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Yesterday October 28, the FDA concluded a 2-day public meeting and scientific workshop on Female Sexual Dysfunction (FSD)—and what (if anything) to do about it. The first day the FDA heard about the problem from the public, and the second day it heard from experts on how to diagnose and measure it.
Measure it? Of course.You have to be able to measure FSD if you're going to fashion biological treatments for it. Because the FDA needs to see objective evidence of results if they're going to approve those biological treatments.
That was the problem that Boehringer Ingelheim faced back in 2010 when they petitioned the FDA to approve flibanserin for women with Hypoactive Sexual Desire Disorder (HSDD). The drug's performance on the measures of sexual well-being used didn't convince the FDA Committee that the drug worked for HSDD.
HSDD, you say? Isn't this week's conference about FSD?
Glad you caught that little detail. No one in the field knows exactly how to categorize women's sexual difficulties. It's unclear whether desire problems should best be treated as distinct (HSDD), or whether lack of desire should be seen as part of a broader group of issues that also includes arousal difficulties (FSD).
The DSM-5, the official guide to diagnosis in this area, went the FSD route in 2013 and lumped desire and arousal together, creating a new entity called Female Sexual Interest/Arousal Disorder (FSIAD). (See "Sex in the DSM-5: True Colors," if you're not confused enough already).
Tricky as it is to categorize female sexual problems, measuring them is even harder. What's the most meaningful way to measure a woman's sexual well-being? There are probably as many answers as there are women. As a sex therapist, I hear from women wanting sex, women wanting to want sex, and most of all from women who are tired of bad sex and bad relationships.
It makes me grateful I'm a sex therapist rather than a drug researcher. I'm very eager to hear what measures the pharmaceutical industry's research scientists are developing now to assess the results of biological treatments like flibanserin.
I've heard all the arguments pro and con about whether as a society we should be dabbling in biological treatments for women's sexual problems. There are strong arguments to be made on both sides. But as a physician, I'm biased in favor of innovation. I know lots of women with good relationships who've done all the right things to bring back their libido, and nothing has worked. Maybe for some it's a foolish quest for a fountain of youth. But who would have predicted before Viagra that a pill could restore a middle-aged or older man's erections?
Sexual medicine specialists who were involved in the original clinical trials of flibanserin tell me they saw results—satisfied women, and happier couples. Placebo? Maybe. But I'm betting that Boehringer Ingelheim and successor Sprout Pharmaceuticals didn't wager hundreds of millions of dollars on flibanserin unless they had some pretty good evidence that it was doing something.
The problem seems to be in figuring out how to measure it—how to reduce the near-infinite variety of women's sexual wants, needs, and feelings into a few meaningful ratings.
Now that Sprout Pharmaceuticals has bought the rights to flibanserin and is committed to winning FDA approval for it, I'm sure they've spent a fair amount of time on the measurement issue. As I followed the FDA meeting yesterday on twitter, I saw lots of tweets about something called "Patient Reported Outcomes (PRO's)," which makes me think they've gotten more sophisticated about listening to women's own opinions about what's important.
I'm eager to see what the pharmaceutical companies' research methodologists come up with. We won't have to wait long, since (sex research geek alert) the entire transcript of this week's FDA meeting is going to be published soon online HERE.
Oh, by the way -- Would you like the FDA to hear your opinion on this issue? They're soliciting comments from the public HERE.
Of course, I'd be interested in your opinions too.
© Copyright Stephen Snyder, MD 2014
www.sexualityresource.com New York City
See related article:
Pink Viagra and the Riddle of Female Sexual Desire
