For Gelsingers, closure is finally at hand

A year after the death of his son during a Penn gene therapy experiment, Paul Gelsinger is beginning to feel closure as his long and painful relationship with the University comes to an official end. Last week, Gelsinger settled his six-week-old wrongful death and negligence lawsuit with the University for an undisclosed sum. But for Penn and its Institute for Human Gene Therapy, where Jesse Gelsinger was a patient, and for other programs like it nationwide, the case may not be closed yet. Gelsinger's death prompted a suspension of all human trials at the IHGT by the U.S. Food and Drug Administration. It also brought national scrutiny to Penn's research methods, which ultimately led the University administration to dramatically reduce the IHGT's mandate. And the lawsuit, which originally named the Penn Trustees, researchers at the IHGT, Penn bioethicist Arthur Caplan, former Health System CEO William Kelley and two other medical centers, threw Penn back into headlines across the country. "It's over with for me and Penn," Gelsinger said. "I let Penn off the hook because there is a bigger problem [with oversight and ethics] that I expect to be addressed. To me, that's what killed Jesse." University President Judith Rodin acknowledged weaknesses in the IHGT's monitoring and oversight of clinical trials, but "continues to believe that these weaknesses did not contribute to Jesse's death." "Penn is still looking ahead, to establishing a national model for clinical research," Rodin added. University spokeswoman Phyllis Holtzman said yesterday that the settlement of the civil suit "does not affect [Penn's dealings with the FDA] or other issues. As we have said all along, we will continue to work with the government on the issues that are currently unresolved." The FDA, which has not contacted Penn since last summer, would not comment on the agreement. Beyond Penn, the larger gene therapy field is still trying to recover from increased oversight and regulations that followed last year's chaos. "This [settlement] does not change anything," said Dusty Miller, a researcher at the Fred Hutchinson Cancer Research Center in Seattle. "Gene therapy is still going to be hampered by new regulations for some time to come, which may improve the safety aspects, but may also make it impossible to make new treatments for genetic diseases." Experts also said that because the lawsuit ended in a private agreement, the public still is not familiar with the events surrounding Jesse's death -- which led to a negative perception of gene therapy on the whole. "It's going to take a while to repair that damage," Miller said. Gelsinger said he hopes that the gene therapy researchers will get past this, but that they should "see the depths of their mistakes." "I'm all for these guys [IHGT researchers], but first they have to lick their wounds and admit what they have done," he said. "I have never wanted anyone to lose their jobs -- just to wake up." With the settlement money, Gelsinger said he plans on establishing a foundation in Jesse's name to distribute money to different charities. He said he also hoped to work with the National Organization for Rare Disorders.

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