Tom Murphy
RedwoodAge.com

The little blue pill means more men can have sex, and now there's a little pink pill that may allow more women to want to have sex.

The pill from German drugmaker Boehringer Ingleheim might help boost the sex drive in women, but it's gotten no love from Food and Drug Administration staff members or the FDA's advisory panel. They say its side effects - it can make women dizzy, tired and nauseous - outweigh its benefits to women who want to want to have more sex. Besides, they note, nobody really knows how it works.

After a negative report from the staff, the advisory panel voted 11-0 to recommend rejection of the drug by the FDA's commissioners.

The so-called "female Viagra" is aimed at premenopausal women who want to boost their sex drive. But the very idea has set off a debate over what is "normal."

For Boehringer, that's at least a $2 billion question, according to financial analysts. Ever since Pfizer brought Viagra to the market in 1998, millions of men have used it and similar drugs to raise the bar in their sexual performance, leading to many billions of dollars in sales.

Alas, the FDA staff says Boeghringer's own studies show the new drug, well, failed to perform as expected. The FDA's review division said two studies showed women were having more satisfying sexual experiences, but not necessarily an increase in sexual desire.

"The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not," the staff noted.

Advisory panel Chair Julia Johnson, who also chairs the Obstetrics and Gynecology Department at the University of Massachusetts Medical School, said the drug's test results weren't “robust enough to justify the risks."

Ethical Issues
And there is an ethical debate brewing over giving women a drug that comes from the antidepressant realm to induce sexual arousal in women, especially because it isn't know how the new drug, called fliberseran, works.

Critics posit that simply marketing the drug could make women think they have a medical problem just because they aren't eager to have sex.

"The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient," Dr. Adriane Fugh-Berman, an associate professor at Georgetown University's medical school, told The New York Times.

Others agreed. "It's a fairly complicated area, unlike in men's sexual dysfunction where there's a major mechanical concern," Dr. Elizabeth Kavaler, a New York urologist, told The AP. "In women there's no mechanical concern, so if she's not having a successful sex life, where is the problem?"

But Boehringer, a private company that generated about $12 billion in sales last year, disagreed. "This is a real disease," Dr. Peter Piliero, the company's director of US medical affairs, told the New York Times. "There's an unmet medical need among premenopausal women to have a treatment."