Thank you for sharing!

Your article was successfully shared with the contacts you provided.
The University of Pennsylvania and the Children’s National Medical Center have agreed to pay the government a total of $1 million to settle fraud allegations related to the death of an Arizona teenager during a gene-therapy experiment. Jesse Gelsinger, 18, of Tucson, Ariz., died on his fourth day of involvement in the study in 1999. Gelsinger had suffered from a genetic disorder that interferes with the body’s processing of nitrogen. Researchers had hoped to cure him by injecting him with a modified virus carrying a gene that could replace the medications and special diet that had been controlling his condition. The Food and Drug Administration concluded that the injection killed him. After the death, Gelsinger’s family said the teen had been misled about the experiment’s potential risks. Federal prosecutors alleged in a civil complaint that researchers should have realized that the experiment had unacceptable side effects. They also alleged that researchers had submitted reports to government entities misrepresenting the study’s clinical findings. U.S. Attorney Patrick L. Meehan said the most significant aspect of the settlement is the impact it will have on the way clinical research on human participants is conducted. “This action covers two major research centers which have instituted important changes in the conduct and monitoring of clinical research on human participants. We hope that these settlements will now serve as a model for similar research nationwide,” Meehan said. The two institutions maintain that Gelsinger’s death was unforeseen and that he was properly enrolled in the study based on the best scientific information available at the time. Neither Penn nor the Children’s National Medical Center, of Washington, D.C., is required to acknowledge any wrongdoing as part of the settlement. Under the agreement announced Wednesday, Penn will pay the government $517,496 and CNMC will pay $514,622 — amounts equal to the federal funding the institutions received to conduct the clinical trial that led to Gelsinger’s death. Penn officials said in a written statement that in the five years since Gelsinger’s death, they had overhauled their rules for clinical research on human subjects. “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. The government also struck separate settlements with the three researchers involved in the experiment — James Wilson and Steven Raper of the University of Pennsylvania, and Mark Batshaw, the chief medical officer at Children’s National Medical Center. The settlements allow the three doctors to continue their research, although all three will have restrictions placed on their future work. Wilson, who oversaw the experiment that led to Gelsinger’s death, is barred by the agreement from being a sponsor of an FDA-regulated clinical trial for five years. Wilson also agreed to lecture and author an article on the lessons learned from the study.

This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.

To view this content, please continue to their sites.

Not a Lexis Advance® Subscriber?
Subscribe Now

Not a Bloomberg Law Subscriber?
Subscribe Now

Why am I seeing this?

LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.

For questions call 1-877-256-2472 or contact us at [email protected]


ALM Legal Publication Newsletters

Sign Up Today and Never Miss Another Story.

As part of your digital membership, you can sign up for an unlimited number of a wide range of complimentary newsletters. Visit your My Account page to make your selections. Get the timely legal news and critical analysis you cannot afford to miss. Tailored just for you. In your inbox. Every day.

Copyright © 2021 ALM Media Properties, LLC. All Rights Reserved.