The U.S. Food and Drug Administration this week approved so-called “Pink Viagra,” the first drug supposedly designed to increase women’s sexual desire.
“Supposedly” because it isn’t entirely clear whose desire is actually being satisfied here – that of the small minority of otherwise healthy women who want to feel aroused but can’t, for no good cultural or psychological or physical reason, or that of the pharmaceutical company that stands to make a bundle.
Flibanserin, the drug involved, is actually an antidepressant. Unlike Viagra, which men take as needed, it has to be taken daily. Fainting, dizziness and sleepiness are among its rare but serious side effects.
You can’t safely drink while you’re on it (which is counterintuitive, romantically speaking). And there are real questions about whether the benefits outweigh the risks and whether it works much better than a placebo.
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That’s why an FDA advisory panel recommended against its approval in 2010 for treatment of “hypoactive sexual desire disorder” in women, and the FDA rejected a second application in 2013.
Those concerns didn’t stop Raleigh, N.C.-based Sprout Pharmaceuticals, which is banking on that FDA approval. After the second rejection, the drug company appealed, lobbied, agitated, ginned up letter-writing campaigns, flogged Change.org petitions, exploited new rules and made political contributions until the beleaguered FDA advisory panel changed its mind.
The drug involved is actually an antidepressant. Unlike Viagra, which men take as needed, it has to be taken daily. Fainting, dizziness and sleepiness are among its side effects. You can’t safely drink while you’re on it. And there are real questions about whether it works much better than a placebo.
Never mind that respected groups, including the National Women’s Health Network and American Medical Women’s Association, urged the FDA to reject flibanserin. Sprout’s principals donated more than $40,000 in 2014, mostly to Democrats.
Sure enough, the company-backed “Even the Score” initiative managed to enlist the National Organization for Women, Reps. Doris Matsui of Sacramento, Jackie Speier of Hillsborough, Lucille Roybal-Allard of Los Angeles, and at least eight other Democratic members of Congress to write FDA Commissioner Margaret Hamburg early this year urging the drug’s approval.
Their argument? That the FDA had approved about two dozen medical treatments for male sexual dysfunction but none for female dysfunction, so there must be a gender bias.
That’s specious, and no way to regulate drugs. Most physicians view a loss of female libido not as something that can be treated with a Viagra-like drug, but as a symptom of some other underlying health concern.
Antidepressants are serious business. They target the brain, not other parts of a woman’s body. It’s irresponsible to market them as romantic accoutrements.
But even if flibanserin – or Addyi, as it has been commercially dubbed – were an obvious solution to an obviously physiological issue, its approval should be based clearly on evidence, not some third-time’s-the-charm political blitz.
The stock price of Palatin Technologies, which also has a female libido drug in the pipeline, has risen by more than 40 percent since February as flibanserin has neared approval. Sprout Pharmaceuticals will likely soon contemplate a public stock offering.
Over the years, the FDA has done much to protect the public from unsafe drugs. In this instance, the pharmaceutical industry seems to be using political muscle to seduce regulators, while claiming to be championing women’s health.