beyond the borders…

Posted on Tuesday 26 May 2015

If you follow these things, you’ve already read this NYT Op-Ed. But I’m still going to post it in toto as a testimony to people like Carl [and Mike and Mary and Leigh] who will persevere against any kind of gradient they meet until the job gets done. They intuitively knew that what happened to Dan Markingson was a lot more than just another tragic casualty of someone with Schizophrenia [as if that’s not bad enough]. They saw that it was a was a pointer to a whole system that was corrupted in a very specific way, and they were absolutely correct. Here, Carl focuses in on the piece of the system charged with ferreting out such things and protecting research subjects from things like this happening – the Institutional Review Boards. That was certainly not the only problem at the University of Minnesota, to be sure. But it’s the designated "cop" in the system, and it just didn’t function, not just with Dan’s case, but in general. It’s supposed to be an anchor, but at the "U", it was just another weak link in an altogether weak chain.
New York Times
MAY 26, 2015

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.

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. The problem extends well beyond the department of psychiatry and into the university administration. Rather than dealing forthrightly with these ethical breaches, university officials have seemed more interested in covering up wrongdoing with a variety of underhanded tactics. Reporting in The Star Tribune discovered, for example, that in the felony case, university officials hid an internal investigation of the fraud from federal investigators for nearly four years.

I hope that the situation at the University of Minnesota is exceptional. But I know that at least one underlying cause of our problems is not limited to us: namely, the antiquated bureaucratic apparatus of institutional review boards, or I.R.B.s, which are supposed to protect subjects of medical experimentation. Indeed, whether other institutions have seen the kinds of abuses that have emerged at the University of Minnesota is difficult to know, precisely because the current research oversight system is inadequate to detect them. The current I.R.B. system of research protection arose in the 1970s. At the time, many reformers believed the main threat to research subjects came from overambitious government and university researchers who might be tempted to overlook the welfare of research subjects. As a result, the scheme put in place for protecting subjects was not a formal regulatory system but essentially an honor code. Under the I.R.B. system, medical research studies are evaluated — on paper — by a panel of academic volunteers. I.R.B.s do not usually monitor research as it is taking place. They rarely see a research subject or even a researcher face to face. Instead, they simply trust researchers to tell the truth, report mishaps honestly and conduct their studies in the way that they claim to be conducting them

These days, of course, medical research is not just a scholarly affair. It is also a global, multibillion-dollar business enterprise, powered by the pharmaceutical and medical-device industries. The ethical problem today is not merely that these corporations have plenty of money to grease the wheels of university research. It’s also that 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. In what other potentially dangerous industry do we rely on an honor code to keep people safe? Imagine if inspectors never actually set foot in meatpacking plants or coal mines, but gave approvals based entirely on paperwork filled out by the owners.

With so much money at stake in drug research, research subjects need a full-blown regulatory system. I.R.B.s should be replaced with oversight bodies that are fully independent — both financially and institutionally — of the research they are overseeing. These bodies must have the staffing and the authority to monitor research on the ground. And they must have the power to punish researchers who break the rules and institutions that cover up wrongdoing. 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.
I’ve used borrowed metaphors ["weak link in a chain", "house of cards"]  but they’re simply figures of speech that don’t seem up to the task. The care afforded to research subjects should be held to a higher standard than what’s called "treatment as usual," simply because there are unknowns in the equation. In this case, and in others [see above], it was decidedly less. That just can’t be tolerated. They’ve finally shut down the operation, and the Chief of Psychiatry has been removed from two positions. But this problem goes much higher into the administration of the Medical School, the University, and the higher levels of those in charge of conducting this Clinical Trial – the Principle Investigator, the Drug Company, and the CRO [Quintiles]. Human experimentation is a privilege, never a right, or routine, or casual. And most Clinical Trial participants won’t have a Carl Elliot et al to champion their rights. In this case, one card falling is only creating a scapegoat and not likely to fix anything. This is an Augean stable that needs a thorough cleaning, even beyond the borders of Minnesota…
    Winge D. Monke, Ph.D.
    May 27, 2015 | 3:32 AM

    Carl Elliot’s work puts the bulk of investigative journalists to shame. Perhaps the competitive spirit will rouse some to sniff around other universities in search of the next revelation. It’s out there. –I haven’t read enough to know all the names, but here’s to Mike and Mary and Leigh, too.

    P.S. This just in from C. Elliot’s blog–an NYT comment by an RCT inspector.

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