‘Pink Viagra’ not a feminist victory

By Abby Seitz, Opinions Editor

Sexual arousal disorders were first recognized in the inaugural edition of the Diagnostic and Statistical Manual of Mental Disorders in 1952. Within one year, the Food and Drug Administration approved Delatestryl to treat erectile dysfunction in men. However, there was no treatment for women struggling with a low libido until August 2015, when the FDA approved flibanserin. The drug is expected to be available nationwide as early as Oct. 17.

The drug’s approval is being hailed as both a medical advance and a feminist victory. However, flibanserin has a complicated past and serious side effects that ultimately outweigh any prospective benefits.

Flibanserin, commonly referred to as “pink Viagra,” was initially introduced to FDA trials as an antidepressant and was rejected. Trial participants reported an increased sex drive as a side effect of the drug. The drug, whose patent was then owned by pharmaceutical company Boehringer Ingelheim, re-entered trials as a libido-booster. Flibanserin was once again rejected by an FDA advisory committee, as participants reported the drug did not increase their sex drive.

In 2011, Sprout Pharmaceuticals bought the patent for flibanserin in  hopes of re-developing it to treat hypoactive sexual desire disorder, a condition that affects an estimated one in 10 women, according to the Society for Women’s Health Research. While HSDD was once considered a mental disorder, it was later merged with other sexual dysfunctions and classified as Female Sexual Interest/Arousal Disorder in the DSM-5, which was published in 2013. HSDD is characterized by a lack of sexual desire that is not related to any issues  such as mental illness, stress or cultural and religious factors. The lack of a pharmaceutical treatment led to female sexual dysfunction being recognized as an unmet medical need by the FDA in October 2014.

In late 2013, the FDA rejected Sprout’s new drug application, citing that any benefits offered were overshadowed by extreme side effects. Sprout appealed, began additional studies and launched a lobbying campaign to encourage FDA committees to approve the drug in the future.

The “Even the Score” campaign, a coalition of 24 health and women’s advocacy organizations, claimed flibanserin’s approval was a matter of equality between the sexes and that men’s sexual dysfunction has been prioritized over women’s for decades, according to the coalition’s website. Framing flibanserin’s FDA approval status as a feminist issue misleads women and takes factual information out of context.

The “Even the Score” website cites “26 FDA-approved treatment options for men’s sexual dysfunction and only one for women.” The site fails to mention that none of those 26 drugs treat or cure a lack of sexual desire. Men’s sexual dysfunction treatments, such as Viagra, treat erectile and arousal dysfunctions through physiological means. Flibanserin, however, works with neurotransmitters in the brain. The two treatments are fundamentally different and there is no score to balance in this instance.

Aside from the social controversy surrounding flibanserin’s approval, the drug is not practical. In trials, results were modest. In the largest trial which featured 1,087 women who had experienced at least six months of low libido, 34 percent reported that flibanserin aided their distress regarding low sex drive “much” or “very much”—as did 25 percent of women who took the placebo. In the other two trials, flibanserin “did not increase sexual desire scores reported in daily diaries,” according to the health research company Informulary.

In trials, one in five women reported experiencing fatigue, dizziness, low blood pressure or fainting—the same side effects that caused the FDA to reject flibanserin as an antidepressant. These concerns are severe enough that flibanserin, a daily pill, is prescribed to be taken at bedtime in order to combat side effects.

The risk of severe side effects has been found to increase when combined with some types of birth control, anti-fungal medications and alcohol—all of which may be used by sexually active women. When flibanserin was rejected in 2013, the FDA recommended further research on how flibanserin responds to alcohol.

The study conducted involved 25 volunteers but only two women, according to a 2015 article in the Journal of American Medical Association. The study’s small and overwhelmingly-male sampling does not present any valuable data. A more thorough study should have been presented, especially considering that flibanserin is a daily medication.

Women’s sexual health is frequently politicized, but fair and safe healthcare should remain a priority. Women should not compromise their physical health for a treatment that was approved based on an aggressive and misleading lobbying campaign, rather than actual scientific data.