FDA considers endorsement of drug that some call a Viagra for women

By Rob Stein
Washington Post Staff Writer
Monday, May 24, 2010; A01

A panel of federal advisers will soon wrestle with a question that has bedeviled poets, philosophers and generations of frustrated men: What do women want?

That enigma will be part of a Food and Drug Administration committee's deliberations next month when it considers endorsing the first pill designed to do for women what Viagra did for men: boost their sex lives. A German pharmaceutical giant wants to sell a drug with the decidedly unsexy name "flibanserin," which has shown prowess for sparking a woman's sexual desire by fiddling with her brain chemicals.

Even before the FDA's Reproductive Health Drugs Advisory Committee meets June 18 to consider the request, the prospect of the drug's approval has triggered debate over whether the medication, like others in the pipeline, represents a long-sought step toward equity for women's health or the latest example of the pharmaceutical industry fabricating a questionable disorder to sell unnecessary -- and potentially dangerous -- drugs.

"Achieving a happy and healthy sex life can be a real and important problem for some women," said Amy Allina of the National Women's Health Network, a Washington-based advocacy group. "But we have lots of questions about the 'pink Viagra.' "

Viagra's catapult to blockbuster status after its 1998 approval set off a flurry of interest in me-too medications for women. Drugmaker Pfizer's hopes that its "little blue pill" would also ignite female libido fizzled, however, making it clear that a woman's sexuality is more complicated than a man's. Germany's Boehringer Ingelheim is optimistic that flibanserin is on the verge of becoming the first prescription medication to tap what some have estimated could be a $2 billion market in the United States alone.

"We believe women deserve options," said Michael Sand, who heads the company's clinical research on flibanserin, "and we're hoping flibanserin may represent a safe and effective option for many women."

Scientists found that flibanserin, developed as an antidepressant, was ineffective for treatment of depression. But the drug appeared to produce an unexpected side effect: boosting women's libido. That prompted the company to study it for hypoactive sexual desire disorder, or HSDD, an otherwise unexplained loss of sexual thoughts, fantasies and desire that can cause significant emotional distress. Some research suggests 10 percent of women may suffer from HSDD.

"It's not that they are averse to sex. It's just that they don't care about it. They just stop thinking about it," said Anita H. Clayton, a professor of psychiatry and neurobehavioral sciences at the University of Virginia who has studied the drug for the company. "It's like a switch has been flipped. It's a loss for them. They miss it. And they want it back."

Lana, a housewife in Northern Virginia, said she feared that her gradual, unexplained loss of sexual desire threatened her marriage.

"You kind of need to have it for closeness," said Lana, who spoke on the condition that her last name not be used. "You've heard the saying, 'Men are like microwave ovens, and women are like crockpots?' Well, I felt like I was a crockpot with a short circuit. I was supposed to be at a woman's peak, but I was fizzling."

The company has sponsored studies involving more than 5,000 premenopausal women ages 18 to 50 in the United States, Canada and Europe in whom HSDD had been diagnosed. A 100-milligram daily dosage increased the number of satisfying sexual experiences that women had reported from the previous month -- a key benchmark the FDA has set for such drugs -- from an average of 2.7 to 4.5, compared with 3.7 among those taking a placebo.

Critics have ridiculed that difference as negligible. But Sand and other researchers say that for many women, the difference is significant.

"What we know," Sand said, "is the overall experience of the increase in satisfying sexual activity, the increase in the amount of desire and the decrease in distress that goes along with that is, in women's voices, considered meaningful."

Exactly how the drug works is unclear, but it appears to decrease levels of one brain chemical, serotonin, while boosting levels of two others: dopamine and norepinephrine.

Although some women experienced minor side effects such as nausea, dizziness and drowsiness, no serious complications have been reported, Sand said.

Critics say that the pharmaceutical industry played a central role in defining HSDD as an official psychiatric disorder and exaggerated its scope by funding key research.

"People think they are sick when they are not. People become patients when they don't need to be," said Ray Moynihan, a lecturer at the University of Newcastle in Australia and author of the forthcoming book "Sex, Lies and Pharmaceuticals."

For many women, waning sexual desire is a normal part of aging. For others, it could be a sign of other medical problems, a dysfunctional relationship or even an abusive partner.

"Is it really a problem, or is it the societal message of what they're supposed to be experiencing, or pressure from a partner, or changes in themselves?" asked Susan Bennett, an assistant professor of medicine at Harvard Medical School.

In weighing the potential risks and benefits of making flibanserin available by prescription, the FDA committee -- its members split evenly between men and women -- will have to navigate the subtle terrain of elusive emotional concepts such as desire, arousal, satisfaction and distress.

"Women's desire for sexual emancipation is very worthy," said Leonore Tiefer, a clinical associate professor of psychiatry at the New York University School of Medicine. "I fear that it's being hijacked by a profit-oriented industry that doesn't really try to understand women and their sexuality."

In addition to potential long-term side effects that will become clear only after many more women take the drug for many years -- as with hormone replacement therapy -- some people fear flibanserin could make women vulnerable to abuse.

"Is this going to make women desire an abusive partner?" asked Liz Canner, a documentary filmmaker who produced "Orgasm Inc.," about the pharmaceutical industry's role in developing drugs for female sexual disorders. "Is it going to make us desire every guy who walks by?"

Sand disputed that concern.

"This isn't some kind of aphrodisiac that we can put in the water and have suddenly sexually interested women in our population," Sand said. "The notion that somehow this is a construct of the pharmaceutical industry is misleading. This isn't something new. This is something women have been suffering for a long time."

The FDA said it never discusses specific products awaiting approval. For her part, Lana, the Northern Virginia housewife, said she hopes the drug is available soon.

"Gradually after I started taking it, I started having thoughts about sex again. I started having dreams about sex. I hadn't had dreams about sex in years," she said. "My desire came back."

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