Newswise — Although the use of growth hormone (hGH) by athletes and entertainers makes headlines, the illegal distribution of hGH continues to be big business for distributors who market to the public for unapproved indications such as anti-aging, body building and athletic enhancement, say researchers from the University of Illinois at Chicago and Boston University School of Medicine.

The commentary appears in the June 18 issue of JAMA.

"Attention needs to be focused not on the end user -- such as baseball players and entertainers -- but on the distributors," said S. Jay Olshansky, co-author of the article and professor of epidemiology at the UIC School of Public Health.

"The distributors of hGH are almost entirely practitioners of anti-aging medicine," Olshansky said. "This is a far greater issue and concern than the one associated with the use of growth hormone for sports, body building and muscle enhancement. Our concern is with the health of the people who have been misled to believe that this hormone has anti-aging or athletic enhancing properties."

The authors, whose previous article in JAMA in 2005 warned that the off-label distribution or provision of human growth hormone to treat aging or age-associated illnesses is illegal in the United States, find that the practice of anti-aging clinics and compounding pharmacies to aggressively market growth hormone for off-label use has only grown worse.

Clinical evidence does support the therapeutic use of hGH for children and adults with certain rare diseases. The effectiveness demonstrated in these rare, approved conditions cannot be translated into effectiveness among healthy aging adults -- a deceptive assertion that, the authors say, is often made by proponents of hGH use for a wide range of panacea-like benefits.

Despite "overwhelming" evidence that the risks and dangers of growth hormone far outweigh any benefit in normally aging individuals, "the prescribing, distribution and sale of hGH for alleged anti-aging aesthetic and athletic enhancement has dramatically grown over the past few years," said Dr. Thomas Perls, coauthor of the article, director of the New England Centenarian Study and associate professor of medicine at Boston University School of Medicine. "Clearly, the coordinated and aggressive marketing campaigns of the anti-aging and age-management industries are highly -- and most unfortunately -- effective."

Contrary to published claims, neither long-term safety nor health benefits have been demonstrated in normally aging individuals taking hGH, according to the authors.

A review of clinical studies among healthy, normally aging individuals found that hGH supplementation does not significantly increase muscle strength or aerobic exercise capacity. However, adverse effects have been documented, including soft tissue swelling, joint pains, carpal tunnel-like syndrome, enlarged breasts, and insulin resistance with an elevated risk of developing diabetes. Animal and laboratory studies suggest an increased cancer risk.

The authors suggest several measures to address the inappropriate distribution and use of hGH:

"¢ The public must be accurately informed by physicians and scientists who do not have a vested interest in hGH, about health risks, fraudulent marketing and illegal distribution of the drug.

"¢ Those organizations accredited to offer continuing medical education that promote or profit from inappropriate and illegal distribution of hGH should, at a minimum, have their accreditation revoked.

"¢ U.S. manufacturers of hGH must be held accountable for controlling the distribution of the drug to companies providing the drug for illegal uses.

"¢ Congressional hearings and media attention surrounding hGH should focus less on user-athletes and more on the distributors who are violating federal and state laws by marketing the drug for non-approved uses.

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JAMA (18-Jun-2008)