If you want to see just how long an academic institution can tolerate a string of slow, festering research scandals, let me invite you to the University of Minnesota, where I teach medical ethics.
His list of major problems in the U’s psychiatry department includes:
- 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.
- The 2004 suicide of Dan Markingson, a seriously mentally ill young man under an involuntary commitment order enrolled, over the objections of his mother, in an industry-funded antipsychotic study run by members of the department.
While university officials have suspended enrollment in psychiatric drug trials, Elliott says it isn’t enough, because officials haven’t admitted serious wrongdoing.
He says the ethical problem arises because “global, multibillion-dollar business enterprise, powered by the pharmaceutical and medical-device industries” have “plenty of money to grease the wheels of university research” and because “researchers themselves are often given powerful financial incentives to do unethical things: pressure vulnerable subjects to enroll in studies, fudge diagnoses to recruit otherwise ineligible subjects and keep subjects in studies even when they are doing poorly.”
Existing institutional review boards, working basically through an honor code, aren’t enough, he concludes.
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.