STAFF EDITORIAL: A damning litany of charges

the University's problems with the government over alleged violations of research protocol are not going away. The notice, a reply to Penn's response to an initial set of FDA charges, counters point-for-point -- and then some -- Wilson's defense of his work on a clinical trial that claimed the life of an 18-year-old patient last year. The letter's strong tone sends a clear sign that the controversy that has surrounded Penn's Institute for Human Gene Therapy for the last several months will not abate. The litany of charges against Wilson is long and damning. The world's foremost gene therapy expert, the FDA charges, "violated regulations governing the proper conduct of clinical studies" and "failed to ensure that only eligible subjects were enrolled [in the study]." The IHGT, further, "did not provide clinical investigators with the information they need to conduct an investigation properly." Penn's feeble response last month to the original FDA charges -- and the government's strong reply last week -- give us the impression that this is a fight the University and Wilson cannot easily win. With every official report, every committee hearing and every terse letter, Penn's academic reputation is further impugned. We are rapidly approaching a point where the benefits of offering a vigorous defense to some very serious charges are becoming outweighed by the costs. And, at some point, owing to a clear pattern of medical malfeasance, Wilson himself will become more of a liability to this University than an asset. Naturally, if University officials feel they are being unjustly persecuted by the FDA, it is their duty to bring the facts of the matter to light. But if the current strategy is to merely wait and see and hope for the best, know this -- these questions are not going away, and the damage will only be greater over time.