FOR IMMEDIATE RELEASE THURSDAY, JULY 25, 1996
GROWTH HORMONE GETS GREEN LIGHT
AIDS ACTIVISTS SECURE APPROVAL FOR EFFECTIVE TREATMENT FOR FATAL CONDITION
BETHESDA, MARYLAND --Food and Drug Administration (FDA) officials
today verbally committed to Accelerated Approval for Recombinant Human
Growth Hormone (Serostim) for AIDS-associated wasting syndrome. AIDS activists
met with the drug's manufacturer, Serono Laboratories and the FDA to demand
approval on July 24th and 25th. Serono committed at the meeting's conclusion
to submitting finalized documents to the FDA early next week.
ACT UP Golden Gate has been monitoring the development of growth hormone
for the last five years. Wasting Syndrome, frequently associated with
late stage HIV disease, kills 2 of 3 people who die each day in San Francisco
of AIDS. This week, members Jeff Getty and Bill Thorne worked with Tim
Horn of the Treatment Activist Group (TAG) to extract the necessary commitments
from Serono and the FDA to approve the drug.
"They've finally seen the light of reason. People with AIDS related
wasting now will have access to a desperately needed therapy." said
Jeff Getty of ACT UP Golden Gate. Members of ACT UP Golden Gate, including
Getty, with severe wasting syndrome were able to obtain the drug by participating
in clinical trials or through the company's Treatment IND (Investigational
New Drug) program. These members have gained 20 pounds or more while
taking the drug. Weight gain has translated into an increase in lean body
mass, better appetite, and increased energy.
The drug's approval comes after several victories won through ACT UP Golden
Gate's work on Growth Hormone. A wholesale price cap of $36,000.00 annually
was secured in writing from Serono a few weeks ago, despite the company's
original demand of $75,000.00 or more. Although the cap is viewed as an
important milestone, the drug's cost will be a problem for cash strapped
public assistance programs as addressed by President Clinton this week
in San Francisco.
"The importance of the availability of this therapy cannot
be underestimated," stated David Mahon of ACT UP Golden Gate, "it's
the first approved therapy that is not an appetite stimulant but actually
directly effects the metabolic dysfunction of AIDS related wasting syndrome."
ACT UP will continue to scrutinize the situation.