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Questions or comments should be directed to inform-editor@umail.umd.edu. ------------------------------------------------------------------------------ Order Code IB92019 Women's Health: The Public Health Service Agenda Updated October 28, 1992 (Archived) by Irene Stith-Coleman Science Policy Research Division CONTENTS SUMMARY ISSUE DEFINITION BACKGROUND AND ANALYSIS PHS Women's Health Plan Congressional Activity SUMMARY In 1991, the Public Health Services (PHS) of the U.S. Department of Health and Human Services (DHHS) reaffirmed women's health as a national public health priority. This commitment, outlined in the report PHS Action Plan for Women's Health, involves a number of PHS agencies and offices. The Plan was developed in response to congressional and public concerns over perceived inattention to women's health issues. For example, the National Institutes of Health, the major Federal biomedical research agency, was supporting a number of studies on heart disease which included only men, in spite of the fact that this disease is the number one cause of death in women and men, killing an estimated 250,000 women and 300,000 men annually. The risk of women developing smoking-related diseases continues to increase each year. More than 106,000 women die annually from smoking-related conditions such as lung cancer, which killed 51,000 women in 1991. The prevalence of men who smoke has decreased recently, while that of women has increased. The Centers for Disease Control indicates that unless current trends in women's smoking are countered, women will smoke at higher rates than men for the first time by the close of this century, yet most educational programs to reduce smoking do not focus on women. The National Commission on AIDS recently identified women as the fastest growing group in the HIV epidemic, yet a number of barriers currently prevent access of high risk women to preventive and treatment services. Other sexually transmitted diseases like gonorrhea and chlamydia infect millions of women each year, and often lead to permanent health problems. In addition, the use and abuse of alcohol and drugs is a serious problem not only for women, but also for exposed infants and other family members. Drinking during pregnancy can lead to permanent physical and mental defects in affected offspring. Moreover, evidence suggests that women who abuse alcohol and drugs may have a greater tendency to engage in risky behaviors that may lead to unwanted pregnancies and sexually transmitted diseases, such as HIV. Although advances have been made in early detection of breast and cervical cancer, breast cancer currently is the second leading cause of cancer mortality. Breast cancer will kill an estimated 46,000 women in 1992. Access to preventive services such as mammography screening often is limited by financial status. Insurance coverage for such screening tests varies, and many poor, underserved, and minority women are among the estimated 34.6 million uninsured Americans. As the PHS Action Plan is implemented, a number of policy issues of interest to Congress will be raised, including: how to address the scientific, legal, and ethical issues associated with the inclusion of women in clinical research; how to better inform the public about environmental and behavioral risk factors in an effort to pro- mote women's health and prevent illness; and how to expand services and access to health care for all women, particularly women of low socioeconomic status and those who are socially or geographically isolated. ISSUE DEFINITION The U.S. Department of Health and Human Services (DHHS), Public Health Service (PHS), in 1991, reaffirmed women's health issues as a national public health priority. This commitment, which is outlined in the report PHS Action Plan for Women's Health, involves a number of PHS agencies and offices. The plan represents a framework of PHS' efforts to address more than 35 women's health priorities based on recommendations made by a PHS Coordinating Committee on Women's Health Issues. As the Action Plan is implemented, a number of policy issues of interest to Congress will be raised, including: how to address the scientific, legal, and ethical issues associated with the inclusion of women in clinical research; how to better inform the public about environmental and behavioral risk factors in an effort to promote women's health and prevent illness; and how to expand services and access to health care for all women, particularly women of low socioeconomic status and those who are socially or geographically isolated. BACKGROUND AND ANALYSIS The U.S. Public Health Service (PHS) in the Department of Health and Human Services (DHHS) represents the largest public health program globally, and is charged with protecting and advancing the physical and mental health of Americans. In 1983, DHHS created a PHS Task Force on Women's Health Issues to identify important women's physical and mental health issues, and to recommend a plan to address those health issues. A major factor cited for doing the study was the need to evaluate how the health risks of women were changing in reaction to growing demands on women. The Task Force examined the status of women's health from childhood through old age and in 1985 developed recommendations in 15 priority areas in six general categories: -- Promoting a Safe and Healthful Physical and Social Environment -- Providing Services for the Prevention and Treatment of Disease -- Conducting Research and Evaluation -- Recruiting and Training Health Care Personnel -- Educating-and Informing the Public, and Disseminating Research Information -- Designing Guidance for Legislative and Regulatory Measures The Task Force was particularly concerned that existing laws should be implemented, and regulations developed and enforced to improve the health status of women. In addition, PHS and other governmental agencies were urged to develop guidelines and regulations to assure that gender discrimination would be minimized in all health programs and plans. In particular, the Task Force recommended that (1) all PHS units be directed to examine their research guidelines to assure that gender differences are routinely studied whenever possible; (2) guidelines be developed to ensure that sufficient numbers of women are included in clinical trials of drugs that will be used by women; and (3) postmarketing surveillance of prescription drugs, particularly psychotherapeutic drugs and drugs prescribed for hormonal changes in women require the reporting of adverse side-effects of drug interactions with alcohol. In response to the 1985 PHS recommendations on women's health, PHS agencies and offices have expanded activities in this area. The Food and Drug Administration and the PHS Coordinating Committee on Women's Health Issues (the Task Force was its predecessor) sponsored a number of conferences on women's health issues (e.g., a National Conference on Women's Health in June 1986 and a Special Topic Conference on Osteoporosis in October 1987). The National Institutes of Health (NIH), the principal Federal biomedical research agency, announced, in 1986, the development of a policy to ensure the inclusion of women in clinical research. However, in a report requested by the Congressional Caucus for Women's Issues and by Representative Henry Waxman, chairman of the House Energy and Commerce's Subcommittee on Health and the Environment, the General Accounting Office (GAO) reported to Congress in 1990 that NIH had done an inadequate job in implementing its policy. GAO reported (National Institutes of Health: Problems in Implementing Policy on Women in Study Populations, June 18, 1990, GAO/T-HRD-90-38) that the policy failed to be effectively communicated or understood within NIH or the research community, and that problems remained. GAO found that NIH was supporting a number of studies on heart disease which included only men, in spite of the fact that this disease is the number one cause of death in women as well, killing an estimated 250,000 women and 300,000 men annually. In addition, other PHS supported activities neglected many women's health issues. Congress has focused largely on NIH's women's health activities. Legislators also have been examining women's health actions of the entire PHS. The September 1991 PHS Action Plan for Women's Health, outlines priorities and goals for seven PHS agencies and several offices. The priorities reflect some women's health activities that were in progress before the development of the action plan, but, in other cases, the activities represent programs that are being developed in response to PHS' reaffirmation of the priority of women's health issues. This issue brief will provide a brief overview of some of the women's health priorities identified in the Action Plan for the following PHS agencies. -- Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) -- Agency for Health Care Policy and Research (AHCPR) -- Centers for Disease Control (CDC) -- Food and Drug Administration (FDA) -- Health Resources and Services Administration (HRSA) -- Indian Health Service (IHS) -- National Institutes of Health (NIH) For more information on the women's health goals of these PHS Offices, see the PHS Action Plan for Women's Health, U.S. PHS, Office on Women's Health, DHHS Publication No. (PHS) 91-50214, September 1991. What Is A Women's Health Issue? The PHS Action Plan's criteria to identify a health problem or condition as a "women's health issue" are: diseases, or conditions unique to women, more prevalent in women, more serious among women, or having different risk factors or interventions in women. Development of the Action Plan The Action Plan identifies widely disparate women health needs, and those of special target populations that will need greater attention during the 1990s. The goals of the PHS agencies and offices represent a plan of action to the women's health priorities being pursued by individual agencies and offices. The priorities were developed from the framework of recommendations of the 1985 Task Force on Women's Health Issues, and the 1990 PHS Healthy People 2000: National Health Promotion and Disease Prevention Objectives. PHS has made commitments to undertake specific activities and accomplish definitive results within 2 years (by September 1993). In addition, the goals of each agency have accomplishments and long-term objectives to be achieved within 12 to 24 months. Some priority issues cut across all of PHS, including: (l) AIDS/HIV as a women's health issue; (2) inclusion of women in clinical research; (3) health concerns of ethnic minority women; (4) alcohol and other drug abuse; (5) smoking and women's health; and (6) women's interaction with the health care system, including access to care and increasing health providers awareness about the uniqueness of women's health needs. The PHS Coordinating Committee has created subcommittees to address crosscutting issues, and to identify and address new ones. Reports have been submitted on the first three crosscutting issues; information on them can be found in the PHS Action Plan. The Action Plan will be monitored by the Office on Women's Health (OWH) in the Office of the Assistant Secretary for Health (OASH) with the assistance of the PHS Coordinating Committee, which replaced the 1983 PHS Task Force. OWH will work with involved agencies and offices to update, revise, and provide progress reports. Although this Action Plan was published in September 1991, some of the objectives were initiated before that date. In addition, significant revisions have been made in some agencies' women's health programs, including that of NIH. The PHS women's health goals are to be met with existing resources and those requested for FY 1993. PHS Women's Health Plan Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) The mission of ADAMHA is to promote effective strategies to address health problems associated with the use and abuse of alcohol and drugs, and with mental illness. The women's health priorities of ADAMHA are focused on research, prevention, and treatment methods for substance abuse (alcohol and drugs) and mental disorders in women. In addition, ADAMHA and NIH share the leading role in PHS activities regarding the inclusion of women in clinical research. Alcohol and Drugs Use and abuse of alcohol and drugs are serious problems for affected women, exposed infants, and other family members. Abuse of alcohol and other drugs during pregnancy is associated with health risks to both the mother and her unborn offspring. Conditions such as fetal alcohol syndrome and fetal alcohol effects can cause serious irreversible physical and mental defects in exposed offspring. Evidence suggests that women who abuse alcohol and drugs may have a greater tendency to engage in risky behaviors that can lead to unwanted pregnancies and exposure to other risks including HIV infection or sexually transmitted diseases (STDs). Research indicates that women may show more severe effects of alcohol and other drug abuse than men. Other factors, such a~ malnutrition, cultural influences, and sexual and physical abuse may play important roles in the differential effects of drugs on women. Research to evaluate the effects of alcohol and other drugs on human subjects generally has used only a small number of women, or has excluded them altogether. ADAMHA indicates that more studies are needed to develop adequate preventive and treatment approaches. Mental disorders An estimated 20% of the American population will have some kind of mental disorder at some time. Many mental disorders are more prevalent in women than men, including clinical depression, panic disorder, and eating disorders like bulimia and anorexia nervosa. Currently, at least 7 million American women have diagnosable depression. The risk of most types of depression in women exceeds that in men by a factor of 2 to 1. This elevated risk may be due a number of social, economic, biological, and emotional factors, and to sexual and physical abuse and violence. The American Psychological Association indicates that available therapies can reduce symptoms in more than 80% of these patients. Most, however, will go untreated largely because their depression will be misdiagnosed (in at least 30-50% of the cases). A number of barriers exist related to the treatment of depression in women. Many antidepressant drugs work differently in women than men, but much of the clinical research on these drugs was done on study populations which had inadequate numbers of women. It is estimated that 70% of antidepressant prescriptions are written for women, often with inappropriate diagnosis, dose amount and monitoring. The drop- out rate for women who take antidepressants, due in part to serious side-effects, may be as high as 67%. According to ADAMHA, additional research is necessary to evaluate gender differences, and the physiological and psychological effects of therapies for depression in women. Objectives ADAMHA has designated several research, prevention, and treatment priorities for substance abuse and mental illness in women and their families. First is a broad commitment that ADAMHA-funded research appropriately address the causes of these conditions and their impacts on the health of women and the health and development of their families. The agency also plans to develop methods to ensure that research findings on the prevention and treatment of substance abuse, mental disorders, and AIDS in women are quickly converted into prevention and treatment methods to be evaluated, (See CRS Report 91-925 SPR, Women With HIV Infection.) ADAMHA has urged researchers and policy makers to identify major gaps in research on addictive and mental disorders in women. The public needs to be better informed about risks to women and unborn offspring associated with alcohol and drug abuse. Another challenge is to develop strategies to prevent women, particularly young ones, from initiating drug use or excessive alcohol use. ADAMHA recognizes the importance of research teams of experts from a number of disciplines to carry out these objectives and believes these teams should consist of specialists in female biology, psychologists and psychiatrists with expertise in substance abuse and mental disorders. A long-term goal of ADAMHA is to seek new information through research on gender-related differences and similarities in mental and addictive disorders. Research result~ should help determine important biological, psychological, and gender-related factors that are involved in the onset and the outcome of substance abuse and mental illness. ADAMHA expects to use this information to plan future research approaches and to develop better preventive and therapeutic methods. These methods should ultimately lead to a significant reduction in the abuse and inappropriate use of alcohol and other drugs, and help prevent HIV infection in women and their children. Agency for Health Care Policy and Research (AHCPR) The mission of AHCPR, which is the successor agency to the National Center for Health Services Research and Health Care Technology Assessment, is to enhance the quality of patient care services. AHCPR supports research related to determining the quality, appropriateness, and effectiveness of health care services and the improvement of access to such services. For example, AHCPR conducts research to assess the effectiveness of particular medical treatments and research on the cost, financing and delivery of health care. The agency is currently funding a number of projects related to women's health that cut across the entire life span. One is a large-scale study to determine the appropriateness and outcomes of cesarean sections, the most frequently performed surgical procedure in the U.S. Cesarean section rates have increased 4-fold during the past 2 decades, from a rate of 5.5 cesarean sections for every 100 deliveries in 1970 to a rate of 24.7 in 1988. In 1988, cesarean sections totaled 967,000 and accounted for an estimated one-fourth of all births (Myers, D.O., Stephen A., 1988 U.S. Cesarean-Section Rate: Good News or Bad, NEJM, July 19, 1990, p. 200). Experts in recent years have questioned the appropriateness of many cesarean sections, and a NIH consensus panel in 1980 made recommendations to reduce cesarean rates. Other areas of AHCPR-funded research related to women's health that are already in progress include those focused on conditions such as osteoporosis, and biliary tract disease, conditions that are particularly serious in older women. Osteoporosis affects an estimated 24 million individuals in this country, 80% of which are women and causes an estimated 1.3 million bone fractures annually. The economic costs associated with osteoporosis were estimated at $7-$10 billion in 1986 (U.S. DHHS, PHS, NIH, Osteoporosis Research, Education and Health Promotion, NIH Publication No. 91-3216, September 1991. AHCPR also is funding research to assess the quality of services for prenatal care and intrapartum care (during childbirth), obstetrical decision-making in labor and delivery, and the decision to perform hysterectomies. In addition, the agency is involved in developing clinical guidelines for treatment of depression and urinary incontinence, illnesses that occur frequently in women. An important AHCPR goal is improving access to care, as well as the quality of care, for women with AIDS/HIV-related conditions. Although AIDS is a major cause of premature death in women in the U.S., many of the diagnostic and treatment methods were derived from study populations that excluded women. Women with HIV infection show symptoms that are different from men with HIV, and data suggest that such women encounter barriers in obtaining health care, including access to diagnostic and preventive services. The agency indicates that more research is needed to determine differences between women and men with HIV infection and AIDS. In addition, support of studies to examine a number of issues related to access and the quality of care, and development and dissemination of clinical guidelines to accommodate the unique needs of women with AIDS and HIV infection have been cited as goals of AHCPR. Centers for Disease Control (CDC) The mandate of the CDC is to provide leadership and advice, and financial and technical support in the prevention and control of diseases and other preventable conditions and to respond to public health emergencies. The agency contains nine centers, including the Center for Prevention Services, the Center for Chronic Disease Prevention and Health Promotion, and the National Center for Health Statistics. Smoking At least 106,000 women die each year from smoking-related conditions; lung cancer is the major cause of cancer mortality in women. Moreover, CDC indicates that three thousand adolescents, most of whom are females, become regular smokers each day. Currently, according to CDC, 25 million adult women (18 and over) and 1 million adolescent girls (younger than 18) smoke (PHS Action Plan, p. 17). For the past 14 years, the prevalence of smoking in female high school seniors has surpassed that of their male counterparts. Based on such trends, CDC estimates that women will smoke at higher rates than men, for the first time ever, by the close of this century. Objective A major goal of CDC's women's health program is to reduce the frequency of smoking among women. Three factors that must be evaluated to develop strategies to reduce the incidence of smoking among women: (l) the accessibility of tobacco products to adolescents, (2) the impact of advertising on women and girls, and (3) the addictive nature of tobacco use. To address these factors, CDC will attempt to strengthen the public health infrastructure to reduce smoking among women, develop and disseminate health education strategies and tobacco control interventions targeted at women, and to meet the Year 2000 objectives. Included are objectives to reduce the rate of smoking among reproductive age women from 29% in 1987 to 12% in the year 2000, and in pregnant women from 25% in 1987 to 10% in the year 2000. Breast and Cervical Cancer The National Cancer Institute (NCI) estimates that 175,000 cases of breast cancer and 13,000 cases of cervical cancer were diagnosed in women in 1991. In addition, breast cancer killed an estimated 44,500 women and cervical cancer an estimated 6,000 women in 1991. Major advances have been made in early detection of breast cancer with the use of mammography screening and in early detection of cervical cancer with the use of the Papanicolaou Smear (Pap smear). However, access to preventive services such as these often is limited by financial status. According to DHHS, insurance coverage for such screening tests varies by geographic locations, and many poor, underserved, and minority women are among the estimated 34.6 million uninsured Americans. Objective An important long-term goal of CDC is to reduce deaths from breast and cervical cancer, particularly with improved screening, to rates consistent with the PHS Year 2000 Healthy People objectives. The objective is to reduce the breast cancer death rate of 22.9 per 100,000 women in 1987 to no more than 20.6 per 100,000 women in the year 2000, and the cervical cancer death rate of 2.8 per 100,000 in 1987 to no more than 1.3 per 100,000 women in the year 2000. An expanded focus on women's health issues in a number of sectors, including public health, political, professional, voluntary and private organizations, has been cited by CDC as being essential to reduce morbidity from breast and cervical cancer. To accomplish this goal, CDC plans to develop a comprehensive national strategic plan focused on early detection and control of breast and cervical cancer. CDC is working with other Federal and nonfederal agencies and groups throughout the public health community to develop and implement the plan. Sexually Transmitted Diseases (STDs) STDs, including gonorrhea, chlamydia, papillomavirus, and AIDS, infect millions of women each year. Pelvic inflammatory disease (PID), one secondary effect of STDs, is treated in an estimated 1 million women annually (CDC, "Pelvic Inflammatory Disease: Guidelines for Prevention and Management," MMVVR, April 26, 1991, p. 1). One-fourth of the cases of PID treated each year require hospitalization, and approximately half of these require surgical procedures. The economic burden associated with PID is significant; CDC estimates that total costs exceeded $4.2 billion in 1990. Many cases of PID go untreated, in part because affected women often show minimal or no noticeable symptoms. Public health experts are particularly concerned about this finding because of the serious reproductive risks associated with PID. Women with PID are at increased risk of ectopic pregnancy, a condition in which the fetus develops outside of the uterus, often in the fallopian tubes, and must be aborted because of a life-threatening risk to the mother. According to CDC, risk of ectopic pregnancy in women after one event of PID increases 7-fold compared to women with no history of PID. PID results in an estimated 50,000 ectopic pregnancies yearly. PID also increases the risk of infertility; 12% of affected women become infertile after one episode. This risk increases to 25% after the second event, and 50% after the third. PID is responsible for at least 125,000 cases of tubal infertility annually. Objective An important goal of CDC is to decrease the rate of STDs in women. To accomplish this objective, CDC indicates that adequate financial and human resources will be required to provide prevention programs at the State and local levels. CDC plans to confront a number of obstacles related to educating Americans, particularly the young, about associated risks and symptoms, to reach its goal of preventing STDs. The agency is planning to support programs targeted at delaying average age of first intercourse among teenagers, reaching teens in a number of settings, including schools, community, church and clinical. In addition, resources will be used to develop strategies to reduce high-risk sexual behaviors associated with alcohol and other drug use, and to increase the use of preventive methods, such as condoms, to prevent the spread of STDs. HIV Infection The National Commission on AIDS recently identified women as the fastest growing group in the HIV epidemic. Through November 1991, about 10% of the more than 202,000 AIDS cases, or 21,000 were adult and adolescent females, according to CDC. Approximately 50% of these females contracted AIDS through intravenous (IV) drug use, and one-third through heterosexual contact. One alarming trend is that cases attributed to heterosexual contact have been increasing in recent years. Cases associated with IV drug use have been decreasing. Seventy-three percent of American women with AIDS are black or Hispanic and live in large metropolitan areas located on the Atlantic coast. Seventy-nine percent of women diagnosed with AIDS are of reproductive age, 15 to 44 years (see CRS Report 91-925 SPR). Objective CDC has designated reducing the incidence of HIV infection among women and children as one of its major women's health objectives. The agency is planning to address a number of urgent issues in this area: (l) development of contraceptives and virucidal (virus-killing) therapies to protect against pregnancy and HIV infection; (2) improvement in surveillance of HIV infection by race/ethnic and socioeconomic category in women and infants; and (3) development of HIV prevention strategies that change behaviors which place women at increased risk of HIV. CDC indicate~ that existing barriers to effective delivery of prevention services to women at risk of HIV must be identified and eliminated, at the same time that new~prevention strategies are being developed. CDC plans also to try to develop strategies to improve educational, social and decision-making skills in women at risk of HIV infection. The Food and Drug Administration (FDA) The FDA as the only regulatory agency within PHS is a consumer protection agency that regulates the safety of foods, drugs, medical devices, cosmetics, and a number of other products. The mandate of FDA is to protect the health of Americans against impure and unsafe foods, drugs and cosmetics, and other potential hazards. FDA also assures the effectiveness of such products. Objectives FDA's activities have important effects on the health and well-being of women, but this role frequently goes unnoticed by the public health community. The agency now intends to work to improve its visibility by strengthening existing communication systems and creating new networks. These communication and collaborative network systems will include representatives of women's organizations. FDA hopes thereby to ensure that its women's health programs and policies are relevant to the health needs of women. The agency will take a number of steps to improve its capability to access the views and concerns of women and representatives of women's health organizations. One is to develop a model workshop to help women and their organizations gain effective access to the agency. The agency also will establish local and national networks to assess women's health information needs and to determine how useful is the information disseminated to women. Another objective of FDA's women's health program is to participate fully in PHS-wide initiatives related to the inclusion of women in clinical research. Although NIH and ADAMHA have the major roles, FDA plans to communicate this policy in clinical studies of new drugs. The agency intends to take steps to continue its assessment of the impact of its guidance to the private sector about this policy, and to evaluate the results of the policy. Steps include revising the FDA guideline General Considerations for the Clinical Evaluation of Drugs to stress the importance of including in clinical studies a full range of patients who will ultimately be treated with the drug. FDA also plans to reassess a current policy that restricts participation of premenopausal women in clinical trials. The private sector generally avoids using premenopausal, or reproductive age, women in many clinical trials. This practice is due largely to concerns about potential damage of drugs to the reproductive system of women, or to the fetus if study group women are pregnant, and the resulting liability risks. GAO presently is evaluating the extent to which women were included in the clinical research supported by the private sector that was submitted for evidence for all drugs approved by FDA since 1988. Results of this study are expected to be released on Oct. 29, 1992. Health Resources and Services Administration (HRSA) HRSA is the principal PHS agency responsible for general health services and resources, dealing with issues related to access, equity, quality and cost of care. Objectives: Training A major goal of the HRSA women's health program is to increase the knowledge of health professions trainees about the uniqueness of women's health issues, and to increase the number of health care providers who specialize in women's health care. The agency's Bureau of Health Professions has taken a number of steps to do this. The agency has established ongoing collaboration with NIH to ensure that current knowledge about the clinical symptoms of HIV infection and AIDS in women is transferred quickly from NIH to the Bureau's AIDS Regional Education and Training Centers Program grantees. This will ensure that the information is made available to health care providers in their area. HRSA also plans to increase the number of health care providers specializing in women's health care, by funding 22 projects authorized under Section 822 of the Public Health Service Act (training of nurse midwives and nurse practitioners). In addition, the agency plans to fund practice models and educational programs that train health professionals to practice in settings that serve the elderly, and in areas that have a large proportion of women, such as rural settings. Women with HIV/AIDS HRSA has designated the support of access to services for women with HIV/AIDS as a major priority. A number of steps have been identified to ensure that grantees supported under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990 adequately develop and make accessible services for women with HIV/AIDS. HRSA intends to focus attention on the probable underreporting of HIV/AIDS in women, and the significance of such under-reporting for HIV/AIDS as a women's health issue. CARE grantees will be required to provide annual reports to HRSA with information on their activities and accomplishments related to women's health, so that the agency can assess progress in this area. One challenge to developing effective HIV/AIDS education and early intervention methods is determining how to reach women at risk. Data indicate that women are less likely to go to AIDS clinics - a major setting for current education and intervention activities - because many believe that such clinics are geared for gay men. HRSA intends to support activities in which health promotion efforts can be made available in settings where women receive routine or emergency health care. Smoking Another goal of HRSA is to expand support of activities to decrease morbidity and mortality of women and their children through a reduction in the incidence of cigarette smoking among women of reproductive age (age 15-44). HRSA's Maternal and Child Health Bureau (MCHB) plans to examine the importance of primary and secondary prevention of tobacco consumption by pregnant women, and the need to avoid risks of cigarette smoking during reproductive years. The MCHB will continue to fund research and demonstration projects to develop and promote effective intervention methods, and communicate information about adverse effects of smoking and effective interventions. Poor, Underserved, and Minority Women HRSA has identified the inferior health status of underserved, poor, and minority women as an area of focus. The health status of these groups generally is significantly lower than that of the general population. One indicator of this is the disparity between infant mortality rates of blacks and the general population. In 1987, the rate for the general population wa~ 10.1 deaths for 1,000 live births, but the rate for blacks was 17.9. The PHS Year 2000 objectives are to reduce the rate for the general population to no more than 7 per 1,000 live births, and the rate for blacks to no more than 11 per 1,000 live births. Poor, underserved, and disadvantaged women, particularly members of minority groups, are at higher risk for chronic conditions like hypertension and diabetes, are less likely to get early diagnostic and preventive services such as screening for breast cancer, and have greater rates of morbidity and mortality from such diseases because of later diagnosis. The inferior health status of these women decreases longevity and the quality of life, and compromises their children's access to health care as well. This is a particularly serious problem for homeless women. HRSA reports that homeless families currently make up one-third of the homeless, and represent the fastest growing segment of the homeless population. The agency indicates 80% of these families are headed by a woman, mostly young single mothers with children. Homeless women are more likely to have mental problems and problems of substance abuse than other homeless people. To address this problem, HRSA's women's health program plans to provide support to identify and implement homeless projects and other primary health care services. HRSA indicates that cultural and behavioral patterns that prevent poor women from seeking care must be changed in order to improve access to primary health care services. In addition, existing primary care systems in underserved areas should be increased. To implement these strategies, a multifaceted approach that includes education, counseling, and public awareness programs is needed. As the lead agency for the Healthy Start program, HRSA initiated a program to identify the most effective ways to decrease infant deaths, provided an estimated $57 million in FY 1991 to fund projects in approximately 10 communities throughout the U.S. with very high infant mortality rates. Grantees focused on activities related to health services outreach, public information, and case management for pregnant women. HRSA also intends to expand resources for primary care services for high-risk pregnant women in geographical areas with the highest infant mortality rates, and for comprehensive family-oriented primary health services. The agency plans to increase the capacity of 25 or more counties to provide care to poor and underserved women. Indian Health Service (IHS) The IHS's mandate is to provide a comprehensive health services delivery system for American Indians and Alaska Natives. Objectives IHS has designated a number of women's health objectives focused on American Indian and Alaska Native women. Women are the primary care-givers in Indian families and, as such, the health status of the entire Indian population can be affected significantly by the health status and health behavior of Indian women. Indian women are often at a disproportionate risk for morbidity and mortality compared to the general population and to women of other ethnic groups. An alarming proportion of Indian women suffer from health problems such as diabetes, cancer, alcoholism, substance abuse, and also from family violence and poverty. Inadequate data exist to accurately assess the interrelationship of health problems of Indian women with social conditions. IHS plans to develop an Indian women's health agenda. The agency also plans to establish a minimum of one regional Indian women's health clinic in each IHS area to provide comprehensive health care services and delivery systems. In addition, IHS plans to establish a national Indian Women's Health Activities Clearinghouse to function as a focal point within IHS for women's health activities. National Institutes of Health (NIH) The mission of NIH is to improve the health of the American people. As mentioned earlier, much of the recent debate on women's health has been focused on NIH. NIH is the major Federal agency that supports biomedical research with a total budget of $8.9 billion for FY 1992. In response to the 1985 PHS Task Force's recommendations, NIH announced a policy to ensure the inclusion of women in study populations. Although this policy was published in the NIH Guide for Grants and Contracts (in October 1986, January & March 1987, January 1988, and June 1989), guidance for implementing the policy was not published until July 1989, and the policy had not been uniformly applied at the time of GAO's examination. NIH has made significant progress in addressing concerns in this area since 1990. Much of this work is being directed by the recently created Office of Research on Women's Health in cooperation with a number of the Institutes, Centers, and Divisions of NIH. Objectives: Inclusion of Women in Research Populations A major focus of NIH's goals on women's health relates to efforts to fully implement the policy on the inclusion of women in NIH-funded clinical research. NIH has taken measures to strengthen and implement this policy including: (l) publishing an expanded policy on the inclusion of women in study populations that more completely explains the policy and how it will be implemented; (2) issuing an "Instruction and Information Memorandum" on the policy, and instituting required courses to train all NIH employees responsible for reviewing and scientifically managing research grants and contracts; (3) briefing all peer review groups that review applications for clinical research, and all institutes and center advisory councils regarding this policy; (4) revising research application forms to require specific information about the inclusion of women and minorities in research studies; and (5) initiating the development of a database tracking system to monitor the enrollment of women and minorities in human subject research. With the assistance of the Institute of Medicine, NIH plans to evaluate medical, legal, and ethical issues related to the inclusion of women in clinical research. Included will be issues involving the use of reproductive age women in research, including whether problems related to potential damage to the fetus and to liability in such women can be resolved. In addition, NIH will examine whether guidelines should be developed to determine the conditions under which drugs should be investigated in women in relation to phases of the menstrual cycle. Evidence indicates that a woman's response to drugs may vary across her menstrual cycle. Women's Health Activities NIH has designated the expansion of support for research on topics of importance to women's health as a major objective for the agency. Two specific programs being developed are: (1) an NIH research agenda on women's health for the next 10-20 years, that will identify research priorities across each stage of life, and (2) a Women's Health Initiative, a large clinical intervention and prevention project to examine a number of serious chronic diseases and their prevention in postmenopausal women (age 50-79). Congress appropriated $10.3 in FY 1992 for the ORWH, and $25 million for the Women's Health Initiative (WHI). NIH's Office of Research on Women's Health (ORWH) is directing the development of the women's research agenda with the assistance of an NIH Task Force on Opportunities for Research on Women's Health. This NIH Task Force is to assess the present status of women's health research, identify research opportunities and gaps in knowledge, and recommend a NIH plan for future directions for research during the next one to two decades. The Task Force is working with experts in the fields of basic and clinical sciences, practitioners, and women's health advocates to develop recommendations for the research agenda. A public meeting was held in June 1991 and a workshop in September 1991, and a report with findings and recommendations was to be published by April 1992. The WHI represents the largest study of its kind ever done. The major focus will be to study causes, prevention, and treatment of three of the leading causes of death and frailty in postmenopausal women -- cardiovascular disease, cancer, and osteoporosis. Researchers believe that menopause and diminished ovarian function play an important role in the cause of all three diseases. In addition, diet modification, exercise, dietary supplements, and behavioral modification such as smoking cessation may play significant roles. The WHI, directed by the ORWH and the Office of Disease Prevention, will investigate the effects of a number of factors on these diseases. The project will involve at least 100,000 women, cost an estimated $619 million, and take 14 years to complete. The project consists of three major parts: (l) A large clinical trial will involve an estimated 60,000 women to assess the effectiveness of specific preventive approaches to breast and colorectal cancer, cardiovascular diseases, and osteoporosis. One preventive approach will focus on preventing heart disease and bone loss with hormone replacement therapy (estrogen and progestin) for cardiovascular disease and osteoporosis. A second trial will examine the effectiveness of a low-fat diet in preventing breast and colorectal cancer. The third trial will determine how effective vitamin D and calcium supplements are in reducing bone loss and fractures. (2) A 32-community prevention study will survey up to 96,000 women to evaluate the effectiveness of community-based prevention strategies, including smoking prevention and increased physical activity to promote healthful behaviors. The study will focus on the prevention of breast, cervical, and lung cancers, and cardiovascular diseases and osteoporotic fractures. (3) An observational study will involve an estimated 100,000 women (including women used in parts 1 & 2) who will be screened for predictors and biological markers of diseases, including cardiovascular disease, cancer, and osteoporosis. The development of the WHI was first announced by NIH director Dr. Bernadine Healy in the spring of 1991. Although there is general consensus on the goals of the project, its design has raised some concern among researchers. One concern involves the exclusion of reproductive age (age 15-44) women from the study. Study populations for the project would consist of women who are at least 45 years old. Critics believe that the study populations should also include women of reproductive age. However, NIH officials argue that such a study would be excessively expensive. In addition, officials believe that it is appropriate to focus on postmenopausal women because two relatively neglected populations are being studied, women and older individuals. Some critics claim that the study, which will involve at least 100,000 women and cost $619 million, is too large, complex and expensive. They believe that much cheaper and smaller investigator-initiated studies should be done instead. However, NIH officials contend that a large centralized study is necessary to be assured of the statistical significance of potential beneficial results. Other concerns about the project relate to compliance of study participants to the stringent regimen (drug, exercise and diet), particularly that to which women in the clinical trial will be subjected. The clinical trial will consist of three different trials that will be done concurrently, and some participants will be participating in all of them. While results from such a study are very important, researchers are concerned about a large drop-out rate among participants because of unpleasant side effects (e.g., bleeding and depression from drugs) and the restricted diet (low fat) over the extended time of the study (14 years). NIH acknowledges that the WHI is large and complex, but believes that it is feasible. In addition, officials who indicate that the project can be modified as it proceeds, if necessary, recently reported that some changes are already underway. The agency now intends to implement the study at one third of its planned size initially so that feasibility of the study's design can be tested. Congressional Activity Congress took a number of actions on women's health issue in the 102nd Congress. The Women's Health Equity Act (WHEA), a package of 22 bills, was introduced in both Houses as H.R. 1161 (Schroeder) and S. 514 (Mikulski), and has received broad bipartisan support. Several provisions of the research title of WHEA passed Congress recently as part of the NIH re-authorization bill, H.R. 2507 (Waxman), the NIH Revitalization Amendments of 1992. However, on June 23, 1992, this bill was vetoed by the President and Congress was unsuccessful in overriding the veto. Revised legislation containing most of the original women's health provisions (H.R. 5495 and S. 2899) never reached the Senate or House floors during the 102nd Congress. These provisions include: codification of the NIH Office on Women's Health (created in 1990); requirement that women and minorities be included as subjects in NIH-funded studies, except in specific circumstances; authorization of an additional $40 million in FY 1992 for osteoporosis research; authorization of $400 million in FY 1993 for research on breast cancer, ovarian cancer, and other cancers of women's reproductive systems; authorization for a CDC program for State registries to collect data on cancer cases; establishment of contraception and infertility research and development centers and a clinical research program in obstetrics and gynecology at NIH. Several provisions of the WHEA also were included in H.R. 3839, the FY 1992 Labor-HHS-Education Appropriations Act, which became law on Nov. 26, 1991, P.L. 102-170. WHEA provisions include: (l) an additional $2 million for CDC's sexually transmitted diseases prevention program to initiate a national screening program for chlamydia in women and their partners; (2) $50 million for CDC to support a comprehensive mammography and pap smear screening program for low-income women; (3) the creation by NIH of a comprehensive gynecological and obstetrical research program, which should include a new intramural clinical and laboratory gynecology research program at the NIH campus; (4) language that strongly urged the National Cancer Institute (NCI) of NIH to make breast, ovarian, cervical (along with prostrate) cancer its top priority, and increased NCI's appropriations for FY 1992 by $275 million, or 14.8% over the FY 1991 level (NCI's funding for breast cancer in FY 1992 increased by $42 million to $133 million, cervical cancer by $8.6 million to $31.7 million, and ovarian cancer by $8 million to $19.8 million); (5) $10.3 million for NIH's Office on Women's Health and $25 million for its Women's Health Initiative. H.R. 3635 (Waxman), the Preventive Health Amendments of 1991, would revise and extend a program of block grants for such preventive health and health services as rape crisis counseling, health education, and risk reduction. It passed both Houses in the 102nd Congress and is now awaiting action by the President. S. 1944 (Kennedy), the Health Promotion and Disease Prevention Act of 1991, passed as H.R. 3635 by the Senate on Nov. 27, 1991, would fund a number of health promotion and disease prevention services, including a new $50 million program to prevent infertility through screening and treatment of sexually transmitted diseases (this is similar to provisions in H.R. 1161 and S.514, the Women's Health Equity Act). H.R. 2441 (Waxman), the Sexually Transmitted Diseases Amendments of 1991, on Oct. 24,1991 was reported to the House from the Committee on Energy and Commerce. It would reauthorize $100 million for a grant program for the prevention of sexually transmitted diseases. Congress recently requested at least two studies on women's health issues. One, requested by the Congressional Caucus for Women's Issues (Co-chaired by Representatives Schroeder and Snowe) and Senator Brock Adams, Chairman of the Senate Subcommittee on Aging, was released in May 1992 by the Office of Technology Assessment. The report, The Menopause, Hormone Therapy, and Women's Health, examines the current status of information and medical practice on menopause and hormone replacement therapy in women. The second, requested by the Congressional Caucus for Women's Issues and Representative Henry Waxman, Chairman of the Energy and Commerce Subcommittee on Health and the Environment, is an investigation by GAO to examine the inclusion of women in research when evaluating new drugs. This study is expected to be released at a House Subcommittee on Health and the Environment hearing on Oct. 29, 1992.