Happy Birthday, Viagra! But What About the Ladies?

Who knew that as a vagipreneur, a person in the business of female sexual health, that I would have a busy season? But these are fast and furious times for female sexual health. Conversations and movie theaters are overflowing with 50 Shades of Grey, an extremely mediocre movie (which my sister accurately renamed "50 Shades of Refund" after seeing it) that has grossed over $500 millionat the box office to date. At one point at the trilogy's height (and I didn't make this up), at least one of the books was being sold every second somewhere in the world. Clearly I have concerns as a woman, wife and mother of teenagers as to how the story depicts relationships and intimacy. But I do value that the phenomenon is creating the opportunity to have important conversations about female sexual satisfaction.



And if that is not enough to keep the female sexual health conversation lively, Sprout Pharmaceuticals recently resubmitted its second NDA (new drug application) for flibanserin, its drug for the treatment of hypoactive sexual desire disorder (HSDD), which actually represents the third attempt for the drug to get approval in five years.

Let's back up a little. First off, what is HSDD? In scientific terms, HSDD is defined as a woman's chronic or ongoing lack of interest in sex, to the point that it causes her personal distress or problems in her relationships. In non-science speak, if you never have any sexual desire, but are not upset about it, you don't have HSDD.

Secondly, how does flibanserin work? In the words of Stephen Stahl, adjunct professor of psychiatry, University of California San Diego School of Medicine,
on Sprout's website, "one of the root of persistent and recurrent low sexual desire, or HSDD, stems from an imbalance of neurotransmitters in the brain ... flibanserin is believed to work by correcting this imbalance and providing the appropriate areas of the brain with a more suitable mix of brain chemicals to help restore sexual desire."

For those just tuning in at home, the first time the FDA rejected the application for flibanserin in 2010 after its submission by Boehringer Ingelheim, the panel explained that flibanserin's benefit was "not robust enough to justify the risks." Long story short, at that point, Boehringer Ingelheim decided to pack up its toys and go home after over a decade of investment in bringing this compound to market.

In 2011, Sprout acquired the failed anti-depressant to make another run at it and submitted its first application for flibanserin approval in 2013 -- supported by 14 additional studies that included 3,000 additional patients -- only to be rejected again. While the data showed that women had two times the number of satisfying sexual experiences with flibanserin (a critical measure for the FDA to show drug effectiveness), the agency stated that flibanserin's "modest" benefits still did compensate for the side effects -- drowsiness, dizziness and nausea.

So what is the rub, and why is it a big deal? From Sprout's perspective, and many other pharmaceutical companies and female health organizations, the FDA has shown a consistent disregard and blatant gender discrimination for women's health. As a result, Sprout has vigorously supported the "Even the Score" public relations campaign, proclaiming their mission as "telling the FDA that it is time to give women the options they deserve for the treatment of sexual dysfunction."

The organization goes on to say that "it's clear that there is an unconscious gender bias at the FDA." For the women who have had meaningful changes from using flibanserin, it seems that maybe a little tiredness is worth it. And just for comparison's sake, the side effects for the erectile dysfunction drugs include cardiovascular issues, blinding headaches and sudden vision loss -- just to name a few of the dozens listed. But maybe anything's worth it for a four-hour erection.

Still other women's groups and female health experts are thrilled that the drug has yet to see the light of day. They object to the medicalization of female sexuality, complaining that the pharmaceutical companies have created this disease to capitalize on economic opportunities. Others say that such classifications simplify the complexities of female sexuality, and that flibanserin won't reflect the diversity of women's sexual experiences. According to sex educator Emily Nagoski, in her recent op-ed in the New York Times, the supporters of Flibanserin are attempting to treat something that isn't a disease. According to Dr. Nagoski:

What these women need is not medical treatment, but a thoughtful exploration of what creates desire between them and their partners ... Feeling judged or broken for their sexuality is exactly what they don't need -- and what will make their desire for sex genuinely shut down.

And just to include the latest bit of fuel to ignite the debate, this year marks the 17th anniversary of the landmark approval of Viagra with many congresspeople using the opportunity to write to the FDA calling for "gender equity." The arguments revolve around the fact that men have access to 26 FDA-approved medical treatment options for sexual dysfunction, while women have zero biological treatment options .

So where does this leave the (royal) us? What is the "truth"? Is HSDD is a disease? Does flibanserin work? Is there a systemic gender bias in the FDA? Will women ever have their equivalent of the "four hour erection"? Well, the literal and figurative jury is still out. But I am confident the sexual squabbling will rage on!