By Margaret Hodson ’16, Editor-in-Chief
The FDA’s recent approval of a libido-enhancing drug for women shows once again that in women’s health—a field that is never just medical—the personal is inherently political. The drug from Sprout Pharmaceuticals is called Addyi, and it was approved by the Food and Drug Administration on Tuesday August 18th. The purpose of the drug is to treat HSDD, or hypoactive sexual desire disorder. About 10% of women suffer from HSDD, meaning they have a lack of sex drive and libido. The FDA rejected Addyi twice—in 2010 and in 2013—before this year’s acceptance of the drug. As is typical of anything regarding women’s sexuality, the approval of the Addyi has been highly controversial.
The lobbying group Even the Score strongly supported the approval of the drug, claiming it was only rejected previously due to gender-based discrimination. In other words, the FDA did not approve the drug specifically because it aimed at increasing the sex drive of women. Even the Score conflated disapproval of the drug with disapproval of women seeking sex. They claim the FDA’s decision wasn’t medical and factual as much as social and political. It was the FDA re-enforcing a societal notion that women’s sexual desires should be stifled, not increased with a pill. After all, there are 26 separate FDA-approved pills for men aimed at treating sexual dysfunction. Addyi is the first and only for women. Members of Even the Score include the National Association of Reproductive Health Professionals, the National Association of Clinical Nurse Specialists, that National Organization for Women, the Society for Women’s Health Research, and the Women’s Research & Education Institute. Evidently, a bulk of Even the Score members are those passionately concerned about women’s issues and involved in the women’s movement. The opponents of Addyi see this as somewhat of an issue. They believe an opportunistic and enterprising pharmaceutical company used the guise of the women’s movement to get a dangerous drug approved via lobbying efforts and public pressure.
The opponents of Addyi point to both its troubling side effects and its low success rate as indications that it should never have been approved by the FDA. Detractors believe it was approved due only to public pressure: the FDA was afraid to upset the women’s movement by appearing to discriminate against women or frown upon their sexuality. Opponents of Addyi point out that erectile dysfunction is notably different from lack of libido. There are currently no pills on the market that seek to help men with a lack of libido. The side effects of Addyi can be quite serious, and include low blood pressure and fainting. In a trial, 1/5 women reported adverse side effects such as the above. The side effects are exacerbated when combined with certain types of hormones (such as those found in birth control) and alcohol. In fact, Addyi isn’t supposed to be taken with alcohol at all. As Addyi is supposed to be consumed daily, this means any women taking the drug would effectively have to be completely sober all the time. For many, this is simply unrealistic. Due to the possible side effects, the drug has the strongest type of warning: the boxed kind. Studies have also shown that Addyi only works better than a placebo for 8-13% of women.
In my opinion, both sides of the argument make valid points. It is easy to see how a bias against the expression of women’s sexuality could have influenced the FDA’s thinking about the drug. However, I hope the Federal Drug Administration is not stupid enough to approve a drug that is dangerous or ineffectual. I also find it hard to believe that so many groups dedicated to women’s health would support Addyi if they did not believe it to be effective and safe. Women’s advocacy groups have all the reason in the world to make sure Sprout Pharmaceuticals is not pulling the wool over their eyes before lobbying relentlessly for their drug. In the end, it is hard to say if public opinion and lobbying trumped facts and science in the case of Addyi. It is certainly interesting how when it comes to women’s sexuality, what is supposed to be just factual and medical (Does the drug work? Is it safe?) becomes political and social.
Sources:
http://www.nytimes.com/2015/08/19/business/fda-approval-addyi-female-viagra.html?_r=0
http://www.vox.com/2015/8/18/9173067/flibanserin-female-viagra-science
