The University of Pennsylvania's Institute for Human Gene Therapy (IHGT) and its director, James M. Wilson, faced increasing pressure from the federal government in late January. The U.S. Food and Drug Administration suspended all eight of the institute's gene therapy clinical trials on Jan. 21. A few days before, the Office for Protection from Research Risks at the National Institutes of Health launched an investigation into whether a clinical trial violated federal regulations governing patient safety.
The federal actions stem from the Sept. 17 death of Jesse Gelsinger, an 18-year-old man from Tuscon, Ariz., who died while participating in one of Penn's gene therapy clinical trials. The FDA, after investigating the death, has found "numerous serious deficiencies in the procedures ... for the oversight and monitoring" of clinical trials, the agency wrote IHGT. The letter also stated that such failures would expose subjects to "significant and unreasonable risk." Specific allegations ...
