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November 29, 2002

Hormones now a men's issue
Testosterone may pose risks, but many like results

By Judy Peres
Tribune staff reporter

Now that science has concluded that the long-term risks of hormone replacement outweigh the benefits for postmenopausal women, men may get their day.

A task force led by the prestigious Institute of Medicine and supported by the National Institute on Aging will evaluate the feasibility of conducting clinical trials of testosterone replacement in older men.

The idea of convening a panel of experts arose in part because of growing concern that men are taking testosterone supplements to boost their energy and libido, despite the absence of solid evidence of the risks and benefits.

"Many, many older men are starting to use testosterone," said Dr. Mitchell Harman, director of the Kronos Longevity Research Institute in Phoenix. "But we don't know anything worth knowing about testosterone in healthy, aging men."

Boston marketing executive Bob Mattioli knows this much: He feels terrific since he started taking testosterone and wouldn't want to give it up.

Mattioli, 54, has been on hormone replacement since 1999, when he noticed that his energy was flagging, he felt stressed out, and he found it difficult to get interested in sex. The drug made a huge difference in his life.

"My libido improved, my energy level is way up, and my workouts became extremely productive--I started converting fat to muscle," Mattioli said. His concentration and memory also got better: "I can stay focused on a big project without having to go back over my notes all the time."

Steve Kelly, 56, who owns a Houston-area production company, says testosterone has rejuvenated him in similar ways. Equally important, it has rejuvenated his marriage.

Kelly and his wife, Mimi, 57, had thought it was just age and stress that made Kelly gradually lose his sex drive and his zest for life after turning 50. But when a blood test showed his testosterone was way below normal, Kelly went on AndroGel, a testosterone cream he rubs into his shoulders after his morning shower.

"Within 30 days," said Kelly, "there was a significant increase in energy level and sharpness of mind. I was thinking and reacting quicker. And my libido was coming back up."

That was 18 months ago, Kelly said, and things have only gotten better: "My self-confidence has returned. I've lost 20 pounds. I feel healthier. I just love life again."

Mimi Kelly says she's "tickled to death" by the changes in her husband: "I feel like I'm in a new romance."

When she returned home from a recent trip to Italy with a girlfriend, she said, "there were roses and perfume and candles lit."

Starting in a man's 20s, testosterone levels decline naturally by about 1 percent per year. Lower levels are associated with physical changes, such as more fat and less muscle, and with decreases in sexual and cognitive function, among other things.

Numerous small studies have suggested that testosterone can improve body composition, bone density, interest in sex and, perhaps, energy, muscle strength, memory and well-being. So, when young men suffer from below-normal testosterone levels, doctors agree they should receive a hormone supplement.

But in older men, the normal decline in hormone levels is not necessarily associated with symptoms. What's more, there are concerns that topping up testosterone could increase the risk of prostate cancer, strokes and heart attacks. Those concerns are at least partly responsible for the fact that no large-scale, long-term study of testosterone replacement has been conducted until now in healthy men with low testosterone.

In women, hormone replacement therapy (typically a combination of synthetic estrogen and progesterone) was long believed to prevent heart disease. But a large random trial by the government-sponsored Women's Health Initiative reported in July that HRT actually increases the risk of heart attacks and strokes, as well as breast cancer, in healthy women.

Since then, most doctors are steering women away from HRT, except for the short-term treatment of menopausal symptoms.

Supplements popular

For men, there is no such clarity. And yet, increasing numbers of men are getting prescriptions for testosterone and taking over-the-counter supplements such as andro (androstenedione) and DHEA (dehydroepiandrosterone), which also increase testosterone levels.

Testosterone is approved by the federal Food and Drug Administration to treat hypogonadism, an abnormally low level of the sex steroid hormone. But some doctors prescribe it "off label" for both men and women whose hormone levels may have declined but remain within normal range.

So, in many instances, testosterone has gone from a drug used to treat a medical condition to one used to help people feel better or younger.

The market for testosterone products has risen from $49 million in 1997 to $216 million last year, according to IMS Health, which tracks prescription drugs sales nationwide. "And I don't think that's because there's an epidemic of hypogonadism," said Dr. Alvin Matsumoto, a gerontologist at the University of Washington and the Veterans Administration Puget Sound Health Care System in Seattle.

Experts believe much of the increase has been driven by the fact that the hormone can now be delivered in the form of skin patches and creams. Another factor is that aging Baby Boomers have come to believe they are entitled to look and feel young indefinitely.

"People think they should still feel like they did when they were 16," said Dr. Michael McGuire, a urologist at Evanston Northwestern Healthcare. "The problem is, we know prostate cancer is stimulated by testosterone. That's why we need a study."

In the absence of good data, McGuire said, "people need to be very cautious." He won't prescribe testosterone unless the patient has a demonstrably low level of the hormone in his blood, and tests rule out any prostate problems. Even then, said McGuire, "the patient has to understand the risks and agree to be followed up at least every six months."

Now men, like women, may learn exactly how dangerous--or beneficial--it is to boost their flagging hormone levels.

The Institute of Medicine, part of the National Academy of Sciences, is setting up a task force that will include prominent epidemiologists, endocrinologists, urologists and oncologists. The panel will spend a year assessing what is known about testosterone replacement and will make recommendations about the design, safety and ethics of conducting clinical trials of hormone replacement in older men.

`Let's get this right'

"Because of the questions with women and HRT, the [government] is saying, `Let's get this right from the beginning,'" said Dr. Adrian Dobs, an endocrinologist at Johns Hopkins.

Harman and Matsumoto believe the ethical issue can be easily settled by ensuring that every participant give informed consent and by close monitoring for prostate cancer.

Added Matsumoto: "It's almost unethical not to do the study soon."

According to Dr. Laurence Levine, professor of urology at Rush-Presbyterian-St. Luke's Medical Center, "There's no evidence whatsoever that testosterone causes prostate cancer." But the hormone may fuel the growth of pre-existing cancers.

He agrees that men with enlarged prostates and those with prostate or breast cancer should never take testosterone. But for others, who have low testosterone levels and who complain of poor energy, lack of sexual desire, loss of bone density or muscle mass--"doesn't it make sense to give back the hormone they're missing?"

Levine says colleagues sometimes accuse him of trying to stop the normal aging process.

He dismisses such criticism: "If you take the attitude that we're all going to die, and we shouldn't do anything to interfere with that process, then we shouldn't be treating heart disease or arthritis either. So much of medicine is about improving quality of life."

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