Thursday, December 5, 2013

For the Record: U of M Faculty Consultative Committee #markingson discussion

(my apologies for formatting inconsistencies-early Thursday morning)

Faculty Consultative Committee
Thursday, November 14, 2013

4.    Committee Business

    Professor Durfee reported that this Committee provides recommendations to the Committee on Committees on who should serve as chair of those committees whose chair serves as an ex officio member of this Committee; it also makes a recommendation about the chair of the Senate Committee on Academic Freedom and Tenure.  Committee members discussed possible candidates to serve as committee chairs.

    Professor Durfee next asked for comments on a letter about the Markingson case that had been addressed to the president and to the Faculty Senate and signed by a large number of bioethicists.  (Mr. Markingson was a participant in a clinical drug trial at the University and committed suicide during the study.)  The letter asked the Faculty Senate to request an independent inquiry of the case.

    Professor Cloyd said the question is whether the Faculty Senate would take on the matter requested by the letter—or what process it would use to deal with the request.

    Professor von Dassow said that in the 24 hours preceding the meeting she and a few other Committee members received letters urging them to act on this matter.  She said the letters were not "cut and paste jobs," rather, each was the individual work of its author, and they come from University alumni and faculty as well as members of the public.  She forwarded a selection of these letters to the Committee last night, since which time the Committee has received additional information about the investigations that are said to have been conducted in the Markingson case.  In addition, a number of faculty senators wrote to the Committee asking that it bring the letter to the Faculty Senate.  The Committee must decide on a response; if it cannot be the December Senate meeting, the next one is not until March.

    Her recommendation, Professor von Dassow said, is that the Committee not make decisions on behalf of the Faculty Senate but put the letter on the docket for discussion.  She said she believes the University administration is in error in refusing to address the issues raised in the letter except to deny them.  She said she does not want to become an expert on IRBs and related research issues and try to adjudicate the matters, but the reply from the General Counsel contains statements that conflict with other material the Committee has seen.  She said she believed the way to proceed is to have open discussion at the Faculty Senate meeting and she believed it should recommend an impartial review of the case.  If the Faculty Senate votes "no" on making such a recommendation, the reasons for doing so should be made clear.

Professor Luepker said he respectfully disagreed with Professor von Dassow.  This is not a matter on which to rush to judgment; "we are uninformed about all the facts," he said, so it is not reasonable to think that a group of 150 people can come to a decision.  There is much information available about this case, some of which he knows, although not all of it.  What bothers him, Professor Luepker said, is that the events in the case are being accelerated to the level Tuskegee and eugenics, and it would not surprise him to next hear a comparison with Dachau.  He said he hoped that any discussion of the case would be based on the facts, not blogs and uninformed commentary.  The case is ten years old, so there is no need to rush to judgment—because there is the potential to do wrong.

    Much of the fight over the case is in the media, Professor Luepker said, and the justification for it is to “help” the University's reputation.  In his view, making unfounded charges through press releases and interviews are not an attempt to help the University or illuminate the facts of the case; the aim is to damage the University.

    Professor Desai said that the letter writers have a constellation of evidence and it should not be the Committee's job to sift through it.  This has not gone away for ten years and the University's name is tarnished, and these are not just media or legal questions.  The senate could ask for an investigation but it is not something the Committee should manage.  She said did not want to be in the position of saying she does not know what is going on; the Senate could call for an investigation but it is not urgent, and it should do so because many people care about the University.

    Professor Satin said that he feels a responsibility to go to his colleagues with answers, and if there was wrongdoing, he does not have the answer.  He said he hoped the Committee could figure out how to figure this out.  If the Committee can do fact finding, that would be great; if the Senate can do fact finding, that would be great; if there is need for an independent investigation, great.  He said he has not looked at all the available information and cannot say whether the situation is acceptable.  At least a group needs to take time to see what information is there and decide if it is necessary to do more.

Faculty Consultative Committee

Thursday, November 21, 2013

3.    Faculty Senate Docket

    Professor Durfee reviewed the draft docket for the December 5 Faculty Senate meeting and noted that the Committee had received a letter from 14 faculty senators asking that issues related to the case of Dan Markingson (a patient in a clinical drug trial in 2003 who committed suicide) be placed on the docket, that there be sufficient time for discussion, that there be a resolution for action, and that a letter from bioethicists be provided to the members of the Faculty Senate.  Professor Durfee asked Committee members how they wished to proceed and noted that the docket as proposed already filled the time allowed for the meeting.

    Professor von Dassow said she believed the Committee was obligated to honor the request from the senators, regardless of the time limitations.  She also suggested that this Committee need not prepare a resolution; the authors of the request could be asked to do so.

    Professor Konstan said he did not believe the Committee could provide an answer in the time left at this meeting to discuss the subject.  It would be ideal if the request were moot; he suggested asking the president if he would assent to an external review, as requested by the letter from the bioethicists, and then the senate would not need to deal with it.  If it is not moot, it would be irresponsible for the Committee not to bring forward the issue:  it has gathered enough attention from colleagues that it should be taken up.  He agreed with Professor von Dassow that the senators could draft a resolution.

    Professor Ben-Ner said he did not know the answer to the discussion about putting a question to the president.  He said he found annoying the table of analyses of the various reports about the Markingson case that were attached to the letter from the senators; anyone could write such rebuttals to anything any agency, judge or faculty member writes. What does this prove or disprove? What is the purpose of the request?  To try to improve IRB rules?  To get at the connection between parts of the Medical School and drug companies?  To reexamine what colleagues from the Medical School have done then and what might they have done differently?  Is to redress an alleged wrong committed in the past?  He said it was not clear what purpose is served.  He said he would be glad to talk about IRB rules and their enforcement, which have apparently changed in different directions during the past decade. He would be prepared to have an evaluation of the relationship between drug companies and clinical drug trials, about which he reads in the media but doesn’t know specific details in the University of Minnesota context.  These are important matters that need to be considered thoughtfully by different bodies at the University without the urgency of a short deadline.

    Professor Durfee said the discussion is about whether the issues raised in the letter should be on the docket.  There has been a request from faculty senators; this Committee has final say over the docket.  It needs to figure out to allocate time.  Professor Ben-Ner said his point was not divorced from the question of why or why not but agreed that a request from multiple senators should be honored.

    Professor Satin agreed and said the issue has gathered enough steam that the Committee should not drag its feet—it should put the matter on the docket.  But it must come with information about the issue and faculty senators must realize that they will need to do a considerable amount of reading if they are to vote intelligently on any resolution.

    Professor Satin said, apropos of Professor Konstan's comment about the possibility of the issue being moot, that irrespective of the outcome, it would be valuable to have a record of where the Faculty Senate stood.

    Professor Ranelli said the matter should be on the docket.

    Professor Luepker said what bothered him, is that the authors of the messages had already concluded what the answer should be.  He agreed with Professor Ben-Ner that the table of analyses was annoying; he is smart enough to read the reports and reach his own conclusions.  As for bringing the matter to the Faculty Senate, a group of 150+ people is not a good decision-making body unless there has been due diligence, and this Committee itself has not had the necessary discussions.  He observed that there is only two weeks before the December 5 Faculty Senate meeting, during which time the Thanksgiving holiday falls.

    If the issue is on the docket, it will need considerable discussion, Professor Durfee observed.  Should it include a resolution, as the 14 senators requested?

    Professor Satin said the matter needs to go on the docket but there should be no decision on December 5.  There is no way that the members of the Faculty Senate will have sufficient time to make a decision.  He suggested putting the topic on the docket for information and providing resources, and also inform the Faculty Senate that the Committee will be working to provide additional material later.  But it should not be put on for anything other than for information, to be followed up at the next meeting.
    Professor Ben-Ner repeated his question:  why conduct now a discussion of events that occurred ten years ago?  What is a Senate resolution seeking to address?  Redress?  He said he could not understand how returning to events of ten years ago would improve current practices.  Before a perfunctory senate discussion of 20-30 minutes, the Committee needs to figure out what it is embarking on and be prepared to offer a reasoned course of action.  The request by faculty senators has to be honored without questioning their motives for bringing up the issue for discussion, but the Committee should focus its effort on improving current rules and practices and not on deconstructing past decisions and analyses by various bodies that weighed in on the matter in the past.

    Professor von Dassow said, in response to Professor Luepker's comment, that of course people who sent him emails had already decided.  She said that only putting the item on the docket for information would satisfy no one but agreed that the Committee could not draft a resolution during this meeting.  Many people know a great deal about the issue so it would not be an incoherent discussion.

    Professor McCormick commented that if faculty senators need information, they also need to be reminded of what information is not available.

    Professor Cloyd said the issue needs discussion broadly and the Faculty Senate is the appropriate venue.  He asked what impact a resolution for action would have.  Professor Durfee said that presumably it would constitute a request to the president to commission an external review of the case.

    Professor Gardner said he was disappointed that the senators who sent the letter to the Committee did not submit a resolution as well, which would have been appropriate and would have helped the discussion here.  This goes to the questions he asked before:  what would constitute an independent inquiry?  How will the Committee know what to move on?  

Professor Konstan suggested that the matter could be referred to the Senate Research Committee.

    His second question, Professor Gardner said, is about what IRB policies are now versus what they were ten years ago.  Have there been changes that preclude events such as those that arose in the Markingson case?  That is a subject about which there could be discussion and one that could be referred to the Senate Research Committee.

    Professor von Dassow said she would like to leave open the possibility that there could be a resolution that faculty senators could vote on at the meeting.  In response to Professor Gardner's question about what would constitute an independent inquiry, it is her understanding that it could be an inquiry conducted by a panel appointed by the governor and composed of people who have the requisite knowledge but who have not already aligned themselves with one side or the other in this case.

    Professor Cloyd said that what needs to be conveyed to the Faculty Senate is that it should take the issues seriously and that this Committee endorses careful consideration; this Committee needs to identify a pathway to a conclusion.  This Committee also asked "what's the question?"  Is it scientific misconduct?  Conflict of interest?  A matter of informed consent?

    Professor Durfee suggested, for the Faculty Senate, that the matter be on the docket for information, with an explanation of the steps that would follow, with time allowed for some discussion, and there be an actual resolution (to be acted on at a later meeting).  [The docket discussion continued following the conversation with the president.]

4.    Discussion with President Kaler

    Professor Durfee welcomed the president to the meeting.  

    The president began with a few remarks about the Markingson case.

    Professor von Dassow commented that letter sent by Trudo Lemmens, et al. talks about the Markingson case because that case was the subject of a lawsuit and is a matter of public knowledge, but the concern is that similar problems exist in other cases as well and that they may represent systemic problems; she noted the criticisms of the reviews of this case that had taken place; she suggested that the University is obligated to examine how research is conducted, and in a public way; she said an independent inquiry could clear things up and provide a public benefit for the University, so it should resolve that there be one.
    Professor Ben-Ner said that if there is a problem with IRB procedures, they should be addressed; if the rules appear to allow conflicts of interest, they should be addressed; if all drug companies participate in research, that should be addressed; if there is a problem with faculty members, it should be addressed.  But it does not make sense to re-open all the details of this particular case.

    Professor Konstan said that this feels like two rams battling each other—the struggle isn't being resolved.  While the University may try to outlast the letter-writers, they seem in it for the long term.  He suggested redirecting the attention to proposing a review that looks at the broader question of how the University currently conducts and oversees research with potential risks to human subjects.  While they may want to avoid re-opening Markingson per se, and avoid subjecting the two researchers involved to double jeopardy, that shouldn't prevent the Committee from taking a serious look at whether the University's research policies and practices uphold the standards it aspires to.  The Committee should pro-actively suggest that it is worth exploring whether institutional practices are consistent with the best practices of its peers, or whether they need to be improved.  In other words, rather than continue rehashing Markingson, the Committee should be looking at whether the University learned something over the past 10 years and whether its current practices and policies are where it wants them to be.

    The president said he would be willing to entertain a question about how such research is conducted.

    Professor Luepker said, apropos of the FDA investigation in the case, that it has indictment powers and that its investigations are exceedingly thorough.  He said he was offended by the interpretations of the investigation that have been advanced.  He agreed with Professor Konstan that it would worth looking at whether there is adequate oversight of this kind of research because there are a many other units, including CLA, that do clinical research.

    Professor Desai said she believed that the case has eroded public trust in the University and that it would be possible to get the best report (similar to the report that followed the Virginia Tech shootings) on what the University needs to do better to protect people coming to it for drug trials.  If there is no trust in the University, its research is not trusted.

    Professor Satin agreed with Professor Konstan's suggestion and commented that the authors of the letter from the bioethicists are reputable people in the field.  

    Professor von Dassow also agreed with Professor Konstan's suggestion as the right and reasonable way to proceed; this is less a matter of finding fault than of finding out what went wrong and what to improve.  If the Faculty Senate were to adopt a resolution that articulated the goal of examining the norms and procedures governing this kind of research at the University, Professor von Dassow asked the president, could he support it?   President Kaler said he would need to think about it; he said that it might be worthwhile to compare the University's current practices with best practices in the field.

3.    Faculty Senate Docket, cont.

    Professor Durfee returned the discussion to the Faculty Senate docket and asked if the Committee wished some discussion time allotted for the letter from the senators.  It may not be especially long, he said, but is that the best way to proceed?

    Professor Konstan thought so and suggested using separate microphones at the meeting for the speakers who support the letter, those who oppose it, and for speakers with questions.  He said it would also be helpful to hear the president's views, if he is willing to share them with the senate.

    Professor Cloyd agreed that time for discussion should be set aside and said that it should be framed as looking at the best possible approaches to conducting clinical research and whether the University is following those practices—and not looking backwards and trying to assign guilt.  Professor Satin agreed on the need to focus on current practices and said that much has changed in the last ten years.

    Professor Gardner said it could be appropriate for someone to move that the issue be referred to the Senate Research to present a proposal for the study of research practices.  Someone should draft a motion.  Professor Konstan said there needs to be a charge to the Senate Research Committee; one outcome of the discussion could be such a charge.

    Professor Bearinger said that per Professor Cloyd, the Committee should take advantage of the conversation it has already had to help the Faculty Senate and avoid having to repeat everything. 

    It was agreed that Professors von Dassow, Durfee, Konstan, and Satin would develop a motion that the Committee would consider for placement on the docket.  The motion would focus on human-subjects research, particularly research with vulnerable subjects.  

    Professor Durfee thanked Committee members for the discussion and adjourned the meeting at 3:00.

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