In a previous post of October 25, I reported about the Markingson case and a letter we wrote with 6 health law, bioethics and medical scholars to the University of Minnesota Senate, which was co-signed by 175 colleagues from various North-American and international institutions. We requested that the university set up an Independent Committee of Inquiry into the death of Dan Markingson, a psychiatric patient who committed suicide while enrolled in a clinical trial at the University’s Fairview Hospital. The case raises, as discussed in the previous post, serious concerns about the protection of very vulnerable patients in psychiatric industry-sponsored clinical trials.
Several things happened since this October 25 posting. There are positive developments, including a Senate vote in favour of an Independent Inquiry, but also concerns about what will happen next, which has motivated us to write last week a follow-up letter to the Senate.
The Senate's Vote for an Independent Inquiry
The first official response to our October letter was lukewarm: we received on November 12 a letter from the University’s General Counsel repeating the University’s mantra that several organizations and institutions had properly investigated the case and cleared the university, the hospital, and researchers of any wrongdoing. At a meeting of Faculty Consultative Subcommittee of the Senate, where our letter was first discussed to determine whether it would even get on the Senate agenda, some suggested we were ill-informed about what had been done in this case. We therefore sent on November 14 another letter, this time to the University Faculty Consultative Committee. We included with the letter an updated list of signatories, and a schematic table that I prepared with Shannon Gibson. The detailed but easy to use comparative table, outlined: 1. The various alleged reviews the University claims have taken place; 2. What these reviews amounted to and what they concluded; and 3. Why they were insufficient. We also contrasted these ‘reviews’ with two institutional actions that arguably identified serious problems in the context of the Markingson case (see previous blog for more details): a professional disciplinary action by the Board of Social Work, and the adoption of a statute by the Minnesota Legislator, improving the protection of psychiatric patients. All this information was already readily available (see various links in previous blog). But we wanted to make it very clear how we had carefully analyzed various official documents and other sources of information before writing the letter. We had experienced how time-consuming it is to look at all previous initiatives and reports and to evaluate in more detail what had been done. Our table aimed at summarizing it all succinctly with links to various sources, so that it could easily be used by those participating in meetings discussing the proposed inquiry.
Media sources reported on our letter writing action, on our summary table, and on other recent initiatives, including a letter written by University of Minnesota faculty member Leigh Turner to the Board of Regents ; and a local television station aired a new investigative documentary on the Markingson case in which another anonymous patient alleged to have been coerced into a psychiatric clinical trial at the University.
In the wake of this new flurry of activities, the University of Minnesota Senate voted at the end of November overwhelmingly (67 to 23) in favour of the establishment of an Independent Inquiry. Media reports indicate that many faculty members stood up in the Senate meeting, to strongly argue in favour of such an inquiry. That same day, Mike Howard also submitted a petition with more than 3,000 signatories to Minnesota Governor Dayton, asking for an external state organized examination of the university's research practices.
The Senate vote for an Independent Inquiry is a very positive development. It shows that the continued actions of faculty members of the University of Minnesota and external support from an international community of scholars can make a difference. But there are reasons to be concerned. The text of the resolution remains vague about what will be investigated. It refers in its preamble to the Markingson case, but the resolution as voted upon states that the inquiry should look at “current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities.” University of Minnesota’s president Kaler accepted the recommendation, but indicated in a subsequent interview immediately that “it’s not a review of the Markingson case; it’s a review of what we are doing now.” “My role is to look forward,” he suggested, hinting that he would be in charge of the process. Yet, to understand whether current research practices sufficiently protect research subjects, it is essential to look at the past, to see what went wrong, in the context of the then existing procedures, guidelines, and financial pressures.
Follow-up Letter: How Should an Inquiry Look Like
We therefore wrote on December 11, 2013 a follow-up letter, emphasizing again what we see as the core requirements for a credible Indepent Inquiry: 1. The Committee of Inquiry needs to have the authority and a wide mandate to look at specific past and present research practices, procedures and guidelines, and at the reaction of the University when things go wrong. This includes a review of the Markingson case. 2. For the Committee to be fully independent, the selection of its members should not be controlled by those who have been the target of criticism in the context of the Markingson case. We emphasized that it is important that all sides are on board with this new Inquiry.
We received this week a response to our letter to the Senate. The letter of December 18, which came again from General Counsel William P. Donohue, states that “[a]s requested by the Faculty Senate, it is our intention to work with appropriate faculty governance committees” to accomplish this inquiry. One has to hope that the faculty members on these committees will insist on an in-depth and fully independent inquiry.
There will certainly be external scrutiny of how the university organizes the inquiry. A recent op-ed by Matt Lamkin and a group of former University of Minnesota alumni sets out in detail what the Inquiry has to do, what powers it needs, and how it has to be established. It asks bluntly whether with this inquiry, the university intends to either "review or whitewash a research subject's death?" Other blogs also raise concerns about what the inquiry will do. (see Carl Elliott and Bill Gleason at the University of Minnesota, and a Nature News blog by David Cyranoski)
One of the disturbing aspects of the Markingson case is how seemingly reliable bureaucracies, set up to protect research subjects and patients, can be conveniently used to shield institutions from further scrutiny, even when they have clearly faltered. If the Committee of Inquiry wil not be sufficiently independent, and if it will not seriously investigate both current and past research practices 'on the ground' (including the Markingson case), and if it sticks to a review of procedures and guidelines, it will not be able to restore public trust. It will simply add insult to injury.
To be continued in the New Year.
