Some argue that a female sexual-dysfunction drug is a matter of equality among the sexes. Others say it creates a medical problem where none exists.''' 
“Aren’t women’s sexual needs as important as erectile dysfunction in men?” To hear one side tell it, that’s the central issue in the debate over what’s known as “pink Viagra,” a sexual-dysfunction drug for women. Health organizations and the pharmaceutical industry say the absence of a female drug is a pressing problem that affects millions of relationships in the U.S. every year—and is the result of decades of inequality in scientific research. On the other hand, some researchers believe these groups, along with the drug industry, are creating a medical need where one doesn’t really exist, and that there isn’t a double standard at play in rejecting the latest female drug, flibanserin. As they see it, pink pill advocates are co-opting the language of equality, while drug marketers ignore the complexities of female sexual dysfunction, and how best to treat it.
One of the difficulties in this debate is the interplay between biological and psychological aspects of a person’s sex drive. How men and women get “turned on” is vastly complicated—and erectile dysfunction drugs and flibanserin work differently. Viagra, for example, doesn’t cause a man to want sex. The drug only works if a man already feels aroused, by helping blood flow into the erectile tissue of his penis. Flibanserin, on the other hand, corrects an imbalance in the levels of certain neurotransmitters, such as dopamine and serotonin, thought to regulate sexual excitement and inhibition.
On October 27, the Food and Drug Administration invited women to a public summit on female sexual dysfunction—and what the medical community should do about it. The FDA heard directly from women about losing their desire for sex and the daily experience of living with, according to the agency’s invitation, the most common form of sexual dysfunction for women: female sexual interest/arousal disorder, or FSIAD. The following day, the FDA held a scientific workshop on the challenges of diagnosing and measuring FSIAD, reigniting a public debate about whether there’s a need for female dysfunction drugs in the first place. Leonore Tiefer, clinical associate professor of psychiatry at New York University’s School of Medicine and founder of the New View Campaign, which challenges the medicalization of sex, co-wrote a Los Angeles Times op-ed in which she claims women at the hearings “appeared to have been coached to demand drug solutions,” and insisted they had “no non-medical problems” that may affect their sex drive. At the same time, numerous medical groups, such as the Society for Women’s Health Research, the American College of Nurse-Midwives, and the Association of Reproductive Health Professionals, strongly urged Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research, to approve a treatment for female sexual dysfunction.
It’s unclear how prevalent desire issues are among women to begin with. Medical sites and the media present vastly different pictures of the problem, some putting it at around 10 percent of the population (16 million people in the U.S.), others putting it closer to 40 percent of women suffering from some kind of sexual dysfunction.
The first figure comes from a 2008 study, published in the Journal of Obstetrics and Gynecology, which surveyed more than 30,000 women. Researchers found that 12 percent of respondents had a sexual problem and felt distress over it. In a healthcare setting, doctors can struggle with what constitutes female sexual dysfunction—a catchall term for women who have trouble with interest or arousal, who experience pain during sex, or have difficulty achieving orgasm—and somebody who reports a lack of a desire may not be concerned about it. It’s also difficult to separate biological factors from emotional and social ones. But a woman isn’t diagnosed with FSAID or considered a candidate for medical treatment if her lack of interest isn’t causing her distress.
The second statistic comes from a 1999 study in the Journal of the American Medical Association, which found that 43 percent of the 1,749 women sampled (as opposed to 31 percent of men) had experienced some form of broadly-defined sexual dissatisfaction, including lack of desire and arousal, in the past two months. But researchers noted that the women surveyed were more likely to suffer from sexual dysfunction if they had unsatisfying personal experiences and relationships—something a pill can’t solve. And while the FDA appears to be of the opinion that female desire disorder (a woman’s body responds to sex but she has no interest in it) and female arousal disorder (a woman wants to have sex, but her body doesn’t seem to respond) can be lumped into one diagnosis, FSAID, most of the letters in support of a female dysfunction drug and many of the scientific studies refer to a different diagnosis: Hypoactive Sexual Desire Disorder (HSDD), which deals with a woman’s “interest level” in sex, but not necessarily her physiological responses to stimulation.
Last fall, when the FDA denied Sprout Pharmaceuticals’ application to market flibanserin, a drug for low female desire, one of the most prominent women’s groups, the National Organization of Women, met with the agency to voice concern about the decision. Four U.S. congresswomen blamed institutionalized sexism, writing the government in support of a drug for female sexual dysfunction. According to a 2007 Johns Hopkins study, published in the American Journal of Medicine, 18 million men have erectile dysfunction—not significantly larger, from a medical standpoint, than the 16 million women who may suffer from a lack of desire and feel distress.
The advocacy group Even The Score argues that the FDA has systematically discounted female sexual dysfunction. Viagra, the first male sexual-dysfunction drug, was approved in the U.S. in 1998, and according to Susan Scanlan, chair of Even The Score, men now have 26 drug options for sexual dysfunction—while women have none. “Women shouldn’t be shamed for having this condition. They should be listened to and helped,” said Scanlan, who believes the recent FDA meetings represent the first step towards “a meaningful solution.”
In addition to nonprofit groups such as Black Women’s Health Imperative and the Center for Health and Gender Equality, Even The Score also lists Sprout Pharmaceuticals—with other drug companies—as supporters on its website.
“Even The Score is a marketing tactic that masquerades as some kind of feminist patient group, but it’s a gimmick,” said Tiefer, who has been vocal at FDA hearings about her opposition to flibanserin and doubts there is a pressing medical need for a female sexual-dysfunction drug. Many couples have difficulties when it comes to a range of lifestyle concerns, from in-laws and children to personal finances and work balance, she explained. But that doesn’t mean one of them has a “biological inadequacy” in any of those areas. So when a couple has an asymmetrical level of desire, why does one of them necessarily suffer from a medical problem? Perhaps, she posits, it’s the “world of cell phones, deadlines, and multitasking” that places stress on couples’ sex lives, not a chemical deficiency. “Having been a sex therapist and a psychologist, I’ve heard from hundreds upon hundreds of people,” said Tiefer, who blames modern life and the societal pressures women face to look a certain way, in part, for creating desire asymmetry among couples.
Illustrating the tension between marketing and medical science, a recent articlein Marie Claire recounts a Baltimore woman’s experience with flibanserin. Writer Virginia Sole-Smith reports that “Cara” is in her late 30s and a development director for a non-profit, with two young children. Her “sex drive dropped dramatically and never rebounded” after the birth of her first baby. A few weeks into the study, however, she claims a drastic change, planning a mid-workday rendezvous with her husband, leaving a trail of clues for him:
With the growth of direct-to-consumer pharmaceutical advertising, there’s been a strong drive to push long-term medications on both men and women, according to Barbara Mintzes, associate professor in the School of Population and Public Health at the University of British Columbia in Vancouver. Unlike Viagra, for example, flibanserin is taken daily, not only in anticipation of sexual activity. Viagra addresses blood flow, while flibanserin works on the chemicals in a woman’s brain. Mintzes, who is also the co-author of Sex, Lies and Pharmaceuticals, believes that women’s sexual difficulties are being repackaged as a new disorder. “It’s not a planned conspiracy against women,” she clarified. “But the aim is to sell a product.” Drug companies see a large marketing opportunity in defining less interest in sex as a medical symptom and leaving a woman’s feelings and relationship circumstances out of the picture, according to Mintzes—not unlike what happened with Viagra advertising. “Male drugs had very stereotyped images of masculinity,” she said, “and not even a hint that a man’s emotions might affect his sexuality.”
In contrast are healthcare professionals who believe some women’s low sexual desire will rebound only with drug treatment. Bat Sheva Marcus, clinical director of New York’s Medical Center for Female Sexuality, assesses physical and psychological causes of women’s sexual issues and treats hundreds of women seeking to improve their sexual experience. Marcus believes in addressing all the sociological and psychological issues about desire and functioning, but also thinks that completely closing off the avenue of drug treatment would be “ignorant and cruel.” As she puts it: Personal distress is not a social construction. “For women, the most vulnerable part of the sexual response is probably desire,” Marcus explained. “A woman’s desire can shut off in a moment, for an evening, weeks, months, or a year. And it’s a problem if it bothers her.” Marcus also cautions about merging desire (interest) and arousal (a body’s physical reaction to sexual activity) disorders under one umbrella diagnosis, FSIAD. While the problems could be related for some women, she argues that from a clinical standpoint, the two are distinct.
In fact, a string of studies provides evidence of a neurological basis for low desire that might be helped by a drug like flibanserin, which was first developed as an anti-depressant. A small 2009 functional MRI study, published in Neuroscience, compared 20 females with no history of sexual dysfunction to 16 women with low desire levels and found the two groups exhibited different brain activity when presented with sexually explicit videos. In 2013, researchers once again used neuroimaging patterns to compare the brain regions that are activated in pre-menopausal women with and without a diagnosis of HSDD. They also saw significant differences between the two groups, specifically in the area of the brain responsible for memory encoding/retrieval and self-monitoring.
“Unfortunately, there has been a steady and concerted effort to undermine this condition,” said Cindy Whitehead, president and chief operating office of Sprout Pharmaceuticals. “The narrative is that it’s all in a woman’s head. But that’s based o opinion and imposed judgment.” According to Whitehead, sexual desire disorders have been medically recognized since 1977, the era of Masters and Johnson, and even after years of research and evolved understanding about female sexuality, there’s still no treatment for women. “No drug works for every person,” she explained. “But science has given us our answer and it’s time that the narrative about female sexual dysfunction shift to respect not only the data, but the women who are living with this. ” Whitehead also clarifies that a woman is a candidate for medical treatment, only if she has low desire, feels distress about it, and is in a healthy relationship, so any social or emotional issues have been ruled out beforehand.
Unlike many current medical controversies, the debate over a female sexual dysfunction drug may see some resolution soon. Flibanserin will be resubmitted to the FDA in the first quarter of 2015, with a decision expected six months later.
“Aren’t women’s sexual needs as important as erectile dysfunction in men?” To hear one side tell it, that’s the central issue in the debate over what’s known as “pink Viagra,” a sexual-dysfunction drug for women. Health organizations and the pharmaceutical industry say the absence of a female drug is a pressing problem that affects millions of relationships in the U.S. every year—and is the result of decades of inequality in scientific research. On the other hand, some researchers believe these groups, along with the drug industry, are creating a medical need where one doesn’t really exist, and that there isn’t a double standard at play in rejecting the latest female drug, flibanserin. As they see it, pink pill advocates are co-opting the language of equality, while drug marketers ignore the complexities of female sexual dysfunction, and how best to treat it.On October 27, the Food and Drug Administration invited women to a public summit on female sexual dysfunction—and what the medical community should do about it. The FDA heard directly from women about losing their desire for sex and the daily experience of living with, according to the agency’s invitation, the most common form of sexual dysfunction for women: female sexual interest/arousal disorder, or FSIAD. The following day, the FDA held a scientific workshop on the challenges of diagnosing and measuring FSIAD, reigniting a public debate about whether there’s a need for female dysfunction drugs in the first place. Leonore Tiefer, clinical associate professor of psychiatry at New York University’s School of Medicine and founder of the New View Campaign, which challenges the medicalization of sex, co-wrote a Los Angeles Times op-ed in which she claims women at the hearings “appeared to have been coached to demand drug solutions,” and insisted they had “no non-medical problems” that may affect their sex drive. At the same time, numerous medical groups, such as the Society for Women’s Health Research, the American College of Nurse-Midwives, and the Association of Reproductive Health Professionals, strongly urged Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research, to approve a treatment for female sexual dysfunction. It’s unclear how prevalent desire issues are among women to begin with. Medical sites and the media present vastly different pictures of the problem, some putting it at around 10 percent of the population (16 million people in the U.S.), others putting it closer to 40 percent of women suffering from some kind of sexual dysfunction.
The second statistic comes from a 1999 study in the Journal of the American Medical Association, which found that 43 percent of the 1,749 women sampled (as opposed to 31 percent of men) had experienced some form of broadly-defined sexual dissatisfaction, including lack of desire and arousal, in the past two months. But researchers noted that the women surveyed were more likely to suffer from sexual dysfunction if they had unsatisfying personal experiences and relationships—something a pill can’t solve. And while the FDA appears to be of the opinion that female desire disorder (a woman’s body responds to sex but she has no interest in it) and female arousal disorder (a woman wants to have sex, but her body doesn’t seem to respond) can be lumped into one diagnosis, FSAID, most of the letters in support of a female dysfunction drug and many of the scientific studies refer to a different diagnosis: Hypoactive Sexual Desire Disorder (HSDD), which deals with a woman’s “interest level” in sex, but not necessarily her physiological responses to stimulation.
The advocacy group Even The Score argues that the FDA has systematically discounted female sexual dysfunction. Viagra, the first male sexual-dysfunction drug, was approved in the U.S. in 1998, and according to Susan Scanlan, chair of Even The Score, men now have 26 drug options for sexual dysfunction—while women have none. “Women shouldn’t be shamed for having this condition. They should be listened to and helped,” said Scanlan, who believes the recent FDA meetings represent the first step towards “a meaningful solution.”
In addition to nonprofit groups such as Black Women’s Health Imperative and the Center for Health and Gender Equality, Even The Score also lists Sprout Pharmaceuticals—with other drug companies—as supporters on its website.
“Even The Score is a marketing tactic that masquerades as some kind of feminist patient group, but it’s a gimmick,” said Tiefer, who has been vocal at FDA hearings about her opposition to flibanserin and doubts there is a pressing medical need for a female sexual-dysfunction drug. Many couples have difficulties when it comes to a range of lifestyle concerns, from in-laws and children to personal finances and work balance, she explained. But that doesn’t mean one of them has a “biological inadequacy” in any of those areas. So when a couple has an asymmetrical level of desire, why does one of them necessarily suffer from a medical problem? Perhaps, she posits, it’s the “world of cell phones, deadlines, and multitasking” that places stress on couples’ sex lives, not a chemical deficiency. “Having been a sex therapist and a psychologist, I’ve heard from hundreds upon hundreds of people,” said Tiefer, who blames modern life and the societal pressures women face to look a certain way, in part, for creating desire asymmetry among couples.
Illustrating the tension between marketing and medical science, a recent articlein Marie Claire recounts a Baltimore woman’s experience with flibanserin. Writer Virginia Sole-Smith reports that “Cara” is in her late 30s and a development director for a non-profit, with two young children. Her “sex drive dropped dramatically and never rebounded” after the birth of her first baby. A few weeks into the study, however, she claims a drastic change, planning a mid-workday rendezvous with her husband, leaving a trail of clues for him:
In the first envelope, Ryan found instructions to pick up oysters during his lunch break. Envelope two asked him to swing by a wine store. Number three only said "12 p.m.," along with the name of a local hotel. "I met him at the door wearing only heels," says Cara now. "Building that anticipation all morning was incredibly sexy. Things hadn't been that hot between us in years."Later, Sole-Smith discloses that she met Cara through a publicist for the drug’s manufacturer and that Cara “posted unusually good results for [her] drug trial.” To readers, Cara’s experience with flibanserin might imply that a woman who doesn’t meet her husband on her lunch break, naked, suffers from low desire. And when it comes to sexuality, there’s already a good deal of insecurity about what is normal, explained Jennifer Fishman, assistant professor in biomedical ethics at McGill University. For both men and women, she said, drug companies often promote an unattainably high ideal of arousal.
With the growth of direct-to-consumer pharmaceutical advertising, there’s been a strong drive to push long-term medications on both men and women, according to Barbara Mintzes, associate professor in the School of Population and Public Health at the University of British Columbia in Vancouver. Unlike Viagra, for example, flibanserin is taken daily, not only in anticipation of sexual activity. Viagra addresses blood flow, while flibanserin works on the chemicals in a woman’s brain. Mintzes, who is also the co-author of Sex, Lies and Pharmaceuticals, believes that women’s sexual difficulties are being repackaged as a new disorder. “It’s not a planned conspiracy against women,” she clarified. “But the aim is to sell a product.” Drug companies see a large marketing opportunity in defining less interest in sex as a medical symptom and leaving a woman’s feelings and relationship circumstances out of the picture, according to Mintzes—not unlike what happened with Viagra advertising. “Male drugs had very stereotyped images of masculinity,” she said, “and not even a hint that a man’s emotions might affect his sexuality.”
In contrast are healthcare professionals who believe some women’s low sexual desire will rebound only with drug treatment. Bat Sheva Marcus, clinical director of New York’s Medical Center for Female Sexuality, assesses physical and psychological causes of women’s sexual issues and treats hundreds of women seeking to improve their sexual experience. Marcus believes in addressing all the sociological and psychological issues about desire and functioning, but also thinks that completely closing off the avenue of drug treatment would be “ignorant and cruel.” As she puts it: Personal distress is not a social construction. “For women, the most vulnerable part of the sexual response is probably desire,” Marcus explained. “A woman’s desire can shut off in a moment, for an evening, weeks, months, or a year. And it’s a problem if it bothers her.” Marcus also cautions about merging desire (interest) and arousal (a body’s physical reaction to sexual activity) disorders under one umbrella diagnosis, FSIAD. While the problems could be related for some women, she argues that from a clinical standpoint, the two are distinct.
In fact, a string of studies provides evidence of a neurological basis for low desire that might be helped by a drug like flibanserin, which was first developed as an anti-depressant. A small 2009 functional MRI study, published in Neuroscience, compared 20 females with no history of sexual dysfunction to 16 women with low desire levels and found the two groups exhibited different brain activity when presented with sexually explicit videos. In 2013, researchers once again used neuroimaging patterns to compare the brain regions that are activated in pre-menopausal women with and without a diagnosis of HSDD. They also saw significant differences between the two groups, specifically in the area of the brain responsible for memory encoding/retrieval and self-monitoring.
“Unfortunately, there has been a steady and concerted effort to undermine this condition,” said Cindy Whitehead, president and chief operating office of Sprout Pharmaceuticals. “The narrative is that it’s all in a woman’s head. But that’s based o opinion and imposed judgment.” According to Whitehead, sexual desire disorders have been medically recognized since 1977, the era of Masters and Johnson, and even after years of research and evolved understanding about female sexuality, there’s still no treatment for women. “No drug works for every person,” she explained. “But science has given us our answer and it’s time that the narrative about female sexual dysfunction shift to respect not only the data, but the women who are living with this. ” Whitehead also clarifies that a woman is a candidate for medical treatment, only if she has low desire, feels distress about it, and is in a healthy relationship, so any social or emotional issues have been ruled out beforehand.
Unlike many current medical controversies, the debate over a female sexual dysfunction drug may see some resolution soon. Flibanserin will be resubmitted to the FDA in the first quarter of 2015, with a decision expected six months later.
