Review of the Public Health Service's

Response to AIDS

February 1985

NTIS order #PB85-246668
Recommended Citation:

Review of the Public Health Service’s Response to AIDS (Washington, DC: U.S. Congress,

Office of Technology Assessment, OTA-TM-H-24, February 1985).

Library of Congress Catalog Card Number 85-600510

For sale by the Superintendent of Documents

U.S. Government Printing Office, Washington, DC 20402
Foreword

This memorandum was prepared in response to a request by the Subcommittee

on Health and the Environment, House Committee on Energy and Commerce, and the

Subcommittee on Intergovernmental Relations and Human Resources, House Committee

on Government Operations. The Office of Technology Assessment (OTA) had been

conducting an assessment of Blood Policy and Technology (published in January 1985)

for the House Committee on Energy and Commerce when transfusion-related cases of

acquired immunodeficiency syndrome (AIDS) began to appear. We were subsequently

asked to review the recent and proposed activities of the Public Health Service (PHS)

in response to AIDS, and to evaluate the planning, resources and staffing of PHS’s efforts to control AIDS.

OTA was asked to examine both technical aspects of research and related issues

of public health policy, in particular:

● the adequacy of PHS’s confirmation of the causal relationship between the newly

discovered retrovirus HTLV-III and AIDS and the adequacy of research to identify other possible agents involved;

● the adequacy and timeliness of PHS’s redirection of general AIDS research toward

HTLV-III work, including research on blood, on treatment protocols, on animal models, and on epidemiological work;

● the adequacy and scope of efforts to develop

● the adequacy and timeliness of the distribution

tion among researchers and regulators; and

● the adequacy of PHS resources to support needed activities that would yield the

best chances for immediate results in the prevention and treatment of AIDS.

vaccines against the disease;

of new knowledge and informaThese questions and related issues of science and public policy are addressed in

this memorandum.

. . .

I l l
OTA Project Staff—Review of the Public Health Service’s

Response to AIDS

Roger C. Herdman, Assistant Director, OTA

Health and Life Sciences Division

Clyde J. Behney, Health Program Manager

Lawrence H. Miike, Project Director

Denise M. Dougherty, Analyst

Jeffrey Stryker, Research Analyst

Anne Guthrie, Research Analyst

Kerry Britten Kemp, Health and Life Sciences Division Editor

Virginia Cwalina, Administrative Assistant

Rebecca I. Erickson, P. C./Word Processing Specialist

John Bell, Senior Systems Integration Analyst
Contents

Chapter Page

1.

2.

SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

The Biology of AIDS.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Federal Support of AIDS Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Related Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

SPECIFIC FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Is There an Adequate Correlation Between HTLV-III and AIDS?. . . . . . . . . . . . . . . 13

How Has the Public Health Service Redirected Its AIDS Research

Toward HTLV-III Work? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Blood Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Epidemiologic Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Treatment Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Animal Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

What About Efforts To Develop an AIDS Vaccine? . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Subunit Vaccine From Cultured Virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Recombinant DNA Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Infectious Recombinant Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Anti-Idiotype Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Prospects for a Successful Vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Has the Distribution of New Information Among Researchers and

Regulators Been Adequate and Timely? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

NCI and CDC Sharing of HTLV-III Culture Samples . . . . . . . . . . . . . . . . . . . . . . . 28

DHHS Announcement of the Discovery of HTLV-III . . . . . . . . . . . . . . . . . . . . . . . 28

Funding of Extramural Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Federal Policy on Commercial Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

How Adequate Are PHS’s Resources Devoted to AIDS Prevention

and Treatment? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Specific Funding for AIDS Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Funding for the PHS Agencies as a Whole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

How AIDs and Other Activities Have Been and Will Probably Be Affected

by Funding Patterns.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Measures To Increase the Number of Extramural Research Projects . . . . . . . . . . 41

Resources for Research on Cofactors and Treatment and

for Public Education. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

PHS View and OTA Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Related Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Confidentiality and Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Prevention Through Education . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Financing of Clinical and Supportive Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Appendixes Page

A.

B.

c.

Acknowledgments and Health Program Advisory Committee . . . . . . . . . . . . . . . . . 57

PHS Organization Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

OASH Summary of Individual PHS Agencies’ Obligations for

Specific AIDS Activities, Fiscal Years 1984 and 1985 . . . . . . . . . . . . . . . . . . . . . . . . 64

vii
Contents—Continued

Appendixes Page

D.

E.

F.

Individual PHS Agencies’ and OASH Office of Public Affairs’

Anticipated AIDS-Related Grants and Activities, Fiscal Year 1985

and NIH AIDS Projects Funded in Fiscal Years 1983 and 1984 . . . . . . . . . . . . . . . . 77

A Partial List of Organizations Involved in AIDS Lobbying,

Public Education, Prevention, or Social Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Glossary of Acronyms and Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

List of Tables

Table No. Page

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

. . . Vlll

History of AIDS Funding, Fiscal Years 1982 to 1985., . . . . . . . . . . . . . . . . . . . . . . . 32

PHS Agencies’ Estimated Obligations for AIDS Activities in Fiscal Year 1984. . . 34

Supplemental Funds for PHS Agencies’ AIDS Activities in Fiscal Year 1984:

Agencies’ Indications Compared to Congressional Appropriations . . . . . . . . . . . . . 34

Amounts Identified for PHS Agencies’ AIDS Activities for Fiscal Year 1985:

President’s Budget Request Compared to Congressional Appropriations or

Estimated Actual Obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Centers for Disease Control: Initial U.S. Budget Request Compared to

Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985 . . . . . . 36

Centers for Disease Control: Overall Agency Budgets and AIDS Budgets,

Fiscal Years 1979 to 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Food and Drug Administration: Initial U.S. Budget Request Compared to

Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985 . . . . . . 37

Food and Drug Administration: Overall Agency Budgets and AIDS Budgets,

Fiscal Years 1979 to 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

National Institutes of Health: Initial U.S. Budget Request Compared to

Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985 . . . . . . 37

Alcohol, Drug Abuse, and Mental Health Administration: Initial U.S. Budget

Request Compared to Estimated Budget Authority for Previous Year,

Fiscal Years 1983 to 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Alcohol, Drug Abuse, and Mental Health Administration: Overall Agency

Budgets and AIDS Budgets, Fiscal Years 1982 to 1985 . . . . . . . . . . . . . . . . . . . . . . . 38

Health Resources and Services Administration: Initial U.S. Budget Request

Compared to Estimated Budget Authority for Previous Year,

Fiscal Years 1983 to 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

National Institute of Allergy and Infectious Diseases: Redistribution Needed

To Fund Fiscal Year 1985 AIDS Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

National Cancer Institute: Estimated Redistribution Needed To Fund

Fiscal Year 1985 AIDS Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

National Institutes of Health: Award Rates and Paylines for All Extramural

Research Compared to AIDS Extramural Research, Fiscal Year 1983. ..,.,... . . 42

Changes in Funding for PHS AIDS Activities Anticipated After Discovery of

AIDS Etiologic Agent.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Funding for PHS AIDS Activities by Type of Activity,

Fiscal Years 1984 and 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Funding for PHS AIDS Activities by Type of Activity and Agency,

Fiscal Years 1984 and 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Chapter 1

Summary
Chapter 1

Summary

The basic cause of acquired immunodeficiency

syndrome (AIDS) is almost certainly a newly discovered virus, human T-cell lymphotropic virus,

type III, or “HTLV-III.” Researchers who have

isolated viruses similar to HTLV-III have given

their isolates other descriptive names, such as

“lymphadenopathy-associated virus” (LAV) or

“AIDS-related virus” (ARV), but these isolates

and HTLV-III are essentially the same.

The AIDS virus preferentially infects and destroys certain white blood cells called “T lymphocytes” that are essential for the functioning of

the body’s immune system. When the immune

system is severely depressed or destroyed by

HTLV-III, other infectious agents such as bacteria or other types of viruses that usually do not

cause disease in persons with normal immune

functions may have the opportunity to cause disease (“opportunistic infections”) because of the

body’s weakened defenses. Different types of cancer may also occur with severe depression of the

immune system by HTLV-III infection. The cause

of these cancers is not certain, but it may be a

combination of depressed immune functions and

infection with other viruses, or perhaps involve

infection by the HTLV-III virus itself.

As more has been learned about the ability of

HTLV-III to cause disease, it has become apparent that a broad spectrum of clinical responses can

occur. Some people have been infected and shown

few or no immunologic abnormalities and no

evidence of illness, others have had severe effects

on their immune systems and developed fulminant and fatal AIDS, while others have manifested

responses between these two extremes. Associated

risk factors are under examination and will help

in understanding why some people exposed to

HTLV-III remain well while others progress to different stages of clinical illness. Since AIDS is a

newly discovered disease and the time between

exposure and the onset of clinical disease can take

several years, it is too soon to tell what percentage of persons exposed to the virus will develop

AIDS. It is also too soon to tell whether persons

exhibiting milder manifestations of disease (e.g.,

fever, some depression of immune functions,

enlarged lymph nodes) will eventually develop

AIDS, continue to exhibit signs and symptoms of

mild disease, or get well.

Prior to the discovery of the etiologic (causative) agent for AIDS, efforts to devise preventive

and treatment strategies had to depend on empirical observations of AIDS’s epidemiology and

effects on the body. The discovery of HTLV-III

now provides a theoretical foundation which

greatly expands the range of possible strategies

to prevent, diagnose, and treat AIDS. It is important to recognize, however, that the discovery of HTLV-III only begins the next phase of efforts to control AIDS, Thus, it remains to be seen

whether the new knowledge that is gained can be

used to develop effective drugs and vaccines

within a few years. Meanwhile, the number of

persons infected with the virus and the number

of AIDS cases continue to grow rapidly.

The activities of the U.S. Public Health Service (PHS) have laid down most of the foundation

for addressing the AIDS epidemic. PHS grantees

“discovered” AIDS as a syndrome; PHS has conducted surveillance of AIDS; and PHS investigators and others have made significant scientific

advances, including the discovery of the probable

etiologic agent for AIDS. PHS is currently coordinating development of a blood test for HTLV-III

antibodies; and research on AIDS treatment, vaccine development, and the many remaining questions about the natural history of the disease is

progressing. Furthermore, PHS investigators at

present are extensively involved in collaborations

with non-Federal researchers, both nationally and

internationally. It has not always been clear, however, that the amount of support for AIDS activ3
4

ities has been equivalent to the effort that indi- ment—prevention of AIDS through education,

vidual researchers and PHS agencies believe is nec- confidentiality and informed consent for research

essary. Furthermore, there are issues that extend and blood donation, and support for the clinical

beyond the biological nature of AIDS which war- and financial needs of AIDS patients.

rant more attention from the Federal GovernTHE BIOLOGY OF AIDS

When the code contained in the DNA (deoxyribonucleic acid) of a cell’s genes is to be “translated” to produce a product such as a protein, an

RNA (ribonucleic acid) copy of the relevant piece

of DNA is “transcribed,” and the RNA copy then

travels to the cell’s production site, where it serves

as a template for protein production. Collectively,

this process is termed “gene expression. ”

HTLV-III belongs to a group of viruses called

“retroviruses,” which are so named because they

can reverse the process of gene expression when

they infect cells. Retroviruses contain RNA, not

DNA, but reproduce by incorporation into the

DNA of the cells they infect. In order to be incorporated into a host cell’s DNA, the retroviral

RNA must be transcribed into its DNA counterpart. An enzyme that the retrovirus produces,

called “reverse transcriptase, ” accomplishes this

process. When the retrovirus is ready to reproduce, it initiates the normal process of gene expression whereby DNA is transcribed into RNA

but at a greatly accelerated rate, spewing out

copies of the retrovirus in its original RNA form.

HTLV-III attacks what is commonly referred

to as the “helper/inducer” subset of T lymphocytes, or, more accurately, the “T4” subset. T lymphocytes are classified into various subsets. One

method of classification distinguishes between T

cells that function to “help” and T cells that function to “suppress” immune functions as the immune system is activated and then is fine-tuned

when the body is invaded by foreign materials.

T lymphocytes can also be classified by the different molecules on their cell surfaces through the

use of monoclinal antibodies that recognize each

type of surface molecule as a separate and unique

antigen. One such classification system separates

T lymphocytes into those that have “T4” and

those that have “T8” molecules on their surface

(named after the monoclinal antibodies used to

distinguish between these two types of surface

molecules or antigens). Functional and surface

molecule methods of classification result in

overlapping categories. Commonly, however,

even though both the “T4” and “T8” subsets contain cells that help and cells that suppress immune

responses, the “T4” subset is referred to as the

“helper/inducer” subset of T lymphocytes, and

the “T8” subset, as the “suppressor” subset.

The primary defect in AIDS is an acquired, persistent, quantitative, and functional depression of

T4 lymphocytes. The T4 cell membrane molecule

that defines the T4 subset of T lymphocytes is now

known to be an essential component of the cellsurface receptor for HTLV-III; i.e., interaction between the HTLV-III virus and the T4 molecule is

apparently the way in which the virus gains entry into the cell.

The T4 molecule can be found not only on T4

lymphocytes but also on some other types of

white blood cells that perform a scavenging or

phagocytic function by engulfing foreign material and consuming debris and foreign bodies. This

observation raises the question of whether these

other white blood cells may also become infected

with HTLV-III. Furthermore, brain cells and T

lymphocytes are known to share some common

c-en ‘surface molecules, and recent evidence has

shown that the brain of an AIDS patient can be

infected and the virus reproduced there. Infection

of the brain would further complicate future treatment prospects because of the general difficulty

in getting drugs into the central nervous system.

The availability of various tests for HTLV-III

should result in a more precise delineation of the

natural history of AIDS. Studies of different

populations at risk, their variations in associated
5

risk factors and in clinical responses upon exposure to HTLV-III, are of immediate relevance

to our understanding of how the disease spreads,

preventive strategies, and the possibility of early

treatment. For example, the human immune system will produce antibodies to whatever antigens

are encountered, so the mere presence of antibodies to HTLV-III does not necessarily mean

that the types of antibodies that will neutralize

the virus have been produced. By studying persons who are at high risk for AIDS but who have

not developed the disease, scientists may discover

which of the several antibodies that are produced

in response to infection with HTLV-III might neutralize the virus.

Production of antibodies upon exposure to

HTLV-III is also the basis for a blood test that will

be used initially for screening blood donations and

plasma collections. It is now known, however,

that some persons can be infected with the virus

but have no current symptoms of disease and not

produce antibodies. The blood test for antibodies

to HTLV-III, therefore, will not replace screening procedures designed to exclude potential blood

donors in groups at high risk for AIDS. Because

of current technical capabilities, the first-generation blood test relies on detection of antibodies

to HTLV-III instead of detection of the virus itself

(or its parts). Large quantities of HTLV-III can

now be grown and used as the antigen to detect

antibodies in tested blood. Methods to mass produce antibodies to detect the presence of viral antigens in tested blood, however, have yet to be

developed.

Use of the blood test raises difficult issues pertaining to informed consent and confidentiality,

because the meaning of a positive test, other than

evidence of exposure to HTLV-III, is uncertain.

Does a positive result mean that a person who

has antibodies to the virus is also infected with

it? This question can be answered on a case-bycase basis by a few researchers who have the capability to test for the presence of the virus, but

the capacity to perform such tests routinely has

yet to be developed. What are the chances that

an antibody-positive person will develop AIDS?

The answer to this question will only come after

long-term monitoring of persons who are HTLV111 antibody-positive.

The discovery of HTLV-III makes possible the

tentative confirmation that newer methods of preparing antihemophilic factors from plasma can inactivate the virus. Some plasma protein products,

such as albumin, are already heated to temperatures that inactivate most viruses without causing these products to lose their activity. However,

the coagulation proteins are not as resilient in preserving their activity when heated. Improvements

in heat treatment using buffers to protect the proteins during heating, however, have recently been

shown to inactivate some viruses, and with the

availability of HTLV-III for testing, these new

methods and further improvements on them have

been shown to inactivate HTLV-III. (The cellular

elements of blood that are used in transfusions—

red blood cells and platelets—and fresh plasma,

would be destroyed by the temperatures necessary to inactivate HTLV-III.)

The discovery of HTLV-III also makes possible the development of more specific therapeutic

approaches to AIDS. Cultures of T lymphocytes

mixed with HTLV-III can be used to test drugs

that might inhibit infection by HTLV-III. At least

three drugs, suramin, ribavirin, and HPA-23,

have been shown to inhibit infection by blocking the action of the reverse transcriptase enzyme

and are now being tested in limited clinical trials.

More importantly, the life cycle of the virus is

now under study, and theories based on the

understanding gained will lead to multiple therapeutic approaches. Thus, for example, the experiments leading to the discovery that the T4

molecule on T4 lymphocytes was an essential

component of the cell-surface receptor for HTLVIII raise the possibility of using monoclinal antibodies against the T4 molecule to block the

virus’s entry into the cell.

The development of a vaccine against HTLV111, using novel as well as established methods,

is now under way. The many unknowns associated with HTLV-III make it prudent to develop

a vaccine that does not contain the virus’s genetic

material, so current efforts are focused on finding and using the part (“subunit”) of the virus that

would elicit the proper antibody to neutralize the

virus. Current efforts to develop a “subunit” vaccine include breaking down the virus and testing

its various parts; taking the gene that corresponds
6

to the particular part of the virus under study and

inserting it through recombinant DNA techniques

into bacteria, yeast, or mammalian cells so that

the subunit can be produced in quantity; inserting the corresponding gene into other, benign

viruses (e.g., into vaccinia virus, used to immunize against smallpox) with the intention of

using those viruses as the vaccine; and developing copies of the relevant viral subunit through

novel manipulations of antigen-antibody interactions.

Despite these rapid developments in vaccine research, serious obstacles remain. The first is that

most of the newer techniques are largely experimental, the first of the vaccines from the most understood recombinant DNA techniques (i.e., a

vaccine for hepatitis B) having just become available. Second, there is evidence that the genes

which code for the parts of the virus that would

be most likely to make an effective vaccine (i.e.,

the surface membrane or “envelope” of the virus)

change frequently, although not drastically. If

these genetic mutations are significant enough that

their corresponding protein molecules change their

antigenic characteristics, it will be difficult to develop an effective vaccine.

In contrast to these promising developments in

understanding the biology of AIDS are the ever

growing number of AIDS patients and the rapidly

enlarging pool of persons who have been exposed

to HTLV-III and who may be carriers of the virus.

The total number of AIDS cases reported to the

Centers for Disease Control (CDC) by the end of

1984 was approximately 7,000, and the number

of reported cases has been doubling every year—

fewer than 900 cases prior to December 1982,

more than 2,000 cases in 1983, and almost 4,000

cases in 1984. Seventy-three percent of patients

diagnosed before January 1983 have died. Forty

thousand new cases are expected to be reported

in the United States in the next 2 years. Furthermore, surveys of high-risk groups (gay men, intravenous drug abusers, hemophiliacs) for the

presence of antibodies to HTLV-III in their blood

have shown marked increases in positive rates

since about 1980, with current positive rates between 65 and 90 percent in some of the tested populations.

AIDS is not only a problem in the United

States. There are at least 500 cases in the rest of

the Americas, 600 in Europe, and several thousand in central Africa. In some parts of central

Africa, where infection with the HTLV-III virus

appears to predate infections in the United States,

heterosexual transmission appears to be common

and may be the predominant mode of transmission. Heterosexual transmission has occurred in

the United States, but is still relatively uncommon

and has been primarily from males to their female

partners, particularly in the intravenous drug

abuser group. A significant portion of U.S. female

intravenous drug abusers practice prostitution,

and the possibility of increased female-to-male

transmission and risks associated through contacts

with prostitutes are under study.

Thus, while significant advances in understanding the biology of the AIDS virus are occurring

and may lead to effective therapeutic drugs and

a vaccine, the number of persons exposed to the

virus and probably carrying it and the number

of AIDS cases continue to increase at an accelerated pace.

FEDERAL SUPPORT OF AIDS RESEARCH

The U.S. Department of Health and Human AIDS activities have come at the initiative of ConServices (DHHS) has designated AIDS as its num- gress, not from DHHS. Personnel ceilings have

ber one health priority, and much of what we been a special problem.

know about the biology of AIDS is a result of federally sponsored activities. However, the Depart- Although AIDS funding has been substantial,

ment’s position has been that funds for AIDS ac- particularly in fiscal years 1984 and 1985, the histivities should be transferred from other PHS tory of specific funding for AIDS has been marked

activities, and increases in funding specifically for by tension among the individual PHS agencies,
7

DHHS, and Congress. Through the Assistant Secretary for Health, individual PHS agencies have

consistently asked DHHS to request particular

sums from Congress; the Department has submitted requests for amounts smaller than those

suggested by the agencies; and Congress typically

has appropriated amounts greater than those requested by the Department. Except when prodded

by Congress, the Department has maintained that

PHS agencies should be able to conduct AIDS research without extra funds. However, threatened

cuts in overall funding and personnel levels have

restricted the ability of affected agencies to redirect

resources. Of greater impact than holding general

funding of PHS agencies about even or decreasing it have been budget requests for decreases in

personnel ceilings. At critical times, several of the

PHS agencies have actually experienced decreases

in personnel.

PHS agencies have been unable to plan their

activities adequately because they have not

known how much funding and staff will be available to them. Furthermore, the uncertain distribution of resources has intensified competition

among agencies now that an etiologic agent for

AIDS has been discovered and there are many directions for research to take concurrently (e.g.,

treatment, vaccine development, cofactor research, natural history studies) and several areas

in which agencies have overlapping expertise.

In addition to the question of whether or not

sufficient resources are being allocated to PHS

agencies’ AIDS activities by DHHS and Congress,

there remains the question of whether resources

are being allocated adequately to the various

AIDS activities. In particular, doubts have been

raised about the adequacy of resources devoted

to the search for factors affecting transmissibility,

the provision of treatment, and prevention through

public education.

In general, the search for factors affecting the

development of AIDS has always accounted for

a large proportion of the AIDS budget. For both

fiscal years 1984 and 1985, greater amounts were

budgeted for cofactor research and epidemiologic

studies after the discovery of HTLV-III than before

its discovery. PHS estimates that 12.6 percent of

the resources allocated to AIDS in fiscal year 1984

were obligated to cofactor research and 31.9 percent to epidemiologic studies. In fiscal year 1985,

a relatively greater proportion (14.9 percent) of

total AIDS resources will be obligated to cofactor research, but substantially less as a percentage of the total (26 percent) will be obligated to

epidemiologic studies than in fiscal year 1984. In

total dollars, however, almost $5 million more

will be obligated to epidemiologic studies in fiscal

year 1985 than in fiscal year 1984, and $6 million more to cofactor research.

About 2. I percent of the AIDS budget for fiscal

year 1985, or nearly $2 million, is being spent for

research on psychosocial factors related to AIDS.

As defined by PHS, this category includes research into the psychosocial consequences of

AIDS as well as research into the contribution of

these factors to the development of AIDS. Psychosocial risk factors include life stress, exhaustion,

health habits, depression, anxiety, coping mechanisms, a sense of helplessness, and the loss of

social support.

Approximately 14.8 percent of the AIDS budget for fiscal year 1985 is devoted to research on

treatment (8.8 percent for the etiologic agent, and

6 percent for opportunistic infections). Except for

treatment given to AIDS patients at the National

Institutes of Health’s Clinical Center, which is a

research hospital, no funds have been allocated

to the treatment of patients per se.

In the past, relatively few funds were allocated

to public education. Between 1984 and 1985, however, the amount allocated to such activities more

than doubled, from $1.4 million to $3.8 million,

most of it for CDC. The AIDS budget in PHS’s

Office of Public Affairs, which has maintained the

AIDS hotline, the Facts About AIDS newsletter,

and developed booklets and a videotape about

AIDS, is scheduled to decrease from $200,000 in

fiscal year 1984 to $120,000 in fiscal year 1985.

Whether information about AIDS has been generated and disseminated on an adequate and

timely basis has also been a cause of recurrent concern. The involvement of multiple organizations

in similar research activities but addressed at different aspects of a common problem is arguably

the best scenario for research. However, it means
8

that researchers are constantly striving to keep

abreast of the work of others.

In addressing AIDS, sharing of information has

taken place through the informal networks that

exist among PHS agencies and among their researchers and has been augmented by coordinating committees, external advisory committees,

conferences, and cooperative agreements on funding extramural research and conducting intramural research. Most of these sharing and coordinating activities would have taken place

regardless of any directive from PHS central management. In some instances, however, PHS (or

departmental level) guidance might have led to

better coordination—e.g., PHS might have directed the National Cancer Institute to share virus

cultures with CDC. Finally, the announcement by

the Secretary of DHHS of the discovery of the

etiologic agent for AIDS appears to have been too

optimistic regarding the use of a blood test to

screen for exposure to HTLV-III and did not take

into account the social implications and ethical

dilemmas that would have to be addressed when

persons who might be carriers of the HTLV-III

virus were identified through a blood test.

Two factors which may have impeded the generation and dissemination of information are matters of more generalizable policy concerns. First,

in the context of a public health emergency such

RELATED ISSUES

It will be some time before the new knowledge

that has been gained about AIDS can be expected

to be translated into effective preventive and therapeutic interventions. In the interim, and probably even if biological remedies for the disease become available, prevention of AIDS through education about ways of minimizing exposure to

HTLV-III has the greatest potential of limiting the

spread of this disease. So far, efforts to prevent

AIDS through education have received minimal

funding, especially efforts targeted at the groups

at highest risk.

The issues of confidentiality and informed consent, first arising in the context of treatment of

AIDS patients and participation in AIDS-related

as AIDS, the Federal grants application and approval process for extramural research works too

slowly. Second, although private industry is involved in similar research and development activities, Federal regulations concerning commercial

development of drugs, biologics, and devices

mean that much of the information generated is

not available to other researchers. A systematic

examination of these more generalizable concerns

is needed.

Thus, OTA finds that while the Federal Government has designated AIDS our country’s number one health priority, increases in funding specifically for AIDS activities have come at the

initiative of Congress, and PHS agencies have had

difficulties in planning their AIDS-related activities because of uncertainties over budget and personnel allocations. Furthermore, in some instances, coordination between PHS researchers

and between DHHS policy makers and PHS researchers could have been better managed. Two

general questions that need further examination

are: 1) how Federal research funding can be accelerated in public health emergencies without

compromising the quality of research to be supported, and 2) how access to commercially sponsored research might be improved without infringing on the property rights of commercial enterprises.

research projects, will soon be a major concern

as tests for evidence of exposure to or infection

by HTLV-III become generally available. Confidentiality safeguards can be improved without

sacrificing the surveillance needs of public health

officials or data sharing among researchers. Informed consent will bean especially difficult issue,

because the first tests to be applied will detect exposure to HTLV-III through the presence or absence of antibodies. However, persons who test

positive will not be able to know whether they

are actually carriers of HTLV-III, will develop

AIDS, or will remain well. These developments

portend even more widespread and serious implications for our country’s public health and

social policies. Decisions will have to be made
9

soon that attempt to balance the public health

concerns surrounding the transmissibility of AIDS

from persons who have antibodies against HTLV111 versus the stigma that may attach to these persons, which could lead to their exclusion from

some occupations and perhaps to even greater isolation from the rest of society.

Finally, providing and assisting in paying for

clinical and supportive services is already a significant problem in those areas of the country with

relatively large numbers of AIDS patients. This

situation will worsen as the number of AIDS patients increases and if new treatments prolong life

but do not restore health. To date, the Federal

response has focused on the biomedical aspects

of AIDS, so the primary responsibility for AIDSrelated activities has rested with PHS. The potential contribution of PHS agencies to the provision

and financing of service needs is severely limited

by the nature of their responsibilities. Thus, if the

Federal Government is to respond to the service

needs of AIDS patients, Federal activities will have

to expand beyond those attributable to PHS and

at a minimum involve other organizational units

within DHHS, such as the Health Care Financing Administration.
Chapter 2

Specific Findings
Chapter 2

Specific Findings

IS THERE AN ADEQUATE CORRELATION BETWEEN HTLV-III AND AIDS?

There is strong and increasing evidence that the

newly discovered retrovirus HTLV-III (human Tcell lymphotropic virus, type III) (57,122,130,132)

is the basic cause of acquired immunodeficiency

syndrome (AIDS). HTLV-III is similar to, but

nevertheless distinct from, two previously identified human T-cell lymphotropic retroviruses,

HTLV-I and HTLV-II. HTLV-I and possibly

HTLV-II cause T-cell leukemias (proliferation),

whereas HTLV-III causes T-lymphocyte death

(suppression). (Lymphocytes and other blood cells

originate in the bone marrow. T cells or lymphocytes are white blood cells that mature in the

thymus gland and mediate cellular immune reactions by helping (“helper T cells”) or suppressing (“suppressor T cells”) immune responses. B

lymphocytes or cells are white blood cells that

mediate humoral (e.g., antibody production) immune reactions and proliferate under stimulation

from factors released by T lymphocytes. )

The genetic material of “retroviruses” consists

of ribonucleic acid (RNA), not deoxyribonucleic

(DNA), but when retroviruses infect cells, they

are incorporated in the DNA of infected cells in

a DNA form known as the “provirus. ” When

retroviruses invade cells, they can reverse the

process of “gene expression” by which information contained in the cells’ genes is transcribed

from DNA to RNA and then translated to direct

the synthesis of proteins. Through the production

of the enzyme “reverse transcriptase, ” retroviruses

produce a DNA analog of their own RNA. The

resulting DNA is then incorporated in the genetic

structure of the invaded cell as the “provirus. ”

Subsequently, the genetic information in the incorporated DNA is “expressed” in the usual way

to produce new retroviruses.

HTLV-III is essentially the same virus as other

retroviruses that have been associated with

AIDS—LAV or “lymphadenopathy-associated virus” (7), IDAV or “immune-deficiency -associated

virus” (107) and ARV or “AIDS-related virus”

(89). The mild confusion that has resulted from

the giving of different names by researchers to

what appears to be the same virus is primarily

the result of scientific caution.

When a possible agent for a new disease is

reported, early published accounts provide the

details of the investigations, and the investigator

assigns a name to the agent. As Broder and Gallo

(23) have observed with respect to the viruses

associated with AIDS: “In theory, each isolate

might have been a different, newly discovered

human retrovirus presenting as an opportunistic

infection, with no bearing on the pathogenesis of

AIDS."

French investigators named their first isolate

“lymphadenopathy-associated virus” (LAV) because it was isolated from a patient with lymphadenopathy syndrome, and they named a subsequent isolate “immune-deficiency-associated

virus” (IDAV) because it was isolated from a patient with AIDS. In a later report on two other

patients, these investigators found isolates (or antibodies to them) that were similar to both LAV

and IDAV (172). Gallo and his coworkers at the

National Cancer Institute (NCI) named their

isolates “HTLV-III” because they were closely

related to, but distinct from, two other recently

discovered human T-cell lymphotropic retroviruses that Gallo and his associates had been extensively studying. Gallo and his coworkers have

now accumulated over 90 isolates of HTLV-III

from around the world (23). Finally, when Levy

and his associates published findings on their

isolate, they chose yet another name, “AIDSrelated virus” (ARV), even though they found that

it cross-reacted with antiserum to the LAV isolated

in France (89).

Investigators in a study that examined antibody

reactivity to both HTLV-III and LAV have found

the results to be identical (32). Gallo and his

coworkers have also reported that they have

found these variously named retroviruses “immunologically and morphologically indistinguish13
14

able from HTLV-III” (66). All of these isolates

have now been cloned (1,66,91), and direct comparisons of the nucleotide sequences of the genomes of the various isolates are being conducted

(56). In this memorandum, therefore, the various

isolates will be collectively referred to as “HTLV111.”

HTLV-III attacks what is commonly referred

to as the helper/inducer subset of T lymphocytes,

the cells which are attacked (depleted) in AIDS.

T lymphocytes are classified into various subsets,

two of which are T4 and T8 (named after the

monoclinal antibodies used to distinguish the antigenically distinct subsets from each other). Although T4 cells have commonly been identified

with helper/inducer functions and T8 cells with

suppressor/cytotoxic functions, both subsets contain cells that help and cells that suppress immune

responses (133).

The primary defect in AIDS is an acquired, persistent, quantitative and functional depression in

the T4 lymphocytes (45,133). Patients with lymphadenopathy syndrome have been found to have a

selective depression in a subset of T4 cells, but

to have normal numbers of cells in the subset of

T4 cells that are the major helper subset for B cell

responses (115). HTLV-III has a selective tropism

for T4 lymphocytes (80), and the immune defects

observed in AIDS are completely compatible with

the cellular defects associated with HTLV-III infections (46).

Furthermore, the T4 cell membrane molecule

that defines the T4 subset of T lymphocytes is now

known to be an essential component of the cellsurface receptor for HTLV-III; i.e., interaction between HTLV-III and the T4 cell membrane molecule is apparently the way in which HTLV-III

gains entry into the cell (39,81). These findings

strongly suggest that HTLV-III tropism depends

on the interaction of HTLV-III with the T4

molecule.

Most infectious retroviruses (including HTLV-I

and HTLV-II) use receptors common to many cell

types. HTLV-III, in contrast, appears to use the

surface receptor molecule specific to the cells (T4

lymphocytes) most affected by HTLV-III infection (39). The T4 receptor molecule can be found

on some types of white blood cells other than T4

lymphocytes. Such cells include macrophages and

monocytes, which perform a scavenging or phagocytic function by engulfing foreign material and

consuming debris and foreign bodies. These other

white blood cells may also become infected with

the virus (65a), adding to the compromised immune function in AIDS patients.

Brain cells and T lymphocytes are known to

share some common cell surface molecules, and

on the basis of this knowledge, some researchers

decided to examine whether HTLV-III can infect

brain cells. Their findings suggest that some of

the neurological abnormalities found in AIDS, instead of being caused by “opportunistic” infectious

agents or tumors, are directly caused by HTLV111 infection (135). Although the investigators

showed that infection was not due to infiltration

of the brain by HTLV-III-infected lymphocytes,

the brain cell type or types directly infected by

HTLV-III—neurons, glial cells (cells which provide the supporting tissue of the brain), or

macrophages (scavenger cells) —have yet to be

determined. The finding that HTLV-III can

directly infect brain cells and replicate in the central nervous system means that future drug treatment for HTLV-III infections will be made more

difficult because many drugs will not enter the

central nervous system if given orally or by intramuscular or intravenous injections.

HTLV-III also has unusual properties that make

it especially virulent. When a retrovirus infects

cells, its RNA is transcribed into DNA, which is

then integrated into the genome of the infected

cells. Normally, this viral DNA is present in the

cytoplasm of the infected cells only for a short

period of time before it is integrated into the cells’

genome. With HTLV-III, however, a substantial

amount of unintegrated viral DNA persists in the

cytoplasm. Although a persistence of unintegrated

viral DNA is unusual for retroviruses, when observed with certain animal retroviruses, it has

been correlated with pathological effects on the

infected cells (134).

Furthermore, when HTLV-III that is integrated

in its “provirus” form in the genome of infected

cells begins to reproduce, special viral genes direct the rate of reproduction. These special genes

have been shown to increase the rate of gene ex-
15

pression of infected cells by 100 to 1,000 times

the rate of expression of uninfected cells. Thus,

HTLV-III is a very efficient reproducer, there being a high level of virus production in HTLV-III

infections which is unusual in HTLV-I and HTLV11 infections (140).

What is now known about the cellular mechanisms associated with infection with HTLV-III is

compatible with certain characteristics in most of

the population groups that have been identified

as being at high risk for AIDS. For example, T

cells that have been activated by antigenic stimuli,

but not resting T cells, are especially prone to infection by HTLV-III (102). Homosexual and bisexual males who have frequent sexual intercourse

with multiple partners are exposed to a variety

of infectious agents that usually do not cause disease but do stimulate the immune system. Injections in intravenous drug abusers lead to stimulation of the immune system because of the injected

drugs themselves and contamination with infectious agents. Injections with Factor VIII concentrates in hemophiliacs also lead to stimulation of

the immune system.

There is also a correlation between exposure to

HTLV-III and the development of AIDS. The

HTLV-III virus has been cultured from patients

with AIDS, AIDS-related complex, and persons

at high risk for developing AIDS; HTLV-III has

been observed by electron microscopy in the T

cells of these groups; and antibodies to HTLV-III

as well as HTLV-III antigens and the genes for

HTLV-III have been isolated in these same groups.

HTLV-III can now be recovered from over 90 percent of patients with AIDS-related complex (23);

and, with the development of increasingly more

sensitive tests, antibodies to HTLV-III can be

detected in nearly all AIDS patients (77,127). In

contrast, other possible viral agents, including

HTLV-I, have been isolated in these patients at

rates which indicate that exposure to these other

viruses was only incidental and not related to

AIDS (although some of these viruses maybe the

cause of specific diseases associated with AIDS).

These results are being duplicated in countries

around the world: the United States and France

(154), France and Zaire (25,26), France (97), Britain (32,58), Denmark (103,104), Greece (118),

Scotland (11), West Germany (9,71), and Japan

(6).

A further indication of the causal relationship

between HTLV-III and AIDS is the chronological

association between the emergence of AIDS as a

recognized disease and increasing exposure rates

to HTLV-III among groups at high risk for AIDS.

Among homosexual men attending a sexually

transmitted disease clinic in San Francisco, for example, the proportion of patients with antibodies

to HTLV-III increased from 1 percent in 1978 to

25 percent in 1980 and to 65 percent in 1984 (154).

Currently, antibodies to HTLV-III are found in

approximately 75 to 90 percent of U.S. hemophiliacs, while percentages for hemophiliacs worldwide are 30 to 90 percent for Factor VIII users and

30 to 50 percent for Factor IX users (158). Since

Factor VIII preparations from U.S. donors are

used throughout the world, almost all studies have

been done on patients receiving U.S. Factor VIII,

at least in part. It is not clear that U.S. Factor VIII

is a priori more infective than Factor VIII from

other sources (160). However, in a study of Scottish and Danish hemophiliacs, 15.6 percent of

Scottish patients, who were largely treated with

Factor VIII concentrates produced in Scotland,

versus 59.1 percent of Danish patients, who received both locally prepared concentrates and

commercial concentrates made in the United

States, were antibody positive to HTLV-III (105).

In one longitudinal cohort study of hemophiliacs,

no HTLV-III antibodies were detected prior to

1979 (from sera stored by a hematologist in Hershey, Pennsylvania). Subsequently, antibodies

were first detected in 20 percent of sera collected

during 1981 and 1982, and increased thereafter.

By 1984, Factor VIII recipients had an overall positive rate of 74 percent, with 90 percent of frequent recipients of Factor VIII (at least twice a

month) having positive antibodies (43,60).

Individual instances of a close correlation between HTLV-III and the development of AIDS

have also been reported. For example, in one

blood donor-recipient pair, both with AIDS, the

virus was isolated from the donor’s lymphocytes

12 months after he developed AIDS and from the

recipient 1 month after she developed AIDS (47).
16

Other investigators have reported on three clinically healthy women intravenous drug abusers

who were serologically positive for the virus and

whose children developed AIDS, probably from

transfer of the virus during pregnancy or the perinatal period (86).

Finally, studies in which chimpanzees were

inoculated with serum and plasma from patients

with AIDS or lymphadenopathy syndrome or with

cultures of the virus have shown that chimps can

be infected with HTLV-III (2,52,53,54). One

chimp developed lymphadenopathy syndrome

but no opportunistic infections, and the lymphadenopathy eventually disappeared (2,155). However, none of the chimps developed fulminant

AIDS.

Thus, identification of HTLV-III as the basic

causative agent for AIDS is now widely accepted

by the scientific community, and current research

is focusing on the relationship between exposure

to the virus and development of the disease. Research on other possible causative agents has been

refocused to examine the roles of these agents as

“cofactors” in the causation of AIDS and of specific diseases associated with the syndrome.

HOW HAS THE PUBLIC HEALTH SERVICE (PHS)

REDIRECTED ITS AIDS RESEARCH TOWARD HTLV-III WORK?

The discovery of HTLV-III has led to the rapid

development of various methods to test for the

virus’s presence. The ability to grow HTLV-III in

cell cultures plus the availability of tools from the ●

field of molecular biology have made it possible

to test people for the presence of antibodies to

HTLV-III and for the presence of whole virus and

fragments (antigens) of HTLV-III. Several diagnostic indicators for exposure to an infection with ●

HTLV-III are identified below:

● Presence of antibodies to HTLV-III. Some

tests for antibodies to HTLV-III use the whole

virus as a source of antigens. Another approach is to fragment HTLV-III and use fragments to test for antibodies that may not be

detected with whole virus preparations. Specific tests are now available to detect antibodies to the proteins that makeup the “core”

of the virus and to the proteins that make

up the “envelope” (surface) of the virus.

These core and envelope antigenic proteins

are specific enough to HTLV-III that they can

be distinguished from the core and envelope

proteins of HTLV-I and HTLV-II (7,32,89,122). ●

Differentiation between antibodies to core

and envelope proteins is important to the

question of whether specific types of antibodies can protect against the development of

AIDS, as well as to the related question of

whether an effective vaccine can be developed (to be discussed later).

Presence of antigens of HTLV-III. The presence of HTLV-III and fragments of the virus

in people can be tested by using sera from

other people known to have antibodies to

HTLV-III.

Presence of HTLV-III genes. The techniques

of molecular biology allow the construction

of genetic probes that can be used to search

through the cytoplasm and nuclei of cells suspected of being infected with HTLV-III (66).

(As noted above, when HTLV-III in its DNA

form is integrated into the chromosomes of

an invaded cell, it is referred to as being in

its “provirus” form. ) These methods have

been used to show the integration of HTLV111 into the genes of helper T cells and the presence of unintegrated HTLV-III DNA (66,134).

Additionally, HTLV-III production by infected cells can be detected by very sensitive

RNA hybridization methods so that individual infected cells can be visualized (68).

Culturing of HTLV-III. With the successful

in vitro culturing of HTLV-III, it is now possible to take cells and sera from people to see

if HTLV-III can be isolated and directly

. grown (89,108,122). . . ,?
17

These diagnostic indicators are being applied

to studies on AIDS, some of which are enumerated below.

Blood Studies

In April 1983, soon after the first cases of bloodtransfusion-related AIDS had appeared, blood

banks and plasma collection centers implemented

donor screening procedures to exclude members

of population groups at high risk for AIDS. Prior

to the announcement of the discovery of HTLV111 in April 1984, blood banks had been searching

for “surrogate” laboratory tests that could be used

to screen out blood that might transmit AIDS.

Two of the tests that were considered were: 1)

T4/T8 cell ratios because of the observation of

lowered ratios in cases of AIDS and AIDS-related

complex; and 2) the presence of antibodies to the

core protein of the hepatitis B virus, because some

of the groups (homosexuals, intravenous drug

abusers) at high risk for AIDS also had a high risk

for hepatitis B. The near availability of tests for

detecting the presence of antibodies to HTLV-III

has effectively made the usefulness of the search

for surrogate tests of these types moot. Research

grants sponsored by the National Institutes of

Health (NIH) on surrogate tests have been reviewed and been reoriented toward cofactors research and/or toward the development of “second-generation” tests for HTLV-III (33).

Screening of blood donors will be undertaken

through tests to detect the presence of antibodies

against HTLV-III as proof of past exposure to the

virus (174). This blood test will augment, but not

replace, blood donor screening procedures currently in place to exclude members of groups at

high risk for AIDS (40). One reason is that researchers now know that some people who have

the virus in their blood have not developed antibodies to it and are also symptom-free (129).

Since a proportion of the tests that are initially

positive will be falsely positive, all positive tests

for antibodies to HTLV-III in the serum of blood

donors will need to be confirmed. PHS has addressed this issue of test reliability in its recommendations for blood and plasma screening (see

box 2-A). In addition to the question of the reliability of tests for detecting the presence of antibodies to HTLV-III, there is the question of what

antibody positivity means. Other than revealing

past exposure to HTLV-III, does it mean that these

people carry the virus? Will they develop AIDS?

Answers to these questions are not known at this

time. (These questions on test reliability and significance are also at issue in obtaining the informed consent of persons who will be tested and

are addressed in the “Related Issues” section near

the end of this chapter. )

The high risk of AIDS in hemophiliacs was presumed to be due to transmission in Factor VIII

concentrates, the assumption being that standard

methods for preparing Factor VIII concentrates

were not sufficient to inactivate a presumed viral agent. There have recently been developed

newer methods of preparation that use heat treatment at a sufficient level to inactivate some viral

agents in Factor VIII concentrates (there is a tradeoff in heat treatment between viral inactivation

and preserving the biological activity of Factor

VIII). With the discovery of HTLV-III, tests of inactivation of this specific virus could be conducted. Preliminary testing has shown that HTLV111 is very sensitive to heat and that recent methods of heat-treating Factor VIII concentrates are

capable of inactivating the virus in vitro. These

findings are being investigated further (42,156).

Other blood-related studies are discussed in the

following section on epidemiologic work.

Epidemiologic Studies

Studies of different populations at risk for

AIDS, their variations in associated risk factors

and in clinical manifestations of AIDS, are of immediate relevance to our understanding of how

the disease spreads, preventive strategies, and the

possibility of early therapeutic interventions.

When AIDS was first recognized, tracking the

development and spread of what was apparently

a new disease had to be done without knowing

what the cause of the disease was. Thus, it was

necessary to survey specific illnesses—which were

essentially limited to only one type of infection

(Pneumocystis carinii pneumonia) and one type

of cancer (Kaposi’s sarcoma)—in the presence of

immune suppression without known causes. This
18
conservative “surveillance” definition of AIDS

made it easier to identify populations at high risk,

but it excluded other possible AIDS-related clinical conditions and probably underestimated the

extent of AIDS.

The availability of various tests for HTLV-III

should allow for a more accurate definition of

AIDS and a more precise delineation of the natural history of the disease, clarifying whether antibodies that can protect against progression to

full-blown AIDS exist and under what conditions

a protective effect might occur. Use of the blood

test for HTLV-III will also enhance epidemiologic

studies of known high-risk groups such as homosexual and bisexual males with multiple sex partners, intravenous drug abusers, recent immigrants

from Haiti, and hemophiliacs.

In the blood area, a large study supported by

the National Heart, Lung, and Blood Institute

(NHLBI) is focusing on immunologic consequences of transfusions. A component that has

been added to the study deals with the collection

and preservation of 200,000 serum samples from

blood donors to be tested when the HTLV-III

screening test becomes available (33). (There are

200,000 samples being collected on the assumption that the rate of HTLV-III-antibody-positive

tests in the donor population will be approximately 0.5 percent, thereby yielding about 1,000

HTLV-III-antibody-positive donors.) The NHLBIsupported study will provide information on the

extent of HTLV-III antibodies in the blood donor

populations in cities in which AIDS is highly prevalent, as well as on the immunologic status of both

donors with positive tests and recipients of their

blood. The study should also provide important

information on the natural history of exposure to

HTLV-III in the blood donor and in the recipient

following blood transfusion.

Identification of HTLV-III as the basic etiologic

(causative) agent of AIDS has opened new avenues to epidemiologic studies of AIDS on a worldwide basis and has provided a plausible, though

preliminary and controversial, explanation of the

origins and spread of the disease from equatorial

Africa to other parts of the world (12,120). AIDS

cases in Africa have been found in epidemiologic

patterns that differ from those in the United

States, where AIDS is still occurring predominantly among homosexual and bisexual males. In

Zaire, the male-to-female ratio of AIDS cases in

one study was approximately 1:1 (120); and in

a study in Rwanda, 9 of 17 patients were female

(170).

HTLV-III is probably already prevalent in the

general population of some African countries. In

Uganda, antibodies to HTLV-III have been found

in preserved sera collected in 1973 of 65 percent

of 65 children of approximately 6 years of age

(131), although there have not yet been any

reported AIDS cases from Uganda. Sera collected

in 1980 from 100 Zairian mothers used as a control group to compare HTLV-III-antibody-positivity with that of known AIDS patients were positive for HTLV-III in five cases, and at least one

AIDS case may have occurred as early as 1977

(26). A study of female prostitutes in Rwanda has

found approximately 20 percent to have antibodies to HTLV-III (16).

Finally, a study among 250 outpatients in a hospital in rural Zaire found that 12.4 percent had

antibodies to HTLV-III (12). The presence of antibodies was higher in children than in adults. One

researcher’s hypothesis about the reason for the

difference in positive antibody rates between the

younger and older patients is as follows. When

the older patients were younger, the incidence of

positive antibodies among them and their peers

was higher and probably similar to that of the

younger patients. However, over the years, some

of the older patients’ peers with positive antibodies

died of unrecognized AIDS, probably of opportunistic infections such as parasitic diseases, which

would not have been distinguished from primary

parasitic deaths in rural areas. A further hypothesis is that HTLV-III was probably endemic in rural areas and entered the urban population only

recently with the immigration of persons from rural to urban areas. Alternatively, a related and

cross-reactive virus that is distinct and does not

cause AIDS could account for their rural pattern

of antibody positivity (16).

Another factor to consider in searching for the

origins of AIDS is that HTLV-III has been shown

to be more similar morphologically and by the

nucleotide sequence of its genes to an animal
—

20

retrovirus known as “visna” virus than it is to the

other two members of the HTLV family, HTLVI and HTLV-II (63). Visna virus causes a chronic

degenerative disease of the central nervous system in sheep and belongs to a subfamily (Lentiviruses) of retroviruses that infect ungulate

(hoofed) mammals, particularly domestic sheep,

goats, cattle, and horses. (Findings described

earlier that HTLV-III can infect the brain (135)

provide further evidence of a relationship between

HTLV-III and the Lentivirus subfamily of retroviruses.) Thus, HTLV-III might have been initially

transmitted from domestic ungulates, and the epidemiologic evidence from central Africa provides

a clue as to when and where that initial transmission might have taken place.

The contribution of a number of cofactors—

i.e., factors or agents which are necessary for or

which increase the probability of the development

of disease in the presence of the basic etiologic

agent of that disease—to the actual development

of AIDS is also being investigated in epidemiologic

and other studies. Results of animal studies and

studies of the prevalence of HTLV-III antibodies

and virus in humans suggest that not everyone

exposed to HTLV-III virus develops fulminant

AIDS. Thus, it is assumed that other factors may

play a role in making people susceptible to development of the disease, primarily through

alterations of the immune system. There are a

number of hypotheses about what these risk factors might be. Factors currently under investigation in U.S. populations include the following

(8,35,95,110,138,165/173):

●

●

●

●

●

●

●

●

●

●

presence of cytomegalovirus;

presence of Epstein-Barr virus;

presence of other herpes viruses;

exposure to hepatitis;

iatrogenic effect of steroids and other medicines (e.g., psychoactive drugs);

use of alcohol and other recreational drugs

(e.g., heroin, cocaine, marijuana, methadone);

cigarette smoking;

antigenic stimulation as a result of

sexual practices;

ethnicity;

particular underlying diseases; and

various

● psychosocial risk factors (e.g., life satisfaction, self-esteem, depression, coping mechanisms, sense of control, social support,

stress).

The resources that PHS is devoting to the investigation of cofactors are discussed below in the

section entitled “How Adequate Are PHS’s Resources Devoted to AIDS?”

Treatment Protocols

The development of effective treatments for

AIDS is urgent, as there is already a serious

worldwide epidemic, By the end of 1984, the total

number of U.S. AIDS cases that had been reported to the Centers for Disease Control (CDC)

was approximately 7,000; and the number of reported cases has been doubling every year—almost 900 cases prior to December 1982, more than

2,000 cases in 1983, and about 4,000 cases in 1984.

Seventy-three percent of AIDS patients diagnosed

before January 1983 have died (157). Furthermore,

extrapolations from trends in the incidence rate

of AIDS (67) suggest that an additional 40,000

new cases can be expected in the United States

in the next 2 years (125). There have already been

over 500 cases in the rest of the Americas, 600

in Europe, and several thousand in central Africa

(125).

Approaches for treating patients with AIDS include the following:

●

●

●

●

treatment for opportunistic infections and

cancers;

reconstitution of the immune system through

bone marrow transplants and lymphocyte

transfusions;

immunologic enhancement with T-cell

growth factor (TCGF), interferon, and immunoregulatory agents such as isoprinosine

and imuthiol; and

agents directed against the HTLV-III virus

itself (84).

Prior to the discovery of HTLV-III, treatment

was directed at the specific opportunistic infections and malignancies associated with AIDS.

Treatment of the immune deficiency itself proceeded along two fronts: 1) attempts to restore
21

immune functions; and 2) the use of known antiviral agents, on the presumption that the epidemiologic pattern of AIDS pointed to an infectious

agent, most likely a virus.

Although the discovery of HTLV-III has not affected treatment protocols for associated opportunistic infections and malignancies, it has affected

treatment protocols for the underlying immune

deficiencies associated with AIDS. Early treatment

methods for immune deficiency involved the use

of general antiviral agents (e. g., gamma interferon) and attempts to restore immune functions

through methods such as lymphocyte transfusions

and administration of TCGF (also known as interleukin-2). These “shotgun” methods were not successful. Which antiviral agents would be effective

and when they should be administered were not

known, The timing of the administration of antiviral agents is probably crucial since they may

have to be administered before HTLV-III invades

cells. Lymphocyte transfusions were analogous to

pouring water in a leaky bucket (since the virus

would destroy these cells), and TCGF stimulated

T cells, a condition now known to enhance T-cell

infectivity by HTLV-III.

With the discovery of HTLV-III, more specific

therapeutic approaches are now possible. First,

the availability of HTLV-III cell cultures makes

possible an in vitro test of possible anti-HTLV111 drugs. One such drug, suramin, has been

shown to protect T-lymphocyte cell cultures

against the cytopathic effects of HTLV-III through

inhibition of the reverse transcriptase of HTLVIII (23) and is undergoing limited clinical trials at

NIH. Another drug, ribavirin, a general antiviral

agent, has also been shown to inhibit HTLV-III

in vitro (99). Finally, French investigators report

that they have tested another chemical, HPA-23

(heteropolytungstate, an inorganic cryptate),

which inhibits the reverse transcriptase enzyme

of murine (mouse) retrovirus in vitro and in vivo.

Four patients, three with AIDS and one with lymphadenopathy syndrome, have been treated with

HPA-23, and virus replication has been inhibited,

though not completely (106).

Strategies directed at the virus itself can also

encompass more than inhibition of reverse transcriptase activity. Eventually, it might be possible to use antibodies against HTLV-III to prevent

or modulate infection (passive immunization).

Moreover, since HTLV-III invades cells, antibody

infusions will probably have to be used before or

at the time of initial infection, perhaps in conjunction with a vaccine to confer more permanent immunity (if such a vaccine proves possible). When

passive immunization would be most propitious

is not known, but the epidemiologic studies now

under way may eventually answer this question.

Another possibility would be to couple toxins

with antibodies against HTLV-III.

Approaches directed at disrupting HTLV-III’S

life cycle might take place at the following points:

1) binding of the virus to the target cell surface,

2) entry into the cell, 3) transcription of RNA to

DNA (the target of reverse transcriptase inhibitors), 4) integration of the virus into the cell’s

genes, 5) transcription of DNA to RNA (in preparation of the virus’s replication and release from

the cell), 6) transfer of the virus to the cell surface, and 7) disruption of the cell and release of

the virus (180). Studies described earlier, which

showed that the T4 molecule on T4 lymphocytes

was necessary for HTLV-III to infect the cell, used

monoclinal antibodies against the T4 molecule

to see if binding of HTLV-III to the T4 lymphocyte

would be blocked (39,81). This blockage was in

fact shown and might constitute a possible method

of inhibiting infection by HTLV-III. Whatever the

mode of attack against the virus, successful therapy depends on whether or not infected cells die

in a short period of time and on whether there

is a regenerative capacity of T cells. It is not

realistic to expect that all of the virus will be

eradicated. Therefore, the hope is that the immune

system can handle a minimum of infection, and

lifetime treatment against the virus may be needed

(180).

Finally, attempts at reconstitution of the immune system (85) may be more successful if done

in conjunction with specific agents against the

HTLV-III virus.

Animal Models

Chimpanzees have been successfully infected

with the AIDS virus and have developed immunologic abnormalities and lymphadenopathy, but
22

no opportunistic infections or tumors characteristic of AIDS (2,52,53,54,155). Other possible animal models are being screened by testing for the

effect of HTLV-III on the animals’ T lymphocytes

in cell cultures.

At NIH, prior to the discovery of the AIDS virus, three chimps were sequentially infused with

plasma from three different patients with lymphadenopathy syndrome, Kaposi’s sarcoma, and

life-threatening opportunistic infections, respectively. Two chimps developed antibodies to

HTLV-III (specimens were stored and subsequently tested when an HTLV-III test became available), and one of the two chimps developed a

transient severe lymphadenopathy 26 weeks after

inoculation, which persisted until 58 weeks after

inoculation (2). At CDC, two chimps were inoculated with concentrated HTLV-III and autologous lymphocytes that had been infected in vitro.

The virus has been found to grow and persist in

the chimpanzees’ lymphocytes, and the chimps

have produced antibodies to the virus; however,

neither chimp has developed any clinical illness

or lymphadenopathy (52). In another study using

tissues and plasma from AIDS patients, chimpanzees were similarly infected and antibodies produced. Infection and antibody production also

occurred in chimps inoculated with whole blood

from chimps previously infected and shown to

have produced antibodies. Except for one infant

chimpanzee which died 5 months after inoculation (cause of death under investigation), all 23

of the inoculated chimps have remained clinically

well for periods of between 2 and 15 months

(53,54). These chimpanzee inoculation studies, in

addition to having promise as an animal model,

may indicate that AIDS is not an inevitable consequence of HTLV-III exposure or even infection.

Primates other than chimpanzees, including

rhesus, stumptailed, cynomolgus, and bonnet macaques, the capuchin, the squirrel monkey, and

the patas monkey, have also been inoculated with

HTLV-III. Rhesus monkeys have recently been

shown to undergo infection by HTLV-III, but

have not produced antibodies and have remained

clinically well (48,53,54). Other animal species

that might serve as animal models are being

screened before inoculation studies are initiated.

Lymphocytes provided by the National Institute

of Allergy and Infectious Diseases (NIAID) from

25 animal species are being studied in cell cultures

by NCI to see if they can be infected by the virus.

In the case of those which are successfully infected

in vitro, the animals themselves will be inoculated

(121).

WHAT ABOUT EFFORTS TO DEVELOP AN AIDS VACCINE?

In general, “live” vaccines produce better immunity because of prolonged stimulation from viral reproduction. Noninfectious “inactivated” vaccines, on the other hand, require frequent booster

shots. Noninfectious vaccines can be made either

from whole inactivated organisms or from parts

(“subunits”) of the organism that have antigenic

properties which stimulate immunity. Neither live

virus vaccines for AIDS nor whole inactivated

preparations containing the genetic material of the

AIDS virus currently hold much promise: 1) because it is not known what constitutes an “inactivated” virus in the case of HTLV-III; and 2) because the genetic structure of HTLV-III contains

segments that may cause cancer by activating normal cellular genes involved in the initiation of

tumors. Thus, only “subunit” vaccines against

AIDS are under serious investigation, albeit

through a variety of methods including the use

of live viruses other than HTLV-III.

When a foreign organism invades the body,

several different antibodies are produced, each

directed at specific subunits of the organism that

the body’s immune system recognizes as different

antigens. Only some of these antibodies will be

directed at subunits of the organism that are crucial to the organism’s life cycle. “Subunits” that

stimulate the production of neutralizing or protective antibodies are necessary to produce an effective vaccine. Such subunits are usually the proteins that make up the “envelope” (external coat),
23

as opposed to the “core” of the virus. One way

to determine which antigenic subunits may produce a protective antibody response is to produce

antibodies against individual antigenic subunits

and determine whether these antibodies neutralize infectious virus in cell cultures (in vitro

testing).

The three-dimensional structure of a viral antigen is probably crucial for eliciting the proper

antibody response; i.e., without the proper threedimensional configuration of the viral antigen as

it appears on the whole virus, antibodies would

be produced against a viral subunit, but might not

“fit” the viral antigen as it actually appears on the

whole virus and therefore might not inactivate the

virus. After they are synthesized, envelope proteins have carbohydrate molecules attached to

them which help to determine their three-dimensional structure. (This modification is referred to

as “post-translational modification, ” and the attachment of a carbohydrate molecule to the protein molecule is called “glycosylation.”) Thus,

HTLV-III subunit proteins produced for use as

vaccines may need to be glycosylated or treated

by some other method to approximate the threedimensional configuration of the virus’s original

subunit.

Relevant to the possible development of a vaccine to protect against HTLV-III is the experience

with a vaccine against feline leukemia virus. Feline

leukemia virus attacks T cells in cats and can cause

either immunosuppression or cancer. There are

three subgroups of the virus, one of which does

not occur naturally but develops in cell cultures

when either of the two naturally occurring types

is cultured. All three subgroups produce an envelope glycoprotein of the same molecular weight

(gp70), but each subgroup’s glycoprotein is structurally distinct from the others.

The first experimental vaccines for feline

leukemia virus used either the inactivated viruses

themselves or the T-cell tumor cultures infected

with the viruses. Both types resulted in immunosuppression in cats because of the presence of p15E

(an envelope protein with a molecular weight of

15,000). Another feline leukemia vaccine was developed by altering the culture medium in which

the virus-infected T cells were grown; the incomplete viruses or fragments that resulted proved to

be about 90 percent protective against the virus

in cats themselves. The envelope proteins produced by this method were: 1) the gp70s of the

three subgroups of feline leukemia virus, which

neutralized the virus in vivo and prevented viremia; and 2) another protein (FOCMA, or felineoncornavirus-associated cell membrane antigen)

formed by lymphosarcoma cells infected with the

virus, which prevented solid tumor formation.

FOCMA maybe identical to or immunologically

similar to the gp70 of the nonnaturally occurring

subgroup of the feline leukemia virus. Field trials

of this subunit feline leukemia vaccine are being

completed, and the vaccine may be available

sometime in 1985 (44).

Experience with the subunit feline leukemia vaccine is relevant to the development of an AIDS

vaccine because: 1) HTLV-III may contain subunits that may be detrimental to the patient; and

2) if there is a subunit that elicits protective antibodies, it is likely to be a high molecular weight

envelope glycoprotein. Of the several protein subunits in HTLV-III, natural human HTLV-III antibodies predominantly recognize an antigen of

41,000 molecular weight (p41). This observation

has led to opposing preliminary conclusions by

researchers. On one hand, some researchers have

suggested that p41 may be of use for prophylactic measures in persons at risk for AIDS (71).

However, antibodies to p41 can be found in all

AIDS cases, even when different isolates of the

HTLV-III virus have been identified. Antibodies

to p41 may therefore be a good diagnostic indicator of infection with HTLV-III, but p41 may not

be the antigen for vaccine development. Another

suggestion, therefore, is that a more specific antigen needs to be identified and that places to look

for antibodies might include lymphadenopathy

patients who get better; selected long-term partners of AIDS patients who are well; hemophiliacs,

many of whom have high positive titers of antibodies to HTLV-III; and patients with only Kapo- ‘

si’s sarcoma and no opportunistic infections (48).

NIH has taken the lead in developing an AIDS

vaccine, at both NCI and NIAID. NIAID would

usually be the primary institute involved in vaccine development, but in the case of AIDS, NCI
24

has the most experience with human retroviruses.

Vaccine development is being pursued both intramurally and through extramural funding of

non-Federal researchers.

NIH is conducting both supportive and direct

activities related to vaccine development (55).

Supportive activities include: 1) large-scale production of HTLV-III to characterize its various antigens and immunogenic properties (and to provide adequate quantities of virus for other

activities); and 2) isolation and characterization

of the virus’s envelope proteins. Related activities include the development of an animal model

to test the efficacy of future vaccine candidates,

as well as epidemiologic and serologic investigations of the natural history of AIDS to determine

whether or not protective antibodies exist, when

in the natural history of AIDS such antibodies appear, when a vaccine would have to be given, etc.

Several activities directed at vaccine development

at NIH are discussed further below.

Subunit Vaccine From Cultured Virus

Viral proteins can be produced either by breaking up whole virus or by changing the conditions

under which the virus is grown so that greater

amounts of specific viral fragments may be preferentially produced. The latter technique has been

used to produce a new subunit vaccine against feline leukemia virus and could be used to produce

an AIDS vaccine. The feline leukemia vaccine and

associated hazards were discussed above.

Recombinant DNA Vaccine

An alternative to using whole virus as a source

of a subunit vaccine is to use recombinant DNA

techniques to make a vaccine. Once the gene(s)

for the viral protein(s) is identified, it is (they are)

cloned and inserted into bacteria, yeast, or mammalian cells, which then produce the protein(s).

The genes for several proteins (p41, p55, and

p54) of unknown specificity from at least three

different isolates of HTLV-III have already been

cloned and inserted into bacteria and yeast (55).

One hypothesis is that the glycosylated envelope

proteins gp120, gp100, and gp46 are the most likely candidates for an AIDS vaccine (74).

Mammalian cells and, to some extent, yeast

cells (but not bacterial cells) have the ability to

glycosylate (add carbohydrate molecules) to these

proteins and are the favored method of synthesis

for subunits that need post-translational modification. (The Merck Institute for Therapeutic Research at West Point, Pennsylvania, for example,

is close to licensing a vaccine for hepatitis B that

uses yeast-cloned hepatitis B virus surface antigen

(101), and Biogen plans to begin human clinical

trials for a similar vaccine in early 1985 (13).)

A related method of preparing an AIDS vaccine would be to synthesize the viral proteins

directly, based on the nucleotide sequences of their

genes. It is now known which nucleotide sequences code for each of the 20 amino acids from

which all proteins are made. To obtain the proper

three-dimensional configuration, however, glycosylation or other methods would probably be

needed.

Infectious Recombinant Vaccine

If the gene(s) coding for the proper subunit of

HTLV-III could be inserted into other viruses that

are not harmful to humans, these viruses themselves could then be used in vaccinations. The result would be a live vaccine with more sustained

antibody production than an inactivated vaccine

but without the hazard of using live, whole

HTLV-III virus for continual stimulation of antibody production.

The vaccinia virus (which has long been used

to vaccinate against smallpox) has already been

used for the insertion of genes from a number of

viruses and one parasite, including hepatitis B

(111,137), rabies (78), herpes simplex, influenza

viruses, and ”malaria. The recombinant vaccinia

virus has been shown to be capable of producing

rabies virus glycoprotein; i.e., following insertion

of the gene for the rabies envelope protein, the

vaccinia virus (which propagates in the cytoplasm

of infected cells rather than in the nucleus) not

only can produce the rabies envelope protein but

also adds carbohydrate molecules to the protein,

resulting in production of a rabies glycoprotein

that produces protective antibodies (78). Some of

these infectious recombinant vaccines have been

tested in animals but not in humans.
25

Much of the work on recombinant vaccinia virus has been done by researchers at NIAID and

their collaborators, and work with HTLV-III

genes in vaccinia virus is being conducted through

NIAID. Meanwhile, NCI has also issued requests

for proposals for the development of human recombinant viruses other than the vaccinia virus.

One reason is that many people have been previously exposed to the vaccinia virus through smallpox vaccinations, and if revaccinated with an

HTLV-III-gene-containing vaccinia virus, their

antibody-producing responses would be short

(anamnestic rather than primary responses). Possible alternatives to the vaccinia virus are the

adenoviruses, and NCI reports that William Jarrett, the discoverer of feline leukemia virus, is interested in examining antibody production in dogs

with a dog adenovirus in which HTLV-III genes

would be inserted. Another possibility would be

to use herpes viruses (48).

Anti-ldiotype Vaccine

Contact between an antigen and an antibody

can be envisioned as a precise fit between two

pieces of a three-dimensional puzzle. If a second

antibody were made against a particular antigen’s

antibody (the “idiotype”), the second antibody

(the “anti-idiotype”) would have a part that

mimics the part of the antigen that was in contact with the first antibody. And if the first and

second antibodies came from the same animal species, they would differ only in that part which

comes in contact with the antigen; the rest of the

molecules of these antibodies would be identical.

Therefore, the anti-idiotype, when used as a vaccine in the animal species from which it was derived, would elicit an antibody response only to

that part which was identical to the original

antigen.

In addition to the specificity of the elicited antibody response, the fact that this anti-idiotype

vaccine would consist mostly of a molecule that

would be recognized as “self” would mean that

it would not be removed from the body as quickly

as it would be if the antibody had come from another animal species. Therefore, if such a vaccine

were made with human monoclinal antibodies,

it would be present in the body for a longer period

and produce more of an immune response. Furthermore, since no part of the anti-idiotype would

have been made from the actual virus (either from

the whole virus or from its genes through recombinant DNA methods), there would be no possibility of infection from the virus or its products.

An experimental anti-idiotype vaccine has been

developed in mice against reoviruses (another

family of RNA viruses), and the researchers are

now applying their methods to HTLV-III (182).

Successful immunization of mice against the bacterium Streptococcus pneumonia with an antiidiotype vaccine has also recently been reported

(loo).

Prospects for a Successful Vaccine

A subunit vaccine, made through purification

from whole virus, special culturing techniques,

or through the use of recombinant DNA technology is the most likely vaccine candidate to be first

available. However, it is not known at this time

whether an effective vaccine against HTLV-III can

be made. The virus has only recently been discovered, and investigations into the relationship

of the natural history of the disease with specific

immunologic responses, which may answer the

questions of whether or not protective antibodies

exist and under what circumstances, have just

begun.

An additional question for vaccine development

is the variation among the different isolates of the

HTLV-III. In contrast to HTLV-I, which has been

found to have only a few minor variations despite its worldwide distribution, HTLV-III isolates

have been found to have many variations. Variations have been observed in the sequences of the

nucleotides that make up the genes (1,23,66,91).

These imply either a large number of subtypes or

the possibility of sequential mutations analogous

to some animal retroviruses. As noted earlier,

HTLV-III is related to visna virus, an encephalitisinducing retrovirus of sheep, which can change

its envelope proteins antigenically (63). On the

other hand, no heterogeneity has been seen so far

in a given HTLV-III isolate, nor has heterogeneity

developed in culture. Most of the heterogeneity

is seen in the genes coding for the envelope pro42-575 0 - 85 - 3
26

teins, and it is not yet known whether the genetic

heterogeneity results in significant antigenic differences (178),

An emerging issue is the question of who might

benefit from a vaccine. Testing of high-risk groups

for exposure to HTLV-III has shown a rapid increase in the percentage of persons exposed-up

to 65 percent for some groups of homosexual and

bisexual males (154), nearly 90 percent in some intravenous drug abusers (141), and up to 90 percent

of hemophiliacs who regularly use Factor VIII concentrates (43,60,79). On the other hand, cases of

heterosexual transmission and transmission between

family members are being reported (28,86,126), and

the disease transmission pattern in central Africa

appears different from that in the United States,

with relatively more female patients in central

Africa and significant rates of the presence of antibodies to HTLV-III in the general central Africa population (12,120,170). Furthermore, since HTLV-III

has now been isolated from semen and saliva

(65,73,181), the population at risk may change

or may include more groups those than currently

identified in the United States.

One way that AIDS may get into the general

population is through female prostitutes. Seventeen of sixty-five AIDS cases not known to belong

to any risk group are now known to have had

frequent contact with prostitutes. There are approximately 200,000 drug abusers undergoing

treatment in public clinics at any one time, totaling about 400,000 over the course of a year.

This number excludes about 1.5 million drug

abusers who are in private treatment or who are

occasional users. About 20 percent of female drug

abusers resume drug use within 1 year after treatment in methadone clinics, and about 31 percent

of female drug abusers admit to prostitution.

Thus, female drug abusers are habitual users and

many are very active sexually (in part to support

their addiction). U.S. cities with large numbers

of drug abusers and where AIDS is most prevalent include New York, Miami, San Francisco, and

Los Angeles, which are also popular tourist areas,

hence intensifying the probability of spread

through female prostitutes (62).

Finally, there is the question of the private sector’s interest in developing and marketing an

AIDS vaccine. There has been great interest by

the private sector in developing and marketing

blood tests for HTLV-III, but the technical difficulties involved in developing and producing an

effective and safe vaccine, and product liability

issues concerning vaccine-related injuries may

make an AIDS vaccine much less attractive commercially than the markets for screening and other

diagnostic tests for AIDS. Although the private

sector seems interested in all AIDS-related products, it remains to be seen whether the interest

generated in the marketing of a blood test will

carry over into the vaccine area. If an AIDS vaccine proves feasible, the Federal Government may

need to assume production activities in addition

to the development

undertaking,

activities it is currently

HAS THE DISTRIBUTION OF NEW INFORMATION AMONG

RESEARCHERS AND REGULATORS BEEN ADEQUATE AND TIMELY?

Whether information about AIDS has been generated and disseminated on an adequate and timely basis has been an issue of recurrent concern.

As the new syndrome, later to be called AIDS,

began to surface, there was relatively fast coordination and dissemination of information among

PHS agencies and outside researchers. In September 1981, only 6 months after the first clusters of

an unusual syndrome involving Kaposi’s sarcoma

and Pneumocystis carinii pneumonia were reported to CDC, NCI and CDC cosponsored a workshop on AIDS at which a significant amount of

information about the syndrome’s epidemiology

and virology was shared with 50 intramural and

extramural participants (164). In the intervening

months, CDC, NCI, and NIAID researchers had
27

begun to reorient some of their intramural research, and the first patients with the syndrome

had been admitted into NIH’s Clinical Center.

Since 1981, individual researchers and PHS

agency managers have coordinated the dissemination of information about AIDS in a variety of

ways. PHS units other than CDC, NIAID, and

NCI began to be involved as more became known

about the disease. Most, if not all, of the PHS institutes and agencies have had internal working

groups or committees meeting on AIDS with

varying levels of intensity depending on research

developments. In addition, there have been numerous interagency meetings and conferences on

AIDS, attended by PHS researchers and PHSfunded grantees. The Assistant Secretary for

Health, PHS, arranged for journals to expedite

their review process so that AIDS research results

could be published more quickly. NIAID took the

lead in publishing the AIDS Memorandum, a

compilation of nonreviewed research on AIDS,

and an AIDS bibliography to speed up the dissemination of information to researchers. Furthermore, interagency task forces have worked on developing recommendations on blood donation

(153) and on the blood test for HTLV-III (159).

At the PHS management level, former Assistant Secretary for Health Edward Brandt established a PHS Executive Committee on AIDS in

May 1983 (21). The committee was chaired by an

individual from CDC (not chosen to be a CDC

representative per se) and had representatives

from all five PHS agencies: CDC, NIH, the Food

and Drug Administration (FDA), the Alcohol,

Drug Abuse, and Mental Health Administration

(ADAMHA), and the Health Resources and Services Administration (HRSA). The committee’s

function was to coordinate PHS efforts, but in

practice, the committee served primarily as a way

in which PHS’s central management was apprised

of progress in AIDS research.

With the announcement of the findings of NCI’s

work on HTLV-III in April 1984, Assistant Secretary Brandt reconstituted the PHS Executive

Committee into the AIDS Executive Task Force,

chaired by him, for the following purposes:

● to develop and implement a strategy for PHS

efforts in AIDS;

● to determine and allocate the resources required to accomplish the strategy; and

● to develop policies and procedures for informing the public, Congress, and the scientific community about PHS’s efforts.

Three panels were established to accomplish

these purposes: 1) a science panel, 2) a resources

panel, and 3) an information panel (18). In September 1984, four specific task forces were also

established: 1) one on vaccine development and

therapeutic intervention, chaired by the Director

of NIH with representatives from NIH, CDC, and

FDA; 2) one on epidemiology and prevention,

chaired by the Director of CDC with representatives from CDC, NIH, FDA, and ADAMHA; 3)

one on blood and blood products, chaired by the

Director of FDA’s Center for Drugs and Biologics

with representatives from FDA, NIH, CDC, and

ADAMHA; and 4) one on psychological, psychiatric, and addictive aspects, chaired by a representative from ADAMHA with representatives

from ADAMHA, NIH, CDC, and FDA. The Science

Advisor to the Assistant Secretary for Health was

designated the PHS coordinator of these task force

activities. The Science Advisor also coordinates

the private sector production of the blood test for

HTLV-III and chairs committees concerned with

animal studies, bioethics, and biosafety, and the

utilization of the blood test (21).

The PHS task forces and committees continue

to meet on a regular basis. Since the discovery

of the probable AIDS etiologic agent, formal information-sharing activity on a management level

has increased substantially, and centralized coordination of activities is also on the increase. Members of the Epidemiology and Prevention Task

Force not only have agreed to distribute articles

prior to publication, but have also agreed to discuss studies at the planning stage (96) in order to

avoid unnecessary redundancies and to ensure

that all the necessary areas are being covered. The

Task Force on Psychological, Psychiatric, and Addictive Aspects is discussing participation by the

National Institute of Mental Health (NIMH) in the

NHLBI study of blood donors (138). As before,

however, information sharing among individual

laboratories and researchers continues both formally (e.g., HTLV Symposium, Dec. 6-7, 1984

(161)) and informally.
28

The Office of Technology Assessment (OTA)

has identified five factors which may have impeded the generation and dissemination of new

information about AIDS. First, NCI has not fully

shared HTLV-III supplies with CDC, perhaps

slowing the comparison of LAV and HTLV-III.

Second, the announcement by the Secretary of the

Department of Health and Human Services (DHHS)

Margaret Heckler of NCI’s discovery of HTLV111 provided overly optimistic assessments concerning the usefulness of a blood test and prematurely committed the Federal Government to require use of the test for antibodies to HTLV-III

in blood and plasma collections. Third, in the context of a public health emergency, the grant application and approval process for extramural research works slowly. Fourth, Federal regulations

covering commercial development of drugs, biologics, and devices mean that much information

is not subject to full public scrutiny. Finally, the

coordination of PHS resources could be improved, as discussed in the section below entitled

“How Adequate Are PHS’s Resources Devoted to

AIDS Prevention and Treatment?”

NCI and CDC Sharing of

HTLV-III Culture Samples

At about the same time that the Assistant Secretary for Health established the first PHS Executive Committee on AIDS in May 1983, the Director of NIH established an NIH Coordinating

Committee. Part of the reason for establishing the

NIH Coordinating Committee was that CDC and

NIAID were collaborating with the French researchers who had just published findings implicating a new virus they called “lymphadenopathyassociated virus” or LAV (7) as the cause of AIDS,

but neither CDC nor NIAID was aware of similar work that had been going on in NCI’s Laboratory of Tumor Cell Biology under Dr. Robert

Gallo (179).

CDC had received samples of LAV from the

French researchers in May 1983 (the month in

which their findings were published) and again

the following month, but had not been able to

culture it. In February 1984, CDC again received

the virus from the French researchers, and this

time, CDC was able to culture it (38). In late April

1984, DHHS Secretary Heckler announced the

discovery of HTLV-III and prospects for a blood

test and vaccine (70). Gallo and his coworkers had

their results published in May 1984 and sent CDC

their cultures later that month. CDC had difficulty growing the cultures in bulk and asked for

more culture materials from the PHS Science Advisor, who was coordinating the production of

the blood test for HTLV-III and arranging for

transfer of large amounts of HTLV-III cultures to

the commercial companies who would develop

the blood test. Subsequently, CDC was given a

small, but in its view insufficient, additional

amount. At the end of 1984, CDC signed a purchase agreement with NCI for 100 liters of material (38).

One consequence of CDC’s use of the French

instead of the NCI virus cultures was that the research papers published by CDC and their collaborators, in which evidence of the AIDS virus

was presented, referred to “LAV” instead of to

“HTLV-III.” This situation might have been

avoided, and comparisons of the “LAV” and

“HTLV-III” isolates might have taken place sooner, if PHS had arranged for sharing of NCI culture

materials with CDC with as much attention as

PHS has given to transferring bulk quantities of

the cultures to the five commercial firms developing blood tests for AIDS under NCI’s license.

DHHS Announcement of

the Discovery of HTLV-III

The announcement by DHHS Secretary Heckler in April 1984 of the discovery of HTLV-III was

a dramatic and extremely positive assessment of

the implementation of NCI’s research into the

HTLV-III virus (70a). The announcement called

AIDS “a disease with two names,” the other name

being “Fear,” announced that an “arrow” had been

aimed and fired at AIDS and had hit the target

“only two or three rings away from the bulls-eye, ”

and concluded that “(y)et another terrible disease

is about to yield to patience, persistence and outright genius. ”

Secretary Heckler’s announcement indicated

that a blood test could be widely available within

about 6 months and that a vaccine might be ready

for testing in about 2 years, and most attention
———

29

has focused on these two developments. In addition, however, Secretary Heckler committed the

Federal Government to the use of the blood test

in screening blood and plasma donations. The

Secretary’s announcement indicated that the blood

test could “identify AIDS victims with essentially

100 percent certainty” and thus should prevent

transfusion-related AIDS, including AIDS in hemophiliacs. The announcement also indicated that

the blood test would allow prompt and early diagnosis of people who may have been infected by

HTLV-III.

In trying to reassure the public of progress

against AIDS, Secretary Heckler appears to have

been too optimistic regarding the use of the blood

test to screen for possible AIDS carriers. The Secretary’s announcement also did not take into account the social implications and ethical dilemmas

that would have to be addressed when persons

who might be carriers of HTLV-III were identified

through a blood test.

As mentioned earlier in this memorandum, it

is now known that the blood test for antibodies

to HTLV-III will not detect all persons exposed

to the virus, because some persons who have the

virus in their blood do not produce antibodies and

can also be symptom-free (129). Furthermore,

studies of hemophiliacs for antibodies to HTLV111 have shown that most hemophiliacs have already been exposed to HTLV-III (43,60); thus,

only new hemophiliacs (and the minority of present hemophiliacs not yet exposed) will benefit

from blood and plasma screening.

Aside from these limitations of the blood test

are the difficult issues of what to tell persons who

are found to have antibodies to HTLV-III and

who should have access to lists of HTLV-III antibody-positive persons. In July 1984, the New York

State Council on Human Blood and Transfusion

Services advised the New York State Health Commissioner that mandatory testing of blood donors

for viruses associated with AIDS was premature

(114). Following this action, the five-member New

York City Board of Health, in a resolution approved unanimously on October 17, 1984, recommended that the blood test be given only in

the context of controlled research programs which

preserve the confidentiality of participants (113a).

The Board of Health noted that although the test

“provided the opportunity for great scientific

strides, ” unanswered questions mean that the test

carries a “threat of mental anguish for those who

receive the results. ” These issues do not seem to

have been raised and addressed prior to Secretary

Heckler’s announcement in April 1984.

Funding of Extramural Research

Another coordination issue is whether or not

NIH funding of extramural research on AIDS

could have taken place more quickly. The policy

question here is not so much whether extramural

funding of specific research areas was tardy within

the time frame of established processes, but

whether the usual processes through which extramural research is funded can and should be accelerated in public health emergencies.

NIH research grants take about 16 months from

conceptualization to awards, and contracts take

about 14 months. The first round of extramural

grants awarded by NCI/NIAID was funded through

cooperative agreements (which have been used

only in the last 2 years), in which researchers from

the funding agency participate to some extent in

the research activities for better control of the

studies. Almost immediately after the NCI-CDC

workshop on Kaposi’s sarcoma, NCI’s Division

of Cancer Treatment, together with NCI’s Clinical Division and NIAID, began to develop requests for applications (RFAs) to investigate multiple aspects of AIDS. These RFAs were developed

and funds set aside during the first half of 1982,

and the RFAs issued in August 1982. Proposals

were received in October 1982, and awards were

made beginning in January 1983. A second round

of RFAs was issued by NCI and NIAID in May

1983, directed at biological agents in AIDS. These

RFAs were awarded in March 1984, at about the

time (April 1984) that the announcement of the

discovery of HTLV-III was made by DHHS Secretary Heckler. (All grantees were contacted to

make sure they were aware of Gallo’s findings

(29)). Thus, these grants took a total of 1 4

months, in part because of negotiations with the

Office of Management and Budget (OMB) over

the specific language used in the agreements (29).
30

Some steps have been taken to speed up the

normal process. For example, mail balloting has

been used instead of face-to-face meetings by reviewers. Or researchers working in relevant areas

have had their grants (or contracts) augmented

to direct their ongoing research specifically at the

AIDS problem. Nevertheless, a period of at least

several months is probably still necessary to fund

new research projects, given the time needed to

conceptualize the problem in researchable terms,

to review the work statements, including outside

experts such as an institute’s advisory body, to

allow respondents adequate time to develop and

write their proposals, and to evaluate and rank

each proposal. In addition, the more the usual

process is shortened, the more serious will be concerns over the quality (and therefore, usefulness)

of the research activities funded. Nonetheless, the

extramural grants process for AIDS research was

not significantly accelerated over the usual grants

process, and the process needs to be examined to

see if bureaucratic processes can be streamlined

without compromising the quality of research that

is funded.

Federal Policy on

Commercial Development

The general policy in this country is to leave

the commercial development of technologies, including technologies derived from Federal biomedical research, to the private sector. Once

under commercial sponsorship, research and development activities are considered proprietary

and will not be made public unless voluntarily

released. Under the Federal Food, Drug, and Cosmetic Act, this restriction applies when the sponsor of a new drug has applied to FDA for Investigational New Drug (IND) status to conduct

clinical investigations. Thus, for example, FDA

cannot divulge even the protocols being used by

the five companies under license from NCI to develop AIDS screening tests to Federal researchers not directly involved in these activities; FDA

is also enjoined from discussing when such trials

will be completed and marketing approval

granted. Federal researchers, on the other hand,

will generally share their research, including their

research materials, their primary concern being

the qualifications of the private researchers and

the quality control processes they have established

(e.g., whether or not their laboratory facilities

meet standards for containment of infectious

agents).

In the case of AIDS, the sharing of information developed by commercial firms was enhanced

in small part because PHS selected the companies

that would get the HTLV-III culture developed in

the NCI laboratory. Thus, for example, Dr. Gallo

met with the five companies soon after they received the materials to discuss their use. However,

other laboratories have cultured the virus and sold

or given it to companies other than the five selected by PHS, and the status of those companies’

activities is formally unknown to any Federal researcher except at FDA. As an illustration, a company (Cellular Products of Buffalo, New York)

not among the five licensees of NCI may be

among the first companies to market an HTLVIII test; and another company (Centocor of Malvern, Pennsylvania) claims to be the first to successfully express polypeptides (small proteins, presumably antigenically similar to proteins of

HTLV-III) specific to antibodies to HTLV-III and

has filed a patent on the method of production

(14).

Conclusion

The involvement of multiple organizations in

similar research activities that are addressed at different aspects of a common problem is arguably

the best scenario for research. However, this scenario means that researchers are constantly striving to keep abreast of the work of others. In addressing the problem of AIDS, information has

been shared through the informal networks that

exist among PHS agencies and among their researchers. This sharing has been augmented by

coordinating committees, external advisory committees, conferences, and cooperative agreements

on funding extramural research and conducting

intramural research.

Although most of these sharing and coordinating activities would have taken place regardless

of any directive from PHS central management,

there have been instances in which PHS (or departmental level) guidance could have led to better coordination. PHS might have directed NCI
.

31

to share virus culture with CDC, and Secretary be raised in this memorandum. A systematic exHecklerfs announcement of the discovery of the amination both of the methods by which the reetiologic agent for AIDS could have been more search grants and contracts process could be acrestrained. celerated in public health emergencies and of the

Other possible impediments to the generation policy of keeping the research activities of comand dissemination of information are matters of mercial developers confidential may be needed.

more generalizable policy concerns that can only

HOW ADEQUATE ARE PHS’S RESOURCES DEVOTED

TO AIDS PREVENTION AND TREATMENT?

As evidenced by the preceding discussions, PHS

has accomplished a great deal with respect to

AIDS: PHS grantees “discovered” AIDS as a syndrome; PHS has conducted surveillance of AIDS;

and PHS investigators and others have made significant scientific advances, including the discovery of the probable etiologic agent for AIDS. PHS

is currently coordinating development of a blood

test for HTLV-III antibody; and research on treatment, vaccine development, and the many remaining questions about the natural history of the

disease is progressing. It has not always been

clear, however, that the amount of support for

AIDS activities has been equivalent to the needs

identified by PHS agencies (see, e.g., 146). Thus,

OTA was asked to address whether PHS has devoted sufficient resources to its AIDS activities.

Resources for AIDS can be examined at two

levels: 1) specific funding for AIDS activities, and

2) overall funding for specific PHS agencies. Although funding for AIDS research has been substantial, particularly in fiscal years 1984 and 1985,

the history of specific funding for AIDS has been

marked by continuing tension among the individual PHS agencies, DHHS, and Congress. Individual PHS agencies have consistently asked DHHS

to request particular sums from Congress; the Department has consistently submitted requests for

amounts smaller than those suggested by the agencies; and Congress typically has appropriated

amounts greater than those requested by the Department. Except when prodded by Congress,

DHHS has maintained that PHS agencies should

be able to conduct AIDS research without extra

funds, by obtaining money from their other activities. However, cutbacks and threatened cuts in

overall funding and personnel levels have restricted the ability of affected agencies to redirect

resources. The Administration has not pursued

the option of seeking an appropriation for the

Public Health Emergency Act, which established

a revolving fund to be used for urgent government response to public health emergencies (Public Law 98-49; see 146).

In large part, PHS agencies’ responses to the

AIDS crisis have been facilitated by the transfer

of money and personnel from other activities. By

DHHS directive, the response to AIDS has concentrated on research into the biology of AIDS.

Psychological and social factors related to AIDS,

the service needs of AIDS patients, and public

education and prevention have not been considered funding priorities.

The U.S. budget process has effects on PHS

agencies apart from the amount of resources they

can devote to AIDS activities. PHS agencies have

been unable to plan their activities adequately because they have not known how much funding

and staff will be available to them. Furthermore,

the uneven distribution of resources has intensified

competition among agencies, particularly now

that an etiologic agent for AIDS has been discovered and there are many directions for research

to take concurrently (e.g., treatment, vaccine development, cofactor research, natural history

studies) and several areas in which agencies have

overlapping expertise. The distribution of resources to activities not directly involving the

etiologic agent remains an issue. Of particular importance is the question of whether sufficient resources are being devoted to the investigation of
32

factors affecting the transmissibility of AIDS, ●

treatment, public education, and prevention.

Five issues concerning the allocation of funds ●

for AIDS to PHS remain open:

●

●

●

the extent to which progress in other disease

the particular problem of personnel ceilings;

and

the extent to which agencies will be able to

pursue AIDS work adequately in the face of

further cutbacks.

.—

areas has suffered as a result of diversions Specific Funding for AIDS Activities

to AIDS activities;

the wisdom of limiting the priority status of As shown in table 1, Congress has consistently

AIDS primarily to biomedical research; earmarked funds for AIDS activities at a level

the manner in which limited resources can higher than that requested by the Administration,

be allocated among agencies; although not necessarily at levels requested by inTable 1 .—History of AIDS Funding, Fiscal Years 1982 to 1985 (thousands of dollars)

Earmarked in

congressional

appropriate ions

PHS agencies’ President’s and/or actually

request budget request obligated

Fiscal year 1985:

President’s budget request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $55,242a

Proposed budget amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35,809a $87,356’

Estimated funds redistributed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — 10,070

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $91,051 $60,589 $97,426b e

Fiscal year 1984:

President’s budget request ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $39,827 f $39,8279 $48,345

Supplement to original appropriation . . . . . . . . . . . . . . . . . . . . . . . 20,076a o 9,475h

Estimated funds redistributed . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — 3,640

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $59,903 $39,827 $61,460i J

Fiscal year 1983:

President’s budget request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . of o

k

Supplement to original appropriation . . . . . . . . . . . . . . . . . . . . . . . N. A.’ $2,000

Estimated funds redistributed . . . . . . . . . . . . . . . . . . . . . . . . . . . .

—

— — 26,736

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N.A. — $28,736j m

Fiscal year 1982:

President’s budget request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . of o

n

Supplement to original appropriation . . . . . . . . . . . . . . . . . . . . . . .

—

of o

n

500

Estimated funds redistributed . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — 5,055

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 0“ $5,559 m

Notes:

a So u rce: E, N, Brandt, Jr., Assistant Secretary for Health, Public Health Service, U.S. Department of Health and Human se~ices, ‘(Proposed FY 1984 and FY 1985

Amendment for Acquired Immunodeficiency Syndrome,” memorandum to the Secretary of Health and Human Services, May 25, 1964.

b .sOurce: E, N Brandt, Jr,, Assistant s~creta~ for Health, public Health se~ice, IJ.S. Department of Health and Human Services, Washington, DC, letter to Off iCe

of Technology Assessment, U.S. Congress, Dec. 20, 1984.

c By subtraction.

d T. be determined, In hearings befora the House Energy and Commerce Subcommittee on Health On Sept. 17, 1984, the Assistant Secretary for Management and

Budget testified that fiscal year 1965 supplemental AIDS funding would be addressed in connection with the submission of the 1986 budget in February 1985.

e Includes $8350,000 for FDA which cannot be obligated until requested by the president.

f Actual figu~e not known, but assumed to be the same as the President’s budget request.

9 Source: IJ.S, congress, l-louse committee on Government Operations, The Federa/ Response to A/DS (Washington, DC: US. Government Printing Office, 1963).

h Source: u,s, Congress, House of Rewese”tatives, “Making Supplemental Appropriations for the Fiscal Year Ending September 30, 1984, and for Other Purposes,

Conference Report 96-977 (to accompany H.R. 6040), Aug. 10, 1964.

\ source: w, H, Little, Office of the Assistar,t Secretav for Health, public Health Service, U.S. Department of Health and Human Services, Rockville, MD, perSOflal

communication, Dec. 28, 1964.

j Amount represents actual obligations, including funds redirected from other activities,

k No request for funds specifically for AIDS was made until May 1963 (U,S, congress, House committee on Government Operations, The Federa/ ~esporrse to AIDS

(Washington, DC: U.S. Government Printing Office, 1963)). As of April 1963, PHS planned to spend $14.5 million on AIDS from existin9 allocations (U.S. Con9ress,

House Committee on Government Operations, The Federal Resporrse to AIDS (Washington, DC: US. Government Printing Office, 1983)),

I N,A, = Not available, CDC, but not NIH, identified funds needed, DHHS did not request them. congress appropriated ‘n acIclltiOnd $2 million for CDC’S AIDS research

in December 1962 (US. Congress, House Committee on Government Operations, The Federal Response to AIDS (VWahington, DC: U.S. Government Printing Office, 1963).

r esource : w, H, Little, office of the Assistant secretary for Health, Public Health Service, U.S. Department of Health and Human Sewices, Washington, DC, Personal

communication, Oct. 26, 1964.

n N. request for funds specifically for AIDS was made until May 1983.
33

dividual agencies. The Administration has maintained that AIDS activities can be funded from

overall agency funds supplemented by appropriations initiated by Congress (see, e.g., 70). The

Administration has continued to maintain this despite the fact that the special panel for AIDS resources established in the Office of the Assistant

Secretary for Health (OASH) investigated and approved the amounts requested by individual

agencies.

AIDS was not discovered until March 1981, so

in fiscal year 1981, there was, of course, no opportunity for the Administration to request money for AIDS work in its initial budget requests.

However, although the need for additional resources was becoming clear in late 1981 and 1982,

no requests for funds were made in those years,

not even through requests for transfer authorities.

In August 1982, Congress appropriated additional

funds for AIDS research in fiscal year 1982, primarily for CDC. Again in December 1982, Congress appropriated an additional $2 million for fiscal year 1983 CDC AIDS research, based on

material prepared by CDC but not officially presented to Congress (146). The Administration did

not acknowledge the need for funds specifically

for AIDS until May 1983, when the Assistant Secretary for Health requested the authority to transfer funds across agency lines (19).

More recently, AIDS activities have been considered in the President’s budgets, although at

lesser amounts than those considered necessary

by affected agencies. The Administration’s initial

budget request for fiscal year 1984 AIDS activities was for $14,461,000, compared to then estimated fiscal year 1983 expenditures of $14,132,000

(145). By August 1983, the expected spending level

for fiscal year 1983 had risen to $25 million, but

the Administration’s official request for AIDS research and surveillance for fiscal year 1984 rose

from $14.46 million to $17.7 million, $7.3 million less than expected fiscal year 1983 spending

levels (146). Subsequent to congressional hearings,

the Administration’s request for fiscal year 1984

more than doubled, to $39.8 million (145). In contrast, Congress earmarked $48,345,000 for fiscal

year 1984 AIDS research (150). It is not known

what the desires of the affected agencies were at

that point, but at least $3,045,000 was redirected

from other areas to meet the needs of AIDS activities, as shown in table 2.

When the discovery of the agent for AIDS was

announced in April 1984, the Assistant Secretary

for Health asked PHS agencies to reevaluate the

needs of their AIDS activities, for both fiscal years

1984 and 1985. On the basis of the agencies’ reevaluations, which were assessed for reasonableness by the newly formed PHS AIDS Resources

Panel, Assistant Secretary Brandt forwarded a

memo to Secretary Heckler requesting a total supplemental appropriation of $20,076,000 and 4 fulltime equivalents (FTEs) for fiscal year 1984 and

a budget amendment of $35,809,000 and 37 FTEs

for fiscal year 1985 (20).

The Assistant Secretary’s requests were not forwarded to Congress by the Department, although

several Members of Congress received copies of

Assistant Secretary Brandt’s memo. Instead,

DHHS Secretary Heckler directed Assistant Secretary Brandt to use “resources currently available to the Public Health Service” and to review

the funding status of AIDS after the passage of

the second supplemental appropriations bill for

1984 and the regular appropriations bill for 1985

(70). The Secretary noted that PHS had been able

to increase spending for AIDS by about $2.5 million over the funding levels in the fiscal year 1984

DHHS appropriations act, implying that funds

were available in the agencies.

Despite the Department’s inaction, Congress

passed a supplemental appropriations bill in 1984

that included $9,475,000 for AIDS research. This

was about half the amount initially requested by

the affected PHS agencies (see table 3).

The President’s initial budget request for AIDS

for fiscal year 1985 was $55,242,000 (150). No

changes were made in allocations to the various

PHS agencies as a result of the discovery of the

etiologic AIDS agent. (As discussed below, funds

were redirected within agencies as a result of the

discovery of the AIDS agent. ) Table 4 compares

the President’s budget request for PHS agencies’

AIDS activities for fiscal year 1985 and the

amounts suggested by Congress in its final appropriation (Public Laws 99-473 [Continuing Resolution] and 98-619 [Appropriations]).
34

Table 2.--PHS Agencies’ Estimated Obligations for AIDS Activities in Fiscal Year 1984

(2)

PHS estimate of

(1) funds redirected

Estimated (included in

Agency obligations column 1)

Centers for Disease Control (CDC) . . . . . . . . . . . . . . . . . . . . .

Food and Drug Administration (FDA) . . . . . . . . . . . . . . . . . . .

National Institutes of Health (NIH):

National Cancer Institute (NCI) . . . . . . . . . . . . . . . . . . . . . .

National Heart, Lung, and Blood Institute (NHLBI). . . . . .

National Institute of Dental Research (NIDR) . . . . . . . . . .

National Institute of Neurological and Communicative

Disorders and Stroke (NINCDS) . . . . . . . . . . . . . . . . . . . .

National Institute of Allergy and Infectious Diseases

(NIAID) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

National Eye Institute (NEI). . . . . . . . . . . . . . . . . . . . . . . . . .

Division of Research Resources (DRR) . . . . . . . . . . . . . . . .

Alcohol, Drug Abuse, and Mental Health Administration

(ADAMHA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Health Resources and Services Administration (HRSA). . . .

PHS total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$13,750

798

16,627

4,871

81

1,510

19,616

60

1,356

2,791

—

$61,460

$398

2,150

154

—

145

198

—

—

—

—

$3,045

Notes:

alnf.l”des supplemental appropriations and $3,w5 million redirected; Source: E. N. Brandt, Jr., Assistant Secretafy for Health,

Public Health Service, U.S. Department of Health and Human Services, Washington, DC, letter to Office of Technology Assessment, U.S. Congress, Dec. 20, 1984.

bsource: M, Gon~ale~, public Health Service, us, Depaflment of Health and Human Services, Washington, DC, perSOna~ Communication, Nov. & 1964. Figures are approximate, and based on the difference between AIDS obligations at two points in

time, one earlier (approximately July 1964) and one later (approximately August 1964). The assumption made by PHS was

that any tncreases in obligations between the two points in time would have had to represent a redirection of funds initially

obligated to other activities into AIDS activities (W. H. Little, personal communication, Dec. 28, 1984). Further estimates of

the amounts redirected to AIDS from other activities in fiscal year 1964 have not been calculated by PHS.

Table 3.— Supplemental Funds for PHS Agencies’ AIDS Activities in Fiscal Year 1984:

Agencies’ indications Compared to Congressional Appropriations n

(thousands of dollars)

Agency Administration’s Congressional

Agency indication request appropriation

CDC . . . . . . . . . . . . . . . . . . . . . . . $3,200 $ – $1,750

FDA . . . . . . . . . . . . . . . . . . . . . . . 2,600 — —

NIH:

NCI . . . . . . . . . . . . . . . . . . . . . 3,900 — 2,000

NIAID . . . . . . . . . . . . . . . . . . . . 8,330 — 4,150

NIDR . . . . . . . . . . . . . . . . . . . . 81 — —

DRR . . . . . . . . . . . . . . . . . . . . . 790 — 400

ADAM HA:

NIMHd . . . . . . . . . . . . . . . . . . . 375 — 375

NIDAe . . . . . . . . . . . . . . . . . . . 800 — 800

HRSA . . . . . . . . . . . . . . . . . . . . . – — —

Total . . . . . .. . . . . . . . . . . . $20,076 $ – $9,475

Notes:

alnitial agency indications were not forwarded to Congress by the Department of Health and Human SerViceS.

bsource: E. N. Brandt, Jr., Assistant Secretary for Health, Publlc Health Service, U.S. Department of Health and Human Services, “Proposed FY 1964 Supplemental and FY 1985 Amendment for Acquired Immunodeficiency Syndrome, ” memorandum

to the Secretary of Health and Human Services, May 25, 1964.

csource: US, congress, House of Representatives, “Making Supplemental Appropriations for the Fiscal Year Ending September

30, 1964, and for Other Purposes, ” Conference Report 98-977 (to accompany HR. 6040), Aug. 10, 1984.

dN\MH = National Institute of Mental Health.

eNIDA = National Institute on Drug Abuse.
35

Table 4.-Amounts Identified for PHS Agencies’ AIDS Activities for Fiscal Year 1985: President’s Budget

Request Compared to Congressional Appropriations or Estimated Actual Obligations

(thousands of dollars)

Notes:

asource: E N Brandt, Jr , Assistant Secretav for Health, Public Health Service US Department of Health and Human se~lces, Washington DC, letter ‘o Off Ice of

Technology Assessment, U S. Congress, Dec. 20, 1964

bsources. w H Little, Office of the Assistant Secretaw for Health, public Health services, u.S. Depaflment of Health and Human sW/lCr2S, Washington, DC, perSOflal

communication, Oct 26, 1964; and E N Brandt, Jr., Assistant Secretary for Health, Public Health Service, U.S. Department of Health and Human Serwces, letter to

Office of Technology Assessment, U.S. Congress, Dac 20, 1984.

clncludes Cranston Amendment and estimated redistribution needed

dlncludedIn total congressional appropriations

elncludes $4,5 million for addition to CDC wrology bu~ldlng

f Contingent on President’s request fOr $8,350,000

gsource: p Fis.chinger, Associate Director, f.Jational cancer Institute, National Institutes Of Health, Bethesda, MD, personal communlcatlon, NOV 6, 1984

hsource. y dueuy, Financial Management section, Natjonal Institute Of Allerqy and lnftxtiws Diseases, National !nStltutOS Of Health, Bethesda, MD, Personal corn”

-.

munication, Nov” 8, 1964

1 Includes an tncrease of $5,347,oOO over previous estimates for AIDS

PHS agencies’ needs for funds for AIDS activities in fiscal year 1985 have necessitated some

redistribution of funds from other activities. At

NIAID, between $5 million and $5.5 million has

been identified as having to come from other activities, and at NCI, the figure is $4,570,000. CDC

has said that it will not need to identify additional

funds from other activity areas (119). Depending

on the number of antibody-positive blood donors

identified in its multicenter study of blood donors,

NHLBI may have to request or identify additional

funds from other activities (175).

In ADAMHA’s opinion, all of the AIDS funds

appropriated as part of the regular budget process have come from the agency’s other activities.

In other words, ADAMHA would have received

the same total dollar amount for its budget regardless of how the funds were designated to be

spent. Only supplemental appropriations and

funds from the Cranston Amendment to the fiscal

year 1985 appropriations for AIDS constituted additional money for AIDS activities (139).

No additional funds have ever been requested

for the AIDS activities at HRSA, although the

agency has been expected to participate in the PHS

response to AIDS. HRSA’s Division of Maternal

and Child Health provides information on AIDS

to recipients of the Maternal and Child Health

Block Grant (which the Administration proposed

transferring to OASH in DHHS (168)) and to Hemophilia Treatment Centers, which are funded

through the Division of Maternal and Child

Health, and recently helped organize a conference

on pediatric AIDS. HRSA expects to be required

to take a greater role in the AIDS situation as the

number of pediatrics AIDS cases increases. An increased role for HRSA might require additional

funds for the agency, and HRSA is optimistic that

money could be obtained if the case were made

to PHS. To date, HRSA has been told that the
—————— —

36

PHS priority for AIDS refers to research into the

biomedical aspects of AIDS, and PHS maintains

that HRSA has had sufficient funding to complete

the AIDS tasks assigned to it (22).

Funding for the PHS

Agencies as a Whole

DHHS has encouraged PHS agencies involved

in AIDS research to take money and personnel

from other activities to avoid asking Congress for

additional funds. However, cutbacks and threatened cutbacks in funding and, in particular, in

personnel levels have restricted the ability of affected agencies to redirect resources to AIDSrelated activities. Tables 5, 7, 9, 10, and 12 compare funding levels suggested in the President’s

budgets for the years 1983, 1984, and 1985 for

CDC, FDA, NIH, ADAMHA, and HRSA, respectively. Tables 6, 8, and 11 show actual overall

agency and AIDS budgets for CDC, FDA, and

ADAMHA.

Table 5.—Centers for Disease Control: Initial U.S. Budget Request Compared to Estimated Budget Authority

for Previous Year, Fiscal Years 1983 to 1985a (thousands of dollars)

1985Rb

1984EC I 1984R 1983E 1983R 1982E

CDC budget:

Excluding preventive health block grantd. . . . . . . . . . . . . . .

Including preventive health block grantd . . . . . . . . . . . . . . .

Percentage increase or decrease over previous year:

Excluding block grant . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Including block grant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CDC FTEse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Infectious diseases budget:’. ... , . . . . . . . . . . . . . . . . . . . . .

Percentage increase or decrease over previous year. . . . .

$280,364 $286,310 $270,023 $243,372 $217,192

$369,864 $374,504 $356,352 $329,701 $298,792

$202,010

$283,610

4,268

N.A.

Notes:

asource: Budget of the U.S. Government, Fiscal years 1~ to ~965

bR = Budget request.

CE = Estimated budget authority.

dThe presidents budget ~ro~osed that preventive heath block grant funds be transferred from CDC to the office of the Assistant Secretary for Health (OASH). CDC

budgets both including and excluding the preventive health block grant are shown here because excluding administration of the block grant would affect CDC’S size

and activity. The preventive health block grant was not transferred to OASH in either fiscal year 1964 or 1965.

eFTEs = Full-time equivalents.

f The cDC AIDS Activity is located in the CDC Center fOr Infectious Diseases.

gN.A, = Not available

Table 6.—Centers for Disease Control: Overall Agency Budgets and AIDS Budgets,

Fiscal Years 1979 to 1985a (thousands of dollars)

1985 1984 1983 1982 1981 1980 1979

Overall CDC budget: $410,530 $380,489 $353,476 $302,242 $288,228 $296,125 $263,972

Percentage increase or decrease over

previous year . . . . . . . . . . . . . . . . . . . . . . 7.9% 7.6% 17.0% 4.9% –2.7% 12.2 ”/0

CDC FTEsb . . . . . . . . . . . . . . . . . . . . . . . . . .

—

4,401C 4,198 4,070 4,317 4,245C 4,052C 4,048

Notes:

asource: Except where otherwise noted, B. Shepard, Centers for Disease Control, Atlanta GA, PerSOnal COmtTIUniCatiOn, Oct. 16, 1964.

bFTE9 = Full-time equivalents.

Csource: E, N. Br~dt, Jr., Assistant Secretav for Health, Public Health Service, U S. Department of Health and Human Services, Washington, DC, letter to Office of

Technology Assessment, U.S. Congress, Dec. 20, 1964.

dlncludes $4,500,1xxI for CDC virology building.

elncludes $1 ,750,C00 in SUppkTIEinkIl appropriations.

f Includes s2,225,000 in supplemental appropriations.

9Supplementel appropriation.

hRedirected fmm suweillanceof hepatitis, studies of chlamydial infections and pelvic inflammatory diseases, purchases of laboratory SUpplieS and equipment, studies

of influenza risk factors and vaccines.

i Estimated.
37

Table 7.—Food and Drug Administration: Initial U.S. Budget Request Compared to Estimated Budget Authority

for Previous Year, Fiscal Years 1983 to 1985° (thousands of dollars)

1985Rb 1984EC 1984R 1983E 1983R 1982E

FDA budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $394,004 $382,574 $385,933 $349,130 $356,163 $328,032

Percentage increase over previous year. . . . . . . . . . . 3% — 10.5% — 8.6% —

FDA FTEsd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7,094 7,191 7,163 7,164 7,180 7,192

Notes:

asource: BUdg@S of the U.S. Government, Fiscal Years 1983 to 1985.

bR = Budget request.

CE = Estimated budget authority.

dFTEs = Full-time equivalents.

Table 8.—Food and Drug Administration: Overall Agency Budgets and AIDS Budgets,

Fiscal Years 1979 to 1985a (thousands of dollars)

1985 1984 1983 1982 1981 1980 1979

$361,645 $338,268 $327,927 $320,852 $295,154

6.9% 3.20/o 2.2% 8.7% —

FDA FTEsC . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7,068b 7,090 7,090 7,159 7,777 7,623d 7,561d

798 $ 350 $ 150 — — —

8

e 7

e 

— —

— —

Notes:

asource~: J, Bivianoj Budget Analyst, Food and Drug Administration, Rockville, MD, personal communication, Aug. 28, 1984; and C. L. Wilburn, Food and Drug Administration, Rockville, MD, personal communication, Nov. 5, 1984.

bE~timate based on Continuing resolution, Twenty FTEs are in qU@iOn and $8,3 rnllllofl will t’lave to be requested by the President in order tO be obligated.

CFTES = Full-time equivalents.

dActual positions; accounting conversion had not been made to FTEs.

eRedirected from other activities (hepatitis, herpes, perfussis, cytOmegalOVirUS, and chickenpox).

Table 9.—National Institutes of Health: Initial U.S. Budget Request Compared to Estimated Budget Authority

for Previous Year, Fiscal Years 1983 to 1985a (thousands of dollars)

1985Rb

1984E I 1984R 1983E I 1983R 1982E

NCI budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $1,101,069 $1,077,303 $989,263 $983,576

Percentage increase or decrease over previous year. . . 2.2%

NCI FTEsd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,292

$955,449 $986,617

0.6%

2,259

$281,405

2.9%

768

–3.2%

2,370

$246,043

4.3%

814

2,387

$ 314,117

2,289

$273,581

2,504

NIAID budget. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 325,379 $235,895

Percentage increase over previous year. . . . . . . . . . . . . . 3.6%

NIAID FTEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 730

NHLBI budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 718,852

Percentage increase over previous year. . . . . . . . . . . . . . 2.2%

DBDRe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 104,890

NHLBI FTEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 913

837

$559,637

762

$ 703,197

772

$628,028 $622,745

0.80/0

$87,930

888

$80,583

2.2%

341

$577,143

3.1 %

$78,339

934

$74,462

3.40/0

369

$ 77,563

936

$71,983

$ 102,466

954

$ 88,163

$87,572

900

NIDR budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 91,096 $78,860

Percentage increase over previous year. . . . . . . . . . . . . . 3.30/0

NIDR FTEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 347 362

$ 335,205

348

$295,719

385

NINCDS budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 344,601 $265,901

Percentage increase over previous year. . . . . . . . . . . . . . 2.8%

NINCDS FTEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 705

$301,022

1.8%

720

$274,505

3.20/o

735 733

$ 154,683

730

$141,561

763

NEI budget. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 157,873 $127,374

Percentage increase over previous year. . . . . . . . . . . . . . 2.1 %

NEI FTEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

$143,276

1.2%

224

$228,542

6.9%

98

$131,550

3.3%0

222

$191,024

3.70/0

99

213

$ 242,636

218

$213,804

227

DRR budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 245,728 $184,177

Percentage increase over previous year. . . . . . . . . . . . . . 1.3%

DRR FTEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 100 99 96

Notes:

asource: Budgets of the U.S. Government, Fiscal Yeas 1983 to 1985.

bR = Budget requast.

CE = Estimated budget authority.

dFTEs = Full-time eqtIiValentS.

eDBDR = Division of Blood Diseases and Resources.
38

Table 10.—Alcohol, Drug Abuse, and Mental Health Administration: Initial U.S. Budget Request Compared to

Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985a (thousands of dollars)

1985Rb 1984EC I 1984R 1983E 1983R 1982E

ADAMHA budget:

Including service block grantd . . . . . . . . . . . . . . . . . . . . . . . . . $844,955 $846,206 $792,854 $777,556 $737,177 $751,007

Excluding service block grantd. . . . . . . . . . . . . . . . . . . . . . . . . $372,655 $384,206 $357,826 $338,556 $305,177 $322,912

Percentage increase or decrease over previous year:

Including service block grant . . . . . . . . . . . . . . . . . . . . . . . . –0.1% — 2.0% — – 1.80/0

Excluding service block grant . . . . . . . . . . . . . . . . . . . . . . .

—

–3.0% —

5.7% — –5.50/0 —

ADAMHA FTEse . . . . . . . . . . . . . . . . . . . . . . . . . . 1,608 1,707 1,698 1,758 1,694 1,757

NIMHf budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $226,318 $250,547 $220,348 $225,985 $195,783 $224,553

Percentage increase or decrease over previous year. . . . . . –9.7% —

–2.50/o — –12.80/o —

NIDAg budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Percentage increase or decrease over previous year . . . . . . . — — —

Notes:

asource: Budgets of the U.S. Government, Fiscal years 1983 to 1985.

bR = Budget request.

cE = Estimated budget authority.

dThe budget ~romsed transfer of ~~i~e b~o~k grant to the Office of the Assistant Secretary for Health, but the transfers were not approved by COnQreSS.

eFTEs s Full-time equivalents.

f NIMH = National Institute of Mental Health,

gNIDA = National Institute on Drug Abuse.

Table 11 .—Alcohol, Drug Abuse, and Mental Health Administration: Overall Agency Budgets and AIDS Budgets,

Fiscal Years 1982 to 1985a (thousands of dollars)

1985 1984 1983 1982

Overall ADAMHA budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $434,093 $384,411 $340,866 $332,423

(NIMH) . .. . . . . . . . . . . . . (283,626) (251,035) (227,342) (229,319)

(NIDA) . . . . . . . . . . . . . . (81,410) ( 71,098) ( 61,854) ( 56,564)

Percentage increase or decrease over previous year: . . . . . . . . . . . 12.9% 12.80/o 2.50/o

(NIMH) . . . . . . . . . . . . . . . . . . . . . . . . (12.90/o)

—

(10.4%) (–0.90/0) —

(14.9%) ( 9.3%) —

1,659 1,660 1,624

AIDS budget . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 2,812 $ 2,791 $ 516

(NIMH) . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

—

(1,787) (1,205) (202)

(NIDA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

—

(1 ,025) (1,586) (314) —

Notes: asources. E, N, Erandt, Jr,, ASSiStant seCretarY for H~lth, public Health Sewice, U.S. Department of Health and Human SerViCeS, Washington, DC, letter tO Office

of Technology Assessment, U.S Congress, Dec. 20, 1984; and US. Department of Health and Human Services, Publ!c Health Service, Alcohol, Drug Abuse, and Mental

Health Administration, “ADAMHA AIDS Research,” xerox copy dated Dec. 14, 1984.

bFTEs = Full-time equivalents.

CN,A, = Not available,

Table 12.—Health Resources and Services Administration: Initial U.S. Budget Request Compared to Estimated

Budget Authority for Previous Year, Fiscal Years 1983 to 1985a (thousands of dollars)

1985Rb 1984EC 1984R 1983E 1983R 1982E

HRSA budget:

Excluding block grantsd . . . . . . . . . . . . . . . . . . . . . $ 245,419 $ 459,031 $ 292,444 $ 481,208

Including block grantsd . . . . . . . . . . . . . . . . . . . . . . $1,187,119 $1,380,151 $1,127,816 $1,315,226 $1,724,1; $1,401,9;

Percentage increase or decrease over previous

year:

Excluding block grants . . . . . . . . . . . . . . . . . . . . –46.50/o — –39.20/o — — —

Including block grants. . . . . . . . . . . . . . . . . . . . . –14.0”/0 — – 14.20/o 23.00/o

HRSA FTEse . . . . . . . . . . . . . . . .

— —

2,704 3,746

Notes:

3,731 4,627 3,787 4,874

asource: Budgets Of the U.S. Government, Fiscal Years 1983 to 1985.

bR = Budaet reauest.

CE = Estimated ‘hdget authority,

dThe presidents ~dgets for fiscal years lg&f and lg85 proposed that several block grants be transferred to the Office of the Assistant SeCretarY for Health (OASH).

HRSA budgets both including and excluding the block grants are shown here because excluding administration of the grants would have affected HRSA’S size and

activity including AIDS activities. For example the proposed transfers included the Maternal and Child Health Block Grant, the program through which HRSA informs

grant recipients of information about AIDS, The block grants were not transferred to OASH in either fiscal year 1984 or 1985.

eFTEs = Full.time equivalents,
—

39

As shown in table 5, for fiscal year 1985, the

President requested a reduction in overall funds

and personnel ceilings for CDC relative to estimated budget authority for the previous year. A

reduction in funding from previous levels for the

CDC Infectious Diseases Activity, of which the

AIDS Activity is a part, was also requested in

both 1984 and 1985, when, as shown in table 6,

CDC’s actual AIDS expenditures have been increasing at a growing rate over the years. CDC

was especially affected by budget cutbacks in the

period when it was starting to become heavily involved in AIDS activities. As shown in table 6,

the agency’s overall budget was reduced by almost

$8 million, or 2.7 percent, from 1980 to 1981, The

1982 appropriation brought CDC’s budget back

to approximately the 1980 level, In 1983, although

the overall agency budget increased a substantial

amount, the number of FTEs at CDC declined to

4,070 from 4,317.

Levels of funding have similarly varied over the

years for other PHS agencies involved in AIDS

activities. As shown in table 7, the President’s

budget suggested 8.6- and 10.5-percent increases

in funding for FDA in fiscal years 1983 and 1984,

but only a 3-percent increase in funding for fiscal

year 1985. FDA is responsible for evaluating the

blood test for AIDS and the safety and efficacy

of blood products and vaccines.

As shown in table 9, presenting figures for NIH,

the President’s budget for 1983 suggested a 3.2-

percent decrease in funding for NCI. Only minimal increases in funding were suggested for NCI

and most of the other NIH institutes in fiscal years

1984 and 1985. If inflation is taken into account,

these minimal increases would represent decreases

in funding. (A 14-percent increase in funding for

the seven NIH institutes involved in AIDS activities was approved by Congress for fiscal year

1985: actual appropriations for the institutes involved were $1,183,806,000 for NCI; $370,965,000

for NIAID; $805,269,000 for NHLBI; $396,885,000

for NINCDS; $181,678,000 for NEI; $100,688,000

for NIDR; and $304,025,000 for DRR).

The Administration’s pattern for ADAMHA

overall, as shown in table 10, has been to suggest more decreases than increases, although increases in funding have been suggested for NIDA.

As shown in table 11, appropriations for

ADAMHA have increased since 1982. Except for

fiscal year 1983, as shown in table 12, the Administration has also suggested substantial decreases

in funding for HRSA. (HRSA’s actual fiscal year

1985 appropriation was $1,427,694,000, )

Of greater impact than suggestions for holding

funding levels about even or decreasing them have

been budget requests by the Administration for

decreases in PHS agencies’ FTE personnel ceilings.

The Administration has consistently suggested decreases in personnel ceilings for CDC, FDA, NCI,

NIAID, NHLBI, NIDR, NINCDS, ADAMHA,

and HRSA. Small increases were suggested for

NEI in the 1984 budget and for DRR in the 1983

budget. Decreases in personnel have actually occurred at several of the agencies at critical times.

No additional personnel resources have been allocated to NIAID for any of its AIDS activities

(etiology, natural history, immunology, treatment, and prevention research) (166).

How AIDS and Other Activities Have

Been and Will Probably Be Affected

by Funding Patterns

The effect of funding patterns for AIDS has varied over time and by agency. Initially, the lack

of resources impeded the funding of extramural

research (NCI and NIAID), prospective studies

of high-risk individuals (NIH and CDC), and animal studies (CDC) (146). As the Nation’s public

health monitor, CDC is required to conduct surveillance of a number of diseases and public health

outbreaks. FDA’s mission is to develop criteria

to help it evaluate the safety and efficacy of the

products it regulates. Thus, neither agency was

easily able to redirect funds and staff into the area

of AIDS without sacrificing other important

work. The mission of NIH agencies is basic research, much of which may be advanced by involvement in the AIDS problem. Thus, in NIH

laboratories, redirection of staff to work on AIDS

have not detracted from other activities as much

as have redirection of staff at CDC and FDA.

This situation at NIH, especially for NCI and

NIAID, may change in 1985.

In 1981, 1982, and 1983, CDC redirected funds

and personnel from a number of activities (e. g.,
40

surveillance of hepatitis, studies of chlamydial infections and pelvic inflammatory diseases, studies

of influenza risk factors and vaccines, and purchases of laboratory supplies and equipment) to

support AIDS activities. In more recent fiscal

years, including fiscal year 1985, Congress has

appropriated amounts greater than those initially

requested by the Administration for AIDS, so the

redistribution of CDC funds from other activities

has not been necessary (119). Personnel ceilings

at CDC remain a problem. Three or four additional staff are needed for a study of blood recipients, but they cannot be promised until the fiscal

year 1985 budget is settled. Congress has recommended a personnel “floor” of 4,400 for CDC. In

the appropriations, 155 FTEs were specified for

AIDS. As of November 1984, only 80 had been

received, and CDC will not find out about the

remainder until OMB completes its budget process (119). CDC’s coordinator of AIDS activities

was not optimistic about getting additional FTEs

(38). The way budgets have been processed has

consistently impeded the making of plans at CDC

(51).

FDA (see tables 7 and 8) has had largely the

same problem as CDC. In the past, personnel and

funds have been redirected from work on interleukin-2 for herpes, chicken pox, and other related

viruses; improvement of current vaccines for pertussis; and research associated with hepatitis vaccines (177). Currently, even though it is well into

fiscal year 1985, FDA’s appropriation is under a

continuing resolution. Additional problems are

caused by the facts that $8.3 million of the money

designated for AIDS by Congress must be requested by the President before it is obligated; and

a reduction in overall agency FTEs was recommended by the Administration and approved by

Congress.

As noted, NIAID and NCI historically have had

fewer problems with the redistribution of funds

from other activities than have CDC and FDA.

In addition, because they are part of a larger

agency, NCI and NIAID have been able jointly

to fund extramural research projects and lend each

other laboratory and other personnel. Currently,

NIAID continues to have problems obtaining staff

to conduct statistical analyses for its five-city

study of high-risk gay men, and NIAID did not

receive a fiscal year 1985 appropriation adequate

to meet the needs it articulated in the Assistant

Secretary for Health’s memo to the Secretary of

DHHS requesting a budget amendment.

NIAID plans to spend $23,262,000 in fiscal year

1985 on its AIDS activities, $4,570,000 of which

will be redirected from other activities (see tables

4 and 13). This redistribution was necessary to

fund continuation costs of activities supported as

a result of the fiscal year 1984 supplemental appropriation of $4,150,000. As shown in table 13,

the redistribution of funds from other activities

means that new grants covering the gamut of

NIAID activities will not be funded; certain nonAIDS projects that had been planned will not be

started. In addition, certain new AIDS projects

that had been requested will be foregone or postponed (142). These include the following (41):

Table 13.—National Institute of Allergy and infectious

Diseases: Redistribution Needed To Fund Fiscal Year

1985 AIDS Activitiesa (thousands of dollars)

Amount Source

$2,258

$1,542

$ 770

18 competing research project

grants (covering the gamut of infectious diseases and immunology) will not be funded

Congressionally requested major

new clinical trials on:

● ribavirin therapy of viral

respiratory diseases

● candidate vaccines for Group

B streptococcal infections

Intramural research on vaccine

development other than for AIDS:

● hepatitis

● rotavirus diarrhea

● pertussis

Total . . . . . $4.570

Note:

asource: Y. duBuy, Finmcial Management Section, National Institute Of Allergy

and Infectious Diseases, National Institutes of Health, Bethesda, MD, personal

communication, Nov. 6, 1964,

. extramural studies of the development of new

vaccines and antiviral drugs for HTLV-III infection;

● extramural studies to develop animal model

systems for testing vaccines and antiviral

drugs for HTLV-III infection;
41

●

●

●

●

intramural clinical protocols of treatment

regimens directed at HTLV-III virus as well

as immune defects resulting from viral infections;

investigations of immune derangements in

addicted parents and children;

epidemiological cohort study of HTLV-III infections in health care workers; and

support for additional AIDS outreach programs directed at health care workers.

NCI will also have to change its funding patterns in fiscal year 1985, and anticipates some

problems as a consequence of changes in personnel ceilings. NCI did not receive any funds under

the Cranston Amendment (see table 4), to the

chagrin of two of its Boards of Scientific Counselors (Boards of the Division of Cancer Etiology

and the Division of Cancer Treatment) (163,176).

In order to fund AIDS activities in 1985, NCI will

take funds from its research projects grants center, cancer centers, cooperative clinical research,

career program development, and clinical education (see table 14). NCI also foresees significant

problems at the end of the current contract year

when it will be unable to fund continuing costs

for anticipated subcontracts at the Frederick

(Maryland) Cancer Facility begun with funding

from the fiscal year 1984 supplemental appropriation. The subcontracts will be a key element in

vaccine development research and it is unlikely

that the research can be completed in 1 year (162).

Table 14.—National Cancer Institute: Estimated

Redistribution Needed To Fund Fiscal Year 1985

AIDS Activitiesa (thousands of dollars)

Amount Source

$2,550 to $2,800 Research project grants pool

850 to 930 Cancer centers

850 to 930 Cooperative clinical research

550 to 610 Career program development

200 to 230 Clinical education

Total . . . . $5,000 to $5,500

Note:

asources: p, Fischinger, Associate Director, National Cancer institute, National

Institutes of Health, Bethesda, MD, personal communications, Nov. 6, 1964. and

Jan. 3, 1985; and E. N. Brandt, Jr., Assistant Secretary for Health, Public Health

Service, US Department of Health and Human Services, Washington, DC, letter

of Office of Technology Assessment, US Congress, Dec. 20, 1964

In addition to funding problems, a number of

factors have come together to make NCI vulnerable to personnel cutbacks. Prior to a year and

a half ago, a category of personnel called “special

experts” could be hired without being counted

against NIH’s personnel ceilings. When the policy was first changed and the experts began to be

counted against the NIH personnel ceiling, it did

not have much impact on NCI, because most of

the institutes at NIH were under ceiling, so the

NIH in the aggregate was within the agency limitation. Personnel slots can be “loaned” across agencies at NIH. Now, however, the other institutes

are up to strength and are subject to an NIH hiring freeze which sets positions at 13,507 FTEs.

NIAID had loaned NCI nine positions and now

needs them back. As a consequence, NCI is currently under a restriction to hire only one person

for every two who leave the institute (162). NIAID

foresees that it may have the same restriction

(166). According to OASH, however, NIAID will

be able to hire three persons for every five who

leave, the restrictions on NCI are in effect only

until NIH receives its final ceiling for 1985, and

the NIH Director has discretion to grant exceptions to the restriction for high-priority needs (22).

These changes reduce the prospects of hiring appropriate personnel for specific project initiatives

in 1985. Thus, for example, NIH expects to have

to make cutbacks in its Clinical Center nursing

staff, which means that fewer patients will be

available for clinical trials and treatment.

Measures To Increase the Number

of Extramural Research Projects

One of the early criticisms of NIH was its inattention to extramural research on AIDS. Critics

charged that not enough extramural research was

being funded and that what was being funded was

taking an unconscionably long time to go through

the system. In order to deal with the problem of

long delays in funding, NIH initiated mail ballots

and other procedures to expedite extramural grant

reviews. Subsequently, the award rate at the three

NIH institutes most heavily involved in AIDS

activities (NCI, NHLBI, and NIAID) was greatly

accelerated. For 1983, as shown in table 15, the

award rate, or the number of approved grants actually funded, in all areas at all three institutes

was around 35 percent; for AIDS, the award rates

were 67 percent for NCI, 100 percent for NHLBI,

42-575 0 - 85 - 4
42

Table 15.—National Institutes of Health Award Rates

and Paylines for All Extramural Research Compared

to AIDS Extramural Research, Fiscal Year 1983a

NCI NHLBI NIAID

All extramural research:

Number of grants approved

for funding. . . . . . . . . . . . . . . 2,610

Number of grants actually

funded . . . . . . . . . . . . . . . . . . 886

Award rate . . . . . . . . . . . . . . . . . 34 ”/0

Payline (priority score at

which approximately 90°/0

of grants were funded) . . . . 181

AIDS extramural research only:

Number of grants approved

for funding. . . . . . . . . . . . . . . 45

Number of grants actually

funded . . . . . . . . . . . . . . . . . . 30

Award rate . . . . . . . . . . . . . . . . . 670/o

Number of grants funded at

priority score ranges:b

100-180 . . . . . . . . . . . . . . . . 8

181-200 . . . . . . . . . . . . . . . . 5

201-250 . . . . . . . . . . . . . , . . 7

251-300 . . . . . . . . . . . . . . . . 10

2,114

748

35%

195

2

2

100%

—

1

—

1

1,406

522

37%

166

17

17

100 ”/0

12

2

2

1

Notes:

asource: N. D, Mansfield, Division of Financial Management, National Institutes

of Health, Bethesda, MD, letter to Office of “technology Assessment, U.S. Congress, Oct. 22, 1W4.

bThe lower the score, the higher the priority.

and 100 percent for NIAID. For NCI, this meant

that a number of extramural grants receiving

rather poor priority score ranges were funded (the

lower the score, the higher the priority for funding). ADAMHA also expedited its review process and funded projects beyond usual priority

scores (151). However, while the use of lower

standards for AIDS research by all of the agencies mentioned undoubtedly increased the number of grants funded, it is believed that it also

resulted in the funding of some studies of poor

quality (56).

Resources for Research on

Cofactors and Treatment and

for Public Education

In addition to the issue of whether sufficient resources are being allocated to AIDS activities by

DHHS and Congress, there remains the question

of how resources are being allocated to the various

AIDS activities. In particular, doubts have been

raised about the adequacy of resources devoted

to the search for factors affecting the development

of AIDS, the provision of treatment, and public

education. In this section, the proportion of the

AIDS budget directed at these activities is summarized.

Cofactor Research

In general, the search for factors affecting the

development of AIDS has always accounted for

a large proportion of the AIDS budget. Immediately after the discovery of the etiologic agent for

AIDS, changes in resource allocations were made.

As shown in table 16, which represents funding

estimates for PHS AIDS activities as of September 11, 1984, for both fiscal years 1984 and 1985,

greater amounts were budgeted for cofactor research and epidemiologic studies (items 1b and

4 in the table) after the discovery of HTLV-III than

before it. As shown in table 17, which represents

the most current estimates, PHS estimates that of

the total PHS resources allocated to AIDS in fiscal

year 1984, 12.6 percent was obligated to cofactor research, and 31.9 percent, to epidemiologic

studies. In fiscal year 1985, a relatively greater

proportion (14.9 percent) of total AIDS resources

will be obligated to cofactor research, but a substantially smaller proportion (26 percent) will be

obligated to epidemiologic studies. In total dollars,

however, almost $5 million more will be obligated

to epidemiologic studies in fiscal year 1985 than

in 1984, and $6 million more to cofactor research.

It is more difficult to estimate the amounts being spent by PHS for research into psychosocial

risk factors. As shown in table 17, research on

psychosocial factors (item 8 in the table) constitutes a relatively small amount of total fiscal year

1985 resources for AIDS (2.1 percent of the budget, equal to $1,949,000). Furthermore, this category, as defined by PHS, includes research both

on the psychosocial consequences of AIDS and

on psychosocial factors which might contribute

to its development. Possible psychosocial risk factors for AIDS include life stress, exhaustion,

health habits, depression, anxiety, coping mechanisms, a sense of helplessness, and the loss of

social support (see, e.g., 8,35,95,110).

Several studies of psychosocial risk factors and

consequences of AIDS are being supported by

NIMH (see app. D). The investigation of psychosocial factors has also been incorporated into epi-
43

Table 16.—Changes in Funding for PHS AIDS Activities Anticipated After Discovery of AIDS Etiologic Agent a b

(thousands of dollars)

Fiscal year 1984 Fiscal year 1985

Appropriate ion Obligation President’s budget

(Public Law 98-139) respread after Before After

Activity before discovery discovery’ discovery discovery

1. Etiologic agent and cofactors:

a. Discovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b. Confirmation and extension of

observations on causative agent and

discovery of role of confections and

cofactors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Development and evaluation of blood tests:

a. Development. . . . . . . . . . . . . . . . . . . . . . . . . . .

b. Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. Epidemiological studies (to determine natural

history of AIDS) . . . . . . . . . . . . . . . . . . . . . . . . . .

5. Development of evaluation of vaccine

(including animal model) . . . . . . . . . . . . . . . . . .

6. Studies of therapeutic intervention:

a. AIDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b. Opportunistic infections . . . . . . . . . . . . . . . .

7. Immunologic studies . . . . . . . . . . . . . . . . . . . . .

8. Psychosocial factors. . . . . . . . . . . . . . . . . . . . . .

9. Simian AlDS .. . . . . . . . . . . . . . . . . . . . . . .

10. Prevention of transfusion-related AIDS . . . . . .

11. Bioethics and biosafety . . . . . . . . . . . . . . . . . . .

12. Information dissemination/public affairs . . . . .

PHS total . . . . . . . . . . . . . . . . . . . . .

21 “/0 $10,697 130/0 $ 6,357 1OO/o $ 5,654 50/0 $ 2,797

6

6

1

6

27

3

7

10

6

1

o

2

1000/0

2,949 8 4,010 1 689 6 3,337

1,553

3,175

3,260

22,651

2,554

4,337

5,247

3,238

1,009

1,612

550

260

973

2,949

559

3,100

5

4

6

2,309

1,895

3,092

5

5

6

2,932

3,109

3,260

3

6

6

13,756 32 16,279 38 21,231 40

1,477 3 1,477 4 2,237 5

3,414

5,183

3,023

709

1,808

22

168

964

7

10

6

1

4

0

0

2

3,414

5,212

3,023

709

1,808

22

207

964 —

8

9

6

2

3

1

0

2

4,471

5,149

3,238

1,009

1,791

550

260

973

8

9

6

2

3

1

0

2

$50,778 1000/o $50,778 100% $56,553 1000/, $56,553

Notes

a Figures are approximate and ~eprment ~alculation~ before passage of the supplemental appropriation for fiscal year 1984 and the appropriation for fiscal year 1985

bsource. u s Department of Health and Human Sewices, “AIDS Public Health Sewice Total,” xerox copy provided by W H Little, Office of the Assistant Secretary

for Health, sheets dated July 27, 1964, and Sept 11, 1964.

CAfter the dlwovewof HTLV.11 1 as the probable et iologi~ agent for AIDS, the remaining $29, Ir)6,@30 availabie for obllgat ions for Various aCtlvltleS WaS redistributed

or “respread” among the actltitles

Table 17.—Funding for PHS AIDS Activities by Type of Activity, Fiscal Years 1984 and 1985a (thousands of dollars)

Fiscal year 1984 obligation

Activity as of 9130/84 Fiscal year 1985 appropriation

1. Etiologic agent and cofactors:

a. Discovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.20/o $5,058

b. Confirmation and extension of observations on

— —

causative agent and discovery of role of

confections and cofactors . . . . . . . . . . . . . . . . . . . . . 12.6 7,732 14.90/0 $13,804

2. Development & evaluation of blood tests:

a. Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7 1,070 1.9 1,754

b. Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7 1,066 4.9 4,569

3. Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5 2,772 4.7 4,400

4. Epidemiological studies (to determine natural

history of AIDS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31.9 19,600 26.0 24,119

5. Development and evaluation of vaccine (including

animal model) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.7 2,879 12.7 11,776

6. Studies of therapeutic intervention:

a. AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3 3,852 8.8 8,158

b. Opportunistic infections . . . . . . . . . . . . . . . . . . . . . . . 8.1 4,957 6.0 5,554

7. Immunologic studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.0 6,753 10.1 9,444

8. Psychosocial factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8 1,105 2.1 1,949

9. Simian AIDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 2,589 2.7 2,546

10. Prevention of transfusion-related AIDS . . . . . . . . . . . . . 0.9 522 0.9 882

11. Bioethics and biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . 0.1 82 0.2 144

12. Information dissemination/public affairs . . . . . . . . . . . 2.3 1,423 4.1 3,827

PHS total . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100% $61,460 100% $92,926b

Notes ZIsource. E N &andt, Jr , ASSiStant s~cretaw for Health, public Health Service, IJ S, f)epartrnent of Health and Human Sewices, Washington, DC, letter tO Off iCe Of

Technology Assessment, US, Congress, Dec 20, 1964

bExcluding $45 milllon for CDC VirO109Y lab.
44

demiologic studies being conducted under the aegis

of other agencies. Thus, for example, NIAID’s prospective study of 5,000 apparently healthy gay

men in five cities has incorporated some psychosocial items (depression, life satisfaction, self-

-esteem, social support, sense of control) into its

basic questionnaire, and grantees are free to develop additional questions. However, most of the

research on risk factors concentrates on factors

other than the psychosocial: cytomegalovirus,

Epstein-Barr virus, herpes virus, hepatitis, the

iatrogenic effect of steroids and other medicines,

alcohol and other recreational drug use, smoking, sexual practices, ethnicity, and particular

underlying diseases (165).

As shown in table 18, all of the PHS agencies,

except FDA and HRSA, are involved in the investigation of confections and cofactors (item 1b)

and in epidemiologic studies to determine the natural history of AIDS (item 4). Further details on

the proportion of resources being devoted to the

various AIDS activities by each agency, including

cofactors and epidemiologic research, are provided in appendixes C and D.

Treatment

Tables 17 and 18, and appendix C, indicate the

relative proportion of PHS resources being devoted to research on treatment. As shown in table

17 (item 6), the most recent calculations indicate

that 14.8 percent ($13,712,000) of the AIDS budget for fiscal year 1985 was to be used for studies

of therapeutic intervention (8.8 percent for AIDS

and 6 percent for opportunistic infections). These

include studies of the drugs suramin, ribavirin,

pentamidine, and dapsone; the use of polyamine

inhibitors to control cytomegalovirus infections;

and the use of interferon and interleukin-2. They

do not include the study of psychosocial factors

related to treatment, which are included in the 2.1

percent of the budget allocated to psychosocial

factors (item 2 in table 17). The PHS emphasis

has been on studies of biological treatment. In addition, except for the treatment given to AIDS patients at the NIH Clinical Center and the benefits

patients gain from certain PHS activities (e.g.,

public education efforts directed at health care

workers, the funding of researchers in extramural

hospitals), no PHS funds have been allocated to

the treatment of AIDS patients per se. The NIH

Clinical Center is a research hospital to which patients are admitted on the basis of ongoing protocols, not need for treatment. The role of Federal agencies other than PHS in obtaining money

for treatment for individual patients is discussed

in the “Related Issues” section below.

Public Education and Prevention

In the past, relatively little money was allocated

to public education about AIDS. Between 1984

and 1985, however, the amount allocated for such

activities in the PHS agencies more than doubled,

from $1.4 million to $3.8 million, most of it for

CDC (item 12 in tables 17 and 18).

The AIDS budget of the Office of Public Affairs in OASH, where much of the public education has taken place, is scheduled to decrease to

$120,000 in fiscal year 1985, from $200,000 in

fiscal year 1984. PHS’s public education activities are discussed further in the “Related Issues”

section below.

PHS View and OTA Conclusions

In general, PHS believes that OTA’s review of

resources for AIDS is overly critical, especially

with respect to fiscal year 1985. In his response

to the first draft of this report, Assistant Secretary for Health Brandt said that OTA failed to

give adequate credit to PHS for the “massive effort” it has mounted in response to the AIDS problem. “Although it is true that each of the PHS

agencies has had to make readjustments and reallocations of its resources, ” the Assistant Secretary wrote; “we have nevertheless been successful

in mounting a coordinated attack in the fight

against AIDS. I assure you that adequate funds

have been appropriated for fiscal year 1985 to permit the PHS agencies to carry out all of the AIDS

requirements which have been presented to me”

(22). More specifically, PHS agencies whose comments were transmitted by the Assistant Secretary stated that other activities will not suffer from

a reallocation of resources to AIDS activities in

fiscal year 1985, that the fiscal year 1985 mix of

AIDS activities is appropriate to meet require-
45

Table 18.—Funding for PHS AIDS Activities by Type of Activity and Agency, Fiscal Years 1984 and 1985a

(thousands of dollars)

Fiscal year Fiscal year Fiscal year Fiscal year

1984 obligation 1985 1984 obligation 1985

Activity as of 9/30/84 appropriation Activity as of 9/30/84 appropriation

1. Etiologic agent and cofactors: 6. Studies of therapeutic intervention:

a. Discovery

C D C $3,33 0

NIH:

NCI 1,373

NINCDS 355

a. AID S

F D A

NIH:

DRR ., .,

NCI

NHLBI : : : : : :

NIAI D

NID R

NINCD S

Tota l

b, Opportunistic infections:

798 895

222

2,817

800

3,117

206

101

8,158

186

244

298

15

4,725

—

86

—

132

1,759

—

1,113

—

50

—

—

Tota l 5,058

b. Confirmation and extension of

observations on causative agent

and discovery of role of coinfecions and cofactors:

ADAM HA 1,036

C D C 1,403

NIH:

D R R 71

NCI 3,929

NEI 25

NHLBI : 483

NIAI D 785

—

3,852

$ 685

3,210 CDC 250

NIH:

DRR . , 274

N C I 170

N E I

NIDR 81

NINCDS . . . . 42

Total 4,957

Immunologic studies:

CDC . . . . . 300

NIH:

DRR ,,, ,, 121

NCI 2,612

NIAID ““”””:”: 3,720

NID R —

Total ., 6,753

Psychosocial factors :

ADAMH A 1,067

NIH:

D R R .,, 4

NIAI D 34

NINCD S —

Total ., 1,105

Simian AIDS:

NIH:

D R R 746

NCI ““ ““” 850

NIAID .,. ,,, 183

NINCDS, . . . . .., ,, 810

Tota l 2,589

Prevention of transfusion-related AIDS:

CDC 500

NIH:

NCI. . ,. 22

NHLBI ,. .. .,,,, —

Total ,. ,,, 522

Bioethics and biosafety:

CDC 54

NIH:

NCI 10

NHLBI ., ::::. ‘. 18

Total 82

Information dissemination/public affairs:

CDC ,. 850

NIH:

NCI . . . . . . . . . . . . . . 71

NIAID ,,. 502

Total, , 1,423

PHS Total $61,460

95

8,058

150

422

1,184

Tota l 7,732

2 Development and evaluation of

blood tests:

a. Development:

C D C 650

NIH:

DRR 7

NCI 111

NHLBI .: 302

Tota l 1,070

b. Evaluation

C D C ,,, 471

F D A —

NIH:

NHLBI , . . 555

NINCDS . . 40

13,804

5,554

32

167

3,695

5,345

205

7.

8.

9.

10.

11.

12.

1,244

9

203

298

9,444

1,479

5

34

431

1,754

1,018

3,270

195

86

1,949

989

1,403

154

—

Tota l 1,066

3. Surveillance:

CDC 2,732

NIH:

N C I 40

4,569

4,335

65

Tota l

4. Epidemiological studies (to determine

natural history of AlDS):

ADAMH A

CDC ..,

2,772 4,400

2,546

707

50

125

882

124

20

—

144

3,260

110

457

3,827

$92,926 b

688

2,710

648

4,068

NIH:

DRR

N C I

NEI ,, ,,:’

NHLBI , . ,

NIAID

NINCDS . . . ,..

Total . . . . . ,,, ,.

5. Development and evaluation of vaccine

(including animal model):

C D C

FDA ..., ,,

NIH:

NCI

NIAID ..:

NINCDS

1

4,098

19

3,513

8,449

122

19,600

—

5,177

135

7,044

6,788

259

24,119

500—

516

4,660

1,582

706

91

4,955

1,458

187

Total. ,,, 2,879 11,776

Notes:

asource: E, N, Brandt, Jr,, Assistant Secretary for Health, Public Health Service, U.S. Department of Health and Human SerViCeS, Washington, DC, letter

to Office of Technology Assessment, U.S. Congress, Dec. 20, 1984.

bExcluding $45 million for CDC virology lab. Includes $8.3 million for FDA which has not Yet been obligated.
46

ments, and that planning for AIDS activities has

been impeded by the rapidly changing problem

of AIDS and related investigations rather than by

inadequate resources, although “perhaps planning

could have been improved if resource availability had been known at the onset. ”

PHS agencies also commented on the five “open

issues” that OTA identified in the introduction to

this section. With respect to the first issue, the extent to which progress in other disease areas has

suffered as a result of diversions to AIDS activities, the comment from PHS was that “other disease areas have not necessarily suffered as a result of the increased emphasis being planned on

AIDS” and that “what we learn from AIDS will

have significant importance in other areas, with

far-reaching benefits for our research on numerous disease conditions. ” Further, the NIH will be

able to fund 1,500 more new and competing research grants (for a total of 6,500) with its fiscal

year 1985 appropriation, providing “momentum

across the entire research base.”1

Commenting on the second issue, the wisdom

of limiting the priority status of AIDS primarily

to biological research, Assistant Secretary Brandt

stated that “the effort has never been exclusively

limited to this priority.” He pointed out that only

about half of ADAMHA’s AIDS activities in fiscal

year 1985 will be for biomedical research and that

the AIDS activities of CDC primarily support

nonbiomedical research activities (i.e., laboratory

investigations, surveillance, epidemiologic studies,

technology transfer, information dissemination,

and programs on disease prevention and control).

He also stated, however, that “a concerted effort

in public education or in areas such as psychosocial factors cannot take place until we have discovered, through biomedical research, the answers we must have to the numerous questions

involving this puzzling disease. ”

As for the manner in which limited resources

can be allocated among agencies, the response

‘Subsequent to the Assistant Secretary’s letter, it was reported

that the Office of Management and Budget (OMB) plans to reduce

NIH’s fiscal year 1985 competing grants from 6,526 to 5,000 by

obligating funds for 1,526 grants in fiscal year 1985 but not actually

spending the money until fiscal year 1986 (FK Reports (“The Blue

Sheet”) l:P&R-1, Jan. 9, 1985).

from PHS was that because Congress appropriates funds by agency, PHS does not have the ability to reprogram funds between its agencies. Nevertheless, the Assistant Secretary noted, PHS has

consistently placed a high priority on AIDS. NIH,

for example, has allocated approximately $9 million of its fiscal year 1985 appropriation increases

to expand AIDS activities.

Assistant Secretary Brandt’s response to the

problem of personnel ceilings in PHS agencies was

that while personnel resources are always limited

and difficult decisions must be made, “careful

management” can “minimize the impact on science

and other AIDS activities. ” The Assistant Secretary further noted, with respect to the problems

NCI and NIAID are experiencing, that “there

is. . . a provision for exceptions to be granted

by the Director, NIH, to these restrictions for

high-priority needs. AIDS is considered a high

priority. ”

Finally, with regard to the issue of the extent

to which PHS agencies will be able to pursue

AIDS work adequately in the face of further cutbacks, the PHS response was that “it is difficult

to predict any actions to be taken in the future, ”

but “as long as AIDS continues to be a high priority health problem, PHS will continue to assign

it a high priority and allocate the necessary resources for its support. ” Assistant Secretary

Brandt pointed out that at NIH there has been a

42-percent increase for AIDS from 1984 to 1985,

as compared to a 14-percent increase in total appropriations for the seven participating institutes.

Greater increases for AIDS research relative to

non-AIDS activities, Brandt noted, are apparent

at “most” of the other agencies.

OTA concludes that although PHS has indeed

undertaken a massive effort and made significant

accomplishments, the statement that AIDS is

DHHS’s number one health priority has not

always been supported by financial and personnel resources. The responsibility for this situation,

however, appears not to rest with the Office of

the Assistant Secretary in PHS, but instead to reflect decisions made at higher levels of the Federal Government. The Administration has not

pursued an appropriation for the Public Health

Emergency Act, choosing instead to rely on se-
47

curing appropriations for individual PHS agencies from Congress. Although insufficient and

uncertain distribution of resources has not been

the sole cause of delays or inadequacies in PHS

AIDS research, surveillance, and service provision, it has resulted in at least inadequate planRELATED ISSUES

This memorandum is primarily focused on the

biomedical questions surrounding AIDS and the

ways in which PHS has attempted to address these

questions. Several related issues that also deserve

mentioning, however, are those that involve confidentiality and informed consent, prevention of

AIDS through education on the risk factors associated with the disease, and financing for the clinical and supportive services that AIDS patients

require.

Confidentiality and Informed Consent

AIDS has been described as a “legal emergency”

as well as a medical crisis (49). Much of the concern centers on discrimination experienced by

members of high-risk groups, especially gay men

and intravenous drug abusers (124). (Private consensual homosexual activity is illegal in 23 States

and the District of Columbia (17). ) There have

been reports of discrimination in housing, employment, health or life insurance coverage, or

in the receipt of medical or dental care, not only

against AIDS patients but also against those

thought to have AIDS.

Two sections of the Public Health Service Act

have been used to protect confidentiality in federally sponsored research. Section 242a of the act

(42 U.S.C. section 242a) authorizes the Secretary

of DHHS to protect the privacy of individuals participating in research on mental health, including

research on the use and effect of alcohol and other

psychoactive drugs, by: 1) withholding from all

persons not connected with the conduct of such

research the names or other identifying characteristics of such individuals; and 2) prohibiting

persons authorized to protect the privacy of such

individuals from being compelled to identify them

in any Federal, State, or local civil, criminal, adning, increased competitiveness among agencies,

inadequate attention to certain areas which are

perceived by many to be important (e.g., public

education and prevention), and a diversion of attention from other critical health areas.

ministrative, legislative, or other proceedings.

(Thus, for example, section 242a has been used

to protect the confidentiality of participants in

NIAID’s five-city study of the natural history of

AIDS. )

Section 242m(d) of the Public Health Service

Act (42 U.S. C. section 242 m(d)) provides that

information may not be used for any purpose

other than the purpose for which it was supplied

unless consent has been given. Assurances of confidentiality based on this section were issued by

CDC in July 1984 to cover the agency’s surveillance work, and epidemiologic studies and studies

of transfusion-related AIDS are being reviewed

by CDC for possible application of section 242m(d)

to these areas.

These two sections of the Public Health Service Act apparently cannot cover all AIDS research. Section 242a applies only to mental health

research or research into drug or alcohol use. Section 242m(d) is applicable only to the Centers specified in the statute (i. e., the National Center for

Health Statistics, the National Center for Health

Services Research, and the National Center for

Health Care Technology). CDC has applied section 242m(d) to its surveillance activities, because

they are similar to the functions and purposes of

the activities carried on by the National Center

for Health Statistics and because both CDC and

the National Center for Health Statistics are

funded in the same way (113).

These limitations of existing statutory assurances of confidentiality have led to a proposal by

the National Gay Task Force and Lambda Legal

Defense and Education Fund to expand section

242m(d) to cover AIDS-related research and surveillance undertaken directly or indirectly by PHS
—

48

(113). The need for such a statute will increase

if members of high-risk groups fail to present

themselves as research subjects (as some gay organizations have advised), fearing breaches of confidentiality.

Closely linked to concerns over confidentiality

is the issue of informed consent. For example, the

National Gay Task Force has stated that if confidentiality is to have any real meaning, researchers must contractually obligate themselves to the

research subject not to disclose identifying information, and that this objective can be accomplished by requiring the researcher to use a strong

consent form containing such a guarantee (113).

Until assurances of confidentiality can be given

for all AIDS-related research, informed consent

may require that research subjects be told that

such assurances cannot be guaranteed. This was

an issue in drafting the consent form for the

NHLBI study in which serum samples of 200,000

voluntary blood donors are being collected so that

they can be tested for the presence of antibodies

to HTLV-III. The wording in the informed consent document that was forwarded to the Institutional Review Boards of the blood centers involved in the study and whose use PHS recommended, was as follows: “Only authorized staff

of this institution and members of the research

team are expected to have access to the information relative to my test; however, officials of the

Food and Drug Administration or others authorized by law may require access to this information” (167).

Another informed consent issue that arose in

drafting the consent document for the NHLBI

blood donor study was the significance of a

positive test for the presence of antibodies to

HTLV-III. (As stated earlier in this memorandum,

aside from indicating exposure to HTLV-III, the

implications neither of a positive test nor of a negative test are known. ) The document that was sent

to the blood centers for their use stated: “The significance of the presence of the antibodies and the

reliability of the method used to detect them are

not known at this time. If my blood is tested and

if these antibodies are detected, I will be informed

of the results and offered further testing to clarify

their meaning” (emphasis in original) (167).

One commentator has concluded that the uncertainty surrounding the blood test meant that

“neither respect for persons nor beneficence allows

us currently to disclose the antibody test results

to the subject or others. Research subjects should

be promised a detailed explanation of their status

when that information is validated” (116). Other

commentators, assuming that it would violate the

same set of ethical principles (respect for persons

and beneficence) for research subjects or blood

donors to remain unaware of the information, despite its uncertain implications, have described the

disclosure of HTLV-III antibody test results as a

question of “how,” not “if” (4,37).

Blood banking and commercial plasmapheresis

organizations are currently grappling with the

social and ethical issues surrounding the imminent

availability of the blood test. One concern is that

if the test is initially available only at blood banks

and plasmapheresis centers, gay men will present

themselves as donors in order to learn the results

of the tests on their blood. Because of the dangers

to the blood supply and the added expenses of

screening and not using blood that tests positively

for antibodies to HTLV-III, there have been suggestions that the test be made available at a low

cost through health centers in high-risk areas.

The questions for blood banks are many. Should

registries of HTLV-III antibody-positive donors

be maintained? Should donors be listed separately

as HTLV-III positive, or should they be aggregated with others deferred for different health reasons? What should recipients of blood products

from donors who are HTLV-III antibody positive

be told? (See previous box on PHS recommendations for screening blood and plasma donations

for recommendations on notification and confidentiality. These recommendations were addressed by an ad hoc group convened jointly by

The Hastings Center, a bioethics organization,

and the American Blood Commission in January

1985 (5).)

Other concerns about the blood test involve its

potential use by employers, the military, the immigration service, health insurers or others.

Should a private insurer, for example, be allowed

to use a positive test result as evidence for denial

of benefits because AIDS was a “pre-existing con-
49

dition”? Should a positive result be the basis for

the dismissal or transfer of a food handler or the

transfer of a prisoner to an isolated section of the

prison?

A task force convened by The Hastings Center recently reviewed Federal, State, and local

statutes as they applied to information gathered

for use in AIDS treatment, research, surveillance,

and scientific and program audits. One of its conclusions was that “administrative and statutory

safeguards should be created at Federal and State

levels to prevent both unjustifiable voluntary and

involuntary disclosure of personally identifiable

data.” The task force found that “(t)he strength

of State and local protections . . . is unknown,

since they have not been challenged in court by

Federal authorities” (10). Its report also contains

specific recommendations on institutional policies

regarding who should have access to what kinds

of data; what kinds of patient identifiers would

be appropriate; how to balance the tensions between the desire for confidentiality and public

health reporting requirements; and what degree

of variability in these policies is appropriate across

various legal jurisdictions, research institutions,

and public health bodies.

The Office of Protection from Research Risks

(OPRR) is the NIH agency responsible for overseeing human subjects research. In general, the policy of OPRR is to provide to local Institutional

Review Boards guidance on informed consent procedures, rather than to establish central Federal

direction, or models of informed consent forms

(98). Officials from OPRR have stated, however,

that legislation providing guarantees of confidentiality might begin to be considered.

Prevention Through Education

In spite of the discovery of the probable cause

of AIDS, prevention through education remains

the primary means of restricting the spread of this

disease. Effective treatment and especially prevention of infection through vaccines represent difficult technical objectives yet to be achieved.

PHS has focused its educational efforts on physicians and other health professionals, leaving

education of high-risk groups largely up to the

leadership of the groups themselves. (Appendix

D provides details about PHS public information

activities. )

Efforts at direct public education have included

the AIDS hotline, the Facts About AIDS newsletter, partial funding of a public television documentary, NIH radio programs, a videotape about

AIDS, periodic announcements by DHHS Secretary Heckler, and the publication of booklets

(147,148). The most direct advice on risk reduction has been published by CDC in two sets of

interagency prevention recommendations, the

latest in anticipation of the blood test to detect

antibodies to HTLV-III (153,159; see box 2-B below for precautions recommended by PHS for individuals likely to have an HTLV-III infection).

Reprints of PHS interagency precautions have

been distributed to community health centers,

other health facilities and drug treatment centers.

NIDA has reprinted AIDS materials and generated materials of its own for distribution to drug

abuse treatment and counseling centers.

Efforts directed at health professionals include

CDC’s conferences for health care professionals

and State health agencies. CDC is cosponsoring

a major international conference on AIDS in April

1985 with nearly a thousand participants expected. PHS has developed videotapes and a

booklet (149) directed to health care workers and

others who might come in contact with AIDS patients as a consequence of their employment (e.g.,

court officers, prison officials, morticians). NIMH

is developing a booklet on Mental Health Implications of AIDS, and its Center for Prevention

Research cosponsored a meeting on the Psychosocial Aspects of AIDS in December 1984. NIAID

has established an outreach program to transmit

the latest technical advances in AIDS research to

primary care physicians and allied health personnel. State and local health agencies in particular

have played a role in distributing information

about AIDS, including advice about prevention,

to their communities. A DHHS-funded U.S. Conference of Mayors’ survey of local, mostly government, groups found that 40 percent of the material distributed had been prepared by the Federal

Government (143).

Perhaps the most controversial aspect of prevention through public education has been the
50

Box 2-B.--PHS Recommendations for Individuals Likely To Have an HTLV-III Infection

An individual judged most likely to have an HTLV-III infection should be provided the following

information and advice:

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and Mental Health Administr@Jw National Institutes of Health; II&@ l!esourcm’~d Services Administration.

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bkiky andh40rtaMy W&y Report 34:14, Jm. 11, 19SS.

provision of advice to gay men and intravenous

drug abusers. One reason may be that providing

advice on preventive practices may be viewed as

condoning bisexuality, homosexuality, or intravenous drug abuse. Another has been that not

enough was known to support definitive guidelines. Too, there is some concern that gay men

may be wary of advice from the Federal Government, believing it to stem from a bias against

homosexuals or to be based on insufficient medithere are preventive measures to which all parties agree. The use of condoms, while not assuredly protective against AIDS transmission, does

provide some protection against sexually transmitted diseases. Likewise, the use of disposable

or sterilized rather than shared or otherwise contaminated needles for intravenous drug use will

almost certainly reduce transmission. These considerations are mentioned very briefly in the PHS

brochure aimed at gay and bisexual men (148) and

cal knowledge (76). Despite remaining questions, are mentioned more explicitly in the recent PHS
51

recommendations. Brochures designed by gay organizations (69,112,128) have provided much

more explicit and practical advice on the relative

safety of various sexual practices.

Rather than funding local groups directly, PHS

has funded the U.S. Conference of Mayors to act,

among other things, as a distribution channel for

PHS-developed materials. The Conference of

Mayors’ role has been expanded to provide risk

reduction and blood test information through gay

community groups. Fiscal year 1984 appropriations provided $150,000 to be used for prevention projects of community groups; funding decisions for specific projects will be made in early

calendar year 1985 (75). Fiscal year 1985 funding

for the Conference is anticipated to be $200,000.

In addition, CDC is expanding its support of research to evaluate education efforts (e.g., changes

in sex practices and number of partners, changes

in drug use) by both private and public groups,

a research area which NIMH is also supporting.

As noted earlier, about 4 percent of the PHS

AIDS budget (exclusive of the Office of Public Affairs in OASH) for fiscal year 1985 was allocated

to public education, compared to 2 percent in

fiscal year 1984 (see tables 17 and 18). One need

found by the U.S. Conference of Mayors’ survey

of local governments was for training and technical assistance in the community, particularly on

safe sex guidelines and the blood test (143). One

critic of PHS’s budget priorities questions the top

priority given to research, sees research and public

education working hand-in-hand, with each less

effective without the other, and concludes that in

the absence of effective interventions and treatment therapies, the only option at this point is

prevention of the disease (92). Furthermore, a representative of the National Gay Task Force has

stated (88): “The PHS knows how to target its

message to specific audiences—using the gay media would be no different but for the fear of being associated too directly with the gay community . . . if the PHS is going to make a conscious

decision to leave prevention education to us, they

should at least provide some funding. ” Finally,

one AIDS researcher has observed (99a): “There

is an immense job left to do in public education

about AIDS risk. This need will certainly become

more evident and acute as the disease moves outside of existing risk groups and into the general

population in the next 2 years. At that time, continued education will be needed for those in the

risk groups about limiting contagion, as well as

for the general population in order to prevent

hysteria and give the public concrete recommendations as to how to reduce risk of contraction.

It would be helpful if Federal funding sources anticipate this trend and plan for such funding. ”

Financing of Clinical

and Supportive Services

Questions on financing of the clinical and supportive services for AIDS patients and who should

be responsible for such financing have arisen repeatedly. It has been estimated that the cost of

caring for an average AIDS patient from diagnosis

to death is about $60,000 to $70,000 (109,117).

The Social Security Administration has two

programs which provide Federal assistance for

those disabled through illness. Both programs

apply to those who are unable to work because

of a physical or mental disability expected to last

at least 12 months or result in death. One program, Disability Insurance (Title II), is for those

who have paid into Social Security; the other,

Supplemental Security Income, is for those who

have not paid enough into Social Security. These

tests can usually be met by AIDS patients. However, other factors complicate the process of meeting eligibility requirements for financial assistance

and of obtaining coverage for clinical and supportive care. First, there have been criticisms that

the use of the relatively conservative surveillance

definition of AIDS by CDC has delayed needed

financial assistance for patients not meeting this

definition of AIDS (83). Second, Federal and State

insurance programs generally reimburse for established and standard treatments, while the most

important and promising treatments for opportunistic infections in AIDS are still in the experimental stage (117). Finally, although admission

to a hospice might be appropriate or desired by

some AIDS patients, recently promulgated reimbursement regulations require that physicians certify that their patients are not expected to live
52

more than 6 months before the Federal Government will reimburse for care (24).

Additionally, the question remains as to which,

if any, government entities—local, State, or Federal—should be responsible for or share in covering the expenses that AIDS patients cannot meet

CONCLUSIONS

Accumulating evidence indicates that the recently discovered retrovirus HTLV-III is the basic

cause of AIDS. As more has been learned about

HTLV-III’S ability to cause disease, it has become

apparent that a broad spectrum of immunologic

and clinical responses can occur. Some persons

have been infected with few or no immunologic

abnormalities and no evidence of illness, others

have had severe effects on their immune systems

and developed fulminant and inevitably fatal

AIDS, while others have manifested responses between these two extremes. Associated risk factors

are under examination and will help in understanding why some people are able to resist infection while others progress to different stages

of clinical illness.

Rapid advances in knowledge about HTLV-III

are being made possible because of previous

knowledge of the existence of a closely related

retrovirus (HTLV-I), recent advances in understanding the functioning of our immune systems,

the availability of recombinant DNA technologies, and tests based on immunologic and recombinant DNA principles. The new knowledge

about HTLV-III has led to an expanded and increasingly precise cataloging of methods that

might be applied against HTLV-III and associated

infections and tumors found in AIDS, and some

methods, such as drugs that might inhibit infection, are already being tried in limited clinical

trials. On the other hand, the discovery of HTLV111 as the primary cause of AIDS can also be seen

as only the beginning of focused efforts to control AIDS, and it remains to be seen whether the

knowledge that is gained can be used to develop

effective vaccines and therapeutic drugs within a

few years.

either directly or through their health insurance

coverage (123). PHS’s potential contribution to

services coverage is limited, if not nonexistent.

Thus, discussions about possible Federal assistance must include other entities in DHHS, such

as the Health Care Financing Administration.

Although DHHS has designated AIDS as its

number one health priority, in terms of financial

support, this priority has been implemented at

PHS and not at the Department level. The Department’s position has been that funds for AIDS

activities should be transferred from other PHS

activities, and increases in funding for AIDS activities have come at the initiative of Congress, not

from DHHS. This has also been the case for personnel ceilings, with personnel allocated to AIDS

activities within the overall ceilings imposed by

OMB on DHHS, which in turn allocates personnel levels to PHS and its agencies.

The question of whether AIDS funds should

come out of existing PHS agency budgets or

whether such funds should augment agency budgets is related to perceptions about: 1) whether

AIDS-related research is part of the overall missions of the PHS agencies involved, and 2) whether the AIDS epidemic is a sufficiently unique and

growing public health problem that it requires additional resources. PHS agencies are involved precisely because their basic activities are relevant

to AIDS research, which also promises to extend

our understanding of immune mechanisms and

the causes of cancer. Such research is attracting

many researchers for purposes in addition to finding a solution to the AIDS problem. The issue,

therefore, is in deciding: 1) when other activities

are being curtailed too much because of fund

transfers from those activities to AIDS-related

activities; 2) when AIDS-related activities are being delayed because of wrangling over how much

funds are to be transferred and from which other

activities; and 3) when such fund transfers become

inadequate to fund AIDS-related activities. There

is probably no way to reach a consensus on when

these thresholds have been or will be reached.
53

Aside from the issue of fund transfers and their

ability to meet AIDS-related research needs without substantially retarding research in other priority areas, the allocation of funds and the sources

of those funds in themselves are important measures of priority-setting for addressing the AIDS

problem. On this point, while PHS has reacted

to OTA’s assessment by stating that the funds

PHS agencies have (including appropriations

voted by Congress and resisted by DHHS) are

adequate (22), PHS had previously asked for additional funds (20), two NCI advisory bodies have

stated that more funds are needed (163,176), and

numerous Federal and non-Federal researchers

have privately told OTA that additional funds

and personnel have been needed.

Another consideration that pertains to the adequacy of resources devoted to AIDS-related research is that research and development are going on internationally and within both the public

and private sectors. Thus, an examination of

PHS’s contribution to AIDS-related research provides an incomplete picture of the extent of activities and resources devoted to addressing the AIDS

epidemic. However, PHS’s activities are laying

down much of the foundation, and PHS investigators have been indispensable and are extensively

involved in collaborations with non-Federal researchers both nationally and internationally.

In contrast to AIDS-related research which is

international and involves both for-profit and

nonprofit investigators, there are other AIDSrelated activities that are domestic in nature and

which involve public health policy. These activities involve issues which could not be addressed

extensively within this memorandum primarily on

the biology of AIDS, but which were of sufficient

importance to be identified and raised briefly—

namely, prevention of AIDS through education,

financing of clinical and supportive services for

AIDS patients, and assurances of confidentiality

and informed consent.

Although significant advances have been made

in understanding AIDS, its primary cause, and

associated factors, it will be some time before this

biomedical knowledge can be expected to be translated into effective preventive and therapeutic interventions. In the interim, and probably even if

biological remedies become available, prevention

through education on ways of minimizing exposure to HTLV-III has the greatest potential of limiting the spread of AIDS. So far, efforts to prevent AIDS through education have received minimal funding, especially efforts targeted at the

groups at highest risk.

Providing and assisting in paying for clinical

and supportive services is already a significant

problem in those areas of the country with relatively large numbers of AIDS patients. This situation will worsen as the number of AIDS patients

increases and if new treatments prolong life but

do not restore health. The Federal response to date

has focused on the biomedical research aspects of

AIDS; thus, PHS has been given the primary responsibility for AIDS-related activities. Increasing demands for Federal support are inevitable,

but the potential contribution of PHS agencies to

providing and financing service needs is severely

limited by the nature of their responsibilities.

Thus, if the Federal Government is to respond to

the service needs of AIDS patients, Federal activities will have to expand beyond those attributable

to PHS and at a minimum involve other organizational units within DHHS. The allocation of responsibility between Federal, State, and local

governments will also have to be determined, and

legislation defining the Federal responsibility will

most likely have to be enacted.

A final related issue identified in this memorandum is that of confidentiality and informed

consent, first arising in the context of treatment

of AIDS patients and participation in AIDS-related research projects, and soon to be a major

concern as tests for evidence of exposure or infection to HTLV-III become generally available.

Confidentiality safeguards can be improved without sacrificing the surveillance needs of public

health officials and data sharing among researchers. Informed consent will be an especially difficult issue, because the first tests to be applied will

detect exposure to HTLV-III through the presence

or absence of antibodies. However, persons who

test positive will not be able to know whether they

are actually carriers of HTLV-III, whether they

will develop AIDS, or whether they are not infected and will remain well.
Appendixes
Appendix A.—Acknowledgments and

Health Program Advisory Committee

The staff would like to express its appreciation to the following people for providing information and assistance

in preparing this memorandum.

Russell J. Abbott

Food and Drug Administration

Rockville, MD

James Allen

Centers for Disease Control

Atlanta, GA

William Allen

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Harvey Alter

National Institutes of Health

Bethesda, MD

Dennis Altman

Institute for Health Policy Studies

San Francisco, CA

David L. Aronson

Food and Drug Administration

Rockville, MD

W. Emmett Barkley

National Institutes of Health

Bethesda, MD

Walter Batchelor

American Psychological Association

 Washington, DC

Ronald Bayer

The Hastings Center

Hastings-on-Hudson, NY

Joseph Biviano

Food and Drug Administration

Rockville, MD

William Blattner

National Cancer Institute

Bethesda, MD

Joseph Bove

Yale-New Haven Hospital

New Haven, CT

Edward N. Brandt, Jr.

Public Health Service

Washington, DC

Samuel Broder

National Cancer Institute

Bethesda, MD

Ronald H. Carlson

Health Resources and Services Administration

Rockville, MD

Bruce A. Chabner

National Cancer Institute

Bethesda, MD

Amoz I. Chernoff

National Heart, Lung, and Blood Institute

Bethesda, MD

Thomas Chused

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Gilbert Clark

American Association of Blood Banks

Arlington, VA

Barry Clendenin

Office of Management and Budget

Washington, DC

Thomas J. Coates

University of California

San Francisco, CA

Marcus Conant

San Francisco, CA

Madge Crouch

Food and Drug Administration

Bethesda, MD

Lee Cummings

Alcohol, Drug Abuse, and Mental Health

Administration

Rockville, MD

James Curran

Centers for Disease Control

Atlanta, GA

Roger Y. Dodd

American Red Cross

Bethesda, MD

57

42-575 0 - 85 - 5
58

Dennis M. Donohue

Food and Drug Administration

Rockville, MD

Walter R. Dowdle

Centers for Disease Control

Atlanta, GA

Yvonne du Buy

National Institute

Diseases

Bethesda, MD

Robert Edelman

National Institute

Diseases

Bethesda, MD

Gary B. Ellis

of Allergy and Infectious

of Allergy and Infectious

Office of Technology Assessment

Washington, DC

Kay Ennis

American Red Cross

Washington, DC

Elaine C. Esber

Food and Drug Administration

Rockville, MD

Bruce L. Evatt

Centers for Disease Control

Atlanta, GA

Elaine Eyster

Hershey Medical Center

Hershey, PA

Bob Fanton

Norden Laboratories

Lincoln, NE

Anthony S. Fauci

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Peter J. Fischinger

National Cancer Institute

Bethesda, MD

Ed Flynn

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Thomas Folks

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Wilford J. Forbush

Office of the Assistant Secretary for Health

Washington, DC

Donald Francis

Centers for Disease Control

Atlanta, GA

Henry Francis

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Joseph Fraumeni

National Cancer Institute

Bethesda, MD

Robert Gallo

National Cancer Institute

Bethesda, MD

George Galasso

National Institutes of Health

Bethesda, MD

Harold Ginzburg

National Institute on Drug Abuse

Rockville, MD

Jon Glaudemans

Office of Management and Budget

Washington, DC

James Goedert

National Cancer Institute

Bethesda, MD

Michael Goldrich

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Michael Gonzales

Office of the Assistant Secretary for Health

Rockville, MD

Robert Gordon

National Institutes of Health

Bethesda, MD

Janet Gornick

Lewin & Associates, Inc.

Washington, DC

Michael Gough

Office of Technology Assessment

Washington, DC

Roger Greene

Office of Management and Budget

Washington, DC
59

Jack Gruber

National Cancer Institute

Bethesda, MD

Darrel Gwinn

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Lowell T. Harmison

Office of the Assistant Secretary for Health

Rockville, MD

Florence Hassell

Office of the Assistant Secretary for Health

Washington, DC

Harry Haverkos

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

David Henderson

National Institutes of Health

Bethesda, MD

James Hill

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Elvin R. Hilyer

Centers for Disease Control

Atlanta, GA

P. Ann Hoppe

Food and Drug Administration

Rockville, MD

John J. Hutchings

Health Resources and Services Administration

Rockville, MD

Harold Jaffe

Centers for Disease Control

Atlanta, GA

Bernard Janicki

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Richard Johnson

U.S. Conference of Mayors

Washington, DC

William Jordan

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Richard Kaslow

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

John H. Kelso

Health Resources and Services Administration

Rockville, MD

Jack Killen

National Cancer Institute

Bethesda, MD

Mary Knipmeyer

National Cancer Institute

Bethesda, MD

Jeffrey P. Koplan

Centers for Disease Control

Atlanta, GA

Richard Krause

Emory University School of Medicine

Atlanta, GA

Marshall Kreuter

Centers for Disease Control

Atlanta, GA

Clifford Lane

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Philip Lee

Institute for Health Policy Studies

San Francisco, CA

Shelbia J. Lengel

Office of the Assistant Secretary for Health

Washington, DC

Jeff Levi

National Gay Task Force

Washington, DC

Jay Levy

University of California School of Medicine

San Francisco, CA

W. Harell Little, Jr.

Office of the Assistant Secretary for Health

Rockville, MD

Gary MacDonald

Federation of AIDS-Related Organizations

Washington, DC

Joan Maher

American Association of Blood Banks

Arlington, VA
60

Audrey F. Manley

Health Resources and Services Administration

Rockville, MD

Norman Mansfield

National Institutes of Health

Bethesda, MD

JoAnne C. Marrone

Food and Drug Administration

Rockville, MD

Malcom Martin

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

James Mason

Centers for Disease Control

Atlanta, GA

Charles R. McCarthy

National Institutes of Health

Bethesda, MD

Charles McKay

National Institutes of Health

Bethesda, MD

Leon McKusick

San Francisco, CA

Doreen Meade

National Institutes of Health

Bethesda, MD

Harry M. Meyer, Jr.

Food and Drug Administration

Rockville, MD

Richard Miller

National Institutes of Health

Bethesda, MD

Stephen F. Morin

San Francisco, CA

Andrew Moss

AIDS Clinic

San Francisco, CA

Bernard Moss

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Frederick A. Murphy

Centers for Disease Control

Atlanta, GA

Maureen Myers

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Theodore Nash

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Jack Needleman

Lewin & Associates, Inc.

Washington, DC

George Nemo

National Heart, Lung, and Blood Institute

Bethesda, MD

Alvin Novick

Yale University

New Haven, CT

John Nutter

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Paul D. Parkman

Food and Drug Administration

Bethesda, MD

John C. Petricciani

Food and Drug Administration

Rockville, MD

Claude Pickelsimer

Centers for Disease Control

Atlanta, GA

Johanna Pindyck

The New York Blood Center

New York, NY

Frances Pitlick

National Heart, Lung, and Blood Institute

Bethesda, MD

Robert Purcell

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Thomas Quinn

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Gerald V. Quinnan, Jr.

Food and Drug Administration

Rockville, MD
61

Robert Reilly

American Blood Resources Association

Annapolis, MD

Zeda Rosenberg

Office of Technology Assessment

. . . . . —- Washington, DC

Alfred Saah

National Institute of

Diseases

Bethesda, MD

Lois Salzman

National Institute of

Diseases

Bethesda, MD

Neil R. Schramm

Kaiser Permanence

Harbor City, CA

Kenneth Sell

National Institute

Diseases

Bethesda, MD

Charles Sharp

National Institute

Rockville, MD

Harley Sheffield

National Institute

Diseases

Bethesda, MD

Bill Shepard

of

on

of

Allergy and Infectious

Allergy and Infectious

Allergy and Infectious

Drug Abuse

Allergy and Infectious

Centers for Disease Control

Atlanta, GA

Marvin Snyder

National Institute on Drug Abuse

Rockville, MD

Joel Solomon

National Institutes of Health

Bethesda, MD

Ellen Stover

National Institute of Mental Health

Rockville, MD

Steven Straus

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Warren Strober

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Timothy Sweeney

Lambda Legal Defense Fund

New York, NY

Bernard Talbot

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

R. Anne Thomas

National Institutes of Health

Bethesda, MD

Paul Volberding

AIDS Clinic

San Francisco, CA

Gordon Wallace

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Myron Waxdal

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

James Wehling

National Heart, Lung, and Blood Institute

Bethesda, MD

Fredette West

National Institute of Allergy and Infectious

Diseases

Bethesda, MD

Roy Widdus

Institute of Medicine

Washington, DC

Nancy William

Food and Drug Administration

Bethesda, MD

James B. Wyngaarden

National Institutes of Health

Bethesda, MD

Neal Young

National Heart, Lung, and Blood Institute

Bethesda, MD
62

HEALTH PROGRAM ADVISORY COMMITTEE

Sidney S. Lee, Committee Chair

President, Milbank Memorial Fund

New York, NY

H. David Banta

Deputy Director

Pan American Health Organization

Washington, DC

Rashi Fein

Professor

Department of Social Medicine and Health Policy

Harvard Medical School

Boston, MA

Harvey V. Fineberg

Dean

School of Public Health

Harvard University

Boston, MA

Patricia King

Professor

Georgetown Law Center

Washington, DC

Joyce C. Lashof

Dean

School of Public Health

University of California-Berkeley

Berkeley, CA

Alexander Leaf

Professor of Medicine

Harvard Medical School

Massachusetts General Hospital

Boston, MA

Frederick Mosteller

Professor and Chair

Department of Health Policy and Management

School of Public Health

Harvard University

Boston, MA

Norton Nelson

Professor

Department of Environmental Medicine

New York University Medical School

New York, NY

Robert Oseasohn

Associate Dean

University of Texas-San Antonio

San Antonio, TX

Nora Piore

Senior Fellow and Advisor to the President

United Hospital Fund of New York

New York, NY

Dorothy P. Rice

Regents Lecturer

Department of Social and Behavioral Sciences

School of Nursing

University of California-San Francisco

San Francisco, CA

Richard K. Riegelman

Associate Professor

George Washington University

School of Medicine

Washington, DC

Walter L. Robb

Vice President and General Manager

Medical Systems Operations

General Electric Co.

Milwaukee, WI

Frederick C. Robbins

President

Institute of Medicine

Washington, DC

Rosemary Stevens

Professor

Department of History and Sociology of Science

University of Pennsylvania

Philadelphia, PA
Appendix B.—PHS Organization Chart

Administrative and Secretary, Health

other offices and Human Services

4

I

I I I I

Office of Human Public Health Service

(Office of the Health Care

Development Financing Social Security

Services Assistant Secretary Administration Administration

for Health) A I

SOURCE: Office of Technology Assessment.

63
Appendi x C.--Summary of Individual PHS

Agencies’ Obligations for AIDS Activities,

Fiscal Years 1984 and 1985

The tables in this appendix show estimated fiscal —National Heart, Lung, and Blood Institute,

year 1984 and 1985 obligations for AIDS activities for —National Institute of Allergy and Infectious

the Public Health Service (PHS) and for each of the Diseases,

PHS agencies listed below: —National Institute of Dental Research, and

Alcohol, Drug Abuse, and Mental Health Admin- —National Institute of Neurological and Commuistration (ADAMHA). nicative Disorders and Stroke.

Centers for Disease Control (CDC). The tables in this appendix were provided to OTA

Food and Drug Administration (FDA). by W. H. Little, Office of the Assistant Secretary for

National Institutes of Health (NIH): Health (OASH), Public Health Service, U.S. Depart-

—Division of Research Resources, ment of Health and Human Services. OASH obtained

—National Cancer Institute, the figures in these tables from individual agencies.

—National Eye Institute,

64
65

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- - -
1. Etiolo~ic fi~erit and Co-factors:

a. Dlscouery . . . . . . . . . . . . . . . . . . . . . . . . . . ,.,,...,,,,..,,,,,., ,,,,,,

b. Confimtion and extension of observ~tions on caus~tiue

a~ent and discovery of role of co-infections and co-f~ctors .,

2, Develomentt Evaluation of Blood Tests:

a. Deuelorment C*****.*** *0*.00S0O*C .0.00..000. ,,,,,...,,, .,,.,,,

b, Eutluation 0.,,,,..,,,,,..,.,.s,SS,,,,,,,.s .s,,.,,..,s..,...,.

3, Surveillance .,.,.,,,, ,s,, . . . . . . .,...,s,., ,.,,,....,.,,,.,,... ,

4, E?ide~ilo~ical Studies (to Determine N~tural tiistorYof(lIDS)

5- owelo~sent ind Evalu~tion of Viccine (includin~hniml Model)

6. Studies of Therapeutic Intervention:

a, AIDS ,,.,..,.,,,*,,*,,,,.*** . . . . . . . . . . . . .**.*. . . . . . . **....***.

b, O~rortunistic Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. ImnolosicStudies ,,.,,,,.,...,,,.,,.,.,,,,.......,... . . . . . . .

8, Psychosocial Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9. Siaian AIDS S..*.*,,,, ,.,.,,,,,,. ,.,,.,,,,0. ● .,,...,.,, ,.,,,.0,

10, Prevention of Transfusion-related AIDS . . . . . . . . . . . . . . . . . . . . . . . .

11, Bioethics and Bios~fety ,,,,,,.0,, .,*,,,,,.,. ,,,,,.,,.., .**.*,,

12, Information Dissemination/ Public fiffairs . . . . . . . . . . . . . . . . . . . . .

INSTITUTE TOTIIL ..,,,...,, 0.,.....,,. ,,.,.s,0,,, ,,,,,.,,

OIDS

DIVISION OF REXIIRCHRESOURGES

(dollars in thousands)

-------FY 1984 -------- ------------------------- FY 1985 --------------------------

OBLIGATION OBLIGATION OBLIGATION OBLIGATION OBLIGATION

APPROPRIATION AS OF9L3(U84 APPROPRIATION AS OF IZ/31/84 AS OF 3/31/85 AS OF6L30/85 AS OF 9/30/85

-----------

201

122

122

730

-------.---

1!175

-----------

71

7

1

132

274

121

4

746

-----------

1}356

-----------

95

9

222

244

167

5

989

--------.--

17731

----------- ----------- -----------

---.------- ----------- -----------

----...----

---------.-
1/04/85

18

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;:

$’*

10,

11,

12,

91DS

tMTION#CllNCEll IN!!TITUTE

(dollars in thousinds)

-------FI 1984 -------- ------------------------- F! 1985 --------------------------

OBLIGATION OBLIGfiTION OBLIGATION OBLIGATION OBLIGATION

APPROPRIATION (KOF 9/30L94 APPROPRIATION AS OF IZ/31i84AS OF 3131185 AS OF 6J30J85ASOF 9130185

----------- ----------- ----------- ----------- ----------- ----------- -----------

Etiolo~lc ~~~nt and Co-factors:

ili~cou?ry ,.,..,,.,,,,..,...,s,O.,,...,,OO.. ,,.,.OOSOO......., lf373 1!373 .

Confirmation and extension of observations on causative

isent and discovery of role of co-infections and co-factors . . 3?929 3f9z9 8f058

lleue]op~ent & Evaluation of Blood Tests:

Development .,,,...,, . . . . . . . . . . .0,..,.,.. ,,,....,., .,0....00. . 111 111 203

Evaluation ,,,,,.,,,,,.,,..,,...,,.,,.

$urvpillance ,.., .,.,.,.,,. .8gg1.0g Iigg

Epidesilo~ictl Studies (to D?termlne Na

Development and Evaluation of Vaccine (

Studies of Therapeutic Intervention:

AIDS . . . . . . . . . . SC..o.t..oo OS*..*..... c

,..,,,.., . . . . . . . . . . ,,,.

-

O...*,..* . . . . . . . . . . ..*, 40 40 65

ural History of AIDS) 4~098 4f098 5?177

n~ludlnq finl~~l Hod~]) 1!543 11582 41955

0..,,,... ,s,s,..,,, ,,,, 11759 1!759 i?r817

Opportunistic Infections ...s,,,.. ,0,...s,s, ..,..,...0 ..,,,,,, 170 170 298

Imnologlc Stud~es ,.,0.,,,., . . . . . . . . . . . ....,s,.,., ,.s.,.,...,

Psrchosoclal Factors

2/612 2rb12 3~b95

..0,,,,,s,.,,.,.,,, ....,,s.,, . . . . . . . . . . . . .

S1-lan hIDS ,,.#.#J!st . . . . . . . . . . . . . . . . . . . . . . SIc.c.,...o c...,... 250 850 1?403

Prevention of Transfusion-related AIDS . . . . . . . . . . . . . . . . . . . . . . . .

Bioethics and Biosafety

22 22 50

10 10 ~Q 8,,,, . . . . . . . . . . . . . . . . . . . . . . . . . . . ,.00...

Irtfornitlcn Dissemination; Publlc Pffalrs . . . . . . . . . . . . . . . . . . . . . 71 71 110

.---------- ----------- ----------- ----------- ----------- ----------- -----------

INSTIVJTE TOT4L . . . . . . . . . ,,...,,,,. . . . . . . . . . . ..,,,s..., t 161588 l&,b~7 2b~851
AIDS

N#TIONAL EYE INSTITUTE

(dollars in thousands)

-------FY 1984 -------- ------------------------- FY 1985 --------------------------

OBLIGATION OBLIGATION OBLIGATION OBLIGATION OBLIGATION

(iPPROPRIftTION MiOF 9/30/84 APPROPR19TIONIISOF 12i31184#lS OF3;31i85 AS OF b/30/85 AS OF 9/30/85

-----------

,..,,.

----------- ----------- ----------- ---------.- ----------- -----------

----------. ----------- -----------

1.

a.

b,

2,

a.

b.

3.

4.

5.

b.

as

b,

7.

8,

9.

10,

11.

12.

r,. * . . , ,s.1 .

tuoloslc ~sent m ~o-tactors:

Discovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Confirmation ind extension of observations on camtive

asent and discovery of role of co-infections and co-fac

Development i Evduition of Blood Tests:

Development ..,..,,,,, .**,,,,.,.* ,,..,,,,,.. ,,,,..,,,,,

Eviluition . . . . . . . . . . ,.,,.,,,,,, ,,,.,....0, ,,,....,,,, ,

ors . . 23 150

.,,.,,

..*.’.

Surveillance ,.,,..,,,, ...,,,,.,.s ,,,,..,0,..,,.,.,,,,,,,.,,,..

E?idesilosical Studies (to Determine Natural HistorYof AIIIS) 18

Development and Euduition of Viccine (includin~~niail Hodel)

Studies of lher~~eutic Intervention:

AIDS .,,*,,.,,, ,..,,,,.,,s*,,...,.,,. ,..,.,.,,,, . . . . . . . . . . . .s.

19 135

O~tortunistic Infections . . . . . . . . . . . . . . . . . . . lb

Iwnolosic Studies . . . . . . . . . . . . . . . . . . . . . . . . .

Psychosocial Factors . . . . . . . . . . . . . . . . . . . . . . . .

Si~ian AIDS ,,,,,,,,,, ,,,,.,,.,,, ,,,,s,s,,,. ●

Prevention of Transfusion-related AIDS .,.,,.

Bioethics and Biosafety . . . . . . . . . . . . . . . . . . . . .

Infomtion Dissemination/ Public Affairs . . .

,

,

.

.

*

,

,

. . . . . . . . . . . ● ✎ ✎ ✎ 17

,.ss...0.. ...s0

. . . . . . . . . . .*.*.

‘.,.,,*.,* . . . . .

..,.*.,... **,..

. . . . . . . . . . . ,*,*

,..,.0.0.. . . . . .

15

----------- ----------- ----------- -----------

INSTITUTE TOTAL . . . . . . . . . . ,,..s,,...,..***....,* ,,...,0. 58 be 300
AIM

NPTIONAL HEART? LUNG AND BLOOD INSTITIJTE

(d~lllr~ in thousands)

-------r~ 1984 -------- ------------------------- F~ 1995 ‘-------------------------

OBLIMTION OBLIMITION OBLIGATION OBLIGATION OBLIGATION

APPROPRIATION hSOF~;?O/a~ APPROPRIATION AS OF IZ/31/84AS OF3/31/85As OF b/30/135 MOF 9/30/85

1/04/85

---------.-

-----------

----------- -----------

----------- -----------

.---------- ----------- ----------- -----------

-----------

1.

a,

b,

2,

am

b.

3,

4.

5.

&*

am

b.

7.

9$0

9,

10,

11,

120

Etiologic Ag~nt artd Co-factors:

Discovery o,m*#o... .,,...’...,..0.s000. .....00.00 .,...ss... . . .

Confirmation tnd extension of observations on causative

a~ent arid discctvery of role of co-infections and co-factors . .

I.)evelctPDent$ Evaluat~on of Blood Tests:

Development ,,.,,,0.0. ,,,..0.s... .O.**0.**SO ,....s0s.0, S....*O

Evaluation ..s0.00’. ,,,s.0..s. .0......00 ● 0.s..s0.0 ,.,..s0.00 . .

Surveillance ,..,...s....s...............O...... . . . . . . . . . . . . . . .

E?idegilogical $tudi?s (to Determine Natwal Hi5tor~offlID5)

o~VelOpment~ndEvaluation of Vaccine (including Anisal Ilodel)

studies of Therapeutic Intervention:

AIDS ● ,,..s.... ,....0.000. ..O..**SC** .s.s..0.... 1s00.0.00.. s..

Or~ortunlstic Infections ● .,,.,*... ....0s0..,. .C.....tooc *.**s

Inwnolosic Studies ,,,,,,,.0s ,.0...0..0s ,,.,,..0.00 ● *,.*..,...

Psychosocial Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SiBian AIDS ,00......0 . . . . . . . . . . . .0.....s0,0 . . . . . . . . . . . ..90.0..

Prevention of Transfusion-related AIDS ...*oot..9..~.*~~.~~~..~

489 4a3

298

195

302

410

302

555

3)671 7r044

800

125

18 18 Bioethics and Biosafety ,0,0,...s. ..0.00...., .0...0s..s0 ..00...

Information Dissemination/ Public Affairs . . . . . . . . . . . . . . . . . . . . .

----------- ----------- -----------

8r884 INST TIJTE TOTAL . . . . . . . . . .*......,* 0...0....s 0..00000.. *
1,

a.

b.

2*

ii.

b.

3,

4,

5b,

6.

a,

b.

7,

8,

9*

10,

11,

12.

AIM

NhTIONRL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

(dollars in thousands)

-------FY 1984 -------- ------------------------- FY 1?85 --------------------------

OBLIGATION OBLIGATION OBLIGATION OBLIGATION OBLIGATION

IIPPROPRIATION AS OF 9/30184 APPROPRIATION AS OF lZ131i8411S OF3/31i85AS Of 6t30185ASOF 9130185

----------- ----------- .---------- ----------- ----------- ----------- -----------

EtioloJic Amt and Co-fictors:

Discovery ,..,,,,,,,.,.,,,,,.,,,.,,,,,.,,,..,, ,..,.,.,.,,,,,,,

Confirs~tion and extension of observations on cwsative

i~ent trtd discovery of role of co-infections and co-factors ,. 1T592 785 lr184

Dpue]oplent &Eva]uation of B]ood Tests:

Development ,0,.,.0,,. .0.,.,,.0,, ,,,,,.,,,,,,,,,,,,,,,, ,,,,,.,

Evaluation s,,.,,,,,, ,.,,,,.,,,, ,,,.s,.0,,, ,,,,...,,., ,s,,,,., .

Surveillance s,,,,,,,,, ,..,,,,,,,. ,,,,,,,.,,,,,.,..,,,,, ..,,,,,

Epidesiloyical Studies (to Determine Natural Histwy of AIDS) 7!141 8!449 6!788 -

Development and Evaluation of V~ccine (includins%iaal Hodel)

studies Of Therapeutic Intervention:

1~085 706 1!458

AIDS ,,,,,.,,,,. m,...,,,..,, ,,,,,,,,,.,, .,,,,,,,,,,, ,,,,.,,,,, lr460 lfl13 31117 -

Opportunistic Infections ,,,,0,,,,. ...,,,,0,,. ,,s..,0,,,, ,,.., 41443 4!124 4r725

Imnolosic Studies ,,,,,.,.,,,,.,,,,.,,,...,,...,,..,,.,.,.,,, 21986 3!720 5!345

Psychosocial Factors ,,.s,,.,,. ,,,,0,,,.,, ,.,0,,.,,,, ● .,,.,,,,* 34 34 34 -

SiBian AIDS ,,,,,,,.,,, ,,,,,,,.,,,, ,.,,,,,,,,s, ,,.,.,,,,,,, ,,,, 158 183 154

Prevention of Transfusion-related AIDS ,,.,.,,,,,.,...,.,.,.,,,

Bioethics ind BiosafetY .,,,,..,,, ,,,,,,,,,,, S,.,S,,..,, ,.,s,,,

Information Dissemination/ Public /lffairs .., ,,. ,. .,.. .,,,,,.,. 169 502 457

----------- ----------- .---------- ----------- ---------.- ----------. -----------

INSTITUTETOTAL ,..,.,,.., ,...,,,,,.. .,,,,.,.,,,.,,,,,.s 19fOb8 19t61b 23rZb2
fIIRS

N/lTIONfiL INSTITUTE OF l)ENTfiL RESEARCH

(doilars in thousands)

------- F’f 1984 -------- ------------------------- F] 19S5 --------------------------

OBLIGATION OBLIGATION OBLIGATION OBLIGATION OBLIGATION

APPROPRIATION AS OF 9/30/S4hPPROPRl/+TION AS OF 12/31/94 AS OF 3/31185 MOFb130/85 MOF 9/30/85

----------- .--.------- .----------

-.---------

----------. .--..--.--- -.--------- -----------

1, Etiolosic Agent and Co-ficiors:

a.

b,

7L .

;:

3,

::

b,

as

b,

;:

9,

10,

110

12,

iliscouery ,.,,.,,,,.,,,,,,,,,..,,,.,.,.,,,,,.,,.,,,..,,=.s,.,.

Con/ir~ation and extension of observations on causatiup

agent and discovery of role of co-infections and co-factors ., Development & Evaluation of Blood Tests:

Development ,0.,,0,,.. 0,,...,,..s s,,,,,..,., .,,.,.0...,tot,,..

Evaluation .,OO,.....,...O.S,.O.,...,,...,...,O ..8,,..,s,0....

$urvelllance ... ,.. .,..O.. ,.. ... .O.O,.. .... ..., O.,,, . . . . . . . . . . .

Epidenilosical Studies 1to Determine Natural Historrof MtK)

llevelopaent and Evaluation of Vaccine (including kimal Hodel)

Studies of Therapeutic Intervention:

206

O~~ortunistic Infections

l~ounolosic Studies ..,,.

Psychosocial Factors ,,,,

Sisian hID$ . . . . . . . . . . . . .

Prevention of Transfusion

Biotthics ind BiostfetY ,

Inforsition Dissemination,

*,*,*,a

#m*,#m*

,,u*,na

,,,,,,,

related

,,,,,,.)

Public

..........0 ......0..... ....0. so 91

,,,,,s..,, 0,,0,,,,,.. ,tt**,o* 205

,,I**a****. m,,.,...,...*8,..,

,,,,,,,.,, ,,,,.,.,,0.0..,.0.,

fIIDS ,,..,,.,,,.,.,.,,,,,,.,,

,,,,,,,,,s ..,,.,,,..0 ,.,,,..,

hffalrs ..,.,,,.,.,.,,O,,S.,,

----------- ----------- ---------.- ---------.- ----------- -----------

IN$TiflJTE TOTRL ,.0.s...0, ..0s00...0. 00.......1. ..00..,$ 30 411
1,

a.

b.

2.

a,

b.

3,

4.

5,

h,

a.

b,

7,

8,

9*

10,

11,

1~,

N8TIONIIL INSTITUTE OF

Etiolosic (bent ~nd Co-factors:

Discovery ...,.,.,.,,,.....,,,,.,...,.,,,,.,, . . . . . . . . . . . . . . . .

Confirmation and extension of observations on cwttive

~~ent ~nd discovery of role of co-infections and co-factors ,,

Develowent &Eualuation of Blood Tests:

Development ● .*,,,.,,, .,*,,,,,,,, .,..,,,,,,, ,.,,...,,., 0....,

Evalu~tion ,0,,,.,.,. ,..,,..,,,, ,,,.s,,,,,, ,,,,,.,.... ,,,,,

Surveillance .,,,.,,0,, ,,,,,.,,,., ● ,.**,,,,,, ...,s,,,,s, ,,.,

Erideailogic~l Studies (to Deterainet4~tur~l History of AIDS

Development and Ev~luation of’hccine (includinyllninal tlode

Studies of Therapeutic Intervention:

AIDS ..,,...,0. ..,,,s...,,,.,,,,,,.,,,,,.,,,,,,,. .,,,,,.,,.

Opportunistic Infections .,,,s,.,, ,,,,.,.,s, *,,,*,,.,, ,,.,,

.

AIDS

NEUROLOGICAL AND COllRllWCIITIVE DISORDERS ANDSTROKE

(dollars in thouritnds)

-------FI 1984 -------- ------------------------- FY 1985 --------------------------

OBLIGATION OBLIGATION OBLIGIITION OBLIGATION OBLIGATION

APPROPRIATION AS OF 9/30/84 Appropriation AS OF IZ/31/84W OF3/31/85As OF b/30/85 AS OF 9/30/85

----------- ----------- .---------- -----------

603 355

,s

)

. .

,s

Imuno}osic Studies .,,,,**,’ ,..,.,..,, ● .,,..,,,, ● ..,..,*., ,..,

Psychosocial F~ctors ,,..,,,,,, ,,,,,,,,,s. ,.,,.,,,,., .,,,,,,,,,

40

~.

LL

91

50

42

8b

259

187

101

8b

431

Si~iin AIDS ,,,,.,,,,, ,,,..,,,,,, ,,,,,,.,,,,,,,,,.,.... ,s,s..,, 944 810

prevention of Trinsfuslon-r~lated AIM *O.,,*,.,, ,,.,,.,,.,. ,.,

Bioethics and Biosafety *,...,,,,, ,,.,,..,,,, . . . . . . . . . . . .*,,,,.

Information Disse~ination/ Public Affairs . . . . . . . . . . . . . . . . . . . . .

----------- ----------- --.-------- -----------

INSTITUTE TOTAL ,.,,,,,,., ,,,,,,,.,,, ,s,,..,,,,, ,,,,,,,, 1!547 i,5ilJ 1!150

----------- ----------- -----------

----------- ----------- -.---------
Appendix D.— Individual PHS Agencies’ and OASH Office

of Public Affairs' Anticipated AIDS-Related Grants and

Activities, Fiscal Year 1985 and NIH AIDS Projects

Funded in Fiscal Years 1983 and 1984

This appendix provides information about AIDSrelated grants and activities as follows:

●

●

●

●

Section 1: Alcohol, Drug Abuse, and Mental

Health Administration (ADAMHA) anticipated

fiscal year 1985 grants and activities:

–National Institute of Mental Health (NIMH),

and

–National Institute on Drug Abuse (NIDA).

Section 2: Centers for Disease Control (CDC) anticipated fiscal year 1985 grants and activities.

Section 3: Food and Drug Administration (FDA)

anticipated fiscal year 1985 grants and activities.

Section 4: National Institutes of Health (NIH) anticipated fiscal year 1985 activities:

—National Cancer Institute,

—National Heart, Lung, and Blood Institute

—National Institute of Dental Research,

—National Institute of Neurological and Communicative Disorders and Stroke,

—National Institute of Allergy and Infectious

Diseases,

—National Eye Institute, and

—Division of Research Resources.

Section 5: NIH AIDS projects funded in fiscal

years 1983 and 1984.

Section 6: Office of the Assistant Secretary for

Health (OASH) Office of Public Affairs AIDS

Public Information Plan for fiscal year 1985.1

The information in this appendix was provided to

OTA by the agencies themselves.

‘Also includes descriptions of public information activities of NIH,NIDA,

NIMH, and CDC.

77
SECTION 1: Alcohol, Drug Abuse, and Mental Health Administration

Anticipated AIDS= Related Grants and Activities, Fiscal Year 1985:

National Institute of Mental Health

National Institute on Drug Abuse
79

NATIONAL INSTITUTE OF MENTAL HEALTH

FISCAL YEAR 1984 -

Extramural Research

During FY 1984 NIMH continued and expanded its research support for projects

focused on the psychiatric, behavioral and psychosocial aspects of AIDS. This

resulted in a portfolio of 14 research projects, totaling $1,204,838. These

projects focus on relationships between psychological conditions and immune

function, development and testing of psychological and behavioral measures to

assess mental health status as it relates to AIDS, changes in high risk

behavior patterns, as well as studies which supplement ongoing NIH research to

correlate behavioral changes with immunological status in large samples over

time.

NIMH funding has allowed investigators to develop and improve inventories

which measure psychosocial and mental health aspects of AIDS in groups at risk

and those with confirmed cases of AIDS. In one study, preliminary results of

assessments of the mental health of those at risk suggest the tendency for

scores on some measures to be poorer than expected. These tentative results

require confirmation and further research to determine their implications. It

has been hypothesized that increased levels of depression, helplessness, and

anxiety correlate with behavior changes in this population. Such inventories,

with ❑ edifications, may be valuable in identifying individuals at risk for

life-threatening illness beyond the AIDS epidemic. Results may hav e

implications for prevention and therapeutic intervention.

An NIMH-supported study is conducting neuropsychological evaluations of AIDS

patients to assess differences between psychological reactions to the disease

and cerebral problems resulting from the disease process which may also effect

mood, cognition and behavior. It has been recognized that clinically

significant alterations in these functions may be overlooked until patients

become disruptive or incapacitated.

In another NIMH supported study of the impact of AIDS on psychological

functioning, preliminary results indicate that the mere experience of being at

risk increased anxiety levels for eventually contracting the disease.

The AIDS patient, like patients with other life threatening illnesses,

struggles with the fear of imminent death, the necessity for abrupt closure on

future plans, and the challenge to maintain a purpose. Knowledge of these

factors is necessary to develop effective intervention strategies.
80

It is hoped that such research will assist in identifying those persons most

at risk for the development of AIDS, and will be helpful in providing

recommendations for both prevention and educational programs.

NIMH research will continue to focus on understanding the needs of these

individuals, along the continuum of disease related events, as well as to

identify those psychological and behavioral factors which may negatively or

positively influence the course of illness. Other research related to immune

function and psychiatric disorders, and the interplay between psychoactive

drugs and immune function is also encouraged and supported by the NIMH.

A more detailed description of projects currently receiving NIMH support is

attached. (Attachment 1)

Intramural Research

Dr. David Rubinow of the Biological Psychiatry Branch, NIMH, is collaborating

with other NIH researchers to assess neuropsychiatric dysfunction in patients

with AIDS. The purpose of this study is to obtain longitudinal

neuropsychiatric evaluations of patients with AIDS.

Educational and Related Activities

The Mental Health Education Branch, Division of Communication and Education,

NIMH, is developing a booklet for health caregivers on Mental Health

Implications of AIDS. The manuscript, which is currently undergoing

clearance, deals with the emotional reactions of AIDS patients and the mental

health implications for their families, friends, and associates. It discusse s

the emotional involvement of caregivers working with terminally ill patients

as well as concerns regarding contagion and related issues.

Four NIMH staff members recently received PHS awards for their participation

in the PHS AIDS hotline activities. -

FISCAL YEAR 1985

During FY 1985, NIMH will continue to support research focused on the

behavioral and psychological aspects of AIDS. NIMH will expand its research

efforts to include an emphasis on psychological reactions of individuals as a

function of receiving information concerning blood test results. NIMH is

encouraging research on the psychological reactions to learning HTLV-III

results.

Additional research areas which NIMH seeks to support include: changing

patterns of intimacy and behaviors among high-risk populations; relationships

between immune function and mental health status, such as depression, anxiety,

suicide attempts, and other responses to high levels of
81

stress; interventions prior to or during the course of the disease; an d

studies of psychological factors that impede participation in either research

or treatment programs. A group of NIMH supported researchers is preparing an

article which will focus on the psychosocial issues for patients and groups at

risk. The article will be directed toward clinicians and will contain

specific recommendations.

The NIMH Center for Prevention Research cosponsored a meeting on the

Psychosocial Aspects of AIDS with the Institute for the Advancement of Health

in New York City. (December 8-9, 1984.) This meeting focused on the

psychological aspects of AIDS and involved numerous NIMH grantees. Principa l

investigators and other project staff from the NIMH funded projects studying

the mental health implications of AIDS attended, along with other researchers,

clinicians, PHS representatives, and others involved in research on the

psychosocial aspects of AIDS.

The meeting was organized to provide the AIDS researchers with an opportunity

to exchange information and to address future research needs and policy issues

related to the mental health aspects of AIDS. Participants explored how

psychosocial factors may affect immune system function, how emotional stress

may affect the course of disease, and how behavioral interventions may

optimize functioning of the immune system. Other broad topics included the

psychological consequences of events along the continuum of disease and

treatment and the potential for psychosocial interventions which could improve

both physical and emotional status. Researchers also shared strategies and

advice regarding issues of sampling, measurement, outcomes, and policy

recommendations. In addition, the group discussed issues related to the

forthcoming HTLV-III antibody blood test.

A psychosocial inventory appropriate for the assessment of psychosocial

variables in homosexual populations, developed by an NIMH-supported

researcher, is currently being made available to other investigators in the

U.S. and Europe.

NIMH-supported researchers and staff will also participate in the

International Conference on AIDS to be held in Atlanta, Georgia, April 14-17,

1985. ADAMHA is a cosponsor of the conference.

Publications and Presentations

During FY1985, research supported by NIMH was cited in several news releases

and in Public Health Service Reports. In addition, the November 1984 issue of

the American Psychologist contained articles describing three NIMH supported

research projects as follows:

"Coping with the Threat of AIDS”, Jill Joseph, et al, MH 39346-01

"Behavioral and Psychological Factors in AIDS", Martin and Vance, M H

39557-01
82

"Psychological Research is Essential to Understanding and Treating AIDS”,

Coates, Temoshok, Mandel, MH 39344-01

Applied Methodology: A Primer of Pitfalls and Opportunities in AIDS

Research, Jane Zich and Lydia Temoshok (in press, Praeger, N.Y.), Boo k

Chapter, MH 39344-01

AIDS and Sexual Behavior Reported b: ]!en in San Francisco, Leon McKusick,

William Horstman, Thomas Coates, (in press, American Journal of public

Health), MH 39553-01

NIMH researchers presented at numerous conferences and workshops including:

A symposium on AIDS at the University of California, May 4-5, 1984

A workshop on statistical problems at the Lakeshore VA Medical Center in

Chicago, Illinois, on August 28, 1984

A symposium on AIDS at the Annual Meeting of the American Psychological

Association, August 28, 1984

A conference on AIDS at Northwestern University Medical School on

December 1, 1984

A conference on psychological aspects of AIDS in Glen Cove, New Jersey,

December 7-9, 1984

Future Symposium: A Symposium on AIDS at the Society of Behavioral

Medicine Sixth Annual Meeting

FISCAL YEAR 198 6

NIMH will continue to support research relevant to the behavioral and

psychosocial aspects of AIDS. It is anticipated that studies will focus on

stress factors related to the blood test to identify the HTLV III virus in

blood donors and high risk populations. There will be a continuing need for

public education for persons at high risk, families and friends, and health

care workers as ❑ ore specific information becomes available.

New directions in research, prevention, and public education programs will be

determined by an examination of research findings and information generated by

workshops and the International Conference.

NIMH will continue to coordinate its activities in this area with ADAMHA and

appropriate NIH institutes.
83

RESEARCH GRANTS

Investigator: Lydia Temoshok, Ph.D. (1 RO1 MH 39344-01)

Institution : University of California, San Francisco

Title : A Longitudinal Psychosocial Study of AIDS Patients

In FY 83, D r. Temoshok received a two year grant to study psychological and

behavioral consequences of having suspected or diagnosed AIDS. Immunological

functions of subjects will be correlated with clinical and psychological

conditions to study relationships of psychological factors, the immune system,

and physical illness.

Investigator: Jill Joseph, Ph.D. (1 RO1 MH 39346-01)

Institution : University of Michigan

Title : Coping Strategies in AIDS Patients

This research focuses on developing and testing psychological and behavioral

measures used in AIDS research. Specifically, the investigator hopes to: (a)

study the relationships among psychosocial variables and measures of immune

function and physical health; (b) quantify the extent of changes in sexual

behavior that are presumed to affect an individual’s risk for contracting

AIDS; (c) examine factors associated with the maintenance or impairment of

psychological and social functioning in response to the threat of an epidemic

of fatal illness .

Investigator: Karolynn Siegel, Ph.D. (1 RO1 MH 39551-01)

Institution : Memorial Hospital for Cancer, New York, New York

Title : AIDS Risk Groups: Predicting Changes in Sexual Practices

This study attempts to identify psychosocial factors associated with changes

in sexual and drug related practices of AIDS patients and those at risk for

AIDS, and the extent to which they comply with treatment or monitoring

regimens. Factors to be examined include: social support, self-esteem,

anxiety, depression, and perceived risks. The sample population will include

asymptomatic homosexual males not diagnosed with AIDS or lymphadenopathy,

homosexual men with generalized lymphadenopathy, and homosexual male AIDS

patients.

Investigator: Marcus A. Conant, M.D. (1 RO1 MH 39553-01)

Institution : University of California, San Francisco

Title : Impact of AIDS on Sexual Behavior of Gay Men

This study assesses changes over time related to the social and psychological

functioning regarding high risk sexual behaviors, health behaviors, intimacy

patterns, and psychiatric symptoms. Dependent measures will be examined in

the context of knowledge of health guidelines, sources and modes of receiving

information, personal beliefs about AIDS transmission, attitudes and behavior s

regarding intimacy patterns, and individual differences in psychological

reaction to the AIDS crisis.
—— -——

84

Investigator: Carole S. Vance, Ph.D. (1 R01 MH 39557-01)

Institution : Columbia University, New York, New York

Title : Mental Health Effects of AIDS on At Risk Homosexual Men

This study is assessing the mental health and behavioral effects of the

epidemic of AIDS on homosexual males (700) who do not have AIDS, but are at

high risk. Data will be collected through two face-to-face interviews. The

methodology will include both retrospective and prospective components.

Outcome measures will be specific and non-specific psychological distress,

drug use, and sexual behavior.

Investigator: Thomas Coates, Ph.D. (1 RO1 MH 39343-01A1)

Institution : University of California, San Francisco

Title : Prospective Psychosocial Study in Men at Risk for AIDS

This study is a collaborative effort with a contract funded by NIAID entitled

"A Prospective Sero-Epidemiological Study of AIDS in Homosexual Men Residing

in San Francisco". Under the NIAID study a probability sample of disease free

single males (1000 homosexual and 200 heterosexual) 25-54 years of age will be

recruited; it is estimated that between 45-75 cases of AIDS will develop

during a four year follow-up. Each subject will receive a physical

examination and donate specimens for serological, virological, and chemical

study. The NIMH portion will address: (1) the psychosocial and behavioral

risk factors for AIDS; (2) the attitudes, behaviors, and beliefs of the cohort

over time; (3) psychosocial consequences of diagnosis of AIDS or of symptoms

possibly associated with later development of AIDS; and (4) exploration of

psychoneuroimmunological relationships.

Investigator: Christopher Coe, Ph.D. (1 RO1 MH/NS 40144-01)

Institution : Stanford University

Title : Psychological Stress and Immune Responsiveness

This project will investigate the development of a nonhuman primate model for

assessing the effects of psychologically induced stress on immune

responses. The research will document the qualitative and quantitative

effects of elevated cortisol levels on basic immune parameters in separated

maternal and newly weaned.

Investigator: Mark Laudenslager, Ph.D. (1-R03-MH-39316-01)

Institution : University of Denver

Title : Coping and Immune Function

This research will provide parametric data on the time course and long term

effects of prior experiences with controllable or uncontrollable shock on

immune system function. Approximately 400 laboratory rats will be used.
85

Investigator: Mark Laudenslager, Ph.D. (5R01 MH37373-02)

Institution : University of Denver

Title : Loss and Separation: Immune Status

This is the second year of a project to study the effects of separation of

mother and offspring on immune system and behavior in primates. Affective

disorders are frequently preceded by important separation and new data

indicate that separation and losses are etiologically significant antecedents

of a variety of nonpsychiatric medical disorders. The project will carry out

a comprehensive series of experiments to study the effects of separation and

loss on the function of the immune system.

Investigator: Steven Schleifer, M.D. (1 RO1 39651-01)

Institution : Mt. Sinai School of Medicine

Title : Major Depressive Disorder and Immune Function

This project will investigate the association between clinical depression and

immunity. Immune function will be examined in drug free patients with mild

and severe depressive disorders and compared with matched controls, mediated

depressed subjects, and patients in remission. The research could contribute

substantially to understanding ways in which the central nervous system

regulates immunity.

Investigator: Rosa T. Canoso, M.D. (RO1-MH-39528-01)

Institution : U.S. Veterans Administration Hospital (Mass.)

Title : Chlorpromazine Immunogenetics and Tardive Dyskinesia

This research is focused on a study of the association of chlorpromazine

treatment and the production of autoimmune antibodies. The study is one of

the first examples of the involvement of autoantibodies in major psychoses.

The prevalence and severity of tardive dyskinesia will be correlated with the

presence of antibodies. Follow-up studies will determine changes in the

immunoneurological, neurological, or psychological parameters after

discontinuation of chlorpromazine.

Investigator: Richard Pillard, M.D. (2-RO1-MH-32170-0A1S1)

Institutions: Boston University

Title : Clinical and Family Study of Sexual Orientation

This research is focused on the study of the familial and clinical aspects of

homosexuality. It will document psychiatric disorders in homosexuals, family

patterns of homosexuality, and gender-specific attributes of behavior. The

research may provide a basis for further studies of genetic, hormonal, or

longitudinal-developmental studies focused on the origins of sexua l

orientation .
86

Investigator:

Institution :

Title :

This research

schizophrenic

Stanley Zucker, M.D. (1-RO1-MH-33684-01)

Veterans Administration Medical Center

Chlorpromazine-Induced Immunopathy

is focused on the study of immunological abnormalities in

patients who are treated with chlorpromazine. The objective is

to characterize the natural history of chlorpromazine induced immunopathy on

the mechanism of immune dysfunction. The research has significant

implications regarding the long term safety of psychoactive drugs and the

interaction of such drugs with the immune system.

Investigator:

Institution :

Title :

This research

by behavioral

Robert Ader, Ph.D. (5 K05 MH 06318-15)

University of Rochester

Psychoneuroimmunology

is focused on understanding the regulation of Immune responses

processes operating through the control nervous system and the

endocrine system. Documentation and elaboration of the relationship between

the central nervous system and the immune system has potential consequences

for understanding the immune processes and clinical implications concerning

chemotherapy in treatment regimens. The capacity of conditioning to suppress

or enhance immune responses raises issues regarding the modifiability of the

immune system and the integration of biologic and psychologic function. The

results will contribute to an understanding of psychoneuroimmunology and the

adaptive process. Animal subjects (rats and mice) are used in this research.
87

.—NATIONAL INSTITUTE ON DRUG ABUSE

Data from CDC indicate that 18% of all cases of AIDS reported, to date, have

occurred in heterosexual drug users. In addition, 14% of homosexuals with

AIDS (comprising 9% of the total number of cases of AIDS) present with a

history of parenteral drug use. Thus, independent of other risk factors,

27% of reported cases of AIDS occur in individuals with a history of

parenteral drug use. In the New York-New Jersey metropolitan areas the

percent of AIDS patients with a history of parenteral drug use is even

greater. New New York City Department of Health reports that 66% of all

cases of AIDS occur in individuals who have engaged in homosexual behavior,

while in 32% of cases there is a history of self-administered parenteral

drug use. Similar data are reported for New Jersey.

Past experience with diseases such as malaria and serum hepatitis has led

investigators to hypothesize that HTLV-III is transmitted among parenteral

drug users through the sharing of contaminated needles. The cultural

practices of native born Haitians include frequent parenteral administrate on

of “medicinal agents” (“picurist”). The needles used in these practices are

frequently reused, without sterilization. These cultural practices have

accompanied the Haitians who have migrated to the large urban centers in the

United States, and may represent a mode of parenteral exposure to HTLV-III.

Drug abusers use substances which have intrinsic immunosuppressive

properties and are associated with chromosomal damage. These substances are

administered in a contaminated vehicle (nonsterile water) which contains

contaminated diluents and impure narcotic. This mixture is self-administered

through blood and dirt-contaminated unsterile needles. The question of

whether this drug-taking behavior is able to produce sufficient insult to

the immune system to enhance the pathological effects of HTLV-III on the

host is the major target of the NIDA research effort.

NIDA’s activities include:

A. Investigator: Des Jarlais, Don C., 1 RO1 DA 03574

Institution: New York State Department of Health

Title: Risk Factors for AIDS Among Intravenous Drug Users

Project Year: Start Date: 9/83, 2 years

10 A group of drug-users who are indicted on various charges and who

may acquire AIDS will be studied. Detailed questionnaires on

lifestyle and drug-use, medical histories, immunologic function,

HTLV/LAV antibody titres, and other factors will be measured. This

group is unique in that they did not seek out treatment and may

have unique variables--types of drug used, disease acquired, extent

of disease.

?. A follow-up study design will be based on the cohort studies of the

drug abuse populations. These studies will focus on changes in the

individual‘s health to see what relationships exist between AIDS

and the immunological status, virological profile, drug abuse life

style or other identified factors. These will include a

proportionate representation of the original groups studied.
—

88

3. Populations of patients in detox and methadone programs have been

studied. Significant numbers of the detox, but not the methadone

patients, have measurable LAV antibody titres (see report in

July 13, 1984 MMWR). Interview data from detox subjects showed

that exposure to the virus is associated with frequency of drug

injection over the previous five years. The virus is relatively

easy to spread among persons who inject illicit drugs. A follow-up

of these individuals to determine the relationships of this virus

to the development of AIDS and a study of all the various groups

will be conducted in 1985-1986. These studies will include drug

addicts and methadone subjects with and without AIDS, with and

without LAV type virus, and with low to high T-helper/suppressor

ratios.

B. Investigator: Hubbard

Institution: Research Triangle Institute, N.C.

A case-comparison study of AIDS patients with a history of

intravenous heroin and cocaine use. The purpose of this study is

to attempt to quantify the risk factors associated with

needle-sharing and AIDS in geographically disparate cities. In

addition, an attempt will be made to quantify the risk factor of

the spouse and children living with needle-sharers. Physical

examinations and immunochemistries will be used to assess health

changes during the study. This study will be the first nationally

based study to determine normative values for the more recently

developed virological studies like HTLV among drug abusers.

Attempts will be made to correlate the findings of this study with

the clustering of AIDS in certain portions of the country. In

addition, the presence and recurrence of other viral infections

like herpes can be analyzed in terms of drug usage patterns. The

hypothesis that several of the psychoactive substances may have

immunosuppressive effects can be tested in a naturalistic setting.

c. Investigator: Cabral, G.A., 1 RO1 DA 3647

Institution: Virginia Commonwealth University

Title: Effect of Cannabinoids on Vaginal Herpes 2 in the

Guinea Pig

Project Year: Start Date: 7/84, 3 years

A preliminary study showed an increase in the severity of herpes-2

infection in guinea pigs administered THC and other cannabinoids.

The researchers are investigating the effect of marijuana (THC) on

the development of herpes-2 in guinea pigs in an attempt to

determine if this effect is mediated by a drug action on the

neurological, immunological, or an other system.
89

D. Investigator: Friedman, H., 1 RO1 DA 3646

Institution: University of South Florida

Title: Marijuana Effects on Immunity

Project Year: Start Date: 4/84, 3 years

This is a study to examine the influence of marijuana components on

both hormonal and cellular immune responses in vivo and in vitro.

For example, they will measure the antibody formation by immune

splenocytes or skin graft rejections, lymphocyte blastogenic

responses, and lymphokine production.

E. Investigator: Falek, A., 5R01 DA 1451

Institution: Georgia Mental Health Institute

Title: Cellular Genetic Aspects of Opiate Use

Project Year: Start Date: FY 1984, 3 years

This is a study of the effects of narcotics on the immune system.

This group is investigating the ability of lymphocytes of addicts

as compared to normal subjects to form rosettes, the extent and

duration of any alteration, mechanism of this effect and any

genetic factors involved. This is an attempt to determine

immunological changes resulting from narcotic and other drug use.

F. Investigator: Watson, E.E., 1 RO1 DA 03684

Institution: University of Mississippi

Title: Marijuana and Bacterial and Transplantation Immunity

Project Year: Start Date: 7/84, 3 years

The overall objective is to assess the potential immuno-suppressive

effects of marijuana smoke through measures of dose-related

increases in susceptibility to microbial infection and tumor growth

in rats receiving marijuana smoke. Resistance to systemic as well

as to localized infections will be assessed.

G. Investigator: Newmeyer, J.A., 1 RO1 DA 03638

Institution: Community Substance Abuse Services

Title: Aids Risk Reduction for Needle-Using Drug Users

Year, Budget: Start date: 9/84, 1 year

It appears that public education programs in the homosexual

community has increased an awareness of the role of lifestyle

factors in predisposing towards AIDS. In certain large cities, it

appears that this may be having a positive effect in decreasing the

rate of increase of the disease among homosexuals. This effect has

not been seen in the drug-abusing population. Funds are needed to

develop methods to alert drug-abusers about the increased risk of

AIDS associated with the use of intravenous drugs and to try to

develop and evaluate new approaches to preventing drug abuse in

those at risk for AIDS.

42-575 0 - 85 - 7
H. Joint NIDA-NCI Study

Recent epidemiologic evidence indicates that the putative agent

HTLV-III can be transmitted by intimate sexual contact or by

injection of contaminated blood, producing AIDS. As NCI now has a

reliable and valid serologic assay for antibodies to HTLV-III, a

seroprevalence study of serum antibodies to HTLV-III will be

ascertained in drug users in the high risk area of the Newark

SMSA. In addition, an attempt will be made to determine specific

risk factors for contracting this newly identified virus. A second

phase of this study, dependent on the results of the first phase of

the implementation, will be an assessment of the actual risk of

developing an AIDS-related illness in antibody positive and

negative individuals. This prospective cohort study of drug users

will attempt to determine the clinical relevance of an individual

being HTLV-III positive.
SECTION 2: Centers for Disease Control Anticipated AIDS= Related

Grants and Activities, Fiscal Year 1985

91
AIDS

CENTERS FOR DISEASE CONTROL

FUNDING

MAJOR FUNCTIONS PLAN-FY85 PROJECTS )

1. Etiologic Agent and

Co-factors:

b. Confirmation & extension $ 3,210,000

of observations on causative

agent & discovery of role

or co-infections and co-factors. 1. Laboratory studies to characterize

retroviruses implicated in AIDS.

$756,700

2. Laboratory studies on diagnosis of

AIDS and development of tests.

$1,806,650

3. Studies on incidence, risk factors and

natural history of AIDS.

$556,650

2. Development & Evaluation of Blood

Tests:

a . Development $1,244,000 1 . Development of tests for opportunistic

infections occuring in AIDS.

$63,000

2. Characterization and development of

tests for viral antigens found in AIDS

patients.

$1,181,000
Page 2

FUNDING

MAJOR FUNCTIONS PLAN-F Y8 5 PROJECTS

b. Evaluation $1,018,000 1 .

Evaluation of tests and test

combinations for sensitivity and

specificity in the diagnosis of AIDS.

$765,000

2. Determination of incidence of viral

antibodies in population groups at risk

for AIDS.

$253,000

3. Surveillance $4,335,000 1. Conduct surveillance of various

national and international population

groups to better determine the prevalence

of AIDS and risks of transmission.

$169,000

2. Conduct surveillance of AIDS and AIDS

related complex among various risk group

members their families and sexual partners.

$306,000

3. Determine the prevalence of retrovirus

antibody and viremia in various U.S.

populations including health care

personnel exposed to potentially infected

materials.

$189,000

4. National surveillance of AIDS

including funding and monitoring “active”

surveillance programs in 15 states/cities.

$3,573,000

5. Field investigations of AIDS cases

without identifiable risk factors.

$98,000
Page 3

FUNDING

MAJOR FUNCTIONS PLAN-FY85 PROJECTS

4. Epidemiological Studies (to

determine natural history of

AIDS. $4,068,000 1 . Conduct various epidemiological

studies of known risk group members,

household members and sexual partners to

better understand sources of infection,

risk factors , and risk of transmission.

$2,435,000

2 . Acquisition, including apheresis,

processing, distribution and storage of

AIDS and AIDS related specimens; Serum

Bank AIDS collection inventory; data

storage and retrieval.

$334,000

3. Conduct studies of the relationship

between AIDS and lymphadenopathy syndrome

in various populations including families

of AIDS patients.

$397,000

4 . Multifaced field and epidemiologic

investigations of AIDS in foreign

countries with AIDS to better understand

prevalence risk factors and

transmissibility.

$366,000

5. Continue studies of pathogenesis of

HTLV-III/LAV infection in chimpanzees and

search for other animal models.

$128,000

6. Provide serologic

laboratory support for

studies.

$408,000

and biologic

AIDS epidemiologic
Page 4

FUNDING

MAJOR FUNCTIONS PLAN-FY85 PROJECTS

5. Development & Evaluation of Vaccine

(including animal model) $ 516,00 0

6. Studies of Therapeutic Intervention:

b. Opportunistic Infections $ 186,000

7. Bioethical & Biosafety Issues $ 124,000

8. Information Dissemination/Public

Affairs $3,260,000

1. Determination of antibody induction

properties of viral antigens found in AIDS

patients.

$516,000

1. Studies on the effectiveness of

certain IND drugs for opportunistic

infections in AIDS patients.

$186,000

1. Studies on required precautions when

handling potentially infective (AIDS)

materials.

$124,000

1. Consult, develop and disseminate

information to health workers treating

patients with AIDS.

$68,000

2. Information/Health Education/risk

reduction activities such as the PHS

hotline, public information program;

Conference of Mayors National Information

interchange system; International

Conference; Laboratory Training Course and

public and professional information.

$850,000

3. Establish contracts and cooperative

agreements with State/local health

departments for AIDS prevention programs.

$2,342,000
Page 5

FUNDING

MAJOR FUNCTIONS PLAN-FY85 PROJECTS

9. Immunologic Studies $ 32,000 Inventory and production of reagents used

for immunologic testing in AIDS patients.

$32,000

12. Prevention of Transfusion-Related

AIDS $ 707,000 1. Epidemiological studies and

surveillance of AIDS patients in whom the

use of blood or blood products is

implicated as a causative mechanism.

$707,000

8

I
SECTION 3: Food and Drug Administration Anticipated AIDS-Related

Grants and Activities, Fiscal Year 1985

97
98

FOOD AND DRUG ADMINISTRATION

AIDS-Related Activities

Fiscal Year 1985

($ in 000s )

a

Evaluation of Blood Test

Facilities renovatio n

b

$ 150

Blood contract s 2,000

Supplies 150

Equipment 350

Personnel 620

Subtotal $3,270

Development and Evaluation of Vaccine

Facilities renovation $ 300

Animal maintenance 1,15 0

Supplies 350

Equipment 1,30 0

Personnel 1,56 0

Subtotal $4,66 0

Studies of Therapeutic Intervention

Personnel $ 895

Total FDA AIDS Activities - Fiscal Year 1985 $8,82 5

.’—...——.———.

a. Sources :

Analyst, Food

of Health and

1985.

N. William, Center for Drugs and Biologics, and J. Biviano, Budget

and Drug Administration, Public Health Service, U. S. Department

Human Services, Bethesda, Md., personal communications, Jan. 8,

b . Two extramural studies are planned, each for approximately $1,000,000: One

to assess the impact of testing on the whole blood and plasma supplies to

determine which groups to exclude from donating; and a second to assess the past

and current HTLV-III exposure of hemophiliacs who received antihemophiliac

factor from pooled plasma donations.
SECTION 4: National Institutes of Health Anticipated AIDS-Related

Activities, Fiscal Year 1985

99
100

REPORT ON AIDS RESEARCH

INTRODUCTION

‘In its report on the fiscal year 1985 budget for the Department of Health

and Human Services, the Committee on Appropriations stated:

With the recent discovery of the likely cause of AIDS and

the ability to mass produce the HTLV-III virus, the Committee

is informed that the Public Health Service will be able to mov e

ahead in the development of a rapid blood test and a vaccine.

While the budget request provides an additional $6 million

for AIDS research at NIH, that request could not have factored

in the recent important discoveries related to the cause of AIDS.

Further, the Committee understands that NIH is currently

reviewing its additional resource requirements for AIDS research

in blood testing, HTLV-III production, vaccine development, monocyte abnormalities, and immune abnormalities; collaborative

therapy trials of AIDS using standard protocols; clinical study

related to treatment and prevention of AIDS; and epidemiological

studies including possible HTLV-III infections in health care

workers.

The Committee believes that within the overall increases

recommended in this bill for NIH, sufficient resources will be

available to meet these additional research requirements. With

that in mind, the Committee requests NIH to provide to the Committee by September 1 a report identifying, by Institute, the

additional funding needed to respond to the recent AIDS discoveries, together with a description of activities to be conducted

in FY 1985. (House Report No. 98-911, pages 33-34)

The following report has been prepared by the National Institutes of Health

of the Department of Health and Human Services in response to the

Committee’s request.

Six NIH institutes and the Division of Research Resources are participating in the effort to conquer the AIDS problem — an effort that has been

intensified by recent scientific breakthroughs. NIH has established an

Executive Committee to coordinate the research efforts on AIDS.

FUNDING FOR AIDS RESEARCH

For FY 1984, NIH estimates that approximately $43,356,000 will be obligated

in AIDS research through NIH-supported programs. This funding includes

about $36,806,000 available in the regular appropriation and $6,550,000

provided by the Congress through a supplemental bill.

Preliminary estimates for AIDS funding in the 1985 President's Budget

totalled $40,316,000 . With the discovery of the causative agent, however,
101

and with the availability of data on more recent funding experience, NIH

now estimates that about $45,663,00 would be obligated within the level of

resources provided by the President’s Budget.

The recent appropriation for 1985 would provide for an estimated total of

$62,164,000 for AIDS research to be conducted and supported by NIH.

Approximately $11 million of this $16.5 million increase over the President’s Budget was achieved through mechanism redistribution of the House

and Senate allowances.

The attached table summarizes NIH funding for NIH research by Institute.

AIDS RESEARCH ACTIVITIES, FY 198 5

The identification of the retrovirus HTLV-III as the cause of AIDS and

the development of a process to produce this virus in large quantities

have provided new impetus in the fight against this serious public health

emergency. The NIH is intensifying its efforts to facilitate the development

of a vaccine and to expand research on the natural history, epidemiology,

accessory etiologic factors, pathogenesis, and animal models, prevention,

and therapeutic methods. The specific avenues of research being undertaken

by each of the participating institutes and the Division of Research Resources

are discussed below.

National Cancer Institute

In 1985, the NCI will pursue new research projects to develop effective

strategies for dealing with AIDS, not only through the use of currently

available drugs and biological response modifiers in patients affected with

the disease, but also through basic research to develop the knowledge

necessary to prevent and cure the syndrome.

Efforts will primarily be directed toward the current commitment to basic

laboratory research, important clinical research to determine whether

interventive measures may be feasible, and continued vaccine developmental

research. Additional focus will involve studies on the etiopathogenesis of

the disease, including definitive studies on modes of transmission; the

nature of the protective antibody and a clear immunological identification

of the patient antibody profile. Additional knowledge is needed at the

level of viral genes, which involves cloning and DNA sequencing.

A number of drugs will be tested both in vitro and in vivo in attempts to

ameliorate or perhaps cure ongoing AIDS. Additional treatment protocols,

such as inoculation with compatible protective lymphocytes, will be

considered.

The NCI will expand its efforts in vaccine development. Past experience in

the area of attempted retroviral vaccines has shown that exceptional care

and expertise will be needed in the successful development of an HTLV-III
102

vaccine. Furthermore, the parameters of retroviral growth and antigenic

configuration are more complex than in the previously studied viruses. The

result is that extensive vaccine developmental research will be required

before a vaccine can actually be developed, and several general methods of

vaccine production will be considered.

In the intramural research program, further work will be conducted on

human cell lines that produce large amounts of HTLV-III; studies to define

the molecular structure of DNA clones of HTLV-III; the determination of

biologically critical parts of viral genome at the molecular level; the

development of rapid immunological assays to detect infection by identifying virus or viral antigens; the development of other ways to halt AIDS

progression; and an expanded search for a safe, effective therapy for AIDS

and its related diseases.

Support will be increased for the NCI Frederick Cancer Research Facility,

which is the prime source for HTLV-III production, the entire early scale-up

into fermentation, and the transfer after exponential expansion into the forprofit sector-for testing blood antibodies.

Other research efforts that will be undertaken include: nutritional assessment and support of AIDS patients, since wasting and cachexia are serious

clinical problems that have not been adequately studied in these patients;

study of “differentiating agents” and low-dose chemotherapy in AIDS patients

with malignancy; considerations of new treatment modalities, including a

number of agents that interfere with the general features of the retroviral

life cycle , such as inhibitors of reverse transcriptase; studies on the

immunologic effects of cytotoxic chemotherapy; and expanded grant support

for the further development of animal models for AIDS.

National Heart. Lung, and Blood Institute

The discovery of the agent that causes AIDS prompted the NHLBI to assess

and redirect previously supported activities and plans for future research.

The Institute is now focusing its efforts on epidemiological studies of the

natural history of the disease after exposure to blood products; evaluation

of the tests , or assays, used to detect the agent in blood and blood products.

The latter category, the prevention of transfusion-related AIDS, is a new

effort planned for 1985. Universal screening of blood products will certainly

help prevent the transmission of AIDS through blood products. However, it

is unlikely that any single test will identify every unit of blood with the

HTLV-III virus. Development of methods to remove or inactivate the virus

from blood products would provide extra assurance that the virus is not

transmitted. A second initiative would develop and test in animals which

immunoglobulin preparations are capable of protecting against AIDS; that is,

which immunoglobulins have neutralizing activity against HTLV-III.

The Institute will continue to support several epidemiological studies. Among

these is a study of blood product use and immune system changes in approximately 3,500 subjects and controls. This study takes advantage of the unique
103

opportunity that now exists to collect and store blood specimens from a

large number of donors before universal screening becomes possible. Samples

will be tested for the HTLV-III virus; those found positive will be linked

to the recipients that had received the blood products. These cohorts of

recipients and donors of positive units will then be followed to determine

the long term immunologic and clinical status. The Institute will also

continue to develop a promising animal model that may prove exceedingly

useful for studies of the transmission of AIDS, the progression of the

disease, and the safety and efficacy of proposed interventions.

National Institute of Dental Research

Scientists at the NIDR are actively involved in the search to identify the

basic mechanisms responsible for the profound immunosuppression that

characterizes AIDS. These investigations have focused on the role of the

monocyte in this disease , in contrast to other NIH laboratories, which have

focused on T and B lymphocyte abnormalities. The NIDR has identified a

number of monocyte abnormalities, including depression of killing function,

chemotactic activity, mediator production, and follow-up microbicidal

product release. In preliminary studies, investigators are beginning to

extend these observations to an examination of monocyte surface receptor

activity and inhibitor production. The oral cavity is often the site of

presentation and incapacitating complications in AIDS as a result of

mucocutaneous candidiasis, herpes simplex virus, and Kaposi's sarcoma”

The continuation and expansion of these studies made possible by the House

allowance are extremely important for several reasons. First, the monocyte

is the first line of host defense against a variety of antigens, bacteria ,

viruses, and protozoan parasites. Second, the monocyte presents antigen to

T lymphocytes and generates a variety of inflammatory mediators that Initiate,

augment, and integrate inflammatory responses. Third, characterization of

the immunosuppression is crucial to identification of immunomodulatory

agents that can be used clinically to enhance or augment the depressed

immune responses in patients with AIDS.

National Institute of Neurological and Communicative Disorders and Stroke

In FY 1985, the NINCDS will continue clinical studies of AIDS patients

with evidence of a neurological disorder as well as patients who have

AIDS but no evidence of brain involvement. In these studies, cerebral

spinal fluid and brain tissues from the patients will be tested for the

presence of retroviruses as well as an attempt to develop diagnostic tests

for AIDS. Serum specimens that have been tested for opportunistic infections will be examined for retrovirus antibodies. Electron microscopic

studies of central nervous tissue for retrovirus will largely supplant

attempts to isolate the virus, but the possibility that viruses other than

HTLV-III could cause or contribute to AIDS will also be considered.

Collaborative studies with NCI attempting to produce AIDS in primates have

demonstrated hematological changes transmitted by passage of infectious
104

materials . Since these early experiments have been successful, experimental diagnostic and therapeutic procedures are being initiated.

In other studies, the NINCDS will test human sera with Simian Acquired

Immune Deficiency Syndrome (SAIDS) agent for evidence of antibodies.

Tissue from ❑ onkeys Infected with SAIDS and other opportunistic infections

(simian virus-40, toxoplasmosis, and measles) will continue to be studied

with electron microscopy. Scientists will conduct comparative immunological characterization of SAIDS and AIDS. Monkeys with SAIDS will be

treated with interleukin-2 in attempts to enhance their susceptibility to

AIDS infection. The experience of developing a vaccine for SAIDS may help

to test procedures for the development of an AIDS vaccine. NINCDS

investigators will apply retrovirus probes in attempts to identify the

AIDS virus in the nervous system.

National Institute of Allergy and Infectious Diseases

In 1985 the NIAID will intensify its efforts in such areas as the natural

history of the disease, development of animal models and vaccines for

HTLV-III, and the development and testing of chemotherapeutic agents for

HTLV-III and the resultant opportunistic infections.

Specifically, 5,000 homosexual men residing in Baltimore, Berkeley, Chicago,

Los Angeles, and Pittsburgh are being followed longitudinally for 3 years.

Funds will be diverted from some activities described in the House report

language in order to undertake new efforts to resolve issues concerning the

clinical spectrum of HTLV-III infections, the implications of a positive

serologic test for an individual, the prevalence of circulating and/or she d

virus in antibody-positive persons, and the prognosis for seropositive

individuals with mild or no signs of the disease. Biological specimens

will be collected and frozen; these will then be made available to intramural and extramural scientists for evaluation.

In an attempt to learn about the pathology of retrovirus infections and for

testing possible vaccines and antiviral drugs for HTLV-III, the NIAID has

scheduled a meeting on “Animal Models of Retrovirus Infection” for November

1984. Several possible animal retrovirus systems that might serve as

models for evaluation of problems associated with HTLV-III vaccine development will be discussed. Full development of these systems will require

extensive in vitro and in vivo testing of the most likely candidates. In

addition, NIAID intramural scientists are attempting to develop a recombinant

HTLV-III vaccine using the vaccinia vector system (VVS). The VVS, developed

by NIAID, has recently been used to develop a vaccine for hepatitis and

shown promise in animal studies. Application of this new technique to the

development of an AIDS vaccine represents a novel and potentially promising

approach.

Prior to and even with the development of an effective vaccine, some patients

will continue to develop AIDS and the opportunistic infections associated

with the syndrome. Consequently, studies of the basic biology of these
105

infections will be continued. Particular attention will be directed toward

the development of new or improved therapy of candidiasis, cryptosporidiosis,

cytomegalovirus, Mycobacterium avium-intracellulare and Pneumocystis carinii

infections. NIAID will develop a mechanism to coordinate testing of

therapeutic agents found in these studies.

An outreach program has been established to transmit the latest technical

advances in AIDS research to primary care physicians and allied health

personnel. These activities will also be continued in FY 1985.

National Eye Institute

Patients with AIDS are susceptible to a variety of ocular infections including one of the herpesviruses, cytomegalovirus (CMV) retinitis, a serious

inflammation of the light-sensitive tissue that lines the inside of the

back of the eye. Investigators have found that patients with CMV retinitis

are at high risk of dying within a few months, apparently because their

immune systems have been drastically impaired by the time the eye infections

occur. In severe cases, blindness may precede death, thereby adding to the

spectrum of suffering for AIDS victims. For these reasons, NEI staff

opthalmologists will continue to perform eye examinations on AIDS patients

at the NIH Clinical Center in consultation with staff of other Institutes

as part of their clinical workups of these patients. New projects planned

for 1985 include an epidemiological study of the various forms of retinitis

that can occur in a population at risk from AIDS. In another east coast

study, investigators will attempt to determine why so many AIDS patients in

that population have ocular herpes zoster infections. The results of blood

immunological assays will be analyzed to make this determination. As in

other diseases, the monitoring of the development of AIDS in the eye may

provide a sensitive index of systemic disease progression and of the

effectiveness of experimental therapies.

Division of Research Resources

The DRR will continue its research efforts in 1985 in the area of AIDS,

SAIDS, and AIDS/SAIDS-related research activities. Clinical studies of

AIDS will continue to be conducted within the General Clinical Research

Centers. In several of these centers, treatment modalities of patients

with AIDS, including bone marrow implantation, are being tested. It i s

anticipated that these studies will facilitate the development of new

treatment methodologies.

Outbreaks of spontaneously occurring SAIDS have occurred in nonhuman primates at four of the seven DRR-supported Regional Primate Research Centers.

The epidemiologic, pathologic, immunologic, and virologic features of

this disease show many similarities to those seen in human AIDS patients,

thus making SAIDS potentially a very good model system for basic studies on

human AIDS. There is a high mortality rate in nonhuman primates affected

by SAIDS, and this disease represents a threat to the health status of

thousands of research animals in these Centers.

42-575- 0

-

8 5

- 8
106

Studies to date indicate that type D retroviruses are the causative agents

of SAIDS at all four Centers. The disease has been experimentally transmitted

to normal nonhuman primates at the California Center by inoculating them

with the type D retrovirus isolated from SAIDS-affected animals. These

retroviruses which appear to cause SAIDS are not the same retrovirus which

has been reported to be the probable causative agent of human AIDS.

Studies on SAIDS at the four Regional Primate Research Centers are continuing.

The retroviruses which have been isolated at the four Centers will be

further characterized by extensive biochemical and immunological studies.

In addition, attempts will be initiated to develop an antiserum to permit

rapid and reliable field detection of SAIDS and SAIDS-carriers in the

Centers' primate colonies. As soon as adequate laboratory characterization

of the SAIDS retroviruses are completed, attempts will be made to develop

vaccines to immunize nonhuman primates against the disease.
107

National Institutes of Health

FUNDING FOR RESEARCH ON ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS)

(dollars in thousands)

1982 1983 1984 Estimate 1985

Actual Actual Approp. Suppl. Total Approp.

NCI . . . . . . . . . $2,400 $9,790 $14,58 8 $2,000 $16,588 $26,851

NHLBI . . . . . . . 5 1,202 4,89 0

NIDR . . . . . . . . 25 25 30

NINCDS .*..*e 31 684 1,547

NIAID ● **9*** 297 9,223 14,918

NEI ● 0..98.0 ● 33 45 58

DRR ● ******* ● 564 699 775

Total . . . 3,355 21,668 36,806

-... . —-.--—- .——..—..

—. 4,890

- - - 30

- - - 1,547

4,150 19,068

- - - 58

400 1,175

6,550 43,356

-— ., —.—...-.-——.

8,45 9

411

1,15 0

23,262

300

1,731

62,164

-.
SECTION 5: NIH AIDS Projects Funded in Fiscal Years 1983 and 1984

108
12-14-84

NIH AIDS PROJECTS FOR FISCAL YEARS 19 J3-84 BY IN ST1l UTE

Gl?hlll II IIMBER START FY Dfll L ARS PERCENT DOLLARS GRANTEE INSTITUTION

PI t F Aklm TO AIM TITLE OF PROJECT Nat 1 on a I FOR A,L.DS

ute 0+ Al ler~y an infect lous Diseases {F.llAIG)—

1 F52 AI07216-01 05-31-8 5 a~ ZU,04!J 100

HL)FFL1l/, JL3SE M

2 PO1 AI12t92-09

STAfVl, WALTER E

5 PO1 AI12I92-1 0

STAMM, HALTER E

S PO1 A112192-1OS I

STAhlM, NALTER E

2 PO! A115036-06

SPARLIHG, PHILIP F

5 POt AI 15036-0 7

SPARLI~G, PHILIP F

2 P50 A115321-06

BELLAtI II, JOSEPH A

5 P50 A11532 ~-07

BELLAIIII, JOSEPH A

3 P50 AI153ZI-07SI

BELLAIIII) JOSEPH A

2 P50 A115332-06

FA}IEY, JOIIII L

3 p50 A115332-06S1

FAHEY, JOtltl L

3 P50 A115332-06S2

FAtlEY, Jllt{N L

3 p50 A115332-06S3

FAttEY, JOIIH L

5 P50 A115332-07

FAHEY, JOtIll L

2 RO1 AI16212-04A1

RItlALD~/ CHARLES R ,

5 ROI AI!621?-05

RIliALLJU/ L.tlARLES R,

07-01-78

07-01-78

07-01-7 8

o7-ot-78

07-01-7 8

09-01-7 8

09-01-7 8

09-01-7 8

09-01-7 8

09-01-7 8

09-01-7 8

09-01-7 8

09-01-7 8

09-01-7 9

JR

09-01-7 9

JR

8 3

84

8fi

8 3

84

8 3

84

84

8 3

8 3

8 3

8 3

84

8 3

8q

827,35 8

869,67 5

108,69 6

424,46 3

463,32 5

110,25 2

117,81 4

23,29 5

432,21 8

76,15 3

170,97 4

54,745

762,75 6

118,39 3

116,09 1

13

IJ

13

14

14

100

100

100

35

33

33

33

33

100

100

PAGE

20,04(’ PALO ALTO MEDICAL FOU?JDATYON RES INST

TOXOPLA:MIC Et4CEPttAL1T15 IN THE IMllUllOSUPPRESSEll HOST

107,557 UNIVERSITY OF WASHINGTON

STD RESEARCH PROGRAM PROJECT

l13,05& UNIVERSITY OF HASHINGTON

STD RESLARCH PROGRAM PROJECT

14,130 U~IVERSITY OF HASHINGTON

STD RESEARCH PROGRAM PROJECT AI-12192

59,425 Ut/IVERSITY OF NORTH CAROLINA CHAPEL HILL

NORTH CAROL PROGRAM ON SEXUALLY TRANSflITTED DISEASE

64,866 UNIVERSITY OF NORTH CAROLINA CHAPEL HILL

NORTH CAROLINA PROGRAM OF SEXUALLY TRANSMITTED DISEASE

110,252 GEORGETOWN UNIVERSITY

INTERDISCIPLINARY RESEARCH ON IMMUNOLOGIC DISEASES

117,81G GEORGETOWN UNIVERSITY

INTERDISCIPLINARY RESEARCH ON IMMUNOLOGIC DISEASES

23,295 GEORGETOb4N UNIVERSITY

CENTERS FOR IIIIERDISCIPLINARY RESEARCH ON IMNUNOLOGIC DI

162,632 UNIVERSITY OF CALIFORNIA 10S /lNG~LES

INTERDISCIPLINARY RESEARCH ON IFIMUNOLOQIC OISEASE

25,130 UNIVERSITY OF CALIFORNIA 10S ANGEIES

ASSESSIhG & MEE1lNG PSYCHOSOCIAL NEEDS OF AIDS PATIENTS

56,421 UNIVERSITY OF CALIFORNIA LOS AIIGELES

EFFECTIVE MANAGEMENT OF THE AIDS CRISIS BY PRIflARY CARE

18,066 UNIVERSITY OF CALIFORNIA LOS ANGELES

INTERDISCIPLINARY RESEARCH ON IMMUNOLOGIC DISEASE

251,709 UNIVERSITY OF CALIFORNIA LOS AN(3ELES

INTERDISCIPLINARY RESEARCH ON IWUNOLOGIC DISEASE

118,393 UNIVERSITY OF PITTSBURGH

CELL MEOIATED IMMUNITY DURING CYTOMEGALOVIRUS INFECTION

116,091 UNIVERSITY OF PITTSBURGH

CELL MEDIATEO ItWIUtlITY DURING CYTOMEGALOVIRUS INFECTION

PROGRAM 1tllG3; SOURCE: OPEN/PENO FILE 8 AIDS FILE
12-14-86 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE ..—.—. —-.—.

● GRANT NUMBER START FY DOLLARS PERCENT DOLLARS GRANTEE INSTITUTION

PI NAME DATE AWARDED TO AIDS FOR AIDS TITLE OF PROJECT

5 RO1 A119772-02

PESANTI, EDHARO L

1 R13 A120166-01

HOLMES, KING K

1 RO1 A120573-01

GARDNER, MURRAY B

5 RO1 A120573-02

GARDNER, MURRAY B

1 UO1 AIZ0671-01

RUBINSTEIN, ARYE

5 UO1 A120671-02

RUBINSTEIN, ARYE

t UO1 A120672-01

FAHEY, JOHN L

3 UO1 AIZ0672-OIS1

FAHEY, JOHN L

3 UO1 A120672-01S2

FAHEY, JOHN L

5 UO1 A120672-02

FAHEY, JOHN L

1 UOf A120673-01

HUGHES, WALTER T

5 UO1 A120673-02

HUGHES, WALTER T

1 UO1 A12067G-01

MA, PEARL

5 UO1 A120674-02

MA, PEARL

1 RO1 A120698-01

CHESS, LEONARD

5 RO1 A120698-OZ

CHESS, LEONARD

08-01-82

08-01-83

09-15-83

09-15-83

05-01-83

05-01-83

05-01-83

05-01-83

05-01-83

05-01-83

04-01-83

04-01-83

04-01-83

04-01-83

09-15-83

09-15-83

83

83

83

84

83

84

83

83

83

8G

83

84

83

8fi

83

86

72,009

7,500

12fi,253

139,472

392,765

672,562

273,954

78,133

76,119

491,012

86,505

91,355

116,974

143,695

161,991

167,150

PROGRAM 8t4143; SDURCE: OPEN/PEND FILE 8 AIDS FIL E

100

100

100

100

100

too

100

100

100

100

100

100

100

100

100

100

72,009 UNIVERSITY OF CONNECTICUT HEALTH CENTER

PNEUMOCYSTIS CARINII1 METABOLISM AND HOST DEFENSES

7,500 UNIVERSITY OF NASHIN(3TON

FIFTH MEETINQ - INTERNATIONAL SOCIETY FOR STD RESEARCH

124,253 UNIVERSITY OF CALIFORNIA DAVIS

SIMIAN ACQUIRED IMMUNOOEFICIENCY SYNDROME

139,472 UNIVERSITY OF CALIFORNIA DAVIS

SIMIAN ACQUIRED IMMUNODEFICIENCY SYNDROME

392,7G5 YESHIVA UNIVERSITY

PATHOGENESIS 8 EPIDEMIOLOGY OF ACQUIRED INNUNODEFICIENCY

672,542 YESHIVA UNIVERSITY

PATHOGENESIS 8 EPIDEMIOLOGY OF ACQUIRED IMNUNODEFICIENCY

273,954 UNIVERSITY OF CALIFORNIA LOS ANGELES

STUDIES OF ACQUIRED IMMUNO DEFICIENCY SYNDROME

78,133 UNIVERSITY OF CALIFORNIA LOS ANGELES

CLINICAL & THERAPEUTIC STUDIES IN KS t RELATED AIDS

76,119 UNIVERSITY OF CALIFORNIA LOS ANGELES

SIGNIFICANCE OF TH SUBPOPUI.ATION REDUCTIONS IN AIDS

491,01 2 UNIVERSITY OF CALIFORNIA LOS ANGELES

STUDIES OF ACQUIRED IMMUNO DEFICIENCY SYNDROME

86,505 ST. JUDE CHILDRENCS RESEARCH HOSPITAL

DEVELOPMENTAL THERAPEUTICS FOR P CARINII PNEUMONITIS

91,355 ST. JUDE CHILDREN’S RESEARCH HOSPITAL

DEVELOPMENTAL THERAPEUTICS FOR P CARINII PNEUllONITIS

116,974 ST. VINCENT’S HOSP & MED CTR NEbl YORK

PREVALENCE AND PATHOGENESIS OF CRYPTOSPORDIOSIS

163,695 ST. VINCENT’S HOSP 8 HED CTR NEH YORK

PREVALENCE ANO PATHOGENESIS OF CRYTOSPORDIOSIS

161,991 COLUMBIA UNIVERSITY NEH YORK

IMMUNOBIOLOGY OF TttE ACQUIRED IMMUNODEFICIENCY SYNDROME

167,150 COLUMBIA UNIVERSITY NE14 YORK

IMMUNOBIOLOGY OF THE ACQUIRED IMtlUNODEFICIEtJ(X SYNDROM E
12-14-8 4 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

, GRANT NUMBER - START FY OOLLARS PERCENT DOLLARS GRANTEE INSTITUTION

PI NAflE DATE ANARDED TO AIDS FOR AIDS TITLE OF PROJEC T

t RO1 A120717-01 09-15-8 3

GUPTA. SUDHIR

5 RO1 A120717-02 09-15-8 3

GUPTA, SUDHIR

1 ROI A120729-01 09-15-8 3

LETVIN, NORMAN L

5 RO1 A120729-02 09-15-8 3

LETVIN, NORMAN L

1 RO1 A120731-01 09-15-8 3

MONTE-RICHER, VICTORI A

5 t?Ol A120731-02 09-15-8 3

MONTE-WICHER, VICTORI A

1 RO1 A120736-01

PARKS, MADE P

5 RO1 AX20736-02

PARKS, WADE P

1 RO1 A120911-OIA1

MILLER, GERALDINE P

1 RO1 A120940-01

IVEY, MICHAEL H

1 UO1 AI21105-O 1

HORWITZ, MARSHALL S

1 Uol A121118-01

TATTERSALL, PETER J

1 Uol A121122-01

PARKS, HADE P

1 UO1 A12f 129-0 1

MULDER, CARE L

1 UO1 A121134-01

PREBLE, OLIVIA T

1 Uol A1211f41-ol

ANDERSON, DEBORAH J

‘ROGRAM #Nt43; SOURCE ’

09-30-8 3

09-30-8 3

09-30-8fi

04-01-8 4

04-01-8 4

03-01-84

02-01-8 4

02-01-8 4

05-01-8 4

04-01-8 4

83

84

83

84

83

84

83

8~

84

84

84

84

84

84

84

84

102,198

110,217

79,446

87,083

47,446

50,818

292,916

293,668

77,193

98,892

118,103

161,339

159,534

88,101

s1,025

70,324

of’EN/f’END FILE 8 AIDS FILE

100

100

100

100

100

100

100

100

100

100

100

100

100

100

100

100

102,19 8 UNIVERSITY OF CALIFORNIA IRVINE

AMLR AND LYMPHOID DIFFERENTIATION IN AIDS

110,21 7 UNIVERSITY OF CALIFORNIA IRVIN E

AMLR AND LYMPHOID DIFFERENTIATION IN AIDS

79,fi4G HARVARD UNIVERSITY

IMMUNOREGULATION XN AID S

87,08 3 HARVARD UNIVERSITY

IMMUNOREGULATION IN AIDS

47,44 6 NEb4 YORK STATE DEPARTMENT OF HEALTH

SEMEN--INDUCED IMMUNOSUPPRESSION

50,81 8 NEW YORK STATE DEPARTMENT OF HEALTH

SEMEN--INDUCED IMMUNOSUPpRESSION

292,91 6 UNIVERSITY OF MIAM I

ACQUIRED IMMUNODEFICIENCY DISEASE IN HAITIAN CHILDREN

293,668 UNIVERSITY OF MIAMI

ACQUIRED IMMUNODEFICIENCY DISEASE IN tlAITIAN CHILDREN

77,193 UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON

HUMAN IN VITRO RESPONSES TO CRYPTOCOCCUS NEOFORMANS

98,89 2 UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR

ASSAY FOR PNEUMOCYSTOSIS IN IMMUNODEFICIENT HOST S

118,10 3 YESHIVA UNIVERSITY

ADENOVIRUSES AS A COFACTOR AND IMMUNE MODULATOR IN AIDS

161,339 YALE UNIVERSITY

ASSESSMENT OF A POSSIBLE PARVOVIRAL ETIOLOGY FOR AIDS

159,53 4 UNIVERSITY OF MIAMI

HTLV RETROVIRUS INFECTION IN HAITIANS WITH AID S

88,101 UNIVERSITY OF MASSACHUSETTS MEDICAL SCH

MOLECULAR BIOLOGICAL STUDIES ON THE ETIOLOGY OF AIDS

51,02 5 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

INFECTIOUS ETIOLOGY OF AIDS IN HEMOPHILIACS

70,324 DANA-FARBER CANCER INSTITUTE

ROLE OF SEMEN IN ACQUIRED IMMUNODEFICJENCY SYNDROME
12:14-84 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

● GRANT NUMBER START FY DOLLARS PERCENT

PI NAME DATE AWARDED

—.

TO AIDS

 -——. .—

1 RO1, AIZ1161-01

SULLIVAN, JOHN L

5 RO1 A121161-02

SULLIVAN, JOHN L

1 UO1 A121175-01

LANGE, MICHAEL

3 UO1 A121175-OIS1

LANGE, MICHAEL

5 UO1 A121175-02

LANGE, MICHAEL

1 Uol A121182-01

SIDDIQUI, ALEEM

1 UO1 A121186-01

MILLER, I GEORGE, JR

1 UO1 A121189-01

CHAGANTI, RAJU S

1 R43 A121209-01

ldIDDER, KENNETH J

1 PO1 A121289-01

RICH, ROBERT R

1 ROI A121510-01

MURRAY, HENRY H

1 RO1 A121516-01

BARTLETT> JOHN G

1 RO1 A121874-01

MC CARIHY, CHARLOTT E

1 RO1 A121897-01

09-15-8 3

09-15-8 3

09-30-8 3

09-30-8 3

09-30-8 3

04-01-8 4

02-01-8 4

02-01-8 4

07-01-8fi

09-30-8 4

07-01-8 4

06-01-8 4

09-30-8 4

M

09-30-8 4

GANGADHARAM, PATTISAPU R

1 RO1 A121917-01 09-30-8 4

MURRAY, HENRY W

I RO1 A121919-0~ 09-30-8 4

CROHLE, ALFRED J

83

84

8 S

84

84

84

84

84

84

84

84

84

84

84

84

84

177,810

192,713

304,989

34,300

336,937

78,98 5

188,495

105,535

42,286

246,750

168,470

228,632

79,054

107,846

109,837

91*541

‘ROGRAM ~Nt43; SOURCE’ OPEN/PEND FILE 8 AIDS FIL E

100

100

100

100

100

100

100

100

100

50

100

100

100

100

100

100

DOLLARS GRANTEE INSTITUTION

FOR AIDS TITLE OF PROJECT

177,810 UNIVERSITY OF MASSACHUSETTS MEDICAL SCH

ItlMUNOREGULATORY DEFECTS IN HEMOPHILIA

192,713 UNIVERSITY OF MASSACHUSETTS MEDICAL SCH

IMMUNOREGULATORY DEFECTS IN HEMOPHILIA

304,989 ST. LUKE’S-ROOSEVELT INST FOR HLTH SC I

PROSPECTIVE STUDY OF IMMUNOLOGIC ABNORMALITIES

34,30 0 ST. LUKESS-ROOSEVELT INST FOR HLTH SCI

PROSPECTIVE STUDY OF IMMUNOLOGIC ABNORMALITIES

336,93 7 ST. LUKECS-ROOSEVELT INST FOR HLTH SC I

PROSPECTIVE STUDY OF IMMUNOLOGIC ABNORMALITIES

78,98 5 UNIVERSITY OF COLORADO HLTH SCIENCES CTR

HEPATITIS B VIRUS AS COCARCINOGEN IN KAPOSI SARCOM A

188,495 YALE UNIVERSITY

RETROVIRUSES AND OTHER VIRAL COFACTORS IN AIDS

105,535 SLOAN-KETTERING INSTITUTE FOR CANCER RES

CYTOGENETIFCS OF LYMPHOID PROLIFERATION IN AIDS PATIENTS

42,286 MOLECULAR BIOSYSTEMS, INC.

POSSIBLE AIDS DIAGNOSTIC TEST

123,375 BAYLOR COLLEGE OF MEDICINE

REGULATORY ABNORMALITIES IN IMMUNOLOGIC DISEASES

168,470 CORNELL UNIVERSITY MEDICAL CENTER

ROLE S EFFECT OF GAMMA INTERFERON IN THE AIDS SYNDROME

228,63 2 JOHNS HOPKINS UNIVERSITY

ENTERIC DISEASES IN A POPULATION AT RISK FOR AIDS

79,05 4 NEW MEXICO STATE UNIVERSITY LAS CRUCES

ASSESSMENT OF DRUG RESISTANCE IN MYCOBACTERIUM AVIUM

107,846 NATIONAL JEWISH HOSP 8 RES CTR-NAT”L AST

IMMUNOPATHOLOGY OF MYCOBACTERIUM INTRACELLULAR IN AID S

109,837 CORNELL UNIVERSITY MEDICAL CENTER

GAMtlA INTERFERON--MYCOBACTERIUM AVIUM INFECTION IN AIDS

91,54 1 UNIVERSITY OF COLORADO HLTH SCIENCES CTR

MECHANISMS OF M AVIUM INFECTION IN AIDS
12- f4-84 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

, G~;NT&MBER START m DOLLARS PERCENT DOLLARS GRANTEE INSTITUTIO N

DATE A14ARDED TO AIDS FOR AIDS TITLE OF PROJECT —-.

1 RO1. A121929-01

IMAEDA, TAMOTSU

1 RO1 A121931-01

GANZ, TONAS

f RO1 A121938-01

ARMSTRONG, DONALD

1 RO1 A121946-01

BARRO14, NILLIAM H

1 RO1 A1219G7-01

LEHNANN, PAUL F

1 ROf A121951-01

LIPSCOPIB, MARY F

1 RO1 A121953-01

MILLER, RICHARD A

1 NO1 A132503-00

CICNA14EC, JOHN L

5 NO1 A132503-01

CICNANEC, JOHN L

t NO1 A132507-00

BAKER, LOUIS N

5 tlOl A132507-05

BAKER, LOUIS N

5 NO1 A132507-06

BAKER, LOUIS N

1 NO1 A132511-00

DETELSt ROGER

5 NO1 A132511-03

DETELS, ROGER

5 NO1 A132511-06

DETELS, ROGER

09-30-84

09-30-84

09-30-84

09-30-84

09-30-84

09-30-84

09-30-84

05-19-83

05-19-83

07-22-83

07-22-83

07-22-83

09-30-8 3

09-30-83

09-30-83

1 NO1 A132513-00 09-30-83

RINALDO, CHARLES R, JR

84

84

84

84

84

84

84

83

84

83

84

84

83

84

84

83

71,792

111,604

38,395

41,240

61,356

178,870

81,518

169,078

l17,6fi9

550,838

578,322

201,697

669,165

5fifi,861

629,025

782,790

:OGRAIl 8N143; SOURCE; OPEN/PEND FILE & AIDS FIL E

100

100

100

100

100

100

100

100

100

100

100

100

100

100

100

100

UNIVERSITY OF MEDICINE 8 DENTISTRY OF NJ

NY%%ERIM AVIUM INTRACELLULAR IN AIDS PATIENTS

UNIVERSITY OF CALIFORNIA LOS ANGELES

M;&:%DAL MECHANISMS AGAINST PNEUMOCYSTIS CARINII

38,395 MEMORIAL HOSPITAL FOR CANCER 8 ALLIED DI

PENTAMIDINE PHARMACOKINETICS IN ANIMALS AND HUNANS

TEXAS COLLEGE OF OSTEOPATHIC MEDICINE

PRf&%NO OF ?lYCOBACTERIAL (3LYCOPEPTIDOLIPID ANTIGEN S

?IEDICAL COLLEGE OF OHIO AT TOLEDO

MAki):::TEIN BIOSYNTHESIS AND ITS ROLE IN PATHOGENICITY

178,870 UNIVERSITY OF TEXAS HLTH SCI CTR DALLAS

PULMONARY DEFENSES IN OPPORTUNISTIC INFECTIONS

81,518 UNIVERSITY OF WASHINGTON

HUMORAL IMMUNITY TO CRYPTOSPORIDIUM IN PRIMATES

169,078 MELOY LABORATORIES

HOUSING ANIMALS FOR STUDIES OF INFECTIOUS DISEASES

117,64 9 ?IELOY LABORATORIES

HOUSING ANINALS FOR STUDIES OF INFECTIOUS DISEASES

550,83 8 NEW YORK BLOOD CENTER

COLLECT SPECIMENS TO DETECT ETIOLOGIC AGENTS OF AIDS

578,322 NEH YORK BLOOD CENTER

COLLECT SPECIMENS TO DETECT ETIOLOGIC AGENTS OF AID S

201,697 NEH YORK BLOOD CENTER

COLLECT SPECIMENS TO DETECT ETIOLOGIC AGENTS OF AIDS

669,165 UNIVERSITY OF CALIFORNIA LOS ANGELES

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

544,861 UNIVERSITY OF CALIFORNIA LOS ANGELES

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

629,025 UNIVERSITY OF CALIFORNIA LOS ANGELES

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

782,790 UNIVERSITY OF PITTSBURGH

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
I 2- t4-a4 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

● G~llN~ATN~MBER START

DATE —.

5 NO1 A132513-01 09-30-8 s

RINALDO, CHARLES R, J R

5 NO1 A132513-04 09-30-8 3

RINALDO, CHARLES R, J R

5 NO1 A132513-06 09-30-8 3

RINALDO, CHARLES R, J R

t NOt A132519-00 09-30-8 3

141NKELSTEIN, HARREN, J R

5 ?401 A132519-oq 09-30-83

MNKELSTEIN, NARREN, J R

3 NO1 A132519-05 09-30-83

HINKELSTEIN, blARREN, J R

1 NO1 A132520-00 09-30-83

POLK, B FRANK

5 NO! A132520-01 09-30-83

POLK, B FRANK

5 NO1 A132520-04

POLK, B FRANK

09-30-83

3 NOi A132520-05 09-30-83

POLK, B FRANK

1 Yol A140012-00 08-07-84

KASLOH, RICHARD A

1 NO1 A1425fi3-00 07-10-86

SMITH, JAMES H

1 NO1 A142544-00 07-23-84

ISE?4AN, MICHAEL D

1 NO1 A142545-00 07-23-84

YOUNG, LOHELL S

1 NO1 A142547-00 07-16-84

LOPEZ-BLRESTEIN, GABRIEL

1 NO1 A142548-00 07-10-84

NALZER, PETER D

FY DOLLARS

A14ARDED

83

84

a~

83

84

84

83

83

84

84

84

84

84

84

84

84

156,000

1, 109,920

665,311

676,951

615,627

44s,285

471,663

94,000

404,269

517,879

33,940

149,225

227,559

186,123

159,494

160,024

‘ROGRAM tN143; SOURCE: OPEN/PEND FILE 8 AIDS FIL E

PERCENT

TO AID S

100

100

100

100

100

100

100

100

100

100

00

00

00

100

100

100

DOLLARS GRANTEE INSTITUTIO N

FOR AIDS TITLE OF PROJECT

. . -

156,00 0 UNIVERSITY OF PITTSBURG H

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

1,109,92 0 UNIVERSITY OF PITTSBURG H

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

665,311 UNIVERSITY OF PITTSBURG H

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

676,951 UNIVERSITY OF CALIFORNIA BERKELEY

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

6t5,627 UNIVERSITY OF CALIFORNIA BERKELEY

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

443,285 UNIVERSITY OF CALIFORNIA BERKELEY

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROIIE

471,663 JOHNS HOPKINS UNIVERSITY

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

94,00 0 JOHNS HOPKINS UNIVERSITY

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

404,26 9 JOHNS HOPKINS UNIVERSITY

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

517,879 JOHNS HOPKINS UNIVERSITY

NATURAL HISTORY OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

33,940 U.S. NATIONAL INSTITUTES OF HLTH

MENTAL HEALTH EFFECTS OF AIDS ON AT-RISK HOMOSEXUAL MEN

149,225 INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS

DEVELOP DRUGS FOR TREATMENT OF PNEUMOCYSTIC CARINII

227,559 NATIONAL JEWISH HOSP 8 RES CTR-NAT”L AST

DRUG TREATMENT OF M. AVXUM-INTRACELLULARE IN AID S

186,123 UNIVERSITY OF CALIFORNIA LOS ANGELES

DRUG TREATMENT QF M. AVIUM-INTRACELLULARE IN AIDS

159,~94 UNIVERSITY OF TEXAS SYSTEM CANCER CENTER

DEVELOP DRUGS FOR TREATMENT OF CANDIDIASIS

160,024 UNIVERSITY OF CINCINNATI

DEVELOP DRUGS FOR TREATMENT OF PNEUMOCYSTIC CARINII
12-14-8 4 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

b GRANT NUMBER START FY DOLLARS PERCENT DOLLARS GRANTEE INSTITUTION

PI NAM E DATE Ak4ARDED

07-23-84 84 lci6,836

TO AIDS FOR-AIDS TITLE OF PROJECT

. .

100 146,83 6 UNIVERSITY OF MISSISSIPP I

DEVELOP DRUGS FOR TREATMENT OF CANDIDIASIS

1 NOI. A142549-00

CLARK, ALICE M

100 671,02S UNIVERSITY OF MICHIGAN AT ANN ARBOR

DEVELOP ANTIVIRAL DRUGS FOR CMV INFECTIONS IN AID S

1 NO1 A142554-00

DRACH, JOHN C

08-01-84 84 671,023

100 137,133 SOUTHERN RESEARCH INSTITUTE

DEVELOP ANTIVIRAL DRUGS FOR CMV INFECTIONS IN AIDS

1 NO1 A142555-00

SHANNON, HILLIAM M

08-01-84 84 137,133

100 157,279 UNIVERSITY OF MASSACHUSETTS MEDICAL SCH

DEVELOP ANTIVIRAL DRUGS FOR CMV INFECTIONS IN AIDS

1 NO1 A142556-00

MRIGHT, GEORGE E

08-01-84 84 157,279

100 284,771 UNIVERSITY OF TEXAS MED BR GALVESTON

DEVELOP ANTIVIRAL DRUGS FOR CMV INFECTIONS IN AIDS

1 NO1 A142557-00

ALBRECHT, THONAS B

09-01-84 84 284,771

1 NO1 A142651-00

BECKER, JEFFREY M

07-30-84 84 222,553 100 222,553 UNIVERSITY OF TENNESSEE KNOXVILLE

DEVELOP DRUGS FOR TREATMENT OF CANDIDIASIS

XNST?TUTE TOTAL 24,691,203 102 21,230,459

Natlcmal Cancer 1nstttute ~NC1l

~1-79 83

84

83

84

83

84

83

84

83

117,855

lq2,570

16,350

251,794

104,431

110,788

52,244

53,720

18G,958

10 11,786 OANA-FARBER CANCER INSTITUTE

THE MOLECULAR BIOLOGY OF REPLICATION RNA TUMOR VIRUSES

10 14,257 DANA-FARBER CANCER INSTITUTE

THE MOLECULAR BIOLOGY OF REPLICATION RNA TUMOR VIRUSES

5 RO1 CA19341-08

HASELTINE, HILLIAM A

06-01-79

09-30-82

09-30-82

08-01-8S

08-01-83

09-30-83

09-30-83

02-07-83

3 RO1 CA33205-OIS1

MARMOR, MICHAE L

100 16,350 NEbl YORK UNIVERSITY

RISK FACTORS FOR KAPOSI’S SARCOMA IN HOMOSEXUAL MEN

2 RO1 CA33205-02

MARMOR, MICHAEL

100 251,794 NEW YORK UNIVERSITY

RISK FACTORS FOR KAPOSI’S SARCOMA IN HOMOSEXUAL MEN

100 104,431 SLOAN-KETTERING INSTITUTE FOR CANCER

INTERLEUKIN-2 IN HUMAN IMMUNODEFICIENCY SYNDROMES

1 RO1 CA33873-OIA1

PIERTELSMANN, ROLAND H

RES

5 RO1 CA33873-02 RES

MERTELSMANN, ROLAND H

100 110,788 SLOAN-KETTERING INSTITUTE FOR CANCER

INTERLEUKIN-2 IN HUMAN IMMUNODEFICIENCY SYNDROMES

100 52,244 DUKE UNIVERSITY

INHIBITORS OF MACROPHAGES IN NEOPLASIA RELATIONSHIP

1 R2S CA34671-01

CIANCIOLO, GEORGE J

5 R23 CA34671-02

● CIANCIOLO, GEORGE J

100 53,720 DUKE UNIVERSITY

INHIBITORS OF MACROPHAGES IN NEOPLASIA RELATIONSHIP

100 18G,958 UNIVERSITY OF TEXAS SYSTEM CANCER CENTER

STUDY OF ACQUIRED IMMUNODEFICIENCY AND KAPOSI’S SARCOMA

1 RO1 CA34674-01

HERSH, EVAN M

PROGRAM :?4143; SOURCE! OPEN/PEND FILE 8 AIDS FILE
12- lfj-84 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

● (3;iN;A;?lBER START FY DOLLARS PERCENT DOLLARS

DATE

GRANTEE INSTITUTION

AWARDED TO AIDS FOR AIDS TITLE OF PROJECT

5 RO1.CA34674-02

HERSH, EVAN M

1 RO1 CA34729-01

SPECTOR, DEBORAH

5 RO1 CA34729-02

SPECTOR, DEBORAH

1 RO1 CA34822-01

SAFAI, BIJAN

1 UO1 CA34975-01

MULLINS, JAMES I

S UO1 CA36975-02

MULLINS, JAMES I

H

H

, 1 UO1 CA34976-01

. VALENTINE, FRED T

5 UO1 CA34976-02

VALENTINE, FRED T

1 UO1 CA34977-Of

ANDES, N ABE

5 UO1 CA34977-02

ANDES, H ABE

1 UO1 CA34979-01

FINBERG, ROBERT H

5 UOt CA34979-02

FINDERG, ROBERT H

1 UO1 CA34980-01

VOLBERDING, PAUL A

3 UO1 CA34980-01S2

VOLBERDING, PAUL A

. 5 Uol CA34980-02

VOLBERDING, PAUL A

1 UO1 CA34981-01

HAUPTHAN, STEPHEN P

PROGRAM tN143; SOURCE:

02-07-83

05-01-83

05-01-83

09-30-8s

05-01-83

05-01-83

06-01-83

06-01-83

09-30-83

09-30-83

09-30-83

09-30-83

05-01-83

05-01-8S

05-01-83

09-30-83

84

83

84

83

83

84

83

84

83

84

83

84

83

83

84

8 3

198,741

99,563

115,844

190,939

143,699

126,262

166,822

171,305

264,616

261,892

60,631

64,561

526,229

48,526

559,702

153,421

OPENZPEND FILE 8 AIDS FILE

100

100

100

100

00

00

00

00

100

100

100

100

100

100

100

100

198,741 UNIVERSITY OF TEXAS SYSTEM CANCER CENTER

STUDY OF ACQUIRED IMMUNODEFICIENCY AND KAPOSI’S SARCOMA

99,563 UNIVERSITY OF CALIFORNIA SAN DIEGO

HUMAN CMV, CELL-RELATED DNA, ONCOGENES & KAPOSI SARCOMA

115,844 UNIVERSITY OF CALIFORNIA SAN DIEG O

HUMAN CIIV, CELL-RELATED DNA, ONCOGENES & KAPOSI SARCOMA

190,93 9 MEMORIAL HOSPITAL FOR CANCER & ALLIED DI

EPIDEMIOLOGY: KAPOSI SARCOMA-ACQUIRED IMMUNE DEFICIENCY

143,699 HARVARD UNIVERSITY

MALIGNANCY ASSOCIATED GENETIC CHANGES--KAPOSI’S SARCOMA

126,262 HARVARD UNIVERSITY

RETROVIRUSES AND AIDS

166,822 NEW YORK UNIVERSITY

ETIOLOGY AND IMMUNOLOGICAL BASIS OF THE AID SYNDROME

171,305 NEH YORK UNIVERSITY

ETIOLOGY AND IMMUNOLOGICAL-BASIS OF THE AID SYNDROME

264,616 TULANE UNIVERSITY OF LOUISIANA

A STUDY OF THE IMMUNODEFICIENCY IN HEMOPHILIA

261,892 TULANE UNIVERSITY OF LOUISIANA

A STUDY OF THE IMMUNODEFICSENCY IN HEMOPHILIA

60,631 DANA-FARBER CANCER INSTITUTE

ANIMAL flODELS OF AIDS

64,561 DANA-FARBER CANCER INSTITUTE

ANI?4AL MODELS OF AIDS

526,229 UNIVERSITY OF CALIFORNIA SAN FRANCISCO

STUDIES OF ACQUIRED IMHUNE DEFICIENCY SYNDROME

48,526 UNIVERSITY OF CALIFORNIA SAN FRANCISCO

STUDIES OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

559,702 UNIVERSITY OF CALIFORNIA SAN FRANCISCO

STUDIES OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

153,421 THOMAS JEFFERSON UNIVERSITY

AIDS--MECHANISM OF DEFECTIVE IMMUNOREGULATION
12- 14-8 G PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

● GRANT NUMBER START FY DOLLARS PERCENT DOLLARS GRANTEE INSTITUTION

PI NAME DATE AWARDED TO AIDS FOR AIDS TITLE OF PROJECT —.-

5 UO1 CA34981-02

HAUPTMAN, STEPHEN P

1 UOf CA3$987-01

PIFER, LINDA L

5 UO1 CA34987-02

PIFER, LINDA L

1 Uot cA3q98a-ol

FISCHL, MARGARET A

5 UO1 CA3G988-02

FISCHL, MARGARET A

1 UOI CA34989-01

SIEGAL, FREDERICK P

5 UO1 CA34989-02

SIEGAL, FREDERICK P

1 UO1 CA34991-01

ZAIA, JOHN A

5 UO1 CA3fi991-02

ZAIA, JOHN A

1 UO1 CA34994-01

PREBLE, OLIVIA T

5 UOt CA34994-02

PREBLE, OLIVIA T

1 UO1 CA34995-01

SAFAI, BIJAN

5 UOI CA34995-02

SAFAI, BIJAN

1 UO1 CA35001-01

HUGHES, JOHN H

_ 5 UO1 CA35001-02

HUGHES, JOHN H

1 UO1 CA35006-01

KIRKPATRICK, CHARLES

PROGRAM 8N143; SOURCE!

9

9

09-30-83

09-30-83

09-30-83

09-30-83

09-30-83

05-01-83

05-01-83

09-30-83

09-30-83

09-30-83

09-30-83

06-01-83

06-01-83

04-01-83

04-01-83

09-30-83

H

84

83

84

83

84

83

84

83

84

83

84

83

84

83

84

83

152,570

24,737

92,620

134,029

169,224

254,011

330,121

107,681

112,662

46,600

40,600

249,999

266,397

60,050

87,614

172,538

OPEN/PEND FILE & AIDS FILE

100

100

100

100

100

100

100

100

100

100

too

100

100

100

100

100

152,570 THOMAS JEFFERSON UNIVERSITY

AIDS--MECHANISM OF DEFECTIVE IMMUNOREGULATION

24,737 UNIVERSITY OF TENN CENTER HEALTH SCIEN

NONINVASIVE DIAGNOSIS OF PNEUMOCYSTIS IN AIDS PATIENTS

92,620 UNIVERSITY OF TENN CENTER HEALTH SCIEN

NONINVASIVE DIAGNOSIS OF PNEUMOCYSTIS IN AIDS PATIENTS

134,029 UNIVERSITY OF MIAMI

A STUDY OF AN ACQUIRED IMMUNODEFICIENCY SYNDROME

169,224 UNIVERSITY OF MIAMI

A STUDY OF AN ACQUIRED IMMUNODEFICIENCY SYNDROME

254,011 MOUNT SINAI SCHOOL OF MEDICINE

AIDSI CHARACTERIZATION OF EARLY DEFECTS

330,12 1 MOUNT SINAI SCHOOL OF MEDICINE

AIDS’ characterization OF EARLY DEFECT S

107,681 CITY OF HOPE NATIONAL MEDICAL CENTER

ROLE OF CMV IN THE ACQUIRED IMMUNODEFICIENCY SYNDROME

112,662 CITY OF HOPE NATIONAL MEDICAL CENTER

THE ROLE OF CMV IN THE ACQUIRED IMMUNODEFICIENCY SYNDROM

46,600 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

INTERFERON AND THE ETIOLOGY OF ACQUIRED IMMUNODEFICIENCY

40,600 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

INTERFERON AND THE ETIOLOGY OF ACQUIRED IMMUNODEFICIENCY

249,999 MEMORIAL HOSPITAL FOR CANCER & ALLIED DI

PROSPECTIVE STUDY OF EPIDEMIC KAPOSI’S SARCOMA AND AIDS

266,397 MEMORIAL HOSPITAL FOR CANCER 8 ALLIED DI

PROSPECTIVE STUDY OF EPIDEMIC KAPOSI’S SARCOMA AND AIDS

60,050 CHILDREN’S HOSPITAL (COLUMBUS)

ASSESSMENT OF SEMINAL PLASMA 8 CMV INFECTIONS ON AIDS

87,614 CHILDREN’S HOSPITAL (COLUMBUS)

ASSESSMENT OF SEMINAL PLASMA 8 CMV INFECTIONS ON AIDS

172,538 NATIONAL JEWISH HOSP 8 RES CTR-NAT’L AST

PATHOGENESIS OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
12-t4-84 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

b Gft:N~A~:MBER ~:::T m DOLLARS PERCENT DOLLARS GRANTEE INSTITUTION

A14ARDED To ~~Ds FoR AIDs TITLE oF PROJECT

——.—— —-—.. . . . ..—. ..-—

S UOl CA35006-02 09-30-83

KIRKPATRICK, CHARLES H

1 Uot cA3501a-ot

DOUGLAS, R GORDON,

3 Uol cA3501a-olst

DOUGIAS, R GORDON,

5 UOt CA35018-02

DOUGLAS, R GORDON,

1 UOt CA35020-Ot

HIRSCH, MARTIN S

3 UO1 CA35020-OtSl

HIRSCH, MARTIN S

5 UOI CA35020-02

ttIRSCH, tlARTIN S

t R13 CA35028-01

TOPP, HILLIAN C

1 ROt CA35460-OIA1

VOLSKY, DAVID J

t ROt CA35676-Ot

HOLLY, ELIZABETH A

5 ROI CA35676-02

HOLLY, ELIZABETti A

t RO1 CA35683-Ot

HOLMES, FREDERICK F

5 RO1 CA35683-02

HOLHES, FREDERICK F

f RO1 CA35706-01

PETERS, RUTH K

_ 5 RO1 CA35706-02

PETERS, RUTH K

9 RO1 CA35922-04A1

SCH!4ARTZ, STANLEY A

JR

JR

JR

o5-ot-83

05-01-83

05-01-83

05-Ot-83

05-01-83

05-0$-83

01-07-83

03-t5-84

09-30-83

09-30-83

09-30-83

09-30-83

09-30-83

09-30-83

09-30-83

84

83

83

84

83

84

84

83

84

83

84

83

84

83

84

83

t8q,583

568,319

137,372

760,065

t24,335

29,000

123,310

20,367

83,465

95,303

147,959

58,453

92,344

103,837

lt8,029

66,747

PROGRAM ?Nt43; SOURCE: OPEN/PEND FILE 8 AIDS FILE

100

100

100

100

100

100

too

100

10

too

100

100

100

100

100

100

18q,583 NATIONAL JEblISH HOSP 8 RES CTR-NAT9L AST

PATHOGENESIS OF ACQUIRED IMMUNE DEFICIENCY SYNDROME

568,3t9 CORNELL UNIVERSITY MEDICAL CENTER

COLLABORATIVE STUDIES OF AID/KAPOSI’S SARCOMA

137,372 CORNELL UNIVERSITY MEDICAL CENTER

COLLABORATIVE STUDIES OF AID/KAPOSI’S SARCOMA

760,065 CORNELL UNIVERSITY MEDICAL CENTER

COLLABORATIVE STUDIES OF AID/KAPOSI’S SARCOMA

124,335 MASSACHUSETTS GENERAL HOSPITAL

VIRUSES ACQUIRED IPNIUNODEFICIENCY AND KAPOSI SARCOMA

29,000 MASSACHUSETTS GENERAL HOSPITAL

VIRUSES ACQUIRED IMMUNODEFICIENCY AND KAPOSI SARCOMA

I23,31O MASSACHUSETTS GENERAL HOSPITAL

VIRUSES ACQUIRED IMMUNODEFICIENCY AND KAPOSI SARCOMA

20,367 COLD SPRING HARBOR LABORATORY

WORKSHOP ON A I D SYNDROME AND KAPOSI’S SARCOMA

8,347 UNIVERSITY OF NEBRASKA MEDICAL CENTER

MONOCLINAL ANTI-EBNA ANTIBODIES

95,303 NORTHERN CALIFORNIA CANCER PROGRAM, INC.

EPIDEMIOLOGY: E141NG’S SARCOMA, ANAL AND RECTAL CARCINOMA

147,959

Epidemiology

58,453

ANAL CANCER IN

NORTHERN CALIFORNIA CANCER PROGRAM, INC.

EWING’S SARCOMA, ANAL AND RECTAL CARCINOM

UNIVERSITY OF KANSAS COL HLTH SC: 8 HOSP

HOMEN: ETIOLOGIC FACTORS

92,344

ANAL CANCER IN

103.837

UNIVERSITY OF KANSAS COL HLTH SCI & HOSP

HOMEN: ETIOLOGIC FACTORS

UNIVERSITY OF SOUTHERN CALIFORNIA

EPIDEMIOLOGY OF EPITHELIAL TUMORS OF THE ANOGENITAL AREA

118,029 UNIVERSITY OF SOUTHERN CALIFORNIA

EPIDEMIOLOGY OF EPITHELIAL TUMORS OF THE ANOGENITAL AREA

66,747 UNIVERSITY OF MICHIGAN AT ANN ARBOR

SUPPRESSOR CELLS IN CANCER AND IMMUNODEFICIENCIES

I
12-14-86

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE .———.—.—

● GRANT NUMBER START

PI NAME DATE

- —-

5 ROt CA35922-05 09-30-83

SCHbJARTZ, STANLEY A

1 UO1 CA35982-01 07-15-83

FRIEDMAN-KIEN, ALVIN E

1 RO1 CA36301-OIA1

LEVINE, ALEXANDRA M

9 RO1 CA36642-04A1

CORLEY, RONALD B

5 RO1 CA36642-05

CORLEY, RONALD B

1 R13 CA36751-01

SELIKOFF, IRVINt3 J

3 R13 CA36751-OIS1

SEIIKOFF, IRVING J

1 UO1 CA37259-01

ROSENTHAL, LEONARD J

1 UO1 CA37265-01

MC DOLN3ALL, JAMES K

1 UO1 CA37295-01

BASILICO, CLAUDIO

1 UO1 CA37314-01

HAYblARD, GARY S

1 UOf CA37327-Ot

GERMAN, JAMES L, 111

1 RO1 CA37437-01

CHOI, YONG S

5 RO1 CA17437-02

CHOI, YUNG S

8

1 UO1 CA37461-01

SCHOOLEY, ROBERT T

1 UO1 CA37465-01

VOLSKY, DAVID J

PROGRAM #N163j SOURCE:

07-15-84

09-s0-83

09-30-83

09-30-83

09-30-83

04-01-84

03-01-84

04-01-84

04-01-84

03-Ot-84

09-30-8S

09-30-83

04-01-84

04-01-84

FY

84

83

84

83

84

83

84

84

84

84

84

84

83

84

84

84

DOLLARS

AHAROED

65,37i

395,000

299,077

123,117

128,564

10,000

25,000

145,662

132,f23

259,408

114,987

76,37 2

107,422

118,837

100,313

125,225

OPEN/PEND FILE a AIDS FILE

PERCENT

TO AIDS

100

100

100

100

100

100

100

too

100

100

00

00

00

100

100

100

PAGE

DOLLARS GRANTEE INSTITUTIO N

FOR AIDS TITLE OF PROJECT -— . . . . . . . .-.—

65,371 UNIVERSITY OF MICHIGAN AT ANN ARBOR

SUPPRESSOR CELLS IN CANCER AND IMMUNODEFICIENCIES

395,000 NE14 YORK UNIVERSITY

EPIDEMIC KAPOSI’S SARCOMA

299,077 UNIVERSITY OF SOUTHERN CALIFORNIA

EPIDEMIOLOGY 8 IMMUNOLOGY IN HOMOSEXUALS NITH PGL

123,117 DUKE UNIVERSITY

HELPER T CELLS:-COMPARISON OF T-T AND T-B INTERACTION

128,564 DUKE UNIVERSITY

HELPER T CELLS~ COMPARISON OF T-T AND T-B INTERACTION

10,000 NEW YORK ACADEMY OF SCIENCES

CONFERENCE ACQUIRED IMMUNE DEFICIENCY SYNDROME

25,000 NEW YORK ACADEMY OF SCIENCES

CONFERENCE; ACQUIRED IMMUNE DEFICIENCY SYNDROME

165,662 GEORGETOWN UNIVERSITY

ROLE OF HCMV IN KS ASSOCIATED HITH AIDS

132,123 FRED HUTCHINSON CANCER RESEARCH CENTER

CYTOMEGALOVIRUS IN AIDS AND KAPOSI’S SARCOMA

259,408 NEW YORK UNIVERSITY

MOLECULAR BIOLOGY OF AIDS-RELATED TUMORS

114,987 JOHNS HOPKINS UNIVERSITY

INTERACTION OF EBV AND CIIV IN AIDS KAPOSICS SARCOMA

76,37 2 NEH YORK BLOOD CENTER

CHROMOSOME MUTATION IN THE PATHOGENESIS OF AIDS

107,422 SLOAN-KETTERING INSTITUTE FOR CANCER RES

FUNCTIONAL ANALYSIS OF T-LYMPHOCYTE SUBPOPULATIONS

118,837 SLOAN-KETTERING INSTITUTE FOR CANCER RES

FUNCTIONAL ANALYSIS OF T-LYMPHOCYTE SUBPOPULATIONS

100,313 MASSACHUSETTS GENERAL HOSPITAL

HUMAN T-CELL LEUKEMIA VIRUS--VIRUS-HOST INTERACTIONS

125,225 CREIGHTON UNIVERSITY

STUDIES OF THE VIRAL ETIOLOGY OF AIDS
12- lfi-8fi PAGE

NIH AIDS PROJECTS FOR FISCAI YEARS 1983-84 BY INSTITUTE

b G$ftNJA~JMBER START FY DOLLARS PERCENT DOLLARS

DATE

GRANTEE INSTITUTION

AHARDED TO AIDS FOR AIDS TITLE OF PROJECT

1 UOI CA37466-01 04-01-84 84 156,966 100 156,966

ESSEX, MYRON E

HARVARD UNIVERSITY

ASSOCIATION BETklEEN HTLV AND AIDS

1 UO1 CA37467-01 03-01-84 84 171,558 100 171,558

GARDNER, MURRAY B

UNIVERSITY OF CALIFORNIA DAVIS

SIMIAN ACQUIRED IMMUNODEFICIENCY SYNDROME--A MODEL

1 UO1 CA37477-01 04-01-84 84 67,918 100 67,918

SUMAYA, CIRO V

UNIVERSITY OF TEXAS HLTH SCI CTR SAN ANT

EPSTEIN-BARR VIRUS AND CHROMOSOMAL ABERRATIONS IN AIDS

1 UO1 CA37478-01 04-01-84 84 163,159 100 163,159 UPSTATE MEDICAL CENTER

POIESZ, BERNARD J ACQUIRED IM!JMJNODEFICIENCY SYNDROME/ASSOCIATION WITH HTLV

1 R43 CA38502-01 09-30-84 84 50,000 100 50,000 IMRE CORPORATION

BALINT, JOSEPH P, JR IMMUNOADSORPTION THERAPY FOR KAPOSI’S SARCOMA

INSTITUTE TOTAL 12,038,483 78 11,728,983

NCI - L’lvl of Cancer BlOlCIQy

=J~CB

afid D! actnc@ls -

25005-01 09 -30-8 2 83 16,241 70 11,369 BIOQUAL, INC .

tlEATHERLY, BRIAN S FACILITY FOR VIRUS INFECTED AND CHIMERIC MICE

3 NO1 CB25005-02 09-30-82 83 250,409 70 175,286 BIOQUAL, INC .

14EATHERLY, BRIAN S FACILITY FOR VIRUS INFECTED AND CHIMERIC MICE

3 NO1 CB25005-04 09-30-82 84 265,162 70 185,613 BIOQUAL, INC .

HEATHERLY, BRIAN S FACILITY FOR VIRUS INFECTED AND CHIMERIC MICE

NCI - DIV.

INSTITUTE TOTAL 531,812 3 372,268

O+ Cancer Treatment —--

5 NO1 CU05724 - 1 5 09-30-80 83 400,000 12 48,000 LITTON BIONETICS

SARNC3AMARAN, M 0 PROVIDE ANIMAL FACILITIES FOR VIRAL CANCER RESEARCH

3 NO1 CM05724-17

SARNGADHARAN, M Q

5 NO1 CN25608-01

SMITH, RICHARD G

3 NO1 CP125608-03

SMITH, RICHARD 0

5 NO1 C?1256f6-02

SARNGADHARAN, H G

5 NO1 CM25616-03

SARNGADHARAN, II (3

09-30-80 84 400,000 12 48,000 LITTON BIONETICS

PROVIDE ANIMAL FACILITIES FOR VIRAL CANCER RESEARCH

09-30-82 83 293,501 20 58,700 HEM RESEARCH, INC .

SUPPLY HUMAN TUMORS NUCLEIC ACIDS AND RETROVIRUSES

09-30-82 83 74,663 20 14,933 HEM RESEARCH, INC .

SUPPLY HUPIAN TUMORS NUCLEIC ACIDS AND RETROVIRUSES

03-21-82 83 579,507 80 463,606 LITTON BIONETICS

PROVIDE HEHATOPOIETIC CELL CULTURES

03-21-82 84 579,507 80 463,606 LITTON BIONETICS

PROVIDE HENATOPOIETIC CELL CULTURES

INSTITUTE TOTAL 2,327,178 6 1,096,845

PROGRAM :N143; SOURCE: OPEN/PEND FILE & AIDS FILE
12-14-84

NIH AIDS .—

PAGE

PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

LIVHEMAN, JAMES L

5 NOI C023909-07 09-09-82

VANDE MOUDE, GEORGE F

3 NO1 CO2391O-O5

GILDEN, RAYMOND

3 NO1 CO2391O-O6

GILDEN, RAYMOND

3 NO1 CO2391O-O7

GILDEN, RAYMOND

3 NO1 CO2391O-10

GILDEN, RAYMOND

3 NO1 CO2391O-11

GILDEN, RAYMOND

5 NOf C023910-12

(31LDEN, RAYMOND

3 NO1 CO2391O-14

(311.DEN, RAYMOND

5 NO1 C023910-15

(31LDEN, RAYMOND

5 NO1 CO2391O-17

QILDEN, RAYMOND

3 NO1 CO2391O-18

(31LDEN, RAYMOND

5 NO1 CO2391O-19

GILDEN, RAYMOND

3 NOf CO2391O-2O

GILDEN, RAYMOND

5 NOf C023910-21

GILDEN, RAYMOND

v

v

v

v

v

v

v

v

v

v

v

v

v

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

08-02-82

GRANT NUMBER START m DOLLARS PERCENT DOLLARS GRANTEE INSTITUTION

NC1 ~“$~f~e f)irectcW RATE i- TO AIDS FOR_AIJ)S TuF OF P-T

—— —.--— -—— .

3 MOt C023909-0~ 09-09-8 2 LITTON BIONETICS

RE%%! AT THE NCI FREDERICK CANCER RESEARCH FACILITY

83

84

83

83

83

83

83

8G

84

84

84

84

84

84

84

7,444,087

7,623,59 3

7,013,488

274,t16

15,812,422

5,862,113

8,601,830

3,747,306

456,525

3,000,000

5,129,000

18,223,986

151,920

2,816,918

3,790,108

INSTITUTE TOTAL 89,947,412

PROGRAM 8N143; SOURCE: OPEN/PEND FILE 8 AIDS FILE

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

15

76,236 LITTON BIONETICS

RESEARCH AT THE NCI FREDERICK CANCER RESEARCH FACILITY

70,135 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

2,741 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

158,124 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

58,621 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

86,018 PROGRAM RESOURCES, INC.

OPERATIONS AT THE MCI FREDERICK FACILITY

37,473 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

4,565 PROGRAM RESOURCES) INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

30,00 0 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

51,290 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

182,24 0 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

1,519 PROGRAM RESOURCES, IMC.

OPERATIONS AT THE NCI FREDERICK FACILITY

28,169 PROGRAM RESOURCES, INC.

OPERATIONS AT THE NCI FREDERICK FACILITY

37,901 PROGRAM RESOURCES, INC.

OPERATIONS AT THE MCI FREDERICK FACILITY

899,473

xi
12-!f4-84 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE

.—-———

GRANT NUMBER START DoLIA~s- - P ERCEN T DOLLARS GRANTEE INSTITUTION

~c~ ——— -

5 

5 

CAHILL, JACK

CAHILL, JACK

NO1

ffv

NO1

 CPO1O44-O7

N*~anCer

kPOIO@i-06 -

ca,se

09-27-8

a#Vteventifl0 83‘“Aw TX~

3 NO1 CP21OO7-O3

BODNER, ANNE

5 NO1 CP21OO7-O4

BODNER, ANNE

1 Yol CP30500-00

STRONG, DOUGLAS

3 Yol CP30500-01

STRONG, DOUGLAS

3 YO1 CP30500-02

STRONG, DOUGLAS

3 Yol CP30500-03

STRONG, DOUGLAS

3 Yol CP30500-04

STRONG, DOUGLAS

6 NO1 CP31041-O1

HANSEN, LOUISE

6 NO1 CP31041-O1O1

HANSON, SUSAN

6 NO1 CP31041-O1O2

HANSEN, LOUISE

6 NO1 CP31041-O2

GREENBERG, BARBARA

6 NO1 CP31041-O2O1

GREENBERG, BARBARA

6 NO1 CP31041-O2O2

GREENBERG, BARBARA

6 NO1 CP31041-O3

DURAKO, STEPHEN J

09-27-80

04-01-82

04-01-82

10-01-82

10-01-82

10-01-82

06-01-84

06-01-84

09-30-83

09-30-83

09-30-83

09-30-83

09-30-83

09-30-83

09-28-84

84

83

84

83

83

84

84

84

83

84

84

83

84

84

84

1,931,539

2,229,226

346,602

374,000

596,350

3,700

400,667

232,683

84,000

618,821

371,241

209,000

348,236

33,912

10,000

654,606

5

5

12

12

2a

28

28

28

28

too

100

100

100

100

100

100

96,577 14ESTAT, INC .

SUPPORT SERVICES FOR EPIDEMIOLOGY STUDIES

1t1p461 WESTAT, INC .

SUPPORT SERVICES FOR EPIDEMIOLOGY STUDIES

~1,592 BIOTECH RESEARCH LABORATORIES, INC.

STORE SPECIMENS FROM PERSONS AT HIGH RISK OF CANCER

44,880 BIOTECH RESEARCH LABORATORIES, INC.

STORE SPECIMENS FROM PERSONS AT HIGH RISK OF CANCER

166,978 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

IMMUNOLOGIC 8 IMMUOGENETIC STUDIES OF CANCER FAMILIES

1,036 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

IMMUNOLOGIC 8 IMMUNOGENETICS STUDIES OF CANCER FAMILIES

112,187 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

IMMUNOLOGIC 8 IMMUNOGENETICS STUDDIES OF HIGH ROSK CANCER

65,151 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

IMMUNOLOGIC 8 IMMUNOGENETICS STUDIES OF HIGH RISK CANCER

23,520 U.S. UNIFORMEO SERVICES UNIV OF HLTH SCI

IMMUNOLOGIC 8 IMMUNOGENETICS STUDIES OF HIGH RISK CANCER

618,821 WESTAT, INC .

CASE-CONTROL STUDY OF ORAL AND PHARYNGEAL CANCER

371,241 WESTAT, INC .

CASE-CONTROL STUDY OF ORAL AND PHARYNGEAL CANCER

209,000 HESTAT, INC.

CASE-CONTROL STUDY OF ORAL AND PHARYNGEAL CANCER

348,236 HESTAT, INC.

SUPPORT SERVICE FOR A SURVEY OF T-CELL SUBSETS

33,912 WESTAT, INC .

SUPPORT SERVICE FOR A SURVEY OF T-CELL SUBSETS

10,000 WESTAT, INC .

SUPPORT SERVICE FOR A SURVEY OF T-CELL SUBSETS

65q,606 WESTAT, INC .

SUPPORT SERVICES FOR STUDY OF AIDS

PROGRAM :N143z SOURCE: OPEN/PEND FILE & AIDS FILE
f2- 14-84

NIH AIDS PROJECTS FOR FECAL YEARS 1983-84 BY INSTITUTE. . . . ------- –. ——— .—.———.— -—.- - — -- . .- -

GRANT NUMBER START FY DOLLARS PERCENT DOLL ARS

PI NAME DATE AWARDED

GRANTEE INSTITUTION

— TO AIDS FOR AIDS TI~LE OF PROJECT . ———

National Heart LunQ INSTITUTE TOTAL 8.444,583

and Blood Institute (NHLBl~- DIV. i310~% Dlsea&”s90a!n’d’9f?esour ces –

1 Y02 HB30006-00 04-02-8 3 8 3 55,58 3 100 55,58 3

ALTER, HARRY

u.S. NATIONAL INSTITUTES OF HLTH

STUDIES OF ACQUIRED DEFICIENCY SYNDROME (AIDSI

2 Y02 HB30006-01 03-28-84 84

ALTER, HARRY

1 Y02 HB30018-00 09-16-83 83

HENDRICKSON, ROY

1 Yol HB30034-00 10-01-82 83

EVATT, BRUCE

4 NO1 HB47002-00 05-25-84 84

HOSLEY, JAMES H

3 NO1 HB47002-01 05-25-84 84

MOSLEY, JAMES H

3 NO1 HB47002-02 05-25-84 84

flOSLEY, JAPIES H

1 NO1 HB47003-00 09-30-84 84

MOSLEY, JAMES H

National ~eapt Lu~~ and B,:! T TUTF TnT4L 31 nstttute -

5 PO1 HL09011-20 03-01-7 6 8 3

KELLNERJ AARON

3 PO1 HL09011-20S1 03-01-76 83

KEILNER, AARON

5 PO1 HL09011-21 03-01-76 84

KELLNER, AARON

5 P50 HL26309-03 05-01-81 83

ROBERTS, HAROLD R

3 P50 HL26309-03SI o5-ol-at 84

ROBERTS, HAROLD R

5 P50 HL26309-04 05-01-81 84

ROBERTS, HAROLD R

3 P50 HL26309-04S1 05-01-81 84

ROBERTS, HAROLD R

60,00 0 100

138,595

140,000

210,000

282,000

62,596

2,345,000

3,293,774

100

100

100

100

100

100

8

60,00 0 U.S. NATIONAL INSTITUTES OF HLTH

STUDIES OF AIDS

138,595 U.S. NATIONAL INSTITUTES OF HLTH

NHLBI/DRR - SIMIAN ACQUIRED IMMUNODEFICIENCY SYNDROM E

140,000 U.S. CENTERS FOR DISEASE CONTROL

NHLBI AGREEMENT HITH CDC: AID S

210,000 UNIVERSITY OF SOUTHERN CALIFORNIA

SERUM REPOSITORY FOR HTLV-III TESTING -AIDS

282,000 UNIVERSITY OF SOUTHERN CALIFORNIA

SERUfl REPOSITORY FOR HTLV-III TESTING -AIDS

62,596 UNIVERSITY OF SOUTHERN CALIFORNIA

SERUM REPOSITORY FOR HTLV-III TESTING -AIDS

2,345,00 0 UNIVERSITY OF SOUTHERN CALIFORNIA

BLOOD USE IMMUNE FUNCTION CHANGE RELATION TO AIDS

3,293,77 4

PAGE

1,371,513

705,891

1,705,963

853,263

4,197

524,127

244,69~

PROGRAM :N143; SOURCE: OPEN/PEND FILE 8 AIDS FILE

2

2

2

3

3

3

3

27,430 NEkl YORK BLOOD CENTER

A RESEARCH AND RESOURCE PROGRAM IN BLOOD

14,118 NEW YORK BLOOD CENTER

A RESEARCH AND RESOURCE PROGRAM IN BLOOD

34,119 NEW YORK BLOOD CENTER

A RESEARCH AND RESOURCE PROGRAM IN BLOOD

25,598 UNIVERSITY OF NORTH CAROLINA CHAPEL HILL

SPECIALIZED CENTER OF RESEARCH IN THROMBOSIS

126 UNIVERSITY OF NORTH CAROLINA CHAPEL HILL

SPECIALIZED CENTER OF RESEARCH IN THROMBOSIS

15,724 UNIVERSITY OF NORTH CAROLINA CHAPEL HILL

SPECIALIZED CENTER OF RESEARCH IN THROMBOSIS

7,341 UNIVERSITY OF NORTH CAROLINA CHAPEL HILL

SPECIALIZED CENTER OF RESEARCH IN THROMBOSIS
12-14-84 PAGE

NIH AIDS PROJECTS FOR FISCAL YEARS 1983-84 BY INSTITUTE — - --————-.—— .—-----

GRANT NUMBER

PI NAME

t RO1 HL31015-O1

?40NTGOMERY, ROBERT R,

START

— DATE —

07-01-83

JR

04-01-84

FY

83

84

84

84

84

84

84

84

DOLLARS

AWARDED - -.—...

100,801

121,754

49,389

164,598

199,602

179,786

175,428

174,410

6,575,416

PERCENT

TO AIDS

100

DOLLARS GRANTEE INSTITUTION

FOR AIDS TITLE OF PROJECT —..———. —.

100,801 MEDICAL COLLEGE OF WISCONSIN

ACQUIRED IMMUNOLOGIC ABNORMALITIES IN HEMOPHILIA

1 RO1 HL32432-01

BOREK, ERNEST

121,754 AMC CANCER RESEARCH CENTER

BIOCHEMICAL MARKERS FOR LATENT CARRIERS OF AIDS

49,38 9 UNIVERSITY OF COLORADO HLTH SCIENCES CTR

DETECTION OF AIDS-AGENT CARRIERS BY SEROLOGIC ASSAYS

100

1 RO1 HL32434-01

BLASER, MARTIN J

04-01-84 100

1 RO1 HL32453-U1

ENGLEIIAN, EDGAR G

04-01-84 100 164,598 STANFORD UNIVERSITY

DETECTION OF THE CARRIER STATE OF AIDS

199,602 UNIVERSITY OF CALIFORNIA SAN DIEGO

NUCLEIC ACID HYBRIDIZATION TO DETECT AIDS RELATED AGENTS

179,786 U.S. UNIFORMED SERVICES UNIV OF HLTH SCI

ACID-LABILE ALPHA INTERFERON IN PRECLINICAL AIDS

1 RO1 HL32471-01

RICHMAN, DOUGLAS D

04-01-84 100

1 RO1 HL32473-01

PREBLE, OLIVIA T

07-01-84 100

175,428 SAN FRANCISCO MEDICAL SOCIETY

LABORATORY DETECTION OF AIDS IN HEALTHY CARRIERS

174,41 0 SOUTHWEST FOUNDATION FOR BIOMEDICAL RES

ASSAY METHODS TO DETECT ANTIGENIC MARKERS FOR AIDS

1 RO1 HL32477-01

PERKINS, HERBERT A

05-15-84 100

t RO1 HL32505-01

DREESMAN, GORDON R

04-01-84 100

INSTITUTE TOTAL 1,290,224

GRAND TOTAL 147,849,861 42,821,224

PROGRAM 8N143~ SOURCE: OPENZPEND FILE 8 AIOS FILE
11-20-8<

DIVISION OF RCSEARCH RESOURCE S

AIDS RESEARC H

1984 SUBPROJECT SUPPORT BY PROGRAM

—. ..- ———. ———.——— ..—--- —.—. —..

DIVISION OF RESEARCH RESOURCES PROGRAM S -

-- OTHER BID -- -

----- DRR ---- - TOTAL

DOLLARS SUBPROJ DOLLARS SUBPROJ GRANTS

.—..-— .— .-. .-——

ANIMAL RESOURCE S 858, 13 8 2 3 9

BIOMEDICAL INSTRUMENTATION

BIOMEDICAL RESEARCH SUPPORT

CLINICAL RESEARCH CENTERS

54,50 0 3

85,82 6 17

357,686 24

DIVISION OF RESEARCH RESOURCE S s s 1,356,15 0 6 7

.— —.— .

3

16

17

4 5

. . .—

OPPE, OD, DR R

PAGE 1
jf-~o-a

DIVISION nF RESEARCH RESOURCE S

AIUS Kt>EARCH

1984 SUBPROJECT SUPPORT BY PROGRA M

-———— —.-.— —-. .———

GRANT NUMBER PROGRAM DIRECTOR SUBPROJECT FUNDS

—.—— .

SUBPROJ INVESTIGATOR BID

INSTITUTION CITY STAT E TOTAL

DRR ————TITL E DRR AWARI ————.——.—

PfiORRO036t-17 KALTER, SEYMOUR S

43326 KALTER, S S

P40RRo0393-17 JACOBY, ROBERT O

43044 SMITH, ABIGAIL L

P51RRO0163-25 LASTER, LEONAR D

4509+ SHIIGI, STANLEY I I

P51RRO0164-23 UAI.SH, JOHN J

45120 RANGAN, SETLUR R

P51RRO0165-24 HATCHER, CHARLES R ,

.45231 MCCLURE, HAROLD M

.45232 MCCLURE, HAROLD M

P51RRO0166-23 LEIN, JOHN N

45585 MOR1ON, WILLIAM R

P51RRO0167-24 BOCK, ROBERT M

45292 UNO, HIDEO

P5tRRoot68-23 TOSTESON, DANIEL C

45367 CHRLIFOUX, L V

4537f LETVIN, NORMAN L

45354 LETVIN, NORMAN L

45357 LEIVIN, NORMAN L

45389 DANIEL, M D

45361 KING, NORVAL Id, J R

45386 DANIEL, II D

P51RRoO169-23 RIIODE, EDWARD A

45462 GARDNER, M

AtlItlAL RESOURCE S

--------------------------- -

09/84-09/85 SOUTIIWEST FOUNDATION FOR BIOMEDICAL RSAN ANTONI O TEXA S

38,99 4 SIMIAN VIRUS DIAGNOSTIC LABORATORY (SAIDS, MEASLES, HERPES )

01/84-12/84 YALE UNIVERSIT Y NEW HAVE N

150

CONNECTICU T

IMMUNOSUPPRESSION INDUCED BY MVM I AN ANIMAL MODEL OF AID S

07/84-04/85 MEDICAL RESEARCH FOUNDATION OF OREGONPORTLAN D

75,00 0

OREGON

SUPPLEMENTAL FUND S

39,51 6 NONHUMAN PRIMATE MODELS FOR IMMUNODEFICIENCY SYNDROME S

05/84-04/85 TULANE UNIVERSITY OF LOUISIAN A

20,00 0

NEW ORLEAN S LOUISIAN A

SUPPLEMENTAL FUND S

57,65 8 CYCLOSPORIN A AND CYTOMEGALOVIRUS INFECTIO N

Joszsq;+;:;; EMORY UNIVERSIT Y ATLANT A GEORGI A

CLINICAL IMMUNOLOGY ANO SURVEY OF MACAQUE COLONY FOR AIDS LIKE DISEAS E

28,6!2 CHIMPANZEES EXPOSED TO HUMAN AID S

20,00 0 SUPPLEMENTAL FUHDS

o7/84;::<:: UNIVERSITY OF WASHINGTON SEATTL E WASHINGTO N

ItlPIUllOLOGY OF ENZOOTIC RETROPERITONEAL FIBROMATOSIS (ERF)

75,00 0 SUPPLEMENTAL FUND S

fJ7/84;:+(:; UNIVERSITY OF WISCONSIN MADISO N MADISO N WISCONSI N

SUPPLEf’lEt4TAL FUND S

28,23 9 KAPOSI SARCOMA LIKE LESIONS IN PIGTAILED MACAQUE S

66,54;

489,47 :

4,301,39 0

2,366,70 3

2,548,58 0

05/84-04/85 HARVARD UNIVERSIT Y BOSTON MASSACHUSETT S

25,70 0 MORPHOLOGIC CHANGES IN LYMPH NODES OF MACAQUES W/ AN IPVIUNODEFICIENCY SYNDROM E

25,70 0 TRANSMISSION OF NATURALLY OCCURRING LYMPHOMA AND MACAQUE AIDS IN MACAQUE MONKEY S

25,70 0 ACQUIRED IMMUNODEFICIENCY SYNDROME IN A COLONY OF MACAQUE MONKEY S

25,70 0 TRANSMISSION OF MACAQUE AIDS BY MEANS OF INOCULATION OF fIACAQUE LYMPHOMA TISSU E

25,70 0 Iflf:UNODEFICIENCY SYNDROME IN MACAQUES & THE ISOLATION OF A NEW TYPE D RETROVIRUS

95.00 0 SUPPLEMENTAL FUND S

25,70 0 HISTOPATHOLOGIC CNANGES IN MACAQUES WITH AN ACQUIRED IMMUNODEFICIENCY SYNDROM E

25,70 0 ATTEMPTS TO ISOLATE A RETROVIRUS FROM HUMAN AIOS PATIENT S

05/84-04/85 UNIVERSITY OF CALIFORNIA DAVI S DAVI S

95,00 0

CALIFORNI A

SUPPLEPIENTAL FUNOS

2,884, 184

37,04 9 SIMIAN ACQUIRED IMMUHE DEFICIENCY SYNDROME (SAIDS)

858,13 8 23 DRR SUBPROJ 9 DRR GRANT S

BID SUBPROJ DRR GRANTS W/BID FUND S

PAG E 1
11-20-8 4

DIVISION OF RESEARCH RESOURCES

AIUS K~>tAKUH

1984 SUBPROJECT SUPPORT BY PROGRA M

——..

GRANT NUMBER PROGRAM DIRECTOR SUBPROJECT FUND S INSTITUTIO N

-------

,SUBPROJ

CIT Y STAT E TOTAL

INVESTIGATO R B I D DRR TITL E D?R AWAR D —-.—- . . . - — -.. . -. _..-.——.—

s1oRRo1945-o1 CAMBIER, JOHN C o l/84-12/84 NATIONAL JEWISH HOSP & RES CTR-NAT’L DENVE R COLORADO 215,000

10874 KIRKPATRICK, CHARLE S 32,25 0 CS: PATtlOGENESIS OF AIDS (LYMPHADELIPATHY, HEPATITIS B, IIEMDPHILIA A, HOMOSEXUAL )

stoRRo!959-01 KELLER, RDBERT H

11o52 ASTER, RICHARD H

01/84- !2/84 MEDICAL COLLEGE OF WISCONSI N MILWAUKE E WISCONSI N 69,00 0

10,35 0 CS UPGRADE : T SUBSETS t IIIMUNOMODULATOR EFFECTS, AIDS, HEMOPHILIACS 1 HOMOSEXUA L

S1ORRO2O34-OI KOENIGSBERG, WILLIAM H01/84- 12/84 YALE UNIVERSIT Y NEW HAVE N CONNECTICU T 238,00 0

11843 SUMMERs, 141LLIAM C 1!,900

BIOMEDICAL INSTRUMENTATIO N

PROTEIN SEQ~ GENETICS OF HSV THYMIDINE KINASE IN DESIGN OF CHEMOTHERAPEUTIC S

54,500 3 DRR SUBPROJ 3 DRR GRANT S

--------------------------- -

BID SUBPROJ DRR GRANTS W/BID FUND S

PAGE 2
!I-20-8L

DIVISION OF RESEARCH RESOURCES

AIDS RESEA~H

1984 SUBPROJECT SUPPORT BY PROGRA M

—.

GRANT NUMBER PROGRAM DIRECTOR SUBPROJECT FUND S INSTITUTIO N

— ——

CITY

SUBPROJ INVESTIGATO R

STAT E TOTAL

B I D DRR TITL E

.—

DRR AWAR[

. . -.. .

S071?R05359-23 LEONARD, FRE D

6f834 SCHULOF, RICHAR D

S07RR05363-23 FOGEL, BERNARD J

57515 KLIMAS, NANCY G

57522 MCKINNEY, CHURCHIL L

S07RR05392-23 MCCOLLUM, ROBERT U

59372 KASPER, LLOYD H

S07RR05399-23 FARBER, SAUL J

56333 FRIEDMAN-KIEN, ALVI N

S07RR05400-23 NAUGHTON, JOHN P

56353 BRASS, CORSTIAAN

k07RR05445-23 GOLDBERG, ALAN M

59407 GOINGS, STELLA A

S07RR05487-22 COFFMAN, JAY D

54413 HAUSER, WILLIAM E

S07RR05513-22 KRUPP, MARCUS A

56883 LUFT, BENJAMIN J

S07RR05593-17 RUSHMER, DONALD S

51220 LEVINSON, WENDY

S07RR05604-07 GORTNER, SUSAN R

57088 LESSOR, ROBERT A

S07RR05649-18 AXEIROD, DAVID E

57149 FLAHERTY, LORRAIN E

S07RR05736-12 KUSCHNER, MARVI N

58606 STEIGBIGEL, ROY T

S07RR058%2-05 HENSON, PETER M

59837 GANGADHARAM, PATTISA

o4/8+;:::: GEORGE WASHINGTON UNIVERSIT Y WASHINGTO N DIST OF CO L 151,83 4

PILOT STUDY OF THYMOSIN THERAPY IN PRE AID S

04/84-03/85 UNIVERSITY OF MIAM I MIAM I FLORID A

8,43 2

237,88 4

IIIMUNOSUPRESSIVE FACTORS IN SERUM OF ACQUIRED IIIMUNODIFICIENCY SYNDROME PATIENT S

8,23 1 AUTOIMPIUNE ANTI T HELPER ACTIVITY IN AIDS PATIENT S

04/84-03/85 DARTMOUTH COLLEG E

2,00 1

HANOVE R NEW HAMPSHIR E 155,00 7

TOXOPLASMA GONOII:ANTIGENIC CHARACTERIZATION AND IMMUNIT Y

04/84-03/85 NEW YORK UNIVERSIT Y NEW YOR K NEW YOR K 26f,265

7,55 7 PATHOBIOLOGY OF DISSEMINATED AND LOCALIZEO KAPOSIS SARCOM A

04/84-03/85 STATE UtlIVERSITY OF NEW YORK AT BUFFABUFFALO NEW YOR K 176,09 4

1,95 1 PATHOGEN FACTORS & EFFECTS OF TREATMENT IN A MOUSE MOOEL OF SYSTEMIC CANDIDIASIS

04/84-03/85 JOHNS HOPKINS UNIVERSIT Y BALTIMOR E MARYLAN D

3 0 6 PARCOVIRIDAE & OTHER VIRUSES IN THE ACQUIRED IMMUNE DEFICIENC Y

04/84-03/85 UNIVERSITY HOSPITAL (BOSTON ) BOSTON MASSACHUSETT S

5,00 0 ROLE OF NAIURAL KILLER CELLS IN IMMUNITY TO TOXOPLASMOSI S

04/84-03/85 PALO ALTO MEOICAL FOUNDATION RES INSTPALO ALT O

22,24 1

CALIFORNI A

IMMUNITY IN ACQUIRED IMMUNODEFICIENCY SYNDROM E

04/84-03/85 GOOD SAMARITAN HOSP 1 NED CTR(PRTLND, PORTLAN D OREGON

1,82 3 PARASITIC ILLNESS IN HOMOSEXUAL ME N

04/84-03/85 UNIVERSITY OF CALIFORNIA SAN FRANCISCAN FRANCISC O CALIFORNI A

4,16 6 RISK SHARING AMONG NURSES ON AIDS UNIT : SOCIAL PSYCHOLOGICAL PROCESSE S

04/84-03/85 NEW YORK STATE DEPARTMENT OF HEALTH ALBAN Y NEW YOR K

6,90 3 ASSAY METHODS TO DETECT CARRIER STATE OF AID S

04/84-03/85 STATE UNIVERSITY NEW YORK STONY BROOKSTONY BROO K NEW YOR K

9,18 0 PATHOGENESIS OF ACQUIRED IMMUNODEFICIENCY SYNDROM E

04/84-03/85 NATIOHAL JEWISH HOSP t RES CTR-NAT’L DENVE R

2,84 0

COLORAOO

EXPERIMENTAL CHEMOTHERAPY OF MYCOBACTERIUM INTRACELLULAR DISEAS E

S07RR070t5-19 BOCKELMAN, CHARLES K 04/84-03/85 YALE UNIVERSIT Y NEW HAVE N

60114 NOVICK, ALVI N 176

CONNECTICU T

ETHNICS DISTRIBUTION OF AID S

S07RR07026-19 ALLEN, RICHARD D o~/8+:3(:; UNIVERSITY OF HAWAII AT MANoA HONOLUL U

55056 CHING, CLARA Y

HAWAI I

P NATURAL KILLER FUNCTION IN ACQUIRED IMMUNODEFICIENCYSYNDROIIE (AIDS )

PAGE 3

212,27 1

57,51 3

34,79 1

47,94 5

21,53J

93,01 1

195,46 3

149,t)41

225,86 9

102,80 5
.P

o

I

I

11-20-8<

D1VIS1ON nF Rr$rARc~ RESOURCES

All15 RESEAITCH

1984 SUBPROJECT SUPPORT BY PROGRA M

GRANT NUMBER PROGRAM DIRECTO R SUBPROJECT FUND S INSTITUTIO N

SUBPROJ INVESTIGATO R BIO DRR TITL E

-..—— - ---- ———

CIT Y STAT E TOTAL

DRR AWARC —

S07RR07206-03 RATHGE, RICHARD W 04/84-03/85 NORTH DAKOTA STATE UNIVERSIT Y FARGO NORTH OAKOTA 15,91 3

52715 GABRIELSON, DAVID A 514 TOXOPLASMA GONOII1 EXOTOXIN AND ITS ITS VACCINE POTENTIA L

BIOMEDICAL RESEARCH SUPPOR T 85,82 6 17 ORR SUBPROJ 16 DRR GRANT S

--------------------------- -

BIO SUBPROJ DRR GRANTS W/BID FUND S

PAGE 4
11-20- 8

DIVISION OF RESEARCH RESOURCES

AIUS Kt5EARCH

1984 SUBPROJECT SUPPORT BY PROGRA M

—-.—-

GRANT NUMBER PRO’G~ii DIRECTOR SUBPROJECT FUNDS

— .——— .-——.——-

SUBPROJ INVESTIGATO R

INSTITUTIO N CITY STAT E TOTA L

—..——

B I D DRR TITLE– -

.- ——.—..-— —

DRR AWA R

.— ——. — ——

M01RRoo030-2s ANLYAN, UILLIAM O 12/83-11/84 DUKE Universit y DURHAM NORTH CAROLIN A

20021 GALLIS, HARRY A 17,551

1,372,27

5 FLUOROCYTOSINE L AMPHOTERICIN B IN CRYPTOCOCCAL MENINGITI S

M01RROO032-24 PITTMAN, JAMEs A, JR 12/83-11/84 UNIVERSITY OF ALABAMA IN BIRMINGHAM BIRMINGHA M ALABAMA

20071 DISMUKES, WILLIAM E 83,72 1

911,7 3

COMPARISON OF TWO REGIMENS OF 5 FC + AMB IN THERAPY OF CRYPTOCOCCAL MENINGITI S

20078 DISMUKES, WILLIAM E 20,244 2 DOSAGE REGIMENS OF ORAL KETOCONAZOLE IN BLASTOMYCOSIS OR HISTOPLASMOSIS

MOIRROO047-24 MEIKLE, THOMAS H 12/83-11/84 CORttEIL UNIVERSITY MEDICAL CENTE R NEW YOR K NEW YOR K

20751 ROBERTS, RICHARD J 5,53 3

1,587,93:

COLLABORATIVE STUDIES OF AIDs/KAPOSIS SARCOM A

M01RRoO051-23 SCHWARZ, M RO Y 07/84-11/84 UNIVERSITY OF COLORADO HLTH SCIENCES DENVE R COLORADO 1,440,94 !

20908 HASIBA, UT E 3,03 8 EVALUATION OF IMMUNE STATUS IN PAIIENTS WITH HEMOPHILI A

20928 ROBINSON, WILLIAM A 1,199 SINGLE STUDY AIDS SYNDROME MANIFESTED BY A KAPOSIS SARCOMA REFRACTOR Y

M01RRoO065-22 STEINFELD, JESSE L 12/83-11/84 VIRGINIA COMPIONWEALTH UNIVERSIT Y RICHMON D VIRGINI A 675,48 :

.21299 KERKERING, THOMAS M f74 5 FLUOROCYTOSINE 1 AMPHOTERICIN B IN THERAPY OF CRYPTOCOCCAL MENINGITI S

M01RROO068-22 KNOblLES, HARVEY C, JR12/83-11/84 UNIVERSITY OF CINCINNAT I

21384 SoLINGER, ALAN M

CINCINNATI OHI O 1,400,02 8

7,44 7 INVESTIGATION OF PATHOGENESIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME S

II01RROO073-22 LEVIN, WILLIAM C 12/83-11/84 UNIVERSITY OF TEXAS MEO BR GALVESTON GALVESTO N

21566 JORIZZO, JOSEPH L 4,481

TEXAS 691,510

IBUPROFEN (MOTRIN) AS AN IMMUNE ENHANCER IN CHRONIC I’IUCOCUTANEOUS CANDIDOSIS

t101RRoO083-22 SCHMID, RUDI 12/83-11/84 UNIVERSITY OF CALIFORNIA SAN FRANCISCAN FRANCISC O

2t805 VOLBEROING, PAU L

CALIFORNIA 1,124,62 0

30,32 2 PHASE II TRIAL OF ALPHA 2 INTERFERON IN KAPOSIS SARCOM A

M01RROO096-24 HOLLANDER, CHARLES S 12/83-11/84 NEW YORK UNIVERSIT Y

21990 BORKOWSKY, WILLIA M

NEW YOR K NEW YOR K

3,09 6

2,501,74 0

LITHIUM ION AS AN IMMUNOLOGICAL ADJUVANT; IMMUNODEFICIENCY

22022 FRIEDMAN-KIEN, ALVI N 12,384 GAMMA INTERFERON TREATMENT OF KAPOSIS SARCOM A

MO1RROO1O2-21 KAPPAS, ATTALLAH 12/83-l t/84 ROCKEFELLER UNIVERSIT Y HEW YOR K NEW YOR K 2,102,91 9

22091 LAURENCE, JEFFRE Y 5,02 0 ACQUIRED IMMUNE DEFICIENCY SYNDRONE

MOIRRO0125-21 EBBERT, ARTHUR, J R 12/83-11/84 YALE UNIVERSIT Y NEW HAVE N

22262 DWYER, JOHN M

CONNECTICU T 2,587,08 9

10,307 CELL MEDIATED IMMUNE DEFICIENCY DIAGNOSIS Z TREATMENT blITH TRANSFER FACTO R

M01RRO0645-13 TAPLEY, DONALD F 12/83-11/84 CCILLIIIBIA UNIVERSITY NEW YOR K NEW YOR K NEW YOR K

23129 APPEL, GERALD B 4,22 1

1,121,26 9

THE STUDY OF 11’VIUNOLOGIC ABNORMALITIES IN AIDS PATIENTS ON DIALYSI S

‘M01RRO0722-12 ROSS, RICliARD S 12/83-11/84 JOHNS HOPKINS UNIVERSIT Y BALTIMOR E MARYLAN D

23213 POLK, FRAN K 5 7 6

292,81 7

LONGITUDINAL STUDIES OF THE ACQUIRED IMMUNE DEFICIENCY SYNDROM E

MOlRRoo827-10 PETERSDORF, ROBERT G 07/84-11/84 UNIVERSITY OF CALIFORNIA SAN DIEG O

23409 KAGNOFF, MARTIN F

LA JOLL A

5 1 5

CALIFORNI A 919,32 9

INTESTINAL IMMUNE FUNCTION IN Homosexual MALEs blITH/WITHOUT AID S

M01RRO0865-11 tlELLINKOFF, SHERMAN Pl12/83-11/84 UNIVERSITY OF CALIFORNIA LOS ANGELES LOS ANGELE S

-23595 GOITLIEB, MICHAEL S 40,444

CALIFORNI A

PHASE II TRIAL OF ALPHA 2 INTERFEROtI IN KAPOSIS SARCOM A

. PAG E 5

I
1 1-20- 8

DIVT%l(lN t_)F RESEARCH RESOURCE S

AIDS RE5EAKLn

1984 SUBPROJECT SUPPORT BY PROGRA M

GRANT NUMBER PROGRAM DIRECTOR SUBPROJECT FUND S

SUBPROJ

INSTITUTIO N CITY

INVESTIGATO R

STAT E TOTAL

B I D DRR TITL E DRR AbIARi

MOIRRO0865-11 MELLINKoFF, sHERMAN M12/83-l!/lJ~ UNIVERSITY OF CALIFORNIA 10S ANGELES LOS ANGELES CALIFORNIA 990,27’

23571 IIITSUYASU, RONALD T 5,331

23588 SAXON, ANDREW

BONE MARROW TRANSPLANTATION IN TWINS: KAPOSIS SARCOMA 8 AIOS

53,29 1 MoDIFIED SERUM IMMUNOGLOBULIN INFUSION :

23594 GOITLIEB, MICHAEL S

DOSE STUOY FOR INMUNODEFICIENCY SYNDROM E

4,758 ALPHA 2 Interferon IN AN ACQUIREO T CELL IPWIUNODEFICIENCY (AID )

MOlRROo997-09NAPOLITAN(),LEoNARD M12/83-11/84 UNIVERSITY OF NEW MEXICO ALBUQUERQUE ALBUQUERQU E NEW MEXICO 773,49’

23738 SIMON, TOBY 3,4$2 EFFICACY OF IV GAMMA GLOBULIN TO PREVENT CONGENITAL k ACQUIRED IPIMUNODEFICIENCY

I’I01RR01346-03 STEIN, JAY H

23971 GRAYBILL, JOHN R

07z84-~ 1/84 UNIVERSITY OF TEXAS HLTH SCI CTR SAN SAN ANTONI O

25,99 7

TEXA S

PtlASE 111 STUDIES OF KETOCONAZOLE IN COCCIOIOMYCOSIS

23967 GRAYBILL, JOHN R 16,59 4 PHASE 11 STUOIES OF KETOCONAZOLE IN COCCIOIOIDAL MENINGITI S

CLINICAL RESEARCH CENTER S 357,68 6 24 DRR SUBPROJ 17 ORR GRANTS

--------------------------- -

BID SUBPROJ DRR GRANTS W/BID FUND S

DIVISION OF RESEARCH RESOURCES 1,356,15 0 67 ORR SUBPROJ 4 5 DRR GRANT S

o------------------------------

BID SUBPROJ ORR GRANTS W/BID FUND S

PAG E 6
SECTION 6: Office of the Assistant Secretary for Health Office of

Public Affairs AIDS Public Information Plan for Fiscal Year 19852

‘Also includes descriptions of public information activities of NIH, NIDA, NIMH, and CDC.

132
133

BACKGROUND

Public information and education activities regardin g

Acquired Immune Deficiency Syndrome (AIDS) have been conducted by

various PHS components since the first AIDS cases were reported

in 1981; a formal public information plan was prepared in 1983.

In September 1983, this plan was refined to include stated

objectives, defined target audiences, and a list of specifi c

projects, activities and materials to be prepared or conducted b y

PHS components during Fiscal Year 1984. It was subsequently

approved by the Assistant Secretary for Health, and a budget wa s

provided for the program . Significant activities are describe d

in the AIDS Operational Plan as updated July 1, 1984.

With the identification of HTLV-III as the probable AIDS

cause by PHS scientists in April 1984, modifications in existing

public information materials were made and revisions became

necessary in the initial plan, reflecting the imminent testing of

a blood test for HTLV-III antibodies and subsequent availability

of the test for the public and to specific risk groups. Also,

experience with the initial plan and with risk groups indicated

additional needs and opportunities for public information and

education activity. The revised plan also makes fuller use of

resources outside PHS, such as health agencies, organizations,

facilities and community groups in promoting, conducting, and

financing AIDS information and education activities. The revised

plan reflects the input of individual agencies through the

Information and Education Panel of the PHS Executive Task Force

on AIDS.

OBJECTIVES: To provide information to the American public

regarding Acquired Immune Deficiency Syndrome (AIDS) sufficient

to create a widespread awareness and understanding of the nature

of the syndrome, its probable cause and test(s) for its

detection, its suspected means of transmission, the relative

threat it poses to specific populations and to the public health ,

and precautions recommended for avoiding contracting the

syndrome.

TARGET AUDIENCES: The nature and effects of AIDS and the public

response experienced to date regarding attitudes toward the

syndrome and to risk groups indicate the desirability of

targeting selected information and appropriate messages to

several audiences. Following are brief descriptions of thos e

audiences and messages:
134

I. General Public, male and female, aged 14 and older, not

specifically identified as being at risk -- This group includes

certain subgroups that will require additional information and

targeted messages, but in general it requires a basic awareness

of AIDS as being primarily an affliction of the risk groups,

information on the incidence of the syndrome among the risk

groups and the total population, the availability of test(s) for

its detection, the means of transmission, and the safety of blood

donation and blood transfusion as it relates to contracting

AIDS. The purpose of providing this information is to allay fea r

in the general public regarding the likelihood of contractin g

AIDS, particularly where such fear needlessly reduces blood

donations, interferes with patient acceptance of medically

necessary blood transfusions, and stigmatizes risk groups so as

to interfere with their functions and relationships in society.

Subgroups of this target audience, not treated separately

elsewhere, include:

--Blood donors not at risk;

--Persons who frequently encounter at risk populations as a

result of their type of work, place of work or residence, or

recreational pursuits;

--Persons who encounter populations at risk as a result of

family relationships or friendships (not including sexual

partners).

--Participants in AIDS-related studies regarding blood

transfusions, blood test(s) for HTLV-III antibodies, AIDS

vaccine, sexual activity, and mental health aspects.

11. Homosexual and Bisexual Male Portion of the General

Public -- This group requires AIDS information sufficient to

understand the nature of the syndrome, whether their sexual

activity renders them among the at-risk population, the

precautions recommended for avoiding contracting the syndrome ,

the availability of test(s) for HTLV-III antibodies, symptoms of

the syndrome, and awareness that significant effort is bein g

applied to developing a vaccine for AIDS and improved treatment

for AIDS patients.

III. Abusers of Intravenous Drugs -- This group needs to be

informed of the dangers of AIDS, the risk of acquiring the

syndrome through use of infected needles, tests-for HTLV-III

antibodies, and symptoms of AIDS.

IV. Recent Haitian Immigrants ‘- In addition to knowledge

of the syndrome, related tests, and its symptoms, this group

needs to-understand what the “at risk” designation means,

precautions for avoiding contracting the syndrome, and sufficient

understanding of the means of AIDS transmission so that they can

counter misconceptions about the syndrome directed against them.

v. Hemophilia Patients -- These frequent recipients of

blood and blood products need to know the risks involved

regarding the potential for contracting AIDS. The group should
135

have access to understandable explanations of the syndrome,

related test(s) , and precautions that blood laboratories take to

protect the purity of their products.

VI. Health Workers -- This audience encompasses a wide range

of occupations and professions that require information on

treating AIDS patients and on self-protection against the

syndrome. There is a particular need to correct misconceptions

about AIDS among this group that interfere with providing good

medical care to AIDS patients.

VII . Other Workers Whose Jobs Bring Them In Close Contact

With At-Risk Populations -- This group, which includes such

occupations as police, prison and other security guards, certain

laundry and custodial workers, and similar service personnel,

usually has less health information and understanding than most

of the audiences in category VI. The group needs basic

information about the nature of AIDS and its means of

transmission so that they will not harbor unnecessary fears about

their work and the at-risk individuals they deal with.

STRATEGIES: To date, all PHS agencies have participated in some

way in public information and education activities regarding

AIDS. Activities have been coordinated by the Office of Public

Affairs, OASH, which has also directly conducted many of the more

than two dozen individual projects comprising the previous AIDS

Public Information Plan .

Information for professionals has been disseminated via the

MMWR, journal articles, bulletins, pamphlets, media interviews

and numerous workshops on AIDS conducted by the agencies and

attended by outside consultants, organizations and the public.

Some 40,000 copies of the MMWR--which has carried articles on

AIDS epidemiology and etiology, PHS recommendations and

precautions for health workers--are regularly distributed to the

health community. In addition, reprints of these articles have

been distributed to community health centers, other health

facilities and drug treatment centers. CDC has also developed

AIDS videotapes and information materials for venereal diseas e

project areas, STD prevention training centers, PHS Regional

Offices and professional groups. Videotapes have been produced

or are in production by OPA, with CDC and NIH for release this

fall to hospital laboratory and nursing staff audiences, public

safety personnel and drug treatment center staffs, and the

public. These will be offered for sale and distributed through

the National Audiovisual Center. CDC has also distributed more

than 40,000 slides for use “in clinical and public health

training, use by the media and for public health education

programs. National and regional conferences have been sponsored

by NIH and CDC to provide clinical information to primary car e

physicians, nurses , laboratory technicians and other allie d

health personnel, and state and local health officials . Specia l

meetings have been sponsored by the agencies to exchange

information on special aspects of AIDS, such as transfusion-
—

136

associated cases, safety of clotting factor concentrates, simian

AIDS, the needs of drug abuse treatment centers and community

centers, and ethical issues in AIDS-related studies.

Early efforts aimed at the populations at risk and at the

public focused on providing information quickly through the news

media, including the gay press, which carried articles, broadcast

news and features and offered documentary programs based on PHSprovided information about AIDS. These channels also promoted

the national AIDS toll-free hotline (800-342-AIDS) operated by

PHS. The hotline is available to the public for AIDS information

24 hours a day and has received more than 600,000 calls, most of

them from individuals in the populations at risk. The National

Institute of Drug Abuse (NIDA) has directed materials about AIDS

to drug users through drug treatment centers. OPA has awarded a

contract to a Haitian community group in Miami, Fla., to conduct

AIDS information activities in the Haitian community there. PHS

information materials have been sent in bulk to Haitian

organizations to enable them to conduct education programs among

their members. PHS has also worked with organizations

representing hemophiliacs to provide information to that group.

The public has been informed through PHS interviews with the

news media, briefings and press conferences, and an assortment of

materials ranging from small reference cards and fact sheets to

booklets and pamphlets. The materials assure that the public

understands that persons outside the identified risk groups are

at very low risk of acquiring the disease and that casual contact

with persons in the risk groups poses no danger to the public

health. The materials are also intended to help allay public

concerns regarding the safety of donating blood and receiving

blood transfusions. PHS officials have participated in countless

television and radio interviews to discuss AIDS. Exhibits have

been built by the Health Resources and Services Administration

(HRSA) for use by AIDS-related PHS components at meetings and

conventions for health professionals and other appropriate

audiences.

The reporting of HTLV-III as the probable cause of AIDS

necessitates revising or supplementing all AIDS information

material and the development of new items for specific

purposes. In addition, greater efforts are necessary for some

target audiences, specifically more effort targeted to drug

users, their families and treatment center staff. Also, new

efforts are needed to explain the HTLV-III antibody test to the

public and to potential participants in various research

projects, as well as to blood donors and recipients.

Cost estimates for the FY 1984 public information activities

amounted to $197,850, in addition to at least $43,000 in services

and expenses contributed by individual components. To ensure

best use of FY 1985 funds and to maximize results of new

materials and projects, the revised plan emphasizes sharing of

materials, development of prototypes for reproduction by others,
137

and the involvement of other agencies, organizations and

facilities in the private and public sector for production,

reproduction and distribution of materials. For example, PHS has

mounted a collaborative project with the U.S. Conference of

Mayors to identify the most effective educational strategies an d

materials in use in various cities and communities and to shar e

those materials and techniques with health officials throughout

the country in mounting their own AIDS information programs .

FY 1985 Information Projects\Activities\Material s

Concerning Acquired Immune Deficiency Syndrome

1. Blood Test Materials (fact sheets and cards): This will

include descriptions of the test(s) for HTLV-III antibodies,

expected to be available and in use by the end of 1984.

Prototype materials will be developed for use by physicians,

health care facilities, blood banks, blood collection agencies,

and similar appropriate entities. Although supplies will be made

available in bulk quantities, entities will be encouraged to us e

‘camera copy” reproducible and print their own materials .

During the research period, it will be necessary to develop

film and/or videotape footage describing the blood test, for use

by the news media and for patient education and participant

education purposes. This would be in addition to the usual press

releases and background explanatory statements used to explain

PHS activities.

2* Facts About AIDS (fact sheet) : This fact sheet, in questio n

and answer form, has been published every two to three months

with basic information about AIDS, for use with all target

audiences. Distribution usually amounts to 25,000 per month. In

FY 1985, about six issues of the fact sheet are planned, with

organizations, health care facilities, and others being

encouraged to reproduce the fact sheet themselves. At least tw o

of the issues will be translated into Spanish.

3 . MMWR Selected Reprints : Several appropriate articles fro m

the MMWR will be collected into one publication for distributio n

primarily to health care personnel on request . Experience ha s

also shown the reprints to be of special interest to many person s

in risk groups and to their families.

4. MMWR reprints of PHS-Recommended Precautions Regarding

AIDS: Demand for this reprint has been at least 10,000 copie s

per month during 1984 among health care workers and families o f

AIDS patients and is expected to continue .

5 . AIDS Hotline : Use of the AIDS hotline has varied from a

high of about 5,000 calls per day to a low of 150 calls per day

between July 1983 and July 1984, with the average expected to be

maintained at about 200 during 1985. Initially, PHS staff
138

answered questions raised by callers, and a tape-recorded three

minute audiotape with AIDS information was used 24 hours a day.

Currently only the audiotape is used, except when a new

development is announced or OPA is aware of a special promotion

of the AIDS hotline number; then the tape is supplemented by a

hotline operator to answer questions. Incoming lines will be

reduced from 8 to 4.

6 . Videotape Updates (trailers) : Three videotapes were

prepared in FY 1984 for use among the public, nurse and hospital

lab workers, and emergency and correctional workers. These tapes

are being promoted and distributed by the National Audiovisual

Center. The 20-minute tapes will require updating as new AIDS

findings occur. This can be accomplished by trailers of up to 10

minutes at the end of the existing tapes, eliminating the need

for reshooting the entire tapes.

7 . Videotape for Primary Care Physicians: NIAID has prepared a

videotape for use by physicians and at hospital continuing

education programs-describing AIDS treatment and research. The

tape was edited from a one-day seminar sponsored by the

Institute and will be distributed through appropriate mailing

lists, for duplication by recipients and return for reuse. A

trailer may be produced for this tape, too.

8. AIDS Publications (Updates) : Four publications have been

purchased from a private publisher for use with the general

public, gay and bisexual men, health workers, and Spanish

language audiences. For FY 1985, these publications must be

updated to reflect new AIDS developments, especially availability

of the blood test. FY 1984 distribution has been in bulk to any

organization or facility that could make effective use of the

materials in reaching a target audience. FY 1985 quantities can

be reduced and commercial (for profit) organizations or

facilities will be limited in quantities that will be provided

free. Instead, these facilities will be encouraged to purchase

the low-cost materials directly from the publisher.

9. Drug Abuser Program: NIDA has reprinted AIDS materials and

generated materials of its own for distribution to drug abuse

treatment and counseling centers. Communities and centers in

California and New York have also developed materials of their

own. FY 1985 activities will include sharing materials possibly

through the Conference of Mayors ( see no. 11), and perhaps

developing appropriate items such as training videotapes and

other educational materials. The program will be aimed at center

staffs, families of drug abusers, mothers, and so-called

recreational drug users.

10. Mental Health Aspects of AIDS: NIMH has been conducting

research on this issue, and during FY 1985 is expected to have

developed sufficient information to release, in publication or

audiovisual form, for use in educating appropriate health

personnel about mental illness aspects of AIDS and the menta l
139

health needs of AIDS patients, their families, and close

friends. A publication listing model mental health programs for

people with AIDS, other hotlines, community efforts, support

networks and education programs will be produced for State and

local officials and other organizations.

11. Conference of Mayors Project : A contract was awarded during

FY 1984 to the U.S . Conference of Mayors to provide for th e

sharing of AIDS information and education experiences and

materials among the nation’s cities and communities . Thi s

channel will be used as a distribution channel for appropriat e

PHS-developed materials (e.g . drug abuse-related AIDS

information) and for the identification of materials and program s

that are most effective in bringing about AIDS risk reduction .

The project may be expanded to provide risk reduction and bloo d

test information through gay community groups. A projec t

evaluating and documenting substantial behavioral changes amon g

high risk group members may also be initiated .

1 2 * Haitian-Related Activities : A contract was awarded in FY

1984 to a Haitian community organization in Miami to develop

materials and conduct a health information and education campaig n

among Haitians in the Miami area with emphasis on AIDS

information . FY 1985 activity will include updating of th e

previous year’s information materials, distribution, and possibl e

application to Haitian communities in other parts of the country.

1 3 . Survey of Physician Knowledge : A FY 1984 survey of publi c

knowledge showed that most Americans had a general understanding

of AIDS being confined to specific risk groups. The survey als o

determined the effectiveness of PHS-distributed informatio n

material . FY 1985 activities will include a survey of physicia n

knowledge about AIDS and their perception of required patien t

information, which will to provide guidance to OPA in ensurin g

the development of materials that are both adequate an d

necessary . This project will be conducted in cooperation wit h

the AMA.

1 4 . Othe r press materials: Press releases, background papers

and statements, and similar materials, in addition to aiding th e

news media, are also useful in secondary distribution to variou s

target audiences. Other suggested materials include 3 mailing s

to weekly newspapers by contractor as part of a features service ,

and an authoritative source material kit and contact list fo r

health writers and editorial writers.

15. NIH Radio Programs: In FY 1984, the NIH produced two 15

minute radio programs on AIDS as special supplements to the NIH

regularly produced interview programs on research topics. Thre e

five minute programs were also excerpted from each of the longe r

programs, with 11 the shows then distributed on albums to abou t

400 radio stations who request the NIH programming . This

successful project is being planned for updating and preparatio n

again in FY 1985. Planned emphasis is on the availability an d

use of a blood test for HTLV-III antibodies.
140

Cost Estimates FY 1985

AIDS Projects and Activities

Blood test materials (fact sheets/cards) . . . . . . . . . . .

Facts About AIDS (fact sheet) (6 issues) . . . . . . . . . . .

Facts About AIDS (Spanish) (2 issues) . . . . . . . . . . . . . .

MMWR Selected Reprints (collection) ● **O,.* ● *O***** ●

MMWR Reprint of AIDS Precautions.... . . . . . . . . . . . . . . .

AIDS Hotline (Code-a-Phone) . . . . . . . . . . . . . . . . . . . . . . . .

Videotape Updates . . . . . . ● ***8** ● ***.*** ● ******9 ● ***e

Videotape for Morticians and pathologists . . . . . . . . . .

AIDS Publications (Updates) . . . . . . . . . . . . . . . . . . . . . . . .

Drug Abuser Program . . . . . . . ● *9**** ● ***W*** , o**  ● *

Mental Health Aspects of AIDS ● .***..* .**.****. ● . . . .

Conference of Mayors Project . . . . . . . . . . . . . . . . . . . . . . .

Haitian-Related Activities . . . . . . . . . . . . . . . . . . . . . . . . .

Survey of Physician Knowledge . . . . . . . . . . . . . . . . . . . . . .

Other Press Materials . . . . . . . . . . . . . ......:. . . . . . . . . .

NIH Radio Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Mailing/Request Handling/Distribution. . . . . . . . . . . . . .

Meetings/Travel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

$ 20,000

5,000

500

3,000

2,000

2,500

5,000

20,000 (1)

22,500

50,000 (2)

10,000 (3)

200,000 (4)

5,000

10,000

15,000

2,500

25,000

TOTAL (NEEDED FOR TAP) (OPA) $120,000

OTHER AGENCY FUNDING (1,2,3,4)

(1) NIH to fund

(2) NIDA to fund

(3) NIMH to fund

(4) CDC to fund
Appendix E.—A Partial List of Organizations

Involved in AIDS Lobbying, Public Education,

Prevention, or Social Services

East Coast

GLH/AIDS Project

P.O. Box 11013

Durham, NC

(919) 286-0079

Gay Men’s Alliance of Hudson Valley

255 Grove St.

White Plains, NY 10601

(914) 997-5149

Long Island AIDS Project

SUNY Health Sciences

Stony Brook, NY 11794

(516) 444-2404

AIDS Task Force, Inc.

P.O. Box 3B/Bidwell

Buffalo, NY 14222

(716) 886-1275

AIDS Program, HCC, Inc.

50 Court St., Suite 1001

Brooklyn, NY 11201

(212) 855-7275

SouTier AIDS Task Force

P.O. Box 1492

Binghamton, NY 13902

(607) 723-6493

Central NY AIDS Task Force

P.O. Box 1682

Syracuse, NY 13201

(315) 475-2430

AIDS Rochester, Inc.

153 Liberty Poleway

Rochester, NY 14604

(716) 232-7181

Capitol District AIDS

332 Hudson Ave.

Albany, NY 12110

(518) 465-6094

Haitian Coalition on AIDS

255 Eastern Parkway

Brooklyn, NY 11238

(212) 783-2676

AIDS Task Force

CDGLF, BOX 131

Albany, NY 12201

(518) 465-6094

Lambda Legal Defense and Education Fund

132 W. 43rd St.

New York, NY 10036

(212) 944-9488

Haitian Committee on AIDS

117 Harvard St.

Dorchester, MA 02124

(617) 436-2808

Fenway Health Community Center/AIDS Action

Committee

16 Haviland St.

Boston, MA 02115

(617) 267-7.573

Gay Men’s Health Crisis, Inc.

Box 274, 132 W. 24th St.

New York, NY 10011

(212) 807-6664

AID Atlanta

1132 W. Peachtree, NW, #112

Atlanta, GA 30309

(404) 872-0600

Philadelphia AIDS Task Force

P.O. Box 7259

Philadelphia, PA 19101

(215) 232-8055

AIDS Educ. Program

5900 W. Junior Coll. Rd.

Key West, FL 33040

AIDS Education Fund

2335 18th St., N.W.

Washington, DC 20009

(202) 332-5939

AIDS Project New Haven

P.O. Box 7

New Haven, CT 06473

(203) 239-7881

141
142

Gay and Lesbian Alliance of Delaware

P.O. Box 9218

Wilmington, DE 19809

(302) 764-2208

AIDS Action Committee

P.O. Box 4073

Key West, FL 33041

(305) 294-5531, ext. 4797

Health Crisis Net.

1930 Bay Drive, #2

Normandy Isle, FL 33141

(305) 448-2882

HERO/Medical Arts Bldg.

Cathedral & Read, #819

Baltimore, MD 21201

(301) 955-3150

Gay Rights National Lobby AIDS Project

P.O. Box 1892

Washington, DC 20013

(202) 546-1801

The Bar Association for Human Rights for Greater

New York

P.O. BOX 1899

Grand Central Station

New York, NY 10163

United States Conference of Mayors

16201 St., N.W.

Washington, DC

(202) 254-8718

National Gay Task Force

80 Fifth Ave.

New York, NY 10011

(212) 714-5800

AIDS Action Council

Federation of AIDS-Related Organizations

1115 1/2 Independence Ave., S.E.

Washington, DC 20003

(202) 547-3101/547-3102

Mayor’s interagency Task Force on AIDS

1025 Worth St., Rm. 604

New York, NY 10013

(212) 566-0484

AIDS Resource Center, inc.

235 W. 18th St.

New York, NY 10011

(212) 206-1414

AIDS Medical Foundation

230 Park Ave., Rm. 1266

New York, NY 10169

(212) 949-7410

AIDS Network Group

Department of Social Work

Memorial Sloan-Kettering

1275 York Ave.

New York, NY 10021

(212) 794-7018

Haitian Community Health Project

391 Eastern Parkway

Brooklyn, NY 11213

(718) 773-1171

AIDS Institute

New York State Department of Health

8 E. 40th St., 3rd floor

New York, NY 10016

(212) 340-3388

Lesbian and Gay Concern Committee

National Association of Social Workers

110 W. 86th St.

New York, NY 10024 (212) 799-3298

West Coast

AIDS Team

P.O. Box 9773

Fresno, CA 93794

(209) 264-2436

Pacific Center AIDS Project

2712 Telegraph Ave.

Berkeley, CA 94705

(415) 548-8283

AIDS Education/Research Foundation

P.O. Box 14227

San Francisco, CA 94123

(415) 626-8784

SF People with AIDS

1040 Ashbury, #5

San Francisco, CA 94117

(415) 665-3787

Los Angeles AIDS Network

811 N. Coronado Terrace

Los Angeles, CA 90026

(213) 483-8574

AIDS InterFaith Network

890 Hayes St.

San Francisco, CA 94117

(415) 558-9644

American Association of Physicians for Human

Rights

P.O. Box 14546

San Francisco, CA 94114

(415) 673-3189
143

Seattle AIDS Action Comm.

113 Summit Ave. E., #204

Seattle, WA 98104

(206) 323-1229

Northwest AIDS Foundation

P.O. Box 3449

Seattle, WA 98114

(206) 527-8770; 622-9650; 322-6698

Gay Men’s Health Group

2353 Minor Ave. E.

Seattle, WA 98102

(206) 322-3919

Seattle Gay Clinic

P.O. Box 20066

Seattle, WA 98104

(206) 322-2873

Cascade AIDS Project

408 S.W. 2nd Ave., Rm. 403

Portland, OR 97204

(503) 223-8299 (10 a.m.-3 p.m.)

AIDS Hotline

P.O. Box 968

Santa Fe, NM 87504

(505) 827-3201

New Mexico Physicians for Human Rights

P.O. BOX 1361

Espanola, NM 87532

(505) 753-2779/984-1217

AIDS Project/L.A.

937 N. Cole Ave., #3

Los Angeles, CA 90038

(213) 871-1284

SF AIDS Foundation

54 10th St.

San Francisco, CA 94104

(415) 864-4376

Diablo V. Community Center

1818 Colfax St.

Concord, CA 94520

(415) 827-2960

Gay & Lesbian Community Services of Orange

County

12832 Garden Grove Blvd.

Garden Grove, CA 92643

(714) 534-0862

Southern California Physicians for Human Rights

7985 Santa Monica Blvd., #109

Los Angeles, CA 90032

(213) 658-6261

AIDS/Kaposi’s Sarcoma Foundation

2115 J. St., #3

Sacramento, CA 95816

(916) 448-AIDS

San Diego AIDS Project

P.O. BOX 81082

San Diego, CA 92138

(619) 294-2437

San Francisco AIDS Project

P.O. BOX 14227

San Francisco, CA 94114

(415) 864-4376

Shanti Project

890 Hayes St.

San Francisco, CA 94117

(415) 558-9644

Bay Area Physicians for Human Rights

P.O. BOX 14546

San Francisco, CA 94114

(415) 558-9353 (adm.) or 372-7321 (medical)

Berkeley Gay Men’s Clinic

2339 Durrant Ave.

Berkeley, CA 94704

(415) 548-2570 or 848-9220

AIDS/KS Foundation/SC Co.

715 North 1st St.

San Jose, CA 95112

(408) 298-4238 (hotline, 12 noon-9 p.m. M-F)

Colorado AIDS Project/GLCC

1436 Lafayette St.

Denver, CO 80218

(303) 831-6268

Central United States

Oklahoma for Human Rights

4107 East 2nd Place

Oklahoma City, OK 74112

Health Guard Foundation

417 NW 9th St.

Oklahoma, OK 73102

(405) 235-5693

AIDS Committee

1627 West Rosewood

San Antonio, TX 78201

(512) 736-5216
144

Oaklawn AIDS Action Project Kaposi’s Sarcoma/AIDS Foundation

5811 Nash 3317 Montrose, Box 1155

Dallas, TX 75235 Houston, TX 77006

(214) 351-1502 (713) 524-2437

AIDS Vol. of Cincinnati

P.O. Box 2615

Cincinnati, OH 45201

(513) 542-0493

St. Louis Task Force on AIDS

P.O. Box 2905

St. Louis, MO 63130

(312) 862-9800

AIDS Support Group

c/o 2309 Girard Ave. S.

Minneapolis, MN 55405

Wellness Networks, Inc.

P.O. Box 1046

Royal Oaks, MI 48068

(313) 876-3582

Howard Brown Memorial Clinic/AIDS Action

Project

National Coalition of Gay Sexually Transmitted

Disease Services

P.O. Box 239

Milwaukee, WI 53201

(414) 277-7671

LGCS/MN AIDS Project

124 West Lake St.

Minneapolis, MN 55408

(612) 827-2821

AIDS Task Force

P.O. Box 190712

Dallas, TX 75219

(214) 528-4233

AIDS Task Force

1022 Barracks St.

New Orleans, LA 70116

(504) 568-9619/524-7023

2676 N. Halsted St.

Chicago, IL 60614

(312) 871-5777
Appendix F.—Glossary of Acronyms and Terms

Glossary of Acronyms

ADAMHA—Alcohol, Drug Abuse, and Mental

Health Administration (part of PHS)

AIDS —acquired immunodeficiency syndrome

ARV —AIDS-related virus

CDC –Centers for Disease Control (part of

PHS)

DBDR —Division of Blood Diseases and

Resources (part of NHLBI)

DHHS —Department of Health and Human

Services

DNA —deoxyribonucleic acid

DRR —Division of Research Resources (part

of NIH)

FDA —Food and Drug Administration (part

of PHS)

FOCMA —feline-oncornavirus-cell-membraneassociated antigen

FTEs —full-time equivalents

HPA-23 —heteropolytungstate

HRSA —Health Resources and Services

Administration (part of PHS)

HTLV-I —human T-cell lymphotropic virus,

type I

HTLV-II —human T-cell lymphotropic virus,

type II

HTLV-III —human T-cell lymphotropic virus,

type III

IDAV —immune-deficiency -associated virus

LAV —lymphadenopathy-associated virus

MCHBG —Maternal and Child Health Block

Grants

NCI —National Cancer Institute (part of

NIH)

NEI –National Eye Institute (part of NIH)

NHLBI –National Heart, Lung, and Blood

Institute (part of NIH)

NIAID —National Institute of Allergy and

Infectious Diseases (part of NIH)

NIDA —National Institute on Drug Abuse

(part of ADAMHA)

NIDR —National Institute of Dental Research

(part of NIH)

NIH —National Institutes of Health (part of

PHS)

NIMH —National Institute of Mental Health

(part of ADAMHA)

NINCDS –National Institute of Neurological and

Communicative Disorders and Stroke

(part of NIH)

OASH

OMB

OPA

OPRR

OTA

PHS

RFAs

RNA

TCGF

—Office of the Assistant Secretary for

Health (part of PHS)

—Office of Management and Budget

(part of Executive Office of the

President)

—Office of Public Affairs (part of

OASH)

—Office of Protection from Research

Risks (part of NIH)

—Office of Technology Assessment

(part of U.S. Congress)

–Public Health Service (part of DHHS)

—requests for applications

—ribonucleic acid

—T-cell growth factor (also known as

interleukin-2)

Glossary of Terms

Acquired immunodeficiency syndrome (or acquired

immune deficiency syndrome): See “AIDS. ”

Active immunity: Protection against a disease resulting

from the production of antibodies in a host (i.e.,

person or animal) that has been inoculated with an

antigen. (Compare “passive immunity.”)

Adenoviruses: Any of a group of DNA-containing

viruses originally identified in human adenoid

tissue, causing respiratory diseases, and including

some capable of inducing malignant tumors in experimental animals. (See also “viruses” and compare “reoviruses” and “retroviruses. ”)

AIDS (acquired immunodeficiency syndrome): A disease believed to be caused by the retrovirus HTLV111 (human T-cell lymphotropic virus, type 111) and

characterized by a deficiency of the immune system. The primary defect in AIDS is an acquired,

persistent, quantitative functional depression within

the T4 subset of lymphocytes. This depression often

leads to infections caused by micro-organisms that

usually do not produce infections in individuals

with normal immunity or to the development of a

rare type of cancer (Kaposi’s sarcoma) usually seen

in elderly persons or in individuals who are severely

immunocompromised from other causes. Other

associated diseases are currently under investigation

and will probably be included in the final definition of AIDS.

AIDS-related complex: A variety of chronic but

nonspecific symptoms and physical findings that appear related to AIDS, which may consist of chronic

145

42-575 0 - 85 - 11
146

generalized lymphadenopathy, recurrent fevers,

weight loss, minor alterations in the immune system, and minor infections. Some persons with

AIDS-related complex may develop full-blown

AIDS, while in others, the condition may represent

the height of clinical illness in reaction to infection

with HTLV-III. AIDS-related complex is sometimes

known as “pre-AIDS.” (Compare “lymphadenopathy syndrome.”)

Antibody: A blood protein produced by mammals in

response to exposure to a specific antigen. Antibodies are a critical component of the mammalian

immune system.

Antigen: A large molecule, usually a protein or carbohydrate, which when introduced into the body

stimulates the production of an antibody that will

react specifically with that antigen.

Appropriation: An act of Congress that authorizes one

or more Federal agencies to incur “obligations” (see

definition below) and make payments from the general fund or various special funds of the U.S. Treasury. Appropriations do not represent funds available in the Treasury, but are limitations on the

amounts that agencies may obligate during the time

period stated in the law.

ARV (AIDS-related retrovirus): A retrovirus recovered

from an AIDS patient and believed to be the same

virus as HTLV-III. (See “HTLV-III.”)

B lymphocytes (or B cells): Lymphocytes that mediate

humoral (e.g., antibody production) immune reactions. B lymphocytes proliferate under stimulation from factors released by T lymphocytes. (Compare “T lymphocytes.”)

Budget authority: Funds that are appropriated by Congress for obligated purposes, or less commonly, requests to Congress for such appropriations.

Clone: A group of genetically identical cells or organisms produced asexually from a common ancestor.

Cofactor: Factors or agents which are necessary or

which increase the probability of the development

of disease in the presence of the basic etiologic agent

of that disease.

Core proteins: Proteins that make up the internal

structure or core of a virus. (Compare “envelope

proteins.”)

Cytopathic: Pertaining to or characterized by abnormal changes in cells.

Cytotoxic: Poisonous to cells.

DNA (deoxyribonucleic acid): A linear polymer, made

up of deoxyribonucleotide repeating units, that is

the carrier of genetic information in living organisms. Recombinant DNA is a hybrid DNA formed

by joining pieces of DNA from different organisms

in vitro.

Envelope proteins: Proteins that comprise the envelope

or surface of a virus. (Compare “core proteins.”)

Enzyme: Any of a group of catalytic proteins that are

produced by living cells and that mediate and promote the chemical processes of life without themselves being altered or destroyed.

Epidemiologic studies: Studies concerned with the relationships of various factors determining the frequency and distribution of specific diseases in a

human community.

Etiologic agent: Causative agent.

Expenditures: Amounts actually expended by Federal

agencies as a result of obligations. (Compare “obligations.”)

Factor VIII: A naturally occurring protein in plasma

that aids in the coagulation of blood. A congenital

deficiency of Factor VIII results in the bleeding disorder known as hemophilia A.

Factor VIII concentrate: A concentrated preparation

of Factor VIII that is used in the treatment of individuals with hemophilia A.

Fulminant: Severe.

Gene: The basic unit of heredity; an ordered sequence

of nucleotide bases, comprising a segment of DNA.

A gene contains the sequence of DNA that encodes

for the synthesis of one polypeptide chain (protein).

Gene expression: The mechanisms through which

directions contained within the genes that code for

a cell’s products are transferred and used to direct

the production process. (See also “transcription”

and “translation.”)

Genome: The genetic endowment of an organism.

Glycoproteins: Proteins with carbohydrate groups attached at specific locations.

Glycosylation: The attachment of a carbohydrate molecule to another molecule such as a protein.

Hemophilia: A rare, hereditary bleeding disorder

caused by a deficiency in the ability to synthesize

one or more of the blood coagulation proteins, e.g.,

Factor VIII (hemophilia A) or Factor IX (hemophilia

B).

Hepatitis: Inflammation of the liver; may be due to

many causes, including viruses, several of which are

transmissible through blood transfusions.

HPA-23 (heteropolytungstate): A drug which has been

shown to inhibit the reverse transcriptase enzyme

of murine (mouse) retrovirus in vitro and in vivo,

and which has been shown in early clinical trials

to inhibit HTLV-III replication in humans, but

which has not eradicated the virus. (Compare

“ribavirin” and “suramin.”)

HTLV-III (human T-cell lymphotropic virus, type III):

A newly discovered retrovirus that is believed to

be the basic cause of AIDs. The target organ of
147

HTLV-III is the T4 subset of T lymphocytes, which

are the master regulators of the immune system. (In

this memorandum, HTLV-III is used to refer to the

various isolates (e.g., IDAV, LAV, ARV) that have

been associated with AIDS.)

IDAV (immune-deficiency-associated virus): A retrovirus recovered from an AIDS patient and now

believed to be the same virus as HTLV-III. (See

“HTLV-III.”)

Idiotype (or idiotope): A site on the variable portion

(combining site) of an antibody molecule that can

be recognized by a combining site of other antibodies.

Immune: Being highly resistant to a disease because

of the formation of humoral antibodies or the development of cellular immunity, or both, or as a

result of some other mechanism (e. g., interferon

activity in viral infections). (See also “active immunity” and “passive immunity.”)

Interferon: A class of glycoproteins (proteins with carbohydrates attached at specific locations) important

in immune function and thought to inhibit viral infections.

In vitro: Literally, “in glass”; pertaining to a biological

reaction taking place in an artificial apparatus; often

used in reference to the growth of cells from multicellular organisms under cell culture conditions.

In vivo: Literally, “in the living”; pertaining to a

biological reaction taking place in a living organism.

Kaposi’s sarcoma: A multifocal, spreading cancer of

connective tissue, principally involving the skin; it

usually begins on the toes or the feet as reddish blue

or brownish soft nodules and tumors.

LAV (lymphadenopathy-associated virus): A retrovirus recovered from a person with lymphadenopathy (enlarged lymph nodes) who was also in a

group at high risk for AIDS, and now believed to

be the same virus as HTLV-III. (See “HTLV-III. ”)

Lymphadenopathy: Enlargement of the lymph nodes,

Lymphadenopathy syndrome (LAS): A condition

which is characterized by persistent, generalized,

enlarged lymph nodes, sometimes with signs of minor illness such as fever and weight loss, which apparently represents a milder reaction to infection

with HTLV-III than full-blown AIDS. Some patients with LAS have gone on to develop full-blown

AIDS, while in others, LAS may represent the

height of clinical illness in reaction to infection with

HTLV-III. LAS is also known as “generalized

lymphadenopathy syndrome. ” (Compare “AIDSrelated complex.”)

Lymphocytes: Specialized white blood cells involved

in the immune response. (See also “B lymphocytes”

and “T lymphocytes.”)

Lymphosarcoma: A general term applied to malignant

neoplastic disorders of lymphoid tissue, but not including Hodgkin’s disease.

Messenger RNA (mRNA): RNA that serves as the

template for protein synthesis; it carries the transcribed genetic code from the DNA to the protein

synthesizing complex to direct protein synthesis.

(See also “RNA.”)

Monoclinal antibodies: Homogeneous antibodies

derived from clones of a single cell. Monoclinal antibodies recognize only one chemical structure and

thus have remarkable specificity. They are easily

produced in large quantities and have a variety of

medical and industrial uses.

Obligations: Amounts stipulated in contractual agreements between the Federal Government and other

parties. (Compare “expenditures.”)

Opportunistic infection: A disease or infection caused

by a micro-organism that does not ordinarily cause

disease but which, under certain conditions (e.g.,

impaired immune responses), becomes pathologic.

Passive immunity: Disease resistance in a person or

animal due to the injection of antibodies from

another person or animal. Passive immunity is usually short-lasting. (Compare “active immunity.”)

Pneumocystis carinii pneumonia: A type of pneumonia primarily found in infants and now commonly

occurring in patients with AIDS.

Post-translational modification: The process by which

the protein product of gene expression is modified,

such as through attachment of carbohydrate groups.

(See also “gene expression, ” “translation,” and

“glycosylation. ”)

Provirus: The genome of an animal virus integrated

into the chromosome of the host cell, and thereby

replicated in all of the host’s daughter cells.

Recombinant DNA techniques: Techniques that allow

specific segments of DNA to be isolated and inserted

into a bacterium or other host (e. g., yeast, mammalian cells) in a form that will allow the DNA segment to be replicated and expressed as the cellular

host multiplies. The DNA segment is said to be

“cloned” because it exists free of the rest of the DNA

of the organism from which it was derived.

Reoviruses: Any of a group of relatively large, widely

distributed, and possibly tumor-causing viruses

with double-stranded RNA. Unlike retroviruses,

which also contain RNA, reoviruses replicate in the

cytoplasm of the cells they invade and do not produce DNA analogs to their RNA for incorporation

into the host cell’s genome. (See also “viruses” and

compare “adenoviruses” and “retroviruses. ”)

Retroviruses: Viruses that contain RNA, not DNA,

and that produce a DNA analog of their RNA
148

through the production of an enzyme known as “reverse transcriptase. ” The resulting DNA is incorporated in the genetic structure of the invaded cell

in a form referred to as the “provirus. ” (See also

“provirus” and “viruses” and compare “adenoviruses” and “reoviruses.”)

Reverse transcriptase: An enzyme produced by retroviruses that allows them to produce a DNA analog

of their RNA, which is then incorporated into the

host cell. (See also “retroviruses.”)

Ribavirin: A drug which has been shown to protect

T4 cells against infection by HTLV-III in vitro, and

which is being tested in AIDS patients. (Compare

“suramin” and “HPA-23.”)

RNA (ribonucleic acid): Any of various nucleic acids

that contain ribose and uracil as structural components and are associated with the control of cellular

chemical activities. (See also “messenger RNA.”)

Serum: The clear portion of any animal liquid separated from its more solid elements, especially the

clear liquid (blood serum) which separates in the

clotting of blood.

Subunit vaccine: A vaccine that contains only portions

of a surface molecule of a pathogen. (See also

“vaccine.”)

Suramin: A drug that has been shown to protect T4

cells against infection by HTLV-III in vitro, and

which is being tested in AIDS patients. (Compare

“ribavirin” and “HPA-23.”)

T-cell growth factor (TCGF, also known as interleukin-2): A glycoprotein that is released by T lymphocytes on stimulation with antigens and which

functions as a T-cell growth factor by inducing proliferation of activated T cells. (See also “T lymphocytes” and “glycoproteins.”)

T lymphocytes (or T cells): Lymphocytes that mature

in the thymus and which mediate cellular immune

reactions. T lymphocytes also release factors that

induce proliferation of T lymphocytes and B lymphocytes. (Compare “B lymphocytes.”)

Transcription: The synthesis of messenger RNA on a

DNA template; the resulting RNA sequence is complementary to the DNA sequence. This is the first

step in gene expression. (See also “gene expression”

and compare “translation.”)

Transfer authority: Authority from Congress to transfer money from one appropriation to another

within an agency or across agencies.

Translation: The process in which the genetic code

contained in the nucleotide base sequence of messenger RNA directs the synthesis of a specific order of amino acids to produce a protein. (See also

“gene expression” and compare “transcription.”)

Tropism: An innate tendency to react in a definite

manner to stimuli.

Vaccine: A preparation of killed organisms, living attenuated organisms, living fully virulent organisms,

or parts of micro-organisms, that is administered

to produce or artificially increase immunity to a

particular disease.

Viruses: Any of a large group of submicroscopic agents

capable of infecting plants, animals, and bacteria,

and characterized by a total dependence on living

cells for reproduction and by a lack of independent metabolism. (See also “adenoviruses,” “provirus, “ “reoviruses,” and “retroviruses.”)
References
References

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

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