FDA: Gene Leader Violated Rules
From Times Wire Reports
The Food and Drug Administration accused a University of Pennsylvania researcher of violating safety regulations in a gene therapy experiment in which a patient died. In a stern warning letter, the FDA said that Dr. James M. Wilson of the University of Pennsylvania “violated regulations governing the proper conduct of clinical studies” in a series of gene therapy experiments designed to correct a liver disease. Wilson headed a gene therapy experimental study that was halted after the death of 18-year-old Jesse Gelsinger of Tucson, the first patient known to have died as a direct result of a gene therapy experiment.
