Last October, the first medication designed to treat low sexual desire in women hit the market. Depending on who you believe, flibanserin (sold under the brand name Addyi) is either a safe and effective treatment for the most common form of female sexual dysfunction, or “a mediocre aphrodisiac with scary side effects.” To some, its approval by the Food and Drug Administration represented a long-overdue feminist victory for equality in sexual health; to others, it seemed like the product of a clever faux-feminist con carefully orchestrated by Big Pharma.
Originally tested as an antidepressant, flibanserin’s application as a treatment for hypoactive sexual desire disorder (HSDD) had been rejected by the agency twice before, in 2010 and 2013. This time, the drug gained the support of a coalition of progressive women’s and health organizations, which launched a multi-pronged lobbying effort for its approval. The Even the Score campaign, which quickly joined forces with the drug’s then-owner Sprout Pharmaceuticals (Valeant Pharmaceuticals acquired Sprout after the FDA’s decision), charged the FDA with “persistent gender inequity” on the grounds that men had 26 FDA-approved drugs to treat their sexual dysfunction, while women had zero. Approving flibanserin, the campaign argued, would be one small step toward “evening the score.”
"A textbook case of disease-mongering by the pharmaceutical industry and by other agents of medicalization."
At first, the Even the Score campaign succeeded in driving the narrative around flibanserin. It convinced members of Congress to sign a letter to the FDA. It pitched the stories of women suffering from HSDD to the media and paid for the women to travel to FDA hearings to testify. But by the time the FDA gave the drug its final approval—with a number of restrictions and a black-box warning label—in August, the narrative had begun to unravel. The media highlighted the campaign’s close ties to—and funding from—the drug’s sponsor. Its claim that the “score” was 26–0 in favor of men’s treatments was debunked as highly misleading: Other than several erectile dysfunction medications, most of the drugs cited were different formulations of testosterone that are not actually sanctioned for the treatment of sexual problems. Flibanserin is, in fact, the first drug—for either gender—ever approved by the FDA to boost libido. Other prominent women’s health advocacy groups, led by the National Women’s Health Network, spoke out against flibanserin and in support of the FDA’s “evidence-based evaluation and decision-making.” As Cindy Pearson, executive director of NWHN, concluded in a press release, “The problem with Flibanserin is not gender bias at the FDA but rather the drug itself.”
Though I’m a feminist writer and editor of the Feministing blog, and count both medicine and sex among my favorite subjects, I only half-followed the controversy as it unfolded. As a casual observer, I found myself uncharacteristically swayed by persuasion from all sides. The suggestion that gender bias at the FDA might be behind the lack of drugs for female sexual dysfunction? Entirely plausible. As the narrative shifted, I considered it equally believable that a pharmaceutical company had brilliantly co-opted feminism for its own profit-seeking aims.
Once flibanserin hit the shelves— where it may soon be joined by other female sexual dysfunction treatments currently in clinical trials—I figured I’d dig deeper into the facts to determine where I stood. I initially hoped—naïvely, I suppose—that this could all be cleared up by a careful analysis of the undisputed data about the drug.
In three clinical studies, flibanserin consistently showed “numerically small but statistically significant” differences from the placebo. Compared to the placebo group, the women in the treatment group said their number of “sexually satisfying events,” reported in a daily diary, increased by 0.5 to one additional event per month, from a baseline average of two to three events per month. Their self-reported scores on desire and distress improved by an additional 0.3 to 0.4 points. After the study, between nine and 15 percent more women in the treatment group than in the placebo group reported that their condition was at least somewhat improved. Meanwhile, the drug’s common side effects included dizziness, sleepiness, and fatigue; the rare, more serious ones included fainting and low blood pressure—risks that were exacerbated by combining it with alcohol, birth control pills, and yeast infection medications. (The FDA was so concerned about the drug’s alcohol interaction study—which enrolled 23 men and just two women—that it’s requiring women to sign a pledge promising not to drink while taking Addyi.)
But since the question before the FDA was whether flibanserin’s benefits outweigh its risks, there was and is ample room for different interpretations of the same facts. The drug’s opponents characterize its effect on desire as modest at best, while its proponents say that a modest boost is exactly what women with HSDD are looking for. Opponents highlight the huge placebo effect—between 29 and 49 percent of those who didn’t get the drug said that the “treatment” helped them—and suggest we explore the factors that are likely behind it. Proponents counter that most clinical trials have a large placebo response; when you’ve demonstrated an effect above that, you’ve succeeded. And while proponents point out that flibanserin’s efficacy and risks are comparable to other drugs that affect the central nervous system, like antidepressants and antianxiety medications, opponents say the drug should be judged not against medications for other conditions but against other treatments for low desire—such as mindfulness and cognitive behavioral therapy—that studies have found to be effective and entirely free of side effects.
The two camps also disagree on just how much is really known about why flibanserin should work. While the drug’s supporters claim it boosts desire by increasing dopamine and norepinephrine and regulating serotonin levels, that’s just a hypothesis. “There’s just simply no scientific evidence for it,” says psychologist Lori Brotto, director of the sexual health laboratory at the University of British Columbia. “Not to say that the evidence doesn’t exist, but that study has just never been done before.” Still, psychologist Sheryl Kingsberg, chief of behavioral medicine in OB/GYN at University Hospitals Case Medical Center and a paid consultant to Sprout, insists that we have at least a theoretical grasp of the relationship between desire and the brain. “We’re not completely in the dark in our understanding of the biologic underpinnings of desire.”
After speaking to several experts on both sides of the debate, this much is clear: Flibanserin is far—really far—from being enough of a slam-dunk to support the charge that the FDA’s hesitancy about it was due to sexism. It is also clear that how one assesses the data on this particular drug is inevitably influenced by one’s beliefs about the benefits and risks of designing a pharmaceutical treatment for low sexual desire in the first place. The controversy has stirred up important, unresolved debates within feminist circles about the advantages and pitfalls of turning to the medical system to address sexual problems. It’s a conversation that speaks as much to the limitations of modern medicine as to its promise.
Though the Even the Score campaign left the impression that the FDA has been rejecting applications for female sexual dysfunction treatments on a rolling basis, until flibanserin, they’d had little occasion to. And that’s not because pharmaceutical companies haven’t been trying to develop them. As soon as Viagra was approved in 1998, the industry began looking for a female counterpart to “the little blue pill.” In the early 2000s, Pfizer ran trials to see if Viagra would work in women. It didn’t. In 2004, the FDA rejected Procter & Gamble’s application for a testosterone patch called Intrinsa out of safety concerns.
For nearly as long as the industry has been hunting for a “female Viagra,” feminist critics have been resisting the search. In 2000, Leonore Tiefer, a researcher and associate professor of psychiatry at New York University School of Medicine, convened a group of feminist social scientists and clinicians “to challenge the distorted and oversimplified messages about sexuality that the pharmaceutical industry relies on to sell its new drugs,” as the organization’s website explains. Dubbing themselves the New View Campaign, the group released an influential manifesto proposing an alternative model for understanding women’s sexual problems that emphasizes socio-cultural, political, psychological, and interpersonal factors. In a 2006 article exploring the pharmaceutical industry’s outsized influence on—not to mention financial interest in—defining female sexual dysfunction, Tiefer called the process “a textbook case of disease-mongering by the pharmaceutical industry and by other agents of medicalization.”
Trying to determine what is sexually abnormal is inherently fraught. Much feminist scholarship has explored how ever-shifting cultural norms dictate what is labeled as a disorder in the Diagnostic and Statistical Manual of Mental Disorders and in the medical community more broadly. “It wasn’t until very recently—just over 40 years ago—that female sexuality really was acknowledged as normal and important and not just about reproduction,” explains Thea Cacchioni, sociologist at the University of Victoria and author of the book Big Pharma, Women, and the Labour of Love. “I think any attempt by experts to define nymphomania, or frigidity, and now ‘female sexual dysfunction,’ really betrays a lot of social constructions.”
Without an objective way to measure something as subjective as desire, there’s no guarantee that what one person means when they say “desire” is the same as what another person does. In fact, HSDD actually doesn’t technically “exist” anymore. Once listed as an official disorder in the DSM, it was merged in the 2013 edition into a new problem called female sexual interest/arousal disorder. The change was pushed by some researchers who believe that desire and arousal are better understood as two sides of the same coin, and that for many people—perhaps especially women—desire sometimes kicks in after, not before, arousal. “They now say you have to have an arousal problem and a desire problem,” Cacchioni says. “Because even the very medicalized American Psychiatric Association recognized that desire is just more abstract and difficult to quantify. How would you quantify normal desire?”
The controversy has stirred up important, unresolved debates within feminist circles about the advantages and pitfalls of turning to the medical system to address sexual problems.
There’s plenty of evidence that sexual desire varies considerably across the population, as well as over the course of both a lifetime and a particular relationship. The original diagnostic criteria for HSDD tried to account for this natural diversity by stipulating that the clinical judgment of deficiency had to be considered within “the context of the person’s life”; that the problem could not be better accounted for by another mental disorder, medical condition, or drug; and that the condition had to cause “marked distress or interpersonal difficulties.” But the fact that the condition hinges not on the actual level of desire but on the presence of distress—which can be influenced by any number of cultural and social factors—is one of the reasons critics question whether it should be treated as a medical issue at all.
Without an objective definition of what’s normal, “low” is an entirely relative term—and often becomes relative to one’s partner’s level of desire. This allows the label to be pinned on whichever half of a couple has lower desire—often but certainly not always a woman—when the problem is really the imbalance between the two. Indeed, HSDD is most often diagnosed in women in long-term relationships whose “interpersonal difficulties” stem from having a partner with a higher libido. “If the woman’s libido is lower than the guy’s, why’s that her problem?” asks Dr. Adriane Fugh-Berman, director of the PharmedOut project at Georgetown University Medical Center. “Maybe he’s oversexed. All of these labels are subjective and relational.”
Kingsberg counters that the patients she sees with acquired HSDD—the kind for which flibanserin was approved to treat—are usually comparing their current level not just to their partner’s but to their own previous level. “This is about restoring their baseline desire when they had normal desire”—or whatever was once normal for them. And while agreeing that it’s common for desire to wane in long-term relationships, she says women with HSDD are complaining of losing it across the board: “This is about hunger; it’s about spontaneous sexual thoughts and feelings”—not just for their partners but when they watch porn or look at a favorite male celebrity. “They’re flat-lined.” She also notes that the disorder isn’t relegated only to women in relationships. “Single women come in saying, ‘I’m avoiding getting into a relationship because I have no desire and that’s going to cause a huge problem in my next relationship.’”
Still, even if a partner doesn’t directly affect one’s sense of what constitutes normal desire, it’s certainly influenced by broader cultural norms—which may be especially hard to live up to these days. Thanks to the sexual revolution, sex is now considered normal—for women no less than for men. But along with that welcome change have come new anxieties. “Now you’re actually considered unhealthy if you don’t have it often,” Cacchioni says. Women are especially burdened with the responsibility for working to improve sex: “You have this explosion of sexual self-help aimed at women, encouraging us to make sure that we’re good at sex, but mostly that we’re good at being sexy.” Men certainly aren’t immune to the pressures of the “sex as health” imperative either. And, to Cacchioni, the growing popularity of off-label prescriptions for testosterone to boost men’s libido—which is rivaling sales of Viagra at this point—suggests that perhaps everyone’s “expectations for desire are just off the charts.”
Amanda Parrish, who participated in one of flibanserin’s clinical trials, isn’t buying it. The 52-year-old suburban Nashville divorcee had been dating her now-husband for a few years when her desire suddenly disappeared. During the eight months she was in the study, it—seemingly just as suddenly—came back. When I spoke to her a week before Addyi became available, she couldn’t wait to get her hands on the drug again. “I’ve got my prescription ready and waiting,” she said. A couple weeks into being on the drug again, she happily reported in an email that she’d felt her “first flutter.”
Parrish sounds frustrated with the suggestion that flibanserin could be pathologizing something that is normal. “If my libido is going to leave at age 48 and never come back, that’s going to distress me. It’s not the world telling me that that should distress me; it’s going to distress me,” she insists. She acknowledges that her desire has waxed and waned before: “When I had four children under the age of seven sleeping in my bed, I didn’t want to have sex. And when my father got ill and was dying, I didn’t want to have sex.” But she notes that it had always bounced back in the past. Most importantly, she says, even if it is common for your libido to “slack off” as you get older, she believes there should be a treatment option available for women who want one. She likens it to losing your bladder control as you age. “Do I want to accept at 52 that when I cough or sneeze or laugh, I pee pee in my pants? Am I going to just accept that as normal and not do anything about it? I don’t think so.”
To Parrish, this is simply about “trying to give hope to women who want hope.” But there’s an inherent tension in medicalizing a condition as ill-defined as low sexual desire: For every woman who feels hopeful for hearing it’s not normal, there’s likely another who feels worse. Validating the distress of some always risks causing distress in others who were feeling OK about their level of desire until they learned that they might have a “disorder”—a risk that opponents predict will only be heightened as more and more treatments follow flibanserin onto the shelves. “This is going to become a condition where not only are women going to think, ‘Oh, there’s something biologically wrong with me,’ [but also] ‘I have to try multiple treatments to fix myself,’” Fugh-Berman says.
Still, it seems to me that the Even the Score campaign had an intuitive appeal because it highlighted a real gendered difference in how likely we are to view sexual problems as natural—or psychological. “The idea that women share their stories of losing all desire and we say, ‘Come on, that’s normal’—that’s actually very unfair to women who wish to want to have sex again,” Cindy Whitehead, the CEO of Sprout, told the Chicago Tribune. She sees flibanserin as a challenge to “the societal narrative that will reduce all things in the bedroom for men to biology and all things for women in the bedroom to psychology.” It’s a dichotomy, Kingsberg says, that does a disservice to both genders. “I certainly see men with erectile dysfunction who have psychological factors that contribute, and if they don’t get that addressed, then no amount of Viagra is going to work for them,” she says.
In part, this narrative rankles feminists because it seems rooted in a lingering sexist myth that men are naturally more straightforward sexual creatures than women. In a culture in which a virile sex drive is considered a key part of being a “red-blooded American male,” we imagine that any sexual difficulties in men must stem from a biological malfunction. In women, who supposedly cannot help but bring all their messy feelings into the bedroom, problems are more likely to be seen as emotional hang-ups. And in a medical system—and a broader society—that tends to favor biological explanations for health problems, women’s sexual dysfunction often ends up being treated less seriously than men’s, dismissed as something that’s “all in our heads.”
"If my libido is going to leave at age 48 and never come back, that's going to distress me. It's not the world telling me that that should distress me; it's going to distress me."
Indeed, flibanserin’s proponents seem to believe that even if the drug doesn’t help most—or even many—women, it will still be worth it because the mere existence of a pharmaceutical treatment will serve to legitimize low desire as a “real” problem worthy of concern. Kingsberg compares it to what antidepressants did for depression in the 1970s and ’80s. “We used to think of depression as ‘just pick yourself up by the bootstraps.’ When we developed pharmacological treatments, it validated the condition,” she explains. That brought people suffering from depression “out of the closet and to their health-care providers”—not just for medication but for psychotherapy as well. “I think the same will be true for HSDD.”
But the fact that medicine privileges the biological can cut the other way too; the availability of pharmaceutical treatments may forestall attention to other factors. In 2006, Tiefer explained her motivations for organizing the New View Campaign to counter the pharmaceutical industry’s growing interest in female sexual dysfunction: “I worried that the mechanistic view of sexuality I had seen applied to men’s sexual function would just be transposed to women.” Indeed, to critics of the medicalization of sex, the fact that doctors are quick to reach for their prescription pads to treat men’s sexual problems—to the neglect of psychological fixes—just underscores their concerns: When doctors—particularly general practitioners with no expertise in treating sexual problems—have pills at their disposal, they tend to use them.
Of course, it’d be one thing if these drugs were actually silver bullets. Even the staunchest opponents of medicalization insisted that if flibanserin had proved more effective, the conversation would be different. “Then I would just be more concerned with how it’s marketed and what kind of factors get missed when you only focus on the physical piece,” Cacchioni says. But she points out that their resistance to the search for a “female Viagra” is, in part, born from a skepticism that it will ever be particularly fruitful. “We’re not surprised that this drug isn’t effective. Because what we’re trying to say is that all research points to the fact that sexual problems are mostly related to your relationship, how you feel about yourself, how society feels about you, and other bigger factors that are external to your body. So simply popping a pill—even if it were able to work on some mechanism in the body—that wouldn’t solve those other problems and therefore you might still feel distress.”
This seems to be the core feminist dilemma: If medicalization is inherently a double-edged sword, the lack of a holistic approach to health—sexual or otherwise—makes those edges even sharper. Emphasizing the biological components may secure greater recognition for women’s sexual problems, but only at the risk of ignoring the complex and important ways our culture propels them. In fact, the very rationale for flibanserin—the idea that desire is rooted, somehow, in neurochemistry—seems to prove how hopelessly intertwined the biological, psychological, and social underpinnings of sexuality really are. After all, we know that neurotransmitter levels are affected by everything from food to exercise to sex itself. Perhaps someday science will pinpoint exactly how they’re altered by shame or self-consciousness, by the trauma of sexual violence, or by the constant daily stress of living in poverty. Perhaps someday medicine will be as invested in knocking down the other barriers to a healthy, satisfying sex life as it is in finding a way to hack the human body for a profitable quick fix.
Lead Photo: (Photo: Getty Images)
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