University of Minnesota counsel Mark Rotenberg will meet with the Board of Regents to discuss a letter requesting an independent investigation into events surrounding Dan Markingson's 2004 suicide.
Eight U of M bioethicists sent the letter last week detailing potential ethical lapses they say may have led to Markingson taking his own life while enrolled in a clinical study at the college. Several more faculty members have since sent a subsequent letter to the Regents supporting the call for an investigation.[jump]
"The letter from the faculty is a serious letter," says Rotenberg. "We take it seriously. The issues they have raised our important to the university and we're going to respond respectfully to their letter."
Rotenberg explains his meeting with the Regents will be an informal briefing, and not open to the public. He could not comment on the specifics of what will be discussed.
"The details of what I say to my clients in our conversations are not something that I disclose to the public," he says.
On a related note, the Regents will not hear a report summarizing student concerns about Markingson's suicide at this week's meeting, despite the efforts of graduate student Matt McGeachy.
McGeachy, a history of medicine student, is one of seven student representatives to the Regents. In a report to the Regents, McGeachy wrote about student concerns regarding conflicts of interest at the U of M, such as those addressed during the recent Troubled Waters fiasco. He also included several paragraphs about lingering controversy surrounding Markingson's suicide.
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.
After McGeachy submitted his portion of the report, a staff member working for the Board of Regents complained that McGeachy's report contained "stylistic concerns" and seemed to summarize only McGeachy's opinion.
In an e-mail, U of M spokesman Dan Wolter explains that the student representatives are meant to advocate for the student population -- not to push a single agenda.
"These reports are intended to represent the views of the various student organizations that the student representatives represent and not necessarily any one individual," says Wolter.
McGeachy argues that questions raised in his report are indeed representative of greater student concerns.
"I guess my question is, on what do they base this idea that it's just one student who's off here on a crusade?" asks McGeachy. "I mean, this has been discussed over and over again by the Graduate Professional Student Assembly. The Student Senate has discussed all of this. It's not like this is the Matt McGeachy club interested in conflicts of interest."
Students representatives chair Matt Privatsky ultimately decided to remove McGeachy's entire piece. He says the decision was not due to the content, but because the other student representatives did not have enough time to thoroughly review the piece and sign off on it by their deadline.
"More than anything, I think it was a time question," says Privatsky.
Here's the report McGeachy submitted in full:
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 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, received 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 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.