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Genzyme and the Research Ethics Questions Associated with Its NeuroCell-PD (TM) Trials
內容大綱
Genzyme Tissue Repair (GTR) had just received favorable Phase I clinical trial results, an important first step in gaining approval from the Food and Drug Administration (FDA) for its NeuroCell-PD. The groundbreaking technology behind NeuroCell-PD (developed by Diacrin, Inc.) used fetal pig cell neural transplants to treat Parkinson's disease. GTR was eager to get NeuroCell-PD to market as quickly as possible but knew that the path to obtaining FDA approval would be difficult. Genzyme, an innovative biotechnology company, had often entered uncharted territories in the past and had set precedents in medical research. Controversy would likely center on whether GTR would use what some were calling "sham" surgery as a placebo control in its Phase II trials of NeuroCell-PD in Parkinson's patients--trials intended to demonstrate both the efficacy and safety of the procedure. In sham surgery, a segment of patients in a study undergo the same aspects of the surgery experience as those receiving the experimental treatment, except that it does not involve fetal pig cells. Details the process for testing NeuroCell-PD and discusses the issues concerning sham surgery. Asks students to make a recommendation on whether to conduct sham surgery.