AIDS TREATMENT NEWS Issue #210, November 4, 1994
John S. James
According to a leading treatment activist working on this issue, U.S. access to the program was cut off after Serono's lawyers received a letter from the FDA saying that the FDA did not approve Serono to import human growth hormone for compassionate use at this time.
Comment
These intended shipments of human growth hormone, to persons in the U.S. for treatment of AIDS-related wasting, would appear to be within the FDA policy allowing personal use of drugs approved abroad. The potential for abuse by athletes is a complication, but must not be allowed to prevent access for essential medical use.
Two other companies (Genentech Inc., and Eli Lilly and Company) already sell human growth hormone in the U.S., where it has been approved and available for years to treat growth hormone deficiency in children. While an approved drug can normally be prescribed "off label" for other medical uses, the distribution of growth hormone is tightly controlled by a unique system set up by the companies and the FDA to prevent abuse. So far, we do not know of anyone who has been able to obtain growth hormone from U.S. sources for AIDS-related use.
Another way to provide the drug would be through a "treatment IND" program, which Serono has applied to the FDA for permission to start.
For several years there has been interest in human growth hormone as a possible treatment for AIDS wasting syndrome. But the first results from a large-scale trial, sponsored by Serono Laboratories, were released only recently, in August 1994, at the International Conference on AIDS in Yokohama. Clearly government and/or corporate attention is needed so that U.S. citizens with this life-threatening condition can receive the drug.
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