'Female Viagra' Gets Backed in 18-6 Vote by FDA Panel

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Flibanserin, otherwise known as the “female Viagra,” is in the hands of the FDA. The administration is due to make a decision by the end of this summer for the third time now as to whether or not the drug is safe for the American public.

Sexuality is such a complex thing. The way Esther Perel, best-selling author of Mating in Captivity: Unlocking Erotic Intelligence, talks about it, it’s hard to believe all issues could be solved with just one pill:

The name “female Viagra” is pretty catchy, but it compares flibanserin to a drug that couldn’t be more different from it in how it works. You see, Viagra and other male enhancement drugs cause physical shifts in a man’s body, working on the arteries to increase bloodflow so the man can get an erection. Flibanserin works on a woman’s chemistry, stepping up the flow of dopamine and norepinephrine. This chemical shift is supposed to help women who suffer from hypoactive sexual desire disorder to feel turned on. However, <a href="http://nymag.com/scienceofus/2015/06/fda-panel-just-approved-female-viagra.html#jumpLink" target="_blank" rel="noopener">Melissa Dahl from NYMag</a> reports that in doing so, this drug also “decreases levels of serotonin, which is associated with sexual inhibition.” What’s more, where Viagra and other male enhancement drugs should be taken on an as-needed basis, flibanserin requires daily use in order to be effective. Sprout Pharmaceuticals is responsible for the drug flibanserin. During the committee hearing it presented the results from its double-blind clinical trials, which lasted 24 weeks. The women who took part were reporting an average of two to three “sexually satisfying events” per month before they began taking the drug or a placebo. At the conclusion of the trials, the initial results were promising, showing 46 to 60 percent of the women had benefited from treatments. But when adjusting the data to take into account the placebo group, the drug only ended up helping 10 percent of the women. <a href="http://www.nytimes.com/2015/06/05/business/panel-backs-a-drug-to-increase-womens-sex-drive.html?_r=0" target="_blank" rel="noopener">Andrew Pollack from The New York Times</a> added in his own article: <blockquote> “Once they started taking the drug, the number of such events increased, but by only about one event per month more than for women in the trial who got a placebo.” </blockquote> The FDA has been slammed after passing up on the drug before by women’s groups under the banner Even the Score. The group states that there’s a gender bias at the FDA, because it has continued to approved numerous male enhancement drugs and not let through the one drug that’s giving women who suffer from hypoactive sexual desire disorder hope. However, Pollack writes that “Michele Orza, the consumer representative on the committee, voted against approval, saying that women with low desire ‘deserve better.’” So, is it the gender bias of the FDA or the market? It’s uncertain at this point. But the FDA is facing a new concern on this third pass: the pressure of the emotional voices that site at the center of this campaign to get the drug approved. For example, take Katherine Campbell, a woman who’s willing to do whatever it takes to revive the sexual part of her marriage. She told Pollack: <blockquote> “Critics say the improvement might only be modest, but, oh, what I would give for even a modest improvement.” </blockquote> Sexuality is such a beautiful part of any relationship and it would pain me to lose that with my own partner. I can relate to the desperation one would feel to have that connection with someone you’ve loved for so long lost over time. But I worry that politics and public pressure may get in the way of scientific decision-making and doing what’s right for the American people. It wouldn’t be the first time (see David Miller and John Wilson and their studies on the vaccine DTP). The FDA was built to protect the American people. I rely on it to keep the food and drug market in check. I can only hope it does what’s best for the women suffering and that researchers continue to find better ways to help women who suffer from hypoactive sexual desire disorder. Read more about the issue at <a href="http://nymag.com/scienceofus/2015/06/fda-panel-just-approved-female-viagra.html#jumpLink" target="_blank" rel="noopener">NYMag</a> and <a href="http://www.nytimes.com/2015/06/05/business/panel-backs-a-drug-to-increase-womens-sex-drive.html?_r=0" target="_blank" rel="noopener">NYTimes</a>. Photo Credit: Shutterstock

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