written by reader “Viagra for Women” – Thumbs Up or Thumbs Down?

Doc Gumshoe looks at flibanserin

[ed. note: Michael Jorrin, who I like to call Doc Gumshoe, writes mostly non-financial articles about health topics for our readers a couple times a month — he is not a doctor (he’s a longtime medical writer), he chooses his own topics, and his words and opinions are his own. Enjoy!]

It was only a couple of weeks ago that the news hit the headlines. An FDA advisory committee voted 18 to 6 to recommend approval of a drug that, it is hoped by some – certainly including the drug’s manufacturer – would enhance sexual desire in women and attain the same kind of market appeal that Viagra and the other drugs that treat erectile dysfunction have attained.

Usually when an FDA advisory committee votes a recommendation by such a decisive margin, the FDA heeds the advice. This time, most observers are not so sure the FDA will go along. According to the news releases, every single advisor who supported approval for the drug did so with important reservations.

I think FDA approval of this drug would do more harm than good, and I hope the FDA resists the pressure that is being placed on it and rejects the application.

The drug is flibanserin, which was initially developed by Boeringer Ingelheim, who dropped it after the FDA rejected it twice – first in 2010 and then again in 2013. A very small company, Sprout Pharmaceuticals, then acquired the rights to flibanserin. Since then, Sprout has mounted a campaign to persuade the FDA that flibanserin should be approved based more on the “fairness” issue than on efficacy and safety.

The “fairness” issue can be stated simply, although somewhat moronically in my view: There are a couple of dozen drugs approved by the FDA that improve sexual performance in men, but there are no FDA drugs that do the same for women. That constitutes gender discrimination. Therefore flibanserin must get FDA approval, regardless of its efficacy and safety data.

Sprout has organized and backed a pressure group called “Even the Score” whose mission has been to mount a campaign whose theme is that the lack of a drug that improves women’s sexual desire is a glaring example of the FDA’s gender bias. And, of course, the phrase “Viagra for women” is the slogan that sums it up.

It’s entirely usual for pharma outfits to do whatever they can to get the FDA to approve the drugs that they have spent billions to develop. They design clinical trials in such a way as to increase the chance that their candidate drug will be viewed as safe and effective, and they enlist the support of experts whom they think the FDA will pay attention to. But approving a drug on the proposition that if there’s Viagra for men, there ought to be Viagra for women? Let’s take a look at that.

“Viagra for women” is very great nonsense.

Really, we should know better. The phrase should have elicited jeers. Viagra, and the other drugs that treat erectile dysfunction, are not aphrodisiacs. They do not treat sub-optimal male libido. What they do is very basic: they inhibit an enzyme, one of the phosphodiesterases (PDE5), which breaks down a molecule called cyclic guanosine monophosphate or cGMP. In turn, cGMP relaxes smooth muscle which leads to increased blood flow, and prolongs the activity of an important mediator of vasodilation, which is nitric oxide (NO). The activity of