Newswise — Because of 1988 and 1990 amendments to the Food, Drug and Cosmetic Act, off-label distribution or provision of human growth hormone to treat aging or age-associated illnesses is illegal in the United States, according to a report in the Journal of the American Medical Association.
The findings, which were peer-reviewed by independent experts and by the journal's legal counsel, appear in the Oct. 26 issue.
A team of three noted health researchers revealed a largely unknown and unenforced law that thousands of entrepreneurs and physicians are breaking. The authors are Dr. Thomas Perls, director of the New England Centenarian Study at Boston Medical Center and associate professor of medicine at Boston University School of Medicine; Dr. Neal Reisman, clinical professor of plastic surgery at Baylor College of Medicine and associate chief of plastic surgery at St. Luke's Episcopal Hospital, who is also an attorney; and S. Jay Olshansky, professor of epidemiology at the University of Illinois at Chicago School of Public Health.
Human growth hormone, or HGH, is a substance released by the pituitary gland that spurs growth and development in children and adolescents. As a drug, it can be prescribed legally only for three rare conditions: HGH deficiency-related syndromes that cause short stature in children, adult HGH deficiency due to rare pituitary tumors and their treatment, and muscle-wasting disease associated with HIV/AIDS. According to the U.S. Food and Drug Administration, any and all other uses of the drug, including the off-label use as an alleged treatment for aging and its related conditions, are illegal.
But many Web sites and anti-aging clinics market HGH with claims that the hormone stops and reverses aging and provides many other benefits, including improved nail and hair growth, better sleep, improved skin tone, better digestion, increased strength, weight loss, better eyesight and enhanced sexual function.
"Prescribing and administering HGH has become a routine intervention in an industry that is variably called anti-aging, regenerative, longevity or age management medicine," said Perls. "Hundreds of thousands of patients who have received HGH in recent years as a purported treatment for aging are unaware that they are receiving the drug illegally.
"Although there is no evidence that HGH administration stops or reverses aging, many people spend a great deal of money on these products," Perls said. "On the contrary, responsibly conducted and peer-reviewed science indicates that HGH could in fact accelerate aging and shorten lifespan. It is associated with very high rates of serious adverse effects, and long-term use could increase one's risk of cancer."
According to Olshansky, "off-label use for many drugs is a normal and accepted practice in medicine, but that is not true for growth hormone. According to laws instituted by Congress more than 10 years ago, HGH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services, and aging and its related disorders are not among them. The use of HGH as an alleged anti-aging intervention is a major public health concern not just because it is illegal, but also because its provision for anti-aging is not supported by science and it is potentially harmful."
Despite the fact that the vast majority of HGH prescriptions should be for children, 74 percent of HGH prescriptions in 2004 were for people 20 and older, and 44 percent were for people 40 to 59. Sales of HGH in 2004 totaled $622 million (almost 213,000 prescriptions) not including sales via anti-aging Web sites. "These data suggest that a very large proportion of HGH sales are for illegal uses," said Perls.
HGH is also distributed through the Internet, often at a high cost and in some cases without physician supervision, according to the researchers. Various forms of HGH -- ranging from pills to sprays to injectables -- are sold to consumers at a cost of $200 to $1,000 per month. One Web site alone was estimated by the Federal Trade Commission to have generated more than $70 million in sales of pills and sprays purported to contain HGH or to stimulate its production.
"Millions of dollars in profits are made off of useless pills and sprays like these," Perls said. "Pills with HGH are destroyed in the stomach, and because the molecule is too large to enter the blood stream via sublingual and nasal sprays, such products have absolutely no biological effect. You might as well be paying hundreds of dollars for sand and water."
"In 1988 and again in 1990, the [Food, Drug and Cosmetic Act] enacted very stringent controls with substantial penalties involving the distribution of HGH," said Reisman.
Despite the fact that HGH is not a Schedule III drug, like, for example, anabolic steroids, Congress specifically authorized the Drug Enforcement Agency to investigate offenses related to HGH distribution.
"Hopefully our paper will raise awareness of the legal issues surrounding the improper distribution, marketing, and provision of HGH and discourage this criminal practice," Reisman said.
Copies of letters to Perls from the FDA and FDA warning letters to Web sites regarding the illegality of HGH provision and distribution for anti-aging can be viewed along with other documentation at www.bumc.bu.edu/centenarian
For more information about UIC visit http://www.uic.edu
For more information about the Baylor College of Medicine visit http://www.bcm.edu
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