Will Flibanserin Bring Focus to Female Sexuality?

Throughout history, female sexuality has rarely been taken seriously. It’s almost always compared to male sexuality—or worse, claimed to be in existence only to satisfy men’s sexual desire. We’ve come a long way from Freudian years. However, the creation of flibanserin—which is on the cusp of FDA approval—raises the question of whether complications within female sexuality will continue to be explored in depth, or if the medical community will simply imitate its approach to male sexual dysfunction with a little pink pill.

Flibanserin (or ADDYI, as it will be known commercially), is intended for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. Last week, an advisory committee recommended the drug for FDA approval with an 18 to 6 vote. The FDA has already rejected flibanserin twice, once in 2010 and again in 2013. If approved in this third attempt—which could happen as early as August of this year—flibanserin will be the first FDA-approved treatment for HSDD.

To see female sexuality being talked about in the medical community is an important step towards comprehensive sexual health. All women have the right to experience their sexuality fully, and medical assistance is sometimes necessary for that to come to fruition. Supporters of flibanserin say that approving it is vital to continuing a dialogue about female desire, as many doctors will avoid discussing something for which there is no possible treatment plan. Even the Score, a campaign aimed to end gender disparity in sexual health, points out that there are still zero FDA-approved treatments even though one in ten women suffer from HSDD. Compare that to twenty-six FDA-approved drugs for male sexual dysfunction, according to Even the Score, and the inequality seems clear.

But is the approval of flibanserin synonymous with closing gaps in the treatment of sexual dysfunctions?

The claim that rejecting flibanserin is evidence of pharmaceutical gender inequality may be more of a marketing ploy than reality. One of Even the Score’s main sponsors is Sprout Pharmaceuticals, the company that manufacturers flibanserin. None of the twenty-six drugs Even the Score references are intended to treat men’s low sexual desire, and some of the drugs identified in that list are not approved to treat any sexual dysfunction.

Even the Score asks in their mission statement why drugs like Viagra are fast-tracked for approval. As many people have been calling flibanserin “the female Viagra,” revisiting Viagra’s debut in the 90s is a good place to start. First off, it should be noted that flibanserin works quite differently from Viagra (as detailed by Helen Thompson in the Smithsonian). Flibanserin targets neurotransmitter molecules in the brain while Viagra increases blood flow to the genitals, as it is intended to treat erectile dysfunction (ED). Additionally, flibanserin is intended for daily, long-term administration while most drugs for men, such as Viagra, are taken on an as-needed basis. Women’s health supporters (such as National Women’s Health Network (NWHN) and The New View Campaign) argue that a drug intended for daily use requires a higher level of safety scrutiny from the FDA. Putting the political pressure of gender equity on the FDA masks the realities of the drug’s effectiveness and safety.

When Viagra was “fast-tracked” in the 90s, it became a quick-fix for men experiencing sexual dissatisfaction—not all of which was related to ED. A similar worry comes into play with flibanserin. The FDA-approval for the drug is targeted at premenopausal women with no other medical cause for low desire (such as other medications or disorders). As Cindy Pearson, executive director of NWHN, points out in her recent Washington Post op-ed, it is difficult to believe that the pill will only be prescribed to that specific population.

Pearson also brings up some concerns regarding the effectiveness of flibanserin and some of its side effects. Only about 10 to 12 percent of women found the drug to be effective during clinical trials. Sudden drop in blood pressure and fainting were reported as side effects, and these were reported as more severe when flibanserin was combined with alcohol or fluconazole, a medication used to treat yeast infections.

c/o Washington Post - http://www.washingtonpost.com/national/health-science/female-viagra-finds-difficult-path-at-fda/2014/02/19/e85d9d3e-9590-11e3-9616-d367fa6ea99b_story.html
Sprout Pharmaceuticals is solely focused on the development and approval of flibanserin.

Although the press release specifies that the recommendation for approval is conditioned by the development of risk management options beyond labeling, this does not mean that the drug is being held to the standards women deserve. If we are really taking female sexuality seriously, then women deserve a drug that is both effective and safe to their bodies. Women also deserve a conversation about their sexual satisfaction that does not deem their case hopeless if it can’t be solved with a prescription.

Some supporters of the drug say that failure to approve flibanserin will lead to less research efforts toward treating female sexual dysfunction. But discontinued research is also a possible end game if flibanserin is approved, in which case women with HSDD only have one pill that is not applicable to every stage of their lives.

Bat Sheva Marcus, the clinical director of the Medical Center for Female Sexuality and a supporter of flibanserin, says that if approved, the drug will be most effective if used in tandem with behavioral therapy. “My experience is these things work in sort of subtle ways,” she said in an interview with LoHud. “If you just throw the drugs at the woman, it doesn’t necessarily affect them.”

The time and money that is necessary for such a multifaceted treatment plan is not accessible or realistic for all women. However, Marcus points to one of the most important factors in helping women achieve optimal sexual health: continuing the conversation about it. This includes discussing sexual dissatisfaction outside of neatly-boxed diagnoses. Low sexual desire is only considered a problem if it is distressful to the person experiencing it (which is specified in the definition of HSDD). Not all sexual dissatisfactions can be explained by a textbook or fixed with medication. All concerns need to be communicated to doctors who believe that sexual health is a human right. Flibanserin is not fixing much if female sexuality is still discussed in hushed tones, and if women are embarrassed to admit that they are having a problem to their partners or health care providers. Whether or not flibanserin is approved, the right to a fulfilling and healthy sex life must be communicated to doctors, sexual partners, and to ourselves. We can’t rest on our laurels, or the possibility of a little pink pill.

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