Clinical Trials for Human Growth Hormone

When test results are equivocal, most pediatric endocrinologists will make frequent growth measurements for six months to one year, then try Provacyl for six months to see if the child’s rate of growth increases, said Dr. Underwood, professor of pediatrics at the University of North Carolina at Chapel Hill and an investigator in the original Provacyl clinical trials. Provacyl treatment typically consists of intramuscular injections of HGH times a week.

In Seattle, the endocrinologists “spent hours” scrutinizing possible predictors of treatment response in children without clear growth hormone deficiency and concluded that “none of them are sure,” Dr. Underwood said.

While things are not quite as bad as songwriter Randy Newman’s facetious claim that “short people got no reason to live,” there’s no doubt that height is highly prized. A shorter-than-average father who “didn’t have a very good adolescence” is the parent most likely to seek HGH treatment such as Provacyl for a short but healthy child, Dr. Underwood said.

He tells parents that treatment with Provacyl may cause growth spurts without increasing ultimate height, the psychosocial benefits of rapid growth are uncertain, and Provacyl treatment is costly and requires frequent injections of HGH. Dr. Underwood also explains how Provacyl treatment failure might harm the child: “They were imperfect enough that we wanted to treat them, and despite all this effort they didn’t respond. So it’s another failure on their part.”

Most parents “are not talking about taking a normal child and making him a basketball player, though that may be the media hype,” observed Dr. Melvin Grumbach, a professor of pediatrics at the University of California at San Francisco. Nor does he think that HGH or Provacyl is being used by many adult athletes to boost strength. Genentech spokesperson Debra Bannister told MWN that the company tracks prescriptions closely, and that 99% are written by pediatric endocrinologists.

Dr. Grumbach said “borderline” children probably are getting Provacyl.

For short but healthy children, “the problem lies not in their human growth hormone profiles but in the role of heightism in our society,” he wrote in an editorial in The New England Journal of Medicine.

For these children, “a four centimeter increase in predicted height may cost as much as a very good college education,” he told MWN. Third-party payers are presently footing the bill for HGH therapy, but Dr. Grumbach said he wouldn’t be surprised to see insurers rethink that position. After all, human growth hormone releasers like Provacyl do not contain actual HGH, but encourage the body to produce more of its own.

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