Carl Elliott attacks FDA investigation of Dan Markingson suicide

Categories: U of M

Carl Elliott 200.jpg
Courtesy Carl Elliott.
Elliott calls the FDA's report a white wash.
Carl Elliott, a University of Minnesota bioethics professor, is attacking the findings of a Federal Drug Administration investigation that cleared the college of any wrongdoing in the 2004 suicide of Dan Markingson, a patient enrolled in a clinical trial.

Elliott authored a column published in Bioethics Forum yesterday, calling the FDA's report on its investigation of the case "misleading, remarkably uncritical, and often simply baffling."

The U of M's Board of Regents recently cited the FDA's findings as one reason to not initiate an investigation into whether ethical lapses contributed to Markingson's suicide.

"If the university is going to use this FDA inspection report as an excuse not to look into the suicide, then the public ought to be able to see the report itself," says Elliott. "And if you look at it alongside the records and documents from the case, it's not hard to see that something went badly wrong."

In his column, Elliott suggests the FDA should have been more critical of whether Markingson was coerced into consenting to the study. The 26-year-old patient was under a stay of commitment at the time, meaning he would have been sent to inpatient treatment if he didn't agree to his doctor's alternative plan, which in this case involved enrolling in the study.

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Elliott goes on to ask whether Markingson was even mentally fit to consent to the study:

What the FDA inspector failed to note is that during the period leading up to his enrollment, Markingson had been repeatedly judged incapable of consenting to neuroleptic drugs. On November 14, 2003 Dr. Olson signed a commitment document stating that Markingson "lacks the ability to make decisions regarding such treatment." On November 17, a pre-petition screening team recommended commitment, noting Markingson's bizarre beliefs and his refusal to acknowledge his mental illness.

The column continues by criticizing what the FDA left out of its report.

In most cases, antipsychotic drug trials will not accept patients with a high risk of violence, says Elliott. Markingson had been committed to the hospital after sharing plans to attend a devil worshipping event in Duluth, where he would likely be called upon to commit murder. He even spoke about killing his own mother. Elliott asks why this was not addressed by the FDA:

If the exclusion criteria had excluded potentially violent subjects, Markingson could not have been enrolled in the trial; he had been involuntarily committed precisely because he was potentially homicidal. In fact, at the time of his enrollment, there seems to have been broad agreement that he was at high risk of acting out his delusions.

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Courtesy Mary Weiss.
Markingson brutally killed himself in 2004 while enrolled in a U of M study.
Elliott also references City Pages February 2 cover story, Dr. Mindbender, which examined the U of M psychiatry department chair's relationship with drug companies.

For years, Elliott has suggested that ethical lapses on part of U of M researchers may have contributed to Markingson's suicide.

Elliott outlined his argument in an article for Mother Jones last year, "The Deadly Corruption of Clinical Trials."

He also recently authored a book -- titled "White Coat, Black Hat: Adventures on the Dark Side of Medicine" -- on the relationship between researchers and drug companies.

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1 comments
Dr. Rational
Dr. Rational

I think this whole episode brings to light an important and significantproblem that we have at the University that I believe should be correctedpost-haste.

Professors without enough work to do.

The facts in this case are clear:

A young man was deemed so unfortunately deranged as to need involuntarycommitment (the rest of his medical history is unknown to the generalpublic - but given that milder psychoses are common we might safely assumethat her was either a repeat or profound problem).

He was treated with a trial medication meant to help.

He was discharged - which we can safely infer means he got (at least alittle) better

He later took his own life (or was, unbekownst to us, murdered in such afashion as to make it look like suicide)

Multiple internal and external reviews suggested there was neither anethical or medical lapse.

THOSE ARE THE FACTS - PERIOD.

What has been suggested and remains the current position of the(overemployed) professors are wide ranging allegations supported myinnuendo and Mother Jones Magazine (I am not joking here - that was therefence used in the actual letter).

These allegations resulted in significant academic and potentially researchproblems for investigators dedicated to the care of a population that isboth desperate for help and extremely difficult to study. Interestingly,while this is the academic equivalent of yelling "fire" in a crowdedtheater, and ALL participants have been cleared of ALL charges - I amunaware of any disciplinary action against the the real criminals in thiscase (who you should know are largely being supported by your tax dollars).

Worse, these turkeys have repackaged their arguments and recruited anothersmaller raft (that is a small collection of turkeys) from the geography andcommunications department who have seen fit to ignore the data as well -while the University people who are attempting to downplay this embarassinglack of integrity are subjected to excoriation on this site .

The outcome here is bad, that's true. But as anyone who has ever dealt withthis population (I have) will tell you - the range of outcomes oftenextends to terrible and rarely to great. Self destruction is common inpsychotic patients. This is not a reason to stop trying to help - butrather a reason to work harder. And the notion that this sort of think"should never happen again" is great in the same way that we should neverhave another plane crash, terrorist attack, or car accident.

At the end of the day what happened here I will grant was probably wellintentioned - but that does not remove culpability from the accusers. Theyhave hurt a program devoted to the care of profoundly sick people andshould answer for their actions.

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