Abstract

AIDS: Serono Laboratories, Inc. has recently been given accelerated Food and Drug Administration (FDA) approval for Serostim, a recombinant human growth hormone genetically engineered from mammalian cells, for treatment of AIDS-related wasting. While the price has not been established, Serono has agreed to a price cap under which no patient will be charged more than $36,000 per calendar year for the drug. Treatment activists played a critical role in getting the human growth hormone approved and available for AIDS patients. The historical background of this activism is detailed, revealing multiple efforts in making the drug more accessible despite barriers restricting its availability, and the pressure used on both the FDA and Serono to reach a compromise on the approval process.