March 26, 2013 | 41
This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues of “good clinical practices” and ethics: consent, investigator responsibilities and conflicts of interest. Then I examined the university’s response. In the most recent post, I turned to the importance of careful documentation of consent.
I’ve experienced research in a variety of settings, from the bench in my fellowship, where I was filtering spit and nasal washings for influenza antibodies detected via laborious cell cultures, to sleeker clinical trials. I’ve conducted extensive literature reviews for my basic science research and subsequent articles, in writing my text on clinical trials, and as part of my regular patient care practice. I’m good at digging for data. But my experience digging for the truth on this series about the CAFE study at the University of Minnesota (UMN) has led me to unanticipated new frustrations and an impasse.
In this episode of my series, I share in greater detail the evolution in my thinking about the UMN’s handling of the Markingson case.
As I noted in my last post, when I started reading about this case, it was as an academic endeavor, seeking a case study for my blog. I like reading and writing about ethical stories, using a person and story to illustrate research conduct. The Markingson case, like some others, was peripherally on my radar. As I read, I became engrossed in the sleuthing as well as the tragic story, in figuring out the puzzle of “he-said-she-said.” I dove into depositions and started a timeline and spreadsheet to keep details straight. I never spoke to the principals…until March 8.
Wanting to put a more human face on my writing, that day I attempted to call several faculty members at the UMN to ask for their perspective. Only one person returned my call, politely telling me that all calls would have to be directed to Mark Rotenberg, the university’s general counsel. He didn’t return my calls either. So I e-mailed him with my questions for my most recent post. That evening, I received a call from Justin Paquette, PR Manager for the Academic Health Center and the spokesperson for this case. I asked Paquette essentially the same things I had attempted to ask Rotenberg, and received disconcerting and evasive answers.
For example, as noted in my last post, there are questions raised about discrepancies in HIPAA (Health Insurance Portability and Accountability Act) forms. In a 2007 deposition of Dr. Stephen Olson, Dan Markingson’s attending physician and study investigator, Mary Weiss’ attorney notes (p. 144-5) that they (neither Weiss nor her legal team) had never been given a signed copy of the HIPAA form. In the deposition, Olson indicated that he didn’t know if there was a signed copy or, surprisingly, what the consequences were if they had not obtained a HIPAA consent. (Understanding the legal requirement to obtain a permission to access medical records, or HIPAA consent, and that failure to do so might be considered a felony is a basic concept I thought researchers were uniformly familiar with).
Yet, in response to a complaint by Mike Howard (close family friend of Dan’s mother, Mary Weiss) alleging misconduct by Dr. Olson, a signed form unexpectedly appeared in 2011—although the Fairview Hospital (the UMN campus where Dan had been admitted) medical records department certified that it didn’t have a copy of this on Dan’s chart.
Furthermore, Rotenberg’s own letter in response to Mike Howard’s complaint to the Board of Regents about Dr. Olson, states at one point that the HIPAA consent was signed November 24, yet later notes that Dan consented to participation in the trial on November 21. A date discrepancy. Rotenberg’s letter acknowledges that the HIPAA consent occurred days after Dan’s enrollment, suggesting a significant breach and possible felony.
Even if we accept that the signed HIPAA form was perhaps misfiled, I have yet to receive a response to my question about how Dan was enrolled on a trial three days before he gave consent for his records to be reviewed.
I asked Rotenberg and Paquette about the discrepancy in the evaluation to consent forms, one with a Bates number (used to identify medical and legal documents), one without. Again, they provided no explanation.
Down the garden path…
There was one response from Paquette that was particularly disturbing, given that he should be very familiar with this trial. Regarding Dan Markingson’s competency, Paquette tried to assure me that “the Court” had declared Dan competent to consent to this trial and had agreed to Dan’s participation. I countered that David Pettit, the case manager, didn’t even see Dan until 10/26/03, five days after he was enrolled on the trial. Surprisingly, Paquette reiterated it wasn’t Pettit, that “the Court had agreed to Dan’s participation.”
Perhaps this was an innocent slip of the tongue or memory. I would have expected the University’s spokesperson for this trial for several years to be more familiar with major details that are recurrently raised, and to be able to provide documents to refute specific concerns. But Paquette and Rotenberg have received multiple e-mails and calls from me since March 8 asking about this point, and have yet to provide any documentation of this claim.
I wonder if that is because there is none. In fact, Dr. Olson (deposition pages 78-79) makes the statement that he never informed the court about Dan going into the study…only that Dan’s county case manager approved it…who was never appointed until days after Dan was signed and enrolled on the trial.
That brings us to the next episode…
After reviewing the deposition again, I wondered if Paquette had deliberately misled me.
So I wrote a letter to Ben Garbe, an assistant attorney general who had represented the Minnesota Board of Social Work in their mild rebuke of the study coordinator. I raised my concerns about the puzzling responses from the university and the lack of transparency, including failure to provide documents to verify their claims.
I expressed my concern about the thinly veiled threats toward faculty. It’s not just Dr. Elliott, the University of Minnesota Professor of Bioethics and most persistent critic of the University’s handling of this case. After all, if you ask questions, you are likely to be accused of making allegations—rather than trying to understand all sides, as General Counsel Rotenberg described Elliott’s media outreach efforts. (Mr. Rotenberg notably asked the university’s Academic Freedom and Tenure Committee to address “What is the faculty’s collective role in addressing factually incorrect attacks on particular University faculty research activities?”)
This question was widely interpreted as targeting Dr. Elliott and challenging academic freedom.
Additionally, if, as the UMN asserts there is nothing to hide, why instruct faculty not to speak with me? Or why are faculty not returning calls? Of course, typically, lawyers advise those involved in an ongoing lawsuit to refrain from speaking to the media. Such proceedings could be behind any evasiveness.
Even some other people who have expressed concern about the UMN’s behavior toward their family members have been reluctant to share more details with me, referring to admonitions from their attorneys.
And Garbe’s response? Astonishingly, he referred me back to the General Counsel’s (Rotenberg’s) office to investigate my concerns about that very office!
Some days I feel like I’m lost in a fun house with mirrors distorting everything beyond belief.
And that, dear readers, is why I have signed on to the petition to ask Minnesota Governor Dayton to launch an independent investigation of possible research misconduct in the psychiatry department of the University of Minnesota. I personally feel that multiple trials conducted by Drs. Olson and Schulz’ team should be examined, including the CATIE trial, which involved NIH. So far, 1,200+ people have signed on, from all over the world, including prominent ethicists and historians, Susan Reverby (the historian who brought unethical syphilis experiments in Guatemala to light), and three former editors of the New England Journal of Medicine. As Dr. Reverby noted, “It is imperative that when injustice happens it be acknowledged and investigated. This is not something we must do only for the past.”
see also: Petition to Gov. Mark Dayton of Minnesota to investigate psychiatric research misconduct at the University of Minnesota – started by Mike Howard (Dan Markingson family friend).
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