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Washington
(H24N).
The family of the first person to die after undergoing gene therapy
has filed a lawsuit against the research team that carried out the
treatment.
Jesse
Gelsinger, 18, died last year at the University of Pennsylvania
after undergoing gene therapy to treat a rare liver disorder. His
family filed the complaint yesterday, one year and one day after
the teen-ager’s death, alleging scientific and regulatory lapses
in the experiment.
Gelsinger
suffered from ornithine transcarbamylase deficiency, a deadly liver
disorder that allows poisonous levels of ammonia to build up in
the blood system. The therapy he underwent involved viruses designed
to carry altered genes that, in theory, would reverse or stabilize
his condition. Those viruses were also known to cause potential
liver damage, but the doctors performing the experiment went ahead
with the therapy, believing Gelsinger’s overall health was strong
enough to sustain him.
His
family’s lawyers contend the research team underplayed the risks
involved and withheld crucial information about liver damage suffered
by earlier volunteers and animal test subjects.
Also
named in the lawsuit was University of Pennsylvania ethicist Arthur
Caplan, who reportedly advised researchers to seek out adult patients
like Gelsinger; other defendants include the Children’s National
Medical Center in Washington, D.C., and the Children’s Hospital
of Philadelphia.
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