By DAVID B. CARUSO
Associated Press Writer
PHILADELPHIA (AP) – The University of Pennsylvania and the Children’s National Medical Center have agreed to pay a total of more than $1 million to settle fraud allegations related to the death of an Arizona teenager during a gene therapy experiment.
Jesse Gelsinger, 18, of Tucson, died on his fourth day in the study in 1999.
The teen had suffered from an inherited disorder that blocks the body from properly processing 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 discontinued the experiment once they realized that it had unacceptable side effects. They also claimed that researchers had submitted reports to the government that misrepresented the study’s findings.
Under the settlement, Penn will pay the government $517,496. The Children’s National Medical Center will pay $514,622.
Neither institution was required to acknowledge any wrongdoing as part of the settlement.
Three researchers – Dr. James Wilson, Dr. Mark Batshaw and Dr. Steven Raper – will also have restrictions placed on their work.
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