Breaking News: FDA seeks to disqualify Penn researcher

In a move described as "the death penalty" for scientists, the Food and Drug Administration has begun proceedings to bar Penn scientist James M. Wilson from ever again testing experimental drugs in the United States. A letter sent by the FDA to Wilson, the director of Penn's Institute for Human Gene Therapy, on November 30 charged that the scientist "repeatedly or deliberately" violated regulations governing the proper conduct of clinical studies. 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. The process for disqualifying a researcher has been initiated only a dozen times in the past three years. Wilson, who until Gelsinger's death was considered perhaps the most promising gene therapy researcher in the country, has until December 30 to draft a response to the FDA letter. 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 amount of money. Jeffrey Kahn, a bioethics expert at the University of Minnesota, described t he 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." Two "warning" letters were also sent to Wilson's collaborators, Steven Raper of Penn and Mark Batshaw of Children's National Medical Center in Washington, D.C. Batshaw is also chair of the pediatrics department at the George Washington University School of Medicine. Penn officials are remaining tight-lipped about the letter, the latest in a string of stinging rebukes the FDA has sent to Wilson. "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 statement issued by Penn on Monday. In its letter to Wilson, the FDA concluded that he "failed to adequately protect the safety and welfare of subjects" and that he "submitted misleading and inaccurate statements" to Penn'ss institutional review board. Among other charges, the FDA alleged that Gelsinger was enrolled in the study despite medical test results indicating his ineligibility. If Wilson's response to the FDA is not satisfactory in the agency's eyes, Wilson's ability to test experimental drugs will be revoked. "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 gene therapy research is conducted in this country, and indeed, it has provoked an immense amount of soul searching in the scientific community over the past 15 months. "Gelsinger's death very clearly had an effect on slowing down the process, if not stopping it altogether for a while," Kahn said. "We ought to think about what's going of for all research. There should be strict regulations." In an interview Tuesday night, Jesse Gelsinger's father said he wants the medical research system, which he sees as corrupt and beholden to industry interests, to reform itself. "There's a lot of money pushing all the buttons," Paul Gelsinger said. "All I've ever wanted is the truth."