I have requested in hearings, through staff, and by telephone that the Administration provide the Congress with these professional judgments. The first promise to do so was made in February. now July. It is I now request that you forward immediately all documents regarding resource and personnel needs for AIDS for Fiscal Year 1986 and any documents regarding supplemental appropriations for AIDS work for Fiscal Year 1985. Such documents should include at a minimum all submissions made to: the Directors of each of the individual National Institutes of Health and the Division of Research Resources, the Director of the National Institutes of Health, the Director of the Centers for Disease Control, the Commissioner of Food and Drugs, the Director of the Alcohol, Drug Abuse and Mental Health Administration, the PHS AIDS Task Force, the Assistant Secretary for Health, the Assistant Secretary for Management and Budget, The Subcommittee on Health and the Environment has scheduled a hearing on AIDS research for July 22nd. If all documents are not received by that date, I will be forced to consider action to subpoena the information. I am indeed sorry to be so blunt in my requests. I do believe that my staff and I have made every effort to cooperate in the Department's schedule and to allow the Administration opportunity to act with reasonable efficiency. For six months, however, the Congress has awaited the courtesy of a response, and none has been forthcoming. During those six months almost 1,800 Americans died of AIDS and almost 3,300 more were confirmed to have this almost certainly terminal condition. Under such circumstances and in light of the Administration's previous years of delay and neglect, I do not believe that we can wait longer. SERVICES-USA THE SECRETARY OF HEALTH AND HUMAN SERVICES July. 19, 1985 The Honorable Henry Waxman Dear Henry: This letter is in followup to our conversation about additional funding for our efforts to combat AIDS. Since the Public Health Service reported back to me on the possible need for additional expenditures, there Deficiencies totaling $45.7 million were found in three major areas: epidemiological studies on the natural history of AIDS; research and development of primary prevention and control measures, such as vaccines and therapeutic intervention; and community health education and risk reduction for AIDS. Given the situation with the Supplemental Appropriation, I decided to act within my own authority as Secretary to reallocate the necessary funds for FY 85 and to request a budget amendment for FY 86. I am enclosing several documents which will provide you with the specific details of these transactions. I look forward to working with you on this critical matter. With best regards, Mayenth. Hackler Margaret M. Heckler Enclosures ACTIVITIES NEEDED TO ADDRESS THE AIDS PROBLEM Food and Drug Administration During the past 12 months, several major developments relevant to the transmission, prevention, and control of HTLV-III infection and AIDS have occurred. Serologic tests to detect HTLV-III antibodies have been licensed, and the tests are being used to screen donated blood and plasma. Furthermore, a number of therapeutic products have been entered into clinical trials and are under active investigation. The pace of these developments requires that FDA expand its surveillance and monitoring efforts. Activities undertaken as part of this request will increase our knowledge regarding the screening tests and enhance our ability to assure the safety of the Nation's blood supply; clarify the possible transmissibility of AIDS through food; and expand the capacity for review and approval or new diagnostic and treatment products. Specific activities will include: A five year followup and evaluation of blood ($1,000,000) A study of the impact of additional tests for A study to determine whether HTLV-III is present Additional quality control monitoring of test kits for HTLV-III (estimated 50 million production per year). Review and approval of second and third generation tests for AIDS, including tests for viral components, and evaluation of diagnostic and treatment products, including an eventual vaccine against the HTLV-III virus. Development of adequate methods for collecting A. Centers for Disease Control Epidemiology and Natural History of HTLV-III Epidemiologic studies indicate a high prevalence of infection in many populations of homosexual men, abusers of intravenous drugs, and persons with hemophilia. Conclusive evidence of heterosexual transmission now exists and this mode may play a predominent role among Haitian-Americans as well as in central Africa where there is evidence for widespread HTLV-III infection. Since HTLV-III infection precedes AIDS by many years, it is important to determine the incidence of new infections in order to monitor the current transmission patterns and to evaluate the impact of changes in behavior. To provide sound advice regarding personal protection, it is important to more clearly define the relationship of a positive test to the HTLV-III antibody and clinical symptoms to transmissibility through sexual activity or to the newborn during pregnancy. Activities undertaken as part of this request will place new emphasis on determining the incidence of HTLV-III infection in selected geographic areas and among major high incidence groups. Investigations will be conducted to determine the persistence of virus infection, virus transmissibility, and inocula size, and to clarify risk factors and prospective factors for HTLV-III infection and subsequent development of AIDS in high-risk groups. Specific activities will include: Increased Surveillance Measurement of the magnitude and trends of HTLV-III high AIDS incidence and three with low to moderate Evaluation of active surveillance procedures and completeness of AIDS reporting through review Laboratory proficiency testing and training of Expansion of work on the sensitivity and specificity Expansion of studies to clarify the extent and hospitals and from infected children in day care centers. |