The non-profits pressuring the FDA to approve a drug billed as female Viagra do not quite make up a top ten list or women’s health advocacy organizations. This health writer has never heard of most of the groups cited in Sunday’s New York Times story.
But familiar women’s health groups, like Boston’s Our Bodies, Ourselves, are siding with the FDA on this one. From their response to an earlier review of the drug.
Women taking the drug had less than one additional “sexually satisfying event” (orgasm not required) than women taking a placebo. And in the meantime, the drug caused dizziness, nausea and fatigue, particularly with long-term daily use, in some women — hardly the recipe for sexual excitement.
The FDA also considered whether the drug had increased women’s desire — a crucial element of the HSDD diagnosis, which involves low or no sexual interest to the point of distress in people who are physically healthy and not depressed — and found that the drug failed in this area.
The FDA takes another look — and offers a live webcast of the deliberations — on Thursday.
In it’s report on the 2010 FDA rejection of the drug, the OBOS website notes another Bay State-based critic of the drug:
According to Julia Johnson, the panel’s chairwoman and head of the department of obstetrics and gynecology at the University of Massachusetts Medical School, the impact of the drug flibanserin … was “not robust enough to justify the risks.”
More here from another independent, feminist women’s health group, The National Women’s Health Network:
Members of the campaign called “Even the Score” are challenging the FDA on what they claim is a perpetuation of a gender bias by virtue of the claim that the FDA is holding drugs that treat women’s sexual problem to a higher standard than those for erectile dysfunction. Even the Score has engaged prominent women’s rights organizations, health care providers, the media and members of Congress in a public relations misinformation campaign to criticize the FDA. There are Female Sexual Dysfunction drugs currently under FDA review, and Even the Score is attempting to move the discussion away from the safety and effectiveness of these drugs and towards controversy about gender bias.
The reality is that no amount of public relations or slick marketing can get around the fact that the drugs currently being proposed for Female Sexual Dysfunction simply don’t work and may be quite dangerous. Poor efficacy, a strong placebo effect, and valid safety concerns have plagued all of the drugs that have been tested so far. There are many reasons why the proposed drugs may not have been effective in increasing women’s sexual enjoyment; chief among them is the heterogeneity of female sexuality and, of course, research demonstrating that sexual problems are mostly shaped by interpersonal, psychological, and social factors. Nevertheless, pharmaceutical executives will continue to drum up hype over the possibility of a “pink Viagra” because the profit market for this type of drug is estimated to be over $2 billion a year.
Note that neither of these groups accept funding from the pharmaceutical industry. Even the score supporter include Sprout, the company seeking approval for the drug and Trimel Pharmaceuticals, a company testing a nasal testosterone gel for “female orgasmic disorder.”