Commentary Sexuality

The Middle Ground in the Fight Over ‘Viagra for Women’

Martha Kempner

Some advocates are calling the Food and Drug Administration's historical hesitation to approve a drug that would treat low sex drive in women sexist; others are saying the development of the medication itself is sexist. Who's in the right?

Last week, Sprout Pharmaceutical resubmitted its New Drug Application to the Food and Drug Administration (FDA) for the approval of flibanserin, a medication designed to increase sex drive in women suffering from what has been called hypoactive sexual desire disorder (HSDD). The FDA has rejected the drug twice before, asking for more research on its safety. This has prompted some people—many of whom identify as feminists—to call the agency sexist and to argue that if the medication were for men, it would have been on pharmacy shelves already. Other advocates, however, think drugs like flibanserin should never make it to market at all, because they believe that HSDD was made up by companies trying to profit off of women’s sexual insecurities. So, what is this pill, why are so many people fighting about it, and is there a happy medium here?

Flibanserin, which will likely have a sexier name if or when it is available for sale, was originally developed as an anti-depressant. As such, it works on neurotransmitters in the brain—increasing levels of dopamine and norepinephrine and decreasing levels of serotonin. In trials, this rebalancing of brain chemistry seems to also increase women’s desire for sex. “Cara,” a woman who has become a bit of a spokesperson (albeit one going by a pseudonym) on behalf of the company’s efforts with the FDA, explained to Marie Claire that she and her husband had wonderful sexual chemistry before kids, but that all but disappeared once she became a mother: “That broke [my husband’s] heart. He’d be lying next to me and I could just feel his anger and sadness in the air.” After she joined the drug trial, she says, her libido returned. As she noted, “Flibanserin helped me remember that person I used to be.”

But, like other antidepressants, flibanserin has side effects—most notably nausea and sleepiness—which were reported by 10 percent of the women, some of whom said their drowsiness was intense enough to interfere with their ability to drive. The FDA cited side effects like these as the main reason for rejecting the drug the first time it was up for review in 2010. At the time, a panel of experts unanimously voted against it because they believed the benefits did not outweigh the risks. The drug’s initial developer, Boehringer Ingelheim, then sold the drug to Sprout, which conducted additional efficacy and safety studies before resubmitting an application for approval. This second application was rejected in 2013; after a formal dispute of the decision, the FDA asked the company to provide more data on flibanserin’s interactions with other medications.

One particular concern is how the drug will combine with a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medications increase serotonin in the brain, which is the opposite of what flibanserin does. Interestingly, and perhaps significantly, doctors consider SSRI use to be linked to many women’s low sex drives. The application Sprout filed last week included more information on drug interactions like these.

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Ahead of the filing, Sprout and supporters have been lobbying hard for the drug’s approval and gone so far as to call the FDA’s rejection of the earlier applications sexist. Several prominent women’s rights groups, as well as some lawmakers, have joined with a group of drug companies all working on this issue to create the Even the Score campaign. Those behind the campaign argue that men have 26 drugs to address sexual dysfunction, while women have none; they say, “Treatments for women’s sexual dysfunction seem to be held to a different standard for approval at the FDA, and women suffer the consequences due to lack of access to safe and effective treatments.”

As Coco Jervis of the Women’s Health Network explains in a recent piece for Rewire, however, these arguments don’t hold up to scrutiny very well. First, she points out that men only have 26 drugs if you count every duplicate drug (a brand name and all of its copies)—in reality, men have about six solutions for sexual dysfunction. And while this is six solutions more than women have, this doesn’t mean sexism is at play.

On a biological level, men and women function very differently when it comes to sexual arousal and performance. Viagra—and medication like it—is all about the plumbing. Men who get aroused but fail to get erections take the pill when they want to have sex, and it increases blood flow to the penis. That is far simpler and more direct than a treatment like flibanserin, which is trying to change how women’s brains are wired and must be taken every day. In a statement made last year, the FDA said, “We do not believe there has been any gender bias with regard to our review of this drug.”

Jervis brings up another important point about the “score” that the campaign is trying to even. She notes that it is unfair to directly compare women’s sexual dysfunction—which is a wide-ranging and not well-defined concept—with men’s impotence. She writes:

The word “dysfunction”—medical jargon for anything that doesn’t work the way it should—suggests that there is an acknowledged norm for female sexual function. That norm has never been established. Although male sexuality is more complex than sheer physical arousal, erections are quantifiable events that scientists can measure in objective terms. By contrast, cis women’s sexual response is, by and large, qualitative, and difficult to subject to clinical trials. Furthermore, as we all already know, sexual desire differs over time and between people for a range of reasons largely related to relationships, life situations, past experiences, and individual and social expectations—and “normality” can vary widely from person to person.

In fact, there is not widespread agreement about whether HSDD, the disorder filbaserin is designed to treat, even exists. In an op-ed for the New York Times, sex educator and author Emily Nagoski points out that HSDD was removed from the Diagnostic and Statistical Manual of Mental Disorders in 2013 and replaced with female sexual interest/arousal disorder (FSIAD). The reason, she explains, is that women often follow a different pattern of sexual desire than expected. Rather than experiencing sexual desire as a spontaneous, frequent occurrence, Nagoski says, many women need to be aroused first. Then, she says, desire will follow. Sexual desire, in this case, is reactive. FSIAD is intended to describe women who have neither spontaneous or reactive desire, many of whom, according to Nagoski, can be helped with non-pharmaceutical treatments like therapy.

Which brings us to those sexual health experts who believe the drug would do a disservice to women. Leonore Tiefer, a clinical professor of psychiatry at NYU School of Medicine, has been an outspoken critic of efforts to create drugs to treat women’s sexual health. She told NPR, “The misrepresentation that everybody should be having it—needs to have it, wants to have it, has a problem if they don’t have it—is to change, really, what sexuality is into more of a medical thing.” And, as she added in Marie Claire“The pharmaceutical industry wants people to think that sexual problems are simple medical matters, and it offers drugs as expensive magic fixes.”

Those who take this view would often prefer to see a concentration on the emotional and relationship components of sexuality, which may very well be at the core of women’s lack of sexual desire. They also point out, again, that all women are different and there is no “right” amount of sexual desire to be “fixed” with medication. Adriane Fugh-Berman, who studies drug companies at Georgetown University, told NPR, “There’s really been a move toward medicalizing normal human experience. And while there are certainly some women who have very troublesome symptoms of low libido, it’s not at all clear that medication is a good answer for them.”

Drug companies indeed stand to profit off women—that is an unmistakable consequence of the availability of a “Viagra for women” on the market. But caught in the fight between them and the scholars who think this medicalization of sexuality is the wrong direction for society are the women themselves. And many of them, like Cara, just want to see their sex drive—which is often buried under kids, laundry, and a full-time job—return to what it used to be.

To me, there seems to be a pretty clear middle ground here (though I realize those on each side of the issue will likely disagree). If a drug can help a woman want and enjoy sex again, that is not in of itself a bad thing. It seems almost cruel to deny her pharmaceutical relief on the grounds that she’s a victim of society’s unrealistic expectations about female sexual desire. It’s dismissive to suggest that her feelings on the issue are not at all her own. And it is demeaning to suggest that a woman didn’t notice her lack of sexual desire until drug companies came along with a solution.

Of course, at the same time, the FDA needs to be extremely cautious (as it has been) before approving any drug that is working on something as important and complicated as brain chemistry. And, if it takes a lot longer to get it right and effective than it did for drugs that make men hard, that’s not sexism—that’s just reality. If it does hit the market, health-care providers should help women carefully decide if this is the right choice.

Women deserve sexual desire and pleasure. For some, it will come easily. For others it may take therapy, relationship counseling, or finding a better partner. And, someday, for others it may come in an easy-to-swallow pill. It’s time to stop bickering and slinging accusations and instead let women find their sexual satisfaction through whatever means works best for them.

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