The controversy surrounding the gene therapy study at Penn that resulted in the death of an Arizona teenager came to a legal end yesterday after more than five years of investigation and debate.
The University agreed to pay $517,496 to settle a suit brought by the federal government that claimed Penn researchers misled several federal oversight agencies by misrepresenting clinical findings.
The settlement also imposed sanctions on the three researchers who led the study and marks the end of a controversy stemming from the death of 18-year-old Jesse Gelsinger in 1999. The teenager was being treated for a liver problem and died from organ failure within days of being injected with a genetically modified cold virus.
The U.S. Attorney's office sued the University, claiming researchers issued several false statements regarding the safety of the treatment. The agencies, which included the Food and Drug Administration, the National Institutes of Health and the Institutional Review Boards, alleged that Gelsinger's treatment was known to produce toxins in humans and that this knowledge should have ended the research and prevented Gelsinger's death.
David Hoffman, the prosecutor for the U.S. Attorney's office, said the case would set a precedent for stricter monitoring of clinical research.
The settlement is "creating a system and a culture that mandates something beyond compliance" with research supervision, Hoffman said. It will encourage "a concern and an understanding that you're dealing with human beings."
But Paul Gelsinger, Jesse's father, said he thought the settlement did not set stringent enough standards for researchers.
"My son's dead because of these guys," Gelsinger said. "These guys are just going to be retrained and overseen. That's all that's happened to them."
Gelsinger -- who settled his own suit against the University for an undisclosed sum in 2000 -- said he wanted a public apology from Penn and the release of all documents associated with the case.
"They call it a tragedy," Gelsinger said. "It was more than a tragedy. This thing was totally avoidable."
Penn officials maintain that they acted within government protocol.
"Jesse Gelsinger was properly enrolled in this study and, contrary to any suggestion otherwise, his death was not foreseeable based upon informed medical judgement and the best scientific information available to Penn or the government at the time," said Lori Doyle, a spokeswoman for the University.
Penn officials issued a statement that said the University is a "national model for the conduct of research" and noted its training and monitoring programs for research staff.
"Out of this tragedy has come a renewed national effort to protect the safety of those who help to advance new treatments and cures through clinical research," the statement said.
As another stipulation of the settlement, the three Penn researchers involved in Gelsinger's treatment -- James Wilson, Mark Batshaw and Steven Raper -- will also have restrictions placed on their future clinical studies.
All three have remained employees of the University, but Wilson, who led the research, has not studied human subjects since January 2000.
Wilson's secretary said he could not be reached for comment because he was out of town, but he released a separate statement that said he will continue to research under the restrictions.
The field of gene therapy lost steam after Gelsinger's death but has gained more acclaim recently.
Arthur Caplan, chairman of Penn's Department of Bioethics, said that yesterday's settlement would likely have no effect on the number of new studies.
"People have already beefed up their oversight of gene therapy ... have already come to grips with the tragedy," Caplan said.
The U.S. Attorney's office in Philadelphia reached a similar settlement, also for more than $500,000, with the Children's National Medical Center, a hospital in Washington that is related to the case.
