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Photo credit: Pedrosimoes7
Photo credit: Pedrosimoes7
Goodbye, flibanserin.
As many of you know, this month the pharmaceutical firm Boehringer Ingelheim pulled the plug on flibanserin, the reputed (and as many have remarked, misnamed) "Pink Viagra," which had been developed as a treatment for something called Hypoactive Sexual Desire Disorder (HSDD) in women.
Many in the sex field claimed that HSDD was a made-up disorder, invented to make money for drug manufacturers.
The FDA's panel of experts charged with evaluating flibanserin disagreed. This summer, they concluded that HSDD was real, but that there wasn't sufficient proof that flibanserin did enough for it to justify the risks.
In all the debate about whether there's really such a thing as HSDD, and whether it's a good idea for the pharmaceutical industry to get involved with it, there's one fact that I haven't heard emphasized:
We clinicians all have long lists of patients that we haven't been able to help as much as we would have liked. We always need good new ideas. And nowhere is this more true than for sexual desire problems.
You might say, "Don't we already know what causes women to lose sexual desire? Isn't a woman's loss of sexual desire usually about something particular -- such as lack of proper rest, or a husband's clumsy lovemaking?"
Very often, yes. Very often it's not a dysfunction at all. Just her sexual system shutting down, out of frustration. Sometimes just attending to a woman's honest needs -- say for rest, appreciation, help with childcare, or just good sex -- will bring desire back.
But sometimes things don't go so smoothly. And biological approaches sometimes yield results. I've known women whose sexual desire recovered with testosterone treatment, when nothing else seemed to help.
Like many physicians, I was intrigued that a new non-hormonal medication for sexual desire might soon be available. I didn't think American women would be lining up to get it. But it was a new idea -- a non-hormonal treatment for desire. As I mentioned, we're always in need of new ideas -- especially for sexual desire.
The FDA's dilemma
The FDA panel said there wasn't evidence that flibanserin made enough of a difference to justify the medical risks.
The FDA has an extremely difficult job -- balancing risks and benefits of new medications, based usually on short-term trials of only a thousand or so patients. That's not very much information to go on, in the grand scheme of things.
Furthermore, the kind of clinical trials required by the FDA often don't tell us much about what kinds of patients a new medication will be particularly suited for. And they don't tell us what other uses that medication might eventually have. New medications that are approved for one condition often have unanticipated benefits for others.
Flibanserin, at the time of its early demise, was just beginning to unfold its secrets . There was discussion about whether it might help us treat sexual problems in patients on SSRI's (Prozac, Zoloft, etc). Sexual side effects of SSRI's are one of the thornier problems in the mental health field. It's a shame we won't get to find out whether flibanserin might have helped.
Don't get me wrong. I'm not second-guessing the FDA on their decision. As I said, the FDA has an extremely difficult job.
But where does this leave us now?
Another look at desire.
I have to assume that Boehringer Ingelheim didn't throw out hundreds of millions of dollars on flibanserin unless it had some pretty solid hunches that the women who took it were experiencing something real in the bedroom.
The problem may be figuring out how to measure it. In the flibanserin studies, the objective outcome measure (number of "sexually satisfying episodes"), and the accompanying subjective ratings may have both been too crude to capture what's really important.
I think the lesson of flibanserin is that we need to go back to the drawing board and rethink the concept of desire.
A very provocative new paper by psychologist and sex therapist Marta Meana in this year's Journal of Sex Research calls into question some of the basic assumptions that are made in the sex field about women's desire (Meana M: Elucidating Women's (hetero)Sexual Desire: Definitional Challenges and Content Expansion, Journal of Sex Research 47:104, 2010).
It's not clear, argues Meana, that we really know what we mean by women's sexual desire. What a woman might call sexual desire may be more reflective of a feeling about herself as a sexual being, rather than about whether she wants to have sex. In a provocative twist, Meana argues that a woman in a state of desire might be perfectly content not to have sex at all. "Sex is not always the goal of women's sexual desire," she writes. "Sometimes, the experience of sexual desire may be its own reward."
I hope that the demise of flibanserin will result in a renewed interest in sexual states of mind, both for women and for men. The drug companies should be interested in this, since it might provide them something to measure. The anti-medicalization people should be interested, since it might give them an enhanced vocabulary to discuss why biological treatments don't make sense, if that turns out to be the case.
And as a physician and sex therapist, I'll be interested in any new ideas that help me do my job better.
We are always in need of new ideas.
Copyright © Stephen Snyder, MD 2010
www.sexualityresource.com New York City
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