Testosterone patch will test FDA's decision making

November 25, 2004

The Food and Drug Administration (FDA) has granted a fast track review of testosterone patches for women with low sex drive, despite concerns about insufficient data and potentially misleading marketing by their manufacturer Proctor & Gamble, claim two articles in this week's BMJ.

The patch is the first drug to be assessed for a controversial condition called hypoactive sexual desire disorder. Proctor & Gamble claims that the patch can increase sexual activity by 74%, which has generated enthusiastic media coverage. It has also urged an international medical society, which it sponsors, to endorse the patch at the FDA regulatory hearing.

But the marketing has caused concern among some sex researchers by failing to state that in absolute terms, the patch may only increase sexual activity by one "episode," or less, per month.

Although an increase of one sexual episode a month may be of value clinically to some women, this is overshadowed by serious doubts about the long term safety of testosterone, say experts.

Rosemary Basson, one of the leading authorities in the field of women's sexual difficulties, says much caution is needed in prescribing testosterone to women. Meanwhile, others have raised serious questions about the disorder because women's sexual "symptoms" may often be healthy adaptive responses and should not be regarded as evidence of dysfunction.

A second article charges media outlets with exaggerating the benefits of the patch in their search for sexy stories.

None of the key clinical trials of Proctor & Gamble's testosterone patch have been published in peer reviewed journals, yet for a year or more excited media reports have sung the praises of the latest panacea for women's "low sex drive," writes author, Ray Moynihan, who recently won an award from the British Medical Journalists' Association, for his BMJ articles on entanglement between doctors and drug companies.

"Given the strong evidence that studies funded by drug companies tend to find more favourable results than independent studies, together with the increasingly common scandals over drug safety and conflicts of interest and the fact that key data on the patch have not yet been peer reviewed and published, the excited media stories tell us much more about their reporters' and editors' lack of interest in journalism than the latest remedy for a lack of interest in sex," he concludes.
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BMJ

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