… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Monday, April 15, 2013
Will no one rid me of this meddlesome priest?
Why the Administration of the University of Minnesota loves Carl Elliot...
As does the departing General Counsel
From the Minnesota Daily
How we have betrayed research subjects
Carl Elliott — professor, University Center for BioethicsApril 15, 2013
It has been five years since the Pioneer Press reported the disturbing sequence of events leading to the suicide of Dan Markingson in a psychiatric research study at the University of Minnesota. During that period, it is hard to say which development has been more remarkable: the indifference of the University community or the torrent of international condemnation.
“I have been following this story, open-mouthed, as it has unfolded,” writes Iain Brassington, a medical ethicist at the University of Manchester. According to Richard Smith, the former editor of the British Medical Journal, “There is clear evidence that things went badly wrong.” Susan Reverby, the Wellesley historian who uncovered the Guatemala syphilis studies, has called for an external investigation, as well as the former editor of the New England Journal of Medicine, the editor of The Lancet and the former editor of the Health and Disability Commissioner of New Zealand.
An editorial in the Medical Journal of Australia has compared the scandal to the Tuskegee syphilis study.
Helen Longino, a faculty member in the University Department of Philosophy for years before moving to Stanford University, has written, “Do you really want the great University of Minnesota to become an academic pariah?”
The answer, apparently, is yes. On campus, there have been no protests, no outraged letters and no calls for accountability. And now that General Counsel Mark Rotenberg is heading for the exit door, we are not even hearing the customary denials of responsibility.
The case itself has become notorious.
In late 2003, Dr. Stephen Olson and his study coordinator, Jean Kenney, recruited a mentally ill young man named Dan Markingson into a highly profitable, industry-funded clinical trial of antipsychotic drugs despite the objections of his mother, Mary Weiss. Not only had Markingson been repeatedly judged mentally incapable of making his own medical decisions, he had been placed under a civil commitment order that legally compelled him to obey Olson’s recommendations.
As Markingson’s condition spiraled downward, his mother tried desperately to get him out of the study, at one point warning the study coordinator. Her pleas were ignored. In May 2004, Markingson violently killed himself. His body was found in the shower of his halfway house with a note that said, “I left this experience smiling.”
This research study had red flags all over it: conflicts of interest for the investigators, financial incentives to keep subjects in the study as long as possible, a dubious scientific rationale and an industry sponsor that was eventually forced to pay $520 million in fraud penalties. Perhaps most astonishing of all, when a lawsuit by Mary Weiss against the University was dismissed on grounds of sovereign immunity, the University filed an action against her, demanding that she pay the University $57,000 in legal costs.
The University never investigated Markingson’s suicide, according to the deposition of Richard Bianco, the former head of research protection, and during the five years since the death became public, the official stance of the University has been: Stonewall, evade, deny. Last fall, the Minnesota Board of Social Work found that Jean Kenney, the study coordinator, had failed to warn Markingson about new dangers of the study drugs, performed duties that have exceeded her training and falsified the initials of doctors on study records. It is likely that Kenney’s misconduct affected other research subjects, yet the University is still pretending that there is nothing to investigate.
Last month, Weiss and her friend Mike Howard started a petition on change.org to Gov. Mark Dayton asking for an external investigation. The petition has attracted more than 2,000 signatures, 175 of them from scholars in medical ethics, clinical research and health law.
The administration has portrayed Markingson’s suicide as an isolated episode from the past. In fact, we don’t know whether other subjects have died, been injured or been mistreated — and unless there is an investigation, we will never know. The Department of Psychiatry has had major research scandals in the past, and the public only learned of them after years of cover-ups and deception by University officials.
If anyone has a duty to make this shameful episode right, it is the faculty and students of the University. Please join Weiss and Howard in their petition to Dayton.
The petition may be found here.
at 12:10 AM