It would be hard not to know about the case of Dan Markingson, a young psychotic man who killed himself while in a clinical trial at the University of Minnesota in 2004 [see A referenced summary of the Dan Markingson case]. Bioethicist Carl Elliot at UM has kept us abreast of the ongoing attempts to block any thorough investigation of the case on his blog Fear and Loathing in Bioethics. In a recent post, Carl mentions a presentation at an ethics conference that defended the handling of the Markingson case by UM.
Fear and Loathing in Bioethicsby Carl ElliotDecember 16, 2014
Well, no conflict of interest unless you count a $13,781 fee paid by the University of Minnesota to give expert testimony on this exact issue. So yeah, if you want to get all technical and everything, then I guess that might count as a conflict. But can you really expect a research ethics expert to keep up with arcane issues like conflicts of interest? I mean, come on.
Well, Ernest Prentice had another problem besides his unacknowledged conflict of interest. He neglected to scope out his audience at the conference before he stepped into it, feet first…
Ernest Prentice, an associate vice-chancellor at the University of Nebraska, seems to have trouble with conflicts of interest, and not just his own. According to Dr. Judy Stone, who attended Prentice’s talk on the Markingson case at this year’s PRIM&R meeting, Prentice also claimed to be unaware of the astonishing conflicts of interest on the IRB whose performance he defended…
He apparently didn’t notice that Dr. Judy Stone who has written extensively about the Markingson case in Scientific American was sitting in the audience…
Scientific AmericanBlog: Molecules to Medicineby Judy StoneDecember 15, 2014
This Blog by Dr. Stone is a must-read, both because it adds to the facts about the Markingson case, but also because it is a classic take-down of Goliath proportions. An old mentor once told me, "Know your audience." And it is likely that Ernest Prentice has learned the wisdom of that advice first hand [in the Q&A that followed his talk]…
The higher-ups apparently think that they can get the Markingson case to go away. But that’s never going to happen. The ethical issues are too fundamental. As much as people love to debate about medical model[s] of disease and evidence-based medicine, medicine itself is much older that these scientific methods. It rests on two ancient intertwined principles:
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Aesculapian authority: Authority is granted to the physician with the implicit contract that it will be used in the service of the patient, and for no other reason.
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Primum Non Nocere: "First, do no harm." This injunction comes from antiquity and essentially says that there will be vigilance for anything that will hurt the patient, including therapeutic zeal.
In the case of Dan Markingson, it is obvious that there was betrayal of both of these principles. Dan was quite ill with a disorder that carried a guarded prognosis – Paranoid Schizophrenia with florid delusions of manifest lethal content. The physician recommendation [Aesculapian authority enforced by judicial authority] was not driven by his needs, but rather by the physician’s need to populate a clinical drug trial. And there is no question that the patient was harmed by being given only a maintenance dose of a blinded medication for six months with no apparent response to the treatment. So Dan was involuntarily committed to a treatment plan that would never have been suggested for him had it not been part of a clinical trial protocol to study maintenance medication. As he had never really responded, there was nothing to maintain. And one can hardly claim that his one doctor’s visit per month is anything like the necessary vigilance.
The usual topic of this blog is the betrayal of these principles by an academic journal, its authors, a pharmaceutical company, or a regulatory body that provides misinformation to patients and physicians about a drug or treatment. The cause is invariably related to conflicts of interest involving money. This case has those same roots, but is at the other end – the process of generating the information. So not only was Dan betrayed as a sick person, but the clinical trial was betrayed by including a subject that didn’t belong. The UM administration, the involved doctors, even the presenter at the conference above, all make the same argument, "We did nothing wrong." While that’s not true, it’s not even the point. They accepted the medical responsibility for Dan Markingson, but they did nothing medical. And that’s why this case won’t go away…
http://www.startribune.com/local/286469611.html
I’ve lived in two houses— a student housing co-op and a boarding house— which each housed a person with schizophrenia. Neither one of them fit the description “Paranoid Schizophrenia with florid delusions of manifest lethal content.” It appears to me that the University of Minnesota put a lot of people at risk. The lack of basic human concern, much less professional psychiatric concern for everyone involved in the actual carrying out of this study is stupefying. What were they thinking?
happy new year, old balls.
love your blog.