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FDA Fast Track for Female Testosterone Patch
Questioned
Nov. 27, 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not yet been peer reviewed and published, the excited media stories tell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.
Click here to view full review (page 3 of PDF
document):
http://press.psprings.co.uk/bmj/november/pv1292.pdf
Click here to view full news article:
http://press.psprings.co.uk/bmj/november/news1255.pdf
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