Human Growth Hormone -- Canadian Number Disconnected for U.S. Calls

In our last issue, AIDS TREATMENT NEWS published a phone
number in Canada for obtaining human growth hormone for HIV-
related wasting syndrome, a major cause of death for persons
with AIDS. As this issue went to press, we learned that this
number for physicians (800/935-8853, for the Serono Canada
Information Line for Human Growth Hormone in HIV-Associated
Wasting) has been disconnected for U.S. callers; it still
works for callers from Canada.

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.