Matt McGeachy 45 Chelsea Avenue Toronto, Ontario, Canada M6P 1B9 February 19, 2015 Dear Legislator: I am writing to you today to express grave concerns over serious allegations of breaches of research ethics at the University of Minnesota. As the Legislature moves forward with the selection of new Regents of the University of Minnesota, I am compelled to write to you to share a number of my concerns. I received my MA in the History of Science, Technology, and Medicine from the U in 2011, and for the 2010-2011 Academic Year, I served as a Student Representative to the Board of Regents. In my capacity as Student Representative, I sat as a non-voting member of two committees (Audit and Educational Policy & Planning) and regularly participated in these meetings to provide the student perspective to the deliberations of the Board and its committees. I also attended full meetings of the Board, and actively participated in the contribution of the regular semi-annual Report of the Student Representatives, where we presented issues of significant student concern to the Board. As you are aware, in 2004 Dan Markingson committed suicide while enrolled in a clinical trial at the University of Minnesota Department of Psychiatry despite desperate attempts by his mother, Mary Weiss, to have him removed from the study as she witnessed the serious decline in his mental state. This trial of a psychiatric drug from AstraZeneca raises some serious questions about the ethical lapses at the U that led to the death of a patient enrolled in a pharmaceutical trial. I would like to offer you my perspective as a former Student Representative to the Board on the following: the serious questions about the University’s claims that the matter has been seriously investigated and that the U has been cleared of any wrongdoing; my own experiences in attempting to bring this matter to the attention of the Board of Regents and the University’s censoring of a report from the Students Representatives; and what I would describe as a culture of coziness between the Regents and the University administration, where dissent is rare and the status quo is paramount. In the Fall of 2010 I determined to look into the Markingson case during my tenure as a Student Representative after reading and discussing the exposé written by Dr. Carl Elliott in Mother Jones. The article seemed to detail so many ethical lapses and raise the possibility of serious wrongdoing that I began to poke around the U for more information about this story. As a graduate student, not only was the integrity of research protocol supremely important to me as an academic, the allegations outlined in the article could have serious implications on the value of my Minnesota degree by undermining the institutional integrity of my alma mater. Over the course of looking into this matter, I was told numerous times – including in a phone call from then-General Counsel Mark Rotenberg – that the matter of the Markingson case had been

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investigated and the University cleared of any wrongdoing by the University of Minnesota Institutional Review Board (IRB); the Minnesota Attorney General’s Office; the Food and Drug Administration; and the Hennepin County District Court. As you are aware from the recently submitted Carlson Report, some of these claims seem to have been “stretched” – the District Court, for example, never cleared the University of wrongdoing in the case – while others seem to have raised serious issues of ethical practice, as in the case of the IRB chair, who was himself a paid consultant to the same drug company that paid Drs. Olson and Schulz in the Psychiatry Department. Still others seem to have been a fabrication, such as the claim that the Attorney General conducted an investigation into the matter. In consultation with the Graduate and Professional Student Assembly (GAPSA), which represents tens of thousands of professional and graduate students at the University of Minnesota, and in light of the Troubled Waters documentary controversy, I proposed including a section of the semi-annual Student Representatives Report to the Board of Regents on research ethics and conflict of interest entitled “Conflict of Interest, Risk, and an Ethical Heat Map,” the text of which follows at the end of this letter. In the report I emphasize that students, and particularly graduate students who depend in part on the reputation of their university for further career advancement, had legitimate concerns about conflict of interest at the U relating to the Markingson case and others. The report proposed creating an “ethical heat map” that included a transparent list of all University faculty who received payments from outside organizations. Ultimately, however, this section of the report never reached the Board – it was censored at the last minute. I received an email from the chair of the Student Representatives group informing me that he had decided not to include this section of the report as it was not deemed germane by Board staff. When I mentioned to the chair that this seemed an awful lot like censorship, I received a phone call from the Board office assuring me that it most definitely was not, but that the content of the report was not meant to be adversarial in nature and that the legitimate concerns expressed in the report had already been dealt with by a wide variety of outside bodies, including the District Court, the Attorney General, and the FDA. The events surrounding the Markingson case and the censoring of this report are troubling, but they are not surprising. The overall culture of the Board of Regents is one of coziness with the University administration – the very management over which the Board is meant to provide oversight in the public interest. In my time as a Student Representative, dissent among the Board was extraordinarily rare. I never witnessed dissent from Regents in either of the committees on which I served, and dissent at the full Board meetings was unusual indeed. My own recollection is that in the Academic Year I spent as a Student Representative, only Regents Laura Brod, Dean Johnson, and Steve Sviggum ever dissented in votes of the whole Board – and even then, it was only once for each of them. While it is certainly true that the University administration goes to great efforts to ensure that the material they put forward before the Board is thorough and accurate, I had the sense while I was there that the only things that made it before the Regents were those things that were guaranteed to pass. All this raises the troubling question of exactly who is looking out for the public interest at the University of Minnesota? I was disturbed to read in the Carlson Report that Regent Richard

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Beeson, currently up for re-election by the Legislature, dismissed the significant findings presented to him as not having meaningfully impacted the U’s brand, as if the leading public university in the State were no more than a retail bank, or grocer. It is my sincere hope that the Legislature will ask the questions of the University that the Regents are unwilling or unable to ask: what is the extent of the conflict of interest that caused the tragic death of a young man entrusted to a University psychiatrist’s care? How can the Regents effectively govern and oversee the University if the administration only ever presents them with information they know will pass, shielding the Regents from unflattering or problematic issues arising from one of the U’s core missions of cutting edge research? What changes are necessary to ensure that research integrity is uncompromised by hefty “consulting fees” from pharmaceutical companies and others? In light of all this information, I would ask the following: delay final selection of new Regents of the University of Minnesota until the Legislative Auditor’s report on the Markingson case is submitted. Insist that the University administration address the serious allegations of violations of research ethics head on, without hiding behind now-debunked exonerations. The citizens of Minnesota and the worldwide network of alumni of the University of Minnesota deserve no less. Thank you for your consideration. Below, please find the full text of the portion of the Student Report that was censored. Please do not hesitate to contact me with any questions. Sincerely, Matt McGeachy (MA – 2011) 248-496-5842 matt.mcgeachy@gmail.com “Conflict of Interest, Risk, and an Ethical Heat Map” This year students, especially those on the Twin Cities campus, have taken a keen interest in the University's policies surrounding conflict of interest. The purpose of this section of our report to the Board of Regents is not to express a litany of woes, but rather to inform the Board that students do care deeply about the ethical conduct of the University and members of our community; to suggest strategies for communicating with students about conflict of interest; and to suggest an added emphasis on the University's ethical responsibilities in new discussions about recalibrating risk tolerance at the University of Minnesota.

Two examples of recent COI controversies that have prompted student interest and media response are the University's handling of the Troubled Waters documentary and the case of Dan Markingson. Troubled Waters and the controversy surrounding its initial suppression and subsequent release received extensive coverage in the Minnesota Daily and the Markingson case was brought to light once again by U faculty member Dr. Carl Elliott of the Center for Bioethics. Though space constraints preclude in-depth review of these cases, they are no doubt familiar to members of this Board and the Administration. Questions linger unanswered about the University's handling of the Troubled Waters affair, largely because the University's relationship, financial and otherwise, with the agricultural industry in this state remains unarticulated to

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students. Likewise, University officials' outside interests, where they exist, are not easily and transparently available to the University community. Thus, when they are found to exist, outside interests carry the air of secrecy -- a situation which might be changed in the future with greater transparency, particularly on the web, where students (and others) first turn for information.

The Markingson case is particularly troubling, resulting in 2004 in the tragic suicide of a patient enrolled in a clinical trial of atypical antipsychotics at the University funded by pharmaceutical firm AstraZeneca, manufacturer of Seroquel (quetiapine), a frequently used atypical. Dan Markingson came to the University for psychiatric treatment and ended up in the clinical trial under the care of his physician, Dr. Stephen Olson. He did not appear to get any better while enrolled in the trial. Despite the protestations of his mother, Mary Weiss, who repeatedly wrote to the Department of Psychiatry seeking his removal from the trial, Dan was continued in the trial, and ultimately committed suicide. While there is no way to know whether he would have taken his own life even had he been removed from the trial, it was disturbing to discover that both his psychiatrist, Dr. Olson, and the head of the Department, Dr. Charles Schulz, receive large sums of money from AstraZeneca, who had also funded the study. Additionally, the U received money for maintaining Dan Markingson's participation in the study.

While this does not imply anything nefarious on the part of either Drs. Olson or Schulz, it does raise questions that need to be addressed in the continuing discussions surrounding conflict of interest and the University's tolerance for risk. The newly adopted administrative conflict of interest policies at the University begin to take steps, but students' understanding of these policies, and how they might address the problems in the two examples recently in students' minds, needs to be broadened. At what point, for example, might greater scrutiny need to be placed on industry-funded trials? From what companies does the University received money to conduct these trials? One possible step would be to centralize this information and make it more easily accessible online, perhaps in a searchable database.

The University was exonerated of legal wrongdoing by many various agencies and courts in the Markingson case, and the Administration continues its inquiry into the handling of the Troubled Waters controversy. Yet students are left with a nagging feeling that the discussion ends prematurely with issues of the law. As Aleksandr Solzhenitsyn commented in his 1978 commencement address at Harvard University:

“Western society has given itself the organization best suited to its purposes, based, I would say, on the letter of the law. ... If one is right from a legal point of view, nothing more is required, nobody may mention that one could still not be entirely right, and urge self-restraint, a willingness to renounce such legal rights, sacrifice and selfless risk: it would sound simply absurd. One almost never sees voluntary self-restraint. Everybody operates at the extreme limit of those legal frames. An oil company is legally blameless when it purchases an invention of a new type of energy in order to prevent its use. A food product manufacturer is legally blameless when he poisons his produce to make it last longer: after all, people are free not to buy it.

I have spent all my life under a communist regime and I will tell you that a society without any objective legal scale is a terrible one indeed. But a society with no other scale but the legal one is not quite worthy of man either. A society which is based on the letter of the law and never

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reaches any higher is taking very scarce advantage of the high level of human possibilities. The letter of the law is too cold and formal to have a beneficial influence on society. Whenever the tissue of life is woven of legalistic relations, there is an atmosphere of moral mediocrity, paralyzing man's noblest impulses.

And it will be simply impossible to stand through the trials of this threatening century with only the support of a legalistic structure.” [Emphasis added.]

Therefore, as the University continues to examine issues related to risk and conflict of interest, it seems prudent that discussions not only of the legal and institutional consequences of risk and COI occur, but that ethical issues play a central role. The Board of Regents may wish to consider inviting ethicists from the University community to present an Ethical Heat Map to begin this crucial conversation at the highest level.

Why does this matter to students? Aside from the natural concern that students have for the good conduct of their University, it matters because the University of Minnesota is a brand – one that stands for a myriad of experiences and expectations, and one that carries itself well beyond the years that students spend here. As in so many other fields, the University has an opportunity here to take the lead by beginning an ethical conversation that could potentially change the tone of discussions of risk and conflict of interest across the nation.

This report offers two concrete suggestions related to student concerns about risk and conflict of interest. First, it suggests a centralized and transparent website that lists known conflicts for University personnel as well as the amount of industry money that comes to the U for trials and research. Second, it suggests that the Board of Regents consider including an ethical dimension to the continuing discussions of risk tolerance and conflict of interest. The University has begun a process of deep thinking on these issues, and the students of the University of Minnesota hope that these crucial issues remain at the front of the Board's collective mind as we continue our collective quest for excellence.