• The Markingson case and the future of health research

    Following the Second World War, there was a revolution in medical and research ethics. This revolution sought to establish the rights of patients and participants in research to make informed choices about medical treatments and research studies. Physicians, patients, and researchers now take these revolutionary changes for granted. The Markingson case, however, teaches us that change is fragile and that there is still much to do.

    Markingson’s story is tragic.

    Dan Markingson was a 26 year-old man from St. Paul and a recent graduate of the University of Michigan who began showing signs of mental illness in the summer of 2003. His thoughts became paranoid and delusional, and he became convinced that he was part of a vast cult, which was calling on him to murder people, including his mother. On November 12, 2003, Markingson was taken to Fairview Hospital in Minneapolis, where he was seen by Dr. Stephen Olson, a psychiatrist at the University of Minnesota. Olson recommended involuntary commitment, and a court agreed. Later, despite objections by his mother, Mary Weiss, Olson recruited Markingson into a clinical trial of antipsychotic drugs [being conducted by researchers at the University of Minnesota Department of Psychiatry]…

    Over the next five months Ms. Weiss repeatedly expressed her concerns about her son’s medical condition, especially his increasing agitation and rage. Her warnings were largely ignored. Finally, in desperation, she warned the study coordinator that her son might kill himself.

    On May 8, 2004, Markingson mutilated himself with a box cutter so violently that he nearly decapitated himself.

    Among other charges, critics of the University of Minnesota researchers allege that Markingson was coerced into the study by the threat of involuntary commitment, that he did not have the mental capacity to consent to the study, that he should not have been recruited given his risk of violence, and that the investigators ignored warnings that Markingson was in danger of committing suicide.

    The University argues that the case has been reviewed by the University’s attorney, the state of Minnesota, and the FDA and was cleared in each investigation. The matter is closed.

    So why isn’t the university’s argument good enough? First, many parties believe that the previous investigations neither asked nor answered all the relevant questions about the Markingson case. These parties include the University of Minnesota Faculty Senate and many leading international physicians and bioethicists, including Lancet editor Richard Horton, former BMJ editor Richard Smith, three former editors of the New England Journal of Medicine (Marcia Angell, Arnold Relman, and Jerome Kassirer), and Hastings Center co-founder Daniel Callahan.

    Second, the study was sponsored by Astra Zeneca, the manufacturer of Seroquel, the drug tested in the study. Astra Zeneca has a history of repeated convictions for deceptive marketing practices, including a $520 million fine for illegally marketing Seroquel to children and elderly patients. The psychiatrists who were in charge of the University of Minnesota site for the Seroquel study received large payments from Astra Zeneca.

    …state pharmacy board records [show] that Dr. Stephen Olson, the CAFE study’s principal investigator, received a total of $238,531 from the pharmaceutical industry between 2002 and 2008. Of that, more than half – $149,344 – came from AstraZeneca. According to pharmacy board records, Dr. Charles Schulz, who was Olson’s co-investigator and the chair of the university’s psychiatry department, received more than $570,000 from the pharmaceutical industry from 2002 to 2008. In his case, not quite as large a chunk came from AstraZeneca, only $112,000.

    The Minnesota psychiatrists had flagrant conflicts of interest between their income from Astra Zeneca and their duties to patients like Markingson. This is not evidence that they abused Markingson. However, a financial tie to a duplicitous organization does mean that the psychiatrists and the university that employs them should not be allowed to stand as judges in their own cases. The University must allow an open and independent investigation.

    Why is the issue of transparency and ethical review so important? It’s important because research ethics have to be built into the foundation of 21st century healthcare. 20th century bioethics sought to regulate interactions between individual physicians (and researchers) and their patients (research subjects). 21st century medicine is not about individual practitioners: it’s about large integrated, healthcare systems. Many of these systems are decorated with the brands of universities, but do not be deceived. The Enormous University Medical Center is not run collegially by its physicians and professors. It is a corporation, run like Exxon.

    The corporate organization of medicine is in many ways a good and necessary thing. We do not have another form of organization that can accomplish the required integration of care and systematic improvement of quality.

    But the corporatization of medicine will be a disaster unless it can incorporate elements of democratic governance. Research ethics can’t be in the foundations of 21st century medicine unless medical corporations can be held accountable. And there can’t be accountability unless there is transparency about how patients and research subjects are treated. Getting a complete and open investigation of the Markingson case is an important battle in a long war.

    @Bill_Gardner 

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