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 ef- forts 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 iden- tify 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 ani- mal models, and on epidemiological work; ● the adequacy and scope of efforts to develop vaccines against the disease; ● the adequacy and timeliness of the distribution of new knowledge and informa- 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. These questions and related issues of science and public policy are addressed in this memorandum. Ill 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. SUMMARY . 3 The Biology of AIDS.... 4 Federal Support of AIDS Research . 6 Related Issues . 8 2. 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. Acknowledgments and Health Program Advisory Committee . 57 B. PHS Organization Chart. 63 c. OASH Summary of Individual PHS Agencies’ Obligations for Specific AIDS Activities, Fiscal Years 1984 and 1985 . 64 vii Contents—Continued Appendixes Page 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 . 77 E. A Partial List of Organizations Involved in AIDS Lobbying, Public Education, Prevention, or Social Services . 141 F. Glossary of Acronyms and Terms. 145 References . 151 List of Tables Table No. Page 1. History of AIDS Funding, Fiscal Years 1982 to 1985., . 32 2. PHS Agencies’ Estimated Obligations for AIDS Activities in Fiscal Year 1984. 34 3. Supplemental Funds for PHS Agencies’ AIDS Activities in Fiscal Year 1984: Agencies’ Indications Compared to Congressional Appropriations . 34 4. Amounts Identified for PHS Agencies’ AIDS Activities for Fiscal Year 1985: President’s Budget Request Compared to Congressional Appropriations or Estimated Actual Obligations . 35 5. Centers for Disease Control: Initial U.S. Budget Request Compared to Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985 . 36 6. Centers for Disease Control: Overall Agency Budgets and AIDS Budgets, Fiscal Years 1979 to 1985 . 36 7. Food and Drug Administration: Initial U.S. Budget Request Compared to Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985 . 37 8. Food and Drug Administration: Overall Agency Budgets and AIDS Budgets, Fiscal Years 1979 to 1985 . 37 9. National Institutes of Health: Initial U.S. Budget Request Compared to Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985 . 37 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 1985 . 38 11. Alcohol, Drug Abuse, and Mental Health Administration: Overall Agency Budgets and AIDS Budgets, Fiscal Years 1982 to 1985 . 38 12. Health Resources and Services Administration: Initial U.S. Budget Request Compared to Estimated Budget Authority for Previous Year, Fiscal Years 1983 to 1985 . 38 13. National Institute of Allergy and Infectious Diseases: Redistribution Needed To Fund Fiscal Year 1985 AIDS Activities . 40 14. National Cancer Institute: Estimated Redistribution Needed To Fund Fiscal Year 1985 AIDS Activities . 41 15. National Institutes of Health: Award Rates and Paylines for All Extramural Research Compared to AIDS Extramural Research, Fiscal Year 1983. ..,.,... 42 16. Changes in Funding for PHS AIDS Activities Anticipated After Discovery of AIDS Etiologic Agent.. 43 17. Funding for PHS AIDS Activities by Type of Activity, Fiscal Years 1984 and 1985 . 43 18. Funding for PHS AIDS Activities by Type of Activity and Agency, Fiscal Years 1984 and 1985 . 45 Vlll. Chapter 1 Summary Chapter 1 Summary The basic cause of acquired immunodeficiency several years, it is too soon to tell what percent- syndrome (AIDS) is almost certainly a newly dis- age of persons exposed to the virus will develop covered virus, human T-cell lymphotropic virus, AIDS. It is also too soon to tell whether persons type III, or “HTLV-III.” Researchers who have exhibiting milder manifestations of disease (e.g., isolated viruses similar to HTLV-III have given fever, some depression of immune functions, their isolates other descriptive names, such as enlarged lymph nodes) will eventually develop “lymphadenopathy-associated virus” (LAV) or AIDS, continue to exhibit signs and symptoms of “AIDS-related virus” (ARV), but these isolates mild disease, or get well. and HTLV-III are essentially the same. Prior to the discovery of the etiologic (causa- The AIDS virus preferentially infects and de- tive) agent for AIDS, efforts to devise preventive stroys certain white blood cells called “T lym- and treatment strategies had to depend on em- phocytes” that are essential for the functioning of pirical observations of AIDS’s epidemiology and the body’s immune system. When the immune effects on the body. The discovery of HTLV-III system is severely depressed or destroyed by now provides a theoretical foundation which HTLV-III, other infectious agents such as bacte- greatly expands the range of possible strategies ria or other types of viruses that usually do not to prevent, diagnose, and treat AIDS. It is im- cause disease in persons with normal immune portant to recognize, however, that the discov- functions may have the opportunity to cause dis- ery of HTLV-III only.