Question marks

Female Viagra ‘Is Bad Science’

The FDA unanimously rejected this ‘unacceptable’ drug five years ago. So why did they suddenly change their minds?

“I was hissed at,” award-winning filmmaker Liz Canner tells me of the moment she took the podium during the FDA hearing on female viagra this June. “You’ve never seen such emotional blackmail.”

Canner is somewhat of an expert on the topic thanks to her 2011 film Orgasm Inc. The feature-length documentary explored big pharma’s search for a cure to “female sexual dysfunction”—a problem no one’s quite sure exists. Flibanserin (marketed as “Addyi”), which got official approval this week, is one of many drugs she followed, all the way until the FDA rejected it in a 2010 hearing.

FDA hearings, for the 46-year-old, are nothing new. But this one was decidedly in a league of its own. “They were cheering and high-fiving,” she says of the group arguing that the drug should be approved. “It was like a football game.”

As headlines across the web proclaimed in June, the FDA panelists concluded the hearing by—unexpectedly—approving the drug. This week, after a final internal review, the decision became final. Flibanserin will hit shelves on October 17.

The FDA’s decision to approve the exact drug it’s twice rejected raises questions not only about flibanserin, but the ethics of the organization itself. Canner, who watched the arguments unfold, said politics, not science, won.

The June 2010 FDA hearing in which panelists rejected flibanserin is one of the final scenes in Orgasm. At the time, the drug was still in the hands of the German pharmaceutical company who created it, Boehringer Ingelheim. After hearing the testimony from both sides, FDA panelists unanimously voted to reject it, calling its serious risks and minimal benefits “unacceptable.”

How did a drug that was rejected five years ago just get approved, with no variations to its chemical makeup? “It’s not like the drug changed,” she says. “All that changed there was the people behind it.”

The people behind it, in this case, is Sprout Pharmaceuticals, a Raleigh, North Carolina-based company dedicated to “breakthrough firsts in women’s sexual health.” A picture of eight women with arms crossed and stern faces greets users on the homepage. The eight males who make up the nine-person Board of Directors must have been out that day.

Canner says it was clear to her, and likely everyone in the room, that pressure had already been put on the FDA. In the months before the hearing, Sprout launched a “sexual health equity” campaign called Even the Score. Its message was simple: The FDA’s rejection of flibanserin isn’t science-based, it’s “gender inequity.” “The FDA has approved 26 drugs marketed for the treatment of male sexual dysfunctions, compared to zero to address the most common form of female sexual dysfunction,” reads the website’s “get the facts” section.

In the months before the FDA panel, Even the Score made huge waves, successfully signing on 26 women’s health and research organizations as official supporters and generating buzz online. Excitement around their gender crusade continued to grow in anticipation of the event. On the day of the hearing, says Canner, they were literally “busing” supporters in.

The FDA’s first move in the hearing made it clear that they’d gotten the message. Canner says they spent time trying to “clear the air,” putting up slides with facts about the drugs they have for women and men. “They put up that slide to say ‘You’re misrepresenting, we’re not sexist,’’’ says Canner. But the FDA’s clear vision in the beginning didn’t stick.

One major organization after another got up and told FDA panelists that “all of their members” needed the drug. “By the end of the hearing, you felt like there were 20 million women in the room who wanted it,” says Canner. Individual women spoke about their marriages—as did their counterparts. “Husbands showed up and started crying, saying it destroyed their marriages and if they didn’t approve the drug they were going to divorce their wives,” says Canner. “It was that man-to-man thing.”

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As the hearing neared its end, Canner was holding on to hope that the FDA wouldn’t budge. “It was much more psychological than the other hearings,” she says. “But because the science was so bad, I was still hopeful the panel would act on that instead of bending on this political pressure.” Outside of known side effects, such as dizziness, low blood pressure, and fainting, researchers brought up potentially fatal health effects from the study—including congenital anomalies in some fetuses and three times more likelihood that those taking it would get in a car crash. When studied on mice, it was even show to cause mammary gland cancer.

After witnessing the hearing, Canner seems less surprised by the final approval than she is disappointed. “It’s a sad day for science and women’s health,” she says. “It’s the ultimate corporatization of health care. That the FDA came to this… it’s abysmal. It’s a sad day for them too because with the precedent they’ve now set, what’s the point of them?