Addyi, a drug that treats low sex drive in women, gained FDA approval on Tuesday after five years and two previous rejections.
The pink pill — formerly known by its generic name, flibanserin — will hit pharmacy shelves on Oct. 17 and will be comparable in price to Viagra, the blockbuster pill that helps men get and maintain erections. Addyi's manufacturer, Sprout Pharmaceuticals of Raleigh, North Carolina, will immediately begin educational initiatives to teach doctors about the drug and the controversial condition it's meant to treat, dubbed hypoactive sexual desire disorder (HSDD).
"It's been a long journey," Cindy Whitehead, CEO of Sprout Pharmaceuticals, told BuzzFeed News.
Addyi's approval, Whitehead contends, is a win for feminism. "I'm hopeful not only for what it could mean for women in which it could work, but also for women at large," she said. "This marks a real shift in our conversations around women's sexuality."
This provocative focus on feminism has been a pivotal part of Sprout's strategy since 2014, when it formed a Washington, D.C., advocacy group called Even the Score. This group is funded partly by Sprout and, according to many experts, was hugely influential in getting Addyi past the FDA.
Even the Score has provided journalists the world over (including BuzzFeed News) with select patient testimonies about HSDD, gotten prominent women's groups to call the FDA sexist, and convinced congresswomen to write letters to the agency.
With this multipronged attack, the group has managed to spin the issue of the drug's approval not in terms of efficacy or side effects (which are not insignificant), but in terms of women's rights. The group's strongest assertion, that men have 26 drugs approved to treat sexual dysfunction while women had none, presented a stirring call to arms to "even the score."
Trouble is, that figure is patently untrue. As the FDA and many experts on the pharmaceutical industry have pointed out, no drugs are currently on the market to treat low libido in men. (Viagra doesn't treat sexual desire, but rather a man's physiological arousal.)
Many of Even the Score's other claims about HSDD and Addyi have been similarly spun, experts say, to sway the drug approval process and get Addyi to market.
"This was the most aggressive public relations campaign I've seen for a drug prior to approval," Adriane Fugh-Berman, associate professor of pharmacology at Georgetown University, told BuzzFeed News. "Cloaking themselves in feminism was brilliant. It was such a novel, brilliant argument."
Addyi was originally tested in 2006 by the German company Boehringer Ingelheim as a potential antidepressant, but turned out not to be a great mood-booster. Based on patient reports, the drug was then tested for its ability to improve libido in women with HSDD, a condition that affects somewhere between 5.4% and 13.6% of women.
Unlike Viagra, which increases blood flow to the penis, the new drug went after something far more elusive: sexual desire's origins in the brain. In 2010, the FDA rejected Boehringer Ingelheim's application, citing its low efficacy.
At this point, Sprout — led by Whitehead and her husband, Bob Whitehead — acquired the drug. The couple had previously led a one-drug company called Slate Pharmaceuticals, which had marketed an implantable testosterone pellet for men with low levels of the hormone. In March 2010, the FDA sent an 11-page warning letter to Slate saying that the company had made misleading and unsupported statements about the drug in its marketing, including suggesting that it could help patients with medical problems such as depression, diabetes, and HIV.
With their new company, the Whiteheads put Addyi through another clinical trial, but looked at different outcomes to measure its efficacy. In 2013, the FDA rejected the drug again, this time on the basis of its side effects, which include sedation, low blood pressure, fainting, and dizziness, as well as drug interactions with everything from alcohol to birth control pills and yeast infection meds. (In Tuesday's announcement, the FDA stated that the drug is not supposed to be taken with alcohol.) The agency also raised long-term safety concerns, to be expected for a once-a-day drug prescribed to otherwise healthy women.
After this second rejection, Even the Score entered the picture. Whitehead claims that the group's original formation had nothing to do with her company: It was an independent coalition of 10 women's groups that had lobbied the FDA for the drug's approval. But it wasn't long before Sprout and Even the Score, in collaboration with multiple PR firms, formally joined forces.
Today Even the Score is a coalition of Sprout and 26 organizations, including many women's nonprofits. (Another pharmaceutical company, Palatin Technologies, which also works on a female sexual dysfunction drug, was also a founding member of Even the Score. But it has since pulled out, reportedly because of Even the Score's allegations that the FDA was sexist and its repeated requests for money.)
Whitehead declined to comment on how much money Sprout has contributed to funding Even the Score, noting only that all of the members were invited to contribute. All groups also pay a membership fee.
According to its founders, the goal of Even the Score was always clear: to advocate for an HSDD treatment, targeting the media, Congress, and finally the FDA. And it would deliver a message similar to what was successfully used in the fight for contraception: a woman's choice. The agency's rejection of flibanserin, these advocates claimed, highlighted "a persistent gender inequity" at the FDA.
"We wanted to know from the FDA's perspective, what is the problem here?" Sally Greenberg, executive director of the National Consumers League, a member of Even the Score, told BuzzFeed News. "I welcome the opportunity to be part of a group of advocates who argue that perhaps there was unconscious gender bias at the FDA."
Other players in the women's health community, however, aren't fans of this unscientific approach. And some even question whether low libido is an illness.
The National Women's Health Network, a large nonprofit that doesn't accept any industry funding, refused to join Even the Score and has been campaigning against the drug's approval.
"The data were awful, just awful," Cindy Pearson, executive director of the National Women's Health Network, told BuzzFeed News, referring to clinical trials showing the drug's relatively low effectiveness and significant side effects. "We do lots of advocacy for women's health, but we said that this deserved to get turned down."
Patient advocacy groups are often formed, and often funded, by industry in order to spread the word about a condition, fundraise for research, and even to help lobby for drug approval.
Even so, many industry watchdogs argue that Even the Score intentionally misled the public by portraying Addyi's approval as a fundamentally political issue.
"It's politicizing what should be a scientific judgment," Steve Woloshin, a professor of medicine at Dartmouth College, told BuzzFeed News. "I think there is a line that gets crossed when you turn the approval process into a political arena."
For example, Even the Score paid for HSDD patients to travel to FDA meetings. And the group convinced 11 members of Congress to sign a letter to the agency. "The call for gender equity in the approval of treatments for sexual dysfunction has grown louder," the letter read.
These and other efforts, some say, succeeded in pushing the public conversation away from what's far more relevant: the quantitative data on the effectiveness and safety of the drug.
"Decisions have to be made within the constraints of the FDA's decision-making power — based on the science and the law," Susan Wood, director of the Jacobs Institute of Women's Health at George Washington University, told BuzzFeed News.
Wood was formerly the director of the Office of Women's Health at the FDA and ended up quitting over a similarly politicized skirmish: the battle to make Plan B an over-the-counter drug.
Unlike that battle, however, which encountered top-down political pressure outside of the scientists and doctors who decide drug approvals at the FDA, Wood argues that Even the Score has turned the fight personal by accusing FDA reviewers of being sexist and paternalistic. "It created a sort of challenge to not just the agency itself, but to the individual reviewers, who are good people and have women's health at heart," she said.
A similar incident happened at an FDA advisory committee meeting in June that had a two-hour period for patient testimonies. A woman associated with Even the Score addressed her comments directly to the men on the panel. "In some cases it was pretty uncomfortable," Walid Gellad, associate professor of medicine at the University of Pittsburgh and one of the panelists, told BuzzFeed News.
Gellad ended up voting in favor of the drug, arguing that while its safety and efficacy can be called into question, it still might work for some small percentage of women. He was part of the majority: The advisory committee voted 18-6 recommending that the FDA approve the drug, a huge swing from the unanimous vote against the drug at a similar meeting last October.
"We saw them not go any further on data, no further on science, but invest all their strategy and money to try to finish this off in an advocacy approach," Pearson, of the National Women's Health Network, said. "It was really disappointing to us that they tried to win by advocacy and marketing rather than by science."
But Even the Score argues that the Addyi approval is just the first step in a longer campaign to make more drugs available to treat sexual dysfunction in women.
"We don't support just one treatment," Greenberg said. Like antidepressants, she added, it's important for patients to have a range of options. "We want women to have the same kinds of choices men have."
The trouble with that, detractors say, is when women's choices aren't the best they can be -- if, for example, a woman takes a pill that doesn't work and leads to unpleasant side effects.
"In that way," said Fugh-Berman of Georgetown, "I would argue that what Even the Score has done is anti-feminist."
Sally Greenberg is the executive director of the National Consumers League. An earlier version of this post called her Susan Greenberg.
Adriane Fugh-Berman is an associate professor of pharmacology at Georgetown University, not the University of Pittsburgh.
Azeen Ghorayshi is a science reporter for BuzzFeed News and is based in New York. Her PGP Fingerprint is 9739 9DAE 607E A66A 3683 AC20 E34B D2A0 8899 74C4
Contact Azeen Ghorayshi at Azeen.Ghorayshi@buzzfeed.com.
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