Until now, the FDA has been standing with me, asking tough questions about drugs marketed to increase womenÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s sex drives. Several drug makers wanting to break into this potential blockbuster market have tried to prove that their products work and are safe. So far, theyÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢ve failed: BioSanteÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s testosterone gel was no more effective than placebos. Procter & GambleÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s Intrinsa patch raised fears over a potential link to breast cancer. And Sprout PharmaceuticalsÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢ flibanserin, the libido drug in front of the FDA now, already has been rejected twice for ineffectiveness and side effects.
For some feminist groups and legislators, this due diligence is evidence of sexism in the FDA. They note that there are numerous approved treatments for male sexual dysfunction and low testosterone, but none for most common form of sexual dysfunction in women. ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œThe FDA must overcome the problem of institutionalized sexism,ÃƒÂ¢Ã¢â€šÂ¬Ã‚Â wrote psychiatrist Anita H. Clayton in a Huffington Post piece, ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œunconscious and perhaps unintended, but damaging nonetheless.ÃƒÂ¢Ã¢â€šÂ¬Ã‚Â
This kind of language could be dangerous, pushing drugs onto the market that are risky to womenÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s physical health. Unfortunately, ThursdayÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s vote recommending approval of flibanserin suggests the rhetoric is winning. Even the Score, a campaign that has fueled the charge that sexism is behind the FDAÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s decisions on womenÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s libido drugs, brought dozens of people to the FDA committee hearing to testify in favor of flibanserin. (Even the Score is backed by Sprout Pharmaceuticals.) One woman said she had seen 30 doctors trying to treat her low libido. Another said she was missing her sonÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s first birthday to attend the hearing, in hopes of accessing a drug that offered ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œeven a modest improvementÃƒÂ¢Ã¢â€šÂ¬Ã‚Â in her sex drive. But while the womenÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s descriptions of the drug made it sound great, the data tell a different story.
In clinical trials testing its effectiveness, flibanserin has either failed or barely passed. Only about 10-12 percent of women in trials benefitted from taking the drug. And even those showing ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œa modest improvementÃƒÂ¢Ã¢â€šÂ¬Ã‚Â in libido were exposed to the drugÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s serious side effects, including sudden drops in blood pressure and loss of consciousness. One woman even suffered a concussion when she fainted during a trial.
Trials studying flibanserinÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s effect while taken with other drugs were especially troubling. Paired with fluconazole, a medication used to treat vaginal yeast infections, flibanserin caused such severe problems that the study had to be stopped early. And the trial studying flibanserinÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s interaction with alcohol was so small (25 people, including just two women), we canÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢t draw any conclusions from the results. Unlike Viagra, flibanserin is a daily pill, so understanding its interaction with alcohol is vital.
History should convince us all to be cautious about new drug treatments marketed for womenÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s health. There are numerous cases of over-medication, over-diagnosis and over-treatment. Women get hurt when companies create and exaggerate conditions to promote use of their drugs. In the 1990s, pharmaceutical companies began marketing drugs for a condition called osteopenia, which they defined as ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œlower than normalÃƒÂ¢Ã¢â€šÂ¬Ã‚Â bone density. In reality, it was a ploy to justify prescribing bisphosphonate drugs -- used to treat the very real condition of osteoporosis -- to millions of healthy women. A small number who took these drugs for osteopenia reported sudden breaks in their upper leg bone, suggesting a treatment that was supposed to prevent fractures could cause them.
In another case, pharmaceutical companies persuaded doctors to prescribe hormones to millions of healthy women to treat what they called ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œpostmenopausal estrogen deficiency.ÃƒÂ¢Ã¢â€šÂ¬Ã‚Â But when researchers tested these hormone ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œreplacementÃƒÂ¢Ã¢â€šÂ¬Ã‚Â therapies in 2002, the evidence didnÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢t support the companiesÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢ claims that the treatments would protect women from heart disease and cognitive decline. Instead, the treatment increased their risk of stroke and breast cancer, hurting the women it was supposed to help.
Similarly, the condition called female sexual dysfunction has been promoted by pharmaceutical companies to justify prescribing drugs to healthy women. ItÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s not a real condition with a scientifically valid diagnosis. But female sexual dysfunction has been defined as a condition affecting 43 percent of women. ThatÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s 68 million potential customers in the U.S. alone for the first drug maker to get its ÃƒÂ¢Ã¢â€šÂ¬Ã…â€œfemale ViagraÃƒÂ¢Ã¢â€šÂ¬Ã‚Â past regulators.
Certainly, low libido is a real and truly distressing condition for some women. But we donÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢t know what causes it and how often it occurs. We donÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢t know if it manifests differently in lesbians and straight women, or in premenopausal and postmenopausal women. These are things we need to address before rushing a libido drug onto the open market for wide consumption. Flibanersin has only been studied on premenopausal women with no medical cause for low desire. ItÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s unlikely that once on pharmacy shelves, it would be used only in those situations. And yet, we know this drug, while barely effective, poses real dangers to womenÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s health.
ItÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s true that men have many more options to address their sexual problems than women do, and that needs to change. But flibanserin is different from Viagra, and women are different from men. Viagra addresses a physical problem by easing blood flow in men who desire sex but have difficulty functioning. Flibanserin, on the other hand, addresses arousal in women who lack sexual desire by targeting neurotransmitters in the brain, our most complex organ. Further, women do have access to medications to treat their physical problems during sex, such as pain during intercourse. Rhetoric that paints the disparities in sexual health medications for men and women as a result of pure sexism ignores these realities.
Every woman -- no matter her age, health status, or relationship status ÃƒÂ¢Ã¢â€šÂ¬Ã¢â‚¬Å“ is entitled to positive sexual experiences. Beyond that, every woman deserves to have positive sexual experiences without risking her physical health. Advocating for a libido drug that accomplishes that is not sexist. In fact, itÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s feminist.