Jeremy Rifkin's Foundation on Economic Trends and thePhysician's Committee for Responsible Medicine have filed alawsuit in Federal District Court to halt clinical trials of humangrowth hormone in children.

The groups charge that the National Institutes of Health-sponsored trials "are a gross violation of federal regulationsprotecting children, and violate all traditional ethical normscontrolling the use of children in research."

Last Oct. 2, the NIH's Human Growth Hormone Protocol ReviewCommittee released a confidential analysis of the ethics andrisks of the trials to NIH Director Bernadine Healy. Sheannounced on June 24 that the studies would continue.

The Foundation charges that the studies have no medical value,and that the sole purpose of the NIH research on children is totest whether the drug increases height.

Joseph Mendelson, the Foundation's attorney, told BioWorldthat the studies violate regulations of the Department of Healthand Human Services (HHS) on "Protection of Children asSubjects in Research." According to the Physician's Committeereport: "All children enrolled in the study receive injectionsthree times a week, some for up to seven years. The committeedetermined that it is reasonable to consider this a greater thanminimal risk."

But Melvin Grumbach, chairman of the NIH committee and apediatrician at the University of California, San Francisco, toldBioWorld that the Foundation had presented the report in amisleading manner, that "there are pros and cons (to theresearch), but the pros far outweigh the cons," and that the NIHcommittee's report was unanimous.

Jim Weiss a spokesman for Genentech Inc., which manufacturesthe growth hormone with Eli Lilly and Co., said that 14,000patients "have been monitored through our NationalCooperative Growth Study since the drug was launched in1985," most of these for five years.

"There has been no cause for safety concerns," he added. --David C. Holzman

(c) 1997 American Health Consultants. All rights reserved.