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Appendixes

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A Summary and Recommendations from Confronting AIDS: Directions for Public Health, Health Care, and Research STATUS OF THE EPIDEMIC The first cases of the disease now known as acquired immune defi- ciency syndrome (AIDS) were identified in 1981. Since then the disease has become an epidemic as of September 1986 more than 24,500 cases had been reported in the United States, and between 1 million and 1.5 million people in the United States probably are infected with the virus that causes AIDS. In the same five years, great progress has been made in understanding AIDS. Much is known about the virus that causes it, about the ways in which the virus is transmitted, about the acute and chronic manifestations of infection, and about its impact on society. Although this knowledge is incomplete, it is extensive enough to permit projections of a likely 10-fold increase in AIDS cases over the next five years, to provide a basis for planning the provision of health care, to guide policy decisions on public health, and to envisage strategies for drug and vaccine development. Early in the epidemic the diversity of diseases observed in patients was explained by the discovery that the common thread was damage to the patient's immune system. For this reason patients succumb to infections with usually harmless microorganisms or to unusual cancers that individ- uals with normal immune systems are able to ward oh. The damage to the immune system results primarily from the destruction of certain crucially important white blood cells known as T lymphocytes. The death of these blood cells is a consequence of their infection with human immunodefi- Confronting AIDS: Directions for Public Health, Health Care, and Research. Copyright 1986 by the National Academy of Sciences. National Academy Press, Washington, D.C. 171

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|72 APPENDIX A ciency virus (HIV), also known as lymphadenopathy-associated virus (LAV), human T-cell lymphotropic virus type III (HTLV-III), and AIDS-associated retrovirus (ARV). The geographic and biologic origins of HIV are not clear, but there is little doubt that this is the first time in modern history that it has spread widely in the human population. Infection and Transmission A test has been developed to detect the presence in a person's blood of antibodies that specifically recognize HIV and that serve as a. marker for viral infection. The virus can be isolated from most persons who test positive for the presence of these antibodies. Anyone who has antibodies to the virus must be assumed to be infected and probably capable of transmitting the virus. Use of the test has greatly improved the safety of the banked blood supply by enabling elimination of donated blood that tests positive. A person infected with HIV may not show any clinical symptoms for months or even years but apparently never becomes free of the virus. This long, often unrecognized period of asymptomatic infection, during which an infected person can infect others, complicates control of the spread of the virus. The virus spreads from infected persons either by anal or vaginal intercourse or by the introduction of infected blood (or blood products) through the skin and into the bloodstream, which may occur in intrave- nous (IV) drug use, blood transfusion, or treatment of hemophilia. In addition, it can spread from an infected mother to her infant during pregnancy or at the time of birth. Studies show no evidence that the infection is transmitted by so-called casual contact that is, contact that can be even quite close between persons in the course of daily activities. Thus, there is no evidence that the virus is transmitted in the air, by sneezing, by shaking hands, by sharing a drinking glass, by insect bites, or by living in the same household with an AIDS sufferer or an HIV-infected person. Male-to-male transmission of virus during anal intercourse and male-to-female and female-to-male transmission during vaginal intercourse have been well documented, but the relative efficiency of various types of sexual transmission is not known. The risk of infection with HIV is directly related to the frequency of exposure to the virus. Groups now at highest risk of infection are homosexual men, IV drug users, persons likely to have heterosexual intercourse with an infected person, and the fetuses or newborn infants of infected mothers. The risk of infection to recipients of blood or blood products is now greatly reduced, although persons in this group already infected may progress to disease.

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APPENDIX A 173 Clinical Manifestations of the Disease HIV infection can result in a wide range of adverse immunologic and clinical conditions. The opportunistic infections (those caused by micro- organisms that seldom cause disease in persons with normal defense mechanisms) and cancers resulting from immune deficiency are generally the most severe of these, but necrologic problems, such as dementia resulting from HIV infection of the brain, can also be disabling and ultimately fatal. Other clinical consequences of HIV infection include fevers, diarrhea, and swollen lymph nodes. Such cases, if not meeting the criteria for AIDS, are termed ARC (AIDS-related complex). It is not yet fully clear that asymptomatic HIV infection and ARC are stages of an irreversible progression to AIDS, but many investigators suspect this to be so. The Public Health Service's Centers for Disease Control (CDC) has established a set of criteria to define cases of AIDS based on the presence of certain opportunistic infections and/or other conditions such as cancer. Opportunistic infections in AIDS patients are serious, difficult to treat, and often recurring. Among these infections, a type of pneumonia caused by a protozoan, Pneumocystis carinii, is the most common cause of death. Cures for any one of the host of opportunistic infections associated with AIDS, with the possible exception of P. carinii pneumonia, would not prolong survival much, because it is the HIV infection that causes the immune system damage and thus, ultimately, the death of AIDS patients. There have been no recorded cases of prolonged remissions of AIDS. Most patients die within two years of the appearance of clinical disease; few survive longer than three years. Statistical Dimensions of the Epidemic Because of the long symptom-free period between infection and clinical disease, HIV has spread unnoticed and widely in some population groups. Studies have shown that infection with the virus is far more common than is AIDS or ARC, and suggest that at least 25 to 50 percent of infected persons will progress to AIDS within 5 to 10 years of infection. The possibility that the percentage is higher cannot be ruled out. As of September 1986, approximately 24,500 cases of AIDS had been reported to the Centers for Disease Control. The number of ARC cases- which is somewhat uncertain, depending on the definition adopted is probably between 50,000 and 125,000. Among homosexual and bisexual men in some cities, as many as 70 percent may be infected. Substantial numbers of IV drug users also are infected, although precise figures are lacking.

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174 APPENDIX A HIV infection is a major and growing problem in some developed countries besides the United States, and it is nearing catastrophic proportions in certain developing countries, particularly in parts of sub-Saharan Africa. Worldwide, as many as 10 million persons may be infected. There is no satisfactory treatment now for HIV infection. Prospects are not promising for at least five years and probably longer for a vaccine against HIV. One drug has recently shown benefits in the treatment of AIDS, but agents that are acceptably safe for possible long-term treat- ment and that effectively halt or cure the disease may also not be available for at least five years. THE FUTURE COURSE OF THE EPIDEMIC Estimates of the future course of the epidemic are important to the planning of health care, public health measures, and research. Following a June 1986 planning conference at Coolfont, Berkeley Springs, West Virginia, the Public Health Service (PHS) issued projections of the course of the epidemic through 1991. Among the most important PHS estimates are the following: By the end of 1991 there will have been a cumulative total of more than 270,000 cases of AIDS in the United States, with more than 74,000 of those occurring in 1991 alone. By the end of 1991 there will have been a cumulative total of more than 179,000 deaths from AIDS in the United States, with 54,000 of those occurring in 1991 alone. Because the typical time between infection with HIV and the development of clinical AIDS is four or more years, most of the persons who will develop AIDS between now and 1991 already are infected. The vast majority of AIDS cases will continue to come from the currently recognized high-risk groups. New AIDS cases in men and women acquired through heterosexual contact will increase from 1,100 in 1986 to almost 7,000 in 1991. Pediatric AIDS cases will increase almost 10-fold in the next five years, to more than 3,000 cumulative cases by the end of 1991. Projections of the future incidence and prevalence of AIDS and HIV infection derived from empirical models such as those used by the PHS pose several difficulties, not the least of which is the assumption that past trends such as the distribution of cases by age, sex, geographic location, and risk grou~will not change with time. Uncertainties notwithstanding, the Institute of Medicine-National Acad- emy of Sciences Committee on a National Strategy for AIDS believes that

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APPENDIX A 175 the PHS estimates are reasonable, and the committee supports their use for planning purposes. This acceptance does not, however, obviate the need to acquire information that will facilitate the construction of better models that will lead to more reliable estimates. Data are needed on many aspects of the virus, its infectivity, the natural history and pathogenesis of disease, the size of the groups at risk, and the epidemiology of the . epic .emlc. The populations at highest risk for HIV infection in the near future will continue to be homosexual men and IV drug users. HIV infection will probably continue to spread in homosexual males, although possibly at a slower rate than in the past because of increased avoidance of anal intercourse and greater use of condoms. Continuing spread of HIV in IV drug users throughout the United States is also expected. Infected bisexual men and IV drug users of both sexes can transmit the virus to the broader heterosexual population where it can continue to spread, partic- ularly among the most sexually active individuals. Although there is a broad spectrum of opinion on the likelihood of further spread of HIV infection in the heterosexual population, there is a strong consensus that the surveillance systems and studies presently in place have very limited ability to detect such spread. Better approaches to tracking this spread can be instituted, but general population surveys are probably neither practical nor ethical. The committee believes that over the next 5 to 10 years there will be substantially more cases of HIV infection in the heterosexual population and that these cases will occur predominantly among the population subgroups at risk for other sexually transmitted diseases. In view of the numbers of people now infected, it is extremely unlikely that the rising incidence of AIDS will soon reverse itself. Disease and death resulting from HIV infection are likely to be increasing 5 to 10 years from now and probably into the next century. But the opportunity does exist to avert an increase in this burden by preventing the further spread of infection. OPPORTUNITIES FOR ALTERING THE COURSE OF THE EPIDEMIC Neither vaccines nor satisfactory drug therapies for HIV infection or AIDS are likely to be available in the near future, but actions can be taken now to reduce the further spread of HIV infection and thus to alter the course of the epidemic. Public Education For at least the next several years, the most effective measure for significantly reducing the spread of HIV infection is education of the

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)76 APPENDIX A public, especially those individuals at higher risk. (In fact, education will be a central preventive public health measure for this disease under any circumstances.) People must have information on ways to change their behavior and encouragement to protect themselves and others. "Educa- tion" in this context is not only the transfer of knowledge but has the added dimension of inducing, persuading, or otherwise motivating people to avoid the transmission of HIV. Education also is needed for those who are in a position to influence public opinion and for those who interact with infected persons. The present federal effort is woefully inadequate in terms of both the amount of educational material made available and its clear communication of intended messages. The committee recommends a major educational campaign to reduce the spread of HIV. If an educational campaign is to change behavior that spreads HIV infection, its message must be as direct as possible. Educators must be prepared to specify that intercourse anal or vaginalwith an infected or possibly-infected person and without the protection of a condom is very risky. They must be willing to use whatever vernacular is required for that message to be understood. Admonitions to avoid "intimate bodily con- tact" and the "exchange of bodily fluid" convey at best only a vague message. In addition to knowing which sexual activities are risky, people also need reassurance that there are sexual practices that involve little or no risk. For example, unprotected sexual intercourse between individuals who have maintained a sexual relationship exclusively with each other for a period of years can be considered essentially free of risk for HIV transmission, assuming that other risk factors are absent. An integral aspect of an education campaign must be the wide dissemination of clear information about those behaviors that do not transmit the disease. Condoms have been shown under laboratory conditions to obstruct passage of HIV. They should be much more widely available and more consistently used. Young people, early in their sexually active lives and thus less likely to have been infected with HIV, have the most protection to gain from the use of condoms. Because in the United States the majority of AIDS patients are men, the implications of HIV infection in women have often been overlooked. Women need to know that if they are infected with HIV they may transmit the virus to their sexual partners and possibly to their future offspring. This message is particularly important for IV drug users and their sexual partners. The most obvious targets for a campaign of education about AIDS are persons whose behavior puts them at special risk for example, male homosexuals who practice anal intercourse without a condom. Education

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APPENDIX A 177 directed at this group could exploit the fact that although HIV infection prevalence higher than 50 percent occurs in male homosexuals in some urban centers, the much larger proportion of male homosexuals not infected outside these areas could protect themselves. Many other groups, including health care professionals, public officials, and opinion makers, must receive education about AIDS. In addition, special educational efforts must be addressed to teenagers, who are often beginning sexual activity and also may experiment with illicit drugs. Sex education in the schools is no longer only advice about reproductive choice, but has now become advice about a life-or-death matter. Schools have an obligation to provide sex and health education, including facts about AIDS, in terms that teenagers can understand. In planning the needed education programs for various groups, cultural traditions and practices should be taken into account, because blacks and Hispanics make up a disproportionately high percentage of AIDS cases. Because so many different groups must be educated in this campaign, its early activities must include the instruction of trainers suitable to each of the groups. Not only must education about AIDS take many forms, but also it must have financial support from many sources. The most fundamental obliga- tion for AIDS education rests with the federal government, which alone is in a position to develop and coordinate a massive campaign. The committee recommends consideration of the establishment of a new office or appointment that would be devoted exclusively to education for the prevention of HIV infection, possibly within the Office of the Assistant Secretary for Health. The office should be responsible for implementing and assessing a variety of innovative educational programs and for encouraging the involvement of state and local governments and private organizations. The committee recognizes that the reluctance of governmental author- ities to address issues of sexual behavior reflects a societal reticence regarding open discussions of these matters. However, the committee believes that governmental officials charged with protection of the public's health have a clear responsibility to provide leadership when the consequences of certain types of behavior have serious health outcomes. If government agencies continue to be unable or unwilling to use direct, explicit terms in the detailed content of educational programs, contractual arrangements should be established with private organizations that are not subject to the same inhibitions. A massive, coordinated educational program against HIV infection will not be cheap. Although there was an increase in funding by the federal government in Fiscal Year (FY) 1986 for such activities, many times the amount budgeted could be spent usefully.

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178 APPENDIX A The committee recommends that substantially increased educational and public awareness activities be supported not only by the government but also by foundations, by experts in advertising, by the information media, and by other private sector organizations that can effectively campaign for health. Legal and administrative barriers to the use of paid television for these educational purposes should be removed. Preventing HIV Infection Among IV Drug Users As a group, IV drug users have incurred the second-largest number of AIDS cases in the United States. IV drug users are also the primary source of heterosexual HIV transmission (via their sexual partners) and of perinatal transmission to newborn children. The large differences in the prevalence of HIV infection in IV drug users in different parts of the country is heartening, because it indicates an opportunity to halt the further spread of infection by changing behavior. Preventing AIDS among the sexual partners of IV drug users may be a more difficult matter. The behavior changes required to prevent hetero- sexual and in utero transmission can entail disruption of sexual relation- ships and decisions to forgo having children. These behavior changes require intensive efforts with persons who are generally distrustful of authority and unlikely to be responsive to the mere dissemination of information. Sexual partners of IV drug users who do not themselves use drugs may also be difficult to reach, because they do not necessarily come in contact with treatment centers or with the criminal justice system. There is no doubt that the best way of preventing HIV infection among IV drug users would be to stop the use of illicit IV drugs altogether. The United States' experience in curbing use of such drugs has not been wholly promising, however. The fear of AIDS will probably lead some IV drug users to seek treatment for their addictions. But in the United States as a whole, the availability of treatment for IV drug use was less than the demand even before the AIDS epidemic. Thus, a major possibility for reducing illicit IV drug use and the transmission of HIV is expansion of the system for treating IV drug use. Through treatment, users who have not been infected with HIV could greatly reduce their chances of being infected, and users who have already been infected would be less likely to infect others. At a purely economic level, treating AIDS costs from $50,000 to $150,000 per case, whereas drug abuse treatment costs as little as $3,000 per patient per year in nonresidential programs. The committee believes that more methadone and other treatment programs, detoxifica- tion programs, and testing and counseling services are needed. In general, the life-styles and the frequent involvement of IV drug users in unlawful activity make it difficult to apply traditional public health

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APPENDIX A 179 measures in an effort to control the spread of infection in this population. It will not be possible to persuade all IV drug users to abandon drugs or to switch to noninjectable drugs. Many may wish to reduce their chances of exposure to HIV but will neither enter treatment nor refrain from all drug injection. Increasing the legal availability of hypodermic needles has received some support among public health officials but has generally been opposed by law enforcement officials, who predict that it would lead to greater IV drug use. However, if drugs are available and clean needles and syringes are not, IV drug users will probably use available unsterile equipment. The committee concludes that trials to provide easier access to sterile, disposable needles and syringes are warranted. Results of such trials should be measured both in incidence of HIV infection and in drug use. Public Health Measures The use of public health methods such as contact tracing is complicated in HIV infection by the frequently long lag between infection and identification of disease, the lack of satisfactory treatment for contacts, the impracticality of follow-up in some circumstances, and the potentially adverse social consequences for those identified (such as discrimination in housing or employment). In 1983-1984, researchers discovered a way to culture the causative agent of AIDS and thus provided the basis for the HIV antibody test used to screen blood. Two years later, this test is used more than 20 million times a year, or about 80,000 times per working day. Although not 100 percent sensitive or specific, the test is at least as accurate as most serologic tests in routine use, and it has made the nation's blood supply much safer. The use of the test remains controversial because of public perceptions about AIDS, the technical limitations of the test, and the sheer magnitude and diversity of the test's present and projected applications. Important questions about the use of the test relate to uncertainties over the long-term implications of positive results. As more data become available from longitudinal studies of the health of seropositive personsthose who test positive for HIV antibodies the implications of a positive result will become clearer, and the significance of the test can be better explained to those tested. Screening tests are of paramount importance in the context of blood, plasma, and tissue banking. The ability to screen blood rather than donors obviates some of the potential for discrimination arising with programs that depend on identifying individuals at risk. The small fraction of false-negative test results and the length of time between infection with the virus and the appearance of antibodies underscore the continuing

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APPENDIX A 191 Animal Models Animal models that reproduce or mimic the consequences of HIV infection in human beings can play a crucial role in improving the understanding of disease pathogenesis and in the development and testing of antiviral drugs and vaccines. However, no completely analogous animal model for HIV infection and disease is now available. The most relevant and promising animal models are provided by nonhuman primates. Therefore, the nation's primate centers should be improved to permit the expansion of the primate populations available for AIDS-related research, the development of appropriate biocontainment facilities, and the education of appropriately trained investigators. The committee believes that available supplies of test animals, especially chimpanzees, will be insufficient for future research needs, and that the plans for the conservation, expansion, and optimal use of these animals appear inadequate. Populations of primate models need to be expanded as rapidly as possible to meet the future needs of research and testing. Furthermore, a national system should be set up to facilitate appropriate access to test animals for valid experimentation by qualified investigators, regardless of institutional affiliation. Chimpanzees in particular must be treated as an endangered national resource that will be irreplaceable if squandered. Thus, mechanisms should be developed to ensure that AIDS-related experiments with chimpanzees proceed only if there is a broad consensus among the interested scientific community that the proposed experiment is critically important to the development of vaccines or antiviral agents and cannot be conducted in any other species or by any other means. Antiviral Agents The development of acceptably safe and effective antiviral agents for the treatment of HIV infection is likely to be a long, hard job with no certainty of success. The ideal AIDS drug must fulfill a number of requirements: it must be conveniently administered, preferably orally; it must be sufficiently nontoxic to be used for prolonged periods, perhaps for a lifetime; and it must be active not only in peripheral immune system cells but in the central nervous system, because HIV may infect the nervous system early in the disease process. Several drugs are under clinical evaluation, but thus far no drug meeting these criteria has been identified. Until an agent effective against HIV and reasonably safe for prolonged administration is identified, the committee believes that the quickest, most efficient, and least-biased way to identify and validate the efficacy

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192 APPENDIX A and safety of treatments for HIV infection is by means of randomized clinical trials in which control groups receive a placebo. When an effective and acceptably safe agent is found, newer candidate drugs should be compared against it. Shortly before the publication of this report, data were released by the National Institutes of Health and the Burroughs Wellcome Company from a study of azidothymidine (AZT) administered for 20 weeks to a group of approximately 140 AIDS patients while a similar group received a placebo. The patients were selected for having had no more than one bout of Pneumocystis carinii pneumonia. There was 1 death in the AZT group compared with 16 deaths in the placebo group. Because of the time at which this information became available, the committee was not able to analyze the data from this study in enough detail to judge the risks and benefits of this drug. Further evaluation will be needed to fully determine the side effects of AZT treatment and its long-term efficacy and safety for various categories of patients. Decisions on the design of studies to test new drugs for HIV infection must be made on a case-by-case basis. Such decisions should take into account the results of further studies on the efficacy and toxicity of AZT, the category of patients to whom the drug under consideration would be given, and preliminary information on the safety and efficacy of the drug. It is essential that mechanisms for the efficient testing of candidate drugs be established. Efforts should be undertaken now to ensure that organizational and financial support will be sufficient to permit the expeditious evaluation of promising therapeutic agents for HIV infection. Success in the development of antiviral agents will be much more likely if the expertise resident in the industrial, governmental, and academic research communities can be engaged and coordinated. Vaccines The development of a vaccine against viruses like HIV has never been seriously attempted, much less achieved. Except for a vaccine used in cats, no vaccine against such viruses is available. The properties of viruses related to HIV suggest that developing a vaccine will be difficult. It is also likely that a subunit vaccine, rather than a whole-virus vaccine, will be needed, and these have additional problems of efficacy. Moreover, even if the scientific obstacles were surmounted, legal, social, and ethical factors could delay or limit the availability of a vaccine. For these reasons, the committee does not believe that a vaccine is likely to be developed for at least five years and probably longer. Because HIV attacks the immune system itself, a successful vaccine development program will require a greatly expanded knowledge base.

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APPENDIX A 193 The urgency of the problem calls for the active and cooperative partici- pation of scientists in government, academia, and industrial labora- tories. Much of the expertise in vaccine development is in the industrial sector. However, contributions of industry to the development of an HIV vaccine are inhibited by the substantial developmental costs in the absence of a significant probability of financial return and by apprehen- sion over potential liability incurred in the course of vaccine distribution. Creative options for the governmental support of industrial research, guarantees of vaccine purchase, and the assumption of reasonable liabil- ity should, therefore, be actively explored and encouraged. The committee finds that the federal coordination of vaccine develop- ment has been inadequate. The National Institutes of Health has recently reorganized its efforts on AIDS, and the committee encourages the appointment of strong leadership to the vaccine program with the authority and responsibility to develop a strategy for a broad-ranging vaccine development program. Social Science Research Needs Social science research can help develop effective education programs to encourage changes in behavior that will break the chain of HIV transmission. It can contribute to the design of policies that reduce the public's fear of AIDS and that help eliminate discriminatory practices toward AIDS patients. And it can shape the establishment of health care and social services for AIDS patients. A major research need is for studies that will improve understanding of all aspects of sexual behavior and drug use and the factors that influence them. There has been little social science research specifically focusing on HIV infection and AIDS. Demographic features and social dynamics related to HIV infection should be thoroughly studied in order to develop effective means to reach people at risk, to delineate the obstacles to behavioral change, and to determine effective language and styles of communication among various population groups. Different approaches to achieving behavioral change in the various groups at risk of HIV infection should be monitored. Wherever feasible, educational programs should have an evaluation component. Treatment, social service programs, and hospital management practices should be assessed to determine which practices work best and are most cost-effective. Experiments based on different models of patient care should be evaluated with regard to their applicability to other areas, providing a foundation on which to build locally relevant programs.

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194 APPENDIX A Funding for Research on AIDS and HIV Confronting the AIDS epidemic will require new and substantially in- creased financial support for basic biomedical and social science research activities. The rapid and effective application of the insights provided by basic research will also require the significant expansion of applied research activities. In addition, funds are needed to provide researchers with adequate equipment and facilities, to attract high-caliber individuals into the field, and to support the training of future investigators. The Public Health Service's request to the U.S. Department of Health and Human Services for AIDS-related research in FY 1988 was $471 million. If appropriated, this budget would represent a doubling of funds from FY 1986 to FY 1988. The National Science Foundation spends just over $50 million annually on social science research, but presently a very small amount of this is on studies related to AIDS. The committee believes that there are sufficient areas of need and opportunity to double research funding again by 1990, leading to an approx- imately $1 billion budget in that year. These funds must be new appropria- tions, not a reallocation of existing Public Health Service funds. Areas of clear need include high-containment facilities for primate research, better containment facilities for universities and research institutes, training funds, construction and renovation funds, equipment funds, social science and behavioral research funding, vaccine and drug development efforts, inter- national studies, basic research efforts, and epidemiologic studies. In addi- tion, funds diverted from NIH programs to support the AIDS effort should be returned. In recent years there has been a steady decline in the proportion of NIH funds spent on grants for investigator-initiated research on AIDS and an increasing proportion expended on contracts for NIH-designed studies. A more balanced growth of support is desirable in coming funding cycles to promote the involvement of the nonfederal basic research community to a greater extent. The level of funding for investigator-initiated studies in all areas (including non-AIDS studies) must be adequate to continue to attract the most able younger scientists to clinical, social science, and basic biomedical research, or the quality and productivity of the scientific enter- prise will suffer. INTERNATIONAL ASPECTS OF AIDS AND HIV INFECTION More than half the countries of the world have reported cases of AIDS. Although reporting may not be reliable in many countries, it has been estimated, based on studies in specific areas, on the number of identified cases, and on the U.S. ratio of cases to seropositive persons, that up to 10

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APPENDIX A 195 million people worldwide may be infected with HIV. A substantial proportion of these are in sub-Saharan Africa, particularly central Africa. It is likely that millions of infected adults will progress to AIDS in the next decade, and that tens of thousands of infants will contract the syndrome perinatally. In response to this situation, many developed and developing countries are initiating research and prevention programs, and the World Health Organization is initiating a global program for the control of AIDS. Rationale for U.S. International Involvement The United States has actively promoted the technological develop- ment of less developed countries for economic, altruistic, and political reasons. Because AIDS most often occurs in young adults, it imposes a particularly severe burden on development efforts in these nations by draining off intellectual and economic assets namely, productive indi- viduals. U.S. technical assistance programs have often included major contri- butions to efforts in improving health through programs in immunization and nutrition. The burden of AIDS and other HIV-related conditions added to the lengthy existing agenda of health problems in developing countries may negate the hard-won gains made by these programs. New knowledge critical to prevention and treatment of HIV infection may be more readily obtained outside of the United States. For instance, the extent of perinatal and heterosexual transmission in central Africa offers opportunities for U.S. research resources to complement local expertise in mutually beneficial investigations. Certain federal agencies have special international responsibilities or may be able to make contributions to the global effort to control the AIDS epidemic through support of activities in the United States. These agencies include the Agency for International [Development, the Food and Drug Administration, and the Centers for Disease Control. There is also need for U.S. involvement in AIDS internationally because the opera- tions of many federal agencies and other organizations require that their personnel visit or live in countries where HIV infection may be relatively prevalent. Such personnel may be at risk of infection or need appropriate care. Risks of Infection Outside the United States Sexual transmission probably accounts for the largest proportion of transmission of HIV outside of the United States. Bidirectional hetero-

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~ 96 APPENDIX A sexual transmission is the dominant mode of HIV transmission in sub-Saharan Africa. HIV infection is also becoming a major problem among female prostitutes in many areas. HIV transmission between homosexual men must be presumed to be possible wherever behavior involving risk of infection is practiced. Knowledge of the frequency with which homosexual behavior occurs in different countries and cultures is incomplete, however, and existing information may not be reliable. Transfusion of blood poses a substantial risk of HIV infection in many countries of the world that have not adopted procedures necessary to prevent such transmission and that lack the laboratories, finances, or personnel needed to institute such measures. Application of currently available serologic tests will be possible only in some situations. The committee concludes that simpler serologic tests that give sensitive and specific results rapidly and reliably are essential before widespread efforts to control HIV transmission via the blood supply in developing countries will be practicable. Transmission of HIV through the sharing of needles and syringes used to inject IV drugs is well documented in countries where IV drug use is common. However, some evidence suggests that in Africa injections administered for medical purposes with unsterile needles and syringes may be a route of HIV transmission. There is no evidence to support the hypothesis that HIV is transmitted through insect vectors or casual contact. Studies in Africa of household contacts of infected persons and the age distribution of AIDS and HIV infection suggest that transmission by casual contact is very infrequent or nonexistent. The relative ineffectiveness of needlestick transmission in health professionals and the age distribution of AIDS and HIV infection also suggest that mechanical transmission by insects is unlikely. International Research Opportunities The United States has contributed greatly to the understanding of AIDS and HIV infection through its investment in domestic research. The international efforts undertaken to date illustrate the reasons and oppor- tunities for the United States to contribute to multinational and bilateral efforts. As is appropriate, some of the United States' support for international efforts on AIDS and HIV is committed for use exclusively through the World Health Organization (WHO). The committee believes that addi- tional bilateral or multinational activities involving the United States outside of the WHO program will be essential to enhancing the prospects for achieving rapid control over the disease.

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APPENDIX A 197 The WHO program is in the early phases of organization, but the need for action in some countries is urgent. The focus of the WHO program is prevention and control of AIDS and HIV infection rather than research opportunities, and links of U.S. investigators or institutions with affected countries could provide a means of rapid response to their needs. The committee recommends that the United States be a full participant in international efforts against AIDS and HIV infection. U.S. involvement should be both through support of WHO programs and through bilateral arrangements in response to the needs and opportunities in individual countries. These arrangements should be pursued in a fashion that is acceptable to host governments. The magnitude of the problem internationally and the variety of reasons warranting U.S. participation in international efforts convince the com- mittee that the United States should make clear its commitment to global prevention and control of AIDS and HIV infection. The following are feasible goals: (1) the total amount of U.S. funding going to international efforts in AIDS-related research and prevention should reach $50 million per year by 1990 (this is approximately 2.5 percent of the amount recommended by the committee for use in the United States for these purposes); (2) increased funding should be provided to the WHO program on the basis of demonstrated capacity to use such funds productively; and (3) increased funds to bilateral research or technical assistance programs or projects abroad should be provided on the basis of review procedures involving persons familiar with the local conditions under which such projects are undertaken. The committee found information to be lacking on the extent and kinds of work on HIV-related conditions by U.S. investigators in other coun- tries or on their collaborations with foreign researchers. The committee recommends that an evaluation be initiated immediately to identify all work under way and to assess and coordinate the roles and responses of the various U.S. federal agencies, private voluntary groups, and founda- tions interested in international efforts on AIDS and HIV. GUIDANCE FOR THE NATION'S EFFORTS No single approach whether education and other public health mea- sures, vaccination, or therapy is likely to be wholly successful in combating all the problems posed by HIV infection. Similarly, neither the public sector, the private sector, nor any particular agency, organization, or group can be expected by itself to provide the solution to the diverse problems posed by the disease. Federal agencies (notably the National Institutes of Health, the Centers for Disease Control, and the Food and Drug Administration) have contributed enormously to the rapid acquisi-

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198 APPENDIX A tion of knowledge about AIDS and HIV or to techniques to help in its control. They should continue their efforts, but greater involvement of the academic and private sectors should now be encouraged. All of these approaches and entities must be organized in a national effort, integrated and coordinated so that participants are working toward common goals and are aware of each other's activities. Such coordination does not imply management by a centralized directorate. However, monitoring of the many activities in the effort is necessary to ensure that important matters are not overlooked and that periodic review can be conducted for the adjustment of priorities and general directions. What Is Needed? The committee found gaps in the efforts being directed against the AIDS epidemic and in the employment of the nation's resources. It also identified as a major concern a lack of cohesiveness and strategic planning throughout the national effort. A body is needed to identify necessary actions and to mobilize underused resources in meeting the challenge of the epidemic. Therefore, the committee recommends that a new entity a National Commission on AIDS be established to meet the need for guidance of the national efforts against HIV. The commission would monitor the course of the epidemic; evaluate research, health care, and public health needs; encourage federal, state, philanthropic, industrial, and other entities to participate; stimulate the strongest possible involvement of the academic scientific community; encourage greater U.S. contribution to international efforts by relevant government agencies and other organizations; make recommendations for altering the directions or intensity of health care, public health, and research efforts as the problem evolves; monitor and advise on related legal and ethical issues; and report to the American public. The commission should achieve its purposes by assuming an advisory role and by acting catalytically in bringing together disparate groups. It should not dispense funds but should be provided with sufficient re- sources to undertake its mission effectively. Establishment of the Commission To oversee and marshal the nation's resources effectively, the pro- posed commission should have certain attributes. It should be able to engage all of the diverse public and private resources that can be brought to bear on HIV-associated problems. It must be sufficiently independent to give critical advice to participants in these efforts. It should have

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APPENDIX A 199 sufficient national and international stature and credibility for its advice to command the attention of participants. The advantages and disadvantages of various institutional locations for the commission were evaluated by the committee. The requirement for spanning both public and private sectors implies that it should not be created within the administrative structure of the federal executive branch. However, the desirability of affirming a national commitment to the control of AIDS and HIV suggests that the commission should be endorsed at the highest levels of government. Accordingly, The committee recommends that the proposed National Commission on AIDS be created as a presidential or joint presidential-congressional . . commission. The committee recommends that the President take a strong leader- ship role in the effort against AIDS and HIV, designating control of AIDS as a major national goal and ensuring that the financial, human, and institutional resources needed to combat HIV infection and to care for AIDS patients are provided. The committee urges all cabinet secretaries and other ranking exec- utive branch officials to determine how AIDS and HIV relate to their responsibilities and to encourage the units within their purview to work collaboratively toward responding to the epidemic on a national and international level. The committee recommends that the U.S. Congress maintain its strong interest in the control of AIDS and HIV infection and increase research appropriations toward a level of $1 billion annually by 1990. In addition, it recommends that by 1990 there be significant federal contri- butions toward the $1 billion annually required for the total costs of education and public health measures. MAJOR RECOMMENDATIONS In summary, the committee recommends that two major actions be undertaken to confront the epidemic of HIV infection and AIDS. They are as follows: 1. Undertake a massive media, educational, and public health cam- paign to curb the spread of HIV infection. 2. Begin substantial, long-term, and comprehensive programs of re- search in the biomedical and social sciences intended to prevent HIV infection and to treat the diseases caused by it. Within a few years these two major areas of action should each be supported with expenditures of $1 billion a year in newly available funds

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200 APPENDIX A not taken from other health or research budgets. The federal government should bear the responsibility for the $1 billion in research funding and is also the only possible majority funding source for expenditures of the magnitude seen necessary for education and public health. Furthermore, to promote and integrate public and private sector efforts against HIV infection, a National Commission on AIDS should be created. Such a commission would advise on needed actions and report to the American people. Curbing the spread of HIV infection will entail many actions, including the following: Expand the availability of serologic testing, particularly among persons in high-risk groups. Encourage testing by keeping it voluntary and ensuring confidentiality. Expand treatment and prevention programs against IV drug use. Experiment with making clean needles and syringes more freely available to reduce sharing of contaminated equipment. The care of HIV patients can be greatly improved by applying the results of health services research. In the meantime, the following actions should be taken: Begin planning and training now for an increasing case load of patients with HIV infection. Emphasize care in the community, keeping hospitalization at a minimum. Find the best ways to collect demographic, health, and cost data on patients to identify cost-effective approaches to care. Devise methods of financing care that will provide appropriate and adequate funding. The recommended research efforts should include the following ac- tions: Enhance the knowledge needed for vaccine and drug development through basic research in virology, immunology, and viral protein structure. Improve understanding of the natural history and pathogenesis of AIDS, and trace the spread of HIV infection by means of epidemiologic and clinical research. Study sexual behavior and IV drug use to find ways to reduce the risk of infection. Encourage participation of academic scientists in research against AIDS, in part by increasing the funding for investigator-initiated research proposals. Solicit participation of industry in collaboration with federal and academic research programs.

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APPENDIX A 201 Expand experimental animal resources, working especially to con- serve chimpanzee stocks, and develop new animal models of HIV infection. Because AIDS and HIV infection are major and mounting health problems worldwide: The United States should be a full participant in international efforts against the epidemic. United States involvement should include both support of World Health Organization programs and bilateral efforts.