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Will The FDA Allow Women To Try Flibanserin?

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Will The FDA Allow Women To Try Flibanserin?

Is Flibanserin just as effective for women as Viagra is for men and will women ever get the chance to find out?

Does flibanserin help desire? Let’s hope the FDA lets women see for themselves.

This summer, the FDA is finally going to decide whether to approve flibanserin, the so-called “Pink Viagra” for women. I hope they approve it. I have a lot of patients who’d like to try it.

After years of waiting while the FDA gingerly tip-toes in the direction of approving its first-ever medication for low sexual desire in women, I’d like to see for myself whether the stuff really works for patients in my office.

Wait a minute, you ask. Don’t we already know whether it works? Hasn’t the company that makes it already tested it in thousands of women, in order to provide data to the FDA?

Good question. Yes, they have. It’s one of the biggest “Phase III” data-sets ever presented to the FDA. But Phase III data only gives you statistical evidence of effectiveness.

Statistical effectiveness isn’t going to cut it in the real world. This is a pill that has to be taken every day. Women are only going to do that if it knocks their socks off.

And we won’t find out whether flibanserin does that (and for whom), unless the FDA approves it.

Ever since Viagra, there’s been a running debate in the sex therapy community –between practitioners who are eager to see pharmaceuticals incorporated into treatments for sexual problems, and those who are concerned that we’re over-medicalizing sex. At sex therapy meetings, I’ve heard thoughtful opinions expressed by both sides.

This year, however, with the FDA poised to make a decision soon, stridently anti-flibanserin editorials have appeared in some very prominent publications, including theLos Angeles Times(link is external) and The New York Times.(link is external) The New York Times article even went so far as to make an analogy between flibanserin and barbaric neurosurgical attempts to cure homosexuality.

As a sex therapist who is also a medical doctor, I thought both these editorials contained significant distortions of logic and of fact. I wrote online about both the Los Angeles Times and New York Times(link is external) pieces, expressing where I thought they’d missed the mark.

Don’t get me wrong. There are serious arguments both pro and con about the idea of offering women a drug to stimulate desire. But I think at this point in the game, what we really need is for individual women to be able to make informed decisions themselves about whether to try the pill or not.

If the FDA decides this summer that the benefits of flibanserin outweigh the medical risks, then a few years from now we’ll have all learned a lot more about what this drug can and can’t do — and for whom. Desire problems are heterogeneous. We don’t yet know which subgoups of women might benefit from this medication. We won’t know — unless the FDA decides it’s reasonably safe, and researchers start to use it in clinical studies.

But as of now, the arguments pro and con have all been theoretical.  For instance, the above New York Times editorial focused on whether women’s desire was “spontaneous” or “responsive.” The article implied that flibanserin targeted the wrong kind of desire — spontaneous desire — and that therefore the whole enterprise was a bad idea.

Reading this, I had a strong sense of deja vu. My mind went back to medical school 35 years ago, in the early 1980’s — sitting in a lecture hall hearing about how there were two kinds of depressions: “endogenous” (out of the blue) and “reactive” (due to catastrophic loss). Anti-depressant medications, I was told, were only effective for endogenous depressions, not for reactive ones.

The distinction seemed clear. It made sense. It may even have been on the exam. But a few years later, we discovered it was wrong.

What changed everything was Prozac. Prozac worked well for both kinds of depressions. The theory said it shouldn’t, but it did.

These days, almost no one talks about endogenous vs reactive depression. That’s the way science works. Theories go away when they no longer fit the facts.

What we really want to know is whether a given treatment works. And no amount of theorizing can give us that answer.

I agree with those who contend that sexual desire — especially women’s desire — is in general more responsive than spontaneous. I agree that sex is not a drive. But I disagree with the idea that we can predict from this whether a given treatment is going to be helpful or not.

As the great French neurologist Jean-Marie Charcot said, “Theory is nice, but it doesn’t keep things from existing.”  Theories tumble in the face of clinical evidence.

Let’s not assume that our current theories — about spontaneous desire, responsive desire, or anything else — will always allow us to predict the future.

Enough with theorizing. Let’s get down to cases.

© 2015 Stephen Snyder MD
www.sexualityresource.com(link is external)
New York City   

The author affirms that he has no financial stake in or professional relationship with the makers of flibanserin, and that he has not received financial compensation from any entity mentioned in this article or in any of the embedded links.

 

Stephen Snyder, M.D., is a sex and couples therapist, psychiatrist, and writer in New York City. He is currently Associate Clinical Professor of Psychiatry at Mount Sinai School of Medicine in New York City. He has lectured nationally on topics related to mental health aspects of sexuality–combining the biomedical perspective of a physician and the psychological perspective of a sex therapist. He has been an active member of the Society for Sex Therapy and Research since 1995. He has been a featured lecturer and discussant at the Society’s national meetings, and has served on both its Professional Book Award and its Consumer Book Award committees. Over 25 years of practice in Manhattan as a psychiatrist, psychotherapist, and sex and couples therapist, he has worked to develop better treatments for sexual problems– including integrative treatments that combine medical and psychological approaches.

His current major areas of interest include: sexuality and the self; diversity of individuals’ sexual natures; current controversies regarding the “medicalization of sexuality”; and sexual psychology in popular culture (be sure to catch his blogs on Twilight, and on Alvin & The Chipmunks). He lives with his wife and children in New York City.

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