Sex Therapy, Flibanserin, and the FDA

October 29, 2014.    As many of you know, in 2010 Boehringer Ingelheim failed to win approval from the FDA committee charged with evaluating flibanserin for something called Hypoactive Sexual Desire Disorder (HSDD) in women.

At the time, many observers argued that HSDD was a made-up disorder, invented to enrich drug manufacturers.  The FDA’s committee members disagreed.  They concluded that HSDD was real enough, but there wasn’t sufficient proof that flibanserin was effective for it.

After the negative FDA committee decision, Boehringer Ingelheim decided to sell its rights to flibanserin to another drug company, Sprout Pharmaceuticals, which plans to re-approach the FDA next year for approval of the drug.

It’s surely no coincidence that the FDA scheduled a public meeting this week to discuss issues in the diagnosis, measurement, and treatment of female sexual problems.   As expected, “sexual medicine” advocates such as Even The Score are facing off against grassroots “anti-medicalization” groups led by the New View Campaign at the meeting. There are serious arguments to be made on both sides.

As an MD sex therapist, I’m a bit biased. We clinicians all have long lists of patients who haven’t been helped enough by our best current methods.  We’re always in need of innovation. And nowhere is this more true than for sexual desire problems.


The Limits of Sex Therapy

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.

Yes, sometimes, but not always.  And sometimes biological approaches yield results, especially in combination with effective counseling.  I’ve known women whose sexual desire recovered with testosterone treatment when nothing else seemed to help.

Flibanserin, if it’s ever approved, is not a miracle drug.  If I understand correctly, it’s effects are generally subtle.  It’s not the iphone-6. American women aren’t going to be lining up to get it.  But it does represent a new approach to the non-hormonal treatment for desire.  And we’re always in need of new ideas—especially for something as notoriously hard to treat as loss of sexual desire.

Flibanserin has yet to unfold its secrets.  There’s been discussion about whether it might help us treat sexual problems in patients on SRI’s (Prozac, Zoloft, etc).   Sexual side effects of SSRI’s are one of the thornier problems in the mental health field.   Like many of my colleagues in sex therapy and sexual medicine, I would be eager to see if flibanserin might be useful for sexual side effects in people with OCD, Panic Disorder, and other conditions for which there’s no good substitute for an SRI.


The Riddle of Women’s Sexual Desire

One principal problem that Boehringer Ingelheim faced in 2010 was figuring out how to measure changes in female sexual desire.  In the initial flibanserin studies, the principal outcome measure (“number of sexually satisfying episodes”) was almost certainly too crude to capture what’s really important.

Many in the field think we need to rethink the concept of desire, at least when it comes to women.

A provocative paper by psychologist and sex expert Dr. Marta Meana in the  Journal of Sex Research calls into question some of our basic assumptions about women’s sexual 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 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.  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.”  What’s being raised here is obviously something more subtle—perhaps close to what people refer to as “sexual aliveness”—than what’s generally discussed by sex researchers.

Today on twitter I saw lots of comments from this week’s FDA meeting about what’s known as “Patient Reported Outcomes (PRO’s),” which if I understand the term correctly means paying attention to what women themselves feel is important for their sexual well-being.  That sounds like a fruitful approach.  As my colleague Michael Krychman, MD wrote me from the FDA meeting, there seems to be general agreement that traditional measures such as “number of sexually satisfying episodes” represent not much more than “downstream events,” only remotely related to the primary action (if any) of the drug.

For those of you with a particular interest in understanding—and yes trying to measure—desire-related issues (and the patience to do a lot of reading), a full transcript of the proceedings of this week’s FDA meeting are to be published HERE soon.  And for those of you with strong opinions on the subject, the FDA is interested in hearing from you HERE.

For me, as a physician and sex therapist, I’m interested in any new ideas that help me do my job better.

We are always in need of new ideas.


Copyright © Stephen Snyder, MD 2014  New York City

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