Microbicides would allow ladies to control their own sexual safety, without depending on men to wear a condom and avoid unsafe sex on the side. Though activists have pushed the products as a funding and research priority since 1990, not one has been approved—prompting charges that the medical establishment ignores women’s safety. (It’s an equal-opportunity offender: No gels for men exist either.) In January, however, the Food and Drug Administration put the HIV-blocking vaginal microbicide VivaGel on what it dubs its “fast track” to approval. Fast-track status means that the FDA will speed the review of all findings. It doesn’t mean more funds will be pumped into VivaGel’s development. The manufacturer, Starpharma, hopes for approval as early as 2008. Anna Forbes from the Global Campaign for Microbicides, says, “2008 is very optimistic. VivaGel hasn’t entered Phase III [human] trials yet.”
VivaGel is the second microbicide to be fast tracked (the first was in 2003 and is still in Phase III trials), and dozens more are creeping up the pipeline. “It’s good news, but we need to move the whole pipeline forward,” Forbes adds. “Nobody knows which one is going to work.”
Global funds for microbicides more than doubled from $66 million in 2000 to $163 million in 2005. “We had several microbicides in advanced trials, and people noticed that women now make up the majority of new infections. It caused a shift in public discourse,” says Forbes. “But we still have only half the funding we need.” The International Partnership for Microbicides recently received a $30 million grant, but the organization’s Joseph Romano, MD, says it needs $100 million more by 2007 to get even one microbicide through Phase III trials. And then, hopefully, fast track a sexual revolution.