FDA Reviews 10 yr old Trial of 3 Antipsychotic Pills at University of Minnesota in which 1 Person Suicided

pharmalot;
by Ed Silverman

The FDA is reviewing a clinical trial that was run more than a decade ago by the University of Minnesota in which one of the participants committed suicide and led to widespread criticism of university research practices, a university spokesman confirms.

The FDA visited the university last fall and spoke with Stephen Olson, a psychiatry department researcher who was the principal trial investigator, according to the spokesman. The trial was designed to examine the effectiveness of three different antipsychotic pills and was funded by AstraZeneca.

“We’re waiting to hear from the FDA about what, if anything, they want to report back,” the spokesman says. “At this point, we only know they are conducting a review of the study.” Olson did not respond to a request for comment. An FDA spokeswoman would not confirm or deny a review is under way.

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Thank You Mr Silverman and WSJ