Kids and Health Care: Shortness
In 2003, the U.S. Food and Drug Administration approved use of a synthetic human growth hormone -- specifically, Eli Lilly and Co.'s Humatrope -- for children with "idiopathic short stature." That means kids who are just short, not because of any underlying disease. Humatrope had been proved to help short children grow into slightly less-short adults.
The decision meant that as many as 400,000 children could get medication for a problem that wasn't quite an illness...but something closer to a personal obstacle or point of social prejudice.
Extreme short stature -- defined as 4' 1" for a boy or girl age 10 and less than 4' 11" for an adult woman or 5' 3" for an adult man -- is not a disease. But it is often one symptom of an underlying medical disorder, such as Turner's syndrome (which affects girls and women), chronic kidney failure, malnutrition or any of several genetic development disorders. In 1997, the FDA added "growth hormone deficiency" to the list of medical conditions that can cause extreme short stature, and for which the use of Humatrope was government approved.
Like the FDA's handling of drugs that treat shyness, impotence or depression, the growth hormone decision took the agency into some dicey political and ethical grounds. Drug companies had made the business decision in the 1990s to pursue lifestyle drugs, which modify conditions that aren't necessarily life-threatening. In order to get these drugs approved by the Feds, the drug companies spent heavily to arrange the testimony of people who either had been (in pre-approval testing) or would be helped by the drugs.
This changed the dynamic of the drug approval process, which had traditionally been very clinical. With drugs like Humatrope, it was hard to show -- scientifically -- that the benefits were significant; the actual inches that it added to most people's height weren't so many. Instead, the review process became more like a congressional hearing -- with emotional testimony from people about how much the drugs had improved their lives.
The decision to use a drug like Humatrope is yet another example of something that must be done on a case-by-case basis. The FDA's decision was important because it meant, in most cases, insurance companies would pay for hormone therapy for short kids. Parents should realize that it's not a miracle pill to produce super tall kids. And years of treatment might draw them just inside the range of "normal height" but you have to consider all the costs and potential side-effects. Another reason to get multiple opinions from doctors beforehand.
