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NOTE: One human guinea pig dealer is out of business, Let us concentrate on University of Colorado's scientist next. we have just begun>>>
http://www.washingtonpost.com/ac2/wp-dyn/A48594-2002Feb8?language=printer
FDA Says Scientist Failed To Explain Gene Test Death
Associated Press
Saturday, February 9, 2002; Page A06
Federal authorities rejected a letter of explanation from a University of
Pennsylvania scientist who led a research project in which a teenager died.
Proceedings will continue to permanently bar James Wilson from testing drugs
on humans.
In a letter sent to Wilson yesterday, the Food and Drug Administration said
his letter explaining alleged safety problems in his research "fail to
adequately address the violations."
The FDA letter said Wilson can request a hearing on the accusations or
accept a consent decree that would block him from using human subjects in
drug testing.
A University of Pennsylvania spokeswoman quoted Wilson as saying, "We will
continue a dialogue with the FDA to reach a resolution satisfactory to all
parties."
Wilson was in charge of a gene therapy experiment in 1999 during which Jesse
Gelsinger, 18, of Tucson, died.
Gelsinger, who suffered from a liver disorder, had been injected with a
genetically altered virus that was designed to give his body a gene that
would treat the liver condition.
An FDA investigation concluded that Gelsinger died as a direct result of the
injection. He was the first patient to die in a gene therapy experiment.
In November 2000, the FDA notified Wilson that it had found evidence of
numerous violations of the rules for conducting the research project. The
agency also told Wilson that it was starting proceedings to bar him
permanently from conducting further drug research on human subjects.
The FDA charges that Wilson "repeatedly and deliberately violated federal
regulations" in the research.
© 2002 The Washington Post Company
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