Flibanserin -- perhaps derived from "female," "libido" and "answer"-- is Big Pharma's latest controversial innovation designed, it seems, to respond to American women's quest for an eternal wet dream. It comes in the form of a daily pill which, of course, is pink.
My first reaction to this news was, are those chemists nuts? Why wouldn't (pre-menopausal) women in their 40s and 50s feel a bit less sexy? They're exhausted from pressure jobs, doing second shift at home, and keeping their communities afloat. Maybe they're also still taking care of kids and elderly parents, not to mention hubby. But, Oh Dear, a whopping seven to ten percent of them seem to be complaining about a condition known as "hypoactive sexual desire disorder" (HSDD), now tagged "female sexual interest/arousal disorder," in the lucrative and highly unscientific psychiatrists' Bible, the DSM-5.
My first question when I read about this new wonder drug was, who defines "hypoactive" and what are the criteria? My second question was what research has been done, how good is it, and who funded it? And since when are situational fatigue -- or relationship problems -- a "disorder"? I decided to look further into the matter. What I found was disturbing.
Before the Food and Drug Administration (FDA) Advisory Committee approved Flibanserin last month (final decision due in August) the FDA had twice refused approval because of concerns regarding lack of effectiveness, frequent side effects, and long-term safety issues. Fewer than 50 percent of women who took the drug experimentally experienced significant improvement (so did 15 to 30 percent of women who took a placebo), and side effects - mainly nausea, dizziness, and fatigue - were worrisome, so much so in the case of fatigue that Sprout Pharmaceutical, the manufacturer, recommended that women take the pill at bedtime to avoid falling asleep driving the next day.
Promoted as the "pink Viagra," Flibanserin is nothing like Viagra, which addresses erectile dysfunction by increasing blood flow to the penis and is taken only when a man wants to have sex. Flibanserin, which is similar to anti-depressants and affects brain chemistry, must be taken daily, potentially for years.
"The simple but appealing notion that a new brain drug can help with HSDD because desire is in the brain has been peddled for the past year as if it were a fancy pair of new shoes," Leonore Tiefer, Ph.D., a clinical professor of psychiatry at New York University's School of Medicine, says. "Flibanserin is not a choice when it's promoted by bad science and half-truths."
Organizations like Our Bodies Ourselves and the National Women's Health Network have expressed concern. In testimony to the FDA in June, Network Executive Director Cindy Pearson said, "Despite over 15 years of research and development on female sexual dysfunction there is still no empirical standard that establishes a single, normal level of sexual desire for women. " Given the reported adverse events and the higher dropout rate in all three trials, many unresolved questions remain." Pearson cited "the clear omission of evidence-based research" and referred to a briefing document provided by the FDA that "represents a body of evidence of adverse reactions that cannot be washed away by advising women to take Flibanserin at night."
Despite all the concern surrounding the drug, a significant number of women's and health organizations along with 15 members of Congress petitioned the FDA to approve Flibanserin in the name of equality, thus thrusting gender politics into matters of medicine and science. In a letter sent to the FDA in January 2014, representatives of a dozen organizations suggested that the FDA was exhibiting sexism and gender bias, arguing that there were already over two dozen drugs for men's sexual dysfunctions on the market (there are, in fact, only eight) and that approving Flibanserin would lead to more equitable access to health care for women. Putting their trust in the DSM-5's questionable diagnostic abilities, they also argued that side effects could be addressed in labeling, that patients could rely on provider competence, and that women could be trusted with their own decision-making. All of these claims have been proven false regarding other drugs in the past.
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