Wilson may lose research ability

In a move described by some as "the death penalty" for scientists, the Food and Drug Administration has begun proceedings to bar Penn researcher James M. Wilson from ever again testing experimental drugs on humans in the United States. A November 30 letter sent by the FDA to Wilson, the director of Penn's Institute for Human Gene Therapy, charged that the scientist "repeatedly or deliberately [violated] regulations governing the proper conduct of clinical studies." Wilson has until December 30 to draft a response to to the charges. Wilson and the University have been the topic of nationwide medical debate since the September 1999 death of 18-year-old Jesse Gelsinger in a gene therapy clinical study. Four months later, the FDA halted all human gene therapy research at Penn, citing multiple violations of federal research regulations. Last month, a civil lawsuit filed by the Gelsinger family against Wilson, Penn and several other scientists and institutions involved in the Gelsinger study was settled for an undisclosed sum. The FDA now "proposes that [Wilson] be disqualified as a clinical investigator." Prior to the Gelsinger controversy, Wilson was one of the most respected gene therapy researchers in the nation. Jeffrey Kahn, program director at the University of Minnesota Center for Bioethics, described the proceedings as the "death penalty, of sorts, for researchers." "It certainly does not bode well for his career," Kahn said. "Sometimes there will be penalties imposed for the misuse of funds or the falsification of data, but to disqualify someone from research is very severe." The process for disqualifying a researcher has been initiated only a dozen times in three years. The rarity of the proceedings has taken many, especially Gelsinger's father, by surprise. "It's never been my intention for somebody's career to be ruined," Paul Gelsinger said. He said that the FDA is attempting to "push more of the heat toward Wilson." "Jim Wilson is their scapegoat," Gelsinger said, contending that the FDA had enough information prior to his son's death to stop the IHGT study. "They've hinted at it to me, but they won't say it publicly." The official FDA position, according to spokeswoman Lenore Gelb, is that the agency has done what it is supposed to do. "We take the violations of federal laws very seriously and the actions we have taken are evidence of that," Gelb said. Should the FDA follow through with Wilson's disqualification, it likely would have little actual effect on his work at Penn. Already facing the FDA ban on human trials, Penn restructured the IHGT last spring to prevent it from experimenting on humans. Officials at Penn are remaining tight-lipped regarding the latest FDA proceedings. "This is obviously a very serious matter, and we know that Dr. Wilson understands its importance, is reviewing the letter carefully and intends to respond in a timely way," read a University statement released Monday. In an interview yesterday, University President Judith Rodin said Penn is waiting for the FDA proceedings to end before deciding upon its next course of action. "Penn of course will, as we have been all along, continue to see this process to the end and then draw our own conclusions once this process has reached a conclusion," Rodin said. In its letter to Wilson, the FDA concluded that Wilson "failed to adequately protect the safety and welfare of subjects" and that he "submitted misleading and inaccurate statements" to Penn's review board. Among other charges, the FDA alleged that Gelsinger was enrolled in the study despite medical test results indicating his ineligibility. Wilson has also been accused of financial improprieties, stemming from his relationship with Genovo, a research company that would have profited from the success of the Gelsinger trial and related studies. If Wilson were to leave Penn, the ban on human research would have a much deeper impact on his work at other institutions. "If that gets taken away, you're pretty well stuck," said Dorothy Nelkin, a New York University professor who has written two books on public perception of medicine. Some claim that the aftermath of the entire Wilson fiasco may involve an overhaul of the way research is conducted in this country. "We ought to think about what's going on for all research," Kahn said. "There should be strict regulations." On Tuesday, the National Institute of Health recommended changing the rules that govern the reporting of "adverse events," such as the death of Gelsinger. The proposal would make NIH regulations more in line with those of the FDA.

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