Experimental Medicine | Early last month the University and the Department of Justice reached civil settlements in the case of Jesse Gelsinger, who died in September 1999 while participating in a gene-therapy study at Penn’s Institute for Human Gene Therapy (IHGT). The University agreed to pay $517,496 to resolve the government’s allegations of false statements and claims. Under the terms of the agreement, Penn and two of its faculty members—Dr. James M. Wilson (the former director of the IHGT and sponsor of the study in which Gelsinger died) and Dr. Steven Raper, associate professor of surgery—and the other parties “do not admit to the government’s allegations and contend that their conduct was at all times lawful and appropriate.” The Children’s National Medical Center (CNMC), one of whose scientists (Dr. Mark Batshaw C’67) also participated in the study, agreed to pay $514,622.
Wilson has not been involved with human research participants since January 2000, and under the agreement he will not be permitted to sponsor any FDA-regulated clinical trials for a five-year period. In addition to numerous other restrictions on his research, he agreed to lecture and write an article “on the lessons learned from the study.”
Gelsinger, 18, suffered from a hereditary liver disorder known as ornithine transcarbamylase deficiency (OTCD), which prevents the liver from properly processing ammonia. He died four days after he was injected with a modified cold virus that was designed to carry corrective genes to his liver. In November 2000, the University reached an out-of-court settlement with the Gelsinger family, which had filed suit against Penn for wrongful death, assault, battery, lack of informed consent, and fraud.
In the civil case, the Justice Department alleged that the study continued even after it had “produced toxicities in humans that should have resulted in termination”; that the IHGT’s reports to the various oversight boards “misrepresented the actual clinical findings associated with the study”; and that the consent form and process “did not disclose all anticipated toxicities.”
According to a statement released by the University, the settlement “recognizes [that] over the last five years Penn has established what is now a national model for the conduct of research, including the mandatory training of investigators and staff coupled with a comprehensive internal monitoring program for research involving volunteers.” Noting that part of the case’s resolution was that Wilson and Raper “may continue to make ongoing contributions to medical research,” the statement concluded: “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. As this investigation closes, we reaffirm our commitment to the safe conduct of research, strengthening our resolve to continue to set the highest standards possible in this important area.” —S.H.
