June 20, 2006

CNN Program on Use of Growth Hormone for Normal Small Children

Since testifying against the approval of growth hormone (GH) for small normal children at an FDA hearing three years ago, additional information confirming the concerns we expressed is now available:

Significant increase in prescriptions since FDA approved GH for use in small normal children

In the months preceding the approval in the summer of 2003, an average of about 10,000 prescriptions a month (120,000 per year) were being filled in the United States. Now, three years later, the number of prescriptions per month has climbed to almost 16,500 or about 200,000 prescriptions per year.  This accounts for a greater than 60% increase in prescribing.

Continuing lack of evidence of a psychological benefit in to GH therapy in otherwise normal short children

Several studies have now found that individuals with short stature are largely indistinguishable from their peers, whether in childhood, adolescence or adulthood. Buffalo New York Psychologist Dr. David Sanborn found that a child’s stature had “minimal detectable impact” on their social standing among schoolmates.

There is no new evidence diminishing the safety concerns of GH

In addition to the need for almost daily injections of this drug (hundreds a year)   for several years, there are persistent concerns about rare but health-threatening pseudotumor cerebri, a condition caused by increased pressure in the brain due to the drug. Symptoms include headache, nausea, vomiting and, in some cases, diminished vision. Because the condition mimics many of the symptoms of a brain tumor-even though it is clearly not a brain tumor – the children need to be carefully evaluated to make sure they are actually suffering from pseudotumor cerebri. There are also abnormalities in sugar metabolism and some possible skeletal abnormalities associated with GH.

No new evidence finds average GH stimulation of growth to exceed 1 ½ to 2 inches

British Pediatrician DG Gill, in an eloquent review of ethical, medical and economic arguments against treating small normal children with growth hormone, wrote, “Does making small normal children bigger also make them better?  There is no evidence that there is a psychological benefit to GH therapy in otherwise normal short children.”[1]

Who can define how big is big enough? Who can say with certainty when smallness becomes a disability? I have always been fond of the simple wisdom contained in this little poem:

I met a little Elfman once
Down where the lilies blow
I asked him why he was so small
And why he did not grow.
He slightly frowned and with his eyes
He looked me through and through
‘‘I’m big enough for me’’ he said
‘‘As you are big for you’’. (JK Bangs)

---