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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
|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.
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.
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
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
)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
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.
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
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
I 80 APPENDIX A need for those who have engaged in high-risk behaviors to refrain from donation. The committee urges that blood and plasma collection centers also establish administrative systems to further encourage self-deferral of donations and diversion of suspect blood to research while maintaining donor privacy. Surveillance Surveillance, which involves both the passive reporting and the active seeking of information, provides data on the prevalence, incidence, and distribution of disease or infection in the population. Such data can be used to monitor the spread of a disease, to shed light on the mechanisms of transmission of infectious agents, to help in designing public health measures to prevent the spread of a disease, to evaluate the effectiveness of interventions, and to guide planning for the provision of facilities. Data on HIV infection and related disease are critical to all aspects of coping with the epidemic. All states require that AIDS cases be reported promptly to local and state health authorities, who then report the cases to the Centers for Disease Control. Unfortunately, anecdotal accounts suggest that the stigma associated with AIDS may have led to some underreporting of new cases and fatalities. Prompt reporting of individual AIDS cases, the disease's manifestations, the cause of death, and underlying risk factors is essential. The committee supports a vigorous program of early reporting of both AIDS and ARC cases (as soon as acceptable definitions for reporting ARC can be formulated) to local and state public health agencies under strict policies of confidentiality. Surveillance of the general population for HIV infection presents ethical, logistic, and practical problems. Specific epidemiologic research is therefore needed to ascertain the spread of infection in certain populations, such as heterosexuals. Mandatory Screening Mandatory screening of the entire U.S. population for HIV infection would be impossible to justify now on either ethical or practical grounds. Mandatory screening of selected subgroups of the population for exam- ple, homosexual males, IV drug users, prostitutes, prisoners, or pregnant women raises serious problems of ethics and feasibility. People whose private behavior is illegal are not likely to comply with a mandatory screening program, even one backed by assurances of confidentiality. Mandatory screening based on sexual orientation would appear to dis- criminate against or to coerce entire groups without justification.
APPENDIX A ~ ~ ~ The committee is generally opposed to the mandatory screening now of population subgroups, but recognizes that arguments can be made for its application in the military. Voluntary Testing In the context of personal health services, the HIV antibody test enables a physician to identify an infected patient. But it should be the patient's decision to be tested, and only after being informed of the implications of a reaffirmed positive test and assured of strict confidenti- ality. The importance of confidentiality should perhaps be emphasized through the establishment of punitive measures against persons who make unauthorized disclosure of antibody test results. Voluntary, confidential testing should be encouraged, because individ- ual and aggregate antibody test results enable epidemiologists to assemble baseline data for longitudinal studies of the incidence, prevalence, and natural history of the disease. Such studies can be used to monitor the spread of the virus and to provide the data needed for changing control strategies. Many persons in high-risk groups are already aware of the dangers their behavior poses to themselves or others. Yet screening programs possibly could identify many seropositive persons who had no reason to suspect they were at risk of infection for instance, someone unaware of a sexual partner's infection or IV drug use. Persons who test positive in any circumstance have a right to know the results. No testing should be undertaken without adequate pre-test and post-test counseling. If situa- tions arise in which the testing agency has no mandate to provide counselingas by the military with applicants rejected because they test seropositivecounseling programs by third parties should be established. The Role of Coercive Measures in Public Health Efforts Proposals have been made to use coercive measures to control AIDS and HIV infection. Newspaper editorials and legislative bodies have discussed measures such as isolation and quarantine traditionally used to contain contagious disease. However, those diagnosed with AIDS do not usually pose great danger in the further spread of the epidemic. Rather, the greater danger lies with the hundreds of thousands of people who are already infected but asymptomatic. These individuals could not be identified without universal screening programs that would infringe on civil liberties in a manner unacceptable in this society. The active voluntary cooperation of individuals who are at risk will be needed to curtail the epidemic. Coercive measures will not solicit this
)82 APPENDIX A cooperation and could prevent it. Believing that coercive measures would not be effective in altering the course of the epidemic, the committee recommends that public health authorities use the least-restrictive mea- sures commensurate with the goal of controlling the spread of infection. Most state health authorities already have laws and regulations that could be applied in unusual situations, such as in the case of a seropositive person who refuses to obey reasonable public health direc- tives. However, the public health statutes concerning infectious disease are outmoded in some states, may not afford civil rights protections adopted by the American courts, and should be reviewed accordingly. Compulsory actions taken to deal with AIDS have largely affected closed populations, such as prisoners, psychiatric inpatients, and the institutionalized mentally retarded. The public authorities who administer these facilities have a legal obligation to care for residents by taking precautions to prevent the spread of diseases. However, although special precautions against the spread of HIV may be necessary in closed populations, coercive measures should be applied only as necessary for the protection of health. Such measures should not be regarded as models for compulsory programs among the general population. Questions have previously arisen about admitting children with HIV infection to school classrooms. An accumulation of evidence about the transmission of the virus has now made it apparent that risk from contact with an infected child is negligible, and has made possible the establish- ment of guidelines for school attendance. The committee recommends that, as a general policy, children with HIV infection be admitted to the same primary and secondary school classes they would attend if not infected. Guidelines published by the Centers for Disease Control are recommended for special circumstances. Funding for Education and Other Public Health Measures The committee did not attempt to work out in detail the cost of the education and other public health measures needed to stem the spread of HIV infection, but it estimated the general magnitude of the funds needed over the next few years. Resources are needed for education, serologic screening, surveillance, increased drug use treatment, and experiments designed to test the effects of greater availability of sterile needles and syringes to drug users. Present expenditures are inadequate. Federal funds for AIDS education and other public health measures are appropriated to the Centers for Disease Control and also via that agency to states through a variety of arrangements, including cooperative agree- ments, contracts, and grants for activities such as establishing alternative
APPENDIX A 183 serologic testing sites (independent of blood donation centers) and demonstration projects for risk-reduction education. The total funds allocated to the Centers for Disease Control for all AIDS education and public health measures are estimated to have been $64.9 million in FY 1986. The Public Health Service budget request to the U.S. Department of Health and Human Services for FY 1988 includes $68.8 million for all AIDS public health and education efforts within a total request of $471.1 million for AIDS-related activities. Expenditures by states for AIDS-related prevention efforts have grown markedly in the last few years. For FY 1986-1987, a total of $65 million in state expenditures is projected. Five states (California, New York, Florida, New Jersey, and Massachusetts) account for 85 percent of the total spent since July 1, 1983 ($117.3 million), with California and New York jointly accounting for 66 percent. If efforts to stop the spread of HIV infection are to be effective, they must start (or be expanded) immediately, not only in areas where there are reported AIDS cases but also in areas where there are few or no cases. Delaying such efforts until cases occur increases the likelihood that the problem of AIDS in those areas will subsequently be much greater. The opportunity to forestall the further spread of infection must not be lost. Some examples illustrate the magnitude of funding needs: · Testing at alternative test sites, including counseling, is estimated to cost $40 per person, and more than 10 million individuals may be candidates for testing. · The most successful education programs to date (exemplified by the experience in San Francisco) have occurred within small geographic areas where there are educated homosexuals. Programs for other groups, such as IV drug users, will face more difficult problems of access and motivation; they will therefore probably require more resources per capita. In addition, large groups such as sexually active heterosexuals who have had a number of partners will need to be reached and motivated to adopt risk-reducing behaviors. · Newspaper, radio, and particularly television advertising are influ- ential means of communicating information, but the use of these media is expensive. One page of advertising in a major newspaper can cost around $25,000 per day, and a minute of national television time can cost between $60,000 and $400,000. Consequently, to influence the behaviors affecting HIV transmission, policymakers must begin to contemplate expenditures similar to those made by private sector companies to influence behav- iorsfor instance, $30 million to introduce a new camera, or $50 million to $60 million to advertise a new detergent. Furthermore, advertising
I 84 APPENDIX A campaigns are judged successful even when they produce relatively modest shifts in behavior. The efforts needed to influence the behaviors that spread HIV will have to be greater and more sustained. California has moved earlier than most states to provide funds for AIDS prevention, undoubtedly because the need for such actions has been reinforced by the occurrence of large numbers of AIDS cases. (It is hoped that other states will not delay launching prevention efforts until they have the same stimulus.) Current annual state expenditures for AIDS prevention efforts in California average 65 cents per capita, and in San Francisco such expenditures approximate $5 per capita. Extrapolated on a population basis for the entire United States, these figures would amount to state expenditures nationwide of approximately $150 million and $1 billion, respectively. The committee believes that the desirable level of state expenditures probably falls between these two figures. It bases this conclusion on the fact that, although San Francisco has a sizable concentration of homosexual men, this group does not unduly bias the California population as a whole. In addition, the need for active prevention of spread among heterosexuals is only now becoming recog- nized, and efforts need to be directed to this group. The risk to heterosexuals is greater in areas of high prevalence, but prevention efforts will need to be relatively uniform nationwide. The committee also believes that expenditures just from the states of the size mentioned above will be inadequate for a number of reasons. For one, the effectiveness of the educational message will be reinforced if it is delivered from a variety of agencies in a variety of settings. Thus, federal efforts should complement those of the states, which in turn should complement the local efforts of employers and private groups. Funds should be provided for these efforts at each level. For these reasons, the committee believes that a necessary goal is a total national expenditure based on per capita prevention expenditures roughly similar to those made in San Francisco by the state of California. This suggests the need for approximately $1 billion annually for education and other public health expenditures by 1990. A major portion of this total should come from federal sources, because only national agencies are in position to launch coordinated efforts commensurate with the potential size of the problem. The process of designing and implementing educational interventions to reduce the risk of HIV transmission, followed by evaluations of their effectiveness, will enable policymakers to evaluate over the next year or two the magnitude of effort needed to bring about a drastic reduction in the spread of HIV infection. It is possible that the amounts envisaged by the committee will not be sufficient to stem increases in the prevalence of
APPENDIX A l 85 infection, especially since some of the groups at risk are difficult to reach with conventional approaches and since, despite the expenditures noted above, the infection continues to spread in areas such as San Francisco, though at a reduced rate. More funding for prevention measures will be necessary if those projected here for 1990 do not prove sufficiently great to slow the epidemic. Discrimination and AIDS The stigma associated with AIDS has led to instances of discrimination in employment, housing, and access to social services. Sometimes AIDS or ARC sufferers are discriminated against by those who misunderstand the modes of transmission and fear infection from mere casual contact. Im- proved public awareness resulting from educational efforts may decrease this problem. In other instances, discrimination is rooted in prejudices against the behavior of those presently most at risk for AIDS or HIV infection. The committee is of the opinion that discriminating against those with AIDS or HIV infection because of any health risk they may pose to others in the workplace or in housing is not justified and should not be tolerated. Laws prohibiting discrimination in employment and housing are encour- aged and supported as formal expressions of public policy. Any form of discrimination against groups at high risk for AIDS should be prohibited by state legislation and, where appropriate, by federal laws and regula- tions. Participation by representatives of high-risk groups in policymaking bodies should be encouraged when appropriate and practicable, and the help of organizations representing high-risk groups should be enlisted for public service programs such as health education, personal counseling, and hospital and home treatment services. CARE OF PERSONS INFECTED WITH HIV The provision of care for persons with AIDS or other HIV-related conditions will place an increasing burden on the health care system of the United States for years to come. Based on experience to date, the committee believes that if the care of these patients is to be both comprehensive and cost-effective, it must be conducted as much as possible in the commu- nity, with hospitalization only when necessary. The various requirements for the care of patients with asymptomatic HIV infection, ARC, or AIDS (i.e., community-based care, outpatient care, hospitalization) should be carefully coordinated. AIDS patients need an array of services that can prove difficult for hospitals to accommodate if they have not organized for the task. The committee recommends that, for provision of hospital inpatient care, AIDS units or teams should be established in high-incidence areas, with
i86 APPENDIX A a nursing and psychosocial support staff trained in AIDS care and integrated with outpatient and community-based staff. Furthermore, for high-incidence areas, where HIV infection puts the greatest logistic and financial stress on health care systems, the development of multidis- ciplinary outpatient clinics dedicated to treating AIDS and other HIV- related conditions should be considered. Systems of community-based care should be able to provide these patients with attendant or homemaking services up to 24 hours daily, as needed; nursing staff able to provide necessary specialized medical intervention; and social support, including small-group housing. The use of volunteer groups to assist in patient care and counseling should be encouraged. Also, representatives of existing agencies and health care providers should organize AIDS care groups to coordinate efforts toward community-based care. Special systems of care may be required to meet the particular needs of certain AIDS patients, such as IV drug users. All physicians should be alerted to the signs and symptoms of HIV infection; opportunities to train in the care of HIV-infected patients should be provided to physicians less familiar with the disease; and medical education programs should include academic and practical train- ing related to HIV infection and disease. Many AIDS patients, being young, have not previously considered the reality of severe illness and death. Therefore, it is important that psychiatric care and psychosocial support be provided to patients with AIDS and ARC, to individuals infected with HIV but asympto- matic, to members of risk groups, and to health care providers for these persons. Various ethical issues pertain to HIV-related disease: society has an ethical obligation to provide an adequate level of health care to all of its members, and health professionals have an ethical obligation to care for all persons infected with HIV. Additionally, persons who may be infected have ethical obligations to protect others from possible infection. They may do this by avoiding unprotected sexual intercourse and by not sharing needles; by refraining from donating blood, sperm, or other tissues or organs; and by notifying care providers of their status so that recommended precautions against the spread of infection can be used during treatment. Implicit in society's obligation to provide appropriate care for persons infected with HIV is the responsibility to ascertain and respect patients' wishes about terminal care. This obligation extends to the provision of a variety of settings such as hospices in which AIDS patients can spend their final days.
APPENDIX A 187 Health Care Costs Resulting from HIV Infection The direct health care costs resulting from HIV infection include those for pre-test and post-test counseling associated with serologic testing, detection and confirmation of infection by serologic testing, monitoring of asymptomatic infected individuals, and treatment of the broad range of HIV-associated conditions. Most studies to date have focused on the direct health care costs for AIDS patients arising from care in and out of the hospital. As estimated by these studies, the average total costs for inpatient care from the time of diagnosis until death range from about $50,000 to $150,000. The difference in the figures derives largely from differences in the numbers of hospital days used. Several factors including hospital readmission, length of stay, and type of care have been identified as making the costs of treating AIDS patients higher than those for treating other patients. These costs also vary with the type of AIDS patient IV drug user, homosexual male, infant because the disease manifestations can differ accordingly. The Public Health Service has estimated that the direct cost of care for the 174,000 AIDS patients projected to be alive during the year 1991 will be $8 billion to $16 billion in that year alone. Because this estimate does not include the care of ARC patients and seropositive individuals, and because it does not take into account the costs associated with experi- mental therapies or lengthened survival times, it significantly underes- timates the total annual direct costs for HIV infection in that year. The costs for care of ARC patients and seropositive personsof whom there are many more than there are AIDS patients also need consider- ation. These patients will incur costs for a longer period of time, and care for HIV-related conditions such as dementia is extremely costly. The committee found no attempts to estimate the future magnitude of the direct health care costs associated with ARC patients and seropositive individuals, but believes they will be substantial. There are also large indirect costs associated with HIV-related condi- tions including AIDS. Some of these indirect costs are the loss of wages for sick persons, the loss of future earnings for persons who are permanently incapacitated or die because of illness, and the cost of infection control in the course of other health services, such as dental care. For urban areas handling a large number of AIDS cases, the strain on available resources will be especially great. Large numbers of infected IV drug users in certain cities will seriously encumber their municipal hospital facilities. In New York City, AIDS patients who are IV drug
188 APPENDIX A users may occupy more than 10 percent of municipal hospital beds by 1991. Having studied the projected course of the epidemic and its implica- tions for health care costs, the committee believes that more information must be gathered on all aspects of the costs of care for persons with HIV-related conditions, especially AIDS. Such data should permit calcu- lation of the direct lifetime health care costs resulting from HIV infection and the indirect costs associated with the disease. It is essential to determine which are the most cost-effective approaches to providing care for patients with AIDS and other HIV-related conditions. Thus, the committee recommends that all demonstration projects be designed to facilitate comparison of patients, their health outcomes (e.g., longevity, quality of life), the effectiveness of care, and the costs associated with its . . provision. The Financing of Health Care for HIV-Related Conditions The financing of care for patients with AIDS and other HIV-related illness now depends on the same variety of public and private plans that apply to patients with other diseases. Most of the public funds for care of AIDS patients come through the Medicaid program, which is estimated to cover about 40 percent of such patients. Medicare serves only a small percentage of AIDS patients, because its two-year time-to-eligibility for individuals below the age of 65 is longer than the remaining life of most AIDS victims (although this may change if survival increases). Private plans cover a substantial proportion of AIDS patient care, as would be expected from the fact that at least 85 percent of Americans have health insurance, much of it through their jobs. Despite the fact that most Americans have health insurance, an estimated 80 million have inadequate coverage or none, mostly because they have no jobs, they have no fringe benefits in their jobs, or they are poor health risks. Their plight is indicative of many shortcomings in health care financing, most of which are underscored in the case of HIV-related conditions. In addition, AIDS poses such potentially large expenditures for care that some insurance companies and employers are already wary of offering coverage or employment to persons at high risk of exposure to HIV. The committee believes that all persons with AIDS or other HIV-related conditions are entitled to adequate care and that mechanisms equitable both to recipients and to providers should be found for financing this care. It is preferable that solution of the problems arising from the financing of care for AIDS and other HIV-related conditions be achieved within a mechanism that ameliorates problems existing in general for the financing
APPENDIX A 189 of care for other serious illnesses. Measures could include national health insurance for catastrophic illnesses or state-based pools for persons medically at high risk. The Public Health Service has proposed the establishment of a com- mission to evaluate the problems of financing the costs of care associated with HIV-related conditions. Finding the optimal mechanism for fi- nancing the care of HIV-infected patients, especially those not now covered, should become the first order of business of such a commis- sion. FUTURE RESEARCH NEEDS Basic Research Since the identification of HIV as the cause of AIDS, analyses of the virus have characterized its entire genetic structure and have enabled the identification of many, if not all, of its genes. At the same time, increased knowledge of how the virus is transmitted has helped in the design of public health and education programs. Such insights, however, provide only the first milestone on what promises to be a long and difficult path toward effective therapy to minimize the effects of HIV infection and toward vaccines to limit the spread of the virus. Developing an effective vaccine or acceptable drugs will depend on a better understanding of the basic biological processes and consequences of HIV infection. The characteristics of viral proteins and their interac- tions with cellular proteins and processes must be determined. And the design of strategies to prevent the clinical manifestations of HIV infection will require a greatly improved understanding of the normal functioning of the human immune system. The same types of basic research that have generated the progress of the past few years can also be expected to yield valuable insights into ways to limit the establishment and progression of HIV infection. Thus, basic research in virology and immunology should be considered an important part of the AIDS research effort and should be fortified in the years ahead. The Natural History of HIV Infection Much remains to be learned about the natural history of HIV infec- tion how the virus establishes and maintains infection and how it leads to the immunologic deficits and pathologic consequences associated with ARC and AIDS. For instance, it is not known what factors activate the provirus; what influences the ability to isolate the virus from an infected
190 APPENDIX A person; whether the virus is transmitted as free virus, as cell-associated virus, or in both forms; or what proportion of infected individuals will become sick. In the study of HIV infections in human beings, there should be a greater emphasis on defining the introduction and spread of HIV in viva, on identifying the in viva reservoirs of infected cells, and on studying the ejects of HIV on the immune and central nervous systems throughout the course of infection. In addition, drug development efforts, epidemiologic studies, and public health measures all require more comprehensive immunologic and virologic analyses than are presently available. Such analyses could resolve questions about the efficiency with which infected persons infect others, the existence and extent of a virus-positive but antibody-negative population, the relevance of host or environmental cofactors in the development of AIDS, and the efficiency of heterosexual transmission. Epidemiologic Approaches Since AIDS was first identified in 1981, much has been learned from epidemiologic research about how HIV is transmitted and about how the virus affects people who are infected with it. But more must be discov- ered. For instance, epidemiologic studies could provide much of the information needed to fashion improved models of the future course of the epidemic. Reporting of AIDS should be continued and augmented by the selective reporting of other stages of HIV infection. In addition, active surveillance is needed of groups of particular epidemiologic importance, such as heterosex- uals and non-IV drug users in high-incidence areas, IV drug users and homosexual men in low-incidence cities, spouses of infected individuals, pregnant women, newborn children of infected mothers, prostitutes through- out the country, and recipients of blood products. Better information is also needed to quantify the number of persons infected with HIV. Epidemiologic studies of the immunologic effects and pathologic man- ifestations of HIV infection can contribute to knowledge of the natural history of infection. Prospective cohort studies should be continued and expanded, and studies should be undertaken to determine differences in the characteristics of infection and disease among different populations. Natural history and epidemiologic studies would be facilitated by better tests for antibodies to HIV and by simpler, quantitative ways of detecting virus. Tests for both virus antigen and infectious particles are necessary. In addition, viral isolation procedures need to be refined so that a standard is available for evaluating other techniques.
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
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.
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.
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
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-
~ 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.
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-
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
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
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.
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.