Thea Cacchioni: How the sexual pharmaceutical industry tried to hijack the FDA

The thin pink line

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      An "Even the Score" petition is currently charging the U.S. Food and Drug Administration (FDA) with sexism for not having approved a sexual pharmaceutical drug for women. However, although drawing heavily on feminist rhetoric of "equality" and "choice", the campaign was created by profit-driven drug companies with sexual pharmaceuticals in the pipeline.

      I’ve always lamented that Canada’s federal health agency maintains a closed-door approach to pharmaceutical regulation. Health Canada makes no room for public or independent input into the drug approval process.

      On October 27 and 28, I attended two pivotal FDA hearings in Silver Spring, Maryland. As a sociologist who has examined the sexual pharmaceutical industry since the rise of Viagra, the first hearing I ever attended on the subject of sexual pharmaceuticals was in 2010 when I signed up to testify against the approval of Flibanserin. Heralded by its makers and in the media as a "pink Viagra", Flibanserin is in fact a daily-use "desire drug" now twice deemed to be unsafe and ineffective by the FDA.

      But in a more unusual move, the FDA billed the meeting last month as a chance for patients, patient advocates, and experts to weigh in on the main diagnosis that sexual pharmaceuticals for women promise to treat: Female Sexual Interest/Arousal Disorder (FSIAD).  Despite the fact that FSIAD is a highly contested diagnostic category, it was selected in the ranks of HIV, Parkinson's, and sickle cell disease as a disease category with "unmet drug needs".

      It seems admirable that the FDA is allowing non-industry people to have a voice in the drug regulation process. However, I wondered from the start whether the intention of this meeting was actually to appease those behind the Even the Score petition.

      It turns out I was right to suspect that the companies behind this faux-feminist campaign would play a major role in this hearing.

      The first day of the meeting was dedicated to "patient" and "patient advocate" perspectives. Upon arrival I noticed two busloads of women carrying goody bags, wearing matching turquoise pashmina scarves, and buttons that read "women deserve". We later learned that Sprout Pharmaceuticals (the makers of Flibanserin) and Veritas, a PR firm hired by Sprout, had paid many of these women’s travel to the meeting, a fact they had to disclose before testifying.

      Day two was billed as the scientific portion of the meeting. To my dismay, the majority of the panel members recruited by the FDA are well-known to be working with or to have worked with drug companies on researching and developing sexual pharmaceuticals. With the notable exception of Dr. Rosemary Basson, a Vancouver-based sexual medicine physician, the majority of panelists seemed interested in which diagnostic criteria and endpoints would capture the widest net of women’s sexual problems in clinical trials.

      While only able to speak in a few audience-designated spots, myself and allies from the New View campaign, a grassroots organization which challenges the medicalization of sex, managed to contribute our own two cents. We reminded the panel that despite numerous attempts and millions of dollars spent, we cannot "even the score" since drug companies have yet to produce a sexual pharmaceutical drug for women that meets adequate safety or efficacy standards. We expressed concern over the numerous social and interpersonal factors that could hinder desire that will not be solved with a pill. We also noted that there seemed to be confusion among patients and panelists about what constitutes "normal" sexual desire in the first place.  

      In my closing comments, while commending the FDA for doing the right thing so far despite mounting industry pressure, I was emphatic on one final point about the meeting on the whole. As drug companies dream up new ways to push their agendas, the line between the drug industry, "patients", and "patient advocates" is increasingly thin.

      Dr. Thea Cacchioni joined UVic in 2011. She is a sociologist and assistant professor in the department of women's studies. Her work has mapped the trials and tribulations of the drug company race to find a sexual pharmaceutical for women. She studies the medicalization of sex, or psychiatric, surgical and pharmaceutical interventions in sexuality, specifically, explanations of women's sexual "dysfunction". In June 2010, she testified at an FDA advisory hearing against the approval of Flibanserin, a daily serotonergic/adrenergic brain drug proposed to treat hypo-active sexual desire disorder in pre-menopausal women despite several "unsexy" side effects.




      Dec 3, 2014 at 8:54am

      "We expressed concern over the numerous social and interpersonal factors that could hinder desire that will not be solved with a pill."

      That will not be solved with this pill or that require voodoo, metaphysical pseudoscience (in Comte's own terms, which is lulzworthy) like sociology to fully deal with?

      The simple fact is that consciousness is wholly material, physical and biological. Reasonable people acknowledge this. Unreasonable people are sort of mystified by the whole process, not realizing that mystification is simply a matter of voltages/chemicals/proteins/etc. within the nervous system.

      I know for a fact that something that could have been diagnosed as a female sexual disorder is what drove my father from my mother---at least so he (perhaps inappropriately) told me. They actually talked to her physician at the time (a woman) who dismissed the issue cavalierly without really understanding the impact it would have, on a line similar to what I am getting from this article, a sort of low-grade feminism 101 which always posits factors beyond disorder in the woman in order to explain any objectionable or problematic behavior. I get the sense that the modern feminist thinks there's nothing crazy or disordered or wrong about sexlessness being unilaterally imposed on a marriage. And there is. Marriage is about mutual submission, in part for the purpose of discharging sexual desire in a safer manner.

      I think your article makes light of the obvious fact that sexual dysfunction can cause serious problems, especially for innocent children in relationships (sexual, adult relationships like marriages) that fall apart due to an inability to maintain adult sexual relations. The idea that "sex is a bonus" is a fundamentally puritannical and unfortunate attitude toward sex. Sex is a necessary part of any healthy relationship. If you have something that requires you to make a go of it, not just cut your losses, like kids, this sort of treatment is better than nothing.

      I know my family had no options, and in the end it destroyed my family---no rational man is going to stay with a woman who won't have sex with him, nor should he be expected to, "for the sake of the children." The woman should be expected to be normally sexually available. Unless we're driven by ideology, not history/custom/reason, in which a woman's total autonomy is the most important.

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      Dec 9, 2014 at 5:12pm

      'Difficulties', please imagine for a second that you are not the centre of the universe. ok? Now imagine that coital sex on demand is not, in fact, your God-given right…you with me? Enforcing sexual access and availability oversteps another human being’s right to bodily autonomy. It’s called rape. Please consider educating yourself on practices of consent.

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