STAFF EDITORIAL: Lay blame where it belongs

If the findings of fault against James M. Wilson and his gene therapy researchers are true, they cannot remain at Penn. There is no place at an institution of Penn's caliber for medical researchers who conduct their work in anything but the most safe and responsible manner. Numerous allegations have been made against Wilson and his IHGT colleagues that, if proven true, should result in their immediate dismissals. Among the FDA's findings are that researchers did not have the informed consent of all test subjects; that they altered the rules for the trial without the consent of the FDA; and that lab test results, patient eligibility forms and drugs were all missing. The FDA also found that the Penn team treated Jesse Gelsinger, 18, without federal approval. Gelsinger's September 17 death forced the inquiry into Penn's gene therapy program. University President Judith Rodin has taken the unusual step of convening an external committee to look into the matter. But this is a decision that should have been made long ago, once the gravity of the situation became clear. We expect that the external panel will uncover where institutional safeguards broke down, something that an internal investigation failed to do. The committee should furthermore look into the conduct of Penn's Institutional Review Board. The board failed in its duty to notice glaring violations of protocol, and a young man who shouldn't have been treated in the first place lost his life. The IRB's actions -- and apparent shortcomings -- merit as much attention as Wilson and the staff of the IHGT. Wilson, one of gene therapy's leading scientists, came to Penn seven years ago promising "to revolutionize medicine as we know it today." Instead, in pursuit of one of medicine's Holy Grails, he oversaw what are alleged to be numerous acts of recklessness. If the report is accurate, Wilson and his team have proven themselves unfit to work on human subjects. And beyond the fate of Wilson and the IHGT, the University must ensure that such lapses are never overlooked again.