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The Markingson Files: University can't control the story of a clinical trial suicide
May 11, 2011
A war of words has erupted at the University of Minnesota campus over bioethics writer and UM professor Carl Elliott's reporting into the suicide of a schizophrenic patient enrolled in a clinical trial.
It has pitted the university's general counsel against Elliott and a group of outspoken faculty members who have been pushing for a larger investigation into the death of Dan Markingson.
For those who haven't been following closely, Dan Markingson killed himself in 2003 at the age of 26 during a clinical trial for the anti-psychotic drug Seroquel. Elliott, who talked about the case with Antidote in March, wrote about Markingson for Mother Jones. Elliott used the case as a touchstone to examine the broader issue of whether clinical trials were being subverted purely for marketing aims and, therefore, putting patients at unnecessary risk:
The documents emerging in litigation suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to "generate commercially attractive messages"?
Because Elliott has repeatedly named the doctors who treated Markingson, Dr. Charles Schulz and Dr. Stephen C. Olson, his fellow professors at the University of Minnesota, his writings have made for an uncomfortable situation on campus.
In the past few months, discomfort has spilled over into what Elliott and his supporters feel is an actual attempt to shut him up.The university's general counsel, Mark Rotenberg, in February asked the university's Academic Freedom and Tenure committee to take up the question of whether a faculty member writing about another faculty member and using factually incorrect statements should be protected by academic freedom.
Rotenberg told Tushar Rae at The Chronicle of Higher Education, ""The faculty, as a collective body, should take an interest in attacks on their members that serve to deter or chill controversial research."
The fact that Rotenberg would question whether academic freedom was broad enough to protect inquiries such as Elliott's was met with strong criticism. At the law blog, Corporate Counsel, two prominent attorneys were recently quoted going directly after Rotenberg.
"The question is absurd on its face, since it assumes exactly what academic freedom exists to protect, namely, free inquiry into what the facts are, whether about faculty work at the University of Minnesota or anywhere else," said Brian Leiter, a professor at the University of Chicago Law School and director of the school's Center for Law, Philosophy & Human Values. "The general counsel of a university should be standing up for the freedom of researchers to investigate controversial matters, even controversial matters at the university itself."
And Naomi Scheman, a professor of philosophy at the University of Minnesota wrote Corporate Counsel to say that "the clear implication is that the articles and letters from Carl Elliott and members of the University's Bioethics Center contain ‘factually-incorrect attacks.' .This presumption is inappropriate and prejudicial. By using the material related to the Markingson case as an example of factually incorrect attacks, the general counsel is characterizing as settled fact what is in dispute. This action serves to create problems of academic freedom where there were none."
Rotenberg contacted Corporate Counsel to say that he had been misunderstood, and he noted that the academic freedom question was just one of many that he had asked the faculty committee to consider. The full list of questions, according to an email he forwarded Corporate Counsel, was:
1. How thoroughly has the Markingson case been addressed by the U and by outside agencies?
2. What is the faculty's collective role in addressing factually incorrect attacks on particular U faculty research activities?
3. To what extent is U medical/health research dependent upon corporate funding? Is this typical of major research universities in the US/worldwide? How much of such research involves human subjects?
4. What risks and challenges are posed by increasing reliance on corporate funding of this type of research?
5. What policies and procedures are in place at the U to address these risks and challenges? Are there policies and procedures at other major institutions, or under consideration elsewhere, that we should adopt here?
As noted above, one of the recurring themes in this discussion is whether Elliott has been factual. His Mother Jones piece was fact-checked, and, to date, none of the physicians or university officials involved has challenged any specific facts in his reporting. They may not like the conclusions he draws from the facts – mainly that the Seroquel trial was only conducted as a marketing exercise with little to be gained for the patients involved – but they can't call his reporting "factually incorrect."
I asked both Elliott and the university for key documents that would tell the story of the Seroquel trial, Markingson's death and the fallout. Reporting accurately on a clinical trial can be a tricky business because of the complexities of the science, the varying levels of conflicts of interest that the researchers involved may have and the necessity to place the latest research into the proper context with existing research. What Elliott was able to do with the Markingson case was not only tell the story of a tragedy but also to illuminate ways other health writers might dissect similar trials.
In upcoming posts, I intend to highlight some of the documents involved in the case to help explain how a story like this can be told well and why this particular story has created such a firestorm.