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November 13, 2003

The Testosterone Gamble

Can American men be rushing into the same reckless use of hormones that brought grief and anxiety to so many unsuspecting women? That disquieting possibility is raised by a new report that laments a huge upsurge in testosterone replacement therapy for men despite a paucity of evidence that it is safe or beneficial. One wonders whether another medical debacle is in the making.

Although hormone therapy is unquestionably effective for counteracting the symptoms of menopause, millions of American women also used it as an anti-aging elixir or to enhance their sexual pleasure, general appearance and sense of well-being. That course of action was shown to be sadly misguided last year when a large clinical trial found that estrogen and progestin, a popular regimen, actually did more harm than good by causing a slight increase in breast cancer, heart attacks, strokes and blood clots. To make matters worse, the presumed benefits soon began to look illusory.

Now it looks as if men could be making a similar mistake. An expert panel assembled by the Institute of Medicine, part of the National Academy of Sciences, warned in a report yesterday that the rapidly growing use of testosterone therapy has outpaced the meager scientific evidence about its benefits and risks. Testosterone therapy has been approved by the Food and Drug Administration only for treating a narrow group of clinical conditions marked by very low testosterone levels, yet doctors have been prescribing it much more widely. Last year more than 800,000 patients, mostly middle-aged men, were treated with testosterone.

There is preliminary evidence from small studies, but nothing close to proof, that testosterone therapy may improve men's sex drive, strength, cognitive function and sense of well-being. There is no compelling evidence of harm, but there are worries that testosterone may increase prostate cancer or cardiovascular problems.

Clearly more studies are needed. The institute's panel urged the government to sponsor small clinical trials with elderly men, the group most likely to benefit, to determine whether testosterone therapy can counteract frailty, weakness, failing memories or the loss of sexual function. Only if testosterone is beneficial in that group would the panel recommend a large-scale trial, which could take many years. Our feeling is that the government should sponsor immediate small trials in middle-aged men as well because they are the primary users. Meanwhile, any baby boomers planning to embark on testosterone therapy to rejuvenate themselves should be aware of the potential pitfalls.

Copyright 2003 The New York Times Company


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