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HUMAN GROWTH HORMONE BAN SOUGHT BY JEREMY RIFKIN’s

Executive Summary

HUMAN GROWTH HORMONE BAN SOUGHT BY JEREMY RIFKIN's Foundation On Economic Trends in a petition filed with FDA Feb. 6. The environmental activist and rDNA research gadfly is seeking an immediate ban pending further study on a possible link between human growth hormone (HGH) and leukemia. More specifically, the petition requests that FDA rescind approval of the two HGH products currently available in the U.S. -- Genentech's Protropin and Lilly's Humatrope. The foundation urges FDA to investigate "whether and to what extent HGH treatment induces patients to develop leukemia." The group seeks "extensive research into the possible relationships, including particularly any causal relationship, between growth hormone treatment and leukemia for both [growth hormone] deficient and non-GH deficient subjects." The possibility of a contaminant in the growth hormone that may be responsible for the "apparent HGH-leukemia connection" should also be investigated, the petition says. The foundation submitted a formal petition to the National Institutes of Health the same day, seeking an immediate halt of all experimental and other uses of genetically engineered HGH. NIH is administering HGH to 80 children in efficacy tests. One survey underway on the possible adverse effects of the drug is being conducted by the National Institute of Diabetes, Digestive and Kidney Diseases (Endocrine and Metabolic Diseases Program Branch). The study involves gathering data from every U.S. patient who has taken the drug. The Rifkin foundation contends the survey will not be completed for at least another year. The petition is based on 1988 reports of preliminary findings in Japan, Europe and the U.S. of a link between the recombinant product and leukemia. Those findings, the foundation maintains, show that the risks of contracting leukemia within four years of completing HGH treatment are "200% to 300% greater" than among people in the same age group who have not received human growth hormone. However, the findings were examined in an international workshop on growth hormone and leukemia over 18 months ago and it was concluded that current evidence was insufficient to conclude there is a link between the therapy and leukemia. In February 1988, a letter submitted to Lancet by physician Shaw Wantanabe and associates of the Japan National Cancer Center Research Institute and The Leukemia Study Group of the Foundation for Growth Science reported the occurrence of leukemia in five Japanese children treated with human growth hormone for GH deficiency. Subsequently, European Society for Pediatric Endocrinology professor Jean-Claude Job, MD, surveyed GH treatment programs in 17 European countries and discovered six patients who had developed leukemia during or after treatment. The Wantanabe letter appeared in the May 21, 1988 issue of Lancet. The observations led to the convening of a workshop in Bethesda, Maryland in May 1988 by the Lawson Wilkins Pediatric Endocrine Society and the Human Growth Foundation. A report issued by the organizations following the workshop cites "a possible increase of leukemia in GH-deficient patients treated with GH." However, the report adds: "we cannot conclude on the basis of current evidence that GH therapy is responsible for this possible increase." The report recommends that "patients can be told that if there is any increase in risk to individual patients, it is small" and that "all patients receiving GH should have close follow-up during and after therapy."

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