Next week, an FDA advisory committee will meet to review a Boehringer Ingelheim pill to tackle FSD, or female sexual dysfunction. This would be the first such drug for the US market and you will see a lot in the media next week. However, a growing group of psychologists, academics and public health advocates contend FSD isn’t an authentic medical condition, or at least not the sort of problem that should be treated with drugs (one critic is about to publish a book). Bandied about but never proven is the statistic that 43 percent of women suffer from this affliction (background). So we spoke with Leonore Tiefer, a clinical associate professor of psychiatry at the New York University School of Medicine, who heads the NewViewCampaign, a grassroots effort devoted to challenging the ‘medicalization’ of sex…

Pharmalot: Tell us about your campaign.
Tiefer: We got started in 2000. The year before, I got upset when I began to hear people ask about a Viagra for women. As a feminist, I thought this would be a calamity and a lot of what’s important to women would be forgotten or ignored in a mechanistic way. Women’s sexual lives are vastly impacted by context – family, feelings, obligations, responsibilities, body image. There’s also a larger cultural context, such as religion and patriarchal views of marriage. There are issues involved, too, such as safety, reputation and violence. You can’t unhook sexuality from this. It’s bound to rules in ways that men’s sexuality is not and is extremely hard to explain to people. Anyway, the group receives occasional donations, but there is no money involved except for keeping up the web site.

Pharmalot: So is FSD real, even for some women?
Tiefer: It was never a condition. It’s an umbrella term. There are four separate categories listed in the DSM (Diagnostic and Statistical Manual of Mental Disorders) – desire, arousal, orgasm and pain. And every article would mention that nomenclature because it gave it legitimacy. But in the minds of press and the industry which wanted to create some sort of existence in the minds of the public, they basically just picked that term because it sounded like erectile dysfunction. I think its entirely a marketing term.

The key term is dysfunction - what is a woman’s sexual function? What is the normal function? That is where the DSM does give specificity that I dispute, and it has become more disputed over time that there is a unitary process. In 1980, there was a revision to the DSM that wanted to move from theory to the observable. Masters & Johnson published a book that contained information about the human sexual cycle and the DSM folded that in. The trouble is it incorporate the claims that a woman’s sexual response is the same as a man’s, but it wasn’t based on any representative research. In fact, there had been coaching, so the observations were tainted. Meanwhile, the categories became hardened into disorder categories, which the FDA allowed to become the basis for drug applications and has led us to this moment.

Pharmalot: And what about the flibanserin pill that will be the subject of the meeting? You don’t believe it has any useful or positive effect?
Tiefer: The data is meager and unpersuasive. They have strong results on their questionnaire about desire and distress. Women are less distressed by the end of the study than at the beginning, although distress has become a kind of industry of its own. There’s controversy about distress - the DSM says you can’t give someone a diagnosis of Hypoactive Sexual Desire Disorder unless they’re distressed. So you have to give someone a drug that has alleviated distress….and this is a failed antidepressant. But there were three things measured – two by questionnaire and one by behavior. Desire also showed significant improvement. As for behavior, the actual number of satisfying sexual episodes said this measure was the least changed of all.

[Editor’s Note: THIS IS FROM A NOV 2009 PRESS RELEASE: Results from three Phase II trials called Daisy, Orchid and Violet that studied 1,378 pre-menopausal women with HSDD found a statistically significant increase in the frequency of satisfying sexual events per month in women taking flibanserin 100mg (from 2.8 at baseline to 4.5), versus placebo (2.7 at baseline increasing to 3.7) over a 24-week study period. Flibanserin also demonstrated statistically significant improvements in desire versus placebo as measured by an electronic diary...Other key secondary endpoints showed flibanserin significantly improved sexual functioning, distress related to sexual dysfunction and distress related to low desire versus placebo.]

Pharmalot: But is it not possible that some women will be helped?
Tiefer: I think the data are meager and I don’t think it’s an effective drug, but then again I don’t think there’s a condition. I don’t know what you’d have to do to persuade me. I guess if I saw a real behavioral change…. It’s an important question. The problem is the marketing. If there weren’t this vast marketing push behind these drugs I don’t think I would be as involved in this whole issue or have started this campaign. It was all around the marketing for Viagra and the consequences as a cultural explosion - capturing of a whole disciplines and the money that went into research. It’s extremely fair to dismiss or skeptically view the way the industry has captured the moment when it comes to this topic. Sexual medicine used to be ridiculed because people were embarrassed and anxious by the topic.

As a consequence, the public is uniformed, but it’s an important topic. Why do women see ‘Sex and The City?’ Because they like like to talk about sex and laugh about sex, But the ignorance has not been helped these past 10 years by the invasion of the pharmaceutical industry into this area of medicine.

Pharmalot: So what do you think the FDA ought to consider?
Tiefer: I think the FDA should look at safety an effectiveness and on that basis reject it. But I also think they should do something about marketing. They should prohibit pre-launch marketing. The disease awareness campaign around HSDD is very widespread. There are celebrity figures on television and endless things on the web, twitters. The FDA ought to be concerned with this .