Government
Government launches new steps against AIDS On Oct. 11, some 600 activists, by will use risk-benefit analysis to appolice count, conducted daylong prove use of a drug if its benefits demonstrations and civil disobedi- outweigh known and potential risks, ence actions around the Food & even if some questions (such as Drug Administration's headquarters lowest effective dosage) remain for outside Washington, D.C. (C&EN, postmarketing study. Oct. 17, page 5), drawing nation• The Centers for Disease Conwide attention to their charges of trol (CDC) unveiled a new wave "criminally inadequate" responses of television and print media ads, by FDA and the Reagan Administra- the second year of its multimedia tion to the AIDS (acquired immune "America Responds to AIDS" edudeficiency syndrome) epidemic. cation campaign, this time targeting By striking coincidence, in the women at risk and sexually active days since the protests, Congress adults with multiple partners. • The National Institute of Allerand the Administration have responded to many of the concerns gy & Infectious Diseases announced raised by AIDS activists. They have establishment of multidisciplinary moved on a variety of fronts to ac- Centers for AIDS Research at seven celerate the fight against AIDS (all universities and award to them of five-year grants. Funded for a total steps initiated well before Oct. 11): • After lengthy controversy and of $6.7 million the first year, the hard negotiations, Congress passed centers are at Purdue University; a compromise bill with bipartisan University of California campuses support stepping up AIDS research, at Davis and San Francisco; Univertesting, treatment, and education, sity of Washington, Seattle; Univerin what one sponsor called "the first sity of Alabama, Birmingham; Stancomprehensive federal response to ford University; and Albert Einstein the AIDS epidemic." Presidential College of Medicine. signing is expected. Meanwhile, international cooper• FDA announced new proce- ation in AIDS research got a major dures aimed at cutting, by as much boost. The U.S/s nongovernmental as half, the time required to clear Institute of Medicine signed a prodrugs for life-threatening diseases tocol with the Soviet Academy of like AIDS or cancer. The agency Medical Sciences calling for joint will work closely with drug spon- research on AIDS and in three othsors early in the approval process er areas as initial fields for cooperato set the most time-efficient ani- tion under a five-year exchange mal and human studies, and will agreement reached last January. The eliminate Phase III of studies. FDA focus will be on basic AIDS virolo-
Angry activists assailing Administration AIDS policies besiege FDA building 16
October 31, 1988 C&EN
gy and host responses to the infection, with a joint symposium in the U.S. in the first half of 1989. The AIDS measure passed by Congress, filling nearly 15 pages in the Congressional Record, was part of an omnibus authorization bill for health programs. The AIDS measure calls for expediting research funding, promoting clinical trials of new drugs, and expanding information programs and education. For example, if there is preliminary evidence of a drug's efficacy in humans, officials are to announce this and invite investigational new drug (IND) use in clinical trials. They are to encourage requests for "treatment IND" status to allow use of the drug to treat AIDS victims not involved in clinical trials. And they are to set up a data bank to inform AIDS patients of clinical trials and treatment INDs. The AIDS bill also establishes an Office of AIDS Research at the National Institutes of Health to coordinate AIDS activities. It authorizes addition of 780 employees to the Public Health Service to work on AIDS-related matters, at least 300 of them at NIH, 350.at CDC, 50 at FDA, 45 at the Alcohol, Drug Abuse & Mental Health Administration, and 25 at the Health Resources & Services Administration. And the bill creates a National Commission on AIDS, succeeding the highly regarded Presidential commission that ended its work in June. The new commission is to monitor implementation of the earlier commission's report, make new recommendations, and promote development of "a consistent national policy" on AIDS, with a final report due in two years. Other provisions of the bill allot block grants to states for home and community-based health services for AIDS victims; target prevention programs at minorities and intravenous drug abusers; and require rapid development of guidelines to protect health and public safety workers against AIDS infection. The bill also provides for testing for the AIDS virus and counseling, but opposition by conservatives forced omission of safeguards on confidentiality and nondiscrimination. Richard Seltzer
