FDA advisers consider whether healthy children can take growth hormone
Tuesday, June 10th 2003, 12:00 am
By: News On 6
WASHINGTON (AP) _ A drug company sought government permission Tuesday for a controversial practice: injecting growth hormone into very short but otherwise healthy children, in hopes of increasing their adult height by roughly 2 inches.
It's a highly charged issue: Is it appropriate to give years of drug injections to children not diagnosed with an actual height-harming disease? Or would it open the floodgates to normal kids just yearning for an extra few inches?
Growth hormone is not to augment growth of normal-height children, but would be restricted to the abnormally short, Eli Lilly & Co. stressed to a panel of government advisers convened to debate the issue. Lilly's cutoff would be boys predicted to be shorter than 5-feet, 3-inches as adults and girls shorter than 4-feet-11.
One doctor showed a picture of 7-year-old twins, one more than a foot shorter than his brother. Because doctors can't find a disease to explain his short stature, today the shorter twin isn't eligible for growth hormone.
``It is in fact unfair to not offer such treatment'' to him when children just as short because of certain growth-stunting diseases can take it, said Dr. Raymond Hinz of Stanford University Medical Center, a Lilly consultant.
But lots of disease-free short children see their growth catch up over time, and studies suggesting growth hormone makes them significantly taller are too few to believe _ tracking only dozens of children to final adult height, said Dr. Harvey Guyda, a pediatric endocrinologist at Canada's McGill University.
``Short stature is not a medical diagnosis,'' he argued.
One key for the Food and Drug Administration's decision is if the increased inches are meaningful in some medical or psychosocial way.
``Is there a need for growth-enhancing therapy in such children?'' FDA endocrinology chief Dr. David Orloff asked the panel of independent scientists advising the agency.
The FDA has long cracked down on cosmetic use of growth hormone. In the 1990s, it won a $50 million settlement with another manufacturer, Genentech Inc., for improperly promoting cosmetic and other uses of its brand.
So Lilly's application for its brand, Humatrope, to be a formally designated treatment for a broader group of children is proving something of a dilemma as the FDA tries to decide which if any might be appropriate candidates.
Some 200,000 children around the world have taken growth hormone since it began selling in the mid-1980s, Lilly estimates. The FDA has approved it to treat children who lack proper growth hormone levels and those whose growth is stunted for a few other reasons, chronic kidney insufficiency and two rare genetic syndromes.
Guyda estimated that 10,000 U.S. children also are getting it for some other reason.
In a study that gave otherwise healthy but extremely short children growth hormone or a dummy shot three times a week for, on average, four years, Humatrope recipients were 1.5 inches taller in adulthood, Lilly reported Tuesday. A second study comparing dosage levels found a higher dose given six times a week let children grow 2.8 inches taller.