'Female Viagra' Gets Thumbs Down From FDA Panel

Critics Say Flibanserin, an Antidepressant, Has Limited Effectiveness and Medicalizes Women's Sexuality

An expert U.S. Food and Drug Administration panel at a hearing Friday did not recommended approval for a German drug company's pill aimed at premenopausal women distressed by low sexual desire.

Pharmaceutical companies have been on an endless quest for an female equivalent to Viagra, which launched in 1998, and many believe that the drug flibanserin holds promise for women who believe they've been left behind.

Boehringer Ingelheim came upon the possibilities of flibanserin when it was tested as an antidepressant and yielded some desirable side effects -- it made sex more pleasurable for women and seemed to increase their libido.

Had the expert panel OKed the drug for this indication and had the FDA eventually approved flibanserin, the drug company would have gotten some fringe benefits too -- an estimated $2 billion in profits, equal or greater than annual sales of the three top men's sex drugs, Viagra, Levitra and Cialis, according to a story in The New York Times.

Boehringer had already begun online promotions with celebrity spokeswoman Lisa Rinna, a former Playboy model and soap opera actress, who says she suffers from female sexual dysfunction.

In fact, Boehringer has "quietly persuaded" the Discovery Channel to keep running a documentary about female sexual dysfunction that comes across like advertising for flibanserin, according to a blog on Pharmalot. The film notes in its introduction that the company provided funding for the project.

Many existing studies, financed by Boehringer, show that as many as 10 percent of all women live with this disorder.

Critics, however, argue that drug companies have essentially created a disease -- hypoactive sexual desire disorder -- for the natural ebbs and flows of a woman's sexuality to market a drug. (The American Psychiatric Association classified it as a disorder in 2002.)

They say the pharmaceutical industry is putting women at risk for side effects that come from taking this pill daily.

Liz Canner, a documentary filmmaker who followed the drug company Vivus as it carried out its own search for a female sex drug after Viagra hit the market in 1998, argued that clinical trials for flibanserin revealed a statistically insignificant improvement in the level of desire for as yet underdetermined risks.

"I can't see why it will be approved," said Canner, whose film "Orgasm Inc." premiered this spring. "I am really shocked the drug has gone this far."......

There was also a very strong placebo effect among the women.

"We ladies are complicated, and this study is only looking at one thing," she said. "It may be a first step in something interesting, but to call it a female Viagra, we are getting way ahead of ourselves."

"Women are not interested in getting a hard on, they want to have desire and arousal," said Reinisch, who is also a consultant to New York's Museum of Sex.

June 19, 2010
abcnews.go.com