FDA halts all gene therapy trials at Penn
Marshall, E.
Science 287(5453): 565 567
2000
ISSN/ISBN: 0036-8075 PMID: 10691531 Document Number: 526108
On January 19, the FDA halted all seven clinical trials run by the University of Pennsylvania's Institute for Human Gene Therapy after finding severe faults in how the institute monitors its trials. This move was sparked by the death of a volunteer, 18-year-old Jesse Gelsinger, in a gene therapy experiment at the institute in September 1999, which also triggered a flood of publicity. University president Judith Rodin asked the provost, physician Robert Barchi, to supervise two reviews of all the university's clinical research; one panel, chaired by Barchi, includes noted members of the Pennsylvania faculty, and the other, whose chair has not been named, will use external scientists. The FDA did not release conclusive findings on its investigations but issued an eight-page report offering preliminary observations that help explain the suspension order and which details 18 problems, some well publicized already.