It's been eight years now since Penn landed perhaps its biggest hire of the 1990s. The man was on the cutting edge of scientific research and his star was clearly on the rise. He was involved in nearly every major scientific breakthrough that his field produced. He promised to "revolutionize medicine as we know it today," and the University gladly threw tens of millions of dollars at him to try to make it happen. And then James M. Wilson, once the pride of the gene therapy world, failed in spectacular fashion. His recklessness killed an 18-year-old man, and his steadfast denial of any culpability has brought shame onto Penn. And not only is he still employed by the University -- next semester, he will lead a preceptorial on gene therapy that promises to focus partially on the "ethical issues" involved in the field. That he is still here is an embarrassment to Penn. That the student committee which runs the preceptorial program invited him to teach is an insult to the memory of a brave young man named Jesse Gelsinger, who died in a Wilson-led study 18 months ago. Wilson, who holds a faculty appointment in the Molecular and Cellular Engineering Department, is the director of Penn's Institute for Human Gene Therapy. He founded the IHGT in 1993, after being lured away from the University of Michigan, where he headed what was at the time one of just three teams in America authorized to conduct gene therapy experiments on humans. He put Penn at the forefront of the burgeoning field, and was one of the most well-respected scientists in the world. He found novel ways to treat illnesses through the insertion of healthy genes into the body to replace defective ones. He was an innovator in a science that is seemingly nothing but innovation. But his work now appears to have been little more than a house of cards -- Gelsinger's tragic September 1999 death demonstrated that. The 18-year-old Arizonan died after Wilson's team injected him with a modified virus that contained new genes intended to stimulate enzyme production in his liver. But something went wrong, and Gelsinger's body shut down. He went into a coma and died a horrible death four days later. After a year-long investigation, the U.S. Food and Drug Administration is trying to bar Wilson from ever again performing research on humans. It's a rare step that has been taken only half a dozen times in the past few years, according to agency records. It is, as one bioethicist has said, "the death penalty" for scientists. A federal investigation of Wilson's lab showed innumerable ethical lapses and regulatory violations: He changed aspects of the experiment without informing regulators. He misled Penn's own scientific review boards. He did not disclose the deaths of several lab animals. He used human patients who should not have been eligible for the experiment. And he hid vital information from patients, including Gelsinger, while they were deciding whether to take part in the experiment. All of those charges are serious enough individually. Together, they form a pattern of severe misconduct. Even more damning are the charges of outright corruption -- that Wilson made scientific decisions because of financial motives. Wilson founded a for-profit company called Genovo, which funded much of the IHGT's research and in turn owned the patent rights to any drug developed in Wilson's lab. If Wilson's experiment had worked, he would have stood to profit handsomely. Wilson's defenders say that the FDA is using him as a scapegoat for its own regulatory mishaps, and that most scientists on the cutting edge of their field play it loose with the rules. That's a pitiful response -- working for a university like Penn is different than working for a for-profit company (or at least it should be). Research universities must hold scientists to the highest of high standards, and most seem to do just that. Of the six other researchers who the FDA has threatened to disqualify over the past 2 1/2 years, agency records show that only one worked primarily at a university. And despite that, despite the fact that Wilson could soon find himself on the scientific world's persona non grata list, he still works for an institution that likes to call itself one of the best research universities in the world. Wilson may be a brilliant scientist, but all of his breakthroughs are now tainted by these allegations. Medical regulations are in place to protect clinical patients from doctors who may not have their best interests at heart, and the success of an experiment certainly does not excuse the means of achieving it. Clearly, University administrators realize the extent of the problems in the IHGT. Last April, they stripped Wilson of all authority to conduct human testing. Since then, the institute has been restricted to performing only animal and cellular research (although the FDA last summer raised questions about Wilson's animal research methods, too). Wilson is a black eye on this institution. He has lost the right to practice his craft here, and he certainly has no place teaching undergraduates about science. He arrived here eight years ago full of hope, a young scientist with an impeccable reputation and the modest goal of ushering in a new medical era. With that goal now out of his reach and his reputation now quite deservedly in tatters, it's time for James Wilson to go.Comments powered by Disqus
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