Sex & Relationships

Are Libido Boosters for Women Just Another Big Pharma Scam?

The pharmaceutical industry attempts to medicalize female sexuality.
Since Margaret Sanger launched the US birth control movement almost 100 years ago and the Pill became available 50 years later, women are supposedly free to be as lustful or aggressive as they want, untethered by pregnancy concerns. Yet new drugs for women's sexuality and media images show that definitions of "normal" female sexuality are still coming from men and big business. 
 
Women are pressured to be more sexual, as the growing "disease" of "hypoactive sexual desire disorder" suggests. They are also pressured to be less sexual, say reports about male researchers who were testing two new female Viagra-style drugs and worried that women will become sexual aggressors.
 
The new pills, made by the Dutch drug company Emotional Mind, are Lybrido, which contains testosterone and sildenafil, the active ingredient in Viagra, and Lybridos, which contains testosterone with the antidepressant buspirone. 
 
Of course, many couples are excited about the prospect of steamy new sexual excursions. But, like pills for insomnia, heartburn, hay fever, shyness, attention deficit and mood disorder, women's sexuality is now also being medicalized into a disease. Women can now be told by their partners and society that they are suffering from female sexual dysfunction even if they feel fine. Or, as an ad when a different "female Viagra" was under consideration put it, "If There is No Desire to Get Physically Romantic, You Could Be Suffering from HSDD."
 
One of two ingredients in Lybridos, buspirone, is actually marketed as a chaser to antidepressants because it is known to reverse their negative sexual side effects. The new drugs' marketers freely admit a large number of US women are on antidepressants, which might well be at the root of their sexual problems! Nearly one in four women between the ages of 50 and 64 take antidepressants said a recent report and both older and new antidepressants can cause diminished libido and anorgasmia, the inability to achieve orgasm, even with adequate stimulation. Needless to say, treating side effects of an expensive pill with another expensive pill is a lucrative business model for Big Pharma.
 
Still another ingredient in both new drugs, testosterone, is rumored to increase libido in some women and is prescribed by doctors, though it has not been approved for such a use in women yet. "This stuff is great if your libido has gone AWOL," wrote a 39-year-old woman on the drug rating site Askapatient.com. "This was prescribed to me by a sexologist. The effect became noticeable after about 17 days, but the full effect wasn't felt until week 5 or 6. Increased intensity of orgasm, frequent feelings of lust, increased desire & arousal. Also excellent for quashing depression, anxiety & insomnia."
 
Yet there are many questions about testosterone's safety. The FDA refused to approved a testosterone patch made by Procter & Gamble to increase women's sexual desire in 2004. Some say the patch, called Intrinsa, was denied approval because it came too soon after the FDA's hasty, industry-friendly approval of Vioxx. Marketed as a super aspirin for everyday arthritis or menstrual discomfort, Vioxx resulted in 88,000 heart attacks and 38,000 deaths before it was withdrawn from the market.
 
Intrinsa produced only "small improvements in sexual parameters and large placebo responses," said a review that proved a nail in the drug's coffin. "Unwanted side effects are common and not always reversible." Who can guess what those side effects are? Nor did it help that three women testified during FDA hearings for Intrinsa that they had developed breast cancer while using it.
 
It’s no secret that testosterone is being huckstered like estrogen once was, as a sexual fountain of youth. People don't lose hormones because they get old, they get old because they lose their hormones is the sales pitch. But 10 years ago a federal study found hormone replacement drugs in women greatly increased the risk of breast cancer, ovarian cancer, heart attacks, stroke, blood clots and dementia and testosterone may prove equally as dicey. In fact, hormone replacement was so injurious to women, that in the first year millions quit--2003--breast cancer in the US fell seven percent and 15 percent for tumors fed by estrogen. Heart attacks also fell. Thank you Big Pharma.
 
Now, testosterone benefits are being hyped and their risks downplayed in the same way. Last year, an issue of Menopausal Medicine, a publication of the American Society for Reproductive Medicine, reported  that "possible beneficial effects of testosterone therapy" include "reduced fracture risk and favorable effects on cognitive function and cardiovascular function," just what was said about estrogen therapy. Is the new therapy safe? "Women should be fully informed that although the combined findings of the randomized trials of testosterone conducted to date have not demonstrated an increased risk for breast cancer or cardiovascular disease, evidence is not yet available regarding safety of long-term testosterone use," says the publication.
 
But there is another ingredient in the two new female Viagras under development that has been rumored to work for female sexuality. In addition to testosterone, Lybrido contains original Viagra, which women say has produced arousal when they have borrowed or sneaked it from their husbands and boyfriends. A 42-year-old nurse told the New York Times that after taking Viagra, "We were watching television, just a regular movie,'' and after an hour she began to feel ''a fullness. I can't say it was a tingling, but it was some effect of the increased blood flow to the area.''
 
Still, if Viagra worked for women, at least without other ingredients added, manufacturer Pfizer, the world's largest drug company, would not have declined to pursue a license for a female version in 2004 when it was raking in billions on the male drug. Studies of women on Viagra drew "inconclusive results" in placebo controlled studies, said the drug giant.
 
Everything Old Is New Again
 
Like the new diet pill the FDA approved last year, Qsymia, which combines half of fen phen with the seizure drug topiramate, neither Lybrido and Lybridos are really "new." Testosterone, Viagra and buspirone are already on the market but cannot be advertised for female sexual dysfunction, or reimbursed by insurance companies.
 
Yet repurposing two diet-related drugs has failed to produce a blockbuster diet pill, reports Reuters and "doctors have been slow to pick it." Will the same thing happen to Lybrido and Lybridos?
 
Three years ago similar excitement about flibanserin, a "female Viagra" made by the German company Boehringer Ingelheim, dwindled like a pre-Viagra age erection. Like Viagra, which was meant to be an angina drug until its erectile effects appeared, flibanserin was meant to be an antidepressant drug until its effect on female sexual desire surfaced. Some trial participants did not want to surrender their unused pills at the end of the study. But, despite medical and media excitement about flibanserin and pleas from Big Pharma, Wall Street, husbands, boyfriends and women, the FDA rejected flibanserin because it didn't seem to work. Why did trial participants swear by it? Placebo reactions are common in libido drugs because sexuality has such a strong mental component and lends itself to suggestibility.
 
The new "female Viagra" drugs Lybrido and Lybridos are receiving so much buzz, they were on the cover of the New York Times magazine in June and anchor a heavily promoted book called What Do Women Want? by New York Times writer Daniel Bergner. They are advancing in the FDA approval process and expected to be cleared for larger clinical trials soon. They could be on the market in two years. But will the drugs, if they are approved, really help women who want help with their sex lives and sexual desire? Or are they just another way of defining and cashing in on female sexuality?

Martha Rosenberg is an investigative health reporter and the author of "Born With a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health (Random House)."