March 10, 2005

'Vaginal Goop' for the Masses?

Microbicides are promising—but they’re not ready to fight AIDS yet.

David Goldenberg

A new study shows that a certain microbicide—a gel smeared on the vagina—might be a way for women to protect themselves from HIV. Because this finding coincides with increased NIH funding for microbicide research and a new Senate bill calling for increased coordination within government agencies for this research, the press has jumped on the story, proclaiming that the gel is the new method for AIDS prevention in women.

It’s an empowering story—women no longer have to worry about whether the men they sleep with will wear a condom. The goop will be cheap and accessible for everyone. HIV will return to the Hell from which it came. But, for now at least, the story isn't true.

In Slate, writer Amanda Schaffer talks about microbicides in Rocky fashion—the only thing missing is a training montage where some of the goop runs up the stairs to the Philadelphia Art Museum. Schaffer claims that the reason microbicides have been ignored is that politicians are squeamish and the scientists think that studying the gel is lowbrow. Finally, the underestimated contender will get a chance.

But when Schaffer asks, “What’s the scientific establishment's hangup?” she misunderstands the scientific process. The “hangup” is that no microbicide has ever been shown to work in a true clinical trial. The recent study showing the most potential, a Mt. Sinai clinical trial with the microbicide PRO 2000, is merely a vignette—only 20 women were tested, and all were HIV positive to begin with. (Among other media outlets trumpeting the trial: the New York Times and WebMD. What the trial showed, however, was that the vaginal fluid of the women who had applied PRO 2000 contained significantly lower quantities of infective agents. In effect, what was done was a phase I trial that only proves proof of concept. It doesn't even show whether the reduction in infective agents is correlated with a reduction in HIV transmission. A more substantial trial with thousands of HIV-free subjects is still in the planning stages.

Other real clinical trials with microbicides have been failures. The story of Nonoxynol-9, which used to be the most popular microbicide in the world, is one reason both the political and scientific world approach this type of vaginal gels with caution. N-9, as the gel was known, was shown in a 2002 study of Kenyan sex workers to not only have no prophylactic effect against HIV, but also to cause types of vaginal irritation that are associated with an increase in the virus.

That’s not to say that no microbicides will ever be found to be effective against HIV. But for now, there are none. Indeed, in her article, Schaffer falls back on a hypothetical mathematical model to show what effect microbicides will have on the spread of HIV.

Even politically, the article is off. Schaffer praises Senators Barack Obama, John Corzine, and Olympia Snowe for backing a bill that would give more funding to vaginal microbicides, claiming that in doing so, they are bravely playing with a political hot potato:

The problem isn't vociferous opposition. It's that few legislators are willing to put themselves on the line for a product that makes them blush. We are talking, after all, about goop for the vagina (as opposed to, say, a vaccine that can be injected neatly into the arm). Which means that we're talking about sex.

That's overstating the case. The NIH has been funding microbicide research for the past three decades; in 1999, the Congress House Appropriations Bill specifically called out microbicides as a possible anti-HIV agent. This year, the National Institute for Allergy and Infectious Diseases named microbicides one of the six priorities for its research agenda for HIV/AIDS treatment and prevention. Certainly, the Bush government has had problems with conflating research with activism—the administration recently made it a requirement for private AIDS groups to sign statements pledging their opposition to prostitution in order to receive federal funding, for example. But this government also has increased NIH funding for AIDS-related research.

Until the randomized microbicide trials are completed, the cheerleading makes little sense.

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- Nature
- posted on Mar 18, 05
Contributor A

I for one wasn't thrilled about the use (repeatedly) in Schaffer's article of the words "goop for the vagina". Good lord. On one hand she's sticking up for microbicides, and on the other she seemes to want to make them sound as unpleasant as possible. I for one find microbicides promising (yes, with caveats, but still). So why "goop goop goop"? It's like if you were trying to promote condoms and you called them "a rubber sock for your ..."

Microbicide-promoters have a great nickname - "the invisible condom". If that's what microbicides could become, they'd do the world an enormous amount of good.

Article by David Goldenberg

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