Q&A: "Viagra for Women" and the History of Libido Drug Development

Last Updated Jun 17, 2010 12:15 PM EDT

On June 18, Boehringer Ingelheim's female libido enhancer flibanserin -- the so-called female Viagra -- goes before an FDA Advisory Committee, and it's not looking good: the FDA's briefing document questions whether its effect is significant to warrant approval. The company says it's confident, and has already convened a gathering of Australian "sexperts" to inform them about the upcoming drug.

At the same time, director Liz Canner is promoting her new documentary, Orgasm Inc., which looks at the last nine years of female libido drug development in the pharmaceutical industry.

She got her start when she was asked by Vivus (VVUS) to create some pornographic movies for women that could be used in laboratory settings to test whether a drug was having an effect. (Vivus has since abandoned that effort in favor of a testosterone cream). Subjects were asked to watch porn, alternated with non-sexually arousing video material, as researchers measured their responses.

"I was working on this with Kim Airs who at the time owned Grand Opening [an adult store]. We were using already produced porn, she was considered an expert because her store was geared toward women. They were worried they were using the 'wrong' porn and it would make the drug look like it didn't work," Canner says. "The porn had to be interspersed with asexual video, so we used documentaries about doorstops. Literally, doorstops."

Vivus was researching a vasodilator, like Viagra, only for women. Canner got permission to film the experimental process, and began interviewing Vivus's executives, including company founder Virgil Place (left). "The founder wears this giant bow tie with chili-peppers on it. He founded the company because he had prostate cancer and really wanted to develop something to help himself," Canner says. (He succeeded: the company marketed Muse, an erectile dysfunction drug that had the market to itself before Pfizer (PFE)'s Viagra came along.)

Boehringer has repeatedly suggested -- in its sponsored Discovery programming, for example -- that "43 percent" of women may suffer from "Female Sexual Disorder" during their lives. But Canner says this statistic is misleading. "That has been debunked. It was taken from a sociology study that has nothing to do with sexual disorders. It wasn't a sexual disorder study," she says. "A small percentage of women have radical hysterectomies or diabetes and these can give you medically induced sexual disorders, but that's a small percentage of women."

Even so, might it not be the case that some women are distressed by their loss of libido or inability to orgasm, and they could be helped by medical intervention? Not every woman's sex life is "an archipelago of regret," as NYU Prof. Leonore Tiefer recently suggested.

"There is no definition of 'sexual function,' so you cannot have 'sexual dysfunction' if there is no 'sexual function,'" Canner says. "Are you stressed due to overwork? Relationship problems? Were you sexually abused? Are you feeling guilty about sex because you were raised religiously? There are so many reasons why you might have desire issues."

Canner is also skeptical about the "standard" at which libido enhancers will be judged. Boehringer's flibanserin, which will be marketed as Girosa, increased the number of "sexually satisfying events" to 4.5 a month on average compared to 3.7 a month on a placebo, and 2.7 by those who took nothing. "The reality is that none of these drugs [12 companies have tried] have been able to come anywhere near that power. It takes a month of taking the pill before you get your .8 of an extra sexually satisfying event over a placebo. And a satisfying sexual event may come from masturbation."

"Sex has become this whole performance," she says. "Now we've set this bar for what healthy sexual performance is. It's totally bogus."

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