FDA Readies for Fight Over 'Female Viagra'

A German drug company is ready to market a pill for premenopausal women who are distressed by low sexual desire, and is prepared to fight for Food and Drug Administration approval at a hearing Friday.

Pharmaceutical companies have been on an endless quest for an female equivalent to Viagra, which launched in 1998, and many believe 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.

If the FDA's panel of experts approves flibanserin Friday, the drug company gets 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 has 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."

"Most women are healthy, and it's not so much that their testosterone levels or serotonin levels or genital engorgement is a problem, it really is that a lot of women are in poor relationships and stressed out due to overwork," she said.

Although she understands women who have had radical hysterectomies and are on libido-inhibiting serotonin-specific reuptake inhibitor antidepressants, or SSRIs, may need medical intervention, most women do not.

"They are just exhausted, doing all the domestic work and working 40 hours a week," said Canner. "And a lot of women have been sexually abused, and that also affects desire. The idea that we are supposed to be desiring sex every minute of the day is a complete fantasy, science fiction, and who would want [that] anyway? What a pain!"

Earlier this year, an FDA staff report recommended against approving flibanersin as a sex drug, saying the company had not made a strong enough argument that the benefits outweighed such side effects as dizziness, nausea and fatigue.

Dr. Peter J. Piliero, Boehringer's director of medical affairs in the United States, has called hypoactive sexual desire disorder "a real disease."

In a multi-nation study made public last year, flibanserin appeared to increase desire and sexual satisfaction in women by several measures by modulating serotonin and other neurotransmitters.

Unlike Viagra, which is used to treat male erectile dysfunction by increasing blood flow to the genitals, this drug acts on the woman's brain to enhance mood.

Lead researchers from University of Ottawa -- whose work is underwritten by Boehringer Ingelheim Pharmaceuticals -- said the drug is effective in treating hypoactive sexual desire disorder or lack of libido.

The drug acts on the central nervous system, keeping serotonin, norepinephrine and dopamine "in balance," she told ABCNews.com.

"The pharmaceutical industry has come up with Viagra to solve a major concern that men have had since the beginning of time," June Reinisch, senior research fellow at the Kinsey Institute for Research in Sex, Gender and Reproduction told ABCNews.com when the first studies were publicized.

"But until now, nobody has seemed that concerned about resolving what women might like."

Reinisch said while the study was "interesting," there were more questions about the data -- women surveyed were 18 to 50, a wide age range, and from different countries.

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.

The randomized, double-blind study on flibanserin was carried out at Canada's Women's Health Center of the Ottawa Hospital, as well as at University of Virginia, University of North Carolina Chapel Hill and Italy's University of Pavia.

Sexual Desire Improved in Study

Premenopausal women treated for 24 weeks showed significant improvements in sexual desire and functioning compared with those on a placebo.

The 1,378 study participants were required to be in a "stable, communicative, monogamous, heterosexual" relationship for at least one year.

All exhibited generalized acquired sexual dysfunction disorder or "little or no receptivity" to sexual activity. Those who had secondary problems with arousal or orgasm were excluded from the study, as well as those with psychiatric and depressive disorders or those who had taken medication that might diminish or enhance sexual function within four weeks before entering the study.

About 43 percent of women experience sexual problems, according to another Boehringer Ingelheim study that examined their prevalence in a representative sample of 30,000 U.S. women. But only 12 percent found those problems "distressing," according to Dr. Jan Shifren, principal author of the PRESIDE study.

"As almost half the U.S. adult female population reported a sexual problem, sexual concerns should not be 'medicalized,'" she told ABCNews.com. As for those who were bothered by their lack of desire, "this group of women deserves effective treatment."

Many safe and effective options are available for treating women's sexual problems, typically addressing the underlying cause, which can be fatigue, stress, relationship conflict, depression or antidepressant medication.

"If an effective and safe medication is identified, it should be available to women, but given potential risks and side effects, drug therapy always should be considered a last resort," said Shifren, who is director of the menopause program in the department of obstetrics and gynecology at Massachusetts General Hospital.

"Women in good relationships who are physically and psychologically healthy are generally satisfied with their sex lives -- and you'll never find this in a medicine cabinet," she said.

Because flibanserin is an acting agent and not a hormone, like testosterone, Shifren said she would want to see the safety data regarding mood effects and possibly blood pressure before prescribing the drug.

Beyond this study, the drug must show clinical improvement for women, effectively decreasing their level of distress about her sexuality "for it to be effective," she said.

Sexual Desire Improved in Study

Problems with sexual desire are "a big deal," for women, according to Dr. Marie Savard, medical consultant to ABC News.

"We know the role of sex is so important to relationships," she said. "But for women it's unrealistic to think a pill is going to fix the impact of so many issues that women face."

Women have many reasons for lack of libido: stress, caregiving roles and lack of self-esteem -- " a big one," said Savard, and it's difficult to "label" women with a simple diagnosis like hypoactive sexual desire disorder.

Still, because flibanserin works on the brain, "which is women's biggest sex organ," it might make sense that women would benefit from the drug.

"Unfortunately, men's erectile dysfunction is simpler to fix," she said. "Give a pill to increase blood flow or the equivalent of an on-off switch.

"Women are turned on by many competing ... variables -- hormones, timing, stress, sleep, self-esteem, and so our turn on is more like an airplane control panel -- lots of switches interacting to make things go."

Savard said she had "no doubt" the study increased episodes of sexual desire, but women must also side effects, especially because this drug is aimed at younger women.

"Do women really want to have to take a pill every day?" she asked. "It's kind of like treating with a gunshot approach. It's better that women understand what her individual cause is, like self esteem, which is the biggest."

Flibanserin has shown positive effects with a strong safety profile, according to Dr. André T. Guay, director for the Center for Sexual Function at the Lahey Clinic in Boston, who served as a medical consultant on the trials.

The drug works in the brain to modulate serotonin, which is a negative transmitter for sexual function. "Because of that, it seems to increase libido," he told ABCNews.com.

"If we are medicalizing hypoactive sexual disorders, than why treat it?" asked Guay. "A lot of things are a natural part of life -- like cataracts -- but we treat them."

He admits the drug may do little to help women -- who, like men, can be affected by obesity and drugs like beta blockers that decrease the flow of blood to the genitals -- become orgasmic.

"It shouldn't be given like candy to every women coming in with bad feelings about herself," Guay told ABCNews.com.

"It's absolutely not a cure-all, and no one in the company or the advisory board thinks it's a cure-all for everything, but it can help."

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