Investigating Research and Accessing Reproductive Material

Abstract

Dan Markingson was acutely psychotic when University of Minnesota psychiatrists enrolled him in 2004 into the local arm of a controversial multisite CAFE clinical trial, an AstraZeneca-sponsored comparative study of three of the newer neuroleptic drugs. He had been repeatedly judged incompetent to make his own treatment decisions—including as late as two days before enrolling in the study—and was involuntarily committed after making delusional threats to his mother. But his commitment was suspended by a “stay of commitment order” from a district court judge that allowed him to leave the hospital under court-imposed conditions, a key condition being that he had to follow the treatment instructions of his treating psychiatrist, Dr. Olson. Shortly after the stay of commitment order, Dr. Olson proposed that Markingson participate in the clinical trial (of which Olson was the lead investigator at the Minnesota site). Markingson was surprisingly assessed as competent to consent to participate in this trial. Seventeen days after his enrolment in the trial, he moved to a halfway house. His mother, Mary Weiss, believing his condition was deteriorating, attempted repeatedly to get her son out of the study. Notes from a social worker and an occupational therapist also suggested that he was not doing well while in the trial. At one point, Weiss explicitly warned the research team that her son was in serious danger of killing himself. Her warnings were ignored. On May 8, 2004, Markingson committed a violent suicide. These are, in short, the facts of a case that has created turmoil in the bioethics and research communities, particularly in North America, since the St. Paul, Minnesota, Pioneer Press reported on it in 2008 in a series of articles. That the case never completely faded away in the 5 years following the first media report and continues to be the focus of heated debate is due to ongoing actions by Mary Weiss and her friend, Mike Howard, as well as the relentless questioning and reporting by Carl Elliott, a University of Minnesota professor of bioethics. After Bioethical Inquiry (2014) 11:11–19 DOI 10.1007/s11673-013-9503-2