The approval of ‘female Viagra’ is nothing short of a disaster

This article was originally published in the Spectator, and can be found here.

Last week, the United States’ Food and Drug Administration (FDA) approved the first ever drug targeted to enhance libido in women. Media outlets churned out adoring articles; the licensing of flibanserin, or ‘female Viagra’ as it rapidly became known, was hailed as a medical breakthrough.

It was a political victory too. The BBC described the result as a triumph for women’s rights campaigners who had finally convinced the FDA to overturn their ‘gender bias’. While men had been popping ‘vitamin V’ for 17 years, women were at last embarking on the road to equality with a pill of their own.

Yet despite the celebrations, the licensing of flibanserin was nothing short of a disaster for evidence-based medicine and health care ethics.

Last week wasn’t the first time the FDA had reached a decision on flibanserin. The agency had previously considered the drug as an antidepressant in 2006, but it had been rejected after evidence failed to prove that it benefited patients. Four years later the drug was considered again, this time as a treatment for ‘hypoactive sexual desire disorder’. Again it was rejected on the grounds of poor efficacy.

Clinical trials showed that on average, patients who took the drug once a day for 24 weeks experienced an increase of 2.5 ‘satisfying sexual events’ per month. Considering a placebo increased the number by 1.5, the results were far from revolutionary. Almost 10 per cent of patients pulled out of the trial as a result of the medication’s side effects, which were the reason behind the drug’s rejection a third time in 2013. Flibanserin was neither adequately effective nor safe enough to warrant the FDA’s approval.

So what changed? As far as scientists were concerned, very little — no major new evidence had been published. Meanwhile, the drug’s manufacturer had begun to fund a well-orchestrated campaign designed to whip up a storm of social justice activism. Women’s right to ‘sexual desire’, claimed the Even the Score campaign, was being neglected at the hands of an unfair licensing process. Before long, flibanserin was in the headlines again; the FDA was due to review the drug a fourth time.

Yet this time the issue had gone national. Officials at the FDA were under enormous pressure to reverse their decision. In some circles, to even suggest that you agreed with the FDA’s original verdict meant you were a misogynist. The campaign culminated in an FDA advisory committee voting 18-6 in favour of approving the drug, and it was licensed soon after.

The FDA’s rethink alarmed a number of scientists. Wasn’t the organisation supposed to endorse evidence-based medicine? Wasn’t its very existence designed to protect patients in the face of lobbying from pharmaceutical companies and politically motivated campaigns? Adriane Fugh-Berman, Associate Professor of Pharmacology at Georgetown University, called it ‘a sad day in drug regulatory history’.

The FDA’s apparent inability to withstand a social justice campaign group isn’t the only problem with flibanserin’s licensing. The case also raises an equally concerning challenge to medical ethics. The drug’s targeting of reduced libido is a worrying step in the medicalisation of everyday life.

Fears were raised in a paper published in the Journal of Medical Ethics, which described how the pharmaceutical industry had begun ‘inventing diseases’ to create a market for their products. Suspicions began when academics estimated that almost a third of women met the diagnostic criteria for ‘hypoactive sexual desire disorder’, the condition for which flibanserin was repurposed to treat. With such a large proportion of women being labelled as hypoactive, questions should surely be raised about what level of sexual activity is deemed to be normal and, more importantly, what level is deemed unhealthy.

Indeed, many women who’ve experienced a reduced interest in sexual activity have already condemned the FDA’s decision, warning that it risks ‘misdiagnosis and mistreatment’ of people whose behaviour results from an entirely natural variation. It’s remarkable; less than 50 years after doctors reneged on the classification of homosexuality as a mental disorder, drug licensing bodies are incessantly campaigning to pathologise sexual diversity of another kind. The medical community has again failed to recognise that not all variation in sexual behaviour necessitates a psychiatric diagnosis.

Many of these concerns were largely sidelined by a predominant narrative about gender inequality. However, greater analysis reveals that the apparent inequity between sexual dysfunction drugs for men and women isn’t as it first appears. Viagra, for instance, treats a physical sexual dysfunction, by increasing blood flow to the genitalia. In contrast, flibanserin targets the vaguer concept of sexual desire, and does so via its psychoactive effects in the brain. No treatment for ‘sexual desire’ had been licensed for either men or women before flibanserin.

Most frustrating is that these misplaced accusations of inequality distract from the real injustices women face in healthcare. Cynthia Pearson is the executive director of the United States’s National Women’s Health Network, an organisation which campaigns for gender equality. Currently it is working towards greater inclusion of women in clinical trials amid fears that medical research neglects women’s health. When I spoke to her, she decried the ‘inaccurate information’ that had been circulated about flibanserin, and has previously expressed resentment at how a legitimate sense of injustice had been ‘misused’ by the drug’s advocates.

The five-year battle over the licensing of flibanserin reveals some worrying truths. Not only has the public’s acceptance of the drug revealed a growing medicalisation of our society, but the enlistment of social justice movements as a means of lobbying licensing bodies has reduced evidence-based medicine to whimsical populism. Gone are the days when pharmaceutical companies had to provide robust scientific evidence and face ethical scrutiny before their drugs were licensed. Today, an angry mob suffices instead.

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