Sunday, June 20, 2010

FDA Deprioritizes Women's Sexual Dysfunction, Again: Flibby is a No-Go

The helpful educational website funded by Boehringer

An FDA advisory panel voted unanimously Friday not to approve Flibanserin, a drug aimed to remedy "hypoactive sexual desire" in pre-menopausal women. This drug has been in clinical trials for a while so we've heard about their poor measures before: the researchers found that women taking the drug reported .8 more "sexually satisfying events" per month than those on placebo (though the placebo users also had an increase in "events") and the difference was statistically significant.

What they failed to show was an increase in desire. They also didn't explain what "sexually satisfying event" meant. But none of the flaws in the research design kept the manufacturer, a German company named Boehringer Ingelheim Pharmaceuticals, from developing a media blast and securing Lisa Rinna, the generously lipped former soap star, as their shiller.

Let me repeat that: this company began advertising the disorder it purports to treat before their drug was approved. Now that the drug has been formally rejected it will be interesting to see how long the website, SexBrainBody, stays up. The site is formally under the guise of the Society for Women's Health Research but surely the grant won't go on forever now that the drug is a no-go.

Of course there is a connection between sex, the brain, and the body. But that framework excludes another important reason women might experience low sexual desire: a shitty relationship. One may feel sexual desire in general, but not for one's long term partner in particular. Such decline is a well documented feature of even the healthiest of marriages. But to pathologize such a problem recalls the days when a husband could present his wife to a physician for being refusing to perform sexually and expect a diagnosis of "frigidity."

But on the other hand, the reason given for rejecting the pill, that its "risks" did not justify the use, seem a bit thin: the side effects include dizziness, nausea, and fatigue. While I'm no advocate of medicalization, drugs for women's sexual dysfunction have repeatedly failed to pass muster with the FDA, sometimes for bullshit reasons. Considering that Viagra increases the risk of cardiac arrest--a leading cause of death for men in the silver fox age group--dizziness, nausea, and fatigue sound pretty mild.

Everyone knows that many men take Viagra, Cialis and Levitra as "enhancements" and not because they have clinical erectile dysfunction, and women ought to have their own fair share of drugs to enhance their sexual experience, either on the front end of desire or the back end of response. The FDA's continued refusal to approve testosterone and other sex enhancing drugs for women suggests a fear of women's sexuality, not agreement with anti-medicalization sentiment.

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