The Institute of Medicine Confronts AIDS Policy-Making

by Leslie M. Hardy,* M.H.S.

Senior Policy Analyst, Office of the Assistant Secretary for Health, Department of Health and Human Services

In the early 1980s, with the appearance of the first reported cases of AIDS, few scientists, public health officials, and policymakers were prepared for what was to follow: the growing spread of HIV infection and the myriad scientific and public health policy questions, ethical dilemmas, and sometimes bitter controversies engendered by this devastating epidemic. Recognizing the need to focus national attention on this widening public health crisis, the Institute of Medicine (IOM) devoted the scientific session of its October 1985 annual meeting to a broad examination of the current knowledge and understanding about AIDS and the many scientific and policy questions that it raised. Drawn from the annual meeting's discussions and written largely for the lay public, Mobilizing Against AIDS: The Unfinished Story of a Virus was published in April 1986.

CONFRONTING AIDS

The 1985 annual meeting was not designed to provide guidance in developing recommendations about the most appropriate course of action to address

*

Until July 1995, Ms. Hardy was a senior program officer in the Division of Health Promotion and Disease Prevention at the Institute of Medicine.



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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 The Institute of Medicine Confronts AIDS Policy-Making by Leslie M. Hardy,* M.H.S. Senior Policy Analyst, Office of the Assistant Secretary for Health, Department of Health and Human Services In the early 1980s, with the appearance of the first reported cases of AIDS, few scientists, public health officials, and policymakers were prepared for what was to follow: the growing spread of HIV infection and the myriad scientific and public health policy questions, ethical dilemmas, and sometimes bitter controversies engendered by this devastating epidemic. Recognizing the need to focus national attention on this widening public health crisis, the Institute of Medicine (IOM) devoted the scientific session of its October 1985 annual meeting to a broad examination of the current knowledge and understanding about AIDS and the many scientific and policy questions that it raised. Drawn from the annual meeting's discussions and written largely for the lay public, Mobilizing Against AIDS: The Unfinished Story of a Virus was published in April 1986. CONFRONTING AIDS The 1985 annual meeting was not designed to provide guidance in developing recommendations about the most appropriate course of action to address * Until July 1995, Ms. Hardy was a senior program officer in the Division of Health Promotion and Disease Prevention at the Institute of Medicine.

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 the challenges posed by the HIV/AIDS epidemic. Yet the IOM realized that such recommendations were indeed warranted and that to formulate rational public health policy in this area, national leadership was critical. As a result, in early 1986, the presidents of the National Academy of Sciences (NAS) and IOM, with the approval of their respective governing councils, initiated a special effort to examine the extent of the problems arising from AIDS, assess the nation's response to this epidemic, and propose an appropriate course of action. Reflecting the urgency of the HIV/AIDS epidemic, the expert committee that conducted this study was asked to produce a report within 6 months following its initial meeting. The resulting landmark publication, Confronting AIDS: Directions for Public Health, Health Care, and Research (IOM/NAS, 1986a), was one of the first published volumes to provide a comprehensive scientific and policy analysis of current efforts to address this epidemic. It also proposed strategies for meeting the scientific, public health, and social challenges that arise in developing rational AIDS policy. Among the report's most significant recommendations was the call for $1 billion in annual federal spending, by fiscal year (FY) 1990, for AIDS-related education and other public health expenditures, as well as $1 billion in AIDS research funding. Confronting AIDS received extensive coverage by all the major news media and was described 2 years later by the New York Times as having “provided a benchmark by which many members of Congress and analysts judged the effectiveness of the nation's efforts to combat AIDS” (Boffey, 1988). During a time in which strong national leadership on the AIDS epidemic was lacking, the 1986 release of Confronting AIDS was viewed by many as a powerful turning point in national AIDS public policy-making. It heightened the awareness of Americans and brought national attention to the HIV/AIDS epidemic, highlighting the importance of continued biomedical research and vigorous public health efforts to contain the epidemic. In June 1988, the IOM released its second comprehensive AIDS policy document, Confronting AIDS: Update 1988. This report of the IOM/NAS AIDS Activities Oversight Committee was a supplement to the original 1986 report and provided an assessment of the nation's progress in the intervening years in fighting the epidemic. The update conveyed new information in epidemiology and biomedical research and provided recommendations for future action in the areas of health care, public health, research, and federal policy-making. Like its predecessor, this report also received wide media and public attention, and once again underscored the need for strong federal leadership in formulating coherent national AIDS policy.

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 The 1986 and 1988 Confronting AIDS reports have been credited with stimulating a number of federal legislative and public policy actions. These reports have been used to support substantial increases in federal spending for AIDS research and other AIDS-related prevention, public health, and health care programs, particularly during the period from FY 1987 to FY 1989. In fact, federal spending for AIDS programs nearly doubled from FY 1987 to FY 1988, and nearly $1.5 billion was appropriated in FY 1989, a 40 percent increase from FY 1988. Both volumes documented significant gaps in the nation's efforts to fight the AIDS epidemic, including the absence of strong federal leadership, clear overarching direction, and effective strategic planning. To address the need for coherent national policy and guidance in controlling the HIV/AIDS epidemic, both reports recommended the establishment of a National Commission on AIDS (which was ultimately chartered in August 1989 and completed its 4-year term in September 1993). The challenges of providing and paying for the appropriate care of HIV-infected people figured prominently in both reports. They noted that the HIV/AIDS epidemic has further exposed the shortcomings and inequities inherent in the U.S. health care delivery and financing system, especially in areas hardest hit by the epidemic. Recognizing the impending fiscal crisis facing many health care providers and institutions that currently bear a disproportionate burden of AIDS-related care, the AIDS Activities Oversight Committee recommended the establishment of an AIDS federal grant program in its report (IOM/NAS, 1988). Consistent with this recommendation, Congress in August 1990 enacted the Ryan White Comprehensive AIDS Resources Emergency Act. The main provisions of this landmark legislation established a federal grant program to offer emergency assistance to cities disproportionately affected by the epidemic and to provide formula block grants to the states for HIV-related care, treatment, and early intervention services. HIV SCREENING Calls for HIV screening of particular groups have waxed and waned in intensity as the dimensions of the epidemic became clear. These screening proposals have frequently engendered spirited debates about what constitutes an acceptable balance between the medical and public health benefits and the consequent personal and societal costs of HIV screening. Such a vigorous debate has surrounded the formulation of rational HIV testing and screening policies for pregnant women and newborns. In light of this ongoing debate, the National Institute of Child Health and Human Development (NICHD) and the

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 Centers for Disease Control and Prevention (CDC) asked IOM to assemble an expert committee to examine the medical, legal, and ethical questions that frame the development of sound perinatal HIV-screening policy and to assess the appropriateness of screening pregnant women and newborns for HIV infection. In its final report, HIV Screening of Pregnant Women and Newborns (IOM, 1991c), the committee recommended voluntary HIV screening (with specific informed consent) of all pregnant women in high-prevalence areas, for the purpose of early diagnosis and treatment. However, the committee concluded that newborn HIV screening was not yet warranted at that time, except when it was conducted anonymously for surveillance purposes. The committee based its conclusions on the following: (a) the HIV-antibody test suitable for screening purposes did not distinguish between HIV-seropositive newborns (who test positive because of passively acquired maternal antibodies) and truly infected newborns, and (b) treatment of asymptomatic HIV-infected infants in early infancy had not been clearly demonstrated to be effective. This last contention was the most controversial in the report, and not all experts in pediatric AIDS agreed on this point. Shortly after the report's release, several medical developments once again spurred debate about the rationale of screening newborns. These included the establishment of guidelines (CDC, 1991) for prophylaxis against Pneumocystis carinii pneumonia (PCP) in HIV-infected children, including all seropositive infants older than 1 month (before a definitive diagnosis of HIV infection can be established), and recommendations for antiretroviral therapy and medical management of HIV-infected children (Working Group on Antiretroviral Therapy, 1993). The committee recognized the need to reevaluate screening policies in light of technological advances and described in some detail a variety of scenarios—such as improvements in HIV diagnostic capability (particularly for neonates) and medical therapy—that might lead to policy modifications. The committee's overriding goal during the study was to provide a rational framework for considering prenatal and newborn screening policy options in an evolving epidemic, recognizing that such policies must be flexible to respond to advances in diagnosis and treatment. The HIV-screening report has been used by a number of states in developing prenatal and newborn HIV-screening policies and has served as the foundation for several national policy discussions on this issue. In addition, an oped article commenting on the study committee's recommendations appeared in more than 30 newspapers across the United States. Since its release in 1991, this report continues to be viewed as a useful resource to policymakers faced with developing a rational screening policy and making decisions about initiating prenatal and newborn screening programs. For example, the U.S. Preventive Services Task Force of the Public Health Service has frequently referred to HIV Screening of Pregnant Women and Newborns in developing its current

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 guidelines regarding HIV screening, as has the CDC in drafting its recommendations for HIV counseling and testing of pregnant women. Most recently, clinical trials results showing that administration of zidovudine (AZT) to HIV-infected pregnant women (and their newborns) can substantially reduce the risk of perinatal HIV transmission (Connor et al., 1994) have strengthened the argument for screening pregnant women for HIV infection. Yet questions remain about the implementation of prenatal screening programs—for example, should they be voluntary, routine (with right of refusal), or mandatory? What are the legal and ethical implications of such screening initiatives? What epidemiological and cost-effectiveness data are needed to form judgments about the appropriateness of implementing screening programs? Are the necessary medical and social services available to meet the needs of HIV-infected women (and their children) who would be identified through such programs? On February 23, 1995, CDC issued draft recommendations for HIV counseling and testing of pregnant women that call for health care providers to ensure that all pregnant women are routinely counseled and encouraged to be tested voluntarily for HIV infection. AIDS RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH Although scientists have made great strides in elucidating the molecular structure and biology of HIV, significant gaps remain in our understanding of the pathogenesis of HIV infection, the mechanisms of disease progression, and the nature of potentially protective immune responses. These gaps in our knowledge, many researchers argue, have frustrated efforts to develop truly effective therapies and vaccines against HIV infection. As the second decade of the HIV/AIDS epidemic progresses, a number of scientists have urged a reexamination of the balance and direction of the AIDS research enterprise and, in particular, enhanced investment in fundamental research targeted at HIV infection and AIDS (Fields, 1994; Paul, 1995). The IOM undertook such an assessment at the request of the National Institutes of Health (NIH) in 1989. This 15-month study was designed to provide NIH with advice on strengthening its institutional capacity to develop and implement an appropriate AIDS research agenda for the future and on improving its ability to identify and pursue the most important research questions. The resulting report, The AIDS Research Program of the National Institutes of Health (IOM, 1991a), focused on the broad content areas of NIH's AIDS research program; on the appropriate balance among those research initiatives; and on the overall management infrastructure and system needed to plan, set priorities for, coordinate, and monitor the NIH-wide AIDS research effort. In particular, the report highlighted the need to balance support for HIV-related

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 research programs with an ongoing commitment to and continued investment in basic research. Rather than establishing a separate “AIDS Institute, ” the committee characterized the NIH's AIDS research program as an “institute without walls” and argued for strengthened management and institutionalization of AIDS research activities at NIH (including strengthening the Office of AIDS Research). The committee also recommended that NIH develop a 5-year AIDS research plan that would “identify AIDS-related research needs and opportunities, assess program balance, identify research areas that need stimulation, set priorities, determine the resources required to carry out the program, and evaluate progress” (pp. 42 –43). The NIH plan on HIV/AIDS research, completed in 1992, was both a response to IOM's call for an overarching research plan and a component of NIH's long-term strategic plan. Although the reorganization of the NIH Office of AIDS Research, which was mandated in the NIH Revitalization Act of 1993, goes beyond the IOM's 1991 recommendations, it is in part an extension of the committee's view of the office as providing an important support, coordinating, and planning role for AIDS research across the institutes. The report also emphasized NIH's role and responsibility in supporting and conducting behavioral and social sciences research, particularly basic research on sexual and drug-using behaviors relevant to the transmission of HIV. For example, the committee joined a growing chorus of voices in urging the expansion of AIDS-related behavioral research, specifically the conduct of the NICHD's National Survey of Health and AIDS Risk Prevalence, which would provide information critical to understanding the dimensions of various risk behaviors and to developing effective educational and behavioral interventions. Several years after the release of The AIDS Research Program, the IOM was asked to assess the AIDS programs of the National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and National Institute of Mental Health, all of which were formerly part of the Alcohol, Drug Abuse, and Mental Health Administration. The committee's assessment focused on the content and management of the institutes' research portfolios, with particular attention to the balance between biomedical and behavioral research, the status of behavioral-science-based AIDS preventive interventions, and the links between research and services activities elsewhere in the Public Health Service. The resulting report, AIDS and Behavior: An Integrated Approach (IOM, 1994), surveys the broad range of HIV/AIDS research supported by these three institutes, including research in the biological, neurological, clinical, psychological, and social sciences. The report also

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 identifies significant advances, as well as gaps, in AIDS research related to sexual behavior, drug and alcohol use, and mental health. AIDS and Behavior received wide public and media attention, focused primarily on two of the committee's recommendations: (1) a call for a national survey of HIV-related risk behaviors (including sexual behavior), and (2) a lifting of the restriction on the use of federal funds to support needle-exchange programs for injection drug users. In addition to stories that appeared in the New York Times and the San Francisco Chronicle, articles outlining some of the committee's main findings and recommendations appeared in numerous local newspapers across the country, as well as in several scientific journals and professional association newsletters. The three institutes have all responded favorably to the report and noted its usefulness in guiding their future planning of AIDS research efforts. The report is also being used by the Office of AIDS Research as a guide in planning and funding activities in AIDS behavioral and social science research across NIH. THE AIDS ROUNDTABLE Communication among policymakers, biomedical researchers, care providers, and patient advocates is an important element in the development of new, more effective therapies and vaccines to treat or prevent HIV infection and its associated medical conditions. Recognizing the need for such ongoing dialogue and following specific endorsement by the IOM/NAS AIDS Activities Oversight Committee, in December 1988 the IOM established the Roundtable for the Development of Drugs and Vaccines Against AIDS as a convening mechanism to explore and help resolve impediments to the rapid availability of safe, effective drugs and vaccines against HIV infection and AIDS. This group was composed of leaders from government, the pharmaceutical and biotechnology industries, academia, and patient advocacy communities, representing a unique blend of expertise and viewpoints on scientific and public policy questions pertaining to HIV/AIDS drug and vaccine development. During its roughly 6-year tenure, the roundtable reviewed the state of scientific knowledge relevant to the design of therapeutic and preventive agents; examined some of the impediments to drug and vaccine development, approval, and availability; and discussed strategies to promote the development of drugs and vaccines against HIV infection. The roundtable also convened workshops and conferences on topics selected for their urgency and for their potential to expedite drug and vaccine development and availability. The roundtable held its first conference in September 1989 to examine the adequacy of surrogate endpoints in evaluating the effectiveness of AIDS drugs and approving them for marketing. Surrogate endpoints are laboratory markers that might be substituted for “true” endpoints of interest, such as increased

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 survival or the occurrence of opportunistic infections, in order to shorten the time necessary to evaluate new drugs. Investigators at the meeting presented data on potential surrogate endpoints for drug approval, including such laboratory markers as CD4+ T lymphocytes, p24 antigen, and plasma viremia, as well as a few clinical measures. The risks and benefits of approving drugs on the basis of surrogate measures of effectiveness were also discussed. A summary of the conference findings, Surrogate Endpoints in Evaluating the Effectiveness of Drugs Against HIV Infection and AIDS (IOM, 1990), has served as one of the seminal policy documents on surrogate markers and drug evaluation. Although several years old, this report continues to be used by officials of the Food and Drug Administration, public policymakers, and patient advocates as a foundation for deliberations regarding the use of surrogate markers in determining drug efficacy and in expediting marketing approval. Another significant roundtable conference was convened in March 1990 to assess various policy options—such as the treatment investigational new drug and parallel track program—for improving access to investigational therapies for HIV infection and AIDS. Participants reviewed the role of treatment investigational new drug regulations, issues of cost and coverage for expanded access programs, the potential for conducting research through programs for distribution of unapproved drugs, and the role of expanded access programs in reaching medically disenfranchised people. The conference report, Expanding Access to Investigational Therapies for HIV Infection and AIDS, was released in March 1991. At the time, this report helped to crystallize much of the scientific and policy debate around expanding (and expediting) access to investigational HIV therapies; it has served as a useful background document to many groups wrestling with how to effectively expand access to (and accelerate approval of) promising therapies for serious and life-threatening diseases. In its other workshops, the roundtable has dealt with a variety of topics—such as progress in HIV vaccine research and policy issues related to vaccine development and evaluation, development of drugs for infants and children with HIV infection, development of effective therapies for AIDS-related infections, gene therapy approaches for treating HIV infection, government and industry collaboration in AIDS drug development, and the changing demographics of the HIV epidemic and implications for clinical research. Over the course of the past 6 years, the roundtable has provided a neutral forum in which to explore and debate a variety of thorny issues surrounding AIDS drug and vaccine development and has fostered increased communication among various public- and private-sector representatives interested in furthering the research and development of effective HIV/AIDS therapeutics. Perhaps most important, the Roundtable has also offered an opportunity to examine areas in which science and public policy intersect and to consider the

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 policy implications of scientific inquiry and discovery in the area of HIV drug and vaccine development. SUMMARY The IOM's long-standing interest and involvement in AIDS policy-making has spanned almost a decade, marked by significant contributions along the way. The 1986 and 1988 Confronting AIDS reports have had, perhaps, the greatest impact in shaping national AIDS policy and pointing the direction for specific legislative actions. Even today, many of their recommendations constitute sound advice for policymakers struggling with the ethical dilemmas and public health challenges posed by the HIV/AIDS epidemic. Subsequent IOM AIDS-related activities have fostered dialogue and a critical examination of perinatal HIV-screening policies and have provided guidance in formulating HIV/AIDS therapeutic and behavioral research agendas. REFERENCES Boffey, P.M. 1988. Expert panel sees poor leadership in U.S. AIDS battle. New York Times, June 2, p. A1. Centers for Disease Control and Prevention (CDC). 1991. Guidelines for prophylaxis against Pneumocystis carinii pneumonia for children infected with human immunodeficiency virus Morbidity and Mortality Weekly Report 40(RR-2):1–13 Connor, E.M., Sperling R.S., Gelber, R., et al. 1994 Reduction of maternal–infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. New England Journal of Medicine 331(18):1173–80. Fields, B.N. 1994. AIDS: Time to turn to basic science. Nature 369:95–6. Institute of Medicine/National Academy of Sciences (IOM/NAS). 1986a. Confronting AIDS: Directions for Public Health, Health Care, and Research. Washington, D.C.: National Academy Press. Institute of Medicine/National Academy of Sciences (IOM/NAS). 1986b. Mobilizing Against AIDS: The Unfinished Story of a Virus, E.K. Nichols, writer. Cambridge: Harvard University Press. Institute of Medicine/National Academy of Sciences (IOM/NAS). 1988. Confronting AIDS: Update 1988. Washington, D.C.: National Academy Press. Institute of Medicine (IOM). 1990. Surrogate Endpoints in Evaluating the Effectiveness of Drugs Against HIV Infection and AIDS, R. Weiss and L. Mazade, eds. Washington, D.C.: National Academy Press. Institute of Medicine (IOM). 1991a. The AIDS Research Program of the National Institutes of Health . Washington, D.C.: National Academy Press. Institute of Medicine (IOM). 1991b. Expanding Access to Investigational Therapies for HIV Infection and AIDS, E.K. Nichols, writer. Washington, D.C.: National Academy Press.

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For the Public Good: Highlights from the Institute of Medicine, 1970–1995 Institute of Medicine (IOM). 1991c. HIV Screening of Pregnant Women and New borns,L.M. Hardy, ed. Washington, D.C.: National Academy Press. Institute of Medicine (IOM). 1994. AIDS and Behavior: An Integrated Approach,J.D. Auerbach, C. Wypijewska, and H.K.H. Brodie, eds. Washington, D.C.: National Academy Press. Paul, W.E. 1995. Reexamining AIDS research priorities. Science 267:633–6. Working Group on Antiretroviral Therapy: National Pediatric HIV Resource Center. 1993. Antiretroviral therapy and medical management of the human immunodeficiency virus-infected child. Pediatric Infectious Disease Journal 12(6):513–22.