AIDS TREATMENT NEWS Issue #213, December 23, 1994
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
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.
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.]