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December 22, 2002

Chasing Youth, Many Gamble on Hormones




Dr. Ron Livesey was fat, tired and out of shape. At 49, he felt that his best years were behind him.


So one day seven years ago, on his way to a medical meeting, he stopped at a doctor's office in Palm Springs, Calif., for his first hormone injections.


Early the next morning, Dr. Livesey was at the meeting, sitting in a darkened auditorium watching slides of technical data. To his surprise, he found himself alert, taking everything in. He continued the hormone treatments.


"People started commenting that I had so much more bounce and energy," he said. He lost 50 pounds ? thanks, he said, to diet changes and exercise made possible by the increased vigor.


So Dr. Livesey, then an internist in New Hampshire, decided to go into business for himself. With a colleague, Dr. Joseph Raffaele, who went on a similar regimen, he founded Anti-Aging Medicine Associates, a clinic in Manhattan. They are part of a growing movement among doctors to offer a hormone replacement therapy that claims to restore the bodies and energy of youth.


Until recently, most scientists considered anti-aging treatments to be little more than snake oil, provided by hucksters. Now, few doubt that growth hormone and testosterone can reshape aging bodies, potentially making them more youthful.


But whether they counteract aging is unknown. And their long-term risks are ill defined. So medical experts ask whether it is right to regard aging as a disease, as fierce as a malignant cancer, to be fought with any and all means, tested or not.


"How much are you willing to pay for a treatment that is not proven?" asked Dr. Huber Warner, an associate director at the National Institute on Aging. "How much risk are you willing to take?"


But Dr. Ronald Klatz of Chicago, the founder and director of the American Academy of Anti-Aging Medicine, says patients cannot wait for long-term studies, which are not even in planning stages and would take years or decades to complete. "We'd have to wait," he said, "until the baby boomers are dead and in the ground and worms' meat."


Clearly, many are not waiting. The academy, which began with 12 doctors in 1993, now has 8,000 physician members in the United States, Dr. Klatz said.


The treatment is expensive: $1,000 a month for the panoply of drugs and dietary supplements, including human growth hormone and testosterone for men and women, estrogen and progesterone for women (the doctors say their "bioidentical" hormones are safe), melatonin, DHEA, vitamins and antioxidants.


The unlikely hero of today's anti-aging movement was Dr. Daniel Rudman, an academic researcher at the Medical College of Wisconsin who asked if he could reverse the effects of aging by giving growth hormone to elderly men.


Aging people, he noted, lose muscle and put on fat, their skin thins and their bones weaken. At the same time, growth hormone levels steadily decline. He observed that the effects of aging also appeared in young people who lacked growth hormone for medical reasons.


So he gave growth hormone to 12 elderly men for six months, reporting that they gained muscle and lost fat. Nine men who served as controls had no such body changes. In his paper, published on July 5, 1990, in The New England Journal of Medicine, Dr. Rudman concluded with this sentence: "The effects of six months of growth hormone on lean body mass and adipose-tissue mass were equivalent in magnitude to the changes incurred during 10 to 20 years of aging."


Dr. Klatz, of the Academy of Anti-Aging Medicine, called the paper "a thunderclap in the medical profession."


"It was the first clinical paper in a mainstream U.S. medical journal to show that there were available interventions that could have a dramatic effect on the physiology of aging," he said.


Human growth hormone has been approved by the Food and Drug Administration for use by people with medical deficiencies, and once a drug is on the market, doctors can legally prescribe it for any reason.


"I was thrilled by the concept," said Dr. Maxine Papadakis of the University of California in San Francisco. But Dr. Papadakis said she worried about the sweeping conclusion about reversing aging. It was a small study, she said, and the men who took part knew who was taking growth hormone and who was not.


Dr. Papadakis set out to test growth hormone in 52 healthy men from 70 to 85. She designed the study so that the men did not know if they were taking the drug or a dummy medication.


Reporting in 1996, she found that growth hormone slightly increased muscle mass and decreased body fat but, paradoxically, did not make the men stronger. People had claimed it improved their mental clarity, but she found no such effects; if anything, those taking growth hormone did slightly worse on memory tests. They also suffered swollen legs and feet and achy joints, making them so uncomfortable that a quarter taking growth hormone had their doses reduced during the study.


Dr. Papadakis said her results were ignored by growth hormone enthusiasts. "They can't let go of the hypothesis because they like it," she said.


Others, like Dr. Warner, worry about animal studies.


"I agree that mice and rats are not people, but mice that don't make growth hormone live longer," Dr. Warner said. "Mice that overproduce growth hormone live shorter lives. The same principle applies in fruit flies and little worms called nematodes. It may be irrelevant, but it makes us wonder."


The next major paper was published on Nov. 13 in The Journal of the American Medical Association. In it, Dr. S. Mitchell Harman of the Kronos Longevity Research Institute in Phoenix and Dr. Marc Blackman of the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health, reported that older men and women taking growth hormone lost fat and gained lean body mass without dieting or exercising. They did not formally assess the subjects' appearance. But Dr. Harman said, "you could see that some of these guys lost a significant amount of pot belly."


On the other hand, many had the same side effects that afflicted Dr. Papadakis's subjects. Although they went away when the subjects stopped taking growth hormone, they gave the investigators pause.


The American Academy of Anti-Aging Medicine said in a statement that the doses used in the study were far too high. Lower doses that reproduce the hormone levels of youth are safe and effective, the group said.


But Dr. Papadakis said those were the levels her study reproduced. "Maybe we don't know the right dose," she said. "But then how can you be giving it to people? Get a grip."


Dr. Livesey and Dr. Raffaele, at the Anti-Aging Medicine clinic in Manhattan, had expected most of their patients to be old people trying to gain enough strength to rise from a chair unassisted, or middle-aged people wanting to look young. Instead, they tend to be baby boomers, the doctors said, who are searching for something that other doctors did not provide.


"By the time they come here, they've already gone to places to look better," Dr. Raffaele said. "They've had the Botox, the plastic surgery. The reason they're here is they want to have a good quality of life." Most keep their visits a secret, he said, adding: "They don't even want to tell their close friends. It's kind of like plastic surgery."


They are like a 50-year-old woman living in New York who arrived at the doctors' anti-aging clinic last February. "I was feeling desperate," said the woman, who did not want to give her name because she is keeping the treatment secret from her friends.


She was depressed, gaining weight, feeling old and fatigued. But, she said, when she began taking growth hormone, estrogen and progesterone, she noticed an immediate change in her mood and energy. It gave her the stamina and enthusiasm to start dieting and working out at a gym and she dropped 10 pounds. She said her libido returned, her hair grew, and even her bunions regressed so she could wear high heels again.


Was it the drugs or the power of suggestion, the diet and exercise or the growth hormone that made the difference? Will she develop a serious disease as a result of taking the drugs or will she enter old age healthy and vigorous, younger than her years?


It is impossible to know, researchers said, and that is why good studies are needed.


"Our concern is that the evidence is mostly based on personal testimonials rather than good data," Dr. Warner said. "It's not hard to get people to believe something works, particularly if they are paying a lot of money for it."


Dr. Alvin Matsumoto, a geriatrician at the Veterans Affairs Puget Sound Health Care System, sounded a similar note of caution.


"For any particular patient, the trick is to determine who is the practitioner who has your best interests at heart. It is hard to distinguish that sometimes."

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