Push for approval of “sexual desire drug” shows how the agency sets itself up for disaster.
On June 12, 2015, these words appeared in the editorial pages of the New York Times: “A study in mice suggested that flibanserin may increase the risk of breast cancer, an outcome that will have to be monitored closely after the drug is on the market.” After the drug is on the market.
Flibanserin is a drug for treating “low sexual desire in women.” Twice since 2010, it has been rejected FDA, citing low efficacy and high safety concerns. Yet, according to the Times, the FDA recently formed an advisory panel to hear from three categories of interested parties: a sprinkling of experts who agree with the previous decisions, a group of high-power lobbyists for the drug company that’s still seeking approval, and a “packed meeting room” of “patients” under the banner of a women’s group (formed by the pharmaceutical manufacturer) called “Even The Score.”
Ostensibly, the score to be settled is that Viagra and similar drugs for male sexual dysfunction are available, while no similar prescription drug is available for women. However, the paper quoted FDA Division of Bone, Reproductive, and Urologic Products director Dr. Hylton V. Joffe, who (correctly) pointed out that “No drugs have been approved for either men or women to treat loss of sexual desire.” (Viagra treats erectile dysfunction, not low sexual desire.) The panel recommended in favor of FDA approval.
This makes for a great opportunity to take a look at the conditions–maladies, if you prefer–for which Americans desire pharmaceutical solutions. If the case above, wherein a drug that may contribute to “one additional sexually satisfying event per month” may also cause breast cancer, is any indicator, then appetite in the U.S. for answers in pill form can only be described as nearly insatiable. In May of 2011, CNN.com commenced a series of reports on the topic, “Americans have been led to believe–by their doctors, by advertisers and by the pharmaceutical industry–that there is a pill to cure just about anything that ails them.”
In June 2015, the Times reported that the FDA panel’s flibanserin approval recommendation was “driven primarily by recognition that women who could benefit from the drug might be reluctant to take it unless it had regulatory approval.” Some might ask if such a motive (any efficacy, however slight, combined with an apparent desire for the drug among some people) applied to other prospective pharmaceuticals wouldn’t result in a 100 percent approval rate, wholly disregarding adverse effects. The editorial board also opined that the panel’s recommendation was laced with so many caveats that it seems clear that flibanserin is only marginally effective and carries some risk of serious adverse effects.
The Times noted problems in the clinical trials which we hear all too often: “The long-term health risks are largely unknown because the clinical studies were too short to estimate long-term risks.” Other issues were less common, but verged on unconscionable: “A small study of the interaction between alcohol and flibanserin in 25 moderate drinkers found that four suffered severe side effects requiring medical intervention. Incredibly, 23 of the 25 subjects were male and only two were female, so the study did not clearly characterize the risks to women.”
The drug maker’s glib answers to flibanserin safety issues and their flippant disregard for women’s overall, long-term health ought to be firmly denounced and this panel’s cowering recommendation rejected.
(Editor’s Note: Between the time that this article was written and when it was published, the FDA did approve flibanserin which is now sold under the brand name Addyi®.)