Healthy Skepticism Library item: 18679

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Publication type: news

Moynihan R
Sex drugs for women don't seem to be working
ABC News 2010 Sep 1
http://www.abc.net.au/unleashed/stories/s2998870.htm

Full text:

If you’re getting a little tired of stories about the hunt for the pink Viagra, you’re not alone. A succession of drug companies and their paid consultants continue to tout the wonders of the latest experimental pill or patch, and some in the media continue to dutifully report there’s a sexual panacea for women just around the corner. But as usual, the gap between the inebriated marketing hype and the sober reality is a vast chasm.

First up was Viagra, with early positive findings generating enormous excitement. One small study found the pill appeared to help women’s lubrication and blood flow, and improve problems of desire, arousal, pain and orgasm. On the basis of this and similar findings, some of Pfizer’s more enthusiastic sales representatives began spruiking the benefits of Viagra for women, long before it had even been assessed for approval for such a use. Some of the promotional techniques proved rather unorthodox, with a whistleblower later alleging that one top-selling sales representative in the United States used to take his doctors to strip clubs. Those specific claims formed part of an historic legal case against Pfizer, which saw the company maintain near blanket denials of all allegations against it, but at the same time agree to settle with US health authorities last year to the tune of $US2.3 billion.

Sadly though, once bigger clinical trials were conducted, the evidence didn’t look quite so promising, and a key study in 2002 found Viagra was unable to significantly beat the placebo, or dummy pill. It apparently helped genital blood flow, as it did with men, but it was not improving the way women perceived their sex lives, any more than a placebo could. Importantly, on a particular dose, around a third of women got flushing and headaches, and one in five experienced “abnormal vision”. By early 2004, Pfizer announced it was pulling Viagra out of the race to be the first female sex drug.

By that time, another unproven aphrodisiac was being mercilessly hyped up, including by esteemed media outlets such as BBC and New Scientist. Reports suggested an experimental testosterone patch could deliver a “74 per cent increase” in satisfying sex for the one in 10 women claimed to have low libido, or hypoactive sexual desire disorder (HSDD). But the truth about the potential risks and benefits of that drug would emerge at a dramatic public hearing of the powerful United States Food and Drug Administration (FDA) in late 2004, an extraordinary day in the recent history of sexual medicine, covered in meticulous detail in Sex, Lies and Pharmaceuticals.

One side effect of all the hype about female sex drugs has been the increasing media attention given to a group called the New View, a loose global network of feminist academics and clinicians, who are offering a very different conception of women’s sexual problems. Rather than an “insufficiency” of blood flow, or a “deficiency” of testosterone to be fixed with pills and patches, the New View, and its co-founder Dr Leonore Tiefer, see sexual difficulties as due to a complex web of personal, social, cultural and sometimes medical reasons, often derived from relationship issues rather than individual dysfunctions. With characteristic humour Tiefer had given a speech not long before the 2004 FDA meeting, entitled ‘Not tonight, dear, the dog ate my testosterone patch.’

‘Not tonight, dear, the dog ate my testosterone patch.’

Click forward to 2010, and this time round it was a drug affecting brain chemicals which was coming to the rescue of tens of millions of women suffering in silence with an apparent disorder of low desire. The German pharmaceutical company Boehringer Ingelheim – a private firm with 40,000 employees across the globe – was developing a medicine called flibanserin. A chemical that affects the neurotransmitters in the brain, including serotonin, flibanserin originally failed as an anti-depressant, before being resuscitated as a possible remedy for reduced libido, or HSDD.

In the lead up to the all important assessment by advisers to the FDA in June this year, the drug company unleashed a major multimedia campaign to raise awareness about HSDD, with company-linked researchers claiming women’s sexuality was now understood to be “more about the brain” than anything else. The company enlisted public relations firms, co-funded a major film documentary on desire, and hired a former Playboy model turned television celebrity to promote the idea of enormous “unmet need” for the treatment of HSDD. In Australia, it kindly funded a love-in for sexperts in Sydney, offering them up to $1,000 each to attend. As part of the television blitz in the US, one high-profile researcher revealed breathlessly that HSDD affected “about 30 per cent” of women.

But as with testosterone and Viagra, this failed anti-depressant didn’t seem to have the right stuff. Staff inside the FDA released a withering assessment of the company’s scientific data, finding the drug had simply failed to beat placebo on the pre-agreed measures of success. At best, compared with the dummy pill, the medicine might offer women an extra 0.7 “satisfying sexual events” per month. And weighed against that purported benefit, were worrying side effects including nausea, dizziness, fainting, and accidental injury. Advisers to the FDA rejected the drug.

The problem for the pharmaceutical industry is that their products simply haven’t so far been able to beat the pesky placebo in any meaningful way – raising serious questions about whether the women enrolled in these company-funded trials really have a medical disorder at all. But rather than work with the placebo, as is revealed in Sex, Lies and Pharmaceuticals, one of the current campaigns by some high profile sex researchers is to try and change the rules for the way drugs are tested, to make it easier for them to beat the dummy pills, and get new drugs on the market. And once a sex drug for women is approved in the United States, no matter how modest its benefits, or serious its risks, the tsunami of advertising behind both the drug and the “disease” will wash over the shores of nations everywhere.

With more pills in the pipeline, the hype about widespread sexual disorders is far from over, though with every successive promotional wave, the industry’s marketing techniques become a little clearer. And as we’ll discover, there is a growing impatience about the unhealthy impacts of pharmaceutical industry influence in medicine, and a growing mood for a major clean up.

The first article in this three-part series, The merging of marketing and medical science, was published on Monday. Part three will be published on Friday.