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26 November 2004
FDA To Fast Track Testosterone Patch Review

The British Medical Journal (BMJ) says the FDA has granted a fast track review of testosterone patches for women with low sex drive, despite concerns about insufficient research data and claims of potentially misleading marketing by the manufacturer Proctor & Gamble.

The patch is the first pharmaceutical to be assessed for the condition called hypoactive sexual desire disorder. Proctor & Gamble claim that the patch can increase sexual activity by 74% but this type of 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 some researchers. Rosemary Basson, an expert 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 normal responses and should not be regarded as sexual dysfunction.

Ray Moynihan of the BMJ says that none of the key clinical trials of Proctor & Gamble's testosterone patch have been published in peer reviewed journals. He points out however, that mainstream media reports have been singing the praises of the latest panacea for women's 'low sex drive'. "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increasingly common scandals over drug safety and conflicts of interest and the fact that key data on the patch have not yet been peer reviewed and published, the excited media stories tell us much more about their editors' lack of interest in journalism than the latest remedy for a lack of interest in sex," he concludes.


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