With only one drug in its portfolio, it’s all-or-nothing for “female Viagra” marketer.
The U.S.-based pharmaceutical company that privately raised $50 million to promote and seek FDA approval for a failed anti-depressant, flibanserin, has no other options but to get the same drug approved–this time as a female sexual desire enhancer.
Conveniently for Sprout Pharmaceuticals, Inc., though erroneous, fibanserin has garnered the popular nickname of “female Viagra.” Early tests have found that the drug acts to marginally increase libido in a small percentage of women while exhibiting myriad adverse effects including breast cancer. As a treatment for Hypoactive Sexual Desire Disorder (HSDD), flibanserin has twice failed to earn FDA approval due to safety and efficacy concerns.
The old saying goes, “Desperate times call for desperate measures.” Adding multiple layers of irony to this unsavory scenario, it was Hippocrates himself who originated the proverb that translates more specifically as, “For extreme diseases, extreme methods of cure… are most suitable.” Even Sprout, Inc. would have difficulty saying with a straight face that HSDD is an extreme disease.
Instead, they have fashioned a “women’s movement” whose only goal is to “even the score” with men, even though there is no FDA-approved medication for male HSDD either. The Even the Score campaign has enlisted more than 60 medical professionals to sign an open letter asking for the pill to be approved, according to the news site AlJazeeraAmerica.com. It reports that “at least a few on the list have been consultants or investigators for Sprout Pharmaceuticals.” So, how impressed should we be by this form letter which is quite different than 60 opinions written by 60 “medical professionals”?
The Even the Score website also lists 18 “non-profit” supporters, each with its own interest in joining the campaign (scoring public relations points with target markets, free publicity, etc.) Sprout is also a sponsor (for-profit, obviously) of the Even The Score campaign, but how much they contribute to it is unknown.
AlJazeeraAmerica.com says another women’s health care group with ties to Sprout assisted with travel expenses for women who traveled to the FDA advisory conference on flibanserin in October 2014, sharing their stories of living with sexual dysfunction. “It’s unclear if they also paid for the expenses of women who traveled to last week’s advisory hearing, which voted to recommend approval of the drug,” they note.
Dr. Leonore Tiefer, associate professor of psychiatry at New York University, has been a vocal critic of what she calls the “medicalizing” of female sexual dysfunction. Women’s sexual issues shouldn’t be treated with a daily dose of medication that changes the chemistry of the brain, she told the site, but prevented “through sexual education, through relationships that are equal.”
“We are in a moment in time of women’s sexual emancipation, where the opportunities are being hijacked by an industry that are really not interested in a women’s well-being,” says Tiefer. “[Sprout, Inc. is] interested in financial opportunities that they have. The gender equity argument was conceived in a smoke-filled backroom between public relations people, consultants and Sprout Pharmaceuticals,” she told Al Jazeera America. “This was after the drug was rejected twice.”
One proponent of flibanserin’s approval publicly acknowledged that Sprout could make great money off the drug; that’s what happens, she says, when a company delivers a product that consumers want. She says the charges of sexism against the FDA are just good advocacy.
It’s advocacy that apparently the FDA can not resist. The October 2014 advisory panel recommended in favor of flibanserin approval.
UPDATE: On August 18, 2015, the FDA approved flibanserin for public consumption. It is now marketed under the brand name “Addyi.”