Will the FDA's Approval of a Low-Desire Drug Make Women Doubt Their Bodies More Than Ever?
03:44 Editor 0 Comments
How to treat low desire in women—how to even measure it—stymies doctors and divides feminists. Molly Langmuir reports from the front lines of sex, marketing, and medicine.
I
lost my virginity on prom night, of all things, but whatever
embarrassment I had about the clichéd circumstances was far outweighed
by my relief at having entered the realm of the sexually active. I saved
the condom wrapper, and the next day, triumphantly mailed it to my best
friend in California. Established right from the beginning was the
following: Sex was something that I did with guys, some of whom I liked,
some of whom I didn't, but that I only really talked about frankly with
other women.
Over the next few years, which I spent at a liberal arts college known for its clothing-optional dorm and frequent "naked parties," I acquired friends with whom nothing sexual was off-limits. We mimicked the sounds we heard each other make through the thin walls of our off-campus housing, debated the appeal of gay soft porn (prompted by a week we were meant to be studying for exams but instead spent watching the Showtime drama Queer As Folk), and described to each other the exact locations of our clitorises. At one point, deep into a conversation about orgasms, we split up into separate rooms and raced to see who could get there first. None of this seemed weird. We were 20, then 21, then 22, with few boundaries, and friends were still way more important than boys.
I am now 35, and these women and I are spread among different cities and mostly married. But when we get together, sex inevitably still comes up, and in the last year or so, a new aspect of it has entered the discussion: a lack of desire, at least the kind that we imagine catches a person unaware, which has been likened to a hunger or a drive. The type we imagine most men feel often, and teenage boys all the time, ready to be triggered by anything from a bodacious 3 written on a blackboard to a visible bra strap.
"I could never have sex again and be totally fine," one friend said to me recently, and while at first that seemed drastic, once I turned it over in my mind, I realized that I basically felt the same way. But it wasn't that I didn't enjoy sex. I did. She did too, she said. It was just that unlike other women we knew who chased it single-mindedly, we didn't have much urge to seek it out. She wasn't worried, but I was less sanguine. Pursuing sex, and not just out of obligation, was fundamental to what I assumed it meant to be a good partner.
Was there something wrong in my marriage? Was this unavoidable, 10 years into a relationship? Were hormones to blame? On the other hand, had I ever really sought sex for sex's sake alone? When I think back to my early twenties, even then sex felt more like a product of other impulses than an end in and of itself. I'd be attracted to someone and want to be close to him, and this sometimes led to hanging out late at night, and that often led to sex—I think?
As it happens, these questions are at the center of a long-running debate that erupted last June when a Federal Drug Administration panel recommended, for the first time, the approval of a drug to treat female desire—the final vote was expected by August 18 (UPDATE: The FDA approved the drug yesterday)libanserin, as it's known, is owned by a company named Sprout Pharmaceuticals and is meant for women with a disorder that some academics and feminist activists say doesn't exist, at least as a biologl entity, but that others—MDs, equally adamant women's-health activists—believe afflicts 10 percent of American women: very low desire that lasts at least six months, prompts emotional distress, and isn't caused by medications, depression, physical illness, relationship troubles, or simply an unskilled lover (whether such factors can be decisively ruled out is, as you might expect, much contested). The lack of clarity about the condition is even reflected in its shifting name. Flibanserin was developed to treat what's known as hypoactive sexual desire disorder, or HSDD, but in the latest Diagnostic and Statistical Manual of Mental Disorders, published in 2013, this diagnosis was expanded to include women with arousal deficits and renamed female sexual interest/arousal disorder, or FSIAD (arousal is marked by physiological changes such as flushed skin and genital swelling; desire refers to the psychological wish to do something sexual).
Flibanserin works by constricting the release of the neurotransmitter serotonin, which is thought to foster a sense of well-being but also to stoke inhibition, and by increasing norepinephrine and dopamine, the chemicals associated with the rush of falling in love (and taking heroin). A main measure of effectiveness for the drug is the number of so-called "sexually satisfying events," defined as acts of intercourse, oral sex, genital stimulation, or even masturbation, that a patient—"not the partner," Sprout emphasizes—deems as such. In three large-scale Flibanserin studies, the female subjects, all premenopausal and in monogamous, heterosexual relationships, were previously, on average, having 2.67 pleasurable "events" a month. Taking the drug raised that to 4.75 such interactions, though in comparing these results to the control group's, researchers concluded that Flibanserin was responsible for only 0.88 of the uptick, the other 1.2 being attributable to the placebo effect.
But what to make of this? One of the most interesting things about the dispute is that it takes place far enough into as-yet-unsettled terrain that there are no easy answers. So you consider yourself a feminist: Do you support a drug that 40 percent of the women who've tried it (in contrast to 25 percent of the control group) said meaningfully improved their condition? Or do you argue that 11 additional successful sexual outings a year don't outweigh the risks of taking a pill that in the short term can cause dizziness, nausea, and fainting, and whose long-term effects are unknown? So you consider yourself sex-positive: What then?
Over the next few years, which I spent at a liberal arts college known for its clothing-optional dorm and frequent "naked parties," I acquired friends with whom nothing sexual was off-limits. We mimicked the sounds we heard each other make through the thin walls of our off-campus housing, debated the appeal of gay soft porn (prompted by a week we were meant to be studying for exams but instead spent watching the Showtime drama Queer As Folk), and described to each other the exact locations of our clitorises. At one point, deep into a conversation about orgasms, we split up into separate rooms and raced to see who could get there first. None of this seemed weird. We were 20, then 21, then 22, with few boundaries, and friends were still way more important than boys.
I am now 35, and these women and I are spread among different cities and mostly married. But when we get together, sex inevitably still comes up, and in the last year or so, a new aspect of it has entered the discussion: a lack of desire, at least the kind that we imagine catches a person unaware, which has been likened to a hunger or a drive. The type we imagine most men feel often, and teenage boys all the time, ready to be triggered by anything from a bodacious 3 written on a blackboard to a visible bra strap.
"I could never have sex again and be totally fine," one friend said to me recently, and while at first that seemed drastic, once I turned it over in my mind, I realized that I basically felt the same way. But it wasn't that I didn't enjoy sex. I did. She did too, she said. It was just that unlike other women we knew who chased it single-mindedly, we didn't have much urge to seek it out. She wasn't worried, but I was less sanguine. Pursuing sex, and not just out of obligation, was fundamental to what I assumed it meant to be a good partner.
Was there something wrong in my marriage? Was this unavoidable, 10 years into a relationship? Were hormones to blame? On the other hand, had I ever really sought sex for sex's sake alone? When I think back to my early twenties, even then sex felt more like a product of other impulses than an end in and of itself. I'd be attracted to someone and want to be close to him, and this sometimes led to hanging out late at night, and that often led to sex—I think?
As it happens, these questions are at the center of a long-running debate that erupted last June when a Federal Drug Administration panel recommended, for the first time, the approval of a drug to treat female desire—the final vote was expected by August 18 (UPDATE: The FDA approved the drug yesterday)libanserin, as it's known, is owned by a company named Sprout Pharmaceuticals and is meant for women with a disorder that some academics and feminist activists say doesn't exist, at least as a biologl entity, but that others—MDs, equally adamant women's-health activists—believe afflicts 10 percent of American women: very low desire that lasts at least six months, prompts emotional distress, and isn't caused by medications, depression, physical illness, relationship troubles, or simply an unskilled lover (whether such factors can be decisively ruled out is, as you might expect, much contested). The lack of clarity about the condition is even reflected in its shifting name. Flibanserin was developed to treat what's known as hypoactive sexual desire disorder, or HSDD, but in the latest Diagnostic and Statistical Manual of Mental Disorders, published in 2013, this diagnosis was expanded to include women with arousal deficits and renamed female sexual interest/arousal disorder, or FSIAD (arousal is marked by physiological changes such as flushed skin and genital swelling; desire refers to the psychological wish to do something sexual).
Flibanserin works by constricting the release of the neurotransmitter serotonin, which is thought to foster a sense of well-being but also to stoke inhibition, and by increasing norepinephrine and dopamine, the chemicals associated with the rush of falling in love (and taking heroin). A main measure of effectiveness for the drug is the number of so-called "sexually satisfying events," defined as acts of intercourse, oral sex, genital stimulation, or even masturbation, that a patient—"not the partner," Sprout emphasizes—deems as such. In three large-scale Flibanserin studies, the female subjects, all premenopausal and in monogamous, heterosexual relationships, were previously, on average, having 2.67 pleasurable "events" a month. Taking the drug raised that to 4.75 such interactions, though in comparing these results to the control group's, researchers concluded that Flibanserin was responsible for only 0.88 of the uptick, the other 1.2 being attributable to the placebo effect.
But what to make of this? One of the most interesting things about the dispute is that it takes place far enough into as-yet-unsettled terrain that there are no easy answers. So you consider yourself a feminist: Do you support a drug that 40 percent of the women who've tried it (in contrast to 25 percent of the control group) said meaningfully improved their condition? Or do you argue that 11 additional successful sexual outings a year don't outweigh the risks of taking a pill that in the short term can cause dizziness, nausea, and fainting, and whose long-term effects are unknown? So you consider yourself sex-positive: What then?
At
the heart of the matter is what we know about how female desire works
and what that tells us about how much of it women can reasonably expect.
Ideally, here is where we'd turn to research, but as the Flibanserin
data suggests, science breaks down when trying to quantify something as
ineffable as desire. In a way, the debate fractures reality into two
distinct universes, and in each, everything makes complete sense until
the moment you step into the other, and then the inverse becomes true.
What is undeniable, though, is this: millions of dollars, maybe
billions, are at stake, along with what constitutes American women's
sense of sexual gratification—or, maybe, of what it means to be
"normal," if there ever can be said to be such a thing when it comes to
sex.
The FDA's headquarters are on the border of DC and Maryland, in an office park where, as the day begins and ends, floods of people rush through doors that lead to sprawling buildings with warrens of rooms and displays of products the agency has helped pull from shelves over the years: "Mrs. Winslow's Soothing Syrup," a drink for colicky babies that mostly contained morphine, for one. The rest of the time the campus, as it's known (it's so gargantuan that buses shuttle visitors in from a parking lot half a mile away), is so void of humans as to feel practically apocalyptic.
Before the meeting in June, a more general session was held here last October for the FDA to hear directly from patients about how much risk they'd consider acceptable in a sexual dysfunction treatment. All the major female-desire stakeholders were on hand—and the scene was more media circus than scientific meeting, or drug-company drama as performance art.
There were the pharmaceutical reps in sleek suits, looking like something out of Men in Black, and the doctors, many of whom had enough conflicts of interest to stock a pharmacy. Before addressing the panel, the speakers had to list their conflicts; one's list was so long, I quit counting after 20. Though whatever you might assume that means should be measured against this: In June, some of the same doctors returned to testify to the need for Flibanserin or something similar, and when they described what it was like to have patients implore them for a drug to boost their libido and have nothing to offer, at least two began crying.
Around a dozen carefully done-up patients were there too, flown in by drug companies to detail their anguish at having low desire. They described "duty sex" and taking so much topical testosterone, "I smelled like a guy and my girlfriends were attracted to me," one said. (Or as Barbara Gattuso, 66, lamented to me later, "You don't feel like a woman. You feel like something has been torn out of you.")
And then there were the activists, some ardently for, others ardently against, a female desire drug. The vibe was fraught. In between sessions, the antidrug camp huddled together, whispering angrily. One woman put on headphones to drown out a certain MD whenever he spoke—that was how angry he made her—and another complained about a patient who'd shown up in red patent leather heels: "What was she saying with those shoes? They scream sex."
Across the room, the patients were also huddled and equally irate. "That lady, I could kill her—I don't need to fix myself up here," a thirtysomething woman said, gesturing to her head. She was talking about psychiatrist Rosemary Basson, MD, the director of the Sexual Medicine Program at the University of British Columbia, who'd just told the panel that 90 percent of women referred to her clinic for low interest or arousal either screened positive for depression or were taking antidepressants, which can dampen libido, the implication being that FSIAD was best addressed psychiatrically.
One way to understand the split between the activists is to understand the historical divisions in the women's movement. In support of the drug, roughly speaking, are so-called "equality feminists"; they tend to be first or second wavers who have deep roots on Capitol Hill and see this as the latest in a long line of straightforward battles against gender bias in medical research. It's a history that stretches back to at least 1990, when one audit of the National Institutes of Health found there were just three gynecologists on staff—and 39 veterinarians. These women have coalesced behind a campaign called Even the Score, which is partially financed by Sprout and two other pharmaceutical firms and is animated by the "gross disparity" between the number of medications for male and female dysfunction. As Even the Score chairwoman Susan Scanlan put it in a booming voice at the FDA, "There are 26 drugs for men and 0 for women!"
This undoubtedly sounds absurd, not to mention sexist (which the FDA categorically denies), and Even the Score gathered more than 60,000 petition signatures protesting the situation. They even put out an online spoof of a Viagra commercial (hashtag: #womendeserve) featuring a sultry lady reclining in a beachfront cabana. "What the fuck," she says. "Are we really so far behind that we don't think women have the right to sexual desire?"
The position of Even the Score and the drug companies is that FSIAD has a strong biological component. They like to talk about studies such as one published in the Archives of Internal Medicine in 2005 that tracked 447 postmenopausal women with low desire and found that for those on a low dose of oral estrogen, a testosterone patch increased their sexual activity by 79 percent. (A few preliminary studies have implied hormone therapy might be effective for premenopausal women as well.) They also bring up published research that has used fMRI scanning to compare the brains of women with and without HSDD. In one such report, 36 women watched erotic movies; those with HSDD appeared to have less activity in the entorhinal cortex, the area of the brain where we lay down emotional impressions, leading the investigators to hypothesize that subjects retained few pleasurable memories of sex, leaving nothing to spark its pursuit. (Though it must be emphasized that brain-imaging research is still in its early stages—in a notorious example of the limits of the field, Dartmouth scientists used an fMRI machine to find cognitive activity in a dead fish.)
On the other side of the activist divide are those who might be called, in old-school parlance, the "difference feminists." This camp tends to focus on the ways in which women's sexuality is unlike that of men. The 26–0 cry is misleading, they contend, because 9 of the 26 male medications are Viagra variants intended for arousal disorder, namely erectile dysfunction, which, compared to low desire—women's number one complaint—is often relatively simple to resolve by increasing blood flow. There are no drugs approved by the FDA to jump-start desire for either women or men, they point out. (The remaining 17 are all testosterone-based formulations, which are sometimes prescribed for low libido for both sexes, but this is an off-label use.)
The FDA's headquarters are on the border of DC and Maryland, in an office park where, as the day begins and ends, floods of people rush through doors that lead to sprawling buildings with warrens of rooms and displays of products the agency has helped pull from shelves over the years: "Mrs. Winslow's Soothing Syrup," a drink for colicky babies that mostly contained morphine, for one. The rest of the time the campus, as it's known (it's so gargantuan that buses shuttle visitors in from a parking lot half a mile away), is so void of humans as to feel practically apocalyptic.
Before the meeting in June, a more general session was held here last October for the FDA to hear directly from patients about how much risk they'd consider acceptable in a sexual dysfunction treatment. All the major female-desire stakeholders were on hand—and the scene was more media circus than scientific meeting, or drug-company drama as performance art.
There were the pharmaceutical reps in sleek suits, looking like something out of Men in Black, and the doctors, many of whom had enough conflicts of interest to stock a pharmacy. Before addressing the panel, the speakers had to list their conflicts; one's list was so long, I quit counting after 20. Though whatever you might assume that means should be measured against this: In June, some of the same doctors returned to testify to the need for Flibanserin or something similar, and when they described what it was like to have patients implore them for a drug to boost their libido and have nothing to offer, at least two began crying.
Around a dozen carefully done-up patients were there too, flown in by drug companies to detail their anguish at having low desire. They described "duty sex" and taking so much topical testosterone, "I smelled like a guy and my girlfriends were attracted to me," one said. (Or as Barbara Gattuso, 66, lamented to me later, "You don't feel like a woman. You feel like something has been torn out of you.")
And then there were the activists, some ardently for, others ardently against, a female desire drug. The vibe was fraught. In between sessions, the antidrug camp huddled together, whispering angrily. One woman put on headphones to drown out a certain MD whenever he spoke—that was how angry he made her—and another complained about a patient who'd shown up in red patent leather heels: "What was she saying with those shoes? They scream sex."
Across the room, the patients were also huddled and equally irate. "That lady, I could kill her—I don't need to fix myself up here," a thirtysomething woman said, gesturing to her head. She was talking about psychiatrist Rosemary Basson, MD, the director of the Sexual Medicine Program at the University of British Columbia, who'd just told the panel that 90 percent of women referred to her clinic for low interest or arousal either screened positive for depression or were taking antidepressants, which can dampen libido, the implication being that FSIAD was best addressed psychiatrically.
One way to understand the split between the activists is to understand the historical divisions in the women's movement. In support of the drug, roughly speaking, are so-called "equality feminists"; they tend to be first or second wavers who have deep roots on Capitol Hill and see this as the latest in a long line of straightforward battles against gender bias in medical research. It's a history that stretches back to at least 1990, when one audit of the National Institutes of Health found there were just three gynecologists on staff—and 39 veterinarians. These women have coalesced behind a campaign called Even the Score, which is partially financed by Sprout and two other pharmaceutical firms and is animated by the "gross disparity" between the number of medications for male and female dysfunction. As Even the Score chairwoman Susan Scanlan put it in a booming voice at the FDA, "There are 26 drugs for men and 0 for women!"
This undoubtedly sounds absurd, not to mention sexist (which the FDA categorically denies), and Even the Score gathered more than 60,000 petition signatures protesting the situation. They even put out an online spoof of a Viagra commercial (hashtag: #womendeserve) featuring a sultry lady reclining in a beachfront cabana. "What the fuck," she says. "Are we really so far behind that we don't think women have the right to sexual desire?"
The position of Even the Score and the drug companies is that FSIAD has a strong biological component. They like to talk about studies such as one published in the Archives of Internal Medicine in 2005 that tracked 447 postmenopausal women with low desire and found that for those on a low dose of oral estrogen, a testosterone patch increased their sexual activity by 79 percent. (A few preliminary studies have implied hormone therapy might be effective for premenopausal women as well.) They also bring up published research that has used fMRI scanning to compare the brains of women with and without HSDD. In one such report, 36 women watched erotic movies; those with HSDD appeared to have less activity in the entorhinal cortex, the area of the brain where we lay down emotional impressions, leading the investigators to hypothesize that subjects retained few pleasurable memories of sex, leaving nothing to spark its pursuit. (Though it must be emphasized that brain-imaging research is still in its early stages—in a notorious example of the limits of the field, Dartmouth scientists used an fMRI machine to find cognitive activity in a dead fish.)
On the other side of the activist divide are those who might be called, in old-school parlance, the "difference feminists." This camp tends to focus on the ways in which women's sexuality is unlike that of men. The 26–0 cry is misleading, they contend, because 9 of the 26 male medications are Viagra variants intended for arousal disorder, namely erectile dysfunction, which, compared to low desire—women's number one complaint—is often relatively simple to resolve by increasing blood flow. There are no drugs approved by the FDA to jump-start desire for either women or men, they point out. (The remaining 17 are all testosterone-based formulations, which are sometimes prescribed for low libido for both sexes, but this is an off-label use.)
0 comments: