University of Minnesota made “serious” ethical errors in trial of antipsychotics, finds report

The University of Minnesota’s handling of a case in which a psychiatric patient participating in a drug trial killed himself raised “serious ethical issues and numerous conflicts of interest, which university leaders have been consistently unwilling to acknowledge,” a scathing report by the state’s legislative auditor has found.1

The patient, Dan Markingson, then aged 27, killed himself in 2004, slashing open his neck and abdomen with a knife, while enrolled in a clinical trial that was comparing three antipsychotic drugs for the treatment of patients experiencing a first episode of psychosis. The drugs being evaluated were quetiapine (marketed as Seroquel), olanzapine (Zyprexa), and risperidone (Risperdal). The trial, called Comparison of Atypicals in First Episode (CAFÉ), was funded by AstraZeneca, the manufacturer of olanzapine.

The new report said that before Markingson’s suicide his mother, Mary Weiss, had repeatedly questioned her son’s treatment team about his care and health, reporting that her son was saying that people were speaking to him through the television and that his treatment was not working. “While progress notes show Weiss’ calls and their content, there is little documented evidence that the study team followed up with her, particularly in a timely way,” the report said.

Weiss filed lawsuits against the …