Abstract

AIDS: The Food and Drug Administration has approved a treatment IND allowing Serono Laboratories to distribute its experimental version of human growth hormone (HGH) to people with AIDS-related wasting syndrome. To receive HGH, a person with AIDS must have lost 10 percent of normal body weight without apparent cause, and must have first tried the appetite stimulants Megace and Marinol. HGH reorients the body's metabolism so that is focuses on rebuilding protein stores that are lost from lean tissue mass during the course of the disease. Wasting can be either acute and caused by a specific gastrointestinal or other infection, or chronic and non- specific. The treatment IND covers 12 weeks of therapy during which physicians will examine their patients 4 times and collect basic safety data for Serono. Patients can be reenrolled for an additional 12 weeks if a need for HGH remains. Patients or third- party payers will have to reimburse doctors for data collection and paper work costs, and will pay $25 per mg (a daily dose is 6 mg). This cost recovery is a precedent-setting aspect of Serono's treatment IND.