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NIAID AIDS-RELATED DRUG DISCOVERY FUNDING

Executive Summary

NIAID AIDS-RELATED DRUG DISCOVERY FUNDING will shift to an increased emphasis on drugs for opportunistic infections, National Institute of Allergy & Infectious Diseases Director Anthony Fauci, MD, said at an Aug. 1 hearing of the House Government Operations/Intergovernmental Relations Subcommittee. The shift will occur over the next two years as current studies focusing on antiviral treatments expire. Fauci suggested that a 60% antiviral therapy/40% opportunistic infection therapy research allocation, as recommended by NIAID's Opportunistic Infections Committee, is a "reasonable empiric goal" but the institute will remain "flexible." Further, it is unclear how such allocations will be defined, for example, in terms of dollars, number of research subjects, or number of studies. To boost its program in basic research on opportunistic infections, NIAID announced Aug. 1 that it is awarding $2.8 mil. to six teams of scientists to design drugs targeted at opportunistic infections such as cytomegalovirus (CMV) and mycobacterium-avium intracellulare (MAI). The grants are part of NIAID's national cooperative drug discovery group program. Awardees and their research topics are Abbott Labs, fungi-cell wall inhibitors; Colorado State University, MAI; Palo Alto Medical Foundation, toxoplasma; Washington University School of Medicine, fungi-enzyme inhibitors; Southern Research Institute, Pneumocystis carinii, CMV, and toxoplasma; and the University of Arizona, cryptosporidium. Similarly, NIAID's funding of its AIDS Clinical Trials Groups (ACTGs) also will increase allotments for opportunistic infections, Fauci told the subcommittee, chaired by Rep. Weiss (D-N.Y.). Fauci said NIAID will begin requiring that each ACTG submit a plan detailing its research related to opportunistic infection. Over the next year, NIAID will link performance on opportunistic infection studies to the group's funding, he stated. "In the next year or so...we'll see a dramatic improvement in the accrual" for clinical studies on opportunistic infections, Fauci predicted. Currently, one-third of all ACTG active protocols address HIV-associated opportunistic infections, representing 21% of all ACTG trial enrollees. About $41 mil. is being spent on opportunistic infection research in FY 1990. For FY 1991, the figure is expected to total about $47 mil. However, Fauci said that "one of the major obstacles to getting people" enrolled in opportunistic infections studies has been the lack of insurance reimbursement for clinical trials. "Once the catch-word 'protocol' is attached to a patient, then it becomes very difficult to get third-party payments, even though the kind of care that [the individual] would get on a protocol would be standard care...that would be paid for" if the person was not enrolled in a clinical trial, he said. The problem of insurance coverage has been discussed "on multiple occasions at the HIV leadership group, where the various agencies of the Public Health Service involved in AIDS activities meet every two weeks," Fauci said. The consensus of the group has generally been that "a solution is not readily at hand," he added. Chairman Weiss told Fauci that "it seems to me outlandish for there to be a concern with budgetary problems to the extent that [insurers] in fact deny care and research for people who are dying by the thousands and tens of thousands." At the hearing, Fred Sattler, University of Southern California's School of Medicine and head of the ACTG's Pneumocystis carinii Pneumonia Pathogen Study Group, remarked that Medicaid and Blue Cross plans "will not pay for costs of hospitalization if patients receive experimental therapy for [PCP] or CMV retinitis, even though these patients would have required hospitalization anyway for treatment of their infections."
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