Health News Review

The following is a guest post by Carl Elliott MD, PhD, a professor in the Center for Bioethics at the University of Minnesota and a writer with credits many journalists would envy.

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Five years ago, the St. Paul Pioneer Press reported the violent death of Dan Markingson in an industry-sponsored antipsychotic study at the University of Minnesota.  Markingson was a mentally ill young man under an involuntary commitment order who had been recruited into the study in 2003 despite the objections of his mother, whose warnings that he was in danger of killing himself were ignored.  In the years since then, the University of Minnesota officials have beaten back the most vocal critics of the study (including me) with a single, unwavering refrain, which can be summarized as: “We have been investigated repeatedly, and we have been exonerated.”  University officials will not discuss the issues; they will not debate their critics; they will not address the facts.  In their view, the case is closed.

Remarkably, many reporters have often simply transcribed this exoneration claim without even bothering to find out the truth.  Is the claim of exoneration valid?  For the most part: no, it’s not.  But it can be difficult to separate the truth from the spin.  Let’s look at each official body alleged to have investigated the university and see what the evidence for exoneration is.

Claim 1: The University of Minnesota’s Institutional Review Board (IRB)

Although university officials claim that the IRB investigated Markingson’s death, they have never produced a written report or any other evidence of an investigation.  (The IRB is the university body charged with protecting human subjects in research.)  In fact, Richard Bianco, the university official responsible for overseeing research subject protection, testified in a deposition that the IRB did not investigate.   Consider the following passages from his deposition.

Q: Has the IRB done any investigation into the death of Dan Markingson?

A: Not a formal investigation, no.

Q: Has the university done any investigation into the death of Dan Markingson?

A: No.

And later:

Q: To the best of your knowledge, did anyone at the IRB, at the University of Minnesota, or anyone under your office investigate this case, actually look at the records and see the court documents that I’m describing, and if so, could you give me the name of that person?

A: Not to my knowledge.

Q: Nobody did that.

A: No.

Claim 2: The Hennepin County District Court

Presumably this claim refers to the lawsuit filed by Mary Weiss against the University of Minnesota IRB and Board of Regents in Hennepin County.   The university won summary judgment by successfully arguing that is was “statutorily immune” from liability.  But immunity does not translate to exoneration.  Far from it, in fact: to ask a court for immunity is to ask it to dismiss a legal claim without mounting a defense.  As Matt Lamkin has pointed out on the Stanford Law and Biosciences blog, to claim that the immunity ruling exonerated the university is “like a diplomat claiming he was ‘exonerated’ for murder by virtue of diplomatic immunity.”

Claim 3: The Minnesota Board of Medical Practice

Mary Weiss filed complaints to the Minnesota Board of Medical Practice about Dr. Stephen Olson, the University of Minnesota psychiatrist who recruited Markingson into the study, and Dr. Charles Schulz, the chair of the Department of Psychiatry and co-investigator for the study.  The Board of Medical Practice replied with form letters saying that “the facts of the case did not provide a sufficient basis for the Board to take disciplinary or corrective action” against the licenses of Olson or Schulz.  Put aside for a moment that there is no publicly available report of the Board’s findings, or even any statement about what exactly it investigated.  Also put aside the fact that when it comes to disciplining doctors, the Minnesota Board consistently ranks among the worst in the country.  The important thing to note here is this: a medical licensing board has no authority to investigate a university or an IRB.  It is at best misleading (and at worst, false) to claim that the board found no fault with the university or that it cleared the university of research misconduct.

Claim 4: The Office of the Attorney General of Minnesota.

Again, university officials have never been able to produce any reports or documentation from the Attorney General’s office, or any other evidence that the office exonerated the university.  It is true that the Attorney General’s office can investigate complaints on behalf of the state’s licensing boards.  (For example, the “corrective action issued against study coordinator Jean Kenney was signed by Assistant Attorney General Benjamin Garbe.)  And some early statements from university officials merely suggested that the Attorney General’s office “assisted” the Board of Medical Practice, rather than claiming (as it did later) that the Attorney General’s office found no fault with the university or its faculty members.  Apparently, as the claim of assistance was repeated over time, it ballooned into a full exoneration.

Claim 5:  University of Minnesota Office of General Counsel

This claim in the Minneapolis Star Tribune, made by  Dr. Aaron Friedman,  the vice president for health sciences and dean of the Medical School at the University of Minnesota, may be the strangest of all.  It appears to suggest that the Office of General Counsel is somehow an impartial investigative body.  Nothing could be further from the truth.  Not only did the Office of the General Counsel defend the university in the lawsuit brought by Mary Weiss, it has also served as the de facto public relations office for the university’s version of the case.  It is true that Mark Rotenberg, the General Counsel, responded in writing to a complaint to the Board of Regents by University of Minnesota faculty members.  But to claim that his letter counts as an impartial investigation borders on the ludicrous, which is why it generated headlines such as University exonerates itself over Seroquel trial.”

Claim 6: The Food and Drug Administration

This claim is the only accurate one.  In early January 2005, in response to a complaint filed by Mary Weiss and her friend Mike Howard, Sharon Matson of the FDA conducted a site inspection and data audit of Stephen Olson.  The FDA issued an Establishment Inspection Report on July 22, 2005 and found “no evidence of misconduct.”

That said, I am not the only one to point out that the FDA produced a flawed, strikingly superficial report.  Matson never even interviewed Mary Weiss.  Among other things, she makes no mention of the fact that Markingson was threatening homicide, no mention of the many documented independent judgments that he was mentally incapable of making his own medical decisions, and no mention of his mother’s objections to his enrollment in the trial.  Matson also reports there was no evidence that Markingson’s condition was deteriorating — despite his mother’s explicit warnings that he was in danger of committing suicide.

To summarize: of the six investigations that university officials claim as exonerations, two do not exist; another was a legal immunity judgment rather than an investigation; a third was not an investigation of the university or its IRB; and another was simply a letter written by the same university attorney who defended the university in court and proclaimed everyone innocent.  Yet reporters have consistently reported these claims as if they were true.  Why?

Your guess is as good as mine.  Some reporters may simply be gullible, especially when they are dealing with the General Counsel for the university.  Another reason may be the complexity of the truth.  It takes a fair amount of work to sort out the falsehoods, the half-truths and the spin in these blanket claims of exoneration.  And of course, once a series of half-truths have appeared and gone unchallenged, it is easier to rely on those rather than do your own fact-checking.

Some fault also lies with me and others who know the facts of the case well.  Many of these mistakes appear in otherwise excellent articles, and I am often reluctant to correct reporters for mistakes that might seem small in comparison.  And of course, many newspapers do not welcome those calls.  When I asked the Minnesota Daily to correct its claim that the university IRB found no evidence of research misconduct, the managing editor simply refused.

The cumulative effect of all these mistakes has been enormously harmful.  Over the past year a series of events have put the Markingson case back in the spotlight.  In November 2012, a “corrective action” by the Minnesota Board of Social Work revealed serious wrongdoing by Jean Kenney, the study coordinator for the trial in which Markingson died.   Over the past two months, an online petition to Governor Dayton calling for an external investigation has gathered momentum, with signatures and endorsements from some of the most prominent medical experts in the world, including the editor of The Lancet and three former editors of The New England Journal of Medicine.  Yet through it all, university officials have gone unchallenged as they claim to have been cleared of wrongdoing.

It is probably naïve to expect reporters to correct the record now.  But I hope that as the public demand for an impartial, competent investigation of research misconduct continues to grow, the facts will be reported correctly.

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Comments

Mike Howard posted on May 24, 2013 at 10:39 am

I guess the General Counsel at the University of Minnesota never got the memo that the state legislature passed “bullying” law’s. The University has used it’s undue influence to intimidate and ridicule anyone that suggest’s wrongdoing on it’s part, and has a storied history of clinical trial fraud, and human subject misconduct.

Carol Countryman posted on May 27, 2013 at 4:40 pm

This reads like something that would happen in Russia. It is terrifying! I would guess that money was behind the study; is money still the reason the university continues its immoral, unethical and outright duplicitous claims? I am grateful to Dr. Elliott and Gary Schwitzer for bringing this to a lay audience far from Minnesota. Certainly I am in no position to prevent something similar from happening (or probably even to recognize it), but it is a reminder that those in positions of power do not necessarily exercise it honorably.