EDITORIAL: Gene death merits inquiry

Penn must commission an independent investigation into its own internal review procedures for medical tests. Since the death, Penn officials, including lead researcher James M. Wilson, have flatly denied that human error or faulty research methords were factors in the death of Gelsinger, 18, who was at first thought to be a relatively healthy patient. But recent media accounts have alleged that Gelsinger was too ill to be eligible for the trial. Reports have also alleged that the Penn team violated research protocols, proceeded without standard supervision, failed to inform patients of known risks, ignored serious side effects from previous trials and misled government regulators. The Washington Post has even alleged that Wilson's financial stake in a local biotechnology firm contributed to his zeal for the project. Wilson will present today a 337-page report in which he will maintain that Penn complied with research protocols and fully informed government regulators. The U.S. Food and Drug Administration and the National Institutes of Health will also issue their findings today. The immediate task rests in reconciling any competing claims and establishing what errors, if any, led to Gelsinger's death. More broadly, the possibility that Penn's internal review mechanisms failed to stop a dangerous experiment in progress leads us to believe that the University ought to take a look inward. If any supervisory processes failed in this case, they must be prevented from doing so again. The University is in a position in which it should complement the FDA and NIH reports with its own internal investigation, conducted by officials unaffiliated with Wilson's Institute for Human Gene Therapy. As one of the largest research universities in the country, particularly in the field of biomedicine, Penn has to answer the question of how such a procedural breakdown may have occurred, and that can only be done by an independent review.