------------------------------------------------------------------------------ This file is also available from the Congressional Research Service. CRS reports are prepared for members of congress and congressional committees. To order additional CRS products, contact the product line at (202) 707-7132, TDD (202) 707-7154, or fax (202) 707-6745. It was prepared for electronic distribution by the inforM staff. Questions or comments should be directed to inform-editor@umail.umd.edu. ------------------------------------------------------------------------------ CRS Report for Congress Congressional Research Service, The Library of Congress 92-281 SPR CRS Reports are prepared for Members and committees of Congress Women With HIV Infection Judith A. Johnson Specialist in Life Sciences Science Policy Research Division March 16, 1992 SUMMARY Although, at present, women account for only 10 percent of AIDS cases reported to CDC, women are the fastest growing group in the HIV epidemic. The route of HIV exposure in women is shifting from IV drug use to heterosexual contact. Because the medical conditions experienced by many HIV-infected women are not included in the CDC AIDS definition, women often are diagnosed and treated later than men. Also, women may not qualify for benefit payments because their symptoms differ from men's. INTRODUCTION AIDS is a blood-borne and sexually transmitted disease caused by the human immunodeficiency virus (HIV). HIV compromises the immune system of its victims, rendering them susceptible to infections. The Centers for Disease Control (CDC) estimates that 1 million Americans are infected with HIV. The median time from infection with HIV to diagnosis of AIDS is 10.5 years; 98 percent of HIV-infected individuals will progress to AIDS within 15 to 20 years. -1 The median survival time from AIDS diagnosis to death is about 10 months for heterosexual men and women; the three-year survival rate after a diagnosis of AIDS is approximately 20 percent. -2 EPIDEMIOLOGY OF WOMEN WITH HIV INFECTION Through January 1992, more than 209,000 adult and pediatric AIDS cases had been reported to CDC. Of this total, approximately 21,600 were adult and adolescent females; half contracted AIDS through intravenous (IV) drug use and a third through heterosexual contact. The proportion of female AIDS cases connected with IV drug use has been decreasing in recent years while the proportion of such cases attributed to heterosexual contact has been increasing. According to the National Commission on AIDS, over the past several years women have been the fastest growing group in the HIV epidemic. Most U.S. women with AIDS are black or Hispanic (73 percent) and live in large metropolitan areas located on the Atlantic coast; however, the proportion of female cases reported from small cities and rural areas has been increasing. -3 According to CDC, at the present time U.S. women are at higher risk than men of encountering an HIV-infected heterosexual partner since most IV drug users are men, almost all hemophiliacs are men, and some HIV-infected men are bisexual. Also, several studies have indicated that the relative efficiency of transmitting HIV from male to female is greater than from female to male. One study found that women are 17.5 times more likely to acquire HIV from male sexual partners than men are from women. -4 The majority of women diagnosed with AIDS (79 percent) are of reproductive age (15 to 44 years). The incidence of pediatric cases is closely tied to the rate in women since 84 percent of children with AIDS have a mother with or at risk for HIV infection. Researchers estimate that HIV-infected women transmit the virus during pregnancy or delivery to between 25 and 35 percent of their children. -5 Of the estimated 1 million HIV-infected persons in the United States, CDC calculates that 80,000 are women of childbearing age. -6 CDC estimates that, in 1989, approximately 1800 newborns acquired HIV through perinatal transmission, and between 1500 and 2100 babies infected with HIV will be born each year. While the death rate from other causes has remained relatively stable among American women, between 1985 and 1988, the death rate due to HIV infection increased by a factor of four. -7 In 1991, AIDS became the fifth leading cause of death in U.S. women of reproductive age. In New Jersey and New York, AIDS was the leading cause of mortality in 1987 among black women aged 15 to 44; the HIV/AIDS death rate in this group of women is comparable to the rate occurring in adult women in West Africa. -8 DEFINITION OF AIDS The current CDC definition of AIDS was devised in 1981 and revised twice; the last change was adopted in 1987. It requires HIV infection along with specific opportunistic infections or cancers (such as Pneumocystis carinii pneumonia or Kaposi's sarcoma, a skin cancer). The list was developed when AIDS afflicted mainly gay males. In women, the early stages of HIV infection produce different symptoms (such as persistent gynecological infections and cervical cancer) than those in the 1987 CDC definition. Consequently, women are often diagnosed later than men and therefore may miss the opportunity for early treatment which could prolong their lives. Critics of the 1987 CDC AIDS definition have charged that many HIV-infected women die of the disease before they meet the definition and consequently there is a significant underreporting of AIDS cases in women. In August 1991, CDC proposed a revised surveillance case definition of AIDS. CDC planned to release a final version of the definition in January 1992 and implement the change for reporting AIDS cases early in April 1992. Because of concerns over the potential impact of the definition, CDC has delayed the implementation indefinitely. CDC's proposal would expand the old definition to include HIV-positive people with CD4-lymphocyte counts of less than 200 per milliliter. A CD4-lymphocyte, also called a T4-helper cell, is a type of immune system blood cell which is depleted by HIV infection. CD4 cells aid in the production of disease fighting substances called antibodies; healthy individuals have CD4 counts of about 1000 per milliliter. Research studies have shown that there is a strong correlation between the development of life-threatening disease in AIDS patients and the level of CD4 cells; as the number of CD4 cells decreases, the risk of developing opportunistic infections and their severity increases. CD4 levels are also being used by physicians as a guide for treatment of HIV-infected people; AZT, an anti-HIV drug, is recommended for those with CD4 counts of less than 500, and treatment to prevent Pneumocystis carinii pneumonia is recommended for persons with CD4 counts of less than 200. CDC estimates that the proposed definition could increase the current AIDS caseload by 150,000 to 200,000. -9 Women's health advocates charge that a significant number of HIV-infected women with serious AIDS-related health problems still will not meet the new case definition. The advocates would prefer adding more women-specific diseases (such as recurrent pelvic inflammatory disease) onto the list. CDC has considered this option but is resisting the idea. The agency believes the list is already too cumbersome for physicians to use (it currently contains more than 20 conditions), and that adding more diseases to the list would make it even more difficult. The National Commission on AIDS has asked CDC to delay implementing the definition so that potential problems posed by the change can be identified and worked out. -10 The Commission is concerned that some HIV-infected women may not be covered by the new definition, and that the CD4 test may not be covered by privacy laws. The CDC definition as originally developed was intended to be used as an epidemiological tool for tracking the epidemic. However, other Federal, State, and private agencies have in the past relied heavily on CDC's AIDS definition in determining who receives benefits (for example, disability payments, housing and nutrition allowances); those who fit the definition qualified for and received benefits much faster than those who did not qualify and were forced to prove their disability some other way. H.R. 2299, "The Social Security and SSI AIDS Disability Act of 1991," would provide interim disability criteria, including medical conditions specific to women, until a proposed advisory panel's future recommendations on these and other matters become law. A companion bill was introduced in the Senate (S. 1188). No action has occurred on either bill. In response to pressure from Congress and AIDS health advocates, in December 1991, the Social Security Administration (SSA) proposed new rules which the agency believes should increase the number of HIV-infected people who qualify for SSA benefits. The ability to qualify for Medicare (after a wait of two years) or Medicaid is often contingent upon qualifying for and receiving SSA disability. These health benefits programs assist low-income individuals in paying for AIDS treatments, which can cost $15,000 or more per year. Women's health advocates claim that HIV-infected women have had more difficulty than men in obtaining benefits in the past and probably will continue to have difficulty, even with the proposed rule change. WOMEN AND AIDS RESEARCH Women's health advocates have charged that research on AIDS in women has focused primarily on women as vectors of disease transmission to men and infants instead of concentrating on how to treat and prevent the disease in women. Rather than being seen as persons at risk, the advocates claim that women are viewed as risk factors--the sexual partner of an HIV-positive male or the mother of an infected infant. A recent article in the Journal of the American Medical Association provides a factual basis for some of these charges. -11 The authors performed a computer-assisted medical literature review and found that little is known about the progression of HIV-infection in women, and that few studies have been performed to clarify this situation. Conditions specific to women (such as cervical disease, and vaginal yeast infections) seem to be more serious in HIV-infected women. The manner in which drugs are absorbed and metabolized may also vary with gender, and the use of oral contraceptives may alter drug metabolism. In addition, the authors point out that most women with HIV differ from the risk groups first affected by AIDS, not only in gender, but also in race, income, and risk behaviors. "These factors combine to yield an amalgam of social barriers to optimal care....[Women] are also subject to discrimination on the basis of gender or childbearing capacity when they attempt to gain access to drug rehabilitation, HIV therapeutics, and research trials....These realities, along with the demographic characteristics of HIV-infected women (often poor and from racial/ethnic minority groups), have created a seriously disenfranchised and medically disadvantaged population." -12 There are a number of reasons why women often are underrepresented in clinical trials of AIDS drugs: (1) they may be excluded because they are women and are either potentially or actually pregnant; (2) they are members of minority groups and lack access to the health care system in general, and to research in particular; (3) they are drug users and are presumed to be noncompliant subjects; and (4) most of the trials so far have focused on AIDS itself, and many women do not fit the clinical definition of AIDS. -13 On the issue of pregnancy, the regulatory system views fetuses as defenseless subjects in need of special risk protection, and pharmaceutical companies seek to avoid potential liability for the possible adverse effects experimental drugs may have on the unborn. The exclusion of women from clinical trials has been general practice in all areas of medical research, not just AIDS. There are those who argue that it may, however, be short-sighted for our society to allow this practice to continue. "A policy that excludes women from research but then exposes them to risks--unknown because unstudied--through the more haphazard route of medical practice, fails to protect their interests in obtaining the safest and most effective therapies....Without scientific evidence to guide them, physicians are left to improvise on dosages and choices of drugs." -14 The Public Health Service (PHS) has recognized this situation as a serious impediment to improving the health of American women. In response to this and other factors inhibiting the advancement of women's health, the agency has developed the "PHS Action Plan for Women's Health," which was published in September 1991. In the "Action Plan," the sections describing the efforts of the Food and Drug Administration, the National Institutes of Health (NIH), and the Alcohol, Drug Abuse and Mental Health Administration specifically identify the importance of including women in clinical trials as major objectives for their women's health programs. A 1990 General Accounting Office (GAO) report found that NIH had scarcely implemented its 1986 policy to include more women in its research studies. Following release of the GAO report, Representative Patricia Schroeder introduced "The Clinical Trials Fairness Act" (H.R. 1160), which would require that women and minorities be included in clinical research conducted under the PHS Act. H.R. 1160 is also included in "The Women's Health Equity Act," (H.R. 1161); no action has been taken on these bills. However, a similar provision was contained in NIH reauthorization legislation (H.R. 2507) passed by the House in July 1991. The Senate's NIH reauthorization bill (S. 1523) is likely to receive floor action in the second session. -15 In August 1991, NIH published a reiteration and further interpretation of its policy concerning inclusion of women in research study populations. PHS sponsored the first National Conference on Women and HIV Infection in December 1990. Following the conference, a core group of participants developed recommendations for further research. They found that increased attention needs to be focused on psychosocial and behavioral as well as biomedical research. This will require greater collaboration between government agencies, research facilities, and community groups. The recommendations will be used by PHS agencies in planning programs and research on women with AIDS. The NIH AIDS Program Advisory Committee, which advises the NIH leadership on AIDS issues, urged the implementation of the recommendations. A number of NIH components including the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development, and the National Cancer Institute, have joined with CDC to form the PHS Women and AIDS Study Group. "This group will review questions that need to be addressed on the natural history of HIV infection in women. In addition, the group will work toward the design of a core dataset for women's studies, to be shared among PHS agencies, to aid in the interpretation of findings from different studies." If NIAID's AIDS Clinical Trial Group has formed a new committee, the Women's Health Committee, to address the growing need for research on HIV-infected women. The Agency for Health Care Policy and Research is sponsoring a panel of health care experts and consumers to develop HIV clinical practice guidelines that address the unique needs of specific population groups, including HIV-infected women. After the guidelines have been drafted and peer reviewed, a pilot test will be conducted for usability at a cross-section of health provider sites. When completed, the guidelines will be widely disseminated to practitioners, patients, medical educators, and consumers. Women and AIDS Research ($ Millions; data, NIH 3/6/92) FY90 FY91 FY92 FY93 Actual Actual Estimate Request $68.2 $97.4 $104.9 $119.0 1. Kolata, G. Studies Cite 10.5 Years from Infection to Illness. New York Times, Nov. 8, 1991 p. B12. 2. Ellerbrock, T. V., et al. Epidemiology of Women with AIDS in the United States, 1981 Through 1990. New England Journal of Medicine, v. 265, Jun. 12, 1991. p. 2971-2975. 3. Ibid., p. 2971. 4. Padian, N. S., et al Female-to-Male Transmission of Human Immunodeficiency Virus. Journal of the American Medical Association, v. 266, Sep. 25, 1991, p 1664-1667. 5. Ellerbrock, Epidemiology Of women with AIDS, p 2971. 6. Gwinn, M., et al. Prevalence of HIV Infection in Childbearing Women in the United States. Journal of the American Medical Association, v. 265, Apr. 3, 1991. p 1704-1708. 7. Chu, S. Y., et al. Impact of the Human Immunodeficiency Virus Epidemic on Mortality in Women of Reproductive Age, United States. Journal of the American Medical Association, v. 264, July 11, 1990. p. 225-229. 8. Ibid., p 228. 9. Navarro, M. U.S. Widens Rules on Who Has AIDS. New York Times, Aug. 8, 1991. p. D21. 10. Change in AIDS Definition May be Delayed. Washington Post, Dec. 11, 1991. p. A9. 11. Minkoff, H.L., and J.A. DeHovitz. Care of Women Infected with the Human Immunodeficiency Virus. Journal of the American Medical Association, v. 266, Oct. 23/30, 1991 p. 2253-2258. 12. Ibid., p. 2257. 13. Levine, C. Women and HIV/AIDS Research: The Barriers to Equity. IRB, Jan./Apr. 1991, p. 18-22. 14. Ibid., p. 20. 15. Other bills introduced in the 102nd Congress which target women with AIDS include "The Women and AIDS Outreach and Prevention Act," (H.R. 1072), and "The Women and AIDS Research Initiative Amendments of 1991," (H.R. 1073); both measures are included in H.R. 1161. 16. APAC Endorses Research Plan for Women and HIV Infection. NIAID AIDS Agenda, Summer 1991. p. 1-5.