On Monday evening, KMSP News aired a report of yet another mentally ill man whose alarming story mirrors that of Dan Markingson, who was coerced into an industry-funded antipsychotic study at the University of Minnesota and committed suicide in 2004.
The man, identified as Robert, says that he was pressured into a pharmaceutical industry study of an unapproved antipsychotic drug called bifeprunox. The psychiatrist in charge of the study was Dr. Stephen Olson -- the same researcher in charge of the study in which Markingson died.
“I was incompetent and didn’t know what I was doing,” Robert told the KMSP reporter, Jeff Baillon. "Then, they say you have a giant medical bill and if you do the research, you won't have this giant medical bill."
Robert says he was told that bifeprunox was safe, yet the FDA soon rejected the drug, asking the sponsor to look into the death of a research subject who had died of liver failure shortly after taking it. Several months later, the sponsor halted all bifeprunox studies.
The side-effects of bifeprunox were so severe that Robert considered suicide. He went to the Fairview emergency room three times, once by ambulance, yet Olson apparently dismissed his symptoms as “psychosomatic.” Olson told the sponsor that Robert's symptoms were probably not related to bifeprunox.
Dr. Michael Carome of Public Citizen, and former Deputy Director of the Office of Human Research Protection, says the case is so alarming it deserves a federal investigation. I agree. In fact, I have been trying to get the University of Minnesota IRB to investigate this case since early January. (You can see my letters here and here.) I have no confidence whatsoever that the IRB plans to give this case or any others a fair review. According to this letter, which I obtained through an open records request, the IRB has been aware of serious problems with research in the Department of Psychiatry at least since 2009.
Nor do I have any confidence that the university plans to open the lid to any further investigation. I filed an open records request for selected Serious Adverse Event (death and injury) reports in October 2013. So far, of the 54 studies I identified, I have received Serious Adverse Event Reports for only three. One, of course, was for the bifeprunox study in which Robert was enrolled.
Former Governor Arne Carlson has written to the Board of Regents asking how many research subjects have died or been serious injured in psychiatric clinical trials at the university. That’s a question that will never be answered until the university is forced to give up those records.