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,
<http://dailynews.yahoo.com/h/nm/20001112/sc/heart_gene_dc_2.html>). |