In a blistering op-ed in the New York Times today, a University of Minnesota bioethics professor says the rot that infected an industry-funded anti-psychotic drug study, leading to the suicide of a research subject, extends beyond the department to the administration.
Carl Elliott writes that the U administration is much more interested in the cover-up than in fixing the systemic issues that have embarrassed the department of psychiatry.
And the issues, as he describes them, provide a cold bucket of water.
Over the past 25 years, our department of psychiatry has been party to the following disgraces: a felony conviction and a Food and Drug Administration research disqualification for a psychiatrist guilty of fraud in a drug study; the F.D.A. disqualification of another psychiatrist, for enrolling illiterate Hmong refugees in a drug study without their consent; the suspended license of yet another psychiatrist, who was charged with “reckless, if not willful, disregard” for dozens of patients; and, in 2004, the discovery, in a halfway house bathroom, of the near-decapitated corpse of Dan Markingson, a seriously mentally ill young man under an involuntary commitment order who committed suicide after enrolling, over the objections of his mother, in an industry-funded antipsychotic study run by members of the department.
And those, unfortunately, are just the highlights.
Elliott writes that while he hopes the U of M is an exception, he thinks the system that oversees medical research and is supposed to protect subjects of medical experimentation is inadequate.
The system is from an earlier time, when medical research was scholarly, not a multi-billion-dollar operation. The researchers themselves have financial incentives to be unethical, pressuring subjects to enroll in studies, “fudge diagnoses to recruit otherwise ineligible subjects and keep subjects in studies even when they are doing poorly.”
There’s very little about the suicide of Dan Markingson that passes a smell test. He didn’t want to be in the study, but he was threatened with involuntary commitment if he didn’t.
Here at the University of Minnesota, we have reached a critical point. Two months ago, after two blistering external investigations, university officials finally agreed to suspend recruitment for psychiatric drug studies. Yet they still refuse to admit any serious wrongdoing.
An honor code is a fragile thing. All the parts have to be in place: pride in the integrity of an institution, vigilant self-policing, a collective sense of shame when the code is violated and a willingness to punish those who break it. At the University of Minnesota, we have very few of those things. And so without sustained, relentless pressure from the outside, I am afraid we are doomed to more of the same.
Only the U administration seems unable to see the ethical vacuum there. In March the legislative auditor cited conflicts of interest by researchers and said the administration has been “misleading.”
“The insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation,” James Nobles wrote.
Meanwhile, the Star Tribune reports today that private businesses are driving U of M research efforts in a huge variety of areas. It’s likely to raise more questions about conflict of interest in scientific research, the paper says.
Related: University of Minnesota Blasted for Deadly Clinical Trial (Mother Jones).
Dan Markingson case finally yields real reforms at the U (Star Tribune).
U’s Kaler responds to critics over Markingson case (Minnesota Public Radio News).