Federal Regulators Reject Female Viagra

The little pink pill designed to boost women's libido hit a snag Friday. A Food and Drug Administration advisory panel recommended not to approve the so-called "female Viagra."

The vote was unanimous. The panel said the drug's impact was not "robust enough to justify the risks," which include dizziness, nausea, and fatigue.

In question is a pill called "Flibanserin." Even though it's been called the female Viagra, it's actually a very different drug. Viagra works by increasing blood flow to the male genitals. This one works on brain chemicals in the pleasure centers of a woman's brain.

The new drug is designed to treat a condition called "hypoactive sexual desire disorder," or HSDD. Ten to 20 percent of women suffer from it.

It's defined as a lack of sexual desire, causing emotional distress.

But the FDA found that the drug had not been proven to increase women's desire.

Even though the vote was unanimous, the panel encouraged the German manufacturer to continue its research and come back with more improvements.

Viagra-like pill for women fails in 2 studies

WASHINGTON -- The first pill designed to boost the female sex drive failed to make a significant impact on libido in two studies, federal health regulators said, though some women did report slightly more sexually satisfying experiences

The Food and Drug Administration is considering Boehringer Ingelheim's drug flibanserin for premenopausal women who report a lack of sexual desire, a market that drugmakers have been targeting for more than a decade since the blockbuster success of Viagra and similar drugs in men.

On Friday, the FDA will ask a panel of experts to advise on the safety and effectiveness of Boehringer's drug. The agency is not required to follow the group's advice.

In its review posted online Wednesday, FDA said two Boehringer studies failed to show a significant increase in sexual desire, as recorded by women in a daily journal.

Women taking the drug reported slightly more sexually satisfying experiences, but FDA said that was not the primary measure of the study.

"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 FDA review said.

The FDA also noted increased side effects like depression, fainting and dizziness among women taking the pink pill.

The drug, which is related to the antidepressant family, affects serotonin and several other brain chemicals, though it's not clear how that increases sex drive.

"We don't know specifically what the exact mechanism of action is, but we believe it acts on brain chemicals that have a role in human sexual response," said Dr. Peter Piliero, executive director for Boehringer's U.S. medical affairs.

Since the launch of Viagra in 1998, more than two dozen experimental therapies have been studied for so-called "female sexual dysfunction," a market some analysts estimate at $2 billion.

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, said arousal in women is so complicated that it may be unrealistic to expect a pill to completely address sexual problems.

Flibanserin Can not Change Why Some Women Do not Want Sex

Flibanserin Can not Change Why Some Women Do not Want Sex

Back in the pre-Viagra age, men were in fact powerless. Now, the guy with a mechanical problem suffering from erectile dysfunction (ED in ubiquitous TV commercials), clearly one of the most successful efforts rebranding Big Pharma. But women were denied a metamorphosis similar to a sexual problem because nobody has yet understood why some people want all the time and others hardly ever. If you're too tired, you're just cold.

This may change with the announcement this week that the pill appears to increase sexual desire in women with low libido. This blockbuster potential, developed by the German drug maker Boehringer Ingelheim, is called flibanserin and he was almost doomed to failure when it was first tested as an antidepressant. Flibanserin did not lift the mood, but researchers have noticed that it had an intriguing quality: it appeared to increase sexual interest in animals and humans.

Could it be Big Pharma Holy Grail: a female Viagra? Undoubtedly inspired by the enticing possibility of Gazelle Global Sales, Boehringer paid for flibanserin clinical trials in nearly 2,000 premenopausal European, American, Canadian and women who suffer from HSDD, a controversial diagnosis that affects apparently as more in four women.

The results, presented earlier this week at the Congress of the European Society for Sexual Medicine in Lyon, France, showed that women in the trial who took a daily dose of 100 milligrams of flibanserin for about six months has increased the number of "sexually satisfying events" (not necessarily an orgasm) to an average of 4.5 against 2.8 in the North American arm of the trial, compared to 3.7 among women on placebo group.The have flibanserin also said they were more interested in sex than those taking a placebo.

Flibanserin will not be on sale anytime soon. Boehringer still needs approval from the FDA and other regulatory agencies around the world, a process that could take years.

However, the announcement has already ignited the smoldering debate over the causes and definition of sexual dysfunction in women. Investigators sex (mostly men) used to believe that women were healthy, just like them, always on the lookout for the moment. Women who have experienced a constant stream of sexual desire were considered abnormal.

But in recent years, female researchers (including the University of British Columbia psychiatrist Rosemary Basson) arrived at a conclusion very different. Basson and her colleagues found that although male sexual progression is essentially linear - desire to arousal to women's sexuality - orgasm is rather circular, with a positive factor (such as emotional satisfaction or of privacy) by strengthening others and ultimately lead to the desire and excitement.

A woman is like a man earlier in a relationship, when it is full of sexual arousal on a new lover. But women in long-term relationships tend to need more stimuli, and that means a guy who meets emotionally (doing the dishes is always useful) as well as physically. May as women turn away from sex because of a large number of disorders other than sex, including depression, alcoholism, hormonal problems, and even pain with vaginal penetration.

According to Boehringer, the women in the study suffered only flibanserin of HSDD, no other condition that may have hindered their sex drive. But this diagnosis is very controversial. To understand what this means, you must define a normal libido. Nobody really knows if the normal means who want sex once a day once a month or once a year. Sex researchers now say that the sex drive of a woman is dysfunctional if it is unhappy about this, if it causes personal distress. Therefore the estimate of how many women suffer from sexual dysfunction range from 9 percent to a high of 26 per cent.

This nuance may be lost if Boehringer finally wins the approval of flibanserin. It's a safe bet that at present there are already test marketing of brand names and a catchy new label for old frigid.

Why the cure for flagging female libido is hard to swallow

Pharmaceutical companies are behind a drive to cast women's sexuality as problematic, pathological and in need of treatment, writes Annemarie Jutel.

In a society which portrays female hypersexuality as desirable, and where women's tumultuous lives don't usually result in perfectly timed and balanced sexual urges, it hasn't been hard to describe low libido as abnormal in order to sell an expensive cure.

Concern with women's sexual drive is not new. Our own great-grandmothers also could have told us that not so long ago, women who were interested in sex for sex's sake, rather than for having babies, were cast as psychopaths by their early twentieth century doctors.

It is similarly not new that marketing medical treatments to women is a big business.

In the nineteenth century, advertising for Dr. Williams' Pink Pills for Pale People, and Pennyroyal and Steel Pills for Females filled the pages of women's magazines. In the early twenty-first century, however, the pharmaceutical industry takes a different tack to pedal their potions.

Disease branding

Direct-to-consumer advertising, while legal in the United States and New Zealand, is not permitted in most Western countries, so the industry has found ways to make both doctors and lay people aware of the medications they hope we'll soon be consuming like lollies to bolster their own bottom line.

An effective way of doing this is what the industry refers to as “disease branding.” This is an approach that focuses on promoting awareness of a particular condition, rather than its cure. The increased public vigilance, on the look-out for signs of the disease, will lead on to sales of the industry's proposed cure.

This sounds a noble alternative to advertising. The industry is keeping its hands clean, and looks like it is helping society. Disease branding is, according to one pharmaceutical journal, a way of creating “new understandings of the seriousness and legitimacy of certain conditions”.

They are walking on thin ice here. Don't forget: they are not a benevolent arm of the ministry of health. Their goal is to sell treatments.

Disease branding of women's sexuality is an important example of the degree to which the industry's targeted health messages are not as squeaky clean and meritorious as they would like us to believe.

Female sexual dysfunction

Today we are all aflutter as we read about Female Hypoactive Sexual Desire Disorder (FHSDD). This apparently not-so-rare disorder strikes (depending on which report you read) anywhere from 10 per cent to 15 per cent of women worldwide (or even 26 per cent as announced by an article published by Agence France Press last month).

FHSDD is a “disease” characterised by low sexual desire resulting in personal difficulties or distress by the sufferer. However, the furore over FHSDD is being carefully developed and promoted by the pharmaceutical industry, aware of the popular appeal of the hypersexualised woman.

A number of pharmaceutical companies funded a meeting to discuss women's sexuality in 1997, according to Ray Moynihan in the British Medical Journal. Half of the attendees were employed by industry, and the other half were researchers and clinicians who had been identified by industry as being “industry-friendly”.

This meeting was followed by a consensus-building conference, eighteen months later, which identified the lack of studies investigating female sexual dysfunction and issued a statement imploring researchers to make this a priority.

This consensus statement made the sweeping statement that 20 to 50 per cent of women suffered from sexual dysfunction, highlighting the imperative to find a “fix” and setting a foundation for the industry-funded researchers to investigate potential solutions to women's sexual problems.

The statement provided industry with what it needed most: scientific validation of the industry's commercial priorities. Who's going to argue with science?

Big pharma's commercial interests

The problem is the hidden commercial interests behind the science.

No less than eight different pharmaceutical companies sponsored the consensus meeting, and 24 others had financial or other relationships with the scientists and doctors who authored the report.

Last month, Boehringer Ingelheim, a German pharmaceutical company, held a conference in Lyon, France, to release the results of studies on a new medication called flibanserin, designed to bolster women's flagging libido.

The trials were funded by this same company, the screening tools used to detect the disease were developed by scientists they sponsored.

The press releases about the conference were designed to heighten concern about FHSDD and joy over its newly-discovered cure. News quickly spread on the wires, as the media failed to investigate the commercial links between the message and those who generated it.

The fact that so many women have a bitter-sweet relationship to Sex in the City, wishing they were a Samantha or a Carrie, yet feeling so sexually flat, may have less to do with a physiological problem than it does with their hard jobs, their demanding children, or their partner leaving dirty dishes in the sink.

Sexuality is a complex expression of social, cultural, psychological and physiological factors and many of us struggle with it, without being “sick.”

Don't let the pharmaceutical industry tell you otherwise.

Prof Annemarie Jutel, RN, PhD is a medical sociologist at the School of Midwifery, Otago Polytechnic in Dunedin, New Zealand. This article is based on a paper on female hypoactive sexual desire disorder she wrote that will appear in an upcoming edition of the Journal Social Science and Medicine.

Female Viagra boosts women's libido

Female Viagra boosts women's libido

A "desire pill" for women has been found after scientists discovered a failed antidepressant reawakens the female libido.

The drug, flibanserin, did little to improve patients' mood, but did do wonders however for women's flagging sex drive, researchers found.
Results from a series of clinical trials showed "significant improvements" in a number of measures of libido among women who had lost interest in sex. Researchers have hailed it as a potential "Viagra for women".

The drug mimics serotonin and a certain forms of dopamine which are substances produced naturally in the body connected with mood, reward, and learning.

Women taking 100 milligrams of flibanserin once a day reported greater numbers of "satisfactory sexual encounters", higher levels of sexual desire, and reduced stress associated with sexual problems.

Professor John Thorp, from the University of North Carolina at Chapel Hill, US, who led the research, said: "Flibanserin was a poor antidepressant.

"However, astute observers noted that it increased libido in laboratory animals and human subjects. So, we conducted multiple clinical trials and the women in our studies who took it for hypoactive sexual desire disorder reported significant improvements in sexual desire and satisfactory sexual experiences.

"It's essentially a Viagra-like drug for women in that diminished desire or libido is the most common feminine sexual problem, like erectile dysfunction is in men."

Viagra, which helps men overcome impotency, also began life with another purpose in mind. It was originally designed to treat angina, the chest pain associated with heart disease.
Scientists discovered that Viagra had the welcome side effect of helping the penis to fill with blood, thereby producing an erection.

Pooled results from three of four trials testing flibanserin's ability to boost women's sex drives were presented at the Congress of the European Society for Sexual Medicine in Lyon, France.

A total of 1,946 pre-menopausal women aged 18 and older were treated either with flibanserin or an inactive "dummy" placebo drug for 24 weeks.

Prof Thorp said the treatment could provide a new alternative for women without having to resort to hormones which can have side effects.