behind the scenes with flibanserin

I (LT) have learned about the machinations of SELLING SICKNESS largely through decades of work as a sexologist examining and trying to limit the medicalization of sexuality.

Flibanserin is a  serotonergic antidepressant proposed to help women diagnosed with inadequate sexual desire which was rejected by the FDA in 2010 because the trial results showed a poor risk/benefit profile. Although it was called “The Pink Viagra,” flibanserin, unlike Viagra, has to be taken daily (like SSRIs) for an indefinite period, rather than being taken as needed. It has a central nervous system type side effect profile, too, as contrasted with Viagra’s peripheral effects. Because the placebo results were practically equivalent to flibanserin’s, it made sense that the FDA would rebuff the drug.

But it turns out that the 2010 rejection was just the beginning, and a new manufacturer has created a totally new promotional campaign to get the drug back in front of the FDA. It’s been an eye-opening experience.

Originally developed by Boehringer-Ingelheim, flibanserin was sold to Sprout Pharmaceuticals after its 2010 defeat. Alarmed, the National Women’s Health Network, wrote to the FDA (and took other actions) in September 2013, “to convey our serious concerns about the resubmission…of flibanserin…” Sprout’s resubmitted application was rejected in December 2013 because the trial results, though based on a larger sample of women, still showed a marginal benefit combined with a substantial risk.

Then things got interesting! Over the course of the next several weeks, organizations not previously known for their  knowledge or interest in sexology (e.g., Jewish Women International, National Consumer’s League, National Organization for Women, Nurse Practitioners in Women’s Health) wrote letters to the FDA complaining that the FDA was showing gender bias by approving drugs for men’s sexual problems, but not for women’s!

The International Society for the Study of Women’s Sexual Health, a pharma-funded sexual medicine group founded by urologists in 2000, commissioned a poll asking 571 women:

Q1. Do you agree or disagree that medical treatment options for conditions that uniquely affect women often lag decades behind those for men?

Agree ………..48%  Disagree …………31%  Not sure ………. 21%

Q2. Do you think that society places more emphasis on men’s sexual satisfaction than women’s sexual satisfaction, or not?

Think society does ……..59%  Think society does not ………30%   Not sure ……11%

Q3. Do you think it’s appropriate that there are 24 drugs approved to treat male sexual dysfunctions while there are zero for the most common form of female sexual dysfunction, or not?

Think it’s appropriate……..27%   Think it’s not appropriate…… 59%   Not sure ……….15%

Q4. Do you think that drug treatments for women’s sexual health should be held to stricter standards for approval than men’s sexual health drugs, or not?

Think they should…….. 31%  Think they should not……… 54%  Not sure ………… 15%

Q5. Do you believe that women can discuss the risks and benefits of medical treatments with their healthcare providers as easily as men, or not?

Think women can……. 74%   Think they cannot ……. 17%   Not sure ……… 9%

Following this, an ISSWSH psychiatrist who has been involved in all the “pink Viagra”-type drug drials over the past decade helped to schedule a meeting with FDA Drug Development Director Janet Woodcock which was followed up with a letter reiterating their complaints. She also wrote a Huffington Post piece to publicize the women’s meeting with Director Woodcock called “The FDA, Sexual Dysfunction and Gender Inequality.” The extent of the politicking can be shown by a letter signed by four Congresswomen raising the spectre of gender bias with regard to sexual dysfunction drugs at the FDA!

Inevitably, the story was picked up in the major press, and received sympathetic coverage in the Washington Post but critical coverage in Slate and in the scientific blog world, where the misinformation about how many drugs there were for men was debunked and the major pharmacological differences between the proposed drugs was properly analyzed.

Finally, women’s health and consumer groups affiliated with SELLING SICKNESS such as the National Women’s Health Network, OurBodies Ourselves, Breast Cancer Action and the American Medical Students Association decided to publicize the feminist counter-narrative, the one emphasizing independent science and safety, the one grounded in the precautionary principle. In addition to speaking with journalists, we sent a lengthy letter to the FDA  arguing that the “gender bias” argument was a red herring and merely a new promotional gambit on the part of the manufacturer. “[While] women deserve to have our problems with sex taken seriously, we do not believe that a minimally effective drug that must be taken daily, causes significant side effects and has not been evaluated for long-term safety offers women a serious solution,” it said. A similar letter went to the groups that met with the FDA initially and to the four interested Congresswomen.

For those of us in the SELLING SICKNESS movement who have been working for feminist causes for most of our lives, it was a painful outrage to see Sprout Pharmaceuticals use the call for gender equality in such a deceptive and dishonest fashion. Hopefully, by the time this contretemps has passed, there will be raised awareness in many places about the need for eternal vigilance in the face of marketing strategies, up to and including the twisting of our most basic values.