AIDS research; and increased personnel and facilities resources to enable NIH to conduct and manage an effective, efficient AIDS research program.
Although the committee was not asked to address health care issues, it could not avoid the finding that NIH-sponsored research on HIV infection and AIDS has been hampered by inadequate participation in clinical trials of some high-incidence groups whose members are not insured for and are unable to pay for treatment or associated medical care. This lack of coverage of some high-incidence populations is part of the larger problem of health care delivery and financing for persons with AIDS, a problem that looms ever larger as more and more individuals acquire the disease in the near future. The committee believes that NIH's mandate is to facilitate the discovery and clinical evaluation of therapeutic, diagnostic, and preventive agents and not to assure health care. This problem must be addressed at more appropriate levels of the federal health policy-making establishment.
Recommendation 1.2: The Health Care Financing Administration (HCFA) should make its reimbursement policies consistent with NIH assessments of promising treatments so that when treatments have moved beyond phase 1 testing, their associated medical care costs (and the costs of the treatment if the sponsor is unable to provide it free of charge) are covered for Medicare and Medicaid beneficiaries.
Changing HCFA policies to cover treatment and other medical care costs associated with research is only part of the solution to the problem of caring for HIV-infected persons. A more comprehensive approach to financing such care will be needed to eliminate barriers to participation in AIDS/HIV clinical research and to ensure that the improved therapies that emerge from federally supported research are available to those who need them.
Recommendation 1.3: The administration and Congress should immediately address and resolve financial barriers to the receipt of appropriate medical care by persons with HIV infection.
HIV and AIDS are not solely challenges faced by physicians and scientists. The management of NIH has also been presented with an unprecedented task in developing, implementing, coordinating, and evaluating a rapidly growing, complex set of AIDS research activities that now involve every NIH institute, center, and division.
AIDS research at NIH is unusual in that it is not organized under an institute as are, for example, cancer research, vision research, and research on cardiovascular diseases. Instead, NIH is managing the AIDS research program as an “institute without walls,” operating the AIDS program from the Office of the NIH Director but using organizational elements analogous to those of the institutes. These elements include a director (the associate director for AIDS research), a national advisory council (the AIDS Program Advisory Committee), an executive committee of senior program officials (the NIH AIDS Executive Committee), and an executive office for staff support (the Office of AIDS Research, or OAR). The committee believes these organizational arrangements and associated administrative processes for managing AIDS research should be strengthened, as an alternative to creation of a separate AIDS institute, and institutionalized as a major long-term program at NIH.