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U.S., Researchers Reach Deal in '99 Gene Therapy Case

By Rick Weiss
Washington Post Staff Writer
Thursday, February 10, 2005; Page A03

The Justice Department yesterday reached civil settlements with the physician-researchers who oversaw a 1999 gene therapy experiment that resulted in the death of Arizona teenager Jesse Gelsinger.

The government had alleged that the research team, led by University of Pennsylvania gene researcher James M. Wilson, had failed in numerous ways to protect patients who volunteered for the experiment, which sought to treat a rare disease by providing them with new genes.

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Among the alleged lapses were repeated failures to halt the experiment when serious toxicities first arose; failure to fully disclose the study's dangers in informed-consent documents; and statements falsely suggesting that earlier patients in the study had benefited from the treatment.

Under the terms of the settlement, Wilson and his major collaborators -- Steven E. Raper of Penn and Mark L. Batshaw of Children's National Medical Center in Washington -- do not admit any wrongdoing. The university and Children's, which have since strengthened their research oversight, will pay fines of $517,496 and $514,622, respectively.

The settlement also requires that Wilson wait until 2010 before again leading research on humans. He has been barred from involvement in such studies since 2000. In the meantime, he must undergo training and education relating to research on human subjects; do his work with enhanced oversight and monitoring; and lecture on and write an article on "lessons learned."

Batshaw and Raper face lesser restrictions.

Gelsinger was 18 when, on Sept. 17, 1999, he became the first person known to die as a direct result of being treated with gene therapy, a still experimental approach to curing diseases.

When the death was reported that month, Wilson said the fatal reaction was a surprise. He also denied any financial conflict of interest with regard to the experiment.

But investigations by The Washington Post and by the Food and Drug Administration during the following months revealed multiple scientific and ethical lapses that undermined those assertions. Among them were unreported deaths of monkeys given similar treatments; the failure to inform the FDA, as required, when patients became so ill from the treatment that, according to FDA rules, the study should have been suspended; and Wilson's failure to disclose that a company in which he had a strong financial interest stood to profit if the treatment was successful.

It also came to light that under the study guidelines, Gelsinger was too sick to get the treatment but was treated anyway.

After Gelsinger's death, several changes in federal and institutional rules governing human research were enacted -- a result that his father, Paul Gelsinger, said yesterday was some consolation. But the government's decision not to pursue criminal charges or impose stricter penalties was disappointing, he said.

"I wanted some accountability, and that's not going to happen," said Gelsinger, who was reached by telephone.

In a short statement released by the university, Wilson neither mentioned Gelsinger nor expressed remorse, but said he looks forward to continuing his research.

© 2005 The Washington Post Company