- The Washington Times - Wednesday, November 12, 2003

ASSOCIATED PRESS

Tens of thousands of aging men are trying testosterone shots, patches and gel in hopes of regaining youthful vigor and virility. A new report uncovers little evidence that it works — or that the therapy is even safe — but recommends careful study to find out.

“Certainly there are people out there who say testosterone replacement therapy is just wonderful, and others who say it doesn’t do any good at all. What we’re saying is we just don’t know,” said Dr. Dan Blazer of Duke University Medical Center, who led an Institute of Medicine probe of the therapy.

The report spotlights a huge area of contention: the claim that because testosterone levels slowly drop with age, men undergo a male version of menopause — dubbed andropause by some doctors and drug companies — that requires treatment.

Many doctors don’t agree that andropause is a real phenomenon. Nor is there evidence that symptoms many older men report — such as decreased libido, frailty and fatigue — really are connected to testosterone when they could be inevitable consequences of aging, Dr. Blazer said.

Demand for prescription testosterone treatment by middle-age and older men whose natural hormone levels are near normal is rising rapidly, the study found. More than 1.75 million prescriptions for testosterone products were written in 2002 — a 170 percent increase from 1999 — for an estimated 800,000 patients.

The Food and Drug Administration has approved testosterone therapy for men with hypogonadism, where the body makes little testosterone. An estimated 4 million to 5 million Americans have hypogonadism, but only about 5 percent are thought to be getting treatment.

That means a lot of men using testosterone are in a gray zone.

Specialists hope the report’s recommendations will help avoid the confusion that has plagued menopausal women, who once considered hormone replacement therapy a rite of passage until a major study declared that treatment too risky.

To determine how it should study the male hormone question, the National Institutes of Health asked the independent Institute of Medicine — which advises the government on scientific issues — to analyze just how much is known about testosterone therapy in older men.

Not much, concludes the report, released yesterday.

Only a few studies have been conducted, all small and lasting only months. That is far too little information to tell if testosterone offers any benefit to men who aren’t markedly deficient in the hormone — much less if it’s safe, concluded a panel of specialists in hormones and men’s health.

The chief safety concern is that boosting testosterone levels for long periods could spur the growth of prostate cancer, already a big risk as men age.

The NIH will do some sort of testosterone research, and hopes to begin studies by 2005, said Dr. Richard Hodes, director of NIH’s National Institute on Aging.

The goal is to get good science fast enough to avoid a repeat of the widespread hormone confusion that women have faced, Dr. Hodes said. In the meantime, testosterone use isn’t justified except for the relatively few men with severe deficiencies, he cautioned.


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