Type the term "human growth hormone" into Google (GOOG ) and the screen immediately fills up with paid ads from Web sites eager to sell the drug as a cure for old age. Human growth hormone (HGH) is approved by the Food & Drug Administration to treat children with growth deficiencies as well as adults with two very specific disorders, but the Web ads make it appear as if HGH can stop the aging process. "Improve overall health by boosting HGH levels," promises one site. "Anti-aging in your own home," screams another.
This hype over HGH disturbs S. Jay Olshansky, professor of epidemiology and biostatistics at the University of Illinois in Chicago. He recently co-wrote a paper, published in the Oct. 26 issue of the Journal of the American Medical Association, describing the distribution of HGH as an anti-aging treatment as both rampant and illegal. The paper cites research estimating that 30% of growth hormone prescriptions in the U.S. are written for non-FDA-approved uses.
Physicians have long been aware that HGH is used illicitly by athletes who believe it helps them to bulk up. But the more recent emergence of the anti-aging market is what most disturbs observers such as Olshansky. "It's incredibly easy to get over the Internet," he says. "I'm sure these anti-aging physicians just want what's best for patients, but it's not legal." Indeed the Food, Drug & Cosmetic Act severely restricts the distribution of HGH.
The synthetic hormone may not be all that effective for adults, either. It's true that the body's natural growth hormone plays an important role, promoting tissue repair, strengthening bones, and stimulating the immune system. Those who tout its powers point out that levels of growth hormone in the body decline with age, and they claim that replacing the hormone with the synthetic version will slow the aging process. But Olshansky says few studies support that claim, and some seem to counter it. In a 2003 study, mice with superhigh levels of growth hormone had significantly shorter lifespans than normal mice.
One of the biotech industry's first products, HGH can do wonders for some children who don't grow normally, but most adults don't qualify for prescriptions. In adults, the drug is approved to treat AIDS wasting syndrome as well as patients who are deficient in growth hormone because of pituitary disorders or other conditions that affect only about 1 in 10,000 adults.
LITANY OF STUDIES.
Some studies in those patients also counteract the legend that the drug builds muscle mass. In a study of 148 patients with adult growth hormone deficiency, most patients experienced only about a 5% increase in lean body mass, and it seemed to disappear after two years.
Growth hormone can touch off scary side effects, too. Some patients have developed diabetes, carpal tunnel syndrome, and edema. Safety concerns, coupled with doubts about the hormone's effectiveness in adults, have spawned a small group of Web sites that aim to debunk HGH wonder-drug claims. Quackwatch.org, run by retired psychiatrist and consumer advocate Dr. Stephen Barrett, has posted an article called "Growth Hormone Scams," which lays out a litany of studies that question the usefulness of HGH in adults.
Still, critics fear that the ready availability of HGH on the Web will lure aging baby boomers to the unproven and potentially unsafe drug, especially since many of the sites advertise themselves as "physician guided." For physicians who follow the FDA's guidance on prescribing HGH, the thought of this biotech product becoming the next lifestyle drug is distressing. "It's misuse," says Mary Lee Vance, an endocrinologist and professor of medicine at the University of Virginia Health System. "I say it's totally wrong."
But for now, off-label use of human growth hormone appears to be a growth industry.
By Arlene Weintraub in New York
Edited by Patricia O'Connell