A 'Viagra for women' has been approved - but don't count your orgasms yet
A new drug claiming to be a 'viagra for women' is on its way to us. It's called Addyi, and it just got approved by the US Food and Drug Administration. It also has everyone really excited because finally, yay, someone cares about women getting off.
The pill, made by Sprout Pharmaceuticals, contains flibanserin, a non-hormonal medication for aiding sexual desire in premenopausal women who suffer from hypoactive sexual desire disorder (HSSD) - a condition where sexual desire is entirely absent.
But hold on for a moment.
There is, in fact, very little reason for excitement.
Because while you think that an organization that banned Haldiram's (as the FDA did earlier this year) has high standards, this approval may be less testament to how safe the drug is, and more a product of some incredibly well-marketed arm twisting.
Here's three facts that explain why:
Fliberanserin has been rejected twice before
This time, though, the drug was approved. Why? Was the formulation changed to make it safer? More effective? Or did they carry out further tests that completely changed our understanding of the drug? Not quite.
In 2013, the drug manufacturers launched an 'Even the Score' campaign, one that had women's groups aggressively throwing their weight behind the drug.
"There are 26 FDA approved drugs to treat various sexual dysfunctions for men," the campaign's site reads, "but still not a single one for women's most common sexual complaint."
This is deliberately misleading. There is no FDA approved drug to increase a man's libido - as this drug does for women. There are drugs that help with erectile dysfunction and low testosterone, like Viagra, but none that help increase a man's sexual desire.
This means that the score was always even. Drugs for sexual dysfunctions, yes. Drugs for enhanced desire, no.
"Even the Score" did however, garner tremendous support, and an advisory team recommended that the FDA approve Fliberansin. This week, it did it did just that.
The drug will be available on pharmacy shelves starting this October.
The drug doesn't quite do what it claims to
Only between 8 and 13 percent of women who tried the drug claim it helped them more than the placebo. Women who've taken the drug have on an average 0.5 more 'sexually satisfying events' in a month.
So for a month of regularly taking a drug, you get to enjoy yourself just a little bit more on 0.5 occasions. Think that over.
The drug does do a lot of things it doesn't advertise
Like make you drowsy and dizzy, faint or cause your blood pressure to drop. And taken with hormonal contraceptives, which is how many women would consume a drug that enhances sexual desire - the side effects only get worse. Oh, and alcohol can also further exacerbate the side effects. (Interestingly, the study that tested the impact of the drug on alcohol consumers tested it on 25 people. Of those, only 2 were women. Which means we don't really know how it would affect women who drink alcohol while taken the drug.)
And to top it off, we don't know how it can affect flibanserin- takers in the long run at all, because the studies were conducted over very short periods of time.
What all of this means is that while prescribing the drug, doctors will have to assess what contraceptives a woman is likely to use, whether she can abstain from alcohol as well as figure out whether she has a cardiac condition. Without the faintest clue about what it could do to her in the long run.
That's simply too much to ask. In the words of an internist in Pittsburgh, Walid Fouad Gellad who spoke to Vox about flibanserin, "If you're going to give something to women and they can pass out any time, that's a real problem". There's very little arguing that. This doesn't necessarily mean that the drug should be banned.
Perhaps, given that no drug in the market exists to remedy a woman's low sexual desire, this one ought to exist.
But a drug that seems to do more damage than good is hardly cause for celebration. Thanks, Spout Pharmaceuticals. But the 'Even the Score' party celebrations will just have to wait.