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Lawsuit in Gene Therapy Death Settled

Suspended Experiment Allowed to Resume
Genetic Crossroads
December 7th, 2000

The family of Jesse Gelsinger, the 18-year-old who died last September
in a gene therapy trial at the University of Pennsylvania, has agreed
to an out-of-court settlement with the institutions and individual
researchers involved in the experiment. The parties to the settlement
included James Wilson, the lead investigator at Penn, and Genovo, Inc.,
a company that Wilson founded and that would have profited from a
successful outcome.

The family released from the lawsuit two other defendants, including
bioethicist Arthur Caplan, who had advised the researchers to enroll
relatively healthy adults such as Gelsinger, instead of critically ill
infants as they had originally planned.

The Washington Post reported that Paul Gelsinger, Jesse's father, said
"he had undergone a painful change of heart in the year after his son's
death" as he learned of "apparent wrongdoing" and eventually concluded
"that he had been duped by scientists who cared more about profits than
safety." (Rick Weiss and Deborah Nelson, "Penn Settles Gene Therapy Suit,"
11/4/00, <http://washingtonpost.com/ac2/wp-dyn/A11512-2000Nov3>.)

About a week after the settlement, Dr. Jeffrey Isner of Tufts University
and St. Elizabeth's Hospital in Boston announced that the FDA will allow
him to resume gene therapy trials it had ordered suspended last May during
investigations triggered by Gelsinger's death. "Much of the hysteria has
died down," Isner told a Reuters reporter. "The atmosphere has been a lot
more positive."

When it closed down Isner's experiment, the FDA issued a strongly worded
letter accusing him of failing to report the death of one patient and
saying he showed a "serious lack of knowledge" about his duties.

Isner's trials are sponsored by Vascular Genetics Inc. of Durham, NC,
a company he helped found in 1997. Like many other gene therapy
researchers, Isner thus stands to gain financially from his own work.
(Maggie Fox, "Doctor: US Restores Heart Gene Therapy Trials," 11/12/00,


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