Carl Elliott attacks FDA investigation of Dan Markingson suicide

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.

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.

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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