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Concerns rise as more men use hormone therapy

Testosterone replacement has become popular as a way to restore vigor, but experts worry about long-term risks.

November 03, 2003|Sally Lehrman | Special to The Times

Many men, as they move into middle age, yearn for the same muscular strength, sexual energy and sense of well-being they had in their youth.

That's why millions of American males are asking their doctors for testosterone replacement therapy, or TRT, to treat a collection of symptoms that some doctors and drug companies have dubbed andropause, or male menopause.

The popularity of TRT is creating concern among scientists, who can't agree on whether andropause is a real phenomenon or not. Some believe that the complaints of older men, such as decreased libido, depression and fatigue, are more likely explained by poor habits in diet, sleep and exercise.

Even as the debate continues, many family physicians and specialists are prescribing the drug. U.S. sales of testosterone replacement drugs have jumped more than fourfold in the last three years, to an estimated $425 million in 2003, according to Wells Fargo Securities. And industry experts predict that the market will continue to climb, perhaps by more than a third, in 2004.

Many men's health specialists, however, worry that testosterone replacement may offer little benefit and may lead to more severe medical problems in the future. Their concerns are heightened by the experience of millions of women, who for years took hormone replacement therapy, or HRT, in the belief that it would protect against age-related disease. Recent studies have shown that HRT actually increases women's risk of heart disease and breast cancer, and many doctors no longer advise it.

A report in 2000 by the American Assn. of Clinical Endocrinologists found that nine out of 10 endocrinologists surveyed were worried about possible misuse of TRT. Doctors interviewed for this story said they were especially concerned by evidence suggesting that testosterone might stimulate prostate cancer and raise the risk of heart disease and strokes. Dr. Shalender Bhasin, an endocrinologist at the Charles R. Drew University of Medicine and Science in Los Angeles, believes it is premature for doctors to recommend TRT to older men reporting age-related symptoms, even if their testosterone levels are low.

Bhasin is one of four specialists who proposed a major government study on testosterone's risks and benefits three years ago. In 2000, hormone sales soared after the introduction of Unimed Pharmaceuticals' Androgel product, a testosterone gel that is rubbed on the skin. "It occurred to me this was a big tsunami ... not a trivial event," Bhasin said.

A clinical trial to assess the risks and benefits of TRT was initially endorsed by a National Institutes of Health panel, Bhasin said, but officials decided to postpone the project until a group of experts could further study the issue.

The NIH asked the Institute of Medicine, which advises the government and nonprofits on health policy issues, to create a task force to review existing data about testosterone replacement in men 65 and older and either recommend a plan for one or more clinical trials or suggest other options that might not include a clinical study. "One of the concerns was the risk for prostate cancer,'' said Evan Hadley, a geriatrics expert at the National Institute on Aging. The Institute of Medicine is scheduled to release its report next week.

Physicians sometimes recommend testosterone supplementation when a man's hormone level falls below 350 nanograms per deciliter, or the lower range of normal, although they don't always agree on the level at which treatment is needed. For many years, men had to go to a doctor's office to get regular shots. Then a skin patch became available, but it often caused skin irritation. Androgel, which can be rubbed on the skin each day, went on the market in February 2000. The Food and Drug Administration approved another gel, Testi, in October 2002. And, in June, the FDA approved a gum-like substance that can be pressed inside one's cheek to release testosterone all day.

While some doctors believe it is likely that the benefits of TRT outweigh the risks, others are concerned that thousands of American men already have embarked on risky experiments reminiscent of the HRT experience with women. Six million American women took estrogen and progestin on the advice of doctors who were convinced by small- and medium-size studies that the treatment could protect hearts, improve bone density and sharpen thinking. But in July 2002, investigators suddenly halted a major clinical trial of HRT, the Women's Health Initiative, because of an increased risk of heart disease, strokes and breast cancer. Since then, the evidence that HRT could do anything more than ease menopausal symptoms has steadily unraveled.

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