Treatment Review #15; December 1994
Serostim is a drug called human growth hormone. Human growth hormone is made and sold in the United States by two companies, Genentech and Lilly. It can only be prescribed for the treatment of growth hormone deficiency in children. The FDA controls the off-label use of human growth hormone because of the potential of abuse by athletes. Also, some parents have complained to the FDA that growth hormone is being aggressively marketed to kids who have not yet reached their full height. The drug is very expensive. Until it's approved for treating weight loss associated with HIV infection, insurance companies won't pay for it. There was some hope that people who could afford it might be able to get it from Canada. The first results from a small-scale clinical trial were encouraging and generated a great deal of interest.
Serono has applied to the FDA for permission to start a treatment IND program. IND stands for Investigational New Drug, and is the label for continuing study of a drug. The drug company has to be willing to provide the drug, and the doctor has to be willing and able to monitor any patient receiving a drug through this type of program. Drug companies are allowed to charge for a treatment IND drug, but none have.
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