On December 20, the FDA approved a program to make human growth hormone available to persons with AIDS-related wasting syndrome, before full marketing approval for this indication; the drug should be available under this program by mid January. Wasting syndrome is a frequent cause of death of persons with AIDS. Human growth hormone has shown considerable promise for treating this condition (see AIDS TREATMENT NEWS #205, August 19, 1994); an application for full approval may be submitted to the FDA in mid 1995.

The new program will allow Serono Laboratories, Inc., the company testing the drug for AIDS-related wasting, to charge to recover their cost for providing this expensive drug -- which can cost $150 per day for the initial treatment, though it may later be possible to reduce the dose. Serono has hired a reimbursement agency to help patients get paid by their insurance companies and other third-party payers, and will provide some drug without charge to those unable to pay.

The rules require that this program is available only to patients "who have tried a course of approved therapy with Megace and Marinol where the response has been determined to be poor and that continued treatment with those agents has been judged by the attending physicians to be of doubtful promise." There may be efforts to get this restriction removed. Megace and Marinol are both approved treatments for significant unexplained weight loss, but are widely regarded as unsatisfactory.

To use Serono's human growth hormone (brand name Serostim (TM)), a physician must first qualify as a site with Serono. Later, less paperwork is required to add each individual patient. Physicians should begin the process by calling the Serostim Information Line, 800/714-AIDS (800/714-2437). Patients also can call this number for information.

Note: Human growth hormone has been an approved prescription drug for years in the U.S. for treatment of growth-hormone deficiency in children. But it is tightly restricted to prevent abuse by athletes, and very few people with AIDS have been able to obtain it from either of the companies which have long marketed it in this country. Serono's version of the drug has been approved in 50 countries, but not in the U.S. It appears to have been easier to obtain the Serono drug through the treatment IND route, than to modify the restrictions on the drug already here.

AIDS treatment activists have made major contributions to the development and access to growth hormone; without their work, the drug would not have been available to patients for a long time. ACT UP/Golden Gate and Project Inform, and the San Francisco AIDS Foundation have taken the lead, and Mother's Voices, ACT UP/New York, Treatment Action Group (TAG), and AIDS Project Los Angeles have provided critical assistance.

ACT UP/Golden Gate has produced a flyer describing the treatment IND program; it will be updated as required. To obtain a free copy, call 415/252-9200, and leave your name and address, slowly, on the voicemail.

[Physicians and patients should know that another alternative for treating wasting syndrome, thalidomide, is currently in clinical trials. The ACT UP flyer on human growth hormone also includes information on thalidomide.]

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