On August 18, the Food and Drug Administration is slated to make a decision on whether to approve a controversial new drug, designed to boost women's sex drives. But the issue goes beyond medicine; it's now become an argument over women's rights.
The drug is called Flibanserin. It's commonly referred to as "Viagra for women," although in reality, it is nothing of the sort. Viagra treats erectile dysfunction, a physical problem where men cannot sustain an erection. The drug is taken as needed, usually just prior to intercourse, and improves blood flow to the penis. Flibanserin, on the other hand, is designed to treat hypoactive sexual desire disorder (HSDD), which psychologists claim is an emotional not a physical disorder, and impacts chemicals within the brain (primarily dopamine and norepinephrine). The drug must be taken daily and there are concerns about long-term side effects, which have yet to be determined by the drug industry.
The drug has failed two attempts at FDA approval, primarily because of low success rates and concerns over side effects, which can include nausea, dizziness, low blood pressure, and fainting.
But the controversy has morphed into an issue over women's rights, involving some surprising advocates on both sides of the issue.
Sprout Pharmaceuticals, the latest company to push for FDA approval, has condemned the FDA, claiming they hold issues of women's sexual satisfaction to different standards than that of men. They cite the glut of drugs targeted to treat male sexual dysfunction, while there are as of yet no drugs to treat issues among women. The company has even ramped up a public campaign, called Even the Score, in an effort to highlight the disparity within the market.
But women's advocates disagree, stating the drug companies are simply looking out for their best interests by pushing for approval, despite the low success rate and potential dangers. These advocates also use the lack of available drugs in their argument, yet they emphasize the challenges HSDD poses regarding drug development. HSDD has been closely associated with underlying psychological issues, such as the health of a woman's relationship, daily stress, lack of sleep, or anxiety and depression; issues which cannot be corrected through a simple pill.
In a collective letter to the FDA, The National Women's Health Network urged the agency to stand tough against such marketing pressure and reiterated the need for further testing.
"As patients, consumer and women's health organizations and supporters, we support the FDA's concern for drug safety shown in its appropriate handling of the Flibanserin applications," their letter stated. "We also appreciate your longstanding support for women's health and safety. Even the Score's effort to make this a conversation about gender equality is misleading and dangerous. The FDA should continue to balance a serious and respectful incorporation of patient input while maintaining a rigorous, science-based review standard for the drugs and devices it approves."