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.


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