GENE THERAPY: UPenn Institute Halts Research on Humans
On its rules regarding clinical trials, the University of Pennsylvania announced that its gene therapy institute, where a clinical study led to the death of a teenage volunteer last year, will no longer conduct experiments on humans. Research at the Institute for Human Gene Therapy, which was found to have "numerous lapses in patient protections," will be restricted to animal and laboratory experiments, the Washington Post reports. UPenn President Judith Rodin said yesterday that any future gene therapy trials involving human subjects will be carried out by departments elsewhere in the medical school and "only after vigorous scientific and ethical review" (Nelson/Weiss, 5/25). Under the restructuring, Director James Wilson will retain his position, but the institute's scope will narrow, and its $25 million annual budget will be reduced by about one-fifth. Additionally, Penn's Center for Bioethics will no longer operate under the institute's auspices, becoming instead an independent department within the medical school. The institute's lab will no longer serve as a federally financed center for manufacturing viral vectors that deliver genes to human cells (Collins, Philadelphia Inquirer, 5/25).
The announcement coincides with the release of a report by an independent panel of experts that reviewed the institute at the university's request. Led by Dr. William Danforth of the Washington University in St. Louis, the committee "strongly suggested, but did not explicitly recommend, that clinical trials at the institute be stopped." The experts concluded that "either because of lack of knowledge or financial resources the institute was not capable of complying with the federal regulations governing clinical trials." To fix the problem, the university would have to develop, record and "put into exact operation ... hundreds of standard operating procedures." The report also called on Penn to review its hospital experimentation committees that consider proposed clinical trials and its conflict-of-interest policies, so as to "avoid even the appearance of conflict" (Stolberg, New York Times, 5/25). In a statement yesterday, Wilson said the changes "will help position Penn in the future as a model environment for the conduct and oversight of all types of clinical research, especially gene therapy." The FDA also welcomed the plans, with Commissioner Jane Henney noting, "This action underscores the importance of research institutions taking full responsibility for protecting and informing research subjects" (Philadelphia Inquirer, 5/25). But Dr. W. French Anderson, a leading gene therapy scientist, said the move is an "overreaction," arguing, "This is throwing the baby out with the bath water. It basically eliminates the gene therapy program if you can't run trials" (New York Times, 5/25).