PHILADELPHIA - 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 a 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 it had unacceptable side
effects. They also claimed that researchers had submitted reports to the
government misrepresenting the study's findings.
Under the settlement, the university will pay the government $517,496. The
Children's National Medical Center will pay $514,622.
The two institutions have maintained 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 institution was required to
acknowledge any wrongdoing as part of the settlement.
Gelsinger family attorney Alan Milstein said the family was "extremely
disappointed" because the agreement did not require the public release of
all documents in the case.
Releasing the documents would ensure that "real changes could be made in the
way human research is conducted in this country," he said.
Penn officials said in a 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.
Three researchers - Dr. James M. Wilson, Dr. Mark Batshaw and Dr. Steven
Raper - also will have restrictions placed on their work. Under the
settlement they do not admit any wrongdoing.
The settlement requires that Wilson wait until 2010 before again leading
research on humans. He has been barred from involvement in such studies
since 2000.
Batshaw and Raper face lesser restrictions.
