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"Why Not Me?" Ask Women As FDA Turns Down 'Female Viagra'


"Female Viagra": image via cogentbenger.com"Female Viagra": image via cogentbenger.comThere are plenty of theories as to why the U.S. Food and Drug Administration (FDA) today failed to approve a new drug to enhance sexual desire among women with low libidos. Very few of them sound like they're based on science.

But apparently there were scientifically controlled, double-blind studies conducted at three universities, lead by the University of Ottawa and underwritten by Boehringer Ingelheim Pharmaceuticals.  And okay, it would have been better if some non-biased organization like the NIH supported the research, but the results showed that the drug flibanserin, which contains a substance known for years to increase sexual desire, was effective in increasing sexual desire.

Okay, so it was a mistake to call this drug a 'female Viagra.'  All of a sudden physicians, and probably some folks in the FDA, started to take the term literally, even though they know very well that  flibanserin doesn't work on blood flow to the genitals, as Viagra and the other erectile dysfunction drugs do for men.  You've got to be a mole to think that women have the same source of sexual dysfunction as men.

Of course, it's not 'Viagra for women.'  Flibanserin works on the brain, which is the main source of a woman's sexual arousal or non-sexual arousal.  Stress, self-consciousness, overwork, worry, and dozens of other mental interruptions impose themselves on a woman's brain to take precedence over sex.  Low libido has been given its own syndrome; it's called Hypoactive Sexual Desire Disorder (HSDD). Flibanserin is an anti-depressant which happens, unlike other anti-depressants, to have a positive effect on sexual arousal, on HSDD, instead of dampening sexual desire. 

The women involved in the study, 1378 of them, were 18 to 50, from three different countries, and were examined by the test administrators to insure that they were in "stable, communicative, monogamous, heterosexual" relationships for at least a year.  These women had HSDD, little or no receptivity to sex.  If the women were identified as 'depressed' or had psychiatric disorders, they were excluded from the study.

These premenopausal women in the study were treated for 4 months and showed improvement in their sexual satisfaction from 2.8 times per month to 4.5 times per month during that time.  Apparently that result was not enough for some critics, because women receiving the placebo had 3.7 satisfying sexual experiences compared to 2.7 before flibanserin treatment.  So the 'placebo effect' was their reason for cheering the fact that the drug did not get FDA approval.

The possible side effects of flibanserin are very mild and very rare, including dizziness, nausea, fatigue, and somnolence or insomnia. As with most new drugs, these side effects are generally short-lived. Look up the most common side effects of some of the other anti-depressants, and you'll find that flibanserin looks like a baby aspirin in comparison.  Yet, a physician was quoted by ABC news saying "If an effective and safe medication is identified, it should be given to women, but given potential risks and side effects, drug therapy always should be considered a last resort." 

Have you heard the list of potential side effects for Viagra and the other drugs for erectile dysfunction? The warnings and contraindications take up two-thirds of every one-minute commercial.

A scientist or physician should point to weaknesses in the methods of investigation or say they need more information, as one physician did, saying she would like to see more information on the effects of flibanserin on blood pressure and heart rate.  Those are important medical issues.

But the bulk of the arguments quoted are against 'medicalizing the sexual problems of women.'  Don't look now, but we are a medicated society. In a country where every other person is on anti-depressants and where every child who doesn't get straight A's must have A.D.D. and is medicated for it, and every man over the age of 50 takes a pill to help him enjoy sex...

I'm not arguing for flibanserin, nor for any specific drug; but why, when it comes to women's sexual pleasure or any ownership of their own bodies, are there always different standards applied?

 

sources: ABC News, Business Week, Flibanserin-HSDD.com, Wikipedia