WASHINGTON, Oct 25, 2005 (UPI via COMTEX) -- A team of researchers reported Tuesday that a little known law passed by Congress more than 15 years ago makes off-label use of human growth hormone illegal, which if true invalidates the increasing practice of prescribing the drug for reversing aging and other unsupported claims.
Since 1990, the distribution of human growth hormone, or HGH, as an anti-aging elixir has grown to a multi-million-dollar industry in the United States. Many Web sites offer the drug under the contention it will lower cholesterol, reduce wrinkles, improve mental function and provide other benefits.
"The irony is hundreds of thousands of patients have been administered growth hormone at longevity clinics across the (country) not knowing they've been receiving it illegally," study co-author Jay Olshansky, professor of epidemiology at the University of Illinois at Chicago School of Public Health, told United Press International.
In addition, "the physicians and clinicians who have been administering it to their patients under off-label use have been doing so illegally," Olshansky said.
HGH, a substance found naturally in the body that stimulates growth in children, is approved by the Food and Drug Administration for the treatment of kids who are short due to an HGH deficiency, adults who have developed tumors on their pituitary gland that causes an HGH deficiency, and HIV/AIDS patients who have muscle-wasting disease.
The concern of Olshansky's team, which published the findings in the Oct. 26 issue of the Journal of the American Medical Association, is that rather than an elixir of youth, the substance actually may be dangerous when used in healthy people.
Initial clinical trials conducted indicate HGH might cause significant problems, including diabetes, carpel tunnel syndrome and an elevated risk of cancer, he said. In what could be the greatest irony of all for those taking the compound as an anti-aging remedy, animal studies suggest it actually may shorten lifespan, he added.
It has yet to be studied in significant long-term trials to determine whether it actually has anti-aging properties.
"Maybe there is a place for growth hormone in the future to influence age-related problems, but we won't know that until the clinical trials are conducted," he said.
Olshansky's team, which included Dr. Thomas Perls, director of the New England Centenarian Study at Boston Medical Center, initiated an effort more than three years ago to inform those in the HGH industry of the legal issues pertaining to the practice of dispensing the drug for reversing aging.
Unexpectedly, the researchers stumbled across language in modifications of the Food, Drug and Cosmetic Act in 1988 and 1990 that forbid the use of HGH for those reasons.
"They basically put in language that made it crystal clear that it is illegal to use growth hormone as an anti-aging intervention," Olshansky said.
The language states that, "Whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services ... is guilty of an offense punishable by not more than 5 years in prison." In addition, the law provides for fines.
The finding was so shocking that the experts who reviewed the article for accuracy before it was published "didn't believe it at first," Olshansky said. "One of them actually said, 'This can't be right.'"
He said the lawyers at JAMA reviewed the Congressional language and agreed it made off-label use of growth hormone illegal. In addition, his team informed the Food and Drug Administration, which agreed the use of the drug as an anti-aging treatment was not allowed.
"We are also concerned with the improper distribution of HGH products," Steven Silverman, director of FDA's Division of New Drugs and Labeling Compliance, responded in a letter to Olshansky's team.
Silverman said the FDA has been actively enforcing the provision since it was enacted, and the agency has sent letters to several companies dispensing HGH over the Internet as an anti-aging treatment, warning them they are in violation. He also noted HGH can cause serious side effects, including bone and joint problems, worsening diabetes and increasing cholesterol levels and blood pressure.
The warning letters may not always be effective, however. The FDA sent a letter in 2002 to the owner of two Web sites -- affordablehgh.com and buyhghdirect.com -- which were dispensing HGH as an anti-aging treatment.
Affordablehgh.com has stopped offering the drug, but it provides a link to another site where the drug can be obtained from a supplier in China, and the buyhghdirect.com appears to be run by the same Chinese supplier, and offers to send HGH "directly to your door."
Olshansky said he expects the Drug Enforcement Administration to become more involved.
"Once this article is published, my guess is the DEA ... is likely to take a much more active role," he said.
Another example of a Web site offering HGH is HGH-Pro.com, in North Hills, Calif., which calls it an "age-defying restorative" and adds, "HGH therapy has been shown to turn back the biological clock by 20 years or more."
Hgh-pro.com did not return a phone call from UPI requesting comment.
Yet another Web site, run by a company called Palm Beach Life Extension in Palm Beach Gardens, Fla., claims it provides "FDA approved prescriptions" from "board certified doctors." The site claims HGH has been shown to reverse the effect of aging, increase lean-muscle mass, reduce body fat and enhance sexual performance, among other benefits.
All such claims are bogus and a violation of the 1990 law, according to the FDA.
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