In March 2013, an online petition was launched asking Governor Mark Dayton to investigate research abuse in the University of Minnesota’s Department of Psychiatry. It was prompted by the death of a mentally ill young man named Dan Markingson. Although researchers in the Department of Psychiatry have been sanctioned repeatedly by federal and state authorities since the early 1990s, officials at the University of Minnesota have resisted calls to investigate Markingson’s death.
In late 2003, a psychiatric research team led by Dr. Stephen Olson at the University of Minnesota recruited Dan into a profitable, AstraZeneca-funded study of antipsychotic drugs (the so-called “CAFE study”). The researchers signed him up over the objections of his mother, Mary Weiss, who did not want him in the study, and despite the fact that he could not give proper informed consent. Dan was acutely psychotic, plagued by delusions, and he had repeatedly been judged incapable of making his own medical decisions. Even worse, he had been placed under an involuntary commitment order that legally compelled him to obey the recommendations of Dr. Olson.
For months, Mary tried desperately to get Dan out of the CAFE study, warning that he was getting worse and that he was in danger of committing suicide. Her warnings were ignored. On April 23, 2004, she left a voice message with the study coordinator, asking, “Do we have to wait for him to kill himself or someone else before anyone does anything?” Three weeks later, Dan committed suicide in the most violent way imaginable. His body was discovered in the shower of a halfway house, his throat slit so severely that he was nearly decapitated, along with a note that said, “I left this experience smiling.”
Remarkably, the University of Minnesota’s Institutional Review Board, the body charged with protecting research subjects, did not investigate the suicide. An official with the local branch of the FDA, Sharon Matson, did conduct an investigation, but she did not even interview Mary Weiss. In a deeply flawed report, Matson cleared the university of blame. Mary filed a lawsuit against the university, but it was dismissed on grounds of “statutory immunity.” The university retaliated against her by filing a legal action called a “notice to assess costs,” demanding that she pay the university $57,000 in legal fees.
In the years since Dan’s death, even more evidence of misconduct has accumulated. Olson and his co-investigator, Dr. Charles Schulz, had financial conflicts of interest from their work with the pharmaceutical industry. AstraZeneca also provided financial incentives for the researchers to keep subjects in the study as long as possible. When AstraZeneca, the CAFE study sponsor, was forced to pay $520 million in federal fraud penalties in 2010, unsealed documents linked Schulz to manipulated research studies.
In the fall of 2012, the Minnesota Board of Social Work found that the CAFE study coordinator, Jean Kenney, had falsified the initials of doctors on study records, failed to warn Dan of new dangers of the study drugs, had been given medical responsibilities far beyond her training as a social worker, and had failed to respond to Mary’s warnings that Dan was in danger of killing himself. Later, evidence emerged suggesting irregularities with “evaluation to consent” documents and HIPAA forms for other subjects.
The Markingson case has generated international outrage, yet the University of Minnesota has managed to stonewall its way through all the criticism, insisting that it has already been exonerated. Even when the state Legislature passed “Dan’s Law” in 2009, banning psychiatrists from recruiting mentally ill patients under an involuntary commitment order into drug studies, the university has continued to insist it had done nothing wrong.