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Executive Summary

AIDS ANTIVIRAL DRUG TESTING: 250 COMPOUNDS HAVE BEEN TESTED IN VITRO under a National Institutes of Health (NIH)/National Cancer Institute (NCI) screening program, a joint Institute of Medicine/National Academy of Sciences committee noted in a report on the AIDS situation released Oct. 29. Acknowledging the limited nature of the screening program, the report observes that the program "has to date been limited largely to in-house selection to compounds collected over the years by NCI for evaluation against cancer in animal models." According to the report, "Confronting AIDS: Directions for Public Health, Health Care, and Research," there is "presently no satisfactory program whereby scientists from academic institutions, research institutes, or the pharmaceutical industry may send significant numbers of candidate antiviral agents for evaluation against HIV in vitro." The committee pointed out that this situation is due in part to "problems related to safe handling of the virus", which has "greatly restricted its use in most laboratory settings." The committee declared that the substantial expansion of the existing NIH screening program "is absolutely essential to future drug development in this area . . . to serve industrial and academic research and research institutes outside of NIH, under a confidentiality agreement if necessary." The report also asserts that the NIH drug development program for contract proposals from "cooperative multidisciplinary groups is woefully inadequate in funding to meet the stated needs." On AIDS drug research, the committee made 12 recommendations, including: the establishment by the federal government of an in vivo and in vitro screening program for potential AIDS drugs; "the selection of unique viral processes or proteins as drug targets" instead of a reliance on mass screening of potential compounds; the review of study protocols on a "case-by-case basis"; and the development of new guidelines for the acceptance of new antiviral agents in clinical evaluations against AIDS. In addition, the committee recommended that, "a conference should be convened as soon as possible to bring together researchers from industry, academia, and the Public Health Service to consider the key issues necessary for the development of antiviral drugs. Such a meeting could consider the unique capabilities of NIH . . . to facilitate industry's development efforts." Written prior to HHS' decision to make AZT the control drug for future AIDS clinicals, the committee report anticipated the government response to the Burroughs-Wellcome drug: "after an effective agent is identified, newer drugs can and should be compared to it rather than to a placebo." Other antiviral agents in clinical studies cited in the committee report include: ribavirin, alpha interferon, suramin, HPA-23, and foscarnet. Commenting on ribavirin, the committee noted that an "independent safety and evaluation committee has reviewed the first 12 weeks of a 24-week clinical trial of ribavirin with 373 patients at eight clinical centers in the United States . . . [and] found that ribavirin's safety profile through 12 weeks is acceptable and that the drug has been well tolerated by the patient groups." The report also notes that clinical studies with alpha interferon "have demonstrated potentially beneficial effects against Kaposi's sarcoma." Commenting on the difficulties of finding a drug for AIDS, committee member David Baltimore, Whitehead Institute for Biomedical Research and MIT, said that the ideal drug for AIDS "must not only stop the replication of the virus and progression of the disease, it must also permit regeneration of the immune system . . . it must be conveniently administered, preferably orally; it must be nontoxic over long periods, perhaps a lifetime; and it must be active not only in peripheral immune system cells but in the central nervous system as well." Baltimore added: "No drug, including AZT, has been shown through testing to meet these criteria." The committee recommended that the annual budget for AIDS research be doubled in the near term. "The Public Health Service's request to HHS for AIDS-related research in FY 1988 was $471 million . . . The committee believes that there are sufficient areas of need and opportunity to double research funding again by 1990, leading to an approximately $1 billion budget in that year."

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