- BIOETHICS FORUM ESSAY
A Medical Student’s Call for Action Against Research Misconduct
Published on: June 3, 2014
Published in: Clinical Trials and Human Subjects Research
Is research misconduct and abuse the norm in the University of Minnesota’s Department of Psychiatry? A recent investigative report from KMSP News in the Twin Cities suggests that the answer may well be yes.
According to the KMSP report for which I was interviewed, in 2007 a psychiatric research team led by Dr. Stephen Olson enrolled a mentally ill young man identified as Robert into a clinical trial for the experimental antipsychotic drug bifeprunox. Robert told KMSP that he was incompetent to consent, and that the psychiatric team used the threat of a significant medical bill to pressure him into the study. Despite Robert’s concerns about the safety of the drug, which was not FDA-approved, researchers minimized the study risks. Dr. Olson specifically noted in his clinical record that he told Robert that “enough patients have been treated to be more sure of its safety.”
Soon after Robert entered the study, the FDA rejected bifeprunox for marketing approval. Within months the sponsor of the trial, Solvay Pharmaceuticals, stopped all research after bifeprunox was linked to the death of a study subject in Europe due to liver failure. There is no record that Robert was ever informed of these developments.
Robert’s condition worsened and he began having abdominal pain so severe that he considered suicide. After three trips to the emergency room, once by ambulance, Robert dropped out of the study. Dr. Olson told the study sponsor that Robert “decided to quit the study due to these psychosomatic Sx [side effects].”
Robert’s case is not an isolated one. His story bears striking similarities to that of Dan Markingson, who was recruited into an industry-funded antipsychotic trial at the University of Minnesota in late 2003, over the objections of his mother, Mary Weiss. Like Robert, Markingson was under the supervision of Dr. Olson and was repeatedly judged to be incompetent to consent to the trial. Unlike Robert, however, Markingson was under a civil commitment order that legally obligated him to obey Olson’s treatment recommendations. On May 8, 2004, Markingson committed suicide.
For over a year, Mary Weiss and her friend Mike Howard have been calling on Governor Mark Dayton to appoint an independent investigation of Markingson’s death and other possible research abuses. The petition has been signed by nearly three hundred experts in medical research, bioethics, and health law. A call for an independent investigation was endorsed by the university’s Faculty Senate last December. But there are still no signs that an appropriate, independent investigation will ever occur–at least, not without public pressure demanding accountability and an end to these ethical violations.
I am a first-year medical student at the University of Minnesota and deeply concerned that my own school would propagate and defend such abuse and disregard for patients. Two weeks ago, I took part in an action on the University of Minnesota campus to mark the 10th anniversary of Dan Markingson’s death. After a vigil outside the building where the university’s Board of Regents was meeting, four students in medical white coats brought a black coffin to the Board of Regents conference room, where we were blocked from entering by security guards and campus police officers. Shortly afterwards, a group of students, faculty members, and community members entered the board room and silently placed flowers on the desks of the Regents and University of Minnesota President Eric Kaler. Meanwhile, the chairman of the Board of Regents, Richard Beeson, issued threats into his microphone, demanding that those with flowers sit down or be removed from the room.
The University of Minnesota department of psychiatry has long history of unethical research dating back to the 1990s, when both the director of child and adolescent psychiatry and the head of the chemical dependency unit were disqualified by the FDA for separate instances of research misconduct (see here and here.) The stories of Dan Markingson and Robert provide evidence of an ongoing trend in the department involving coercion, intimidation, and corporate money. How many more cases of abuse must be revealed before any action is taken?
Medical students have a critical role in speaking out about ethical misconduct, advocating on behalf of our patients, and ensuring that appropriate care is provided to all–including mentally ill patients subjected to exploitation by the pharmaceutical industry and its research mills. I urge all concerned individuals to help put public pressure on Minnesota Governor Mark Dayton, the University of Minnesota’s Board of Regents, and President Eric Kaler. Not only do we need a legitimate independent investigation into the death of Dan Markingson, but we also need an answer to an ever-more pressing question: how many psychiatric research subjects have died or been seriously injured in psychiatric research studies at the University of Minnesota?
Make a call to Governor Dayton and Richard Beeson, the chairman of the Board of Regents, today and ask major donors to stop funding the University of Minnesota as long as these abuses continue.
Eden Almasude is a first-year medical student at the University of Minnesota.
Posted by Susan Gilbert at 06/03/2014 02:09:58 PM |