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doing in this area? What are the current activities designed to comply with this Congressional directive? What are the future plans?
Answer. The NIAID continues its commitment to elucidate behavioral factors that affect acquisition, transmission and progression of HIV disease. One immediate step has been the hiring of an expert in HIV transmission and disease progression among intravenous drug users (IVDUS). She is currently working with program staff to recommend strategies for improving outreach to and follow-up of IVDUS in clinical and epidemiological studies. These studies will address such concerns as the recruitment of IVDUS and compliance with treatment regimens. In support of this effort, NIAID and NIDA have set up an interagency agreement to support recruitment outreach activities.
The NIAID has developed plans for the initiation of a large-scale women's HIV/AIDS cohort study of HIV transmission and disease progression. We have organized an interagency working group to help with the development of the study's protocol. One specific focus of the study will be HIV risk behavior and correlates of infection acquisition in intravenous drug users. Investigation of health care access and the psycho-social and economic impact of HIV disease in these populations has been selected as a high priority by this working group as well.
Data collection continues in the Women and Infants Transmission Study (WITS). Over 150 seropositive pregnant women and 115 nonpregnant women have been enrolled to date. Analysis is ongoing to determine the effect of drug use and sexual activity during pregnancy on perinatal HIV transmission.
The Heterosexual AIDS Transmission Study (HATS) has accrued over 70 couples whose HIV status is discordant. After receiving education about how to prevent HIV transmission, the couples will be followed for approximately two years to document seroconversion rates, behavioral risk factors for seroconversion, and emotional and behavioral responses to HIV infection. In addition, the HATS is recruiting 1,000 high risk seronegative individuals to study risk factors associated with acquisition of HIV infection. A psychosocial questionnaire to assess health related beliefs and behaviors is in the process of being developed.
The Multicenter AIDS Cohort Study (MACS) and the San Francisco Men's Health Study (SFMHS) are continuing to look at behavioral risk factors in relationship to disease acquisition and progression. Plans are underway to place the Young Men's Health Study within the SFMHS. This study will examine sexual behaviors in conjunction with knowledge, attitudes, and beliefs about HIV infection and AIDS in a population-based sample of gay men aged 18-29. This study will also assess attitudes toward potential participation in anti-HIV vaccine trials.
The Institute's treatment research program is expanding the behavioral research component of its research agenda within the AIDS clinical Trials Group (ACTG). To assess quality of life factors, this work began with one protocol, a study of three treatments for Pneumocystis carinii pneumonia. These parameters include physical functioning, productivity and work status, neurological and emotional well being, social functioning, and overall quality of life/ satisfaction. The results of this study will be monitored by a new Quality of Life Working Group that will develop new studies that are expected to be placed in drug protocols to assess quality of life issues with the goal of obtaining a wide range of this type of information.
A ma jor expansion of pediatric efforts and supplements to a number of adult AIDS Clinical Trial Units' grants targeted to minorities are providing social services to patients in need of this type of intervention. Data are being collected to enable the ACTG to assess the value of these activities, which include the provision of
transportation to trials, health care, counseling, and other support services. The Patient Care Committee of the ACTG is also developing nested studies to develop data on drug compliance as well as recruitment and retention in such groups as intravenous drug users and women with HIV.
Most of the donors who have transmitted HIV infection by transfusion were individuals who had risk factors but failed to exclude themselves during the donation process. The NHLBI, recognizing this problem, has initiated a study (as part of an ongoing program to study the epidemiology of transfusion transmitted retroviruses), which investigates donor behavior, in hopes of developing interventions that would help exclude donors at risk for HIV. In addition, the NHLBI funds programs designed to develop recruitment strategies to attract blood donors at low risk for HIV infection and to increase the utilization of autologous blood.
The NHLBI also has an active education program, the National Blood Resource Education Program (NBREP), which was developed in 1987 to ensure an adequate and safe supply of blood and blood components and to ensure that blood components are transfused only when necessary. Within the last year the NBREP has convened an expert panel to address the appropriate use of blood components and has developed a position paper which summarizes the current state of the art on the appropriate use of blood and blood products and has been distributed to more than 200,000 health care professionals. In addition, an expert panel on autologous transfusion has been convened and separate papers resulting from this meeting have been distributed to health care professionals and patients to have surgical procedures. A national survey of physicians' knowledge, attitudes, and practices with respect to appropriate autologous and homologous blood usage and related patient education is planned in the upcoming year. Data from this survey will be used to help in the NBREP'S planning and evaluation activities.
QUESTIONS SUBMITTTED BY SENATOR DALE BUMPERS
VACCINE INJURY COMPENSATION PROGRAM
Question. I understand that more than 4,000 pre-1988 claims have been filed in the Vaccine Injury Compensation Program, yet the FY 92 budget justification does not include a request for funding for pre-1988 claims. Why did you fail to request funding? Can the Subcommittee expect a supplemental request from the Department for pre-1988 claims?
Answer. Due to the sudden influx of over 2,700 claims received during the last few weeks before the October 1, 1990 deadline, and the uncertainty of the number of claims that would be submitted in response to the subsequent four-month extension of the deadline, the Department did not have an opportunity to thoroughly examine the new claims and develop estimates in time for submission of the FY 1992 President's budget. Clearly, Congress did not anticipate the number of claims that would be filed, since it only authorized appropriations of $80 million per year for this program. We now have better information for developing budget estimates. A total of 4,047 pre-1988 claims have been filed. This includes another 817 claims filed in response to the extension of the deadline.
After we develop and confirm estimates, the Department will consider approaches for providing support for adjudicated claims.
Question. When will you forward to the Subcommittee an estimate of the cost of compensating the 4,000 plus pending claims?
Answer. The Department has contracted with an actuarial firm to develop estimates for the over 4,000 pending claims. We expect to have these estimates within a few weeks.
Question. Some contend that the awards that are being made under the Vaccine Injury Compensation System dramatically exceed the average award that was anticipated. After more than two years of administering the program, are you prepared to make recommendations for modifications in the system that might make it operate more smoothly and that might address the larger-than-anticipated awards?
Answer. We will be reviewing a variety of issues related to this program and will seek advice from many sources, including the Department of Justice, Congress, and the Advisory Commission on Childhood Vaccines. Any potential revisions to the authorizing legislation will reflect scientific knowledge regarding causation of adverse effects related to vaccines, as well as the level of resource versus need consideration.
Question. How much money did you request of the Secretary for HIV programs in your original presentation for FY 92, as compared to the final level in the President's budget?
Answer. The FY 1992 HIV/AIDS request to the Secretary was $2,033,021,000 (including the Food and Drug Administration and the Indian Health Service). The FY 1992 President's Budget request for HIV/AIDS is $1,950,261,000.
DUPLICATION OF EFFORTS
Question. The natural history and transmission studies relating to HIV that are sponsored by PHS agencies are critical contributions to our understanding of this epidemic. I am concerned, however, by the number of different agencies involved in these studies. As I understand it, there are cohorts being studied at NIAID, NCI, NIDA and CDC. Are any of these studies duplicative, so that they might be merged or possibly reduced in number to save limited funds ?
Answer. CDC and NIAID conduct studies of the natural history of HIV disease. While these studies are addressing some of the same issues, each study has unique qualities either in the study design, the study participants, or the major emphasis. Having independent studies also allows for prompt confirmation of results from one study by the other study.
Question. Is the data collection in these studies such that they can be compared or merged in a meaningful way, so that larger cohorts could be formed?
Answer. CDC and NIAID staffs are in constant contact through review panels, scientific meetings, working groups, telephone consultation, etc. to look for ways to collaborate and to prevent duplication of efforts. As an example, a productive collaboration was recently established by combining CDC's heterosexual transmission study sites with NIAID sites into one multicenter study. In addition, CDC has recently established a working group with colleagues at several other PHS agencies to develop a common protocol for studying the natural history of HIV disease in women.
Question. What level of interaction is taking place among these agencies to assure that these studies are complementary and coordinated?
Answer. The data collection for the natural history studies in women will use a common protocol that will enable PHS agencies to collect comparable data for a single large cohort. The CDC and NIAID
are in the process of combining their heterosexual transmission studies by adopting a similar protocol which will result in comparable data that will be merged resulting in a more meaningful analysis of research questions. NIDA has worked to assure that HIV natural history and transmission studies that are funded complement, rather than duplicate each other and also that, as much as possible, they complement work being done by other agencies or institutions. This has involved close coordination between NIDA program staff and both NIDA grantees and representatives from other agencies. ADAMHA and CDC have established a formal work group for facilitating coordination and collaboration between the two agencies.
Question. The PHS is to be commended for its recognition of the disproportionate impact AIDS has had on minority communities. However, I am concerned about the coordination and duplication of programs targeted at minorities at risk. The budget justification for the Office of Minority Health says: "grants are made to national minority and community-based organizations which conduct health education and prevention activities directed to minority groups." The CDC justification says that the CDC Office of Minority HIV Policy Coordination is "providing funds directly to approximately 100 national, regional, and community-based organizations which represent or serve minority populations." How do these programs differ? What is the reason for separate administration of these programs?
Answer. CDC's direct-funded community-based organizations (CBOS) serving racial and ethnic minority populations must be nonprofit and must serve minority populations within the 31 high AIDS incidence metropolitan statistical areas, and the memberships of their governing bodies must have at least 50 percent racial and minority representation. CBOS currently funded by OMH may serve high, medium or low HIV incidence geographic areas, both urban and rural. OMH tends to fund organizations in areas with a lower incidence of HIV/AIDS. OMH-funded grants range from $50,000 to $75,000 annually, compared with CDC's which range from $20,000 to $225,000 annually.
Both CDC and OMH maintain ongoing collaboration to ensure that grantees of either agency are not funded to conduct the same activities. This is essential in ensuring that funds are wisely allocated and that a range of community needs are addressed.
CDC and OMH are currently discussing the relative benefits of separate administration, conjoint administration or the transfer of the OMH program to the sole administration of CDC. It is quite possible that OMH will merge and/or transfer its national and local HIV grants program with those of CDC.
Question. Similarly, the OMH justification says that it will "continue to support data collection and studies related to the knowledge, attitude and behavior of minority populations relative to AIDS as well as the incidence of AIDS among minority groups." At the same time the CDC justification lists numerous surveys to assess HIV knowledge and attitudes. How are these different and how are these coordinated? Could they be merged to save administrative costs?
Answer. The CBOS funded by either OMH or CDC may be involved with data collection and studies as part of their activities; these efforts are likely to represent different research methodologies and sample populations.
Merging efforts in at least some of these research areas in which it is feasible may benefit both CDC and OMH, as well as enhance the quality of data collection, replications and interpretation. This is being investigated as part of the initiative to develop a single administration for all of these efforts.
RYAN WHITE CARE FUNDING
Question. No increases are requested for funding of the Ryan White CARE programs HRSA and CDC. Given the rising number of AIDS cases and the increasing burden on our public hospitals as reported in recent studies, why is the Administration not increasing funding for these programs ?
Answer. In FY 1992, we are requesting the same level of support as Congress provided in FY 1991. We remain concerned about establishing fragmented approaches to health care on a disease specific basis. We prefer to address health services needs through existing mechanisms. To this end I would note that the estimate of services provided by the Health Care Financing Administration for HIV/AIDS increased 30 percent in FY 1992, to $1.36 billion.
Question. As you know, Title III of the CARE bill provides for early intervention services for people with HIV infection. These services are designed to provide testing, counseling, and drug treatment that will delay the onset of full-blown AIDS. In its budget justifications, the NIH reported that there is "an apparent decrease in the expected incidence rate of AIDS in the U.S. population. This decrease was abrupt and began in 1987. The most. plausible explanation for the decrease is the impact of therapy on preventing seriously immune compromised persons from progressing to AIDS.... It is noteworthy that decreases were most prominent in groups with the best access to care, but were not seen in groups (e.g., drug abusers) who have limited access to therapy." This would seem to underscore the need for expansion of the early intervention programs in Title III, since this is what they were designed for. Why hasn't the PHS requested more funding in this area?
Answer. We have multiple health problems in the United States that need to be addressed. The FY 1992 for Ryan White is maintained at the FY 1991 level and budget increases are directed to other high priority areas such as Project Healthy Start, National Health Service Corps Recruitment, and the Health Care for the Homeless. Some of these programs also will increase services for people who are HIV infected, although they are not specifically targeted for this group.
QUESTION SUBMITTTED BY SENATOR HARRY REID
CHRONIC FATIGUE SYNDROME
Question. In recent years, Chronic Fatigue Syndrome has been of great concern nationally, and especially in Northwest Nevada, where there has been a "cluster" of this illness. Who is supervising PHS activities related to this illness?
Answer. The activities related to Chronic fatigue Syndrome (CFS) are performed independently by two agencies of the Public Health Service, the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health and the Centers for Disease Control (CDC).
The NIAID has initiated two epidemiologic studies: one to estimate the prevalence of CFS in a population-HMO and the other in a general medical practice.
The CDC will continue to enroll new patients in its surveillance system across the U.S. These studies will help CDC to identify whether there are immunologic or virologic markers associated with CFS.