FDA Panel Meets To Discuss Ways To Test Safety, Efficacy of Experimental Microbicides To Prevent HIV Transmission

An FDA panel yesterday met to discuss ways to test the safety and efficacy of microbicides in preventing HIV transmission, Dow Jones News Service reports (Middleton, Dow Jones News Service, 8/20). Microbicides include a range of products such as gels, films, sponges and other products that could help prevent the sexual transmission of HIV and other sexually transmitted diseases (Kaiser Daily HIV/AIDS Report, 6/2). Although HIV is primarily transmitted through heterosexual intercourse in much of Africa and Asia, no female-controlled HIV prevention method currently is widely available (Kaiser Daily HIV/AIDS Report, 7/29). The panel yesterday was discussing whether tests of microbicides should compare the product to condom use, to an inactive placebo or both. They also discussed how long a experimental microbicide trial should be and what data would need to be reported to show that the microbicide was effective, according to Dow Jones News Service. Dr. Debra Birnkrant, director of the FDA's division of antiviral drugs, said, "There is extreme urgency to develop a topical microbicide rationally and get it on the market as soon as possible. ... We've been wrestling with these issues for a few years now."

Conclusions
The panel was unable to come to a consensus on the issues and said that the first experimental microbicide to be tested would "likely face the highest hurdle" and future products would "benefit from the knowledge gained by the first successful product," Dow Jones News Service reports. Some panelists said that they were concerned about requiring a comparison to condom use because women cannot always require their partners to use condoms in some countries where microbicides will be tested. Other panelists expressed concern that women who require their partners to use condoms -- currently, the most effective way to prevent HIV transmission -- may stop doing so in the future if a microbicide is approved. Dr. Roy Gulick, director of clinical trials at the Weill Medical College of Cornell University and chair of the panel, said, "In summary, we're not sure. All approaches have value," adding, "There is no one right answer here" (Dow Jones News Service, 8/20). The Bill & Melinda Gates Foundation in March announced that it would award $60 million to the International Partnership for Microbicides for research into the use of microbicides to prevent HIV transmission. Researchers hope to have a product on the market by 2007 (Kaiser Daily HIV/AIDS Report, 6/2).