Is research misconduct and abuse the norm in the University of Minnesota’s Department of Psychiatry? A recent investigative report from KMSP News in the Twin Cities suggests that the answer may well be yes.
According to the KMSP report for which I was interviewed, in 2007 a psychiatric research team led by Dr. Stephen Olson enrolled a mentally ill young man identified as Robert into a clinical trial for the experimental antipsychotic drug bifeprunox. Robert told KMSP that he was incompetent to consent, and that the psychiatric team used the threat of a significant medical bill to pressure him into the study. Despite Robert’s concerns about the safety of the drug, which was not FDA-approved, researchers minimized the study risks. Dr. Olson specifically noted in his clinical record that he told Robert that “enough patients have been treated to be more sure of its safety.”
Soon after Robert entered the study, the FDA rejected bifeprunox for marketing approval. Within months the sponsor of the trial, Solvay Pharmaceuticals, stopped all research after bifeprunox was linked to the death of a study subject in Europe due to liver failure. There is no record that Robert was ever informed of these developments.
Robert’s condition worsened and he began having abdominal pain so severe that he considered suicide. After three trips to the emergency room, once by ambulance, Robert dropped out of the study. Dr. Olson told the study sponsor that Robert “decided to quit the study due to these psychosomatic Sx [side effects].”
Robert’s case is not an isolated one.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.