Monday, January 24, 2000
WASHINGTON - The University of Pennsylvania said the FDA has temporarily suspended all gene therapy research at the university's Institute for Human Gene Therapy (IHGT) as a result of alleged violations of safety regulations uncovered during an investigation of the widely publicized death of Jessie Gelsinger, a gene therapy patient, in September.
The FDA investigation apparently has produced new revelations about procedural improprieties on the part of university investigators. According to the university, the FDA asserted in a letter on Friday that IGHT failed to complete paperwork formally enrolling patients in the trial in which Gelsinger died, and that they allegedly wrote up and filed undated eligibility forms after the death.
The university said the agency also is alleging that IGHT could not document its compliance with informed consent procedures for many of the subjects enrolled in the trial.
All told, the university confirmed that the agency has listed 18 violations of rules or agreements by IGHT investigators.
IGHT has not responded to the allegations. However, the institute's director, James Wilson, acknowledged at a public meeting in December that he had failed to comply with other FDA reporting procedures.
A university spokesperson said the institution will respond
to FDA's charges this week. The university also plans to appoint a committee
of scientists from other institutions to review its procedures for ensuring
the safety of participants in clinical trials (see BioCentury, Oct. 4 &
Dec. 13, 1999).
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