HUMAN GROWTH HORMONE SCHEDULING

HUMAN GROWTH HORMONE SCHEDULING: Genentech is proposing that Congress apply a narrowly drawn criminal statute to limit HGH marketing in lieu of a Justice Department proposal to define human growth hormone as an anabolic steroid and require criminal restrictions on its illegitimate use. In an Aug. 22 letter to Senate Judiciary Committee Chairman Biden (D-Del.), the company said it supports "efforts at preventing the abuse of growth hormone for non-medical purposes . . . In our view, this is possible by crafting a narrowly drawn criminal statute to bar the sale of HGH for illegitimate purposes." The letter refers to proposed legislation, recently forwarded to Congress by the Department of Justice, mandating that human growth hormone be defined as an "anabolic steroid" under the FD&C Act and the Anti-Drug Abuse Act of 1988. According to Genentech, the net effect of the statutes "makes it a crime to distribute, or possess with the intent to distribute, any anabolic steroid for any human use other than the treatment of a disease pursuant to a physician's order." Under the proposal, HGH would be regulated with criminal force equal to anabolic steroids. The proposed legislation was introduced in the House (HR 995) Feb. 9 by Rep. Stark (D-Cal.) and in the Senate (S 466) by Biden on Feb. 28. The House Judiciary Committee held a hearing on the issue on March 22. The legislation is also pending before the Senate Judiciary Committee. Genentech objects to defining HGH as a steroid on medical and scientific grounds: "The two substances are quite different, and the differences should produce different legal and regulatory consequences," the firm stated. The letter points out that Genentech's Protropin (somatrem), approved by FDA as a treatment for children with endogenous growth hormone deficiency, "is the first line drug therapy for these children, whereas, anabolic steroids are not the first drug of choice in treating any condition for which they have been approved." Furthermore, Genentech anticipates that "if the Justice Department definition is mechanically adopted, it could have the effect of promoting the scheduling of HGH at the federal and state levels." The Senate committee is reportedly considering an amendment to list anabolic steroids as a Schedule II drug under the Controlled Substances Act. Genentech contended there are several differences between HGH and steroids: "1) there is firm evidence of extensive actual abuse of steroids, while evidence of HGH abuse is almost totally anecdotal; 2) the manufacturers of HGH have voluntarily imposed strict controls on its distribution . . . while there are no such controls on steroids; 3) HGH is much more expensive than steroids, which seriously limits the potential for abuse of HGH; 4) HGH has not been shown by any valid scientific study to benefit athletes, while the medical consensus is that steroids can be of significant value to some athletes; 5) steroids, unlike HGH, are easy for criminals to synthesize; and 6) some steroids are available in easily abused oral formulations, but HGH must be injected." In a July 10 letter to Vice President Quayle accompanying its proposed bill, the Justice Department notes that its definition of anabolic steroids would include HGH. The proposed legislation, the department said, "adds to the [steroids] definition the synthetic growth hormone substances, somatropin [Lilly's Humatrope] and somatrem, which while chemically not anabolic steroids, are widely used by athletes and others as though they were 'anabolic steroids'." The letter states, "it is clear that the proposed language would cover both human growth hormones and synthetic fragments of such hormones which might be developed which retain growth promoting effects." Justice explained that "without a definition [of anabolic steroids], the government may be obligated to present scientific evidence on a case by case basis that the drug involved is an anabolic steroid." The letter adds that such an "evidentiary burden" may have a "significant effect" on the department's ability to combat "the growing steroid abuse problem facing the nation."