Why the University of Minnesota psychiatric research scandal must be investigated

April 9, 2013

Three former editors of the New England Journal of Medicine have called for an investigation. So has the scholar who uncovered the Guatemala syphilis studies. The former Health and Disability Commissioner of New Zealand has called the conduct of the researchers “unethical,” pointing out the need to “put in safeguards in place to prevent a similar tragedy from happening again.” A recent Medical Journal of Australia editorial compared it to the exploitation of poor black men with syphilis in Tuskegee, Ala. Yet the University of Minnesota, where the research scandal occurred, simply keeps repeating, “Nothing to see here, folks. Just move along.”

The research abuse in this case is so stunning that when I first learned about it I could scarcely imagine it happening anywhere, much less at the university where I work. In late 2003, psychiatric researchers at the University of Minnesota recruited a mentally ill young man named Dan Markingson into a profitable, industry-funded research study of antipsychotic drugs. 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 about demons, 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 the psychiatrist who recruited him into the study.

For months, Mary tried desperately to get Dan out of the study, warning that he was getting worse and that he was in danger of committing suicide. But 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 went through this experience smiling.”
Conflicts of interest, other issues

As outrageous as that sounds, there is more. The psychiatrists had financial conflicts of interest from their work with the pharmaceutical industry. The study sponsor also provided financial incentives for the researchers to keep subjects in the study as long as possible. Last fall, the state Board of Social Work found that the study coordinator 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.

After Dan’s suicide, it got even worse. When Mary’s lawsuit against the university was dismissed on technical grounds of “sovereign immunity,” the university lawyers filed a legal action against her called a “notice to assess costs,” demanding that she pay them $57,000 in legal fees. Yes, you read that correctly: The U tried to force the mother of a suicide victim to pay it $57,000.

None of this is a secret. The case has generated international outrage. Yet for three years the University of Minnesota has managed to bluster and 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 continued to insist it had done nothing wrong.
A petition to Gov. Dayton

Two weeks ago, as a last resort, Mary Weiss, the mother of Dan Markingson, and her friend Mike Howard started a petition to Gov. Mark Dayton. Their request is simple: Please appoint an external, impartial panel to investigate the scandal. More than 1,200 people have signed, including well over 150 academic experts. Many University of Minnesota alumni have joined as well. A typical but telling comment: “I am ashamed of my alma mater right now.”

This is not an issue from the distant past. We do not know if other research subjects have died, or if they have been injured or mistreated. We do not even know if mistreatment is still continuing today. That may well be the most compelling reason for Minnesotans to sign the petition. If a case of research abuse this brazen can be sanctioned and defended by the university, there is no way to feel confident that other research subjects are being protected. In 2004 it was Dan Markingson. But it could have been any of us.

Source: Carl Elliott, "Why the University of Minnesota psychiatric research scandal must be investigated," MinnPost, March 28, 2013.