If you think that most recommendations for drug approval in the US are made on the basis of careful epidemiology on the nature and severity of the disease, the numbers of patients afflicted, plus scientifically-derived data on the benefits and harms related to the drug, then the decision on June 4th to recommend the approval of flibanserin for hypoactive sexual desire disorder should give you pause. With the FDA review committee recommending approval, in a vote of 18 for and 6 against, there is clearly more than science that has contributed to this decision.
Thea Cacchioni, a sociologist and assistant professor in the Department of Women’s Studies at the University of Victoria, has been mapping the trials and tribulations of the drug company race to find a sexual pharmaceutical for women for years. She was in Washington, DC in June 2010 testifying at a previous FDA advisory hearing around the approval of Flibanserin (failing that vote 10 to 1), and has been following this week’s hijinks very closely.
“They [the members of the FDA advisory committee] were emotionally blackmailed by the Even the Score campaign, whose activists maintained “something was better than nothing,” she said. These campaigners were, of course, the type normally found when there is a backer with deep pockets, in this case the manufacturer of flibanserin, whose care and feeding of the activists was important to keep reinforcing the mantra that we need an FDA-approved aphrodisiac for women.
This activity is classic faux-advocacy. The vocal and articulate activists and the specialists-for-hire are all part of what my coauthor Ray Moynihan and I called “Astroturf Activists” in our book Selling Sickness. Astroturf looks and feels like real grass, but as we know, it’s plastic, has no real grassroots, and really represents no community other than the one created by the big industry (be it tobacco, oil or in this case, the drug industry) that pays their bills. I can assure you, having seen this dozens of times over the last two decades, if there was no drug company funder, there would be no Even the Score campaign.
The FDA reviewers, clearly interested in hearing all sides of the issue, were astonishingly swayed by the Even the Score astroturfers. These advocates skillfully employed all the tools of slick, tech-savvy modern PR — schmoozing with Congress, as well as Tweeting and Facebooking under the banner of “gender equity” — to convince the panel that women with low sexual interest should be considered very sick people who need a daily drug to make their sex drive more “normal” (as if such a thing as “normal” actually exists). More astonishing too, is that those FDA reviewers seemed to swallow the red herring arguments around safety: that the drug, under the right conditions (like when the patient is sober and there is a full moon out) may be, possibly, used in a way where its risks can be “managed.” That argument seemed to eclipse the bigger issue that the drug is for a questionable disease and is only a smidgen more “effective” than a placebo.
Unlike erectile dysfunction drugs like Viagra which are PRN (you take them when you ‘need’ them), this drug is to be taken continuously, thus exposing the patients to more potential harm. The review hearing contained some pretty damning revelations from the data that suggested flibanserin, when consumed with alcohol, can cause potentially fatal hypotension and syncope. And then there’s the mice data, which uncomfortably showed that flibanserin treatment “resulted in a highly significant dose-related increase in the incidence of mammary tumors in female mice.” So will American women be trading 0.7 more “satisfying sexual experiences” per month to become a data point in the next spike in new cases of breast cancer in the US?
Time will tell, but all I can say is, so much for the valuable “patient perspective” being part of drug approval processes. Methinks if this drug gets final approval to be sold in the US, the rest of the world will sit back and watch as American women become guinea pigs in a bold new experiment in the medicalization of sexual behavior.
Suffice to say, Thea Cacchioni and other women who aren’t taking drug company money and are advocating against the medicalization of female sexuality are gobsmacked by the FDA committee’s decision. “I thought it was going to be a joke,” noted Ms. Cacchioni. “There was not a single person, even the ones voting in favor of approval, who didn’t express some reservations about the drug, its safety and minimal effectiveness,” she said.
We now have to wait to see if this is something the FDA will actually approve. As for me, in future hearings, I’d like to hear more from the mice.
Alan Cassels is a drug policy researcher with an interest in how clinical research and experience on pharmaceuticals gets translated for policy-makers, prescribers and consumers.