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Does the Pink Viagra work?


Does the Pink Viagra work?

Despite diehard urban legends in the 1960's about Spanish Flies, "nymphomania" and the proverbial "girl on the gearshift" (who everyone swore they knew), drugs to boost women's libido are not recent. They date all the way back to Roman times when the wife of Augustus Caesar dosed her guests to liven a party and Marquis de Sade did the same, seventeen hundred years later.

Now a new female libido drug, dubbed the Pink Viagra, has husbands, boyfriends and Wall Street cheering, if not its intended patients.

On June 18 an FDA advisory committee will consider approval of flibanserin, manufactured by Germany-based Boehringer Ingelheim Pharmaceuticals, for "treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women."

Flibanserin was rolled out at the European Society for Sexual Medicine's annual meeting in Lyon, France last November as an exciting new treatment for libido impaired women. Volunteers reported the number of "satisfying sexual encounters" they had on the drug increased from 2.7 to 4.5 times a month in pooled data from placebo-controlled Phase III studies in the U.S. and Europe. Placebo worked too, with women reporting satisfying sexual experiences increased to 3.7 a month. (Evidently just thinking about sex, rather than "England," stokes desire.)

To participate in trials, women had to be "in a stable, monogamous, heterosexual relationship" for a year, free from depression and parenting, eldercare and income stress - but who does that leave? - and "willing to try to have sexual activity" at least once a month.

Like Pfizer's 12-year-old Viagra which was meant as an angina drug until its erectile effects appeared, flibanserin was groomed to be an antidepressant until its effect on female sexual desire surfaced during the study and trial participants didn't want to return their unused pills according to Medpage. It wasn't effective as an antidepressant despite 15 years of forced swim, "learned helplessness" and stereotactic experiments in animals.

Chemically, flibanserin modulates dopamine and serotonin like other psychoactive drugs but is less like current SSRI antidepressants than older drugs like Buspar and Serzone says an article on Neuroskeptic.com. (The antidepressant, Serzone, barely used today because of liver toxicity, was linked to male and female priapism, an abnormal and painful erectile state.) Flibanserin may even share antipsychotic effects with Haldol and Zyprexa speculates a 2002 article in CNS Drug Reviews.

Despite its rep as a female Viagra, flibanserin really isn't. Viagra exerts mechanical actions, increasing blood flow to the genitalia without increasing desire while flibanserin does the opposite - increasing desire not blood flow.

But the bigger difference is dosage: while Viagra is taken as needed and even impulsively, flibanserin is taken all the time for the 4.5 or 3.7 times a month sexual activity occurs.

While the push to take daily drugs for occasional occurrences like antidepressants for anxiety and "prevention" drugs for disease "risks" certainly turbo charges pharma sales, some wonder if women will want to alter their chemistry for a few enchanted nights. Sure women take birth control pills all month long but when women were offered the chance to treat painful periods by taking a repurposed Prozac called Sarafem every day, there were few takers.

Of course to be covered by insurance, women who take flibanserin need to suffer from hypoactive sexual desire disorder or HSDD which is where the controversy about the Pink Viagra starts.

HSDD, is defined in the current Diagnostic and Statistical Manual of Mental Disorders (DSM) as "the persistent or recurrent lack (or absence) of sexual fantasies or desire for any form of sexual activity" causing "marked distress or interpersonal difficulty."

In light of the fact that many women have low sexual desire and are okay with it and other women have low sexual desire because of very real things their partner (or partners) is doing or not doing, do women really want to be told there's something wrong with them?

"I have long had a problem with the tendency of the healthcare system, aided and abetted by the pharmaceutical industry, to diagnose as a problem a symptom or sign experienced by the majority of people," wrote Ingrid Nygaard, M.D. in a 2008 Obstetrics & Gynecology editorial, adding that the diagnosis might be driven by grants, stock shares and providers' need for income.

Nor was sex researcher Petra Boynton, PhD, at University College, London impressed with Boehringer Ingelheim's efforts to presell flibanserin in 2008 and 2009 before it was developed or approved.

"I've had two invitations to attend two two-day long 'training days' at top London hotels (with an honorarium of 1000 per session)," she writes on her blog. "My understanding of the aim of these events were to highlight FSD (or more specifically Hypoactive Sexual Desire Disorder) as a problem and inform practitioners about treatment approaches. From that, key advisors who'd attended training days could speak further and influence colleagues to also promote FSD as a problem and recommend future treatments as they came on board."

Even though Boynton declined, Boehringer-Ingelheim invited her to write a paper for the British Journal of Sexual Medicine. "They had clear instructions about what they wanted me to say and how this would set the scene that HSDD was a prevalent and distressing problem doctors ought to be aware of - presumably so they could be alerted to a problem and be more willing to prescribe a pill when said medication became available."

Flash forward to March of this year when Boehringer-Ingelheim rolled out its Sex Brain Body: Make the Connection campaign starring TV personality Lisa Rinna - replete with glitzy disease branding web site in the Restless Legs/Excessive Sleepiness/Social Anxiety Disorder tradition. Nowhere is flibanserin, not approved yet, mentioned.

Same with an inside cover spread in the June 10, 2010 New England Journal of Medicine which elevates HSDD to a new public health problem without mentioning a drug "solution."

The Discovery Channel is also airing, "Understanding Female Sexual Desire: The Brain-Body Connection," a documentary about the effect of HSDD on three women's lives, funded by guess who?

A Top News article cajoles, "If There is No Desire to Get Physically Romantic, You Could Be Suffering from HSDD," in June with racy boudoir photo.

Of course some gynecologists, sex researchers and patients welcome the fact that pharma is no longer ignoring women's sexuality. Why should men have all the fun, they ask? But others see in HSDD marketing the same forces responsible for the terms "frigid," "nymphomaniac," battles for safe and effective birth control and reproductive health care and social tolerance of violent or degrading pornography - namely, men defining women's sexuality for their own purposes. Nor do Google search images for HSDD, which are pretty "800 number/phone sex" allay fears.

And there are other questions surrounding flibanserin like its safety profile. What are its long term effects when trials, which only lasted a few weeks, were marred with side effects like dizziness, nausea, fatigue and somnolence?

And does it even work?

Flibanserin is "much more likely to put you to sleep than it is to make you enjoy sex in any given month," speculates Neuroskeptic. "Any sedative can increase sexual desire, as anyone who has ever been to a bar will know. So whether this drug actually has an aphrodisiac effect, as opposed to just being a sleeping pill, is anyone's guess."

Others take it a step further and say a candlelight dinner would work just as well to boost sexual desire.

Or help with the housework.

Martha Rosenberg is a columnist and cartoonist, who writes about public health

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