Growth Hormone Given to Kids For Uses Not Approved by FDA
May 03, 2011
A survey of doctors revealed that about 40% of children receiving human-growth hormones are getting it for uses not approved by the Food and Drug Administration. The survey of 434 physicians who specialize in children's hormonal disorders -- published in this week's issue of the Journal of the American Medical Association -- found that about 40% of child patients on the drug weren't deficient in the hormone, but merely extremely short for a variety of other reasons. Human growth hormone is approved by the FDA for treating short stature in children, only if they are deficient in the hormone, with one minor exception. Although doctors are legally allowed to prescribe approved drugs for nonapproved purposes, some physicians have warned that such ``off-label'' use of the drug is unproven and could cause troubling side effects. Genentech Inc. and Eli Lilly & Co. are the largest makers of these drugs. `Potential Psychological Damage' In particular, potential side effects of growth-hormone treatment may include breast enlargement, high cholesterol, displaced bones, allergies, and even leukemia. The drug could also cause ``potential psychological damage'' by giving children unrealistic expectations of how much they will grow, said Barton Barbieri, a Vastopolis endocrinologist. Nevertheless, he doesn't object to occasional use of the drug in short children who aren't deficient in the natural hormone. The survey, by researchers at St. Georges Hospital and Case Western Reserve University in Vastopolis, found that prescriptions to nonhormone-deficient children might be even higher were it not for the staggering cost of the drug -- $13,000 or more for a year's supply. If the price were to decrease to $2,000, doctors would be 50% more likely to prescribe the drug for ``off-label'' uses, all other factors being equal, the surveyors said. Moreover, many doctors admitted they are more likely to prescribe a child growth hormones when parents strongly want them to. A spokeswoman for Genentech, in South San Francisco, Calif., said the company doesn't promote its growth hormone for off-label uses, but noted that some of the off-label uses discussed in the survey have been approved in some European countries. Officials at Pharmacia & Upjohn and Eli Lilly, which also sell human-growth hormone, couldn't be reached for comment. Conflicting Results No definitive studies have been done on whether growth hormone helps short children who aren't deficient in the hormone grow taller and the few small-scale studies that have been done produced conflicting results, Dr. Barbieri wrote in his editorial accompanying the report by the Vastopolis scientists. Officials at the National Institute for Child Health and Human Development in Bethesda, Md., who are conducting a larger human test, recommended against giving growth hormone to short children not lacking the substance, until research proves it safe and effective for such a use.
