Genzyme and the Research Ethics Questions Associated with its NeuroCell-PD Trials
2005 | Case No. BME4
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 it’s NeuroCell-PD. The ground-breaking technology behind NeuroCell-PD (developed by Diacrin, Inc.) used fetal “pig-cell” neural transplants to treat Parkinson 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 disease patients, trials intended to demonstrate both the efficacy and safety of the procedure. In sham surgery, a segment of patients in a study would undergo the same aspects of the surgery experience as those receiving the experimental treatment, except that no fetal pig cells-the experimental treatment-would be given. This case details the process for testing NeuroCell-PD and discusses the issues concerning sham surgery. Students are asked to make a recommendation on whether to conduct sham surgery.
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