The Hedgehog Review

The Hedgehog Review: Vol. 18 No. 1 (Spring 2016)

Pink Pills and Economic Man

Joseph E. Davis

The Hedgehog Review

The Hedgehog Review: Spring 2016

(Volume 18 | Issue 1)

In his 1982 book Gender, the social critic Ivan Illich made the provocative argument that the prevailing social and economic order, structured as an association of possessive individuals competing for scarce resources (i.e., the Homo economicus of economic theory), creates uniform and interchangeable men and women, who are believed to “perceive the same reality, and have, with some minor cosmetic variations, the same needs.” A system of unhindered economic competition and commodification, he maintained, requires a “genderless sexuality” in which men and women largely say, do, desire, and perceive “the same thing.”

Just such a deep presumption of basic sameness underlay the recent and aggressive political campaign to win Food and Drug Administration (FDA) approval for a drug—now commonly referred to as the “pink pill”—to treat “sexual dysfunction” in women. The pressure campaign, “Even the Score,” was orchestrated by a pharmaceutical company with a lackluster product—flibanserin—but the vigorous support of twenty-six organizations, from the National Organization for Women and the National Council of Women’s Organizations to the Association of Reproductive Health Professionals. The pro−pink pill forces claimed that it was “sexist” that men had drugs to treat sexual dysfunction while women did not. It was high time, they argued, that the FDA level the playing field by approving flibanserin, the availability of which would provide some small restitution for decades of prioritizing “men’s sexual dysfunction…over women’s.” Pressing this demand were members of Congress, 60,000 signatories to a petition, compensated thought leaders from the academy and industry, and powerful lobbyists working on behalf of Even the Score.

All of this activism came to a head at the FDA advisory panel hearings in June 2015, which one dissenting member described as “very high pressure” and “kind of an intimidating environment.” The intimidation worked. The advisory panel recommended approval by a margin of 18−6, and in August 2015 the FDA approved flibanserin to treat “acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.” Within two days of this triumph of genderless sexual “equity,” the owners of Sprout Pharmaceuticals, whose one possession was flibanserin, sold the company for $1 billion and a share of future profits.

The flibanserin story speaks to our age. For many years now, pharmaceutical companies have raced to win FDA approval for a treatment for the “mental disorder” of low or absent sexual desire in women. But contrary to what Even the Score campaigners allege, “women’s sexual dysfunction” has not been overlooked. There is a whole industry of non-pharmaceutical therapeutic interventions, techniques, and training exercises, not to mention at least one FDA-approved apparatus for treating orgasmic difficulties, the Eros-Clitoral Therapy Device. But ever since sildenafil (brand name Viagra), the impotency drug for men, came on the market in 1998, there has been a fierce industry competition to get FDA approval for a pill, a patch, or a cream for women, with a number of competitors entering and exiting the field. The experience with Viagra, widely used recreationally, suggested the potential for a blockbuster.

One of the competitors was testosterone, the male hormone. Another was Viagra. After some eight years of testing Viagra on women, its manufacturer, Pfizer, gave up in 2004, acknowledging that a drug that enhanced blood flow to the pelvic region after sexual stimulation might not induce women to desire sex in the first place. At the time, a professor of clinical medicine at Columbia University made a troubling suggestion: “What we need to do is find a pill for engendering the perception of intimacy.” She seemed serious.

The German pharmaceutical company Boehringer Ingelheim thought it had such a pill in flibanserin. Originally tested in men and women as an antidepressant, the compound proved ineffective and was rejected by the FDA. But unlike most antidepressants, this one did not diminish sexual desire among the drug-trial participants; in fact, female participants scored higher than women on either a placebo or an approved antidepressant when asked “How strong is your sex drive?” Seeing an opportunity, Boehringer repurposed the drug for a different disorder.

In 2010, Boehringer sought FDA approval to market flibanserin, under the brand name Girosa, to treat HSDD. The Diagnostic and Statistical Manual of Mental Disorders defined the condition at that time (it has since been changed) identically for men and women. The key criteria: “A. Persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity. B. The disturbance causes marked distress or interpersonal difficulty.” In an apparent effort to prepare the market for the launch of Girosa, Boehringer also funded an epidemiological study, conducted by researchers with ties to the company, that suggested that 10 percent of women suffered from “desire disorder” (although more than a third of those so labeled suffered from depression, with other problems also present). There were serious profits to be made.

The FDA, however, found Boehringer’s data unimpressive. Two double-blind clinical trials testing flibanserin against a placebo found, in the words of the FDA, that “the treatment effect on [self-reported] desire was neither statistically significant nor clinically meaningful.” Compared with those taking a placebo, women taking the drug reported, on average, less than one additional “satisfying sexual event” per month. Nearly 15 percent of study participants taking flibanserin dropped out because of adverse side effects (compared to 7 percent of those on a placebo). An FDA committee—composed, incidentally, mainly of women—voted unanimously to reject the drug. Boehringer then sold flibanserin to Sprout, which had been formed for the sole purpose of trying again for regulatory approval.

Sprout renamed the drug “Addyi,” sponsored another clinical trial, and approached the FDA in 2013. The new trial showed marginally improved results over those from the two trials conducted in 2010, achieved by shifting the primary endpoints of efficacy on a self-rating scale of questionable validity. Further, as reported in The BMJ, almost all of the named study investigators were Sprout consultants or employees. A public-relations firm helped write up the results. Even then the drug was found to be little better than a placebo. According to the FDA, when findings from the two trials in 2010 and the one in 2013 were combined, “about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements” in at least one of the primary outcomes—“satisfying sexual events,” or “sexual desire,” or “distress.” More than a third of the women in the 2013 study reported side effects. With such weak results, the FDA again demurred. Sprout appealed the decision and, in February 2014, was again denied.

Despite this track record, in August 2015 the FDA officially approved Addyi for HSDD, though with strong safety warnings. What had changed?

Sprout did no further clinical trials. What it presented to the FDA were additional safety data, including a study showing a lack of next-day driving impairments and a study, which, strangely, was done almost entirely with men, showing that interaction with alcohol was responsible for many side effects. But the big new development was political: the Sprout-supported Even the Score campaign. The Sprout cofounders also started spreading money to Democratic PACs, and members of Congress began lobbying the FDA.

The campaign got what it wanted, but what did it get? The letters and the lobbying presupposed, solely on the basis of claims by Boehringer and Sprout, that flibanserin was a “safe and effective medical option for treatment.” The evidence, however, suggests that it is neither safe—especially if the patient does not completely abstain from alcohol and many common medications—nor effective, and that the FDA had acted with good reason in its previous disapprovals.

But as important as the impact on health is the very question of sexual desire, and what is at stake in conceptualizing it as something that can be chemically regulated. The talk of gender bias and parity, couched, paradoxically, in the genderless language of “sexual dysfunction,” obscures this question. In its advocacy at the FDA, Even the Score had insisted that the “score” was twenty-six FDA-approved drugs for men’s dysfunction to zero for women’s. Putting all the drugs in the same register cleverly created the impression of inequity, while also implying that they were equivalent treatments for the same problem. They are not. The drugs for men—basically Viagra-type formulations (PDE5 inhibitors), vasodilators, and testosterone—are not central nervous system agents. Nor are they approved to treat sexual desire disorder. Flibanserin is the first and only member of that class.

Although low sexual desire is allegedly a big problem for men too, medical concern has long focused largely on women. Explanations since the 1990s have been matched to the action of whatever drug was being tested to treat it: a hormone problem, for instance, in the case of testosterone. Flibanserin, a psychiatric drug, regulates levels of the familiar neurotransmitters dopamine and norepinephrine while inducing transient decreases in serotonin in particular areas of the brain. Hence, low desire is now conceived as a neurochemical imbalance. Driving this home, Even the Score defines HSDD as a “persistent biological lack of desire.” It does not claim that the disorder is unique to women.

Talk of a biological lack of desire suggests that there is some normal level of desire in the human body, male and female, and implies that distress might arise directly from this somatic insufficiency. In this view, the pink pill works by mechanistically resetting desire to a more normal level—which also happens to be more in keeping with what is desired—and so the distress disappears. The complex and fundamentally interpersonal nature of sexuality, the differences between men and women, the larger social context of romantic ideals and expectations, standards of comparison, social pressure, and past experience: These issues and more are not so much denied as made irrelevant. Mysteriously, biologically, men and women want, or want to want, “the same thing.”

—Joseph E. Davis

Reprinted from The Hedgehog Review 18.1 (Spring 2016). This essay may not be resold, reprinted, or redistributed for compensation of any kind without prior written permission. Please contact The Hedgehog Review for further details.

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