January 30, 2003 (USA TODAY) -- A task force of prominent scientists from a variety of specialties will meet Thursday in Washington, D.C., to begin reviewing whether testosterone replacement therapy in older men should be studied in a clinical trial.
Testosterone production in men peaks in adolescence and early adulthood. While it declines with age, it almost never shuts down the way estrogen production does in women going through menopause.
Although testosterone replacement therapy has never been studied in a large clinical trial, increasing numbers of older men have been using it. More than 1 million prescriptions for testosterone products were written in 2001. Proponents regard testosterone supplementation as a virtual fountain of youth, capable of restoring sex drives and increasing energy, even though there is little scientific evidence to back up these claims.
And it's not known whether testosterone supplements might increase the risk of certain diseases, such as prostate cancer or stroke, two leading killers of men. For that reason, the National Institutes of Health last summer decided not to proceed with a large-scale clinical trial of testosterone supplements.
The testosterone situation is somewhat akin to that of estrogen supplementation in postmenopausal women. For decades, doctors prescribed estrogen to older women in the belief that it would protect them from the diseases of aging. But when scientists finally began testing that belief a few years ago, they discovered that the hormone combination of estrogen plus progestin actually increased the risk of some ailments. As a result, the number of women taking postmenopausal hormones has dropped dramatically.
The testosterone task force, led by the Institute of Medicine and supported by the National Institute on Aging, includes Elizabeth Barrett-Connor of the University of California-San Diego, and Deborah Grady of the University of California-San Francisco, two leading postmenopausal hormone researchers. Other members include Baruch Brody, who directs the medical ethics center at Houston's Baylor College of Medicine and cardiologist Robert Califf, director of the Duke Clinical Research Unit in Durham, N.C. The committee chairman is Dan Blazer, a professor of psychiatry and behavioral sciences at Duke.
At Thursday's meeting, task force members will hear presentations by Richard Hodes, director of the National Institute on Aging, as well as several other top scientists at the institute. Glenn Cunningham of the Baylor College of Medicine, one of the scientists who proposed the large-scale trial of testosterone replacement therapy, will present an overview of it.
Committee members will discuss such issues as how many men use testosterone replacement therapy, and the risks and benefits. In November, the task force will issue a final report with recommendations on how to design and conduct a large-scale clinical trial of testosterone replacement therapy and whether such a trial is needed.
Copyright 2003 USA TODAY, a division of Gannett Co. Inc.
