Separating fact from fiction on 'female Viagra'
Next month, the Food and Drug Administration is expected to decide whether to approve the first drug for women who lack sexual desire. An FDA panel recently recommended approval and generated a lot of controversy over whether its decision reflected the scientific merits of the drug, flibanserin, or successful marketing.
Why is the FDA on the cusp of approving a drug that it has rejected twice for having low efficacy and causing significant side effects? Articles and op-eds in many media outlets, including The New York Times and the Washington Post, have cited robust marketing for the drug, which has been dubbed the “female Viagra” and “little pink pill.” Sprout Pharmaceuticals, the manufacturer, helped form an advocacy group, Even the Score, as part of a PR campaign geared to doctors, nurses, members of Congress, and women’s advocacy groups. Its message is that the FDA has been sexist for approving drugs to treat sexual dysfunction in males but not in females. In other words, the agency should even the score by approving flibanserin. (Three members of the FDA advisory panel give their perspectives in the current JAMA.)
What hasn’t been reported until now is that the promotion of flibanserin started before the first application was made to the FDA, with industry-sponsored continuing medical education (CME). A commentary in the Journal of Medical Ethics examines CME courses that presented hypoactive sexual desire disorder in women – the condition that flibanserin is supposed to treat – as a disease in need of greater attention.
Specifically, the article examined 14 CME modules approved by a provider accredited by the Accreditation Council of CME and available in 2010, a year before the first FDA application for flibanserin. All of the modules were funded through educational grants by Boehringer Ingleheim, the original manufacturer. In addition, 12 of the modules had at least one author with financial ties to Boehringer Ingleheim. After the drug was sold to Sprout Pharmaceuticals in 2011, that company funded three CME modules on hypoactive sexual desire disorder.
The Journal of Medical Ethics article underscores the challenge that health reporters face in getting unbiased information about drugs pending approval, particularly when there’s controversy about them. On the one hand, reporters have more tools than ever – most notably, ProPublica’s Dollars for Docs – for checking out doctors before interviewing them to see if they have financial ties to industry. On the other hand, industry-funded CME is exempt from disclosure under the federal Sunshine Act, which requires transparency of physician-industry financial relationships.
“Although it is illegal for pharmaceutical companies to market drugs prior to regulatory approval, there are no restrictions on marketing diseases, and industry seeks to establish a disease state in the minds of clinicians years before an expected drug launch,” write the authors of the Journal of Medical Ethics article, who include Adriane Fugh-Berman, MD, the director of PharmedOut, a Georgetown University Medical Center project that advances evidence-based prescribing and educates health care professionals about pharmaceutical marketing practices. “Continuing medical education (CME) courses are an important part of promotion prior to drug approval and have become a key marketing tool for increasing physician receptivity to new products.”
Fortunately, in the case of flibanserin, reporters can reference an excellent article in Slate to get the names of several doctors who have spoken out in favor of the drug and have financial ties to Sprout.
Many of the doctors accusing the FDA of sexism have received some sort of monetary compensation from Sprout. Dr. Sheryl Kingsberg, chief of behavioral medicine at University Hospitals Case Medical Center and a vocal critic of the FDA’s rejection of flibanserin, told the American Prospect, 'There’s some underlying institutional sexism at play.' She added: 'The FDA is saying we need more driving trials because flibanserin makes women sleepy. But it’s a drug you take at bedtime.' In another story about the FDA’s rejection of flibanserin, Kingsberg blamed a double standard in society's 'willingness to allow women to take any risk for improving their sexual health.' Neither story disclosed that Kingsberg receives consulting fees from Sprout. Anita Clayton, who wrote that passionate HuffPo plea, is also a consultant for Sprout, which was not disclosed in her piece. And the International Society for the Study of Women’s Sexual Health (ISSWSH), which conducted a poll that found '[n]early two-thirds of women polled believe it's inappropriate that the score is 24-0 when it comes to federal approval of treatments for desire, arousal or orgasm dysfunction in men vs. women,' is also financially connected to Sprout. Not disclosed in the press release for that poll is that the group’s leader, Irwin Goldstein, director of sexual medicine at Alvarado Hospital, has also received funding from Sprout. [The original link is broken, but here’s another one that documents Goldstein’s ties to Sprout.]
To this list I will add the authors who presented a study at a clinical meeting of the Association of Obstetricians and Gynecologists in 2013 that concluded that flibanserin was safe. James A. Simon, the lead author, is a consultant and advisory member of Sprout Pharmaceuticals (and 16 other drug companies); Molly Katz, MD, was a principal investigator in Boehringer Ingleheim clinical trials; Krista A. Barbour, PhD, has “relevant financial relationships with Sprout Pharmaceuticals;” and James P. Symons, PhD, is an employee of Sprout.
[Photo by December Dollinger via Flickr.]