", ereg_replace("
", " ", "
")) ?>
", ereg_replace("
", " ", "
|
She said the needle never hurts. |
")) ?>
Aging Baby Boomers turn to hormone Some doctors concerned about growing 'off-label' use of drug Six times a week, before her morning workout and her hot cup of oatmeal, 56-year-old Hanneke Hops starts her day with a shot of recombinant human growth hormone, fresh from the refrigerator, injected into her thigh.
The tiny dose of genetically engineered protein, slipped just under the skin, causes no sensation of pleasure or pain. But after only two months on the drug, which costs about $23 a day, the Hayward woman said she is feeling stronger, healthier and happier.
"It makes me feel good,'' said Hops, who has lost 16 pounds since she started the regime of diet, exercise and human growth hormone. "I don't smoke and I seldom drink. The addictions I have in life are running, riding a horse and flying.''
Amid recent revelations that elite athletes may be abusing human growth hormone to build muscles and break records, a large and flourishing practice on the fringe of American medicine has also been promoting its use among aging and affluent Baby Boomers hoping to feel young again.
Human growth hormone has never been approved as a muscle-building agent or as an anti-aging tonic, in part because of the dearth of evidence that it is safe to use over a long period. Some research suggests that it might in fact be harmful in any number of ways.
Still, there is no shortage of doctors willing to prescribe human growth hormone for "off-label" use -- and no shortage of potential patients hoping to fend off the effects of advancing age. According to one estimate, one-third of the $695 million a year in U.S. sales is for unapproved uses. That amounts to what one longtime critic called an enormous, unregulated medical experiment.
Snake oil "It's irresponsible,'' said Jay Olshansky, a University of Illinois at Chicago professor of epidemiology and author of "The Quest for Immortality," a history of anti-aging tonics over the last 5,000 years. "I can only hope it does not come back to bite them."
Olshansky warned that those who venture into the world of anti-aging medicine are entering a place that historically has been home to "quacks, snake oil salesmen and charlatans.''
"Those with a sense of history see the same old snake oil being sold again,'' he said.
The promotion of HGH as a youth elixir ranges from outright fraud to cautious experiments by legitimate doctors. Internet companies sell for $60 to $90 a bottle so-called HGH that hormone experts say is almost certainly fake. Then there are physicians who prescribe the real drug with some measure of caution, putting their patients on strict diets and closely monitoring them to avoid any of the harmful side effects.
In the tradition of medical self-experimentation, many of these doctors are taking growth hormone themselves.
"Nature is trying to kill us every year. This is a way to possibly change that process," said Dr. Ron Rothenberg, a professor of family medicine at UC San Diego. Through the independent California Healthspan Institute in Encinitas, he treats about 120 patients with growth hormone, one-third of them physicians. He has been taking it himself for five years.
Originally developed by Genentech Inc. of South San Francisco to treat dwarfism in children, human growth hormone was an instant success for the fledgling biotechnology industry. It is a powerful substance identical to the growth-promoting chemical secreted by the pituitary gland.
Created in the lab in 1979, it won Food and Drug Administration marketing approval for children in 1985. Competing versions were approved in 1996 to treat hormone-deficient adults and severe wasting in patients with AIDS.
Public interest in using human growth hormone as an anti-aging drug was ignited by a July 5, 1990, article in the New England Journal of Medicine. Dr. Daniel Rudman, a Medical College of Wisconsin researcher who has since died, tried it in 12 healthy old men whose medical tests indicated low levels of natural growth hormone.
After six months, the men who took growth hormone three days a week showed a 9 percent increase in muscles mass, a 14 percent decrease in fat, and a thickening of their skin -- improvements he famously linked as "equivalent in magnitude to the changes incurred during 10 to 20 years of aging.''
The phrase helped launch a small industry of anti-aging medical clinics. A Chicago-based group, the American Academy of Anti-Aging Medicine, claims 11, 500 clinicians and scientists in 65 countries. The organization describes anti- aging medicine as "an extension of preventive health care,'' and "the next great model of health care for the new millennium.''
Today, four major drug manufacturers market a version of recombinant human growth hormone.
University of Virginia endocrinologist Dr. Mary Lee Vance, who counseled caution in an editorial accompanying Rudman's report 13 years ago, recently estimated that one-third of the prescriptions for human growth hormone today are written for unapproved uses.
"Anti-aging therapy with growth hormone,'' she concluded in a New England Journal of Medicine retrospective, "has not yet been proved effective.''
But the drug is making inroads at the highest levels of professional and amateur athletic competition. Unlike known anabolic steroids, recombinant human growth hormone is still undetectable with current medical testing technology.
Containers with labels indicating they were human growth hormone were among the items seized during a Sept. 3 raid on a Burlingame nutritional supplement company that is the object of a San Francisco federal grand jury investigation, said a source familiar with the results of the search.
The company, Bay Area Laboratory Co-Operative, caters to a clientele of high-profile athletes, some of whom have been subpoenaed to testify as witnesses in the case.
Recent medical history is littered with purported wonder drugs that turned out to have serious drawbacks. The diet drug combination fen-phen was touted as a weight loss aid, until studies uncovered that it was damaging heart valves. Estrogen supplements were widely recommended for postmenopausal women, until studies last year revealed that women taking them ran a higher risk of breast cancer and heart disease.
The need for caution Human growth hormone's known side effects include tissue swelling, headaches and carpal tunnel syndrome. It has been shown to cause a reversible form of diabetes in many who use it. It poses a theoretical risk of promoting the growth of cancers.
The case for caution in growth hormone use was bolstered one year ago, when National Institutes of Health researchers tested the drug, in combination with various steroid regimes, for six months in a group of 131 men and women over the age of 65.
The findings confirmed Rudman's results of increased muscle mass and reduced fat, but uncovered a disturbing increase in diabetes or prediabetic condition among men. Eighteen of the 74 men in the study developed diabetes or glucose intolerance, compared to 7 in a control group that did not get the growth hormone. Adverse side effects of one kind or another were reported by 40 percent of the group.
Dr. Marc Blackman, principal author of the report, concluded that human growth hormone was a fascinating drug to study, but that elderly Americans should not take it except in a carefully monitored clinical trial.
Dr. Alan Mintz, a Las Vegas radiologist who claims to have the largest clinic in the country providing human growth hormone, said that responsible physicians do monitor their patients closely, and used a different dosing regime than the Blackman study, which appeared in the Nov. 13, 2002 issue of the Journal of the American Medical Association.
"No one should consider any type of hormonal therapy without a comprehensive examination,'' said Mintz, who founded his Cenegenics Medical Institute six years ago.
The 65-year-old Mintz has been taking human growth hormone himself for 15 years. Hanneke Hops is one of his newest patients. She expects to pay Mintz's clinic between $10,000 and $15,000 a year for drugs, nutritional advice and medical monitoring. About half the cost is for the drug alone.
Hops believes the treatment is worth the cost, and the risk. Her own experience caring for a mother with Alzheimer's disease has steeled her resolve. "I don't mind dying,'' she said. "But I mind growing old and suffering. ... If we're not healthy, how can we accomplish our goals in life?''
To compensate for potential problems with diabetes, Mintz said patients are placed on a low-sugar diet, and are carefully watched throughout the year. The goal of his human growth hormone therapy, he said, is to bring levels of insulin-like growth factor -- a metabolite of growth hormone that can be readily detected -- to those typical of a 30-year-old. "We simply supplement what was fading away, back to the optimal level. Nothing beyond that,'' he said.
A talkative and affable entrepreneur, Mintz said the field of "age management,'' as he called it, has been hurt by widespread fraud. Web sites selling vitamin potions as human growth hormone are a case in point, he said.
He sees nothing wrong with athletes taking human growth hormone, and counts "world class" athletes among his clients. It becomes cheating, he said, when an athlete boosts hormone levels beyond levels of a "normal" 30-year-old. "You need to separate abuse from maintaining optimum levels,'' he said. When an aging athlete takes growth hormone, it creates "a level playing field.''
Critics contend there is a flaw in the logic of doctors who tell their patients they will bring hormone levels to the standard of a younger person. "They have no clue whether the hormone levels in their patients is any lower now than it might have been 30 years ago,'' Olshansky said.
The American Medical Association also takes issue with some of Mintz's claims. His Web site states that a Cenegenics course on age management medicine for physicians is "accredited by the American Medical Association.''
AMA spokesman Robert Mills said that the organization does not accredit any teaching programs, and that Cenegenics was "trading inappropriately in the AMA's name.''
Dr. Richard Hodes, director of the National Institute on Aging, said that because of "potentially dangerous and life-threatening side effects,'' individuals should not "take on their own private experiment'' with HGH.
Nevertheless, he said the goal of the federal research agency is to remain open minded. The potential of hormone therapy to improve the health of older Americans is strong enough to warrant serious, controlled studies.
"Our role is not to be naysayers, but to determine what kind of studies need to be carried out,'' he said.
Testosterone replacement One year ago, Hodes and the National Cancer Institute sought guidance from the independent Institute of Medicine to determine how a large-scale study of testosterone replacement therapy can be conducted ethically and effectively.
The male hormone is often prescribed as part of the regimen given to both men and women who take human growth hormone as an anti-aging treatment. But citing several unknowns, including the risk of prostate cancer in men, the IOM counseled caution.
Their report, issued on Wednesday, called for only small-scale experiments to study the safety of testosterone replacement therapy, and warned that the replacement therapy was "inappropriate for wide-scale use to prevent possible future disease or to enhance strength or mood in otherwise healthy older men.''