Bioethics Scholar Discusses Jesse Gelsinger Case
September 15, 2009 — Health law and bioethics scholar Robin Fretwell Wilson discussed unanswered questions concerning the death of Jesse Gelsinger, a patient who took part in a human gene-therapy trial at the University of Pennsylvania in September 1999.
Gelsinger suffered from ornithine transcarbamylase deficiency (OTC), a rare genetic disorder that prevents the body from processing protein.
As part of the clinical trial, researchers were testing the safety of an adenovirus vector delivering the normal OTC gene into liver cells.
Gelsinger died after being injected with the adenovirus, apparently having suffered a massive immune response that led to multiple organ failure and brain death.
“I’m going to suggest to you today that there is some more responsibility to go around,” said Wilson, adding that much remains unknown about this case 10 years after the young man’s death. A lawsuit his father, Paul Gelsinger, filed against the University of Pennsylvania and the researchers in the Court of Common Pleas in Philadelphia County was settled, as was a second suit brought by the federal government.
A professor of law at Washington and Lee University of Law, and the co-editor of “Health Law and Bioethics: Cases in Context” Wilson visited the Earle Mack School of Law as a guest of the Health Law Program and the Health Law Society.
Citing documents provided to Paul Gelsinger’s attorney by a whistleblower at the University of Pennsylvania, Wilson outlined a chain of communications that she said demonstrate serious lapses in oversight of conflicts of interest between researchers, the university and a private biotech firm, Genovo, in which Penn scientists had a financial interest.
Wilson said the documents show that a lead researcher who had a financial interest in Genovo maintained a role in designing the study and treating Jesse Gelsinger, even after university oversight groups acknowledged his conflict of interest.
“This is an unchecked honor system,” she said, adding that the researchers did not halt the study despite signs of trouble.
Citing documents from the federal lawsuit, Wilson said trial subjects who received lower doses of the experimental drug than Gelsinger were found to have “grave toxicities,” yet the study continued.
She also cited a consent form that she said was signed by participants in the study, which neglected to mention the deaths of monkeys previously treated with the adenovirus. While earlier drafts of the consent form clearly alluded to the animal deaths, Wilson said, the version presented to Gelsinger omitted this information.
“There were mixed messages in the informed consent document,” Wilson said. “It didn’t directly say monkeys died. They clearly side-stepped the truth.”
As expenditures rise for stem-cell research and other studies involving human subjects, Wilson said, the Gelsinger case continues to raise questions about the oversight of scientists who have a financial stake in their work and incentives to burnish their careers.
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