Sci. Aging Knowl. Environ., 2 November 2005
Prescribing growth hormone to fight aging is illegal
The nightly news might not show handcuffed doctors marching off to jail any time soon. But the widespread use of growth hormone (GH) to fight aging breaks the law, warns a group of researchers--plus it relies on shaky science.
Everyone agrees on one thing about GH: Its output peaks during puberty and then gradually declines. A 70-year-old manufactures only about half as much of the hormone as does a 20-year-old. The controversy concerns whether ramping up GH in seniors curbs the infirmities of aging. Some people aren't waiting for the evidence. A 1990 study showing that older men who received GH injections gained muscle mass and lost fat helped set off a hormone gold rush (see "Growing Pains"). Many doctors and clinics now offer GH as an "antiaging" panacea, claiming that it tones muscle, trims fat, sharpens thinking, and provides other benefits. Moreover, the Web teems with sites peddling GH or an assortment of sprays and pills purported to boost the hormone's production.
Nobody knows how much of the GH sold in the United States goes toward so-called antiaging therapies. To get a rough idea, geriatrician Thomas Perls of Boston Medical Center and colleagues consulted a company that tracks prescriptions. You'd expect that children with growth abnormalities would receive the bulk of the hormone, Perls says. But patients who were more than 19 years old garnered 74% of GH prescriptions. Adults rarely need the hormone, which suggests that most of them are receiving it for illegitimate purposes, Perls says. Given that a month's worth of GH injections can run $1000, that's a lucrative market.
It's also illegal. The law permits doctors to prescribe medicines for conditions not covered by the original Food and Drug Administration (FDA) approval, what's known as off-label use. However, Perls and colleagues note, stricter regulations that forbid off-label use govern GH and anabolic steroids. Under the 1988 and 1990 amendments to the Food, Drug, and Cosmetic Act, doctors can prescribe GH to adults for only two conditions: muscle deterioration due to AIDS and chronically low GH levels. The latter condition afflicts only around 1 in 10,000 adults and is not synonymous with age-related GH decline, says Perls. What's more, he adds, GH doesn't qualify as a dietary supplement, as some advocates argue. "There's no way around that it's illegal," he says. Doctors who prescribe GH to counteract the effects of aging risk 5 years in prison and a $250,000 fine.
And there's no evidence it benefits normal oldsters, Perls says. No trials have shown that long-term GH treatment increases muscle strength or delays aging. Animal studies suggest the opposite: Mice deficient in GH live longer than normal. Moreover, GH can incite side effects such as carpal tunnel syndrome, and it might promote cancer (see "Strong Muscles, Strong Tumors?"). Perls and colleagues urge doctors to stop prescribing GH for nonapproved conditions and call for federal and state law enforcement agencies to crack down on illegal GH distribution.
The paper reinforces the view that until we know more about GH's effectiveness and safety, doctors shouldn't prescribe it for healthy seniors, says endocrinologist Marc Blackman of the National Center for Complementary and Alternative Medicine in Bethesda, Maryland. FDA, the Federal Trade Commission, and pharmaceutical companies need to work together to educate doctors and the public about GH and to stop illegal sales, says endocrinologist Mary Lee Vance of the University of Virginia Medical Center in Charlottesville. The article also highlights how little we know about why GH quantities plummet with age, says endocrinologist William Sonntag of Wake Forest University School of Medicine in Winston-Salem, North Carolina. Answering that question might provide a way for doctors to battle aging without breaking the law.
November 2, 2005
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Science of Aging Knowledge Environment. ISSN 1539-6150