone about an exposure to HIV 
without revealing the name or exact identity of 
the source of the exposure. 

RECOMMENDATIONS 

In addressing these obstacles to progress in 
confidentiality protection, the Commission rec- 
ommends the following: 

9-28 Adoption of federal legislation that man- 

dates that identifying information ob- 
tained by any provider, laboratory, 
payor, or agency through HIV testing 
and counseling cannot be disclosed with- 



9-29 



out the written consent of the individual 
except under the following circum- 
stances: 

• to members of the individual's direct 
care giving team (i.e., the attending 
physician, primary or staff nurse, con- 
sulting physicians with a special need 
to know, or outpatient case manager). 

• to health care workers accidentally 
"exposed to the blood or blood con- 
taminated body fluids" of the individ- 
ual, as defined by the Centers for Dis- 
ease Control guidelines, where infor- 
mation on exposure cannot otherwise 
be shared without identifying the in- 
dividual. 

• for statistical reports if used in such a 
way that no person can be identified. 

• to the state health agency, if required 
by state or federal law or regulation 
for epidemiologic or partner notifica- 
tion purposes. 

• to blood, organ, semen, or breast 
milk banks that have received or will 
receive blood, an organ, semen, or 
breast milk from the individual. 

• to a spouse or sexual partner when 
the individual will not inform such 
party with respect to the identifying 
information. 

• by a court order issued pursuant to 
application of a state public health of- 
ficer. Court proceedings held in con- 
nection with disclosure requests by 
state public health officers should be 
held in private. Prior to requiring dis- 
closure, the individual should be pro- 
vided an opportunity to participate in 
the proceeding to determine whether 
a disclosure will be ordered. Records 
of the proceedings should not be 
open for public inspection and should 
be sealed at the close of the proceed- 
ing. Public health agencies should ad- 
vocate that court orders for disclo- 
sure of name-linked information 
should not be issued except when 
compelling reasons for disclosure are 
demonstrated. 

• to the victim of a sexual assault. 

The statute should classify violations of 
confidentiality as misdemeanors, punish- 
able by a fine of up to $10,000. 
The statute should not preempt state 
statutes which are consistent. 
The statute should restrict the re-release 
of information shared except as provided 
within the entire body of the statute. 

Federal and state information and educa- 
tion efforts should continue to empha- 



127 



size the importance of confidentiality to 
the success of HIV prevention strategies. 

(9-30) Public health and health care institutions 

should adopt strict policies regarding ad- 
ministrative or disciplinary action to be 
taken if a staff member discloses confi- 
dential information, and these institu- 
tions should regularly provide training 
on these policies for all employees and 
volunteers. 

Agencies responsible for accrediting or 
licensing health care institutions should 
require as part of their accreditation or 
licensing process that such institutions 
adopt strict confidentiality policies. Ac- 
crediting and licensing agencies should 
prepare and publish guidelines for confi- 
dentiality policies, and, in their periodic 
reviews of health care institutions, evalu- 
ate institutions' confidentiality policies 
for consistency with the agency's mini- 
mum standards of compliance. 

(9-31) Educational programs on confidentiality 

should discuss: 

• the special sensitivity that must be ac- 
corded information about HIV-infect- 
ed individuals. 

• the adverse consequences that could 
occur if information is erroneously re- 
leased. 

Educational programs for all health care 
workers should emphasize the impor- 
tance of confidentiality. 

Insurance companies should adopt clear 
and comprehensive policies regarding 
the confidentiality of HIV-related infor- 
mation in their possession. Special care 
must be taken to avoid inadvertent con- 
veyance of HIV-related information to a 
proposed insured's employer (even in 
those situations where the employer is 
the applicant) or agent, or improper 
access of such information through the 
Medical Information Bureau. 

9-34 Clear and comprehensive policies must 

be adopted by the federal government 
with regard to the confidentiality of 
HIV-related information held by institu- 
tions of the federal government, includ- 
ing the military. 

9-35 Health care-giving institutions must 

assure patients that confidentiality will 
be respected, except in the most explicit 
and rigorously defined instances. Pa- 
tients should be advised of the potential 
consequences should they voluntarily 
disclose confidential HrV information. 



(9-32) 



(9-33) 



Section III. Health Care Provider 
Notification of Sexual Partners 

Adherence to the principle of confidentiality 
does not relieve our responsibility to protect 
those who may unknowingly be in immediate 
danger of being exposed to HIV. A successful 
approach to the HIV epidemic will need both 
to recognize the pivotal importance of protect- 
ing the confidentiality of HIV-related informa- 
tion and to devise clear programs, policies, and 
procedures for protecting uninfected persons. 
The primary ethical obligation to warn rests 
with the infected individual. 

The health care provider should not have a 
legal duty to warn a patient's sexual partner in 
these instances, as some court cases have held 
in other third party warning situations. Notify- 
ing sexual partners, as a legal responsibility, is 
the responsibility of the state or local health 
department as discussed in Chapter Six. The 
health care provider's obligation in these in- 
stances is to advise the infected individual 
about behaviors that may cause harm to others, 
to counsel the patient to notify third parties, to 
persuade the infected individual to behave in 
ways that will reduce, if not eliminate, the risk, 
and to fulfill any legal obligation to notify the 
state or local health department of cases of 
HIV seropositivity or the diagnosis of AIDS. 
Beyond that, a health care provider who con- 
cludes that a patient cannot be persuaded to 
notify a sexual partner at risk should have the 
option, but not the obligation, to inform the 
sexual partner. 

Federal legislation should be adopted setting 
forth a uniform policy on third party warnings 
about HIV outside of the usual public health 
notification process. At present, there is consid- 
erable controversy on the question of a physi- 
cian's liability for failure to warn third parties 
and on the application of various state confi- 
dentiality statutes to this issue. Very specific 
federal legislation that permits notification of 
spouses and sexual partners at risk of contract- 
ing HIV would provide needed guidance to 
health care providers faced with infected pa- 
tients who refuse to inform such persons of 
their infection. Consistent with our recommen- 
dation that the federal government should 
clearly delineate where confidentiality may or 
may not be violated, notification of third par- 
ties at risk should be included in confidentiality 
legislation as an instance when the confidential- 



128 



ity of HIV-related information may be 9-40 
breached. 

Inclusion in the more stringent protection of 
a confidentiality statute will also emphasize that 
notification of sexual partners is a compromise 
of the confidentiality of HIV-related informa- 
tion and should, therefore, be exercised only in 
the narrow, specified circumstances. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in notification of sexual 
partners: 



• Difficulty exists in appropriate reconciliation of 
the rights of partners to notification and codes of 
medical ethics that have long and appropriately 
asserted that communications between doctors 
and patients are privileged and that doctors must 
maintain the confidentiality of patient communi- 
cations. 

• There is considerable controversy surrounding 
the legal liability of a physician for failure to 
warn an endangered third party which is con- 
fused with the public health responsibilities in 
partner notification. 

• Many health care providers are not skilled in 
providing proper counseling. 

• Given the demands of clinical practice, it is diffi- 
cult for health care providers to perform third 
party warnings in an appropriate manner. 

RECOMMENDATIONS 

In addressing these obstacles to progress in 
health care provider notification of sexual part- 
ners, the Commission recommends the follow- 
ing: 

9-36 Adoption of federal HIV confidentiality 

legislation that includes a provision per- 
mitting, in specific instances, disclosure 
by health care providers to a patient's 
spouse or other specific sexual partner 
at risk of contracting HIV. 

9-37 State statutory provisions for health care 

provider notification of sexual partners 
concerning risk of HIV infection should 
be tied to stringent protection of confi- 
dentiality. 

9-38 Notification provisions must specify 

those persons who are authorized to do 
the notification. 

9-39 Notification provisions should include 

sanctions for confidentiality breaches 
that are inconsistent with the terms of 
the statute. 



9-41 



9-42 



9-43 



Notification of sexual partners by health 
care providers should be discretionary 
and should not be imposed as a legal 
duty to warn. However, all health care 
providers should report HIV cases with 
identification to state public health au- 
thorities. Using the information reported 
by providers, all public health agencies 
should be involved in partner notifica- 
tion programs as discussed in Chapter 
Six. In no case is the identifying infor- 
mation to be released by the agency to 
the person notified or forwarded to 
other agencies such as the Centers for 
Disease Control. 

All health care providers and public 
health officials should counsel patients 
about behaviors that may cause harm to 
others, encourage them to notify sexual 
partners, and teach strategies for preven- 
tion of the spread of the virus. 

The health care provider's decision to 
warn should be made on a case-by-case 
basis and should consider such factors 
as: 

• the patient's own statements, includ- 
ing commitment to notify third par- 
ties; 

• the patient's relationship with the 
third party; 

• the potential additional risk presented 
by a delay in notification; 

• whether the third party is pregnant or 
considering pregnancy; 

• the likelihood that the third party has 
no reason to believe that he/she is at 
risk; 

• the availability of a partner notifica- 
tion program in the local public 
health department; 

• the strength of the physician-patient 
relationship; and 

• other material factors. 

Education programs for health profes- 
sionals should include basic skills which 
enable them to become more adept in 
counseling HIV-infected individuals and 
their partners, including the ability to 
explain viral transmission accurately and 
clearly in nontechnical language. The 
curriculum should also include principles 
of psychosocial counseling and tech- 
niques for supporting individuals in pa- 
tient-managed notification. In addition, 
the curriculum should clarify the proce- 
dures for professional-managed notifica- 
tion if the HIV-infected individual does 
not warn partners within a specific time 
frame set by the state. To help train 



129 



these individuals, HIV counseling pro- 
grams should be incorporated in the fol- 
lowing: 

• existing professional education proc- 
ess. 

• continuing medical or professional 
education. 

• professional societies and associa- 
tions. 

• existing and planned HIV regional 
education and training centers. 

9-44 Counseling of persons notified should 

include the provision of information on 
testing, community health care and other 
support services available to HIV-infect- 
ed individuals. 

9-45 Notified women of childbearing age and 

their sexual partners should be provided 
access to counseling about the risks of 
perinatal transmission. 

Section IV. Criminalization of HIV 
Transmission 

Extending criminal liability to those who 
knowingly engage in behavior which is likely to 
transmit HIV is consistent with the criminal 
law's concern with punishing those whose be- 
havior results in harmful acts. Just as other 
individuals in society are held responsible for 
their actions outside the criminal law's estab- 
lished parameters of acceptable behavior, HIV- 
infected individuals who knowingly conduct 
themselves in ways that pose a significant risk 
of transmission to others must be held account- 
able for their actions. Establishing criminal 
penalties for failure to comply with clearly set 
standards of conduct can also deter HIV-infect- 
ed individuals from engaging in high-risk be- 
haviors, thus protecting society against the 
spread of the disease. 

Because of the problems in applying tradi- 
tional criminal law to HIV transmission, howev- 
er, states should review their criminal codes to 
determine the possible need to adopt a crimi- 
nal statute specific to HIV infection. Use of 
traditional crimes such as murder or attempted 
murder to prosecute an individual for HIV 
transmission presents such difficulties as prov- 
ing that the intent of the HIV-infected individ- 
ual was to transmit the virus and to cause the 
victim's death, and proving that the act of 
transmission was the actual cause of death. Al- 
though the assault model provides a more 
useful tool for criminal prosecution of HIV 
transmission, the penalties for assault would 



prove too lenient in those cases where the 
transmission was intentional. An HIV-specific 
statute, on the other hand, would provide clear 
notice of socially unacceptable standards of be- 
havior specific to the HIV epidemic and tailor 
punishment to the specific crime of HIV trans- 
mission. Indeed, a few states, including Florida, 
Idaho, Louisiana, and Nevada, have recognized 
the advantages of legislation specific to HIV 
transmission and have passed criminal statutes 
ranging from prohibiting a person infected with 
HIV from having sexual intercourse without in- 
forming sexual partners of the infection to pro- 
hibiting HIV carriers from donating blood. 
While we encourage continued state efforts to 
explore the use of the criminal law in the face 
of this epidemic, we caution that criminal sanc- 
tions for HIV transmission must be carefully 
drawn, must be directed only towards behavior 
which is scientifically established as a mode of 
transmission, and should be employed only 
when all other public health and civil actions 
fail to produce responsible behavior. The use 
of criminal sanctions should not substitute for 
use of public health measures to prevent trans- 
mission, as discussed in Chapter Six. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in criminalizing the trans- 
mission of HIV: 

• Traditional criminal laws are not well suited to 
the prosecution of HIV transmission. 

• Penalties for prostitution are too lenient and en- 
forcement of prostitution laws is erratic. 

• Concern that criminal sanctions will undermine 
public health goals by diverting attention and re- 
sources from effective prevention policies such as 
education, testing, counseling, and partner notifi- 
cation and inhibit people from seeking testing. 

• The view of some that criminal sanctions are pri- 
marily punitive rather than preventive and as 
such would not effectively deter HIV-infected in- 
dividuals from engaging in behaviors likely to 
transmit the virus. 

• Fear of intrusive policing of private sexual activi- 
ty and danger of selective prosecution and 
misuse of the criminal law to harass unpopular 
groups. 



130 



RECOMMENDATIONS 

In addressing these obstacles to progress in 
criminalizing the transmission of HIV, the 
Commission recommends the following: 

9-46 Adoption by the states of a criminal stat- 

ute — directed to those HIV-infected indi- 
viduals who know of their status and 
engage in behaviors which they know 
are, according to scientific research, 
likely to result in transmission of HIV — 
clearly setting forth those specific behav- 
iors subject to criminal sanctions. With 
regard to sexual transmission, the statute 
should impose on HIV-infected individ- 
uals who know of their status specific af- 
firmative duties to disclose their condi- 
tion to sexual partners, to obtain their 
partners' knowing consent, and to use 
precautions, punishing only for failure to 
comply with these affirmative duties. 

9-47 HIV criminal statutes should include 

strong, uniform confidentiality protec- 
tion. 

9-48 Prior to instituting a case against an ac- 

cused individual, prosecuting officials 
should consult with local public health 
officials to determine whether to pros- 
ecute the individual for an HIV transmis- 
sion criminal offense or whether public 
health intervention would be more ap- 
propriate. Systems should be set up to 
facilitate this dialogue. 
During the presentation of the state's 
case, the prosecuting attorney should in- 
troduce, consistent with federal and state 
rules of evidence, any information held 
by the public health department regard- 
ing intervention measures taken with re- 
spect to the infected individual. 

9-49 HIV criminal statutes should include a 

provision stating that prior to termina- 
tion of any period of incarceration or 
probation under the statute, the offender 
will be interviewed by state public health 
officials for the purpose of determining 
whether further action will be required 
by the public health authorities upon re- 
lease of the individual. Such interview 
proceeding must be subject to procedur- 
al due process safeguards, and any 
action taken by the public health au- 
thorities must be pursuant to powers 
provided by the state's public health 
laws. 

9-50 States should refrain from criminally 

prosecuting HIV-infected individuals for 
HIV transmission when the alleged 
criminal conduct did not involve a scien- 



tifically established mode of transmis- 
sion. 

9-51 Prostitution laws should be strictly en- 

forced. 

Section V. Sexual Assault and HIV 
Transmission 

The HIV epidemic has added a new and dis- 
turbing specter to the problems of sexual as- 
sault victims. Witnesses have testified before 
the Commission about the increase in the num- 
bers of victims of sexual assaults and their 
growing concern over the possibility of expo- 
sure to the HIV virus as a result. 

Victims of sexual assault deserve consider- 
ation and must be given attention and support 
so that they will not be forgotten in the tragedy 
surrounding the HIV epidemic. The Commis- 
sion believes that it is important to plan an 
approach which will take into consideration 
both the emotional impact of an assault and the 
possible exposure to HIV. This approach must 
balance the rights of the victims to be treated 
with fairness and dignity with the due process 
rights of the perpetrators. 

In 1985, the FBI recorded 87,340 rapes in 
the United States, or approximately 239 rapes 
per day. This number greatly underestimates 
the true scope of rape since it includes only 
female victims 16 years and older and only 
instances that were reported to police. Govern- 
ment estimates suggest that for every rape re- 
ported to police, three to 10 rapes are not 
reported, making rape one of the most under- 
reported crimes. In addition, the American 
Humane Association estimates that 110,878 
children were reported as victims of sexual 
maltreatment in 1984, a 54 percent increase 
from 1983. 

The risk level for HIV transmission to sexual 
assault victims is as yet unestablished. Howev- 
er, the physical trauma associated with sexual 
assault increases the vulnerability of body 
tissue and must be factored into assessments of 
risk of viral transmission. In addition, the high- 
risk behavior of many sexual offenders (the 
term sexual offender refers to the perpetrator 
of a sexual assault), in turn, increases the risk 
level of their victims. Children who are sexually 
molested are potentially at elevated risk of in- 
fection if the sexual offender is HIV-infected, 
since many cases involving children have pat- 
terns of repeated contacts over long periods of 



131 



time. The Surgeon General has stated that all 
child sexual assault victims must be considered 
at risk for exposure to HIV. 

Studies of sexual offenders and child molest- 
ers indicate that many often have large num- 
bers of victims and high rates of recidivism. 
Therefore, even a small number of infected 
sexual offenders have the potential for infect- 
ing large numbers of people. 

Victims or their immediate family members 
are aware of their risk of exposure to sexually 
transmitted diseases, including HIV, and are 
beginning to ask questions about, and exhibit 
anxiety over, possible exposure to HIV. Many 
are requesting to be tested. Even in cases 
where the sexual offender is apprehended, the 
issues of testing perpetrators who refuse to be 
tested voluntarily without their consent and 
state laws governing confidentiality of all HIV 
test results may obstruct the victim's ability to 
get information on HIV status. This restriction 
on access to information can cause the victim 
anxiety added to the trauma of the crime itself. 
If HIV status information is available, it should 
be provided to the victim in the context of a 
support and counseling system which can help 
the victim understand the information and 
make decisions about testing or personal con- 
duct. 

The complexity of establishing HIV exposure 
and subsequent seroconversion requires follow- 
up over time. The presence of antibodies may 
take weeks or months to determine, and follow- 
up of sexual assault victims will be necessary. 
Unfortunately, success of past programs which 
included follow-up counseling have not been 
impressive for a variety of reasons. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to assisting victims of sexual assault 
crimes in light of possible exposure to HIV: 

• HIV testing is not currently included in the rou- 
tine tests for sexually transmitted diseases of- 
fered to sexual assault victims. Where testing is 
requested, it may be expensive. Since routine 
tests are usually performed as soon as the assault 
is known, an HIV antibody test of the victim 
would not reveal exposure as a consequence of 
the rape. 

• There are no published studies available on the 
incidence of HIV infection as a result of sexual 
assault or among perpetrators. 



• The criminal justice system and most state laws 
have not addressed fully how to approach the 
HIV-infected sexual offender. 

• Mandatory testing of accused sexual offenders is 
not widely available. 

• In some states, laws prohibit release of informa- 
tion on a sexual offender's HIV status to victims. 

• There is no mechanism for reporting cases of 
HIV-infected sexual offenders once apprehended 
and subsequent notification of victims. 

• Most current counseling programs for victims of 
violent crimes do not include a component on 
HIV, and counselors are not currently trained to 
provide such services. 

• Children typically experience problems in 
coming forward and making adults believe their 
accounts of molestation. 

RECOMMENDATIONS 

Monitoring and Data Collection 

9-52 Public health officials, criminal justice 

systems, and various organizations that 
deal with victims and perpetrators of 
sexual abuse must collect and compile 
data so that the scope of HIV prevalence 
and transmission associated with sexual 
assault can be determined. 

9-53 The Centers for Disease Control should 

monitor and publish the number of re- 
ported cases where HIV transmission 
occurs through sexual assault including 
geographic breakdowns. 

9-54 Criminal justice and victim service orga- 

nizations should collect data on the fre- 
quency of sexual assault victims' requests 
for HIV testing and the frequency of 
positive results for both victims and per- 
petrators. 

9-55 Support for incidence and prevalence 

studies of HIV among the sexual assault 
population, such as those currently 
funded by the National Institute of 
Mental Health, should continue with in- 
creased funding. 

Testing and Counseling 

9-56 Programs which provide medical and 

counseling services to sexual assault vic- 
tims should make voluntary HIV testing 
a part of the sexually transmitted disease 
screening process free of charge and 
make appropriate counseling about as- 
saults and HIV available by trained staff. 



132 



9-57 Training programs for HIV blood test 

counseling and partner notification tech- 
niques should include components fo- 
cusing on the sexual assault population. 

9-58 Federal and state public health authori- 

ties should provide service providers and 
counselors who assist child and adult vic- 
tims of sexual crime with the most cur- 
rent information and training on HIV, 
along with information on the location 
of confidential and anonymous testing 
sites and funding and training for the 
performance of tests. 

9-59 Model programs for the long-term 

follow-up care of victims who do and do 
not test positive initially should be devel- 
oped and funded. If a victim converts to 
positive infection status, there should be 
counseling and health care intervention 
provided throughout the various stages 
of HIV infection. These individuals 
should receive highest priority for par- 
ticipation in clinical drug trials. 

9-60 Social services, law enforcement, mental 

health, medicine and community-based 
services should cooperate to provide ef- 
fective response to child sexual abuse 
by a well-coordinated, multidisciplinary 
team which protects and treats victims 
and their families and deals effectively 
with perpetrators, incorporating con- 
cerns related to HIV exposure. 

9-61 Basic curricula/ training programs for 

health, counseling, and criminal justice 
professionals should include identifica- 
tion of undisclosed sexual trauma, dy- 
namics of victimization, and patterns of 
trauma and recovery as well as HIV 
transmission. 

9-62 Victim advocacy programs should in- 

crease public awareness concerning the 
potential impact of HIV on victims of 
crime through education. 

Testing of Offenders and the Victims' Access to 
Results 

9-63 Criminal justice authorities, under the 

guidance of public health officials, 
should develop a mechanism to order 
that a sexual offender submit to an HIV 
test at the earliest possible juncture in 
the criminal justice process. The results 
of such a test should remain confidential 
and be disclosed only to the victims, if 
they so desire, and public health offi- 
cials. Where the victim of the sexual as- 
sault is a minor, the test results should 



be disclosed to the minor's parents and/ 
or caretakers. 

9-64 The criminal justice system should peri- 

odically conduct follow-up testing of 
convicted offenders who test HIV nega- 
tive to monitor for possible development 
of antibodies or other evidence of infec- 
tion at a later time, with notification of 
victims as appropriate. 

9-65 In the cases where a sexual offender is 

not apprehended, or where apprehended 
and there is a possibility of HIV infec- 
tion even though current test results are 
negative, victims should at least be of- 
fered testing over time and counseling as 
to the potential for transmitting the dis- 
ease and as to proper precautions. 

9-66 Adult victims who choose not to know of 

the sexual offender's HIV status should 
be informed of the possibility of infec- 
tion and offered testing and counseling 
so that they can take appropriate precau- 
tions. 

Criminal Justice System Approaches to Sexual 
Offenders 

9-67 Courts should utilize restitution orders 

whenever possible so that sexual offend- 
ers are held directly accountable for the 
financial effects of their crimes. 

9-68 State laws and federal laws (in the limit- 

ed areas where federal laws preside over 
criminal actions, such as on Indian reser- 
vations) should include provisions for 
enhanced sentencing in cases where 
sexual offenders commit sexual crimes 
knowing they are HIV-infected. 

9-69 Criminal justice facilities should test all 

convicted sexual offenders for HIV prior 
to a parole hearing or release from 
prison. If parole is granted, a positive 
test result should affect the degree of su- 
pervision the sexual offender receives 
following release. 

9-70 If a convicted sexual offender is HIV-in- 

fected, this information should be in- 
cluded in the sexual offender's criminal 
record and used in sentencing hearings 
for subsequent sexual assault convictions 
as a basis to further enhance sentencing. 
The criminal justice system should re- 
strict availability of information on HIV 
status to those individuals within the 
criminal justice system with a need to 
know. Under no circumstances should 
this information be released as general 
public information. 



133 



9-71 The criminal justice system should de- 

velop and implement sound treatment 
programs for sexual offenders which in- 
clude an HIV prevention component. 

Section VI. Correctional Facilities 

A recent joint study sponsored by the Na- 
tional Institute of Justice (NIJ) reports that as 
of October I, 1987, there had been a cumula- 
tive total of 1,964 confirmed AIDS cases in 70 
federal, state, and local correctional systems re- 
sponding to the study. This figure represents a 
156 percent increase in AIDS cases in all re- 
sponding United States correctional systems in 
the two years since NIJ's first survey, and a 59 
percent increase in the one year since the 
second survey in 1986. While most correctional 
systems have adopted policies in response to 
the growing problem of AIDS cases in prisons 
and jails, many key policy issues, such as HIV 
antibody testing and housing of infected in- 
mates, remain matters of considerable contro- 
versy. 

New York State corrections officials testified 
that all prisoners are tested for sexually trans- 
mitted diseases (STDs), but that such tests do 
not include HIV tests. Further testimony indi- 
cated that STD-free prisoners are allowed con- 
jugal visits in New York, but that officials did 
not know whether HIV-infected inmates were 
allowed conjugal visits because no tests were 
performed. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in the correctional facili- 
ties area: 

• Many inmate populations contain a high concen- 
tration of individuals at risk for HIV infection 
but few jurisdictions are attempting to assess the 
prevalence of HIV infections in prison or to in- 
tervene in the epidemic by test-linked counseling 
of at-risk prisoners and subsequent partner noti- 
fication. 

• Many correctional systems are overcrowded. 

• The high cost of medical care for HIV-infected 
inmates is a difficult burden for correctional sys- 
tems with limited budgets. 

• Misinformation is common among inmates and 
correctional system staff regarding modes of HIV 
transmission. 

• Screening inmates through HIV antibody testing 
raises many legal and fiscal concerns that have 
not been addressed in most jurisdictions. 



• Policymakers in most states have yet to define 
the responsibility of the correctional system to 
protect the community, correctional staff, and 
uninfected inmates from HIV infection. 

• There are concerns about confidentiality and the 
safety of inmates identified as HIV-infected. 

• There are concerns about discrimination against 
and rights regularly accorded prisoners (e.g., 
parole and furlough) being denied on the basis 
of HIV antibody status. 

• The lack of HIV tests prior to conjugal visits 
puts those visiting unnecessarily at risk. 

RECOMMENDATIONS 

In addressing these obstacles to progress, the 
Commission recommends the following: 

Prevention 

Education and training of inmates and staff 
are a key strategy for curbing the spread of 
HIV infection in prisons and jails. Education 
and training programs are important not only 
as a means of protecting people from infection, 
but also as a means to counteract misinforma- 
tion and rumors about HIV, thereby dispelling 
unwarranted fears about the disease, an espe- 
cially important goal in the often highly- 
charged close living quarters of a prison. 

9-72 All correctional systems should immedi- 

ately institute an HIV prevention pro- 
gram for both inmates and staff. These 
systems should: provide education and 
training on a regular basis; be based on 
the most current medical knowledge; in- 
clude the latest information on risk re- 
duction behavior and technology; and 
allow for participant involvement such as 
question and answer sessions, peer edu- 
cation, and counseling. Teams conduct- 
ing training should include health per- 
sonnel whenever possible. Training and 
informational materials should be brief, 
presented in a clear straightforward 
manner, and be structured for the edu- 
cational level and concerns of the par- 
ticular audience. 

Testing 

As of November 1987, twelve state correc- 
tional systems (Alabama, Colorado, Idaho, 
Iowa, Missouri, Nebraska, Nevada, New Hamp- 
shire, Oklahoma, South Dakota, Utah, and 
West Virginia) have implemented or are plan- 
ning to implement mass screening programs. 
The Federal Bureau of Prisons (FBP) reas- 
sessed its earlier policy of mass screening and 



134 



now tests inmates: prior to release; who exhibit 
clinical indications of the virus; who request to 
be tested; who are released for community ac- 
tivity purposes; and who have exhibited preda- 
tory and promiscuous behavior. In addition, for 
study purposes, FBP tests a 10 percent sam- 
pling of incoming inmates who are retested at 
three, six, 12, and 18 month intervals. 

9-73 All correctional systems should regularly 

offer and strongly urge voluntary HIV 
testing and counseling for HIV infection 
at intake, at medical check-ups, during 
incarceration, and before release to all 
inmates. Counseling and testing should 
also be regularly offered to staff. 

9-74 All correctional systems should adopt 

HIV testing policies that are consistent 
with the Federal Bureau of Prisons' 
policy for testing inmates for HIV. HIV 
testing programs should also provide for 
mandatory testing of inmates whose con- 
victions were a result of sex or drug-re- 
lated crimes or who have a history of in- 
travenous drug abuse. Testing policies 
should be consistent with applicable 
state or federal law. 

9-75 HIV testing programs instituted by cor- 

rectional systems should include exten- 
sive counseling services pre- and post- 
testing and while test results are being 
determined. Counseling of those inmates 
found to be HIV-infected must be con- 
sistent with that recommended for all in- 
fected persons, including full informa- 
tion about methods of preventing fur- 
ther spread of infection. 

9-76 Rights regularly accorded to all inmates 

(e.g., parole and furlough) should not be 
abridged solely on the basis of HIV in- 
fection. 

9-77 Disclosure of test results should be 

strictly limited. The correctional system's 
disclosure policy should specify clearly 
who is permitted to receive the informa- 
tion, what information is to be released, 
and under what circumstances. Test re- 
sults should be reported to public health 
authorities so that partner notification 
can be performed. 

9-78 The Centers for Disease Control should 

work with federal, state, and local cor- 
rections health officials to evaluate the 
various inmate testing programs and 
make those results regularly available to 
appropriate policymakers. 



Housing 

The Centers for Disease Control guidelines 
suggest that no special housing arrangements 
be made for HIV-infected individuals except 
under defined medical circumstances. Given 
the fact that sexual activity and drug use do 
take place in prisons, segregation may appeal 
to some prison officials as a means of further 
limiting the spread of HIV. However, as an 
infection control device, such "identify and iso- 
late" plans are never 100 percent successful. 

9-79 The National Institute of Justice should 

continue to review and evaluate prison 
housing policies making up-to-date in- 
formation and guidance available to 
prison systems regularly. 

9-80 Each correctional facility should establish 

a policy on how to manage the housing 
of known HIV-infected prisoners based 
on such factors as: current public health 
guidelines, physical space limitations, 
staffing levels, and prevalence of infec- 
tion in the facility. 

9—81 Correctional facilities should provide a 

means for protecting those HIV-infected 
inmates whose safety would be at risk if 
placed in the general prison population. 



Treatment 

9-82 



The care and treatment available to 
HIV-infected inmates in correctional fa- 
cilities should be equal to that available 
to HIV-infected individuals in the gener- 
al community. 



9-83 Correctional systems should establish 

drug treatment programs based on the 
therapeutic community model for those 
inmates identified as drug abusers and/ 
or incarcerated for drug-related crimes. 
This model has successfully utilized 
former addicts as counselors because of 
their value as role models. The inmate 
should remain in drug treatment for no 
less than nine to 12 months unless pre- 
cluded by the length of the sentence and 
should be referred upon release to drug 
treatment facilities near their homes. 

9-84 Correctional systems should make coun- 

seling services available to all HIV-in- 
fected inmates. For successful treatment 
of inmates who are intravenous drug 
abusers, counseling is particularly impor- 
tant during those periods immediately 
prior to and immediately after release. 
The inmate should receive concentrated 
counseling on the importance of avoid- 
ing risk behaviors and drugs during the 



135 



9-85 



pre- and post-release periods. This 
counseling should also include admon- 
ishment that failure to do so could result 
in immediate disciplinary action as well 
as affect parole and/or enhance future 
sentencing. 

Correctional systems should encourage 
the development of support groups 
within their institutions. 



Section VII. Ethical Issues 

Ethical questions present some of the most 
vexing problems associated with HIV infection 
and society's efforts to understand it, prevent 
it, control it, and treat it. Ethics is a discipline 
which helps us determine what is right and 
wrong and to act accordingly. Ethical principles 
such as beneficence, autonomy, and justice 
guide us in searching for solutions, as do ethi- 
cal and legal precedents. But the HIV epidemic 
seems to raise some new ethical questions, or, 
perhaps more accurately, has produced a new 
dimension to familiar ethical questions. A 
number of complex questions are forcing us to 
define our commitment to principles of com- 
passion, individual liberty, and the public good. 
Determining the ethically appropriate and feasi- 
ble response and putting that response into 
motion is posing formidable challenges for our 
society. 

We recognize that ethical considerations and 
decision-making are contained in every facet of 
our discussion of and response to this epidem- 
ic. We have chosen to incorporate ethical con- 
siderations into all sections of this report. In 
the preceding sections on discrimination and 
confidentiality, as well as in the sections on 
patient care and societal issues, references are 
made to ethical principles and decision-making, 
and our recommendations were made in light 
of those ethical considerations. 

In this section the Commission has separated 
out a few areas for emphasis. These include: 
the obligations of health care providers; the 
ethics of treatment decisions; the ethics of re- 
search; and, very importantly and too often ne- 
glected in the ethical debate, the ethics of HIV- 
infected individuals, themselves, as well as the 
ethics of others toward them. There are many 
excellent discussions of ethical issues surround- 
ing HIV infection in research literature. In this 
report, considerations of ethical issues are lim- 
ited to those which surfaced repeatedly during 
the hearings and site visits conducted by the 
Commission. 



The Obligations of Health Care Providers 

History is replete with examples of health 
care workers providing care and demonstrating 
a devotion to patients which transcended any 
possible danger to themselves of contracting 
patients' diseases. Health care workers have 
worked valiantly caring for the sick or injured 
in conditions of squalor, poor sanitation, and 
exposure to infectious diseases — as in the 
cases of cholera, influenza, and the bubonic 
plague. Some health care workers have suf- 
fered, and some have died, as a consequence. 

The current generation of health care work- 
ers had not confronted an infectious disease 
that posed such a serious threat. In recent 
years, most patients requiring care were those 
with chronic diseases presumably caused by en- 
vironmental or lifestyle factors, not by microor- 
ganisms. But now there is HIV infection, which 
poses the danger of infection with a blood- 
borne virus. Health care workers, by virtue of 
their exposure to blood and body fluids, are at 
some risk of acquiring an HIV infection while 
caring for infected patients. In many areas, de- 
spite the low risk, health care workers, includ- 
ing physicians, nurses, emergency medical tech- 
nicians, and others, have been plagued with a 
fear of this disease that sometimes interferes 
with their ability and/or willingness to care for 
infected persons. 

In addition to the actual risk — and the per- 
ceived risk — of infection, some health care 
workers have expressed disapproval of the life- 
styles and behaviors of some of the people who 
have acquired HIV infection (homosexual men, 
intravenous drug users, and prostitutes). Some 
have allowed this disapproval, and a feeling 
that "they got what they deserved," to interfere 
with the care they provide to infected persons. 
Fortunately, this is a minority view, and there 
are large numbers of health care workers who 
tirelessly provide quality care to HIV-infected 
persons in a compassionate and sensitive 
manner. 

The ethical principle of beneficence (do no 
harm and promote good), amplified by the role 
of promoter of health and provider of care to 
which the health professional is committed and 
licensed to practice, serves as a solid rationale 
for the provision of care to all who need it. 
Health care providers also have an obligation 
to plan for and provide optimal treatment and 
care to every patient. This necessitates knowl- 



136 



edge of and employment of all available tech- 
nologies to achieve early diagnosis and treat- 
ment. 

In addition, codes of ethics and statements 
from the various professional associations pro- 
vide guidance for health professionals. The 
Commission applauds these groups for clear 
statements of obligation. A few examples: 

"A physician may not ethically refuse to treat a 
patient whose condition is within the physician's 
current realm of competence solely because the 
patient is infected with HIV." — American Medical 
Association 

"The nurse provides services with respect for 
human dignity and the uniqueness of the client, 
unrestricted by considerations of social or eco- 
nomic status, personal attributes, or the nature 
of the health problem." — American Nurses' Asso- 
ciation 

Health care providers also have the obliga- 
tion to protect their patients by maintaining 
confidentiality of information. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to fulfillment of the obligation of 
health care providers to provide care, in conso- 
nance with ethical principles, to HIV-infected 
patients: 

• Although the risk of acquiring an HIV infection 
from caring for a patient is calculated to be less 
than one percent (i.e., less than one percent of 
all possible exposures actually results in trans- 
mission of the virus), the perceived risk is great, 
causing fear and concern about "catching AIDS 
from patients" on the part of some health care 
workers and, in the process, forming a barrier to 
meeting ethical obligations. 

• There is an apparent lack of education and 
awareness on the part of too many health care 
workers about what the risks are and how to pro- 
tect themselves. Until this is remedied, they will 
unwittingly continue to contribute to the nation's 
misunderstanding of the epidemic. 

• Health care professionals face increasingly diffi- 
cult ethical decisions involving patient care. 
Technological advances are out-stripping current 
ethical guidelines, and the study of ethics is fre- 
quently lacking in the curricula of health care 
professional schools. 

• Although the professional associations have all 
issued statements and ethical guidelines, these 
are just guidelines and not rules. Despite the 
guidelines, a number of health care workers still 
refuse to care for HIV-infected persons. 



• There is insufficient data on possible variations 
of risk in different settings (e.g., emergency 
room) or with different activities (e.g., various in- 
vasive procedures), as well as insufficient data on 
the protectiveness of infection control apparatus. 

• Concern about HIV infection may be deterring 
young men and women from entering the health 
care professions or certain subspecialties. This 
may exacerbate an existing shortage in some 
professions. 

• Some providers are concerned that treatment of 
HIV-infected persons will drive away other pa- 
tients and place the provider at economic risk. 

• Reluctance to be perceived as "overreacting" to 
the epidemic may be leading some physicians to 
refrain from regularly offering HIV testing by 
which they could enhance their ability to diag- 
nose and deliver more informed care. 

RECOMMENDATIONS 

In response to these obstacles to progress, 
the Commission makes the following recom- 
mendations: 

9-86 Health care providers have an obligation 

to provide care, within the limits of their 
competencies, to all persons who need 
it, regardless of their HIV status. This 
obligation does not preclude appropriate 
referrals when the provider lacks the 
technical or professional skills to provide 
the indicated services. 

9-87 Health professional associations should 

establish or reaffirm clear guidelines on 
their members' obligations and responsi- 
bilities and disseminate them widely to 
all members. The development of such 
guidelines should be done with the input 
and participation of practicing members. 

9-88 Health care providers have the obliga- 

tion and responsibility to become — and 
remain - educated about HTV infection 
and related subjects so that they can 
provide competent care to patients and 
prevent unnecessary risk to themselves. 

9-89 Health care providers should employ ap- 

propriate infection control procedures at 
all times. Employers of health care pro- 
viders have the obligation to assure that 
necessary equipment and supplies are 
available and that all workers are ade- 
quately trained in their use. 

9-90 Health care providers involved in pro- 

viding direct care to patients have a right 
to know all known relevant patient infor- 
mation which might assist them in 



137 



making treatment or care decisions. All 
health care providers have the responsi- 
bility to use this information appropri- 
ately and maintain the confidentiality of 
this information. 

9-91 The health professional associations 

should continue and expand their efforts 
to educate their members and the public 
about HIV infection and should include 
discussions of pertinent ethical concerns. 

9-92 The National Institutes of Health should 

encourage interdisciplinary research ef- 
forts in ethics directed toward a better 
understanding of the processes, ele- 
ments and components of the ethics of 
the decision-making process with par- 
ticular emphasis directed toward the eth- 
ical dilemmas raised by the HIV epidem- 
ic. 

9-93 Health care professionals have the re- 

sponsibility to educate adequately all pa- 
tients about the transmission of HIV, in- 
cluding those patients who need assur- 
ance that they cannot become infected 
by going to the same provider or the 
same health care setting as infected pa- 
tients. Professional organizations should 
stress this educational responsibility in 
all of their education and training curric- 
ula on an accelerated basis. 

9-94 Physicians have the responsibility to take 

all feasible steps to achieve accurate, 
early diagnosis. 

The Ethics of Treatment Decisions 

The decisions of health care providers about 
treatment for HIV-infected persons should be 
based on the same ethical principles as deci- 
sions about treatment for an individual with 
any illness. This includes the presentation to 
the patient of viable medical options based on 
scientific data about efficacy and a respect for 
the patient's right to participate in decisions 
about his or her own care. Ethically, decisions 
about individual diagnosis, treatment and care 
should not be made on the basis of socioeco- 
nomic concerns, such as ability to pay, or more 
global concerns, such as allocation of scarce 
health care resources. In addition, social preju- 
dices of any type should not in any way influ- 
ence decisions on treatment. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress in making ethical deci- 
sions about treatment: 



• Preferences in treatment are sometimes difficult 
to elicit from individuals or groups of individuals 
who have limited education. 

• Care givers often lack information, or are dis- 
couraged, about medically viable options for HIV 
infection and its consequences. 

• Care givers may be reluctant to discuss future 
treatment options with patients because of fear, 
inexperience, or concern about patients' reac- 
tions. 

• The competence of an HIV-infected individual, 
especially in the late stages of the disease, may 
be compromised by neuropsychiatric complica- 
tions. 

• If given the choice, a proportion of those with 
HlV infection may select a person other than 
next-of-kin to make critical decisions for them in 
the event of their incompetence. 

RECOMMENDATIONS 

9-95 All care givers should give HIV-infected 

patients the same respect, dignity, and 
decision-making autonomy as any other 
patient. 

9-96 All health care providers should make 

informed consent by the patient an es- 
sential first step in any HIV-related 
treatment or intervention. 

9-97 All health care providers should give 

HIV-infected patients the opportunity to 
express preferences about care and 
about life-sustaining therapies as early 
and as often as possible after diagnosis. 
Legal, psychological, and moral counsel 
should be made available to all patients 
to help them express their wishes. 

9-98 The nation's universities and health care 

professional schools, through research 
grants and study groups, should fund 
and conduct the further examination of 
actual and potential ethical controversies 
which arise in providing care to HIV-in- 
fected patients. 

Ethical Considerations of Research 

In the Commission's limited examination of 
ethical issues related to research, several areas 
of concern were brought to the forefront. Of 
particular concern are: equitable and fair access 
to clinical trials and experimental drugs; the 
vital importance and difficulties with informed 
consent for research protocols; the appropri- 
ateness of placebo-controlled trials at certain 
stages of HIV-related disease; the protection of 
confidentiality of research subjects; and ethical 



138 



questions about the allocation of economic and 
human resources for research. All of these 
issues are considered in the chapter on re- 
search in this report. 

Other research issues with ethical underpin- 
nings include the importance of research on 
education and behavior change, which is ad- 
dressed in the chapter on education, and the 
importance of research to help delineate the 
most effective (from considerations of both 
therapy and cost) health care services for HIV- 
infected persons, which is addressed in the 
chapter on patient care. 

In this section on research ethics, we have 
chosen to limit our discussion to one issue — 
ethical considerations relevant to releasing sci- 
entific information. Research and scientific in- 
vestigation about HIV is occurring at a remark- 
able pace. While this information must be 
made available as soon as possible to those 
who need it, it also must be reliable and be 
presented in an appropriate manner to the gen- 
eral public. The Commission has seen and 
heard many examples of information released 
to the public without adequate scientific and 
peer review, which only contributes to fear, 
anxiety, and mistrust of scientific information 
among members of the public. 

Obstacles to Progress 

The Commission has identified the following 
obstacles to progress regarding the release of 
information: 

• The timely release of reliable information about 
all aspects of HIV infection is imperative. Be- 
cause of this, some scientists and journalists may 
have overlooked an ethical responsibility to 
report scientific information after adequate peer 
review and within an appropriate context for un- 
derstanding. 

• While some journals and organizations have fa- 
cilitated the dissemination of HIV-related infor- 
mation, the usual review protocols are slow and 
are seen by some as an obstacle to be bypassed. 

RECOMMENDATION 

9-99 Scientists and researchers are encour- 

aged to subject all information related to 
the HIV epidemic to adequate peer 
review and to report it to the media 
within a context which promotes under- 
standing among all members of the 
public, and which minimizes sensational- 
ism. 



Ethical Behavior of HIV-infected 
Individuals 

One of the most basic of ethical principles is 
that of non-maleficence. Non-maleficence es- 
sentially directs us to do no harm. Our society 
values highly the rights of individuals to privacy 
and liberty. But liberty entails a responsibility 
not to harm or interfere with others, a respon- 
sibility to be non-maleficent. In this context, 
the Commission believes that HIV-infected per- 
sons have certain ethical responsibilities which 
they must meet in order to prevent harm to 
others. Fulfilling these responsibilities is also 
an affirmation of the rights of others. 

Obstacle to Progress 

• Persons who are infected with HIV or at risk for 
infection with HIV may not be aware of, or in 
some cases not comply with, their ethical respon- 
sibility to avoid harm to others. 

RECOMMENDATIONS 

9-100 Persons infected with HIV or at risk of 

infection with HIV should take appropri- 
ate steps to avoid infecting others. This 
includes: not donating blood, sperm, or 
organs; not infecting others sexually; not 
sharing needles or other sharp instru- 
ments contaminated with blood. 

9-101 Persons infected with HIV or at risk of 

infection with HIV should inform those 
persons who might be at risk of acquir- 
ing infection from them in the course of 
specific interactions. Specifically this in- 
cludes: informing sexual partners and in- 
forming health care providers (doctor, 
dentist, nurse, and others). 

9-102 Any provider of counseling and support 

to HIV-infected individuals should incor- 
porate these principles into the informa- 
tion and support provided. 

9-103 If, in the process of providing health 

3_45 care, a health care worker is exposed to 

the blood or body fluids of any patient, 
the health care worker has the right to 
know the infection status of that individ- 
ual. Consent agreements obtained in the 
traditional health care provider/patient 
context will normally provide for this. In 
the unusual case of denial of consent, 
competent medical authorities should 
make the determination whether testing 
should be done and, if done, should 
note the rationale in the medical record. 



139 



Ethical Behavior of Others to Those 
Infected 

In addition to the basic principle of non- 
malelicence, our society values a respect for the 
liberty and dignity of each human being. The 
Commission has seen and heard examples of 
instances in which HIV-infected individuals 
were not accorded this basic respect by other 
citizens. As many witnesses before the Commis- 
sion so eloquently expressed, the degree to 
which we are able to show respect, compassion, 
and concern for those who are infected or ill 
reflects the nature of our belief in human dig- 
nity and our own self-respect. 

Violence against those perceived to carry 
HIV, so-called "hale crimes," is a serious prob- 
lem. The Commission has heard reports in 
which homosexual men in particular have been 
victims of random violent acts that are indica- 



tive of some persons in society who are not 
reacting rationally to the epidemic. This type of 
violence is unacceptable and should be con- 
demned by all Americans. 

Obstacle to Progress 

• There have been too many examples of discrimi- 
nation, disrespect, violence, and inhumane treat- 
ment of persons infected with HIV by other 
members of the community. 

RECOMMENDATIONS 

9-104 All human beings deserve respect and 

preservation of their dignity in interac- 
tions with other human beings. HIV-in- 
fected persons arc no exception to this 
basic ethical rule. 

9-105 Violent acts against individuals with HIV 

infection or those perceived to carry 
HIV should be prosecuted to the fullest 
extent of the law. 



140 



CHAPTER TEN: FINANCING HEALTH CARE 



Equitable financing of the HIV epidemic has 
been one of the greatest challenges placed 
before our health care delivery system. This 
epidemic has magnified flaws in the methods 
and mechanisms of the health care financing 
system in this country and magnified the 
impact on the delivery of quality care and serv- 
ices. 

The Commission believes that the financing 
issue is one of the most difficult problems of 
the HIV epidemic. It is not easy to answer the 
questions about treating AIDS and HIV infec- 
tion apart from other devastating sicknesses 
and diseases. If we can make changes in our 
financing system, do we do it only for those 
with HIV or do we do it for everyone? Allocat- 
ing limited health care resources when the 
needs are so great presents a significant chal- 
lenge. 

The catastrophic financial impact that HIV 
infection has had on the personal lives of many 
was shared with the Commission during four 
days of public hearings. Persons with sympto- 
matic HIV infection testified on the obstacles 
they must overcome when becoming ill as a 
result of HIV: the constant fear of losing a job 
and thereby a means of paying for health insur- 
ance; a daunting number of forms to be filed 
for various assistance programs and, very often, 
a long waiting period before receiving benefits, 
if at all; and the painful process of "spending 
down" — using up most resources on medical 
bills if insurance is unavailable and income and 
assets are too high — in order to qualify for 
Medicaid benefits. The obstacles faced by these 
persons point out the limited access to quality 
care, as well as the limitations of financing ill- 
ness care in general across the nation. 

Our current pluralistic approach to financing 
health care involves a combination of private 



and public funding. A person with HIV infec- 
tion pays for care either out-of-pocket, through 
private health insurance, or through the public 
health system involving either Medicaid or 
Medicare. 

Medicare provides health insurance benefits 
for persons over age 65 and qualified disabled 
persons while Medicaid provides medical serv- 
ices for the needy and medically needy. For a 
disabled individual to qualify for the Medicare 
program, a 24-month waiting period (which 
may total 30 months or more when disability 
waiting periods and administrative processing 
time are taken into account) must be completed 
while receiving a Social Security Disability In- 
surance benefit. For Medicaid health coverage, 
generally the individual must be receiving ben- 
efits under either Aid to Families with Depend- 
ent Children (AFDC) or Supplemental Security 
Income (SSI) programs, or must "spend down" 
on medical bills according to individual state 
requirements. 

Section I. Financing 
Comprehensive Care 

In the public hearings on finance, the Com- 
mission addressed the problems of equitable 
financing of care for persons with HIV infec- 
tion and discovered linkages with the broader 
issues of financing our health care system. The 
issues brought to the surface by the HIV epi- 
demic have been part of our health care financ- 
ing system for a long time: the impact of cata- 
strophic illnesses; increasing costs of inpatient 
services (including funds for recruitment and 
retention of nurses); lack of alternatives to hos- 
pital care; and inadequate reimbursement 
mechanisms. 



141 



214-701 



88 



OL 3 



For example, the costs for treating a person 
with symptomatic HIV infection are high, but 
are comparable to other high-priced treat- 
ments, such as those for cancer or heart dis- 
ease. Hospitals are not adequately reimbursed 
for care provided to those with HIV infection, 
but this is true for many other illnesses. Cost- 
effective alternatives to hospital care in general 
should be encouraged, particularly for persons 
with HIV infection, but financial incentives are 
generally lacking to generate the appropriate 
level of services. 

A number of factors, however, set apart the 
HIV epidemic from other health care crises. 
One factor is that the overall costs to the 
nation both in terms of medical care and lost 
productivity are large and will continue to grow 
as the prevalence of HIV infection increases. 
This disease has struck many persons in their 
prime earning years, challenging the estab- 
lished approach for financing care for episodic 
illnesses and creating the potential for an im- 
balance in the system over the long term. In 
addition, a few geographical areas are harder 
hit than other parts of the country. While this 
situation has created an immediate funding 
crisis for large urban areas, the impact of the 
HIV epidemic on the financing of care is begin- 
ning to be more broadly felt throughout the 
nation. 

Costs of Care 

The costs of inpatient care for a person with 
AIDS are high, but are comparable to other 
high-cost medical conditions or illnesses. Cur- 
rent estimates of lifetime hospital costs for a 
person with AIDS are under $100,000 and 
annual treatment costs are approximately 
$40,000. In comparison, the estimated costs of 
a liver transplant are $175,000, of end-stage 
renal disease $158,000, and of a heart trans- 
plant $83,000. 

Nationwide, the costs for the provision of 
medical care to persons with AIDS are project- 
ed to increase from about $1.1 billion in 1985 
up to $8.5 billion in 1991. As a proportion of 
United States personal health care expendi- 
tures, medical care costs for treating AIDS will 
grow from 0.2 percent to 1.4 percent over the 
same period. Total costs to the nation associat- 
ed with AIDS — personal medical care and 
services, lost income, decreased consumption, 
and insurance payouts — were approximately 
$8.7 billion in 1986 and are projected to reach 



a total of $66.5 billion in 1991, based on the 
projection of 173,000 cases of AIDS. 

To put these costs in perspective, catastroph- 
ic illnesses cost the nation about $56 billion 
each year. If taken together, heart disease, 
stroke, cancer, and motor vehicle accidents ac- 
count for about 20 percent of national medical 
expenditures. Total national health care ex- 
penditures exceeded an estimated $425 billion 
in 1986. 

A major obstacle to encouraging more cost- 
effective, out-of-hospital care has been a lack of 
data on actual cost savings for such care. We 
have heard testimony that case-managed care, 
used in determining appropriate levels of care, 
can save as much as $12 for every one dollar 
spent on AIDS case management. Better data 
on the savings of out-of-hospital care should be 
available after June of this year when the 
Health Resources and Services Administration 
(HRSA) will be evaluating the costs of out- 
patient and clinic services to determine cost- 
effectiveness of patient support services. 

Reimbursement for Care 

Both public and private health insurance re- 
imbursement is based on the expected costs of 
a service. If the individual has no health insur- 
ance or inadequate coverage, the unreimbursed 
costs must be paid out-of-pocket or the hospi- 
tal and other patients incur the cost for provi- 
sion of service. Unreimbursed care in public 
hospitals must eventually be compensated by 
the community through general revenues. 

While reimbursement has been inadequate 
from both public and private payers to hospi- 
tals for the costs of treating persons with HIV 
infection and AIDS, the problem is felt most 
acutely in the public hospital systems, particu- 
larly in the South. The average national inpa- 
tient cost of caring for a patient with AIDS has 
been estimated at about $630 per day. The 
Medicaid reimbursement rate in the South, 
however, averages about $282 per day and in 
other regions of the country about $500 per 
day. 

Reimbursement has also been inadequate in 
promoting care in alternate, more appropriate 
settings. The Medicaid program, the primary 
payer for most individuals with AIDS, is restric- 
tive in reimbursement levels for certain types of 
facilities. For instance, care for a person with 
AIDS in a long-term care institution can cost 
an estimated $200 per day, but in most states 



142 



Medicaid reimburses only about $50 per day. 
State Medicaid programs also do not adequate- 
ly cover outpatient services needed by commu- 
nity-based programs to help individuals with 
AIDS. 

Provision of Services 

A major problem in the provision of services 
for persons with AIDS is that public and pri- 
vate payers set limits on the extent of services 
that are covered and in many instances the 
excluded services are those that are most rele- 
vant in the care of persons with AIDS. Federal 
law requires that the state Medicaid program 
provide certain services, such as inpatient and 
outpatient care, physician services, and skilled 
nursing services at home for eligible persons. 
The states then have the option to provide 
other services, such as home health care aides, 
clinic services, and personal care services. 

In order to encourage more innovation in 
providing health care for persons with AIDS, 
several states have activated additional options 
under their Medicaid programs. New Jersey 
and New Mexico were the first two states in the 
country to use a waiver authorized under Sec- 
tion 2176 of the Omnibus Budget Reconcilia- 
tion Act of 1981. This waiver allows states to 
provide cost-effective home and community- 
based care for persons with AIDS. California 
applied and was recently approved for the Sec- 
tion 2176 service waiver. Exercising other op- 
tions, New York has started a system for pro- 
viding a range of care for AIDS patients and is 
collecting data on the costs of this care. This 
model program which could be used or modi- 
fied in treating other illnesses or medical con- 
ditions demonstrates how payment can be tied 
to the delivery of an appropriate range of serv- 
ices. 

States should continue to explore the set of 
options at their disposal under the Medicaid 
waiver program to provide appropriate, cost- 
effective services to persons with AIDS and 
extend those services to all persons with symp- 
tomatic HIV infection. We have heard testimo- 
ny, however, indicating that significant adminis- 
trative problems exist in obtaining approval for 
these waivers. The waiver review process is 
burdensome and includes administrative re- 
quirements, which may be unnecessary. 

Another problem in the provision of services 
is a scarcity of resources available for dealing 
with HIV infection in both the inpatient setting 
and in providing community-based, out-of-hos- 



pital care, particularly in areas that are dispro- 
portionately affected by HIV. While there are 
excess hospital beds in many parts of the coun- 
try, New York City is currently experiencing a 
shortage of beds, and it projects a need for 
approximately 1,300 to 1,500 beds by 1991 to 
care for AIDS patients. In these hard-hit areas, 
there is an inadequate provision of long-term 
care, a lack of capital funding to provide facili- 
ties, and/or a lack of treatment facilities for 
intravenous drug abusers. 

In addition to providing care for those with 
acute illnesses, most public hospital systems 
provide much of the acute care for drug abus- 
ers with HIV-related illnesses. In the New York 
City Health and Hospital Corporation system, 
75 percent of the people with AIDS are drug 
users or the children of drug users. 

The issue of financing services for persons 
with HIV infection brings into focus another 
problem inherent with funding care for episod- 
ic illnesses — that of linking the reimbursement 
stream and licensure requirements of a facility 
to the general health status of the residents of 
a facility. Some facilities can provide services, 
such as drug treatment, testing, counseling, in- 
formation, and education, while also providing 
a place for patients to live. A continuous fund- 
ing stream must be available to support care 
for individuals with HIV infection and to reim- 
burse the facility adequately for costs. This is 
particularly true in the case of HIV-infected 
children who are abandoned in hospitals — 
boarder babies. These children could be better 
cared for in alternative residential settings, 
such as foster homes or group homes. Current 
state licensing, Medicaid, and Supplemental Se- 
curity Income regulations restrict support for 
these types of facilities because the care being 
provided is in a setting other than the currently 
allowed, fully licensed Skilled Nursing Facility 
or Intermediate Care Facility. 

While the Commission recognizes that some 
suggested major adjustments will not happen 
in the near future, the current situation calls 
for immediate action to provide funding neces- 
sary to help the hardest hit areas and provide 
care for people in desperate need of assistance. 
This would mean providing targeted assistance 
in the form of block grants to the hardest hit 
areas and encouraging cost-effective care 
through enhanced reimbursement from the 
federal government. The administrative hurdles 
of the waiver programs should also be reviewed 



143 



and trimmed back to encourage innovative pro- 10-2 
grams of care as soon as possible. 

In the medium term, the data being collected 
currently and under proposed demonstration 
projects will provide the information and expe- 
rience upon which a long-term strategy can be 
developed and implemented. 

Obstacles to Progress 

• Data is lacking on the costs of treating AIDS and 
HIV infection, the cost-effectiveness of various 
care modes, and the sources of payment. 

• There are limited community support systems 
for HIV-infected persons to facilitate out-of-hos- 

pital care and to provide emotional and financial 10-3 
assistance. 

• Incentives and supporting regulations are lacking 
for continuity of care, for appropriate, cost-effec- 
tive alternatives to inpatient care, and for ade- 
quately managed care starting from initial diag- 
nosis. 

• The private and public health care reimburse- 
ment systems emphasize institutional care and 
are unresponsive to alternative health services, 
which may be more desirable from the patient's 
perspective and more cost-effective over the long 
term. 

10-4 

• Incentives are lacking for development of alter- 
native care facilities. Administrative roadblocks 
exist for expansion of housing, and funding 
streams are inadequate to support existing facili- 
ties. 

RECOMMENDATIONS 

Financing Cost-Effective Care 10-5 

10-1 The Health Care Financing Administra- 

tion should continue actively to encour- 
age states to take advantage of a number 
of options available in their Medicaid 
programs. These options include, but 
are not limited to, amending plans to 
provide case management services tar- 
geted to certain groups such as persons 
with HIV infection; adopting hospice 
benefits useful to persons with AIDS; ap- 
plying for home and community-based 
services waivers (Section 2176 waivers); 
applying for "freedom of choice" waiv- 10-6 
ers permitting case management service 
mechanisms and innovative reimburse- 
ment methods to be used for services to 
persons with HIV infection; and devel- 
oping special incentive payment rates for 
services to persons with AIDS and other 
patients with high-cost care require- 
ments. 



The Health Care Financing Administra- 
tion (HCFA) should change the Medicaid 
waiver review process, streamlining and 
eliminating aspects of the application 
process which delay approval, expanding 
the availability and size of the waiver 
program, and providing more flexibility 
for testing innovative treatment alterna- 
tives. To this end, HCFA should con- 
vene a meeting of state officials or 
spokesmen, including state Medicaid di- 
rectors, in order to discuss specific 
changes in the waiver review process as 
well as a minimum package of benefits 
that should be reimbursed for care of 
symptomatic HIV patients. 

The Health Care Financing Administra- 
tion, in conjunction with the Health Re- 
sources and Services Administration, 
should encourage additional demonstra- 
tion projects of reimbursement mecha- 
nisms to providers for cost-effective care 
of very ill patients, including experimen- 
tation in capitation, prepaid care, and 
use of case management by various pro- 
viders. The results of these demonstra- 
tion programs should be compiled and 
distributed to federal and state officials 
for consideration in legislation and pro- 
gram changes. 

Private health insurers should begin re- 
viewing and revising the services eligible 
for reimbursement and the rates of reim- 
bursement to cover adequately program 
costs, such as home health care, focusing 
on appropriate and cost-effective serv- 
ices for individuals with HIV-related ill- 
nesses. 

In light of some states' experiences with 
Diagnostic Related Group (DRG) reim- 
bursement for HIV-related illnesses, the 
Health Care Financing Administration 
should consider whether to create a 
system of well-defined Medicare and 
Medicaid DRGs which takes into account 
the full costs of caring for an individual 
with various manifestations of HIV infec- 
tion, including the costs of implementing 
the Centers for Disease Control's Uni- 
versal Infection Control Precautions. 

The Health Care Financing Administra- 
tion should establish a demonstration 
project which increases the federal Med- 
icaid matching rate for states that give 
providers a higher rate for promoting 
long-term care, comprehensive home 
care, outpatient services, and case man- 
agement of a full range of services, in- 
cluding coordination with other provid- 



144 



ers, to encourage cost-effective care for 
HIV-infected patients. 

10-7 The Health Care Financing Administra- 

tion should amend federal Medicaid reg- 
ulations to allow non-hospital-based 
drug rehabilitation programs in a resi- 
dential setting to receive federal reim- 
bursement and to promote expansion of 
residential programs. This may entail ex- 
empting these programs from inclusion 
in the definition of Institutions for 
Mental Diseases. 

10-8 States should re-evaluate Medicaid and 

Supplemental Security Income reim- 
bursement levels for supportive housing 
programs for people with AIDS and 
review how facilities are licensed in 
order to provide in a residential setting 
the level of care needed for homeless 
persons. 

10-9 The Department of Housing and Urban 

Development should increase funding to 
encourage state and local governments, 
in concert with foundations and private 
enterprises, to establish programs to 
subsidize supportive housing for persons 
with HIV infection. 

10-10 The Health Care Financing Administra- 

2_g tion should encourage states to provide 

exceptions to limits on state Medicaid 
payments for providing necessary inpa- 
tient care for infants in hospitals with 
disproportionately large Medicaid pa- 
tient populations. 



Targeted Assistance 

10-11 
2-11 



The Health Care Financing Administra- 
tion and the Health Resources and Serv- 
ices Administration should institute a 
program of special project grants to pri- 
vate and public agencies for the develop- 
ment or expansion of outpatient services 
and home care. 



10-12 The Health Care Financing Administra- 

tion, together with the Health Resources 
and Services Administration, should es- 
tablish a stop-loss provision for Medicaid 
which would provide block grants to 
states when the proportion of Medicaid 
funds spent on AIDS care exceeds a pre- 
determined level, similar to the provi- 
sion under the Supplemental Unemploy- 
ment Benefit Program. 



Section II. Financing Health 
Insurance Coverage 

Access to adequate health care has been hin- 
dered by a lack of health insurance in general. 
As many as 35 million Americans may be with- 
out health insurance coverage. In one public 
hospital in Texas dealing with a large propor- 
tion of AIDS patients, fully 75 percent of its 
patients had no health insurance. 

The lack of adequate health insurance among 
persons with AIDS is an even greater problem. 
The uninsured make up a larger proportion of 
persons with AIDS than among the general 
population (20 percent vs. 16 percent) and per- 
sons with AIDS have a much greater reliance 
on Medicaid than the general population (40 
percent vs. nine percent). Private health insur- 
ance and Medicaid cover about the same pro- 
portion of funding for individuals with AIDS 
(40 percent), but private insurance coverage 
among the general population is much higher 
(62 percent). This situation will become worse 
as the proportion of intravenous drug abusers 
among persons with AIDS continues to rise 
and if private insurance limits coverage for per- 
sons with AIDS. 

The reasons vary for the lack of adequate or 
any health coverage among persons with HIV 
infection: small employers may be unable to 
provide affordable health benefits; employees 
losing their jobs may be unable to pay high 
premiums to continue benefits or may not be 
able to obtain other coverage as a result of pre- 
existing illness exclusions; employees may have 
inadequate health coverage from self-insured 
companies which are exempt from state insur- 
ance regulations under the Employee Retire- 
ment Income Security Act (ERISA). 

Inadequate coverage still persists, notwith- 
standing the provisions established under the 
Consolidated Omnibus Budget Reconciliation 
Act (COBRA). COBRA allows an employee and 
his or her dependents to continue employer- 
provided coverage for 18 months after losing 
his or her job if the employee pays the premi- 
um at a cost of no more than 102 percent of 
the employer's premium. This enables the 
former employee and dependents to continue 
private health insurance for at least part of the 
24-month waiting period to qualify for Medi- 
care and avoids the problem of spending down 
to qualify for Medicaid. The Commission be- 
lieves that the provision of adequate health in- 



145 



surance benefits through COBRA can be ac- 
complished with a program of financial assist- 
ance to the disabled person unable to afford 
the high premiums until qualifying for Medi- 
care and this would be preferable to a reliance 
on the Medicaid program. 

The financial impact of the HIV epidemic on 
the employer is unclear, particularly on the 
ability of the small business to provide health 
insurance benefits. Information is not available 
on the extent to which small businesses have 
been turned down for coverage or have experi- 
enced large increases in insurance premiums 
because of AIDS cases among employees. 

The Commission has heard testimony indi- 
cating that our pluralistic approach to financing 
care, involving a mix of public and private re- 
sources, can provide adequate health insurance 
coverage if some adjustments are made. Others 
have suggested that, short of a national health 
insurance system, there could only be a patch- 
work approach to financing care for persons 
with HIV infection. In light of the connection 
between the lack of adequate health insurance 
for persons infected with HIV and the lack of 
adequate health insurance in the general popu- 
lation, the Department of Health and Human 
Services should evaluate the problems of fi- 
nancing our overall health care system and de- 
termine what changes should be made to pro- 
vide full access to comprehensive health care. 
There is a need to reinforce private health in- 
surance coverage, making it more comprehen- 
sive while pursuing innovative approaches to 
financing care. 

State uninsurable risk pools, now operating 
in 15 states and under consideration in 13 
others, have provided a partial solution to com- 
prehensive coverage of the uninsurable, but 
they face several problems. Experts have testi- 
fied that the deficits in most of these pools are 
disproportionately financed by the small and 
medium-sized firms paying for group health in- 
surance since many of the larger companies are 
self-insured and thereby exempt from contrib- 
uting to high-risk pools. In addition, high pre- 
miums and coinsurance charges preclude many 
of the individuals in need of this health cover- 
age from participating. On the other hand, 
such programs in some states are threatening 
to strain state budgets. 

A reinforcement of the current pluralistic 
system, while adjustments are made and exist- 
ing gaps in coverage are filled, should enable 
all persons to gain access to necessary care. 



Obstacles to Progress 

• With the large number of uninsured persons and 
the diversity of the population needing compre- 
hensive care, the financing of health care costs in 
general is currently inadequate and will continue 
to become an increasingly greater problem as the 
number of persons progressing to symptomatic 
HIV infection increases. 

• Health care benefit eligibility and coverage provi- 
sions are inadequate for HIV-infected persons 
losing employment, applying for individual cov- 
erage, or near or below the poverty line. 

• A pluralistic approach involving public and pri- 
vate financing of HIV-related care is being jeop- 
ardized by inadequate insurance coverage of 
HIV-infected individuals. 

• Information is not available on the impact of 
AIDS or HIV infection on the insurance costs of 
small businesses. 

• The potential of Medicaid financing for the care 
of persons with AIDS varies substantially accord- 
ing to where the person lives because basic eligi- 
bility levels and the "spend down" provisions as- 
sociated with Medicaid are established by the 
state and vary enormously. 

• The potential of Medicare financing for the care 
of persons with AIDS is limited because of the 
two-year waiting period to qualify for Medicare 
benefits. 

• The funding for health care coverage of persons 
with uninsurable risks is not equitably shared, 
and costs incurred by individuals in state unin- 
surable risk pools are substantial as are the pool 
losses, while the coverage is limited. 

RECOMMENDATIONS 

10-13 The Secretary of Health and Human 

Services, in conjunction with an inde- 
pendent outside body, should evaluate 
our current system of health care financ- 
ing and recommend changes needed to 
achieve access to and provision of health 
care for all segments of our society. 

10-14 In the course of the evaluation described 

in (10-13), consideration should be 
given to two major options: 

• Extending the COBRA provision 
beyond the 18-month period for em- 
ployee-paid, group rate premiums 
from the employer's health insurance 
coverage to provide adequate cover- 
age for the former employee until 
qualifying for Medicare. Consider- 
ation should be given to providing 
federal assistance to help pay the pri- 



146 



vate insurance premium for persons 
unable to pay the full premium. 

• Decreasing the waiting period for 
qualifying for Medicare from 24 
months to 12 months in order to pro- 
vide health insurance coverage after 
the 18-month COBRA provision has 
expired. Consideration should be 
given to providing federal assistance 
to help pay the private insurance pre- 
mium for persons unable to pay the 
full premium. 

10-15 The federal government should experi- 

ment with providing tax incentives for 
insurers to provide community-rated, 
open-enrollment policies. The federal 
government also should make available 
refundable tax credits to be used for 
purchasing insurance by people who do 
not receive any employer health insur- 
ance and provide premium subsidies for 
private health insurance for persons 
unable to pay the full premium. 

10-16 The federal government should conduct 

a study examining the extent to which 
HIV has presented special underwriting 
problems in the small group health in- 
surance market. 

10-17 The federal government should encour- 

age all states to enact a qualified state 
poo! for medically uninsurable individ- 
uals with the following provisions: 

• The federal government should ex- 
periment with providing technical as- 
sistance to states to ensure adequate 
coverage, financing from a combina- 
tion of private and public sector 
funds, adequate provision of benefits, 
and mandated case management; 

• The federal government should con- 
sider amending the Employee Retire- 
ment Income Security Act (ERISA) to 
include self-insured plans in pool 
funding; and 

• The federal government should con- 
sider establishing a risk pool fund, 
administered by a non-profit or limit- 
ed-profit corporation acting as a rein- 
surance organization and should be 
the source of stop-loss subsidies for 
state risk pools. The Health Care Fi- 
nancing Administration should evalu- 
ate the various sources of public and 
private financing that would be avail- 
able for this fund to cover administra- 
tive losses and to subsidize costs to 
patients. 



10-18 



Medicaid 

10-19 



The federal government should require 
that all patients using 50 percent or 
more federal dollars for their care par- 
ticipate in a case-managed system. 



10-21 



10-22 



The Health Care Financing Administra- 
tion should consider requiring states to 
move toward a minimum Medicaid eligi- 
bility floor at 50 percent of poverty 
within two years and implement a 
phased-in plan for moving to 100 per- 
cent of poverty, giving states the option 
of further raising the income threshold 
for the disabled. 

10-20 The Health Care Financing Administra- 

tion should consider amending regula- 
tions to enable individuals to retain eligi- 
bility to Medicaid benefits, although en- 
titlement to Supplemental Security 
Income benefits may be lost when be- 
coming entitled to Social Security Dis- 
ability Insurance benefits. 

States should consider enacting medical- 
ly needy provisions under their Medicaid 
programs, if they have not done so. 

States should consider expanding their 
medically needy programs by allowing 
low-income individuals to pay an 
income-related premium for the purpose 
of buying into Medicaid. 

10-23 The Health Care Financing Administra- 

tion should re-evaluate the regulations 
which stipulate eligibility requirements 
for hospice care under the Medicaid pro- 
gram and consider the impact of waiving 
the six-month prognosis requirement for 
persons with AIDS. 

Social Security 

10-24 The Social Security Administration 

should consider proposing a statutory 
change allowing individuals with sympto- 
matic HIV infection, as well as other dis- 
abled persons, to work when they are 
healthy enough to resume working with 
earnings offsetting a percentage of bene- 
fits, but without disqualifying them for 
eligibility to their Social Security Disabil- 
ity Insurance benefits, much like the pro- 
vision of the Supplemental Security 
Income program under Section 1619 of 
the Social Security Act. 

10-25 Those agencies providing assistance to 

HIV-infected individuals (such as the 
Social Security Administration and the 
Health Care Financing Administration) 
should consider streamlining the proc- 
esses of enrollment in programs and re- 
ducing the bureaucratic red tape. 



147 



CHAPTER ELEVEN: THE INTERNATIONAL 

RESPONSE 



The human immunodeficiency virus has pre- 
sented the world community with the greatest 
public health threat of this century. It was not 
until 1982 that researchers in France and the 
United States isolated and identified HIV - 
when it already had a firm foothold in four 
continents. Today, 136 nations of the 175 
countries reporting to the World Health Orga- 
nization (WHO) have recorded cases of AIDS. 
Moreover, it is estimated that between five and 
ten million people worldwide are currently in- 
fected with HIV, with approximately one and 
one half million of these in the United States. 

Two years ago, world leaders acknowledged 
that the epidemic required a global strategy to 
combat the spread of the virus. The 1986-87 
World Health Assembly charged WHO with 
providing leadership in the international fight 
against AIDS. At WHO's request, the Centers 
for Disease Control (CDC) detailed Dr. Jona- 
than Mann to WHO to serve as Director of the 
Global Programme on AIDS (GPA). 

The following year, the World Health Assem- 
bly unanimously endorsed WHO's Global 
Strategy for the Prevention and Control of 
AIDS. Five months later, in October 1987, the 
Global Strategy was presented to the United 
Nations General Assembly, which adopted a 
resolution of support for GPA's leadership role 
in the worldwide program of prevention and 
control. WHO/GPA has provided assistance to 
many nations, enabling them to prepare nation- 
al HIV plans to combat the spread of the virus, 
thereby becoming eligible for financial assist- 
ance from the international body. Other United 
Nations organizations, including UNICEF, are 
contributing their expertise and resources to 
support components of GPA. The strengths of 
WHO and the United Nations Development 
Program (UNDP) are now being combined in 



the UNDP/WHO Alliance to Combat AIDS in 
developing countries. UNDP Resident Repre- 
sentatives have begun collaboration with GPA 
to implement, monitor, and evaluate national 
program support activities. 

Further, GPA in conjunction with the UNDP 
is coordinating the Global Blood Safety Initia- 
tive to safeguard blood supplies from the HIV 
and other pathogens. Under this initiative, a 
broad consortium of governmental and non- 
governmental agencies will work together to 
establish blood transfusion systems capable of 
implementing adequate quality control proce- 
dures on a routine, sustainable basis. The 
Commission strongly supports placing a high 
priority on the objective of a safe blood supply 
— because it is achievable, and the transmission 
of this virus through blood products is prevent- 
able — independent of development of a vac- 
cine or successful therapeutic agent. 

The Commission supports and commends 
WHO and the GPA for its leadership role and 
comprehensive program of prevention, treat- 
ment, and control of this disease. As the nation 
with the largest number of reported cases of 
AIDS in the world, as a major contributor to 
WHO and GPA, and as a country with exten- 
sive scientific resources, the United States has 
the motivation, the commitment, and the re- 
sources to support GPA. 

The United States should develop its own 
long-range international plan of action which 
includes encouraging all multilateral organiza- 
tions in which it has membership to lend full 
support to this global effort. The United States 
bilateral strategy should include full coopera- 
tion with GPA in providing aid to designated 
recipient countries within the context of their 
national HIV programs. One of the most seri- 
ous deficiencies developing nations face in en- 



149 



deavoring to combat the epidemic is the lack of 
infrastructure (e.g., trained manpower, techni- 
cal equipment, and basic medical supplies) in 
their health care delivery systems. The United 
States should therefore maximize the effective- 
ness of its bilateral aid by providing technical 
assistance and training to host country nation- 
als, which will assist in the development of in- 
frastructure and complement the programs of 
GPA. 

It is essential that all United States agencies 
and organizations work together to assure max- 
imum effectiveness and coordination of finan- 
cial and technical resources. The Agency for 
International Development (A.I.D.), which is 
responsible for directing the economic assist- 
ance activities of the United States in the devel- 
oping world, should develop a coordinated 
program of support with GPA to lessen the 
impact and control the spread of the virus. The 
research community must also be encouraged 
to collaborate with their colleagues abroad, 
sharing resources and information and avoiding 
duplication. 

In the establishment of public health pro- 
grams in developing countries, just as in do- 
mestic programs, knowledge of and experience 
with local cultures and habits is vital, particu- 
larly in the areas of education and behavior. 
The United States has an extensive network of 
non-governmental organizations, including pri- 
vate voluntary organizations, which have expe- 
rience in international public health programs 
and are well positioned to transfer technology 
and assistance to developing , nations. A.I.D. 
should be directed to place much greater em- 
phasis on the use of these organizations to im- 
plement effective research, education, and con- 
trol programs at the grassroots level in devel- 
oping countries. 

Section I. World Health 
Organization/ Global Programme 
on AIDS 

WHO /GPA Assistance Programs 

The Commission endorses the strong leader- 
ship of the World Health Organization's Global 
Programme on AIDS in bringing together the 
international community in a collaborative 
effort to address the HIV pandemic. The Com- 
mission recognizes GPA and its Director, Dr. 
Jonathan Mann, for the enormous progress that 
has been made in enhancing the global under- 



standing of the epidemic and stimulating a 
global response. The Commission supports the 
work of GPA in assisting governments to devel- 
op national HIV plans. The Commission be- 
lieves that the United States, as a contributor 
to multilateral and bilateral programs, should 
provide increased financial and technical sup- 
port to GPA to develop programs which pro- 
vide a focus for the world community. 

Obstacles to Progress 

• The health care infrastructures in many countries 
most affected by HIV have inadequate financial 
and technical resources. Public health officials in 
these countries are confronted by critical short- 
ages in trained personnel, supplies, equipment, 
and facilities. 

• Lack of coordination among donors may place an 
additional burden on scarce managerial person- 
nel in many developing countries. 

• Competing donors may generate an undesirable 
sense of rivalry or multiple agendas with diver- 
gent objectives. 

• Many development experts and host country 
health officials fear that the current focus on pre- 
vention and treatment of HIV disease may drain 
financial and technical resources away from exist- 
ing health care programs, such as expanded pro- 
grams of immunization, which are immediately 
critical to the well-being of the entire population. 

• Some countries have been reluctant to collect 
and disseminate their own data on HIV preva- 
lence because of a potential negative impact on 
tourism or development funding. 

• Carefully coordinated and controlled internation- 
al programs do not always provide the flexibility 
and creativity necessary to discover the best al- 
ternative means to address the HIV pandemic at 
the local level. 

RECOMMENDATIONS 

The United States gives financial support to 
both the World Health Organization and GPA, 
providing more than 20 percent of the WHO 
budget and contributing $22 million to GPA, 
with $15 million in 1988 alone. As a member 
nation of WHO and contributor to GPA, the 
United States, therefore, has a voice in devel- 
opment of WHO/GPA programming. 

11-1 Recognizing that the United States has 

paid in full its 1987 assessed contribu- 
tion to the World Health Organization 
(WHO), the United States government 
should continue direct contribution of 



150 



sufficient resources to the WHO's 
Global Programme on AIDS (GPA). In 
addition, the United States should make 
a long-term commitment of support for 
the GPA to enhance its capacity for 
long-range planning. 

11-2 The United States contribution to the 

World Health Organization (WHO) 
should receive special consideration and 
be exempt from restrictions placed upon 
contributions to other specialized agen- 
cies of the United Nations. WHO has a 
superior record both in the proper use 
of its funding and the elimination of po- 
litical issues from its agenda. In the 
event there is any change in the manner 
or direction in which WHO fulfills its re- 
sponsibilities, appropriate action could 
then be taken. 

1 1-3 The World Health Organization's Global 

Programme on AIDS should continue its 
efforts to develop national HIV plans, 
working closely with host-country minis- 
tries of health to ensure a sense of na- 
tional ownership, proper budgeting of 
recurrent costs, and coordination of 
donor agency contributions. This col- 
laborative process will help ensure that 
responsibility for these programs rests 
with national governments from their in- 
ception. National HIV programs will be 
most effective if they are integrated into 
the primary health care network and do 
not divert scarce resources from the 
many other health problems facing de- 
veloping countries. 

11-4 The World Health Organization's Global 

Programme on AIDS, through their own 
resources and those of donor nations, 
should strengthen and expand training 
and technical assistance to host country 
nationals to enable them to implement 
and sustain national health care pro- 
grams. Assistance programs must ad- 
dress not only HIV, but also the building 
of the health care infrastructure. 

11-5 The World Health Organization's Global 

Programme on AIDS should give specific 
technical assistance to national institu- 
tions in those areas in which it has a de- 
cided strength, such as epidemiologic 
surveys, surveillance, health promotion, 
blood safety, and laboratory diagnosis, 
to enable them to develop their own ca- 
pacity to sustain these programs. Addi- 
tional programs and services should be 
carried out by bilateral donors and other 
organizations with skills in such areas as 
education, patient management, and 
counseling, utilizing the coordination 



mechanism of the national HIV commit- 
tees. 

11-6 The regional programs of the World 

Health Organization's Global Pro- 
gramme on AIDS (WHO/GPA) should 
be enhanced by making it possible for a 
broader range of interested groups and 
donor organizations to develop a con- 
certed approach to this complex epidem- 
ic. WHO/GPA should encourage coun- 
tries to turn to bilateral donors and non- 
governmental organizations for assist- 
ance in developing HIV-related educa- 
tion and counseling programs. 

11-7 Financial and technical resources need to 

be targeted not only to those countries 
in which current needs are acute, but 
equally to those countries where low 
prevalence rates indicate that education 
programs may be most effective. A small 
investment in these low prevalence areas 
now will result in a greater gain in the 
future through the containment of HIV. 

11-8 Programs must respect human rights. All 

countries share the dual responsibilities 
of protecting the rights of the healthy as 
well as those infected with the virus. Re- 
sponsible behavior can be undermined 
by a climate of fear and discrimination. 
When discrimination occurs, the capacity 
to fight the disease is effectively reduced, 
threatening public health. 

1 1-9 The Commission supports the proposal 

of the World Health Organization's 
Global Programme on AIDS to establish 
coordinated biennial donor evaluations 
to diminish the burden of constant eval- 
uations on in-country program adminis- 
trators and project staff. 

WHO/GPA International Research 
Efforts 

Obstacles to Progress 

• There is a lack of uniformly collected data on 
scope and prevalence of HIV due to lack of re- 
sources, both human and technical, to collect 
such data. 

• Because of concern over intercultural and inter- 
national stigmatization and discrimination, there 
is resistance to sharing existing prevalence infor- 
mation. 

• Insufficient epidemiological or behavioral re- 
search is underway to provide basic information 
required to test the effectiveness of current inter- 
ventions. Neither has operations research been 



151 



undertaken to evaluate prevailing responses to 
the epidemic. 

• There is a lack of common research terminology 
and inadequate capacity to disseminate research 
objectives and results. 

RECOMMENDATIONS 

11-10 The World Health Organization should 

continue its efforts to gather, summarize, 
and publish all data on HIV for member 
governments. A collaborative electronic 
media network for information exchange 
should be established so that feedback 
can be shared on epidemiological data as 
well as effective protocols. This should 
include shared information about drugs 
under investigation internationally. 

11-11 The World Health Organization's Global 

Programme on AIDS should continue to 
provide the forum for the exchange of 
current scientific information. It is im- 
portant that these exchanges bring to- 
gether national policymakers, represent- 
atives of research communities and 
working level personnel. Provision 
should also be made for international 
coordination of research efforts between 
both the medical and social science re- 
search communities. 

11-12 To facilitate these critical exchanges of 

information, universally standardized ter- 
minology should be defined and used. In 
recognition of this need, the World 
Health Organization's Global Pro- 
gramme on AIDS should convene an 
international consultation to develop this 
terminology. 

11-13 Research into the development of inex- 

pensive, fast-response tests for detecting 
HIV infection should be continued. 

1 1-14 The World Health Organization's Global 

Programme on AIDS should play a lead- 
ership role in developing and imple- 
menting protocols for international vac- 
cine field trials. 

11-15 International adoption of standardized 

clinical staging systems is needed so that 
comparisons can be made in the natural 
history of infection and in treatment 
regimens. 

11-16 Epidemiological and behavioral research 

is required to test new technologies and 
alternative approaches to the contain- 
ment of HIV as they are identified. Com- 
parative analysis of this research would 
facilitate identification of optimal meth- 
ods of intervention. 



11-17 Multidisciplinary international HIV re- 
search centers are needed in developing 
countries. Each center should have suffi- 
cient resources to support teams of 
international and national scientists to 
make comprehensive studies of HIV in 
regional settings. 

Section II. Other Multilateral and 
Bilateral Programs 

The Commission strongly supports the 
recent joint efforts of the United Nations De- 
velopment Program (UNDP) and WHO. The 
experience of UNDP in multisectoral, socioeco- 
nomic development, combined with the health 
policy, technical and scientific expertise of 
WHO, will support governments of developing 
countries in initiating, implementing, monitor- 
ing, and evaluating national HIV prevention 
and control plans. 

The Commission commends the World Bank 
and other international development banks for 
their active recognition that a basic standard of 
health for all is a fundamental goal of develop- 
ment programs. Because prevention of disease 
can stimulate overall productivity, basic preven- 
tive and curative services need to be extended 
to the entire population in developing coun- 
tries to reinforce efforts to combat a wide 
range of diseases, including HIV infection. 

Non-governmental organizations (NGOs), es- 
pecially private voluntary organizations (PVOs), 
are potentially valuable resources in the strug- 
gle to slow the spread of the virus because of 
their close association with local communities 
and their ability to handle culturally sensitive 
issues. Many NGOs and PVOs have a proven 
track record in community acceptance for 
health delivery, community-based development 
programs, trained local staff, and strong links 
to national organizations and national policy- 
makers. Some have attained a high level of ex- 
pertise in training and mobilizing professionals 
and lay persons in sensitive tasks, implemented 
under difficult circumstances. 

Private organizations in collaboration with in- 
digenous PVOs could implement national poli- 
cies and stimulate alternative community-based 
responses to the epidemic. Private funding 
would allow NGOs the flexibility to develop 
innovative alternative approaches to the prob- 
lems at hand. 



152 



Bilateral Assistance Programs 

Consistent with United States foreign policy 
objectives, the primary mandate of A.I.D. is to 
help developing countries seeking United 
States assistance realize their aspirations. The 
fulfillment of this mandate requires that A.I.D. 
draw heavily on the technical staff of other fed- 
eral agencies, universities, PVOs, and commer- 
cial contractors. 

Obstacles to Progress 

• United States policy for bilateral and multilateral 
assistance still lacks the coordinated strategic 
planning required of a significant partner in 
GPA. A.I.D. has difficulty in clearly defining its 
long-term objectives to contain the spread of 
HIV. 

• Because of concern for the federal deficit, A.I.D. 
is reluctant to request the technical or financial 
resources required to achieve long-term goals. 
The funding designated for HIV-related pro- 
grams worldwide is insufficient to meet requests 
for assistance. Other A.I.D. accounts may be 
drawn down to fund HIV components. If other 
A.I.D. funding is available for use in HIV-related 
programs, clarification for the provider commu- 
nity is necessary. 

• A.I.D.'s pre-existing commitments of anticipated 
funds have resulted in limited funding available 
for PVOs that have the experience to assist in 
worldwide HIV programming. 

• Budgetary restrictions impede A.I.D.'s ability to 
obtain sufficient numbers of technically qualified 
personnel with health expertise in HIV, adding 
to the problem of supervision and coordination 
of assistance directed at controlling the global 
epidemic. 

• Biomedical and behavioral research has not yet 
been extensive enough to provide clear guide- 
lines for appropriate interventions. Interventions 
now being used to stem the spread of the epi- 
demic have not been evaluated. 

• Improvement is needed in infrastructure and 
health care delivery systems to sustain develop- 
ment efforts. 

RECOMMENDATIONS 

11-18 The Agency for International Develop- 

ment (A.I.D.) should develop a five-year 
strategy which outlines the main goals of 
the United States in the global effort to 
address the HIV epidemic. The plan 
should include objectives for support of 
the Global Programme on AIDS and the 
development and implementation of bi- 
lateral assistance programs which con- 
tribute to national HIV programs and 



which complement those of other 
donors. If more funding and additional 
technically qualified health related per- 
sonnel are needed, representatives of 
A.I.D. should request them. Current lim- 
ited funding for critical health programs 
should not be diverted. 

11-19 The Agency for International Develop- 

ment should concentrate its HIV-related 
assistance on clearly defined programs in 
which it has pronounced expertise. Par- 
ticular emphasis should be given to 
those programs which can be sustained 
and copied. 

11-20 The Agency for International Develop- 

ment should review existing service de- 
livery programs in child survival, mater- 
nal and child health, immunization, and 
family planning to identify areas where 
HIV-related components could be added 
to reach target populations. 

11-21 Current support for international health 

projects needs to be expanded to in- 
clude basic support for health care infra- 
structure and delivery systems. This 
would provide a solid basis for all HIV 
prevention and care programs. 

11-22 Bilateral assistance should emphasize the 

education and training of local health 
care workers so they can train others in 
the community as well as provide serv- 
ices. 

11-23 The Agency for International Develop- 

ment should increase its support for im- 
proved epidemiologic data collection 
and modeling for a better global under- 
standing of the dynamics of the epidemic 
in all parts of the world. This work 
should be coordinated with the World 
Health Organization's Global Pro- 
gramme on AIDS, and the database and 
modeling should be available to the 
international assistance community. 

11-24 United States bilateral assistance should 

include special attention to the Western 
Hemisphere and the Pacific Rim in light 
of immigration, tourist, commercial, and 
strategic considerations. 

11-25 Private sector organizations should join 

the public sector in support of research 
projects and field programs. 

11-26 Qualified private voluntary organizations 

should be identified and encouraged 
through the commitment of funds of the 
Agency for International Development to 
develop programs of health care service 



153 



delivery, education and research that 
support and complement local govern- 
ment and national priorities. 

1 1-27 Non-governmental organizations (NGOs) 

and private voluntary organizations 
should, when possible, undertake joint 
projects with host country NGOs, pro- 
viding technical assistance and training 
as requested and assisting them to iden- 
tify local needs, develop effective re- 
sponses, and monitor outcomes. 

1 1-28 The Agency for International Develop- 

ment (A.I.D.) should clarify the sources 
and availability of additional funds 
within other A.I.D. accounts for HlV-re- 
lated programs. Non-governmental orga- 
nizations, including universities and pri- 
vate voluntary organizations, should be 
advised of the availability of these funds 
and the method of access to them. 

1 1-29 The Agency for International Develop- 

ment (A.I.D.) should identify processes 
to allow for regular review of all bilateral 
HIV programs to assess progress, recog- 
nize innovations, respond to resource 
and program gaps, and foster economy 
and efficiency. A.I.D. should establish a 
forum for facilitating communication 
among non-governmental organizations 
and federal agencies. 

Peace Corps 

Throughout its history, the Peace Corps' 
most effective programs are those which have 
been developed at the request of and in close 
collaboration with host country governments. 
The Peace Corps is continuing to explore inno- 
vative nontraditional ways of deploying volun- 
teers and is currently identifying opportunities 
for collaboration with other assistance organi- 
zations. Through its unique and well-estab- 
lished ability to provide education, the Peace 
Corps should expand its current capacity to 
assist host countries to implement their HIV 
prevention programs. 

RECOMMENDATIONS 

11-30 The Peace Corps should develop a port- 

folio of available HIV-related training 
and assistance programs to be offered to 
host country governments that have re- 
quested assistance. These programs 
should complement existing ones. The 
Peace Corps should receive supplemen- 
tal funding to finance these programs. 

11-31 Using the best health education tech- 

niques available, volunteers should re- 



spond to requests for assistance by work- 
ing with host country personnel to inte- 
grate HIV education into a full range of 
curricula. In addition to teaching trainers 
to work with village level organizations, 
they should develop targeted education 
programs for specific hard-to-reach pop- 
ulations. 

11-32 Volunteers should help strengthen exist- 

ing health care services through the 
training of national health care workers 
in all specialties. 

11-33 The Peace Corps, the United States 

Public Health Service, and non-govern- 
mental organizations should work col- 
laboratively to avoid competition for re- 
sources and duplication of efforts. 

Bilateral Research 

The National Institutes of Health (NIH) con- 
ducts international research under the authority 
of the International Health Research Act of 
1960. This Act authorizes NIH to "advance the 
status of the health sciences in the United 
States and thereby the health of the American 
people through cooperative endeavors with 
other countries in health research, health plan- 
ning and research training." Similarly the Alco- 
hol, Drug Abuse, and Mental Health Adminis- 
tration and the Food and Drug Administration 
conduct international research. 

Obstacles to Progress 

• There is an inadequate epidemiological data base 
to serve as the basis for targeting assistance pro- 
grams. In addition, there is a dearth of reliable 
information on appropriate interventions re- 
quired to combat the spread of HIV. 

• The dramatic increase in federal funding for HIV 
research has not been accompanied by a propor- 
tional increase in federal staff positions to con- 
duct or manage the research efforts to handle 
the current domestic obligations in HIV or to 
expand the international research effort. Current 
staffing is insufficient to respond to international 
requests for technical assistance in various types 
of research and programming which could have 
substantial benefits for our own control pro- 
grams. 

• Federal scientists are strictly limited in interna- 
tional travel, with no distinction made between 
travel to attend scientific meetings and travel to 
conduct or evaluate federally funded projects. 

• An expanded international HIV effort for NIH 
will depend upon the presence of a critical mass 
of interested and capable scientists in the aca- 



154 



demic community — both in the United States 
and in host countries. There are few academic 
institutions with the scientific expertise for HIV 
studies in developing countries and with the 
international experience and contacts to support 
large-scale, multidisciplinary HIV projects. 

• Researchers are forced to spend substantial 
amounts of time writing proposals because of the 
current system of short-term grants and low 
funding levels. 

RECOMMENDATIONS 

11-34 As a part of the strategic planning proc- 

ess implemented by the Department of 
Health and Human Services a five-year 
plan should be developed outlining the 
research priorities and goals of the De- 
partment's research institutions. This 
should be done in conjunction with five- 
year plan of the Agency for International 
Development and the work of the World 
Health Organization's Global Pro- 
gramme on AIDS. 

11-35 Research, epidemiological training, and 

control programs should have three 
basic components: collaboration, re- 
search training, and institutional sup- 
port. The Department of Health and 
Human Services should establish a pro- 
gram to assist developing countries to 
improve the quality and capacity of lab- 
oratories and increase the number of 
epidemiologists capable of tracking the 
epidemic. Collaborative programs that 
combine research and training are an ap- 
propriate and effective means of 
strengthening capabilities of developing 
countries to deal with the HIV epidemic. 

11-36 The federal government should establish 

an international HIV research support 
unit. Such a unit could coordinate efforts 
by the Agency for International Develop- 
ment, the National Institutes of Health, 
the Centers for Disease Control, and 
other public agencies, thereby respond- 
ing more effectively to requests from 
other governments for assistance in re- 
search. 

1 1-37 Full-time equivalent positions in the Na- 

tional Institutes of Health and the Cen- 
ters for Disease Control should be ex- 
panded so these agencies could respond 
to international requests for technical as- 
sistance and enhance cooperation with 
the World Health Organization's Global 
Programme on AIDS. 

1 1-38 Travel restrictions should be reevaluated 

to permit appropriate participation in 



international scientific meetings and to 
provide requested technical assistance. 

11-39 Research grants should be awarded for 

three- to five-year periods at adequate 
funding levels. 

11-40 Postdoctoral training fellowships should 

be established to enable social scientists 
and biomedical researchers to learn 
more about the socio-behavioral aspects 
of the epidemic. 

Coordination in Drug Development 

RECOMMENDATION 

11-41 The United States, through the Depart- 

ment of Health and Human Services and 
the Food and Drug Administration, 
should develop a mechanism for working 
with other nations with similar drug de- 
velopment and control programs to 
accept their data leading to the approval 
of experimental drugs for HIV disease to 
be used in clinical trials. 

HIV-2 Research 

RECOMMENDATION 

11-42 Research is needed to determine the 

clinical significance of HIV-2. Studies 
conducted in West Africa will be most 
useful in determining the effects of this 
virus where levels of infection in certain 
populations are already high. Continued 
research is needed to determine the nat- 
ural history of HIV-2 and analyze its re- 
lationship to HIV-1. 

Section III. Department of Defense 

Because of the size and unique mission of 
the Department of Defense (DoD), it provides 
the nation with a critical source of much 
needed research on HIV. The Department has 
developed long-range comprehensive HIV pro- 
grams which are reviewed periodically to 
ensure their adherence to current scientific in- 
formation. 

DoD has undertaken an extensive national 
HIV testing program providing important op- 
portunities for epidemiological research that 
are nowhere else available in this magnitude. In 
addition, identifying HIV-infected individuals at 
an early stage of infection and providing for 
their health care and follow-up can provide im- 
portant epidemiological and treatment informa- 
tion and strategies. 

The Commission is impressed with the level 
of planning and implementation which has 



155 



taken place at DoD and, in particular, its reli- 
ance on solid scientific and medical data as the 
basis for policy decisions. 

Obstacle to Progress 

• In 1986, DoD received $33.6 million for HIV re- 
search. By 1989, research funds for HIV will 
have declined to $8.8 million. This is detrimental 
to a sustained program and the external contract 
program will likely be cut back as a result. 

RECOMMENDATIONS 

11-43 Publication of data has lagged behind 

the HIV testing program. The Depart- 
ment of Defense should pursue expedi- 
tious peer-reviewed publication of this 
data so critical to public health and com- 
munity leadership as they develop ap- 
propriately targeted education and pre- 
vention programs. 

1 1-44 To maintain a complete research pro- 

gram, the Department of Defense will 
need sustained HIV-related funding of 
$20 million annually. 

Section IV. Freedom of Movement 

The Commission concurs with WHO that the 
screening of international travelers for HIV in- 
fection would require an unjustified, immense 
diversion of resources from other critical pro- 
grams of education, protection of the blood 
supply, and care. At best, border screening 
programs would only briefly retard the spread 
of HIV. 

RECOMMENDATIONS 

11-45 The United States, through its relevant 

federal agencies, should communicate 
with other governments that may be 
considering institution of HIV-related 
travel restrictions in order to prevent the 
implementation of ineffective and cum- 
bersome regulations. 

1 1-46 The Centers for Disease Control annual- 

ly produces and distributes a booklet, 
"Health Information for International 
Travel," which is sent to local health de- 
partments and individual physicians. In- 



formation on HIV infection should be 
expanded to increase understanding of 
HIV transmission and prevention, and 
include information on the relative safety 
of the blood supply in nations other than 
the United States and the avoidance of 
high-risk behaviors. These educational 
materials should discuss specific preven- 
tive measures in clear, easily understood 
language and should caution HIV-infect- 
ed persons against travel to nations 
where other communicable diseases are 
endemic. 

Section V. Refugees 

Current United States policy requires testing 
of refugees for HIV and refusing asylum to 
HIV-infected refugees except in the most ex- 
traordinary circumstances. This policy is based 
on regulations issued by the United States 
Public Health Service under the authority of 
the Immigration and Nationality Act and the 
Public Health Service Act. These regulations 
were revised most recently in 1987 pursuant to 
Public Law 100-71, which required the addition 
of HIV infection to the list of "dangerous con- 
tagious diseases" warranting exclusion. Medical 
and other professionals testifying before the 
Commission have questioned the medical and 
organizational basis of the regulations. As of 
April, four months into the program, six pro- 
spective refugees have been detected with HIV. 

RECOMMENDATION 

11-47 The Department of State, the Depart- 

ment of Health and Human Services, 
and the Immigration and Naturalization 
Service should reevaluate the policy of 
testing refugees 12 months after the im- 
plementation of this policy. This evalua- 
tion should include consideration of the 
change in level of protection offered to 
the United States by this policy, consid- 
eration of potential impact on refugee 
populations and host governments, and 
consideration of cost and benefits. Rec- 
ommendations resulting from this re- 
evaluation should be made to the Presi- 
dent. 



156 



CHAPTER TWELVE: GUIDANCE FOR THE 

FUTURE 



The Federal Response to the HIV 
Epidemic to Date 

In June 1987, the President wisely directed 
that a comprehensive national strategy be de- 
veloped over the ensuing year to deal with the 
HIV epidemic. He appointed a 13-member 
Commission on the HIV epidemic to accom- 
plish this objective and provided them discrete 
guidance in the form of an Executive Order to 
chart their course. The preceding chapters in 
this report constitute the Commission's recom- 
mended national strategy. Until now, federal 
agencies have had to work as diligently as pos- 
sible within existing frameworks and without 
reference to an integrated national plan. 

Over the past year, the Commission has 
heard testimony from over 100 officials of the 
federal government representing virtually every 
agency which has been significantly involved in 
responding to the epidemic. In addition, Com- 
mission staff has met with congressional offices 
and reviewed voluminous documents which de- 
scribe policies, programs and legislative initia- 
tives designed to respond to the HIV epidemic. 
Hundreds of others, including persons infected 
with HIV, representatives of state and local 
governments, the private sector and communi- 
ty-based organizations have offered the Com- 
mission their reflections about what the re- 
sponse of the federal government has been and 
what the response should be. 

Additionally, no comprehensive legislation 
addressing the HIV epidemic has been enacted 
by the Congress. While appropriations for 
HIV-related research and activities have stead- 
ily increased since 1982, no comprehensive 
substantive legislation has emerged. Congress 
has spent considerable time examining the HIV 
epidemic via committee hearings in both the 
House and Senate and in floor debate when 



various provisions were addressed. Several 
pieces of comprehensive HIV legislation have 
been introduced and considered, but none has 
yet been endorsed by both houses. 

As a result of the aforementioned, all Com- 
missioners believe we have now arrived at a key 
milestone for placing this epidemic under 
closer management control than heretofore 
practicable. With a national strategy in hand, 
Commissioners believe that some special man- 
agement oversight entity is needed at this early 
juncture in the epidemic to see that an action 
plan to carry out the strategy is aggressively 
followed. The goal of this entity should be to 
help bring the existing institutional process up 
to an acceptable level of efficiency in the near 
term and to remain in being until demonstrat- 
ed management control over the epidemic is 
assured. 

Future Management Options 

The Commission heard about and consid- 
ered a number of possible recommendations 
regarding how the nation's response to the epi- 
demic should be managed from this point 
onward. Some of these options came from wit- 
nesses and some were developed by Commis- 
sioners after listening to the many concerns 
and ideas expressed. These options include: 

• Establishment of a national advisory commission 
on AIDS and HIV infection. 

• Appointment of a Deputy Secretary for HIV and 
an oversight commission. 

• Establishment of a separate Department of 
Health. 

• Appointment of a Crisis Deputy Secretary within 
the new Department of Health. 

• Establishment of a commission, Congressional 
AIDS committees, and a Cabinet-level AIDS offi- 
cer. 



157 



• An Executive Order to put into effect the 20 
most important recommendations made by this 
Commission. 

• Revision and implementation of the Public 
Health Emergencies Provision of the Public 
Health Service Act to allow streamlined action 
when a public health emergency is declared. 

RECOMMENDATIONS 

12-1 In order to assure rapid implementation 

of the key recommendations of this 
report, the President should: 

• Appoint a continuing external over- 
sight committee, composed of seven 
members including experts on HIV 
infection and public members, to pro- 
vide an ongoing evaluation of the na- 
tion's response to the epidemic. 

• Clearly establish the chain of com- 
mand from the Cabinet to all affected 
units of the federal government, with 
a single designated official to manage 
implementation of this report and re- 
lated activities within the existing 
structure. 

12-2 For the longer term, the President 

should assure that the following changes 
in federal health structure are evaluated: 



Establishment of an independent De- 
partment of Health because health 
care is now taking almost 12 percent 
of our national resources and may 
not be receiving appropriate attention 
or visibility within the current struc- 
ture. 

An expansion of the Public Health 
Emergencies provision of the Public 
Health Service Act to enhance the 
ability of the nation's chief health of- 
ficials to request the President to de- 
clare public health emergencies in the 
nation when public health informa- 
tion about such an event is made 
available by relevant federal, state, or 
local public health agencies, or other 
appropriate sources. 
Delegation of authority during a de- 
clared public health emergency to fa- 
cilitate procedures which enhance 
emergency responsiveness including 
approaches to hiring, acquisition of 
new space, increases in personnel 
ceilings, awarding of grants and con- 
tracts, regulatory review, and interde- 
partmental and interagency activities. 



158 



APPENDICES 



Appendix A 



A HISTORY OF THE UNITED STATES' RESPONSE 

TO EPIDEMICS 

Up to 1776 

Smallpox was the most devastating disease of colonial times. Introduced from Europe, 
the disease quickly killed an estimated 50 percent of the entire native American Indian 
population — nearly six million people. It was able to run through this population 
largely unchecked because the native population did not have the natural immunity of 
the Europeans who had lived with the disease for several centuries. 

But the colonists, too, suffered from numerous outbreaks. From 1675 to 1775, there 
were only two intervals as long as five years when the colonies were entirely free of 
smallpox. New England had major epidemics in 1633, 1648, and 1666; New York in 
1663; Virginia in 1667. (This last outbreak is thought to be responsible for the move 
of the Virginia capital away from Jamestown). 

The foci of the epidemics were the great port cities — New York City, Boston, New 
Orleans. The first public health measure tried against smallpox seems to have been 
the quarantine of incoming ships. New England, for example, established quarantine 
procedures in 1699 in response to their smallpox epidemics. 

The first preventive medical measure for smallpox was variolation — inoculation with 
smallpox matter taken from the lesions of a person with an active case of the disease. 
This procedure was introduced from Europe to the colonies by the Reverend Cotton 
Mather and Zabdiel Boylston during a smallpox epidemic in Boston in 1721. Results 
were clear and were confirmed in 1752 in another epidemic in Boston in which the 
mortality of those who had been inoculated was 1.5 percent versus an at-large mortali- 
ty of 9.1 percent. 

Yellow fever was another terrible disease in colonial America. There were approxi- 
mately 135 major yellow fever epidemics from 1660 to the end of the nineteenth 
century. These epidemics, too, were concentrated largely in the port cities. (It is 
thought that yellow fever was brought to the colonies by mosquitoes aboard ships 
engaged in the Africa trade). In this period, Philadelphia suffered 20 epidemics, New 
York City 15, Boston 8, and Baltimore 7. Boston, Philadelphia, and Charleston were 
all struck in the 1690's. In Charleston, seven percent of the population died in two 
months in 1699. Medical treatment for this disease was the normal seventeenth and 
eighteenth century method for treating any fever — bloodletting and purging. No 
public health measures seem to have been directed at control of the disease. At this 
point, there was still no idea of the cause — whether it was contagious or caused by 
"miasma," that is, pollution in the air. 

Two other diseases of note in these times were typhoid fever and diphtheria. In 1730, 
typhoid fever epidemics broke out in Connecticut and South Carolina and the disease 
rapidly spread throughout the colonies. It was estimated that approximately 500,000 
persons were infected every year, of whom 30,000 to 40,000 died annually. 

Diphtheria was the other colonial disease which caused great mortality. One of the 
first modern outbreaks of epidemic diphtheria occurred in New England in 1 735. This 
episode killed 5,000 persons overall or 2.5 percent of the total New England popula- 
tion. The vast majority of its victims were children. At this time, there was no effective 

161 



medical procedure to cure or alleviate symptoms. Death was usually from suffocation 
as the false membrane completely closed off the throat. Diphtheria is a highly conta- 
gious disease and quarantine was and still is a common and effective public health 
procedure for this disease. 

Up to the Twentieth Century 

At the time of the American Revolution, the average life expectancy of the American 
citizen was less than 40 years of age. Smallpox was still the greatest problem — 
responsible for 10 percent of all deaths and the single greatest cause of infant 
mortality. But this communicable disease was one of the first to disappear as a threat. 

It was in 1798 that Edward Jenner announced his discovery that inoculation with 
cowpox protected the recipient from smallpox. This represented a great advance over 
variolation. People could no longer contract and spread the disease as sometimes 
occurred when it was acquired through inoculation with the live smallpox virus. 

The disappearance was brought about through one method — preventive inoculation, 
either variolation or vaccination. These preventive measures were actively espoused by 
two American Presidents. In 1776, Washington ordered the entire Continental Army 
variolated and, in 1800, Jefferson vaccinated himself, his family, and his friends while 
generally encouraging the practice. 

The effectiveness of vaccination was firmly established in 1802 by a series of con- 
trolled experiments on human volunteers. These were the first controlled medical 
experiments on humans in the United States — the first clinical trials. The incidence of 
the disease gradually tapered off, with the last reported case of smallpox in the United 
States occurring in 1953. 

But while smallpox was beginning to disappear from the American landscape, yellow 
fever was beginning to loom larger. In the 1790's, major epidemics of yellow fever 
struck Charleston, Baltimore, and New Orleans. The largest epidemic, however, struck 
Philadelphia in 1793. By the time this outbreak ended, 5,000 people had died. As a 
direct response to this epidemic, the city created its Board of Health in 1793. 

While there was still no adequate medical treatment for yellow fever, two differing 
public health approaches were followed. Those who believed in the growing "germ 
theory" of disease advocated quarantine and isolation for the ill. Those who felt that 
the condition was caused by "miasma" began massive public works efforts. These 
included waste removal and improvement of the water purification processes. Much of 
the infrastructure of cities — sewage treatment and water purification plants — came 
into existence as a result of attempts to control epidemic diseases. 

These public works also helped control another disease problem — the spread of 
cholera. This disease first became a problem in 1832 when the entire country was 
struck by an epidemic that had raged worldwide for six years and was brought to the 
United States by Irish immigrants. In New York City, the epidemic lasted about six 
weeks and 3,000 people perished. The city of New Orleans was hardest hit with 5,000 
deaths, roughly 20 percent of its population. 

The next virulent cholera epidemic struck 16 years later in 1848. In New York City 
20,000 contracted the disease and of these 8,000 died. New Orleans again lost 5,000 
citizens and the disease spread up the Mississippi Valley and went west with the forty- 
niners. Cholera epidemics recurred in 1853, 1866, and 1873. 

Public health measures directed at control of the spread of this disease were confused 
by the "germ theory" and "miasma theory" controversy. Health officers generally 
supported both quarantine and sanitary measures. 

Yellow fever epidemics continued to occur with alarming frequency for the next 
hundred years. An epidemic in New York City in 1798 killed 1,600. It was followed by 
two more in 1805 and 1822. The disease peaked in the 1850's while continuing to 

162 



strike mostly port cities. New Orleans was again most affected -- in four outbreaks in 
the decade the city lost almost 20,000 people. 

A severe outbreak which killed 15,000 persons occurred 30 years later in the Missis- 
sippi Valley and prompted the first national public health action. Up to this time, 
(1878) involvement of the federal government in health issues had been mostly 
limited to two actions taken in 1798. At that time, Congress set up a system of 
compulsory hospital insurance for merchant seamen and President Adams established 
"marine hospitals" to provide care for sick and disabled merchant seamen. The 
federal government later centralized direction of the marine hospitals under the 
Surgeon General of the Marine Hospital Service in 1871. 

In 1878, Congress passed the National Quarantine Act which gave some quarantine 
power to the Surgeon General of the Marine Hospital Service. It allowed the Surgeon 
General to declare quarantine, but allowed local authority to overturn any such 
decision. No appropriations were made available for the implementation of this Act. 

It was also partly in response to this same yellow fever epidemic that the National 
Board of Health was established by the Congress in the following year. This body 
accomplished little and was terminated four years later under pressure from the 
Surgeon General. 

The federal government increased its role in the control of epidemic disease by giving 
the Marine Hospital Service a yearly appropriation of $100,000 to provide assistance 
to the states in preventing communicable disease epidemics and also by establishing 
the Hygienic Laboratory on Staten Island. This laboratory originally carried out 
examinations of specimens from immigrants entering the country. It soon began 
investigation into the causes of disease and other independent research. Four years 
later, it was transferred to Washington, D.C. and it became the National Institute of 
Health in the 1930's. 

Prior to these actions, public health had been the province solely of state and local 
governments and the affected citizens themselves. The first governmental health 
actions taken were by state and local health boards, most of which had been estab- 
lished in response to previous outbreaks of communicable disease. Thus, in 1855 
when New Orleans was being struck by epidemics of yellow fever and cholera, Louisi- 
ana created the first state board of health. The Metropolitan Board of Health was 
created in New York City in 1866 during the third great cholera epidemic. Still, by 
1872, only three states and the District of Columbia had established state boards of 
health. 

The other diseases of colonial times were still afflicting the country. Typhoid fever, 
for example, killed more soldiers during the Civil War than died in battle. Diphtheria 
and tuberculosis were major problems as well. 

Diphtheria swept across Europe and the United States in 1857 and became endemic in 
many large cities. In New York, the average mortality rate for this disease for a period 
of six years never fell below 42 percent. From 1866 to 1890, diphtheria caused 43,000 
deaths in New York City. In 1885, John O'Dwyer pioneered the technique of intuba- 
tion (insertion of a tube into the trachea) which greatly decreased case fatality rates. In 
1892, the New York Department of Health established a bacteriological laboratory and 
this laboratory demonstrated that half of all diphtheria cases in the city were "pseudo- 
diphtheria." This meant that quarantine of suspected diphtheria cases was actually 
causing more cases to occur. Patients who did not really have the disease were being 
put in the same ward with actual cases and becoming ill from the exposure. This 
discovery naturally reduced the number of cases. Diphtheria was finally dismissed as a 
serious threat when Emile Roux developed an antitoxin in 1893. Diphtheria antitoxin 
was first used to combat an epidemic in Massachusetts in 1900. The New York City 
Department of Health began the first program of active immunization of school 
children in the United States for diphtheria in 1927. Since that time, the number of 
cases has decreased in the United States to the rate of four per year. 

163 



Tuberculosis was a disease that had been endemic in the United States for many years. 
With Dr. Robert Koch's demonstration in 1882 that the disease was caused by a 
bacillus and the realization that the disease was preventable and not genetic as 
previously thought, efforts were made to stamp out the disease. In 1884, the first 
tuberculosis sanatorium for the poor was established in New York. In 1889, the New 
York City Department of Health, declaring that tuberculosis was "communicable and 
preventable," developed public health policy which was implemented in 1893 and 
1894. These policies required that public institutions report all cases of tuberculosis to 
the Department of Health. Physicians were encouraged with the incentive of free 
diagnostic services to report voluntarily. When this voluntary program failed, the 
requirements were made mandatory. At the same time, in 1892, the Pennsylvania 
Society for the Prevention of Tuberculosis was founded. This body represented the 
first effort by both lay and professional people to attack a specific disease. 

It was at the end of the century that schools first became involved in health issues. In 
1894, Boston became the first city to employ school medical inspectors to identify and 
send home the contagiously ill. The next year, New York state appointed a chief 
medical inspector for the state's schools. But these school health services lost their 
medical emphasis as authority was transferred from local boards of health to boards of 
education. By 1911, three out of every four cities vested health authority in boards of 
education. 

Up to the Present 

The turn of the century, for all the advances made in the health field, ended on an 
ominous note. In 1899 there was an outbreak of the bubonic plague in New York City. 
Another outbreak occurred in San Francisco two years later. Both of these were 
controlled by public health measures still used today to control the plague — quaran- 
tine and sanitation. 

More ominous events had occurred in 1894 when Vermont reported 132 cases of 
polio in one year — the largest number of poliomyelitis cases to date anywhere in the 
world. The death rate from this disease was 13.5 percent. Five years before this, the 
first major episode of influenza had struck the United States. After this initial bout, 
epidemics of varying degrees of severity began to strike the United States regularly. 
Epidemics of influenza A still occur every one to three years in this country, and 
influenza B every three to four years. 

But more medical advances did occur. In 1900, Major Walter Reed identified the 
mosquito as the vector for yellow fever. This meant that the disease, while transmissi- 
ble, was not contagious. It eliminated several inappropriate public health strategies, 
most notably isolation and quarantine, and it pointed to correct ones. These correct 
methods, which were essentially ways of reducing the mosquitoes' breeding habitat, 
were so effective that within 20 years of Walter Reed's discovery, yellow fever had 
been eliminated from the United States. The last epidemic of yellow fever struck New 
Orleans in 1905, causing 3,500 cases and 400 deaths. After this, New Orleans moved 
to eliminate mosquito breeding grounds and no further epidemics occurred. 

Medical research was progressing rapidly at this time as well. In 1910, Dr. Paul Erlich 
discovered salvarsan (better known as "606" and so named because it was the 606th 
compound he tested for effectiveness in treating the disease) for use against syphilis. 
This was the first chemotherapeutic agent ever developed, but this "magic bullet" was 
only partially effective. Its discovery, however, stimulated further research which led 
eventually to the development of the sulfonamides and antibiotics. 

In the 1930s and 1940s, before the advent of antibiotics, the number of deaths from 
syphilis in the United States averaged from 15,000 to 20,000 per year. In 1941, 
gonorrhea and syphilis were the second and third most reported communicable dis- 
eases in America (behind measles). After the steep decline in the number of cases 
following the introduction of penicillin and the other antibiotics, the number of cases 

164 



has been steadily rising. The number of cases of all stages of syphilis has quadrupled 
since 1957. 

Syphilis has been one of the major endemic diseases in this country since the 16th 
century. However, it was with the country going to war in 1914 that many of the first 
efforts to reduce incidence of the disease were pursued in the name of public health. 
The most striking of these was the attempt to close all the red light districts near any 
military base, but other measures included isolation and quarantine. The stigmatiza- 
tion which sometimes accompanied diagnosis created great difficulty in the public 
health arena for establishing public policy regarding the control of this disease. 
Another of the most commonly cited reasons for the failure to control the disease is 
that sex education was not a permissible public health measure in the country at that 
time. 

It was also at the turn of the century that federal involvement became greater. In 
1902, the Marine Hospital Service was expanded in the first step of its transition into 
the Public Health Service (PHS) and was renamed the United States Public Health and 
Marine Hospital Service. 

In 1909, the Public Health and Marine Hospital Service (PHMHS) published Bulletin 
56 which showed that between 1880 and 1907, 500 outbreaks of milk-borne disease 
had occurred. The Board of Health of New York City made pasteurization of milk 
mandatory. PHS, in 1924, issued its first Standard Milk Ordinance and Code in order 
to ensure uniform standards across the country. 

Also in 1909, the Surgeon General decided that PHMHS should play a more active 
role in the conquest of typhoid fever. PHMHS paid special attention to water-borne 
typhoid because of its prevalence and the ease with which it could be corrected. 
PHMHS was also very involved in setting up local health organizations. In the previ- 
ous century, they had encouraged local community efforts by building marine hospi- 
tals. Now, it was because of a recommendation from PHMHS that the first county 
health organization was established after a typhoid fever outbreak in Yakima County, 
Washington. 

The Public Health Service, so named in 1912, was made responsible for the care of 
disabled war veterans in 1918. PHS rapidly expanded until in 1922 when it had 81 
hospitals operating across the country. But in 1924 the Veterans' Bureau - the 
predecessor of the Veterans' Administration — assumed responsibility for all veterans' 
affairs and 57 PHS hospitals were transferred to the Bureau. 

Not all of the federal involvement in health affairs came from the Public Health 
Service however. A national program to eliminate bovine tuberculosis was instituted in 
1917 under the United States Department of Agriculture. This program included 
elimination of all infected cattle and the pasteurization of milk. It was instrumental in 
ending the threat of this form of the disease. 

Private citizens were also involved in health issues. In 1918, 23 state and local 
associations joined together to form the National Tuberculosis Association. (This 
became the American Lung Association in 1973). With the discovery of streptomycin 
which accelerated the decline in the incidence and mortality from tuberculosis, this 
disease gradually became less of a threat. 

Influenza, which had been making its periodic recurrences since the end of the 
previous century, suddenly became a focus of attention. In 1918 and 1919, an influen- 
za pandemic killed 20 million people worldwide and 548,000 in the United States 
alone. All public health measures were ineffective, including the closing of public 
establishments and the wearing of face masks. Other major epidemics of the disease 
have occurred in 1947, 1957, and 1968. 

Just before the great influenza epidemic, the northeastern part of the United States 
was struck by a devastating poliomyelitis epidemic. In New York City alone, 9,000 
cases occurred. Cases occurred throughout the summer months in the 1930's. This 
led, in 1938, to the establishment of the National Foundation for Infantile Paralysis, a 

165 



private philanthropic effort which funded research into cures and therapy for the 
disease. This organization funded the first fund-raising campaign of its kind, the 
March of Dimes. Polio outbreaks continued throughout the 1940's. The breakthrough 
for control of this disease came in 1953 when Dr. Jonas Salk developed his inactivated 
polio vaccine. The availability of a cure stimulated federal involvement in the produc- 
tion and distribution of vaccine and firmly established the federal government as the 
leader in the health field. 

The Public Health Service remains the principal health agency of the federal govern- 
ment. The mission of PHS is to protect, improve, and advance the health of the 
American people. In that regard, PHS plays an active role in responding to various 
health crises, including epidemics of communicable disease. 

CHRONOLOGY 

1633' 

1648 Smallpox epidemics in New England. 

1666 

1 663 Smallpox epidemic in New York. 

1667 Smallpox epidemic in Virginia. 

1668-1893 Yellow fever. There were 135 major yellow fever epidemics in American 
port cities through this time. There has been no outbreak of yellow fever 
in the United States since 1942. The case mortality for most of these 
epidemics varied between 12 percent and 80 percent. 

1675-1775 There were only two five-year intervals when the colonies were entirely 
free of smallpox. The main centers of infection were port cities like 
Boston, New York, and Charleston. 

1699 Yellow fever outbreak in Charleston killed seven percent of the popula- 

tion. 

1721 Rev. Cotton Mather and Zabdiel Boylston began the use of variolation 

(smallpox inoculation) during a severe smallpox epidemic in Boston. It 
was highly effective. 

1730 Typhoid fever epidemics occurred in Connecticut and South Carolina 

and spread throughout the colonies. Approximately 30,000 to 40,000 
persons died of typhoid fever each year and approximately 500,000 were 
infected each year. 

1735 One of the first modern outbreaks of epidemic diphtheria occurred in 

New England. It killed 5,000 people overall or 2.5 percent of the total 
population. The vast majority of these deaths occurred among children. 

1752 Another epidemic of smallpox hit Boston. Variolation was clearly demon- 

strated to be effective — a case fatality rate of 1.5 percent among those 
variolated versus 9. 1 percent in the general population. 

1776 At the time of the American Revolution, smallpox was the greatest cause 

of infant mortality and accounted for 10 percent of all deaths. 

1776 George Washington ordered variolation for every man in the American 

Army. 

1776 The average life expectancy of American citizens was less than 40 years. 

1790's Yellow fever epidemics ocurred in Charleston, Baltimore, and New Orle- 

ans. 

1790's Diptheria was epidemic. This disease is highly contagious and isolation 

was an effective measure commonly employed. Quarantine of adult con- 
tacts from food handling is also still employed. 

1793 Yellow fever, Philadelphia. Public health measures in this epidemic 

turned on which theory of disease was ascribed to — either contagious (in 
which case quarantine was recommended) or anti-contagious (in which 
case sanitary measures were pushed). 5,000 persons died in this epidem- 
ic. 

1793 In direct response to the yellow fever epidemic, a Board of Health was 

created in Philadelphia. 

166 



1798 Edward Jenner announced that inoculation with cowpox protected the 

recipient from smallpox. 
1798 Yellow fever, New York City, 1,600 died. 

1798 Congress set up a system of compulsory hospital insurance for merchant 

seamen. 
1798 President John Adams established "marine hospitals" to provide care for 

sick and disabled merchant seamen. 
1802 A series of controlled experiments of human volunteers established the 

value of vaccination — literally, inoculation with cowpox. This was the 

first controlled medical experiment on humans in the United States. 

Effective control of smallpox depends on one factor — vaccination. 
1805 Yellow fever, New York City. 

1811 Congress authorized the establishment of a separate hospital service for 

naval personnel. 
1822 Yellow fever, New York City. 

1832 Cholera epidemic. In New York City, a quarantine was established 

against the advice of the professional medical community. Quarantine 

was ineffective because cholera cannot be contracted casually. In New 

York, the epidemic lasted about six weeks and 3,000 people perished. 

The city of New Orleans was hardest hit with 5,000 deaths — 20 percent 

of the population. 
1848 Cholera epidemic. In New York, 20,000 people were struck of whom 

8,000 died. Almost 5,000 died in New Orleans. The disease spread up 

the Mississippi Valley and went west with the forty-niners. 
1850's Yellow fever reached its peak in the 1850's striking New Orleans hardest. 

In four outbreaks in this decade, New Orleans lost almost 20,000 people. 
1853 Cholera epidemic. 

1855 Louisiana created the first state board of health. 

1857 Diphtheria swept Europe and America and became endemic in large 

cities. In New York, the average mortality rate for this disease for a 

period of six years never fell below 42 percent. 
1861-1865 Typhoid fever killed more soldiers in the Civil War than died in battle. 
1866 Cholera epidemic, relatively mild. 

1866 The Metropolitan Board of Health was established in New York City. 

1866-1890 Diphtheria caused 43,000 deaths in New York City. 
1869 Massachusetts established the first effective state board of health. 

1871 The federal government centralized direction of its marine hospitals 
under the Surgeon General of the Marine Hospital Service. This was 
located within the Treasury Department. 

1872 Only three states and the District of Columbia had established boards of 
health. 

1873 Cholera epidemic, widespread. 

1874 The bacillus responsible for causing leprosy was identified. This altered 
the tradition of separating lepers out. 

1878 Yellow fever, Mississippi Valley. More than 75,000 people were stricken 

and 15,000 died in this outbreak. 

1878 It was this epidemic of yellow fever which prompted the passage of the 
National Quarantine Act which gave some quarantine power to the Sur- 
geon General of the Marine Hospital Service. It allowed the Surgeon 
General to declare a quarantine, but allowed local authority to overturn 
the decision. There were no appropriations made available for imple- 
menting this Act. 

1879 A National Board of Health was established by Congress. This body did 
little and was terminated four years later under pressure from the Sur- 
geon General. 

1882 Dr. Robert Koch, developer of Koch's postulates, demonstrated that 
tuberculosis was caused by a bacillus. 

1883 National Board of Health was terminated. 

167 



1883 The Marine Hospital Service was given a yearly appropriation of 
$100,000 to provide assistance to states in preventing epidemic diseases. 

1884 Edward L. Trudeau established the first tuberculosis sanatorium for the 
poor in the United States. 

1885 John O'Dwyer pioneered the technique of intubation which greatly re- 
duced the mortality rate for diphtheria. 

1887 The Hygienic Laboratory was created on Staten Island. It originally 

carried out examinations of bacteriological specimens from immigrants to 
determine their eligibility for entering the country. The lab soon began 
investigation into the causes of disease and other independent research. 
It was transferred to Washington, D.C. four years later and became the 
National Institute of Health in the 1930's. 

1889 The New York City Department of Health declared tuberculosis to be 

"communicable and preventable." Public health policy was developed 
which was implemented in 1893-1894. This was a great change from 
policy before isolation of the etiologic agent, when the disease was 
assumed to be hereditary and so chief concern was felt by the patient and 
family. 

1889 Influenza pandemic. In the United States, epidemics of influenza A still 

occur every one to three years and epidemics of influenza B occur every 
three to four years. 

1892 The New York City Department of Health established a bacteriological 

laboratory. This lab demonstrated that half of all diphtheria cases in the 
city were actually "pseudo-diphtheria." This meant that quarantine of 
suspected diphtheria cases was actually causing more cases to occur. 
Patients who did not really have the disease were being put in the same 
ward as actual cases and becoming ill from the exposure. 

1892 The Pennsylvania Society for the Prevention of Tuberculosis was found- 
ed. This was the first effort by both lay and professional people to attack 
a single disease. 

1893 Diphtheria antitoxin was developed in Paris by Emile Roux. 

1893 New York City required that public institutions report all cases of tuber- 
culosis. Physicians were encouraged to report voluntarily with the incen- 
tive of free diagnostic services. Reporting requirements were made man- 
datory when the voluntary program failed. 

1894 Boston became the first city to employ school medical inspectors to 
identify and send home the contagiously ill. 

1894 Vermont reported 132 cases of polio in one year — the largest epidemic 
to date anywhere in the world. The death rate was 13.5 percent. 

1895 New York state appointed a chief medical inspector for the state's 
schools. These school health services lost their medical emphasis as 
authority was transferred from local boards of health to boards of educa- 
tion. By 1911, three out of four cities vested health authority in boards of 
education. 

1899 Bubonic plague outbreak in New York City. 

1900 Diphtheria was the ninth leading cause of deaths in the United States, 
responsible for 2.3 percent of all deaths. 

1900 The first large scale use of diphtheria antitoxin was used to combat an 

epidemic in Massachusetts. 

1900 Major Walter Reed identified the mosquito as the vector for yellow fever. 
This meant that the disease, while transmissible, was not contagious. It 
eliminated several public health strategies (e.g., isolation and quarantine) 
and pointed to the correct ones (e.g., protection from mosquito bites). 

1901 Bubonic plague in San Francisco. The public health measures taken then 
are still those recommended by the United States Public Health Service 
(PHS) ~ quarantine and sanitation measures. 

168 



1902 The Marine Health Service was expanded in the first step of its transition 

into PHS and was renamed the United States Public Health and Marine 
Hospital Service. 

1902 New York City introduced nurses into schools. 

1905 The last epidemic of yellow fever occurred in the United States. It struck 

New Orleans, causing 400 deaths and 3,500 cases. New Orleans moved 
to eliminate mosquito breeding grounds after this. 

1907 Salversan, a cure for syphilis and the first "magic bullet" for any disease, 

was discovered. 

1909 The Public Health Service published Bulletin 56 which showed that 

between 1880 and 1907, 500 outbreaks of milk-borne disease had oc- 
curred. The Board of Health of New York City made pasturization of 
milk mandatory. 

1909 The Surgeon General of the United States Public Health and Marine 

Hospital Service (PHMHS) decided that PHMHS should play a more 
active role in the conquest of typhoid fever. PHMHS paid special atten- 
tion to water-borne typhoid because of its prevalence and the ease with 
which it could be corrected. PHMHS branched into sanitary engineering 
and its studies led to improved municipal water systems and improved 
sewage treatment facilities. 

1911 The first county health organization was established after a typhoid fever 
outbreak in Yakima County, Washington. 

1912 The Marine Health Service was renamed the Public Health Service and 
its duties were expanded. 

1916 The northeastern part of the United States was struck by a devastating 
poliomyelitis epidemic. In New York City alone there were 9,000 cases. 

1917 A national program to eliminate bovine tuberculosis was instituted under 
the United States Department of Agriculture. This program included 
elimination of all infected cattle and the pasteurization of milk. 

1918 Twenty-three state and local associations joined together to form the 
National Tuberculosis Association. This became the American Lung As- 
sociation in 1973. 

1918 The Public Health Service was made responsible for the care of disabled 

war veterans. PHS rapidly expanded until 1922, at which time it had 81 
hospitals operating across the country. 

1918-19 Influenza pandemic killed 20 million worldwide and 548,000 in the 
United States alone. All public health measures were ineffective, includ- 
ing the closing of public establishments and the wearing of face masks. 

1921 Last typhus outbreak in the United States. 

1921 A public hospital for the care of patients with leprosy was established in 

Carville, Louisiana. 

1924 Clinical trials showed that diphtheria immunization was successful. Since 

this time, there has been a drastic decline in the number of cases, which 
has persisted to the present rate of less than four cases per year for the 
entire United States. 

1924 The Veterans' Bureau — the predecessor of the Veterans' Administration 

— assumed responsibility for all veterans' affairs, and 57 PHS hospitals 
were transferred to the Bureau. 

1924 PHS issued its first Standard Milk Ordinance and Code in order to 

ensure uniform standards across the country. 

1928 The New York City Department of Health began the first program of 

active immunization of school children in the United States. 

1938 The National Foundation for Infantile Paralysis, the sponsor of the 

March of Dimes, was established. 

1940's Polio outbreaks, generally in the summer. 

1943 The discovery of streptomycin which accelerated the decline in the inci- 

dence and mortality of tuberculosis. 

1947 Influenza pandemic. 

169 



1953 Dr. Jonas Salk developed inactivated polio vaccine. 

1950's Polio outbreaks stimulated federal involvement in the production and 

distribution of vaccine. 

1953 Last reported case of smallpox in the United States. 

1957 Influenza pandemic. 

1968 Influenza pandemic. 

1981 The United States Public Health Service hospitals were closed. 



170 



Appendix B 



BUDGET ESTIMATES FOR 
FINAL REPORT RECOMMENDATIONS 

(In millions) 







Total Federal 
dollars over 

FY 88 
appropriated 


Total State 


Total 


Prevention and education 


200 


100 


300 


Incidence and 


prevalence 


50 

924.5 

25 

200 

247.5 

300 

50.5 . 

1,997.5 


50 


International .. 


750 


1,674.5 
25 


Patient care.... 
Research 


200 
52.5 


400 
300 
300 


Societal 




50.5 


Total ... 


1,102.5 


3,100 



These are the estimated low end (start-up funding) cost estimates for the recommendations. 



171 



Appendix C 



WALTER REED HIV-1 STAGING CRITERIA 

Introduction 

The purpose of this staging criteria is to provide physicians with a pragmatic HIV-1 
diagnostic system. This system is based upon qualitative and quantitative clinical 
parameters and could be used to classify and follow patients throughout the entire 
course of their infection. The system is based on the following staging parameters: 

A. Exposure to HIV-1 

B. Presence of HIV- 1 antibody 

C. Chronic lymph node swelling 

D. Number of T-helper cells 

E. Presence of Delayed Hypersensitivity Reaction (DHS) 

F. Candida fungal infection 

G. Other opportunistic infections 

Walter Reed Staging Criteria (WR) 

WRO: High-risk contacts of HIV-1 infected individuals or blood products. These 
individuals have negative antibody tests and all other staging parameters are 
within normal limits. 

WR1: Individuals are only HIV-1 antibody positive and all other staging parameters 
are within normal limits. 

WR2: Individuals are HIV-1 antibody positive, exhibit chronic lymph node swelling, 
but all other staging parameters are within normal limits. 

WR3: Individuals are HIV-1 antibody positive, chronic lymph node swelling may be 
present, but T-helper cell counts are below normal. All other staging param- 
eters are within normal limits. 

WR4: Individuals have HIV-1 antibody, chronic lymph node swelling may be 
present, T-helper cell counts are below normal, partial impairment of the 
Delayed Hypersensitivity Reaction (DHS). All other staging parameters are 
normal. 

WR5: Individuals have HIV-1 antibody, chronic lymph node swelling may be 
present, T-helper cell counts below normal, DHS practically or completely 
absent, Candida fungal infection may be present, but other opportunistic infec- 
tions are absent. 

WR6: Individuals have HIV-1 antibody, chronic lymph node swelling may be 
present, T-helper cell counts below normal, DHS practically or completely 
absent, Candida fungal infections may be present and other opportunistic 
infections are present. 



173 

214-701 - 88 - 7 : OL 3 



A STAGING SYSTEM FOR HTLV-III DISEASE 



STAGE HTLV-III CHRONIC 

ANTIBODY LYMPHADEN- 

AND/OR VIRUS OPATHY 
ISOLATION 



T-HELPER 
CELLS/mm 3 



DHS 



THRUSH 



O.I. 



WRO 



>400 



NL 



WR1 



WR2 



WR3 



WR4 




4- 



+ 



4- 




>400 



>400 




NL 



NL 



NL 







WR5 



C AND/OR 4- 



WR6 



+ 




PC 



The Walter Reed staging classification for HTLV-III/LAY infection. The essential criteria for assignment to each stage are indicated by 
hexagons. DHS denotes delayed hypersensitivity; NL, normal, P; partial cutaneous anergy, which is defined as an intact cutaneous response to 
only one of the four test antigens; C, complete cutaneous anergy to the four test antigens; and O.I., opportunistic infection. 



174 



Appendix D 
OFFICE OF PERSONNEL MANAGEMENT 

Guidelines for AIDS Information and Education and for Personnel Management 

Issues 



March 1988 



Introduction 



This information and guidance is designed to assist Federal agencies in establishing 
effective AIDS education programs and in fairly and effectively handling AIDS-related 
personnel situations in the workplace. In this guidance, the term AIDS is used to refer 
either to the general AIDS phenomenon or to clinically diagnosed AIDS as a medical 
condition. HIV (human immunodeficiency virus) is used when the discussion is refer- 
ring to the range of medical conditions which HIV-infected persons might have (i.e., 
immunological and/or neurological impairment in early HIV infection to clinically 
diagnosed AIDS). 

General Policy 

Guidelines issued by the Public Health Service's Centers for Disease Control (CDC) 
dealing with AIDS in the workplace state that "the kind of nonsexual person-to-person 
contact that generally occurs among workers and clients or consumers in the work- 
place does not pose a risk for transmission of [AIDS]." Therefore, HIV-infected 
employees should be allowed to continue working as long as they are able to maintain 
acceptable performance and do not pose a safety or health threat to themselves or 
others in the workplace. If performance or safety problems arise, agencies are encour- 
aged to address them by applying existing Federal and agency personnel policies and 
practices. 

HIV infection can result in medical conditions which impair the employee's health and 
ability to perform safely and effectively. In these cases, agencies should treat HIV- 
infected employees in the same manner as employees who suffer from other serious 
illnesses. This means, for example, that employees may be granted sick leave or leave 
without pay when they are incapable of performing their duties or when they have 
medical appointments. In this regard, agencies are encouraged to consider accommo- 
dation of employees' AIDS-related conditions in the same manner as they would other 
medical conditions which warrant such consideration. 

Also, there is no medical basis for employees refusing to work with such fellow 
employees or agency clients who are HIV-infected. Nevertheless, the concerns of these 
employees should be taken seriously and should be addressed with appropriate infor- 
mation and counseling. In addition, employees, such as health care personnel, who 
may come into direct contact with the body fluids of persons having the AIDS virus, 
should be provided appropriate information and equipment to minimize the risks of 
such contact. 

OPM encourages agencies to consider the following guidelines when establishing 
AIDS education programs and in carrying out their personnel management responsi- 
bilities. 

175 



I. AIDS INFORMATION AND EDUCATION PROGRAMS 

There are several important considerations in establishing effective AIDS information 
and education programs. The following guidance is intended to help agencies develop 
methods for establishing successful programs. 

A. Timing and Scope of AIDS Information and Education Efforts 

AIDS information and education programs are most effective if they begin before a 
problem situation arises relative to AIDS and employee concerns. Experience in the 
private sector has demonstrated that employees' level of receptivity to accurate infor- 
mation will be higher when management has a policy of open communications and 
when educational efforts are initiated before a problem situation occurs. Education 
and information should be of an ongoing nature. This approach will reassure employ- 
ees of management's commitment to open communications and employees will receive 
updated information about AIDS. By providing AIDS information to all employees, 
agencies will enhance employees' understanding about the nature and transmission of 
the disease. 

B. Educational Vehicles 

Education and information efforts may be carried out in a variety of ways. Agency 
news bulletins, personnel management directives, meetings with employees, expert 
speakers and counselors, question and answer sessions, films and video-tapes, employ- 
ee newsletters, union publications, factsheets, pamphlets, and brochures are likely to 
be effective means of providing information to employees about AIDS. 

C. Employee Assistance Programs 

For employees who have personal concerns about AIDS, agency employee assistance 
programs (EAPs) can be an excellent source of information and counseling, and can 
provide referrals, as requested, to community testing, treatment, and other resources. 
EAPs can also provide counseling to employees who have apprehensions regarding 
the communicability of the disease or other related concerns. Because EAPs are in a 
unique position to offer information and assistance, agencies are encouraged to estab- 
lish AIDS information, counseling, and referral capabilities in their EAPs and to make 
employees and supervisors aware of available services. In addition, EAPs can be a 
good source of managerial/supervisory training on AIDS in the workplace. As with 
other services provided by the EAP, strict adherence to applicable privacy and confi- 
dentiality requirements must be observed when advising employees with AIDS-related 
concerns. In addition to services provided by the EAP, the agency's occupational 
health program, health unit, or medical staff should be prepared to assist employees 
seeking information and counseling on AIDS. 

D. Training and Guidance for Managers and Supervisors 

Supervisors and managers should be prepared to deal with employee concerns and 
other issues related to AIDS in the workplace. Agencies should consider, therefore, 
conducting ongoing training and education programs on AIDS for their managers and 
supervisors on the medical and personnel management dimensions of AIDS. These 
programs can be used to educate managers and supervisors on the latest research on 
AIDS in the workplace, to provide advice on how to recognize and handle situations 
which arise in their organizations, and to convey the importance of maintaining the 
confidentiality of any medical and other information about employees' health status. 
In addition, managers and supervisors should be given a point of contact within the 
agency where they can call to obtain further information or to discuss situations which 
arise in their work units. Agencies should attempt to initiate training and guidance 
activities before problems occur. 



176 



E. Sources of Information and Educational Materials 

A great deal of information about AIDS is available to Federal agencies. OPM encour- 
ages agencies to explore various sources of information and to keep abreast of the 
latest research on AIDS in the workplace. The U.S. Public Health Service (PHS) has 
developed a great deal of material on the medical and other aspects of AIDS. Informa- 
tion about AIDS can be obtained by requesting it from PHS offices or from the AIDS 
Clearinghouse (America Responds to AIDS, P.O. Box 6003, Rockville, Maryland 
20850; telephone (800) 342-7514). PHS offices are located throughout the country 
and can be contacted for information relating to AIDS. (See section III for a listing of 
PHS regional office locations). In addition, the American Red Cross has developed an 
extensive assortment of educational materials on AIDS. Information about the materi- 
als available through PHS and other sources is contained in section III. [For reasons 
of space, section III which lists AIDS information sources and the location of PHS 
regional offices is not included in this report.] 

II. PERSONNEL MANAGEMENT ISSUES AND CONSIDERATIONS 

When AIDS becomes a matter of concern in the workplace, a variety of personnel 
issues may arise. Basically, these issues should be addressed within the framework of 
existing procedures, guidance, statutes, case law, and regulation. Following is a brief 
discussion of AIDS-related issues which could arise in various personnel management 
areas, along with some basic guidance on how to approach and resolve such issues. 
Agencies are cautioned that, as with any complex personnel management matter, the 
resolution of a specific problem must be based on a thorough assessment of that 
problem and how it is affected by contemporary information and guidance about 
AIDS, current law and regulation bearing on the involved issue, and the agency's own 
policies and needs. 

A. Employees' Ability to Work 

An HIV-infected employee may develop a variety of medical conditions. These condi- 
tions can range all the way from immunological and/or neurological impairment in 
early stages of HIV infection to clinically diagnosed AIDS. At some point, a concern 
may arise whether such an employee, given his or her medical condition, can perform 
the duties of the position in a safe and reliable manner. This concern will typically 
arise at a point when the HIV-infected employee suffers health problems which affect 
his or her ability to report for duty or perform. Also, in some situations the concern 
may stem from the results of a medical examination required by the employee's 
position. Under OPM's regulations in 5 C.F.R. Part 339, Medical Determination 
Related to Employability, it is primarily the employee's responsibility to produce 
medical documentation regarding the extent to which a medical condition is affecting 
availability for duty or job performance. However, when the employee does not 
produce sufficient documentation to allow agency management to make an informed 
decision about the extent of the employee's capabilities, the agency may offer, and in 
some cases order, the employee to undergo a medical examination. Accurate and 
timely medical information will allow the agency to consider alternatives to keeping 
the employee in his or her position if there are serious questions about safe and 
reliable performance. It will also help determine whether the HIV-infected employee's 
medical condition is sufficiently disabling to entitle the employee to be considered for 
reasonable accommodation under the Rehabilitation Act of 1973 (29 U.S.C. Section 
794). 

B. Privacy and Confidentiality 

Because of the nature of the disease, HIV-infected employees will have understand- 
able concerns over confidentiality and privacy in connection with medical documenta- 
tion and other information relating to their condition. Agencies should be aware that 
any medical documentation submitted to an agency for the purposes of an employ- 
ment decision and made part of the file pertaining to that decision becomes a 

177 



"record" covered by the Privacy Act. The Privacy Act generally forbids agencies to 
disclose a record which the Act covers without the consent of the subject of the 
record. However, these records are available to agency officials who have a need to 
know the information for an appropriate management purpose. Officials who have 
access to such information are required to maintain the confidentiality of that informa- 
tion. In addition, supervisors, managers, and others included in making and imple- 
menting personnel management decisions involving employees with AIDS should 
strictly observe applicable privacy and confidentiality requirements. 

C. Leave Administration 

HIV-infected employees may request sick or annual leave or leave without pay to 
pursue medical care or to recuperate from the ill effects of his or her medical 
condition. In these situations the agency should make its determination on whether to 
grant leave in the same manner as it would for other employees with medical condi- 
tions. 

D. Changes in Work Assignment 

Agencies considering changes such as job restructuring, detail, reassignment, or flexi- 
ble scheduling for HIV-infected employees should do so in the same manner as they 
would for other employees whose medical conditions affect the employee's ability to 
perform in a safe and reliable manner. In considering changes in work assignments, 
agencies should observe established policies governing qualification requirements, 
internal placement, and other staffing requirements. 

E. Employee Conduct 

There may be situations where fellow employees express reluctance or threaten refus- 
al to work with HIV-infected employees. Such reluctance is often based on misinfor- 
mation or lack of information about the transmission of HIV. There is, however, no 
known risk of transmission of HIV through normal workplace contacts, according to 
leading medical research. Nevertheless, OPM recognizes that the presence of such 
fears, if unaddressed in an appropriate and timely manner, can be disruptive to an 
organization. Usually an agency will be able to deal effectively with such situations 
through information, counseling, and other means. However, in situations where such 
measures do not solve the problem and where management determines that an 
employee's unwarranted threat or refusal to work with a HIV-infected employee is 
impeding or disrupting the organization's work, it should consider appropriate correc- 
tive or disciplinary action against the threatening or disruptive employee(s). In other 
situations, management may be faced with an HIV-infected employee who is having 
performance or conduct problems. Management should deal with these problems 
through appropriate counseling, remedial, and, if necessary, disciplinary measures. In 
pursuing appropriate action in these situations, management should be sensitive to 
the possible contribution of anxiety over the illness to work behavior and to the 
requirements of existing Federal and agency personnel policies, including any obliga- 
tions the agency may have to consider reasonable accommodation of the HIV-infected 
employee. 

F. Insurance 

HIV-infected employees can continue their coverages under the Federal Employees 
Health Benefits (FEHB) Program and/or the Federal Employees' Group Life Insur- 
ance (FEGLI) Program in the same manner as other employees. Their continued 
participation in either or both of these programs would not be jeopardized solely 
because of their medical condition. The health benefits plans cannot exclude coverage 
for medically necessary health care services based on an individual's health status or a 
pre-existing condition. Similarly, the death benefits payable under the FEGLI Program 
are not cancelable solely because of the individual's current health status. However, 
any employee who is in a leave-without-pay (LWOP) status for 12 continuous months 

178 



faces the statutory loss of FEHB and FEGLI coverage but has the privilege of conver- 
sion to a private policy without having to undergo a physical examination. Employees 
who are seeking to cancel previous declinations and/or obtain additional levels of 
FEGLI coverage must prove to the satisfaction of the Office of Federal Employees' 
Group Life Insurance that they are in reasonably good health. Any employee exhibit- 
ing symptoms of any serious and life-threatening illness would necessarily be denied 
the request for additional coverage. 

G. Disability Retirement 

HIV-infected employees may be eligible for disability retirement if their medical 
condition warrants and if they have the requisite years of Federal service to qualify. 
OPM considers applications for disability retirement from employees with AIDS in the 
same manner as for other employees, focusing on the extent of the employee's 
incapacitation and ability to perform his or her assigned duties. OPM makes every 
effort to expedite any applications where the employee's illness is in an advanced 
stage and is life threatening. 

H. Labor-Management Relations 

AIDS in the workplace may be an appropriate area for cooperative labor-management 
activities, particularly with respect to providing employees education and information 
and alleviating AIDS-related problems that may emerge in the workplace. In addition, 
to the extent that an agency proposes AIDS-related policies or programs which would 
affect the working conditions of bargaining unit employees, unions must be accorded 
any rights they may have to bargain or be consulted as provided for under 5 U.S.C. 
Chapter 71. 

I. Health and Safety Standards 

In 1985, the CDC published guidelines relating to the prevention of HIV transmission 
in most workplace settings, CDC Recommendations for Preventing Transmission of Infection 
with [HIV\ in the Workplace, 34 MMWR 681 (November 15, 1985). The CDC published 
specialized guidelines in 1987 relating to health-care workers (which in part updated 
the health-care worker provisions contained in the workplace guidelines), CDC Recom- 
mendations for Prevention of HIV Transmission in Health-Care Settings, 36 MMWR Supp. no. 
2S (August 21, 1987). The Department of Health and Human Services (HHS) and the 
Occupational Safety and Health Administration (OSHA) of the Department of Labor 
have initiated a program to ensure compliance with safety and health guidelines and 
standards designed to protect health-care workers from blood-borne diseases, includ- 
ing AIDS. See Department of Labor/Department of Health and Human Services — 
Joint Advisory Notice: Protection Against Occupational Exposure to Hepatitis B Virus (HBV) 
and Human Immunodeficiency Virus (HIV), 52 Fed. Reg. 41818 (October 30, 1987). The 
CDC and OSHA/HHS guidance is intended to increase the availability and use of 
educational information and personal protective equipment and to improve workplace 
practices bearing on the transmission of AIDS and other blood-borne diseases. OPM 
strongly encourages agencies, especially those with employees occupying health-care 
and related positions, to establish health and safety practices consistent with this 
guidance. Sources are available in OSHA to discuss the published guidelines. 

J. Blood Donations 

One area of personnel management which agencies may overlook when considering 
AIDS policies and practices is employee blood donations. OPM joins the American 
Red Cross in urging agencies to encourages employees to consider donating blood. 
Under guidelines established by the American Red Cross, there is no risk of contract- 
ing AIDS from giving blood. However, fears associated with AIDS have contributed to 
a situation where many of the nation's blood banks are in short supply. This situation 
threatens the health status of the American public. 

179 



As part of its effort to educate the public so as to overcome these fears, the American 
Red Cross has produced three publications which address blood donations where 
AIDS is an issue. These publications are: "You Can't Get AIDS From Giving Blood, 
But Fear Can Run Us Dry," "What You Must Know Before Giving Blood," and "AIDS 
and the Safety of the Nation's Blood Supply." These publications are available 
through your local Red Cross chapter or by contacting the Red Cross National 
Headquarters AIDS Public Education Program (by writing to 1730 "D" Street, N.W., 
Washington, D.C. 20006 or by calling (202) 639-3223). 



180 



Appendix E 
PUBLIC HEARING SCHEDULE 



Date Subject Site 

1987 

September 1-2 Site Visit New York City, NY 

September 2-3 Site Visit San Francisco, CA 

September 9-10 Federal Overview Washington, DC 

September 30 Congressional Caucus Washington, DC 

October 15-16 State Response Hearing and Personnel Washington, DC 

Meeting 

November 10-12 Site Visit and Hearing South Florida 

November 24 Reports of the Institute of Medicine and Washington, DC 

the American Medical Association 

December 10-11 Incidence and Prevalence Washington, DC 

December 17-18 Intravenous Drug Abuse and HIV Infec- Washington, DC 

tion 

1988 

January 13-15 Care Washington, DC 

February 18-20 Research: New Drugs, Vaccines, and Be- New York City, NY 

havior 

February 29 Executive Session Washington, DC 

March 1-3 Prevention and Education Washington, DC 

March 16-18 Discrimination: Workplace, Housing, Nashville, TN 

and Schools 
Ethics: Denial of Care and Research 
Testing: Confidentiality and Duty to 

Warn 

March 24-25 Western States Response and Site Visits San Francisco, CA 

April 5-6 Societal and Legal Concerns Washington, DC 

April 18-20 International Washington, DC 

April 26-27 Finance Washington, DC 

May 9-11 Safety of the Blood Supply, AIDS in the Indianapolis, IN 

Workplace, Health Care Worker 

Safety 

May 16-18 Final Hearing Washington, DC 

June 7 Executive Session Washington, DC 

June 16-17 Executive Session Washington, DC 



181 



Appendix F 
BIOGRAPHICAL INFORMATION 

Presidential Commission on the Human Immunodeficiency Virus Epidemic 

COLLEEN CONWAY-WELCH, of Tennessee. Since 1984, Dr. Conway- Welch has 
been a professor and the Dean of Nursing at Vanderbilt University and Associate 
Director of the Vanderbilt University Hospital Department of Nursing. She received 
her B.S.N, degree from the Georgetown University School of Nursing in 1965; her 
M.S.N, degree from the Catholic University of America in 1969; her C.N.M. degree 
from the Catholic Maternity Institute in 1969; and her Ph.D. degree from New York 
University in 1973. Dr. Conway-Welch was born April 26, 1944 in Iowa. She is 
married and resides in Nashville, Tennessee. 

JOHN J. CREEDON, of Connecticut. Mr. Creedon has been with the Metropolitan 
Life Insurance Company in New York City since 1942. He has been serving as 
President of the Company since 1980, and Chief Executive Officer since 1983. Mr. 
Creedon is also Chairman of the Business Roundtable's Task Force on Health and 
Welfare Benefit Plans. He served as General Chairman of the Greater New York 
Blood Program Campaign for 1986 and 1987. Mr. Creedon earned his B.S. degree in 
1952 from New York University School of Law, and his LL.B degree in 1955 and 
LL.M degree in 1962 from New York University School of Law. He served in the 
United States Navy during World War II. Mr. Creedon was born August 1, 1924 in 
New York City. He is married, has six children, and resides in New Canaan, Connecti- 
cut. 

THERESA L. CRENSHAW, of California. Since 1975, Dr. Crenshaw has been the 
Director of the Crenshaw Clinic, which specializes in the evaluation and treatment of 
sexual dysfunction, sexual medicine, and human relationships. She was Immediate 
Past President of the American Association of Sex Educators, Counselors, and Thera- 
pists. Dr. Crenshaw received her B.A. degree from Stanford University in 1964 and 
her M.D. degree from the University of California at Irvine in 1969. She served in the 
United States Navy from 1967 through 1973. Dr. Crenshaw was born September 25, 
1942 and resides in San Diego, California. 

RICHARD M. DEVOS, of Michigan. Mr. DeVos co-founded Amway Corporation in 
1959, and has since been serving as President of the Corporation. He attended Calvin 
College in Michigan. Mr. DeVos served in the United States Air Force from 1944 
through 1946. He was born March 4, 1926. Mr. DeVos is married, has four children, 
and resides in Grand Rapids, Michigan. 

KRISTINE M. GEBBIE, of Oregon. Since 1980, she has been an Adjunct Associate 
Professor with the Department of Psychiatric/Mental Health Nursing, School of Nurs- 
ing at Oregon Health Science University. Prior to that, she was the Assistant Director 
for Health at the Department of Human Resources, and Administrator of the Oregon 
State Health Division in Portland. Mrs. Gebbie graduated from St. Olaf College (R.N., 
1965) and the University of California School of Nursing (M.N., 1968). She was born 
June 26, 1943 in Sioux City, Iowa. Mrs. Gebbie is married, has three children, and 
resides in Portland, Oregon. 

BURTON JAMES LEE III, of Connecticut. Since I960, Dr. Lee has been a practicing 
physician at the Memorial Sloan-Kettering Cancer Center in New York, specializing in 
the diagnosis and treatment of lymphomas, and since 1981 has treated patients with 

183 



HIV infection. He was President of the General Medical Staff at the Memorial Sloan- 
Kettering Hospital from 1972 through 1974, and from 1983 through 1985. Dr. Lee 
earned his B.A. from Yale University in 1952 and his M.D. from the Columbia 
University College of Physicians and Surgeons in 1956. He was born March 28, 1930 
in New York City. Dr. Lee is married, has three children and three step-children, and 
resides in Greenwich, Connecticut. 

FRANK LILLY, of New York. Since 1976, Dr. Lilly has been Chairman of the 
Genetics Department of the Albert Einstein Medical Center in New York City. He has 
also served as a Professor of Genetics for the Albert Einstein College of Medicine 
since 1974. Dr. Lilly earned his B.S. degree from West Virginia University in 1951. He 
earned his first Ph.D. from the University of Paris in 1958, majoring in organic 
chemistry, and his second Ph.D. from the Cornell Graduate School of Medical Sci- 
ences in 1965, majoring in biology. Dr. Lilly served in the United States Army from 
January 1952 through December 1953. He was born August 28, 1930 in Charleston, 
West Virginia and resides in New York City. 

JOHN CARDINAL O'CONNOR, of New York. John Cardinal O'Connor was or- 
dained a priest in 1945. He was named Archbishop of New York in 1984, and 
Cardinal in 1985. John Cardinal O'Connor served as Bishop of Scranton, Pennsylvania 
in 1983. While in the United States Navy, 1952-1979, he was appointed Navy Chief of 
Chaplains in 1974, and Titular Bishop of Cursola and auxiliary to the Military Vicar in 
1979. John Cardinal O'Connor was born January 15, 1920 in Philadelphia, Pennsylva- 
nia. He currently resides in New York City. 

BENY J. PRIMM, of New York. Since 1983, Dr. Primm has been President of the 
Urban Resource Institute and, since 1969, President and Executive Director of The 
Addiction Research and Treatment Corporation in Brooklyn, New York. Dr. Primm 
graduated from West Virginia State College (B.S., 1950) and the University of Geneva 
(M.D., 1959). He served in the United States Army. Dr. Primm was born May 21, 1928 
in Williamson, West Virginia. He has three children and resides in New Rochelle, New 
York. 

PENNY PULLEN, of Illinois. Miss Pullen was first elected to the Illinois State House 
of Representatives in 1976, and has been serving in the State House since that time. 
In January 1987, she was appointed House Minority Leader. Miss Pullen is the 
sponsor of HIV-related legislation in the State of Illinois. She earned her B.A. degree 
from the University of Illinois at Chicago in 1969. Miss Pullen was born March 2, 
1947, in Buffalo, New York. She currently resides in Park Ridge, Illinois. 

CORY SERVAAS, of Indiana. Since 1973, Dr. SerVaas has been Editor and Publisher 
of The Saturday Evening Post. She has also served as President and Research Director 
of the Benjamin Franklin Literary and Medical Society and Medical Director of the 
Foundation for Preventative Medicine, 1976 to present. Dr. SerVaas earned her A.B. 
degree from the University of Iowa School of Journalism in 1946 and did post- 
graduate work at Columbia University. She earned her M.D. degree from the Indiana 
University School of Medicine in 1969. Dr. SerVaas was born June 21, 1924 in Pella, 
Iowa. She is married, has five children, and resides in Indianapolis, Indiana. 

WILLIAM B. WALSH, of Maryland. Dr. Walsh founded Project HOPE (Health 
Opportunity for People Everywhere) in 1958, and has been serving as President and 
Medical Director since that time. He is also a clinical professor of internal medicine at 
Georgetown University. Dr. Walsh earned his B.S. degree in 1940 from St. John's 
University in New York, and his M.D. degree from Georgetown University School of 
Medicine in 1943. Dr. Walsh served in the United States Navy from 1941 to 1954. He 
received the Presidential Medal of Freedom in June 1987, and received the National 
Institute of Social Sciences Gold Medal in 1977. Dr. Walsh was born April 26, 1920 in 
Brooklyn, New York. He is married, has three sons, and resides in Bethesda, Mary- 
land. 

ADMIRAL JAMES D. WATKINS, (Chairman, Presidential Commission on the HIV 
Epidemic) U.S. Navy, Retired, of California. Admiral Watkins served as the Chief of 

184 



Naval Operations, U.S. Navy, from 1982 to 1986. Prior to this, he was Commander in 
Chief of the U.S. Pacific Fleet, from 1981 to 1982. Admiral Watkins is a 1949 graduate 
of the U.S. Naval Academy and received his master's degree from the Naval Postgrad- 
uate School in 1958. During his military service, Admiral Watkins received several 
Distinguished Service Medals, including three Legions of Merit and the Bronze Star. 
Admiral Watkins was born March 7, 1927 in Alhambra, California. He is married, has 
six children, and resides in the District of Columbia. 



POLLY L. GAULT, (Executive Director, Presidential Commission on the HIV Epi- 
demic). Prior to her appointment to the Commission, Ms. Gault served for six years as 
the Staff Director of the United States Senate Subcommittee on Education, Arts and 
Humanities chaired by Senator Robert T. Stafford of Vermont. For the previous four 
years, Ms. Gault managed the legislative activities of the Handicapped, Education and 
Aging Subcommittees of the Senate Labor and Human Resources Committee, as well 
as the Labor-HEW Appropriations Subcommittee for Senator Richard S. Schweiker of 
Pennsylvania, ranking Republican member. Ms. Gault was born in Abington, Pennsylva- 
nia, on June 15, 1953. She graduated from Mt. Holyoke College in 1975, Magna Cum 
Laude, Phi Beta Kappa. 



185 



Appendix G 
PHYSICIAN REVIEW GROUP 

Dr. James Baker is an Assistant Professor of Emergency Medicine at the Johns 
Hopkins University School of Medicine and is a member of the Johns Hopkins AIDS 
Research Group, and a member of the American College of Emergency Physicians 
Task Force on AIDS. 

Dr. John Bartlett is a Professor of Medicine and Director of AIDS Patient Care at the 
Johns Hopkins Hospital Moore Clinic. 

Dr. Gerald Friedland is a Professor of Medicine and Co-Director of the AIDS Center 
at the Albert Einstein College of Medicine. 

Dr. David Henderson is Coordinator of AIDS Activities at the National Institute of 
Health Clinical Center. 

Dr. John Johnson is a specialist in Pediatric Immunology, and is Director of the 
Pediatric AIDS Program at the University of Maryland. 

Dr. Phillip Pierce is Director of the AIDS Clinic at Georgetown University Hospital. 

Dr. Alfred Saah is an Associate Professor of Epidemiology at the Johns Hopkins 
School of Public Health, and a Collaborator in the Multicenter AIDS Cohort Study. 

Dr. Timothy Townsend is a Pediatician and Epidemiologist, and is the Hospital 
Epidemiologist at Johns Hopkins. 



187 



Appendix H 
EXECUTIVE ORDERS 

Federal Register / Vol. 52, No. 124 / Monday, June 29, 1987 / Presidential Documents 24129 

Presidential Documents 



Executive Order 12601 of June 74, 1987 

Presidential Commission on the Human Immunodeficiency 
Virus Epidemic 



By the authority vested in me as President by the Constitution and laws of the 
United States of America, including the Federal Advisory Committee Act, as 
amended (5 U.S.C. App. I), and in order to create an advisory commission to 
investigate the spread of the human immunodeficiency virus (HIV) and the 
resultant acquired immune deficiency syndrome (AIDS) in the United States, it 
is hereby ordered as follows: 

Section 1. Establishment, (a) There is established the Presidential Commission 
on the Human Immunodeficiency Virus Epidemic to investigate the spread of 
the HIV and the resultant AIDS. The Commission shall be composed of 11 
members appointed or designated by the President. The members shall be 
distinguished individuals who have experience in such relevant disciplines as 
medicine, epidemiology, virology, law, insurance, education, and public 
health. 

(b) The President shall designate a Chairman from among the members of the 
Commission. 

Sec. 2. Functions, (a) The Commission shall advise the President, the Secretary 
of Health and Human Services, and other relevant Cabinet heads on the 
public health dangers including the medical, legal, ethical, social, and econom- 
ic impact, from the spread of the HIV and resulting illnesses including AIDS, 
AIDS-related complex, and other related conditions. 

(b) The primary focus of the Commission shall be to recommend measures that 
Federal, State, and local officials can take to (1) protect the public from 
contracting the HIV; (2) assist in finding a cure for AIDS; and (3) care for those 
who already have the disease. 

(c) In particular, the Commission shall (1) evaluate efforts by educational 
institutions and other public and private entities to provide education and 
information concerning AIDS: (2) analyze the efforts currently underway by 
Federal, State, and local authorities to combat AIDS; (3) examine long-term 
impact of AIDS treatment needs on the health care delivery system, including 
the effect on non-AIDS patients in need of medical care; (4) review the United 
States history of dealing with communicable disease epidemics; (5) evaluate 
research activities relating to the prevention and treatment of AIDS; (6) 
identify future areas of research that might be needed to address the AIDS 
epidemic; (7) examine policies for development and release of drugs and 
vaccines to combat AIDS; (8) assess the progression of AIDS among the 

189 



24130 Federal Register / Vol. 52, No. 124 / Monday, June 29, 1987 / Presidential Documents 

general population and among specific risk groups; (9) study legal and ethical 
issues relating to AIDS; and (10) review the role of the United States in the 
international AIDS pandemic. 

(d) The Commission shall make a preliminary report to the President not later 
than 90 days after the date the members of the Commission are first appointed 
or designated. The Commission shall submit its final report no later than 1 
year from the date of this Order. 

Sec. 3. Administration, (a) The heads of Executive departments and agencies, 
to the extent permitted by law, shall provide the Commission, upon request, 
with such information as it may require for purposes of carrying out its 
functions. 

(b) Members of the Commission may receive compensation for their work on 
the Commission at the daily rate specified for GS-18 of the General Schedule. 
While engaged in the work of the Commission, members appointed from 
among private citizens of the United States, to the extent funds are available, 
may be allowed travel expenses, including per diem in lieu of subsistence, as 
authorized by law for persons serving intermittently in the government service 
(5 U.S.C. 5701-5707). 

(c) The Office of the Secretary of Health and Human Services, subject to the 
availability of appropriations, shall provide the Commission with such admin- 
istrative services, funds, facilities, staff, and other support services as may be 
necessary for the performance of its functions. The heads of other Executive 
departments and agencies, to the extent permitted by law, shall cooperate 
with the Commission and provide such personnel and administrative support 
as may be necessary for the performance of its functions. 

Sec. 4. General Provisions, (a) The functions of the President under the 
Federal Advisory Committee Act, as amended (5 U.S.C. App. I), except that of 
reporting annually to the Congress, which are applicable to the Commission, 
shall be performed by the Secretary of Health and Human Services, in 
accordance with guidelines and procedures established by the Administrator 
of General Services. 

(b) The Commission, unless sooner extended, shall terminate 30 days after 
submitting its final report to the President. 



|KR Doc. 87-14837 
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June 24, 1987. 



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190 



Federal Register / Vol. 52, No. 138 / Monday . July 2 0. 1987 / Presidential Documents 27315 

Presidential Documents 



Executive Order 12603 of July 16. 1987 

Presidential Commission on the Human Immunodeficiency 
Virus Epidemic 



By the authority vested in me as President by the Constitution and laws of the 
United States of America, including the Federal Advisory Committee Act. as 
amended (5 U.S.C. App. I), and in order to increase the number of members of 
the Presidential Commission on the Human Immunodeficiency Virus Epidem 
ic, it is hereby ordered that Section 1(a) of Executive Order No. 12601 of June 
24, 1987, is amended by changing the number of members of the Commission 
from 11 to 13. 



|KK Doc. 87-16596 
Filed 7-17-87: 11:28 am| 
Billing code 319S-01-M 



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July 16. 1987. 



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191 



Appendix I 



THE SECRETARY OF HEALTH AND HUMAN SERVICES 

WASHINGTON. DC. 20201 



CHARTER 

Presidential Commission on the Human 
Immunodeficiency Virus Epidemic 

PURPOSE 

Executive Order 12601, dated June 24, 1987 established the Presidential 
Commission on the Human Immunodeficiency Virus Epidemic to investigate the 
spread of the HIV virus and the resultant acquired immune deficiency 
syndrome (AIDS) In the United States. 

AUTHORITY 

Executive Order 12601, dated June 24, 1987 as amended by Executive Order 
12603, dated July 16, 1987. The Commission is governed by provisions of 
Public Law 92-463 (5 U.S.C. Appendix 2), which sets forth standards for the 
formation and use of advisory committees. 

FUNCTION 

The Commission was directed by the Executive Order to: 

(a) The Commission shall advise the President and the Secretary of 
Health and Human Services, and other relevant Cabinet heads on the 
public health dangers including the medical, legal, ethical, social, 
and economic impact, from the spread of the HIV and resulting 
illnesses including AIDS, AIDS-related complex, and other related con- 
ditions. 

(b) The primary focus of the Commission shall be to recommend measures 
that Federal, State, and local officials can take to (1) protect the 
public from contracting the HIV; (2) assist in finding a cure for AIDS; 
and (3) care for those who already have the disease. 

(c) In particular, the Commission shall (1) evaluate efforts by educa- 
tional institutions and other public and private entities to provide edu- 
cation and information concerning AIDS; (2) analyze the efforts 
currently underway by Federal, State, and local authorities to combat 
AIDS; (3) examine long-term impact of AIDS treatment needs on the 
health care delivery system, including the effect on non-AIDS patients 
in need of medical care; (4) review the United States history of 
dealing with communicable disease epidemics; (5) evaluate research 
activities relating to the prevention and treatment of AIDS; (6) iden- 

193 



tify future areas of research that might be needed to address the AIDS 

epidemic; (7) examine policies for development and release of drugs and 

vaccines to combat AIDS; 

(8) assess the progression of AIDS among the general population and among 

specific risk groups; (9) study legal and ethical issues relating to 

AIDS; and (10) review the role of the United States in the inter- 
national AIDS pandemic. 

The heads of Executive departments and agencies, to the extent permitted by 
law, shall provide the Commission, upon request, with such information as 
it may require for purposes of carrying out its functions. 

STRUCTURE 

The Commission shall consist of thirteen members appointed or designated by 
the President. Members shall be distinguished individuals who have 
experience in such relevant disciplines as medicine, epidemiology, viro- 
logy, law, insurance, education and public health. The President shall 
designate a Chairman from among the members of the Commission. 

Members shall be invited to serve for the life of the Commission. 

The Office of the Secretary of Health and Human Services, subject to the 
availability of appropriations, shall provide the Commission with such 
administrative services, funds, facilities, staff, and other support ser- 
vices as may be necessary for the performance of its functions. 

Responsibility for management and support services shall be provided by the 
Office of the Secretary, Department of Health and Human Services. 

MEETINGS 

Meetings shall be held as often as necessary at the call of the Chairman 
with the advance approval of a Government official, who shall also approve 
the agenda. A Government official shall be present at all meetings. 

Meetings shall be open to the public except as determined otherwise by the 
Secretary of Health and Human Services; notice of all meetings shall be 
given to the public. 

Meetings shall be conducted, and records of the proceedings kept, as 
required by applicable laws and Departmental regulations. 

COMPENSATION 



Members of the Commission may receive compensation for their work on the 
Commission at the daily rate specified for GS-18 of the General Schedule. 
While engaged in the work of the Commission, members appointed from among 
private citizens of the United States, to the extent funds are available, 
may be allowed travel expenses, including per diem in lieu of subsistence, 
as authorized by law for persons serving intermittently in the government 
service (5 U.S.C. 5701-5707). 



194 



ANNUAL COST ESTIMATE 

Estimated annual cost for operating the Commission, including compensation 

and travel expenses for members but excluding staff support, is $950,000. 

Estimate of annual man-years of staff support is 8, at an estimated annual 
cost of $400,000. 

REPORTS 

The Commission shall make a preliminary report to the President not later 
than 90 days after the date the members of the Commission are first 
appointed or designated. The Commission shall submit its final report no 
later than 1 year from the date of Executive Order 12601. 

TERMINATION DATE 



Unless renewed by appropriate action prior to its expiration, the 
Presidential Commission on the Human Immunodeficiency Virus Epidemic shall 
terminate 30 days after submission of its final report to the President. 

APPROVED 

This Charter is being approved by the Secretary of Health and Human Services 
pursuant to the authority delegated to him by the President in Executive Order 
12601. 



^f^t^-t, ^ Gr- 





atis R. Bowen, M.D. 
Secretary 



195 



Appendix J 



GLOSSARY 

affective pertaining to a feeling or mental state. 

AIDS Treatment Evaluation Unit (ATEU) original name of the AIDS Clinical Trial 
Groups, established by National Institute of Allergy and Infectious Diseases to test 
new AIDS-related drugs. 

AIDS Clinical Trial Group (ACTG) experimental drug testing system administrated 
by National Institute of Allergy and Infectious Diseases. Also, one of the 35 medical 
centers in the group. 

animal models trials done in animals prior to human studies. For example, tests of 
various substances in standardized genetic strains of mice or the tests of HIV vaccine 
in chimpanzees. 

antibody a molecule produced in response to antigen which has the particular proper- 
ty of combining specifically with the antigen which induced its formation. 

antigen a molecule which induces the formation of an antibody. 

aseptic meningitis inflammation of the membranes that envelop the brain and spinal 
column caused by a viral agent. 

autologous transfusion blood transfusion in which the patient receives his or her own 
blood. 

basic research research in the basic or pure sciences. Not product-oriented. 

candidiasis yeastlike fungus infection. A common opportunistic infection. 

clinical trials studies in human subjects. 

co-factors those factors which can influence an individual's likelihood of becoming ill 
or influence the progression of disease. Commonly cited HIV-related co-factors in- 
clude a history of intravenous drug abuse, and presence or history of sexually trans- 
mitted diseases or other immunocompromising conditions. 

cohort studies studies that follow groups of similar individuals over time, noting who 
develops a disease and who does not, and comparing these two groups at the end of 
the study to determine co-factors and other elements that may influence outcome. 
Cohort studies of gay men in San Francisco have determined that behavior modifica- 
tion can influence incidence of HIV infection, and reduce the number of new cases. 

crystallography the study of crystal structure. Used to study the structure of crystal- 
lized viruses. 

cytomegalovirus one of a group of herpes viruses that infect man, monkeys, and 
rodents. 

dementia general designation for mental deterioration. 

DNA (deoxyribonucleic acid) basic genetic material. A nucleic acid found chiefly in 
the nucleus of living cells that is responsible for transmitting hereditary characteristics. 

197 



double blind trials see placebo controlled trials. 

ELISA acronym for "enzyme-linked immunosorbent assay," a test used to detect 
antibodies against HIV. 

epidemiology study of the relationships of the various factors determining the fre- 
quency and distribution of diseases in a human environment. 

etiology study of the factors that cause disease. 

genome the genetic "endowment" of an organism. A complete set of chromosomes. 

GP 120 glycoprotein on the surface of HIV and a target for several potential vaccines. 

Hodgkin's disease a chronic progressive disease of unknown etiology that is charac- 
terized by inflammatory enlargement of the lymph nodes, spleen, and often liver and 
kidneys. 

hospice establishment or program which cares for the physical and emotional needs 
of terminally ill patients. 

HTLV human T-cell lymphotropic virus. This is the family of viruses to which HIV 
belongs. 

immunology the medical study of the immune system. 

immunomodulators drugs which alter the state of immune system, usually to improve 
response. 

immunosuppression artificial prevention or diminution of the immune response. 

in vitro "in glass", observable in a test tube. 

IND (investigational new drug) status of a drug after approval for use in clinical trials 
but before approval for marketing. 

institutional review board (IRB) committee within a hospital or other institution 
through which all new research protocols and projects must pass. IRBs are comprised 
of physician members of each medical service, nurses, administrators, and patient 
representatives. They check to see consent forms are properly worded, all procedures 
are properly followed, etc. 

intervention (in behavior modification research) those techniques or devices by which 
one behavior is interrupted and another, presumably healthier, behavior is instituted. 

Kaposi's sarcoma a cancer or tumor of the blood and/or lymphatic vessel walls. It is a 
common opportunistic infection in HIV infection. 

LAV (lymphadenopathy-associated virus) the name given by French researchers to the 
first reported isolate of the retrovirus now known to cause AIDS. 

lentivirus a virus that can cross the blood/brain barrier, destroy brain tissue, and 
remain in the body in a chronic sub-clinical state for long periods. HIV is a lentivirus 
that causes forms of mental incapacity in an estimated 70 to 80 percent of patients, 
and end-stage dementia in many. Lentiviruses persist in the body by evading natural 
defense mechanisms. In animals, the chronic state is common. In this state, animals 
infected with a lentivirus are "carriers" and may not get sick themselves for a long 
time, but can transmit the virus to other animals. 

look-back program program that attempts to identify recipients of blood from a 
donor who is later found to be HIV antibody positive. 

lymphadenopathy disease of the lymph nodes. 

lymphocyte white blood cells, some of which are involved in the immune response. 

198 



lymphoma any of the various cancers of the lymphoid tissue. 

magic bullet in theory, a single drug that can knock out a particular malignant cell or 
other disorder without any toxicity. 

microbiology science which deals with the study of microorganisms, including bacte- 
ria, fungi, and viruses. 

molecular biology field of biology in which biological systems are analyzed in terms 
of the physics and chemistry of their molecular components. 

monoclonal derived from a single cell. 

morbidity frequency of disease occurrence in proportion to the population. 

mortality frequency of number of deaths in proportion to the population. 

myelopathy pathological changes in the bone marrow. 

NDA New Drug Application. After clinical trials are completed, an NDA is filed with 
the Food and Drug Administration so that the drug may be placed in the market. 

oncovirus sub-family of retroviruses that includes tumor-causing agents. 

opportunistic infection an infection caused by an organism that rarely causes disease 
in persons with normal immune systems but attacks immunosuppressed patients. 
Infections common in patients with AIDS include toxoplasmosis, Pneumocystis carinii 
pneumonia, cytomegalovirus, and tuberculosis. 

orphan drugs drugs designated for use in diseases with annual patient incidence of 
200,000 or less, or for which the company is not expected to be able to make a profit. 
Tax benefits and market exclusivity accompany orphan drug status. 

P-3 biosafety level applicable to clinical, diagnostic, teaching, research, or production 
facilities in which work is done with agents which may cause serious or potentially 
lethal reactions as a result of exposure by inhalation. Practically, there must be special 
airflows and filters, an antechamber with sink, protective garments must always be 
worn, and nothing may be taken out of the room without being sterilized. 

parenteral taken into the body other than through the digestive tract, as by intrave- 
nous or intramuscular injection. 

pathogenesis the development of morbid conditions or of disease, more specifically, 
the cellular events and reactions and other mechanisms occurring in the development 
of disease. 

perinatal occurring near the time of birth. 

peripheral neuropathies functional disturbances and/or changes in the peripheral 
nervous system. 

persistent generalized lymphadenopathy (PGL) a condition characterized by swollen 
glands that remain enlarged despite the absence of known current illness or drug use. 

pharmacology science which deals with the study of the action of drugs on living 
systems. 

placebo an inactive substance used as a control in an experiment. 

placebo controlled trials clinical trials in which patients are randomized to one 
treatment group or another. One group of the trial participants receive the study drug 
and the other half receive a placebo. In double blind studies, neither the patient nor 
the physician knows if the patient is getting the drug or the placebo. This is done to 
eliminate the "placebo effect," the early positive response of almost all patients to 
receiving any therapy. 

199 



Pneumocystis carinii pneumonia opportunistic infection most frequently diagnosed 
in patients with AIDS. Caused by a parasite commonly present in the normal popula- 
tion, Pneumocystis carinii infection is life-threatening in immunosuppressed patients. 

polyclonal derived from different cells. 

principal investigator lead scientist running a study or lead doctor running a clinical 
trial. 

psychobiology interactions between body and mind in the formation and functioning 
of personality. 

psychosocial associated with the systems of psychological support services — often 
needed by persons with HIV infection. 

reagent substance used in a chemical reaction to detect, examine, measure, or 
produce other substances. In virology, strains of HIV are reagents. 

recombinant DNA DNA prepared through laboratory manipulation in which genes 
from one species of an organism are transplanted or spliced to another organism. 

retrovirus one of a group of viruses that have RNA as their genetic code and have the 
ability to copy that RNA into DNA and incorporate it into an infected cell. 

reverse transcriptase an enzyme produced by retroviruses that allows them to 
produce a DNA copy of their RNA. This is the first step in their natural cycle of 
reproduction. 

RNA (ribonucleic acid) basic genetic material. A nucleic acid associated with the 
control of chemical activities inside a cell. 

sero- prefix referring to blood serum. 

seroconversion the initial development of antibodies specific to a particular antigen. 

serologic pertaining to blood serum. 

seropositive condition in which antibodies to a specific antigen are found in the 
blood. 

seroprevalence prevalence based on blood serum tests. 

serostatus condition of the blood — infected or uninfected. 

shooting gallery location where drug addicts meet to "shoot" intravenous drugs, 
often sharing needles. 

STDs sexually transmitted diseases. 

surveillance process of monitoring public health conditions such as epidemics. Passive 
surveillance monitors conditions through the receipt of reports; active surveillance 
employs investigative techniques. 

syndrome pattern of symptoms and signs, appearing one by one or simultaneously 
that together characterize a particular disease or disorder. 

T-cell cell that matures in the thymus gland. T-lymphocytes are found primarily in the 
blood, lymph, and lymphoid organs. Subsets of T-cells have a variety of specialized 
functions within the immune system. 

T4 cell count measure of the state of the immune system based on the number of T4 
lymphocytes present in the blood. 

treatment use regulations Also: compassionate use. Process by which a drug company 
applies to the Food and Drug Administration, in special cases, to distribute drugs to 
the desperately ill even though the drug has not been approved for use outside a 

200 



clinical trial. In some cases, this also applies to drugs that have been approved for use 
but not for the disease for which it is being requested. A change in the rules in June 
1987 allowed for the release of such drugs earlier than usual for AIDS, but to date, 
only one has been so used. 

virology study of viruses and virus diseases. 

Western blot blood test that involves the identification of antibodies against specific 
protein molecules. This test is more specific than the ELISA test in detecting anti- 
bodies to HIV in blood samples. It is used as a confirmatory test for positive ELISA 
samples. The Western blot requires more sophisticated lab technique than the ELISA 
and is more expensive. 



The Commission acknowledges the work of the National Academy of Sciences in 
Confronting AIDS, which was invaluable in the preparation of this glossary. 



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