Yesterday, the FDA approved the first drug to treat low or absent sexual desire in pre-menopausal women. Popularly known as “female Viagra,” the drug, Addyi, has created a clear divide in feminist circles.
On one side of the debate are advocates for the drug. Many of them are part of Even the Score, a coalition that has framed the controversy surrounding the drug—which has been up for FDA approval a total of three times—as an issue of gender equality. They argue, for instance, that it is unfair that there has not been a treatment for women’s low libido, since Viagra and similar drugs for men have been approved for years—although these drugs treat erectile dysfunction, not decreased libido.
“I think it’s a historic decision for women’s health,” Dr. Anita Clayton, interim chair of psychiatry and neurobehavioral sciences at the University of Virginia, tells the Ms. Blog. “I’m convinced, and everyone else ought to be as well, that this drug works and it’s safe.”
Critics, however, say that the drug’s risks—including low blood pressure, nausea and dizziness—don’t outweigh its benefits, which include an increase of no more than one “sexually satisfying event” per month.
“This is a triumph of marketing over science,” says Cindy Pearson, executive director of the National Women’s Health Network. “Women don’t have enough information to accurately assess the risk of this drug.” She added that the FDA’s decision to require post-market studies of the drug “is feeble and unreliable” since “about half of all studies required by the FDA post-approval are never completed.”
In June, a governmental advisory committee recommended the FDA approve the drug. Prior to that meeting, the FDA had rejected the drug twice for not meeting risk-to-benefit ratio standards. The drug’s manufacturer, Sprout Pharmaceuticals, conducted a safety study after the drug was rejected a second time using mostly male participants; the drug was approved anyway.
