Bioethics Forum Essay
The Score is Even
Three years ago, a small pharmaceutical company with a big agenda created a fake feminist group so that they could get a bad drug approved by the Food and Drug Administration. The story of how this happened is a case study in how industry affects medical discourse, the subject of a PharmedOut conference that will be held this week.
Sprout Pharmaceuticals, run by Cindy and Robert Whitehead, was determined to obtain regulatory approval for flibanserin (Addyi), an antidepressant-turned-aphrodisiac that had already twice failed to gain approval by the FDA. To create this fake feminist campaign, Sprout hired Blue Engine Media, a PR firm that created a sham organization called Even the Score. The campaign hired two feminists: a former director of the FDA Office of Women’s Health, and the former president of the Women’s Research and Education Institute – both well-known to women’s groups. Even the Score recruited and paid consumer advocacy groups to pressure the FDA into approving flibanserin for Hypoactive Sexual Desire Disorder – a condition previously created by industry to sell another drug.
Describing itself as “[a] campaign for women’s sexual health equity” created “to serve as a voice for American women who believe that it’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction,” Even the Score claimed that flibanserin approval would begin to rectify gender drug inequity since there were 26 drugs for male sexual dysfunction and none for women. Consumer groups that were part of Even the Score included the National Organization for Women, National Consumers League, Black Women’s Health Imperative, Jewish Women International, and The National Council of Women’s Organizations. Supporters sent letters to the FDA advocating for approval of the drug, and many groups testified at the FDA in favor of Addyi’s approval.
Members of Even the Score were effective shills for the drug. Sally Greenberg, executive director of the National Consumers League, cited possible “unconscious gender bias at the FDA” and called Addyi “the biggest breakthrough for women’s sexual health since the pill.” At an advisory panel at the FDA hearing for Addyi, Lori Weinstein, of Jewish Women International spoke, “on behalf of the 75,000 members . . . who share our belief that FSD [female sexual dysfunction] has been overlooked for far too long . . . We believe the science is there for the approval of the drug.”
On August 18, 2015, the FDA approved Addyi. Susan Scanlan, chairwoman of Even the Score, told the New York Times, “Today, we write a new chapter in the fight for equity in sexual health.” Two days later, Sprout sold the drug to Valeant Pharmaceutical for one billion dollars. (Talk about equity!)
And that was it for Even the Score. The day-after-approval victory video, which trumpeted that the score was now “26 to 1!” was the last posting on the Even the Score site. The last time @eventhescore tweeted was over a year ago. The site, completely dormant for many months, disappeared entirely several months ago. So much for Even the Score’s promise that “. . . there is still a long way to go before we achieve true gender equity in sexual health – and Even the Score will be there every step of the way.”
Where did this purportedly grassroots feminist movement go? The last word heard from NOW was a press release the day after Addyi’s approval that stated that “Hypoactive Sexual Desire Disorder (HSDD) is a serious condition experienced by about ten percent of pre-menopausal women, yet it has taken seven years for this drug, Flibanserin (Addyi), to get the green-light.”
Leaving aside the fact that there were never 26 sex drugs for men and none for women (the real score was about 8 to 3, and no drug has ever been approved to boost libido in men), did the women’s groups that believed Sprout’s hype also believe that the approval of one drug constituted gender equity? Although Terry O’Neill of NOW had stated, “Clearly we need more than just one medication — women need to have an array of choices that meets their specific medical needs,” NOW’s interest in pharmaceutical gender equity seems to have disappeared with its funding.
It’s sad to see advocacy groups become mouthpieces for pharma. It is even sadder when those mouthpieces are feminist groups that should be protecting the interest of women but instead are protecting a company’s bottom line. Every single one of the advocacy groups that don’t take money from pharmaceutical companies opposed Addyi’s approval and use. For example, the National Women’s Health Network, the Jacobs Institute for Women’s Health, the National Center for Health Research, the Reproductive Health Technologies Project, and the New View campaign all publicly opposed the drug before and after approval. “This decision to approve flibanserin is a triumph of marketing over science,” said Cindy Pearson, head of the National Women’s Health Network.
Before Addyi’s approval, most media reported the differing perspectives as a catfight among women’s groups, but identifying funding would have made the distinction simple. Had the FDA required the women testifying at the advisory committee meeting on Addyi to disclose their connections to Sprout, it would have been clear that the few women who testified against the drug had no connections to the company, and that the dozens of women who provided emotional appeals to approve the drug had been ferried to the meeting by Sprout.
Addyi was never a true symbol for gender equity. The drug doesn’t work well and was never safe; because of its dangers, health care providers and pharmacists must be certified to prescribe or dispense the drug. In trials, flibanserin increased “sexually satisfying events” by less than one event a month (an event, by the way, that need include neither an orgasm nor a partner). Its predominant effect may be sedation – each dose is as sedating as four shots of liquor. It interacts dangerously with alcohol and many common drugs, and even on its own can cause precipitous drops in blood pressure and sudden prolonged unconsciousness. Feminists shouldn’t be championing a dangerous, ineffective drug aimed at women.
The epidemic of low libido that Sprout and its shills positioned as a major women’s health issue in need of drugging never existed. That’s evident from Addyi’s flaccid launch; prescriptions for Addyi have numbered by the thousands, rather than the millions. Valeant claims that more than 35,000 doctors and 17,000 pharmacies are certified to prescribe or dispense Addyi, but by May of 2016, after a year on the market, Addyi was selling only 1,000 prescriptions per month. In November 2016, Sprout investors sued Valeant for failing to commercialize the drug.
Perhaps the lawsuit explains Valeant’s not-so valiant effort to save its loser drug. A barebones website dubbed Find My Spark (the apparent daughter of Even the Score), has been created by Valeant in partnership with the American Sexual Health Association, apparently to spark up Addyi’s paltry sales. Score and Spark (cue Joni Mitchell) share many of the same hired experts: Drs. Sheryl Kingsberg and Michael Krychman, both consultants to Sprout and advocates for the approval of Addyi, provided video testimonials on the website. In an op-ed, Kingsberg said, “Flibanserin will transform how many practice medicine and benefit the lives and sexual relationships of millions of women and their partners.” Kingsberg’s vision of Addyi has yet to pan out. The drug has done so poorly in the marketplace that it wouldn’t be surprising if Valeant dumps its billion-dollar lemon of a purchase.
Where are the crowds of women with low libido clamoring for Addyi? They never existed, except in a PR firm’s fantasy.
Several lessons can be learned from the story of Even the Score. First, don’t trust, support, or listen to purported consumer advocacy groups that take money from pharmaceutical companies. Their opinions, or silence, are up for sale, and they don’t truly represent the best interest of the constituencies they claim to stand for. The FDA, especially, should not let industry-funded groups suggest topics for or run so-called “patient-focused drug development” meetings. The FDA should require all speakers at FDA meetings, including patients, to disclose all conflicts of interest with industry, including travel funding. And anyone paid by, funded by, or representing industry, including representatives of consumer or professional groups paid by industry, should be barred from testifying at public meetings or advisory committee meetings. Industry-funded groups should not be allowed to suggest topics for or run so-called “patient-focused drug development” meetings.
Second, the media, the FDA, and patients should listen to independent advocacy groups. Only the groups that don’t take industry money truly represent consumers. Reporters, regulators and policymakers who want a consumer perspective must make a distinction between consumer groups that are bought off and those that aren’t.
The failure of flibanserin is due in large part to the actions of the truly independent advocacy groups, which got the word out about the lack of efficacy and the dangerous side effects of Addyi. If there was a score to be evened, the potential customers and payers for this drug settled it by shuttering their wallets. The market of women desperate for aphrodisiacs never existed. We hope this message gets out before the next dangerous ineffective drug is shoved through the FDA because of bullying from consumer groups paid to pander to industry.
Alycia Hogenmiller is the project manager at PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates health care professionals about pharmaceutical marketing practices and is holding its annual conference this week.. Alessandra Hirsch, MS, is a medical student at the University of Illinois at Chicago and project consultant to PharmedOut. Adriane Fugh-Berman, MD, is a professor of pharmacology and physiology at Georgetown University Medical Center and director of Pharmed Out.
Thank you for this article. I wonder about the other-than-humans on whom this shame medicine was tested. That they’re not mentioned, speaks to a lack of regard for their experience as test subjects.
This is a sad and despressing story about two bad companies and their amoral efforts to shill. Too bad the conclusions paint with an indiscriminant and holier than thou brush an entire industry. Even worse that the recommendations blithely trample over the First Amendment, demanding that certain opinions be forbidden and restrained, in obvious violation of the a Constitution. Ironically, given the articles excellent narrative, the authors propose solutions for a problem that doesn’t exist. The story itself documents that all of these amoral efforts failed. The market is actually smarter than given credit for. The in loco parentis infantalization of the medical community and of patients, said to be gullible, incapable of judgement in the face of PR and thus in need of protection, is insulting and at odds with the facts presented.
The authors need to study more the nature and causes of conflicts of interest. In practice, while potential financial conflicts are easily to identify, and thus easily cited, a potential doesn’t mean an actual conflict. If you give me a donut or fly me to Miami, I will not, in fact, say whatever you want me to say. The absolutists betray their own delicate moral fiber by suggesting otherwise. Moreover, there are far more actual conflicts that hinge on status and reputation and career than have ever been documented to be due to money alone. For example, those who make their living and build their academic careers on criticizing the pharmaceutical industry, rarely seem to find anything about the industry to applaud, but see evil and danger everywhere. Is that objective truth or is it a consequence of realized conflict of interest? Can we have disclosed in advance of every article the past number of pro versus anti industry screes from the authors? I posit this career bias is a more serious ethical conflict than the lost soul who accepted an honorarium at a speaking engagement or picked up a branded trinket at an information booth.
Thanks for this antidote to bad medicine!
Isn’t the real problem that politically -motivated advocacy in general appears to have a role in drug approval?
If the drug is unsafe and ineffective, then presumably regardless of whether ‘real’ feminist advocates or ‘paid’ feminist advocates argued it should be made available then surely it should not be. The only questions of interest are surely whether it is safe and effective. If it is safe and effective then some people might decide never to take it because they think female desire should not be medicated. other people might take it because they think they should have the ability to control their levels of desire. Both are perfectly understandable perspectives, but why should one persons, or a group of people’s view impinge on others?
Likewise, the uptake seems to be irrelevant. A group of feminist advocates who are unpaid don’t speak for all women any more than those who are paid. Women have a variety of views. But when it comes to FDA approval is the level of interest in the drug actually relevant? Presumably as long as the individual patients who take it are well informed and consent to it and are not inappropriately prescribed it it is really up to the company how much of a market there is (of course this might differ in a publicly funded health system.
There weren’t all that many clinical trial participants that testified before FDA committees. Those who were simply shills for Sprout–if they didn’t in fact receive any benefit from taking flibanserin, or worse, didn’t even have libido problems in the first place–bear a significant share, per capita, of the responsibility for this fiasco, to the extent that they manipulated FDA employees into voting for something that wasn’t all it they claimed it was. If Valeant, having relied on the FDA’s judgement in making a catastrophic mistake, Should investigate the indiduals who influenced the FDA (and possibly Valeant, directly) and in the veracity of their testimony. (Valeant’s CEO at the time is no longer with the company.)