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Big Pharma Urges Women to Fight for Access to Harmful Pill

Monday, October 27, 2014 By Mara Kardas-Nelson, Truthout | Report
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Taking pill(Image: Taking pill via Shutterstock)The support of readers like you got this story published - and helps Truthout stay free from corporate advertising. Can you sustain our work with a tax-deductible donation today?

It's a sexy premise: The notion that the Food and Drug Administration, beset by deep-seated and subconscious sexism, is purposefully denying women who have problems with sexual arousal and satisfaction the medical fix they need.

That's what a new campaign, funded by a pharmaceutical company and organizations that it supports, is charging. Called "Even the Score," the campaign has artfully co-opted feminist rhetoric like "choice" and "gender equality" to craft the idea that a medical solution to women's lack of sexual desire is being overshadowed by the medical community's focus on male sexual dysfunction, and that it's high time women's sexual pleasure gets the focus it deserves.

The campaign website states: "We believe that women have the right to make their own informed choices concerning their sexual health; that gender equality should be the standard in access to sexual dysfunction treatments; and that the approval of safe and effective treatments for low desire should be a priority for the FDA." The pharma-funded campaign deploys dramatic statistics to highlight its point: "Even the Score" claims that 43 percent of women experience female sexual dysfunction, or FSD, and that while 26 drugs meant to tackle male sexual problems have been approved by the FDA, none have been approved for women.

To reverse this supposed "institutional sexism," the campaign is ramping up efforts for the FDA to approve a pill, flibanserin, meant to address the umbrella category of "female sexual dysfunction." (Flibanserin is a failed antidepressant from Boehringer Ingelheim, now being pushed for treatment of female sexual disorder by Sprout Pharmaceuticals, who funds the "Even the Score" campaign).

Efforts will intensify next week during two FDA meetings on "Female Sexual Interest/Arousal Disorder (FSIAD),"  a designation included in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, which combines two different classifications of female sexual issues: one in which women affected by sexual problems can speak to the FDA  about their experiences and offer their thoughts on available medical technologies; and the other, a scientific workshop, intended to help address the clinical development of drug products that can treat the disorder.

However, the premises on which the "Even the Score" campaign is grounded have been refuted by solid evidence. First, those tantalizing statistics: According to Georgetown University Medical Center's PharmedOut project, only eight products have been approved for erectile dysfunction by the FDA, and several of the 26 included in the "Even the Score" campaign are simply different dosages of the same drug. Most importantly, none of the drugs geared toward men are prescribed for lack of sexual desire - central to the problem of female sexual dysfunction - but rather for the lack of a physical response to sex.

As for the claim that 43 percent experience sexual dysfunction: That statistic was refuted over a decade ago, with the researcher whose questionnaire originally fueled that figure stating that it has been used to exaggerate the number of women who face serious problems finding sexual pleasure.

"The ["Even the Score"] campaign exploits women’s legitimate concerns about gender bias in medical research as it disseminates phony sexuality facts," writes the New View campaign, which was formed in 2000 "to challenge the distorted and oversimplified messages about sexuality that the pharmaceutical industry relies on to sell its new drugs." Unlike Even the Score, New View receives no industry money.

New View and others challenge more than just the statistics. Critics question whether women's sexual problems can be understood through a purely medical lens, and with a purely medical solution.

"There are definitely biological, medical, psychological components that are painful for women to have a satisfying sex life," says Karen Hicks, a health educator at Lehigh University and a member of the New View campaign. "Is it your relationship? Is it your past experiences? Have you been raped? Are you stressed? Do you just need to talk to your partner?  All of these things can affect desire and arousal. For some women, there are biological issues, but for many women, the issues are more ambiguous and harder to find the cause for."

Writing nearly a decade ago in the highly respected medical journal, PLoS Medicine, psychologist Leonore Tiefer wrote that when women experience problems around sex, biology and medicine may only be a small part of the issue, and that history of sexual repression impacts the way everyone experiences sex.

"A long history of social and political control of sexual expression created reservoirs of shame and ignorance that make it difficult for many people to understand sexual satisfaction or cope with sexual problems in rational ways." That is, a pill won’t be able to fix social and political influences that impact how we view, and have, sex.

Thea Cacchioni, a Sociologist and Professor of Women's Studies at the University of Victoria, and a member of New View, says that the clinical trials that test drugs for female sexual dysfunction inadvertently demonstrate that good sex is about more than just the physical.

"In every clinical trial for any sexual pharmaceutical drug for women, the placebo effect has been very high. What this tells me is that when women are given license to focus on their sex lives and time and space, when they prioritize their sex lives, their sexual enjoyment and satisfaction increases."  Rather than addressing these underlying causes and using a wide range of techniques to help improve women's sexual satisfaction, pharmaceutical companies are "selling sickness, creating disease, and saying you have the magic cure," says Hicks.

Female "sexual dysfunction" is not the only syndrome that has been hyper-medicalized. Medical journalist Ray Moynihan, doctor Iona Heath and David Henry, professor of clinical psychology, note in the British Medical Journal that, "pharmaceutical companies are actively involved in sponsoring the definition of diseases and promoting them to both prescribers and consumers" and that such diseases which may only affect a small percentage of the population are made to seem "widespread, serious, and treatable."

They warn that "inappropriate medicalization carries the dangers of unnecessary labeling, poor treatment decisions, iatrogenic illness [that is, illnesses related to the medical treatment itself], and economic waste, as well as the opportunity costs that result when resources are diverted away from treating or preventing more serious disease. At a deeper level, it may help to feed unhealthy obsessions with health, obscure or mystify sociological or political explanations for health problems, and focus undue attention on pharmacological, individualized or privatized solutions."

It's important to note that those who are critical of the medicalization of female sexual problems aren't saying that many women don't have problems engaging in and enjoying sex, or that those problems aren't serious. Many note that there may even be a medical cause for some women. Instead, they caution that understanding women's lack of sexual desire as only medical in nature neglects to acknowledge that women's sexual problems can come from a myriad of issues, be they psychological, social, and/or medical, and that women deserve to have the best science can offer.

They worry that the over-medicalization of women's sexual problems, and industry pandering a pill as the solution, could lead to millions of women being exposed to medicine with "health hazards and side effects," as New View states - and potentially without any medical benefit.

Above all, though, women's health advocates say that any drug that comes on the market should be held to the highest clinical standards - meaning it should be both safe and effective. And there's no evidence that flibanserin is either effective or safe.

It's already been rejected three times by the FDA, and with good reason: it's been found to be only slightly better at increasing the frequency of "satisfying sexual events" than a placebo and comes with some significant side effects for many women. What's more, whereas male sexual enhancement drugs like Viagra are only taken at the moment they're needed, filbanserin is envisioned to be taken once a day for as long as a woman's sexual problems last - which for some, could be in perpetuity. 

As the National Women's Health Network, Our Bodies Ourselves, and other consumer safety and feminist organizations wrote earlier this year in a letter to the FDA, urging them not to approve the drug, "The problem with flibanserin is not gender bias at the FDA but the drug itself."

However, next week's FDA meeting may signal that the body is bending to industry pressure. FDA spokeswoman Stephanie Yao notes that the FDA decided which areas to prioritize for public engagement based on public comments, which primarily came from patients, and that "FSD was identified because it is a chronic condition that affects functioning and activities of daily living and because of its complexity in finding the best ways to design clinical trials and evaluate the efficacy of potential medications."

But Cacchioni is concerned that the meetings will be biased. She says that she and other independent experts "tried to get on the [scientific] panel," taking place on the second day of the FDA hearings, but "the FDA invited almost solely industry-sponsored experts." She also surmises that most of the women who will be able to attend the meetings to speak about female sexual disorder may be connected to the Even the Score campaign, and therefore look favorably upon a medical diagnosis and medical solution (and specifically towards flibanserin).

There's good reason to think Cacchioni's skepticism is warranted. A memo circulated by the International Society for the Study of Women's Health, a cosponsor of the Even the Score campaign that is connected to Sprout Pharmaceuticals, notes that "funding is now available (money is from multiple sources) to help support travel and hotel costs for patients to attend the meeting."

"It seems benevolent, that we'll hear from lay women and that their voices are represented," says Cacchioni. "But [industry will] have money that will bring in the patients who come from a particular perspective.  . . . I don't think this will be without bias. I don't think this will be an objective portrayal of the 'average woman.' " 

Copyright, Truthout. May not be reprinted without permission.

Mara Kardas-Nelson

Mara Kardas-Nelson is an award-winning journalist who focuses on health, environment, international development, local culture and women's issues. Her work has appeared in North American, European and African publications, including Al Jazeera, AlterNet, The Nation and the Mail & Guardian.

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Big Pharma Urges Women to Fight for Access to Harmful Pill

Monday, October 27, 2014 By Mara Kardas-Nelson, Truthout | Report
  • font size decrease font size decrease font size increase font size increase font size
  • Print

Taking pill(Image: Taking pill via Shutterstock)The support of readers like you got this story published - and helps Truthout stay free from corporate advertising. Can you sustain our work with a tax-deductible donation today?

It's a sexy premise: The notion that the Food and Drug Administration, beset by deep-seated and subconscious sexism, is purposefully denying women who have problems with sexual arousal and satisfaction the medical fix they need.

That's what a new campaign, funded by a pharmaceutical company and organizations that it supports, is charging. Called "Even the Score," the campaign has artfully co-opted feminist rhetoric like "choice" and "gender equality" to craft the idea that a medical solution to women's lack of sexual desire is being overshadowed by the medical community's focus on male sexual dysfunction, and that it's high time women's sexual pleasure gets the focus it deserves.

The campaign website states: "We believe that women have the right to make their own informed choices concerning their sexual health; that gender equality should be the standard in access to sexual dysfunction treatments; and that the approval of safe and effective treatments for low desire should be a priority for the FDA." The pharma-funded campaign deploys dramatic statistics to highlight its point: "Even the Score" claims that 43 percent of women experience female sexual dysfunction, or FSD, and that while 26 drugs meant to tackle male sexual problems have been approved by the FDA, none have been approved for women.

To reverse this supposed "institutional sexism," the campaign is ramping up efforts for the FDA to approve a pill, flibanserin, meant to address the umbrella category of "female sexual dysfunction." (Flibanserin is a failed antidepressant from Boehringer Ingelheim, now being pushed for treatment of female sexual disorder by Sprout Pharmaceuticals, who funds the "Even the Score" campaign).

Efforts will intensify next week during two FDA meetings on "Female Sexual Interest/Arousal Disorder (FSIAD),"  a designation included in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, which combines two different classifications of female sexual issues: one in which women affected by sexual problems can speak to the FDA  about their experiences and offer their thoughts on available medical technologies; and the other, a scientific workshop, intended to help address the clinical development of drug products that can treat the disorder.

However, the premises on which the "Even the Score" campaign is grounded have been refuted by solid evidence. First, those tantalizing statistics: According to Georgetown University Medical Center's PharmedOut project, only eight products have been approved for erectile dysfunction by the FDA, and several of the 26 included in the "Even the Score" campaign are simply different dosages of the same drug. Most importantly, none of the drugs geared toward men are prescribed for lack of sexual desire - central to the problem of female sexual dysfunction - but rather for the lack of a physical response to sex.

As for the claim that 43 percent experience sexual dysfunction: That statistic was refuted over a decade ago, with the researcher whose questionnaire originally fueled that figure stating that it has been used to exaggerate the number of women who face serious problems finding sexual pleasure.

"The ["Even the Score"] campaign exploits women’s legitimate concerns about gender bias in medical research as it disseminates phony sexuality facts," writes the New View campaign, which was formed in 2000 "to challenge the distorted and oversimplified messages about sexuality that the pharmaceutical industry relies on to sell its new drugs." Unlike Even the Score, New View receives no industry money.

New View and others challenge more than just the statistics. Critics question whether women's sexual problems can be understood through a purely medical lens, and with a purely medical solution.

"There are definitely biological, medical, psychological components that are painful for women to have a satisfying sex life," says Karen Hicks, a health educator at Lehigh University and a member of the New View campaign. "Is it your relationship? Is it your past experiences? Have you been raped? Are you stressed? Do you just need to talk to your partner?  All of these things can affect desire and arousal. For some women, there are biological issues, but for many women, the issues are more ambiguous and harder to find the cause for."

Writing nearly a decade ago in the highly respected medical journal, PLoS Medicine, psychologist Leonore Tiefer wrote that when women experience problems around sex, biology and medicine may only be a small part of the issue, and that history of sexual repression impacts the way everyone experiences sex.

"A long history of social and political control of sexual expression created reservoirs of shame and ignorance that make it difficult for many people to understand sexual satisfaction or cope with sexual problems in rational ways." That is, a pill won’t be able to fix social and political influences that impact how we view, and have, sex.

Thea Cacchioni, a Sociologist and Professor of Women's Studies at the University of Victoria, and a member of New View, says that the clinical trials that test drugs for female sexual dysfunction inadvertently demonstrate that good sex is about more than just the physical.

"In every clinical trial for any sexual pharmaceutical drug for women, the placebo effect has been very high. What this tells me is that when women are given license to focus on their sex lives and time and space, when they prioritize their sex lives, their sexual enjoyment and satisfaction increases."  Rather than addressing these underlying causes and using a wide range of techniques to help improve women's sexual satisfaction, pharmaceutical companies are "selling sickness, creating disease, and saying you have the magic cure," says Hicks.

Female "sexual dysfunction" is not the only syndrome that has been hyper-medicalized. Medical journalist Ray Moynihan, doctor Iona Heath and David Henry, professor of clinical psychology, note in the British Medical Journal that, "pharmaceutical companies are actively involved in sponsoring the definition of diseases and promoting them to both prescribers and consumers" and that such diseases which may only affect a small percentage of the population are made to seem "widespread, serious, and treatable."

They warn that "inappropriate medicalization carries the dangers of unnecessary labeling, poor treatment decisions, iatrogenic illness [that is, illnesses related to the medical treatment itself], and economic waste, as well as the opportunity costs that result when resources are diverted away from treating or preventing more serious disease. At a deeper level, it may help to feed unhealthy obsessions with health, obscure or mystify sociological or political explanations for health problems, and focus undue attention on pharmacological, individualized or privatized solutions."

It's important to note that those who are critical of the medicalization of female sexual problems aren't saying that many women don't have problems engaging in and enjoying sex, or that those problems aren't serious. Many note that there may even be a medical cause for some women. Instead, they caution that understanding women's lack of sexual desire as only medical in nature neglects to acknowledge that women's sexual problems can come from a myriad of issues, be they psychological, social, and/or medical, and that women deserve to have the best science can offer.

They worry that the over-medicalization of women's sexual problems, and industry pandering a pill as the solution, could lead to millions of women being exposed to medicine with "health hazards and side effects," as New View states - and potentially without any medical benefit.

Above all, though, women's health advocates say that any drug that comes on the market should be held to the highest clinical standards - meaning it should be both safe and effective. And there's no evidence that flibanserin is either effective or safe.

It's already been rejected three times by the FDA, and with good reason: it's been found to be only slightly better at increasing the frequency of "satisfying sexual events" than a placebo and comes with some significant side effects for many women. What's more, whereas male sexual enhancement drugs like Viagra are only taken at the moment they're needed, filbanserin is envisioned to be taken once a day for as long as a woman's sexual problems last - which for some, could be in perpetuity. 

As the National Women's Health Network, Our Bodies Ourselves, and other consumer safety and feminist organizations wrote earlier this year in a letter to the FDA, urging them not to approve the drug, "The problem with flibanserin is not gender bias at the FDA but the drug itself."

However, next week's FDA meeting may signal that the body is bending to industry pressure. FDA spokeswoman Stephanie Yao notes that the FDA decided which areas to prioritize for public engagement based on public comments, which primarily came from patients, and that "FSD was identified because it is a chronic condition that affects functioning and activities of daily living and because of its complexity in finding the best ways to design clinical trials and evaluate the efficacy of potential medications."

But Cacchioni is concerned that the meetings will be biased. She says that she and other independent experts "tried to get on the [scientific] panel," taking place on the second day of the FDA hearings, but "the FDA invited almost solely industry-sponsored experts." She also surmises that most of the women who will be able to attend the meetings to speak about female sexual disorder may be connected to the Even the Score campaign, and therefore look favorably upon a medical diagnosis and medical solution (and specifically towards flibanserin).

There's good reason to think Cacchioni's skepticism is warranted. A memo circulated by the International Society for the Study of Women's Health, a cosponsor of the Even the Score campaign that is connected to Sprout Pharmaceuticals, notes that "funding is now available (money is from multiple sources) to help support travel and hotel costs for patients to attend the meeting."

"It seems benevolent, that we'll hear from lay women and that their voices are represented," says Cacchioni. "But [industry will] have money that will bring in the patients who come from a particular perspective.  . . . I don't think this will be without bias. I don't think this will be an objective portrayal of the 'average woman.' " 

Copyright, Truthout. May not be reprinted without permission.

Mara Kardas-Nelson

Mara Kardas-Nelson is an award-winning journalist who focuses on health, environment, international development, local culture and women's issues. Her work has appeared in North American, European and African publications, including Al Jazeera, AlterNet, The Nation and the Mail & Guardian.