The FDA's willingness to talk about maybe someday permitting prescription marijuana hasn't translated into any greater compassion for those suffering from the Wasting Syndrome now. Last year, a drug called recombinant human growth hormone (rHGH) was made available to US AIDS patients via a toll-free hotline to the Canada offices of Massachusetts-based Serono Laboratories, which markets the drug under the brand name Serostim. Serostim has been used safely around the world for treating growth hormone-deficient children, but has never been approved for marketing in the US. Studies at the San Francisco General Hospital using Serostim for AIDS Wasting Syndrome have demonstrated significant, sustained weight gains consisting of lean tissue, a critical point rarely achieved with other treatments.
In early November, however, callers to the hotline got only a recording saying the number had been disconnected. According to Jeff Getty, of the San Francisco chapter of ACT UP, Serono had received a threatening communication from the FDA, ordering them not to send the drug into the United States. Serono backed off and shut down the hotline.
Getty and Martin Delaney of Project Inform speculate that difficult relations between the FDA and Serono have prompted FDA to depart from its usual policy of allowing life-threatened patients to purchase non-FDA- approved medicines from other countries. But while the bureacrats have their power trip, AIDS victims are still wasting away.
The information in this article was obtained from the San Francisco Bay Guardian.
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