Wednesday, February 4, 2015

Reading between the lines on bifeprunox

Let's do a little reading between the lines.  Last year, I asked the IRB Executive Committee to look into a study of bifeprunox conducted by Stephen Olson.

A couple of weeks ago, we got this letter from Brian Herman, VP for Research at the U.  Herman admits that the FDA paid a visit to Stephen Olson last November, but he is not saying what the FDA found. He does, however, say this: "There currently are no internal or external findings against Dr. Olson that would warrant the University restricting his privilege to conduct human subjects research."

Fast forward to this letter from Debra Dykhuis, the Executive Director of the Human Research Program, which states that "the work of the IRB investigation panel has been completed."  That investigation panel was commissioned to look into Stephen Olson's conduct of the bifeprunox study.

Dykuis says the investigation is complete.  Herman says there are no findings that warrant restricting Olson's ability to conduct research.  Does this mean that the IRB investigation has cleared Olson?

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