Experts: Testosterone Not Proven Safe for Wide-Scale Use
Study Shows Drug Inappropriate to Prevent Future Disease or Enhance Strength
By Marc Kaufman
Washington Post Staff Writer
Wednesday, November 12, 2003; 1:08 PM
The widely used male hormone testosterone has not been shown to be either safe or beneficial for the many men who use it to improve their strength and mood, an expert panel of doctors concluded today.
In a major report from the congressionally chartered Institute of Medicine, the panel said that while the drug, which has been approved by the Food and Drug Administration, can be useful for men who suffer from a particular medical condition, it is "inappropriate for wide-scale use to prevent possible future disease or to enhance strength or mood in otherwise healthy older men."
Testosterone, used by more than 800,000 men last year, has become a popular prescription drug for men who believe it can help them build up their muscles, improve their thinking, increase their libido and slow the aging process.
But the IOM review concluded that there is insufficient research to know whether it provides any of those benefits to otherwise healthy men or to gauge the seriousness of known increased risks of prostate cancer and blood-clotting.
"For men whose testosterone is already in the normal range, there is no proof that it makes them better in any way," said panel member Deborah Grady of the University of California, San Francisco. "If there is no proven benefit for them, they shouldn't be taking testosterone no matter what the risk. And here there is a possible problem with prostate cancer."
While women have a sudden decrease in the production of the female sex hormone estrogen during menopause, most men experience a gradual tapering off in testosterone production that begins in their forties and continues at about a 1 percent a year. That decline, called andropause by some, is the subject of heated medical debate, with some researchers saying that it is predictable and normal while others say it is associated with a number of diseases and conditions that can be kept at bay by taking additional testosterone.
The FDA has approved testosterone use only for hypogonadism, a usually disease-based condition that results in the production of insufficient amounts of testosterone in the testes. But the year-long IOM study concluded that a significant majority of the more than 1.75 million testosterone prescriptions written in 2002 were for men who did not suffer from the condition.
The sharp increase in testosterone use since 1999 is to some extent a function of the newly developed and approved ways to administer the drug. While testosterone used to be given by monthly injections, men can now receive the hormone from a patch or a gel. Because of the way testosterone behaves in the body, it is not given as pills in this country.
The panel, which had been asked to review the testosterone issue by the National Institutes of Health's Institute on Aging and National Cancer Institute, recommended that a series of studies be undertaken to determine whether the hormone can help older men cope with some of the predictable conditions of aging. It did not recommend that the studies include younger men because they were expected to receive less benefit for the same risks.
Gabrielle Braswell, spokeswoman for Solvay Pharmaceuticals, which makes the testosterone product Androgel, said the company is pleased by the IOM recommendation for more study and did not quarrel with the panel's statement of concern about broad testosterone use. "We believe it is appropriate to use (Androgel) for the conditions approved by the FDA," she said.
At several points in its report, the IOM panel referred to the recent turnaround by researchers and doctors regarding the usefulness and safety of estrogen therapy for post-menopausal women. While the drug had been widely recommended to reduce the physical discomforts that can accompany menopause and to potentially improve the long-term health of women, a major federal study found last year that the risks of estrogen outweighed the limited benefits. As a result, usage has plummeted.
But even as the medical consensus was changing sharply on estrogen, men were increasingly asking doctors for prescriptions of testosterone. The IOM study reported that the number of patients taking testosterone more than doubled between 1999 and 2002, and the number of prescriptions almost tripled. Panel Chairman Dan G. Blazer of Duke University Medical Center said the number of men taking the drug has continued to increase sharply, with more than 2 million prescriptions expected this year.
Some of the increase has been driven by aggressive advertising, much of which holds out the hope of precisely the kind of benefits that the IOM report said had not been confirmed by rigorous clinical trials. On the Web site for the market-leader Androgel, for instance, the company asks: "Fatigued? Depressed Mood? Low Sex Drive? Could be your testosterone is running on empty."
Panel chairman Blazer said that his group was not urging that doctors stop prescribing testosterone off-label to otherwise healthy men. He said that doctors and their patients need to "be thinking more carefully about its use," given the absence of clear information on the drug's benefits and risks.
William Hazzard, a professor at the University of Washington School of Medicine, said the testosterone issue is becoming increasingly important because of the aging of the "baby boom" generation. "We're concerned that a population-based drive to increase testosterone use could be trumping science at this instance," he said.
© 2003 The Washington Post Company
Study Shows Drug Inappropriate to Prevent Future Disease or Enhance Strength
By Marc Kaufman
Washington Post Staff Writer
Wednesday, November 12, 2003; 1:08 PM
The widely used male hormone testosterone has not been shown to be either safe or beneficial for the many men who use it to improve their strength and mood, an expert panel of doctors concluded today.
In a major report from the congressionally chartered Institute of Medicine, the panel said that while the drug, which has been approved by the Food and Drug Administration, can be useful for men who suffer from a particular medical condition, it is "inappropriate for wide-scale use to prevent possible future disease or to enhance strength or mood in otherwise healthy older men."
Testosterone, used by more than 800,000 men last year, has become a popular prescription drug for men who believe it can help them build up their muscles, improve their thinking, increase their libido and slow the aging process.
But the IOM review concluded that there is insufficient research to know whether it provides any of those benefits to otherwise healthy men or to gauge the seriousness of known increased risks of prostate cancer and blood-clotting.
"For men whose testosterone is already in the normal range, there is no proof that it makes them better in any way," said panel member Deborah Grady of the University of California, San Francisco. "If there is no proven benefit for them, they shouldn't be taking testosterone no matter what the risk. And here there is a possible problem with prostate cancer."
While women have a sudden decrease in the production of the female sex hormone estrogen during menopause, most men experience a gradual tapering off in testosterone production that begins in their forties and continues at about a 1 percent a year. That decline, called andropause by some, is the subject of heated medical debate, with some researchers saying that it is predictable and normal while others say it is associated with a number of diseases and conditions that can be kept at bay by taking additional testosterone.
The FDA has approved testosterone use only for hypogonadism, a usually disease-based condition that results in the production of insufficient amounts of testosterone in the testes. But the year-long IOM study concluded that a significant majority of the more than 1.75 million testosterone prescriptions written in 2002 were for men who did not suffer from the condition.
The sharp increase in testosterone use since 1999 is to some extent a function of the newly developed and approved ways to administer the drug. While testosterone used to be given by monthly injections, men can now receive the hormone from a patch or a gel. Because of the way testosterone behaves in the body, it is not given as pills in this country.
The panel, which had been asked to review the testosterone issue by the National Institutes of Health's Institute on Aging and National Cancer Institute, recommended that a series of studies be undertaken to determine whether the hormone can help older men cope with some of the predictable conditions of aging. It did not recommend that the studies include younger men because they were expected to receive less benefit for the same risks.
Gabrielle Braswell, spokeswoman for Solvay Pharmaceuticals, which makes the testosterone product Androgel, said the company is pleased by the IOM recommendation for more study and did not quarrel with the panel's statement of concern about broad testosterone use. "We believe it is appropriate to use (Androgel) for the conditions approved by the FDA," she said.
At several points in its report, the IOM panel referred to the recent turnaround by researchers and doctors regarding the usefulness and safety of estrogen therapy for post-menopausal women. While the drug had been widely recommended to reduce the physical discomforts that can accompany menopause and to potentially improve the long-term health of women, a major federal study found last year that the risks of estrogen outweighed the limited benefits. As a result, usage has plummeted.
But even as the medical consensus was changing sharply on estrogen, men were increasingly asking doctors for prescriptions of testosterone. The IOM study reported that the number of patients taking testosterone more than doubled between 1999 and 2002, and the number of prescriptions almost tripled. Panel Chairman Dan G. Blazer of Duke University Medical Center said the number of men taking the drug has continued to increase sharply, with more than 2 million prescriptions expected this year.
Some of the increase has been driven by aggressive advertising, much of which holds out the hope of precisely the kind of benefits that the IOM report said had not been confirmed by rigorous clinical trials. On the Web site for the market-leader Androgel, for instance, the company asks: "Fatigued? Depressed Mood? Low Sex Drive? Could be your testosterone is running on empty."
Panel chairman Blazer said that his group was not urging that doctors stop prescribing testosterone off-label to otherwise healthy men. He said that doctors and their patients need to "be thinking more carefully about its use," given the absence of clear information on the drug's benefits and risks.
William Hazzard, a professor at the University of Washington School of Medicine, said the testosterone issue is becoming increasingly important because of the aging of the "baby boom" generation. "We're concerned that a population-based drive to increase testosterone use could be trumping science at this instance," he said.
© 2003 The Washington Post Company
