… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Sunday, October 26, 2014
The Management of the University of Minnesota
The Management of the University
1. Internal Audit.
In September 2014 the Audit Committee of the Board of Regents received an internal audit update. The expected implementation rate of outstanding essential recommendations since June 2014 was 40%. You might think that the U of M administration would easily clear such a low bar. You would be wrong. The actual implementation rate of 23% did not even come close. See p. 8 of the October 2014 BOR FRI Docket.
The report on this dismal performance did not rouse the somnolent Regents who asked nary a question. But there are serious questions to ask. What is the effect of the failure to meet even the low expected implementation rate for essential recommendations? What are the essential recommendations that have not been implemented? Are the multiple levels of administration at the University an obstacle to achieving even essential goals? How many resources of the University are being squandered as a result of the failure to implement the recommendations?
2. External Audit.
The Deloitte Consulting firm, the external auditor for the University, is about to expand its role (and profits) by providing advisory services for the Enterprise Asset Management project. For this service the University will pay to Deloitte the sum of $1,744,000 in fees and expenses.
When this matter was presented to the Audit Committee of the Board of Regents in September 2014 Regent Brod asked about the effect of this contract on the role of Deloitte as an external auditor. An associate vice president responded that the appearance of independence is at the heart of the issue in retaining an external auditor. He acknowledged that there is general guidance for the examination of non-audit services but no clear dollar amount or ratio to determine when the independence of the external auditor may be affected. He promised to provide the general guidance at a later meeting.
So did the Regents decide to wait until they had at least some general guidance on whether $1.7 million (and the prospect of millions more in income for non-auditing services now that the wall has been breached) might cause an external auditor to go easy on the administration on future audits? No, instead the docile Regents voted unanimously to approve the contract. See p. 9 of the October 2014 BOR FRI Docket.
As the external auditor Deloitte knew that the U of M spent more than $37,000,000 on administrative consulting and professional services in fiscal year 2014. See line 18(d) of the Expense Summary in the Administrative Cost Benchmarking Report at p. 77 of the October 2014 BOR FIN Docket. Having seen the explosive growth of the university administration--consulting firm complex Deloitte hopped on the gravy train. Who now is left to be vigilant about the escalating costs of administration?
3. Facilities Management.
The condition of 50% of the facilities at the University is below average or worse. It would require an investment of $1 billion to bring all facilities to at least fair condition. In September 2014 the associate vice president in charge of facilities management informed the Finance & Operations Committee of the Board of Regents that the current approach to facilities management is unsustainable. Expenses have increased by 75% over the last decade. The increase is due to rising service costs and the addition of space even though there has been a reduction in operations cost per square foot. See p. 23 of the October 2014 BOR FRI Docket.
Although the addition of space is a major factor in the soaring expenses, the Regents are planning a 10 acre Education District in downtown Rochester that would accommodate 587,000 square feet of development. See p. 60 of the October 2014 BOR FAC Docket.
Constructing the Education District before the administration comes to grips with the current unsustainable approach to facilities management will accelerate the deterioration of existing facilities. See Crumbling Academic Infrastructure.
4. Budget Management.
For the last three fiscal years the administration has presented an Administrative Cost Benchmarking Report to the Regents. The Report divides expenses into three broad categories: direct mission activities (instruction, research, and public service); mission support and facilities, and leadership and oversight.
Once again in fiscal year 2014 there were net increases in all three categories. See the Report at pp. 72, 74, and 76 of the October 2014 BOR FIN Docket. Vice president Pfutzenreuter noted that savings within each category "are masked by program growth and service increases." See p. 79 of the Docket (emphasis added).
Yes, the University budget operates like a giant balloon. When one side is pinched to reduce expenses, another side expands with even greater costs. See The Phantom Reduction Part II.
Just as the Wall Street bankers created a housing bubble using other people's money, the senior administrators and the Regents have created a higher education bubble. The U of M budget exploded from $2 billion in fiscal year 2002 to $3 billion in fiscal year 2012. See p. 18 of the 2002 annual financial report and p. 15 of the 2012 annual financial report. Skyrocketing tuition far exceeded the reduction in state appropriations. See Ten Year Review of University Inc.
When this budget balloon bursts, the senior administrators and the Regents will walk away unscathed just as the investment bankers did. The students (and their parents) will suffer the harm from the student loan debt that inflated the balloon. They will be shackled by that debt for many years (or even decades for many students in the graduate and professional schools).
5. Cost of Administration.
Many hours are wasted on unneeded and unexplained paperwork and permissions, making University authorities seem both oppressive and out of touch.U of M Strategic Plan at p. 84 of the October 2014 BOR FRI Docket.
The Expense Summary in the Administrative Cost Benchmarking Report for fiscal year 2014 is a list of personnel and non-personnel expenses for the three broad categories of expenses: direct mission activities (instruction, research, and public service); mission support and facilities; and leadership and oversight. Here are the administrative expenses for mission support and facilities and leadership and oversight:
The Report shows total operating expenses of $3,171,787,000 for fiscal year 2014. So the cost of administration ($918,956,000) accounts for 29% of those total expenses. See the Expense Summary in the Report at p. 77 of the October 2014 FIN Docket.
Is 29% in administrative overhead excessive? There is no national system for comparing administrative costs at universities so we have to look to the world outside the campus. With an administrative overhead of 20% American private health insurance companies have the highest administrative costs of any health insurance system in the world. See T.R. Reid, The Healing of America (New York: Penguin Press 2009) at pp. 36--38.
The Affordable Health Care Act now requires health insurance companies to send rebates to consumers if administrative costs and profits consume more than a set percentage of premiums (20% for individual and small group markets and 15% for large group markets). See the August 17, 2014 Star Tribune report on Health Insurers Must Pay Up or Pay Back.
It is likely that there would be an immediate and sharp reduction in the cost of administration if the legislature were to require the University to send rebates of state general appropriations to the state treasury if the U of M administrative costs exceeded 15% of its total expenses.
The U of M administrators might resist by asserting that the University enjoys the privilege of a separate constitutional status. Then it is also likely that the citizens of Minnesota, outraged by the spectacle of highly paid senior administrators claiming special privilege, would vote to abolish that status. See The Cost of "Top Talent" Part III.
6. Finding Solutions.
Our system of higher education is broken. Over the past decade we have seen escalating costs, skyrocketing tuition, and staggering student loan debt.
Freezing tuition in return for an increase in state appropriations is a shell game and not a solution.
The U of M administration should revise its new Strategic Plan to include the steps necessary to reduce the escalating costs of higher education--not just ways to reduce the rate of increase but to actually reduce the costs. The very expensive report produced last year by Huron Consulting fails too often to describe the specific actions necessary to get from point A to point B just as it fails too often to provide even ball park estimates of the costs of implementing its recommendations and the savings to be realized. See The $495,000 Report.
The state legislature should obtain a commitment from the University to review the increase in administration over the past 40 years. If there has been an increase in the number of administrators that is disproportionate to any increase in the number of students or in the level of research, we should ask why. If there has been a substantial increase (in constant dollars) in the compensation of any administrator, we should ask why.
We should also compare the compensation paid to senior administrators in state government who have similar qualifications and duties to University administrators. For example, the annual salary of the state commissioner of human rights is $108,000. The annual salary of the vice president at the U of M Office of Equity & Diversity is more than twice that amount at $225,000. See Nice Work If You Can Get It.
Each biennium the citizens of our state now invest more than $1 billion in the U of M in general appropriations. With that much at stake the legislature should appoint a qualified person to monitor on a continuing basis the operations of the University and the use of state appropriations. This legislative liaison (or watchdog) should have the responsibility to review the information produced by senior administrators, to collect additional information through his or her own independent research, and to meet with all groups at the University so that the perspectives of other well-informed and thoughtful members of the University community are presented to the legislature.
Michael W. McNabb
University of Minnesota B.A. 1971; J.D. 1974
University of Minnesota Alumni Association life member
Friday, October 3, 2014
Monday, September 15, 2014
The Phantom Reduction Part II
"The Conjurer," painted by Hieronymus Bosch. The painting accurately displays a performer doing the cups and balls routine, which has been practiced since Egyptian times. The shell game does have some origins in this old trick. The real trick of this painting is the pickpocket who is working for the conjurer. The pickpocket is robbing the spectator who is bent over. Source
The Phantom Reduction Part II
"OK, so you're not raising tuition; why do the costs increase so much that we have to buy that freeze?"
State Senator Terri Bonoff in the September 12, 2014 Star Tribune report.
There are two principal reasons for the continuing escalation of costs at the University of Minnesota:
(1) The promise to reduce the cost of administration by $90 million over a six year period will not reduce the U of M budget by a single penny. President Kaler intends instead to simply spend the $90 million on "mission and mission support." See The Phantom Reduction.
(2) Reductions in some categories of expenses are more than offset by increases in other categories.
There was a net increase of $41.7 million in expenditures for mission support and facilities (from $956,896,120 in fiscal year 2012 to $998,643,697 in fiscal year 2013). There was a net increase of $7.9 million in expenditures for leadership (from $263,801,546 in fiscal year 2012 to $271,699,441 in fiscal year 2013).
The one expense that is most symbolic of the cost of administration is the compensation for leadership. The highly paid senior administrators, deans and directors collected an additional $2,250,198 in compensation for fiscal year 2013. (The total compensation for those leaders in fiscal year 2013 was $104,088,093.) See A Complete Accounting.
A former interim U of M president observed in November 2013 that "with real productivity gains, tuition could actually be reduced, assuming that state funding for the U holds where it is at currently." (emphasis added) See A Question of Productivity.
The Star Tribune has advocated a concentration on greater efficiency:
A freeze at the price Kaler and Rosenstone propose appears to resume a pre-2008 growth rate that had long exceeded the rate of inflation. It wouldn't appear to give the institutions much incentive for changes in higher education that might slow that growth rate or bring costs down.
See the September 18, 2014 Star Tribune editorial.
It will be necessary to stop and then reverse the escalating costs of higher education in order to reduce the staggering amount of student loan debt. The eventual solution will involve substantial reductions in the cost of administration and better allocation of state appropriations. See Whose Fault--Crushing Student Debt and Devouring Our Children.
Michael W. McNabb
University of Minnesota B.A., 1971; J.D. 1974
University of Minnesota Alumni Association life member
Tuesday, September 9, 2014
For the Record: Most damning evidence in #Markingson case from Minnesota Board of Social Work
The U of M administration uses this 2005 FDA conclusion as a primary reason to reject calls for another investigation. But in 2012 the Minnesota Board of Social Work took corrective action against the social worker who was the study coordinator. Perhaps the most damning findings were these:
2(g)(1) Despite the large amount of data gathered as part of the CAFE study, the records are devoid of any evidence that the data was critically analyzed or used in the treatment planning process. . .
2 (g)(4) There were critical omissions in Licensee's [U of M study coordinator] documentation that were relevant to suicide prevention and chemical dependency treatment. . .
2(h) On March 17, 2004 Licensee received an e-mail message from the CAFE study sponsor warning of a new risk of hyperglycemia and diabetes for patients taking medications used in the CAFE study. This new information effectively invalidated client #1's [Dan Markingson's] original informed consent.
See pp. 3--4 of the report of the Minnesota Board of Social Work (emphasis added).
See also A Question of Accountability
Monday, September 8, 2014
For the Record: Univ. of Minnesota faculty concerns about investigation into clinical trials
Sep 7, 2014
Last fall 14 faculty senators at the University of Minnesota called for the Faculty Senate to take action to address ethical concerns arising from the tragic death of Dan Markingson in a clinical trial conducted at the University of Minnesota. The Faculty Senate passed a resolution last December calling for an independent investigation, and President Kaler agreed to conduct such an investigation. Unfortunately, events since then have led some of the senators who called for a review to have serious concerns about both the scope of the review and the impartiality of the team conducting it. The letter appended below, which we have sent to Vice President for Research Brian Herman and Professor Will Durfee, expresses some of our concerns.
The team conducting the investigation will be on campus this week (Tuesday and Wednesday).
Two of the signatories of the letter, Naomi Scheman have agreed to serve as our media contacts.
In addition, at the end of the email, you will find useful links that provide background information about the independent investigation.
Teri L. Caraway
Associate Professor and Faculty Senator
Department of Political Science
University of Minnesota, Twin Cities
Dear Vice President Herman and Professor Durfee
As members of the University of Minnesota Faculty Senate who called for an investigation into human subject research at the University in the wake of the Markingson case (as detailed in the "whereas" sections of the resolution), we would like to express our concerns with the process as it is unfolding so far. Although the resolution passed by the Senate and supported by President Kaler called for a review of present policies and practices, it has been clear to us that a review can serve the stated purpose of clearing the cloud of suspicion about the treatment of vulnerable human subjects only if it also looks at relevant aspects of the past. In particular, an investigation of "present practices" needs to include how the University has dealt and is dealing with--including learning from--serious allegations concerning past practices.
Our intention of communicating that conviction to the review team has, however, come up against concerns regarding conflicts of interest on the part both of members of the review team and of AAHRPP, which selected the team and is supervising the review. Put simply: we are convinced that a credible review would need to investigate the Markingson case, but that such an investigation would itself need to be credible, especially in light of the history of the University's appealing to clearly noncredible reviews as supposedly exonerating; and the conflicts of interest raise serious questions about the credibility of the present review.
We do not want to prejudge the work of the review team or to impugn the integrity of its members. We do, however, want to put on the record our sense that the review is not proceeding in a way that seems likely to satisfy the principal requirements behind the resolution we brought to the Senate: for a genuinely credible, independent review that takes a hard look at how the University dealt--and continues to deal--with activities that are widely perceived as profound breaches of ethical responsibility.
Teri L. Caraway, Associate Professor, Political Science
Cesare Casarino, Professor, Cultural Studies & Comparative Literature
Francis Harvey, Associate Professor, Geography, Environment, & Society
Amy Kaminsky, Professor, Gender, Women, & Sexuality Studies
Rick McCormick, Professor, German, Scandinavian, & Dutch
William Messing, Professor, School of Mathematics
Kevin P. Murphy, Associate Professor, History and American Studies
David Pellow, Professor, Sociology
Riv-Ellen Prell, Professor, American Studies
Naomi Scheman, Professor, Philosophy
JB Shank, Associate Professor, History
Karen-Sue Taussig, Associate Professor, Anthropology
cc: Eric Kaler, Eva von Dassow, and Rebecca Ropers-Huilman
LINKS TO BACKGROUND DOCUMENTATION
October 2013 letter from 170+ scholars calling for an investigation:
List of signatures from October 2013 letter:
November 2013 letter from faculty senators to the FCC:
Minutes from the Faculty Senate meeting that passed the resolution calling for an investigation (starts on page 16; the resolution was amended as described in the minutes):
The AAHRPP's proposal:
Professor Trudo Lemmens's et al April 2014 letter to President Kaler regarding the RFP:
Public Citizen's letter expressing concerns about the investigation:
Professor Trudo Lemmens's et al June 2014 letter to President Kaler:
Professor Leigh Turner's July 16, 2014, letter to the AAHRPP regarding conflicts of interest:
Wednesday, September 3, 2014
U of M Scoreboard: Athletics Department 84, All Other Departments 16
U of M Scoreboard: Athletic Department 84
All Other Departments 16
The U of M administration has announced a $25 million donation from Land O' Lakes. Of the total amount $21 million (84%) goes to the athletic department and $4 million (16%) goes to all other (academic) departments.
This new commitment and innovative model of support . . . will further position the U as a continued leader in addressing society's pressing challenges.
President Eric Kaler in the September 3, 2014 Star Tribune report at http://www.startribune.com/sports/gophers/273662841.html. (emphasis added).
Especially that pressing challenge of winning football and basketball games.
The writer of a letter to the editor in the September 5 Star Tribune argued for excellence in both sports and academics at the U of M. But there is a limit to available funds. Most large universities, including the U of M, continue to provide annual multi-million dollar subisdies (in direct and indirect support) to their atheltic departments despite the exponential increase in TV revenues. See Athletic Accounting. Beyond the cost, big time sports are simply irrelevant to the purposes of a university.
The window to the U of M is not athletics (as President Kaler claimed in the September 5 column of Sid Hartman) but rather its performance in the fields of education, research and public service. Imagine the effect of the Land O' Lakes $25 million donation if the U of M administration had persuaded the company to give most of the funds for those purposes. A donation for agricultural research would have promoted the University and the state economy as well as the corporate purpose of Land O' Lakes, the purpose of its foundation, and the financial interests of its shareholders.
Michael W. McNabb
University of Minnesota B.A. 1971; J.D. 1974
University of Minnesota Alumni Association life member
Comment by Bill Gleason:
I noticed a tweet from the Ministry of Propaganda this morning:
Seems a little misleading in light of the distribution of the loot ...
Perhaps they are embarrassed?
Monday, June 23, 2014
For the Record: A necessary audit of University of Minnesota drug research
"It is time to eradicate this stain on the reputation of
a splendid university."
Arne Carlson, former governor of Minnesota
Over the span of the program, it has drawn considerable negative press, including headlines in the Star Tribune in August 1993 — “University kept silent for 4 years on research misconduct by Garfinkel” (Dr. Barry Garfinkel was convicted and sent to prison) — and continuing to May of this year, when Science magazine published a lead article analyzing the Markingson case and continuing issues.”
During this time, Dr. Carl Elliott, a professor in the Department of Bioethics, and his colleague, Dr. Leigh Turner, have been critical of the oversight of this program, including the various reports that cleared the university of wrongdoing. A large and distinguished cadre of doctors, researchers and scientists from the United States, as well as Canada and New Zealand, has joined in this criticism. As a result of the publicity, Elliott and Turner continue to receive calls from parents and families of enrollees declaring their concerns over mistreatment, failure to protect the harmed and misinformation given to potential subjects. This has been verified by a local TV investigation.
Unfortunately, instead of this compelling matter being resolved internally, the debate has continued to spill out to the public, drawing national media attention from the likes of the New York Times and the Boston Globe.
The legislative auditor now has the opportunity to conduct a thorough and professional audit of this operation covering the past 10 years. It is imperative for the well-being of all concerned that his report be exhaustive and credible in order that the necessary changes are instituted. This means that inherent conflicts of interest be closely monitored, that the integrity of the study be improved and that the subjects be fully protected.
This audit should involve:
1) A thorough review of the finances, including the number of studies, payments to doctors and clinicians, administrative costs, etc.
2) An examination of the conflicts of interest built into the process. This should include a background inspection of all program personnel as well as those who serve on an oversight board. Transparency should be the rule.
3) A disclosure of the number of tests, enrollees, injuries and deaths.
4) A full understanding of the oversight process, commencing with the Board of Regents. Are its members independent of management? How do they manage dissent involving management, faculty and/or the public? Why did they not intercede, particularly knowing the ills of the past involving criminal misconduct and continuing with public reports of ongoing concerns relative to the care of enrollees?
5) That the legal and human rights of the enrollee are fully protected and that the family is involved. This includes upfront disclosure of all needed information, professional monitoring and care, if harm is caused.
Logic would indicate that certain areas of management require more oversight than others, particularly when significant money comes from drug companies for testing on humans. Somehow, that special attention appears not to have been there, even when respected members of the faculty raised red flags.
I am most hopeful that the legislative auditor not only will deal with these concerns but also will come forth with standards that will significantly improve independent oversight and be fully protective of our enrollees, who all too often are our most vulnerable citizens. It is time to eradicate this stain on the reputation of a splendid university.
Sunday, May 18, 2014
For the Record: U Flunks on Rigorous Core Courses - Professor Eva von Dassow
"Housework is a breeze. Cooking is a pleasant diversion. Putting up a retaining wall is a lark. But teaching is like climbing a mountain." Fawn Brodie
My colleague, Professor Eva von Dassow, has graced these pages before. Her comments to the University of Minnesota Board of Regents went modestly viral - twenty-five thousand views, and are still worth considering. They may be found here:
When Professor von Dassow Speaks, Hopefully Somebody Will Listen...
The following material is reprinted with the permission of the author and the Minneapolis Star-Tribune where it was first published.
Counterpoint: U flunks on rigorous core courses
May 16, 2014
Article by: EVA VON DASSOW
Readers may be interested in what faculty members at the University of Minnesota think of the curricular requirements celebrated for their breadth and rigor by Vice Provost Robert McMaster in a recent counterpoint article (“Quality of curriculum at U is second to none,” April 26).
McMaster, describing our set of liberal-education requirements as “comprehensive,” states that “all students must complete seven courses in what we call the core”; he then lists 11 categories of requirements.
There is in fact no set of core courses. Rather, hundreds of courses have been submitted by individual faculty members for approval to meet one or another of the LE requirements. The mechanism for obtaining approval is to write a proposal claiming that the course does this and adding similar claims to the syllabus; proposal and syllabus are submitted to the Council on Liberal Education. If the council finds the right words on the proposal and syllabus, the course is certified as meeting the selected liberal-education requirement. (You can see how many courses meet which requirements here: http://tinyurl.com/UMNOneStop.)
Thus no student need ever take, for example, a course in history. Students can satisfy the liberal-education requirement in “historical perspectives” by taking any course, in any college, that has been certified as meeting this requirement. Same with “mathematical thinking” and the other nine requirements. All of the approved courses may be fine components of a liberal education, but then, what university course isn’t?
Faculty members submit courses for liberal-education certification under duress, in effect, because if we don’t, our courses will get insufficient enrollment, inasmuch as students are constrained to choose courses that meet requirements. Many of us nonetheless find it absurd to be required to prove that a history course is a history course, a math course is a math course, and so on. The chorus of faculty discontent with this structure of requirements has reached such a pitch as to provoke a movement to change it.
Of the university’s student learning outcomes, McMaster says faculty members use them “to make certain our undergraduates are indeed learning, and this learning is measured.” Indeed, for every undergraduate course, faculty members are required to claim that it meets one of seven prescribed outcomes.
One would think the desired outcome of studying anatomy is to learn anatomy, that of studying Arabic to learn Arabic and so forth throughout the course catalog. But the student learning outcomes were intentionally written to be so broad that at least one of them could be construed to apply to any course or subject — including nonacademic ones.
Our athletics programs could make a sound case that, through their participation in a sport, student-athletes meet the learning outcomes McMaster lists. Surely members of the football team “can identify, define and solve problems,” in practice and in play; they “can locate and critically evaluate information,” with lightning rapidity on the field; they “have mastered a body of knowledge,” namely, about football; and they can and must “communicate effectively” to play as a team. And “this learning is measured,” all right, game by game.
Though we may decry the liberal-education requirements as a travesty of liberal education and the learning outcomes as vacuous (a view not universally held; after all, we’re a university), the faculty still teach what we say we teach — anatomy, Arabic, Hebrew, history, math and so forth. What guarantees that students learn, or rather, how is anyone to know whether they did?
For a century or so, grades have been used as a proxy for assessing student achievement. Yet we all know of colleagues who just give all students As and Bs, because it’s much easier to do that than to conduct a true assessment and risk the trouble that can ensue. Those easy As are failing our students, while making the job ever harder for those of us who keep trying to uphold standards and grade accordingly.
No wonder employers are dismayed to find that, for all the tuition graduates have paid, they often lack either skills or knowledge. This is what results from emphasizing requirements instead of subjects, metrics over substance, credentials in place of learning and graduation rates over education.
Eva von Dassow is associate professor of classical and Near Eastern studies at the University of Minnesota. The views expressed here are her own.
Thursday, April 24, 2014
Wednesday, April 23, 2014
Monday, April 21, 2014
For the Record: Important questions remain unanswered in U of M Markingson case
Dale Hammerschmidt, MD, FACP, is an emeritus professor, Division of Hematology, Oncology and Transplantation, University of Minnesota Department of Medicine.
As we were waiting for our first patients of the morning to be checked in, a colleague and I discussed his experience at a university-wide committee meeting the previous day. He reported vigorous criticism of the University of Minnesota Medical School (and certain Medical School faculty), centered upon the deaths of research subjects in clinical trials. Particularly prominent in the discussion was the suicide a decade ago of Dan Markingson, a patient who became a subject in a comparative trial of newer antipsychotic agents. My colleague perceived this as old news, a lack of understanding of the realities of research into the treatment of life-threatening illnesses, and at a certain level an attack on clinical investigation by faculty from outside the Medical School.
I’m sympathetic to his perception, but I also think there are substantive reasons that the Markingson case continues to cause concern; there are questions raised by it that have never had a satisfying (public) resolution.
Some of the concerns involve the conduct of the study at this site, some involve the study design more broadly, some involve Markingson’s specific experience, and some involve the fundamental issues in conducting research involving the care of vulnerable persons. When these different themes get lumped together, an accusatory tone and defensiveness may get in the way of learning from the events.
Accordingly, I’ll not spend much time here on allegations of site-specific misconduct; I’ve never reviewed that part of the record in detail, and I don’t have much to add. I will register my disappointment, however, at the university’s response. On several occasions, we have been told that the university and its investigators have been “exonerated,” because the attorney general chose not to prosecute and the federal oversight bodies (FDA and OHRP) did not effect any sanctions. I think that most faculty members understand that a decision not to prosecute is quite a few steps shy of “exoneration,” and I think most faculty members would like to see a higher behavioral standard than “freedom from felony prosecution.”
On several occasions, it has been suggested that an outside review panel be convened, to review the case and study in detail; these suggestions have not been taken seriously (at least until very recently), which I think is unfortunate. The careful review of serious misadventures is one of our important tools for improving clinical practice; it should also be one of our key tools for improving research practice. Even if no misconduct is found and no weakness in human subjects’ protection is found, a thorough and independent review would show that the university is taking the matter seriously, rather than sweeping it under the carpet.
Looking beyond the narrow concerns of misconduct per se, there are several questions we might ask that I think are very important:
- Markingson was in an unusual situation, known as “stay of commitment;” that is, a court had ruled in favor of his commitment, but stayed its implementation as long as he co-operated in treatment and did well. Technically, he was his own legal consent authority, but he was demonstrably vulnerable and by definition compromised in his ability to give consent. Routine ethical guidelines and federal regulations* provide that there be special protections for vulnerable research subjects; we might thus ask: Were there adequate protections in place for this vulnerability? What would be the best sort of protections to use in this sort of circumstance in the future?
- A fellow on a stay of commitment is in a dependent position with respect to his treating psychiatrist – the stay is conditioned on co-operation with therapy. This could have a coercive effect if the treating psychiatrist is also the one inviting the patient’s participation in a clinical trial or the one conducting the clinical trial. Here we might ask: Were there adequate protections against this adverse influence? In fact, can there ever be adequate protections for the situation (must the person inviting study enrollment be someone uninvolved in the patient’s care)?
- Because the commitment was stayed, no family member was named as a guardian or decisional surrogate for Markingson, and none had clear legal status with respect to his care. That set the stage for tension (a mild word) when a family member was concerned that he was not doing well on his randomly-assigned therapy. So another question: Were there adequate provisions in place for a response to family concerns? Is there a way that such a scenario can be planned for in the design of this sort of study? Might the person most likely to have been named guardian have been a good choice to serve as a special advocate (as part of the special protections)?
- The study was a drug-company-sponsored comparison among newer (but not experimental) drugs useful in managing major psychiatric illnesses. The interests of the sponsor and the best interests of the participating patients can come into conflict in such a study. An additional concern: Did the incentive structure of the study militate unreasonably against code-breaking or crossing over when a patient was not doing well? In fact, one might well ask if it is ever appropriate for a clinical study comparing competing products in vulnerable subjects to be conducted by the sponsor of one of the products.
If we ask questions like these honestly and critically, we may not like all the answers. We may have to admit that we could do a lot better; we may have to admit that there are circumstances where we really don’t know what’s best. But that’s how we move forward. And improving our research practices is far preferable to abandoning our efforts.
*45 CFR §46.111(b) [Criteria for the approval of research]: When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as … mentally disabled persons …, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
*Identical wording appears in the FDA regulations at 21 CFR §56.111(b)
Tuesday, March 25, 2014
For the Record: The Silence of the Bioethicists #markingon
Well, Clarice - have the lambs stopped screaming?
My colleague Leigh Turner writes in Health in the Global Village:
Silence from the Bioethicists
University of Minnesota Bioethicists Remain Silent as a Research Scandal Unfolds
For four years, my colleague Carl Elliott has made an extraordinary effort to help Dan Markingson’s mother, Mary Weiss, and her friend, Mike Howard, fight for justice by calling for an independent investigation of alleged psychiatric research misconduct at the University of Minnesota. During this time, many faculty members at the University have become involved in challenging university officials’ refusal to conduct a credible inquiry. Numerous faculty members signed a petition that asks Governor Dayton to establish a panel tasked with investigating Markingson’s death. Last December the Faculty Senate passed the “Resolution on the matter of the Markingson case.” Bill Gleason has for years written about Dan Markingson and pressed for an inquiry into possible research misconduct. Kirk Allison organized a campus screening of Off Label, a documentary that addresses the Markingson case. I have written to President Kaler, the Board of Regents, Governor Mark Dayton, and Minnesota’s Attorney General, and urged them to investigate Markingson’s death and related allegations of psychiatric research misconduct.
University faculty – myself included – should have done more to hold senior administrators accountable. Still, there has been some dissent at an institution ruled by officials who refuse to investigate disturbing reports of possible research misconduct. Acknowledging these critical voices, I am struck by the silence of my colleagues at the Center for Bioethics. The faculty members who should have been most vocal in response to allegations of research misconduct at our own institution have remained silent.
Jeremy Olson and Paul Tosto first reported Dan Markingson’s death in 2008. Elliott’s Mother Jones article, “Making a Killing,” was published in 2010. Since then, there has been extensive news coverage of alleged research misconduct at the University. During this period, faculty members at the Center for Bioethics have never had a meaningful discussion addressing Markingson’s death; the possibility that serious psychiatric research misconduct occurred at our university; and university officials’ repeated refusals to support a credible investigation. There seems to be an unspoken yet collective understanding within the Center for Bioethics that it is taboo to discuss Dan Markingson’s death and related allegations of psychiatric research misconduct. The silence is deafening.
University officials have responded to Elliott’s investigative work and whistle-blowing by attempting to frame him as a lone, self-promoting, rogue employee who twists facts and uses this “unfortunate tragedy” to advance his own interests. My bioethicist colleagues have done little to counter this institutional script. Remaining silent, they have allowed university administrators to isolate, insult, and attempt to intimidate Elliott.
Despite former General Counsel Mark Rotenberg’s misleading claims in reply to Elliott’s article in Mother Jones and subsequent blog posts, at no point did bioethics faculty members at the University ever challenge Rotenberg and demand credible responses. Rotenberg has made many inaccurate assertions about the Markingson case. Faculty members at the Center for Bioethics have never demanded better responses from senior university officials.
Justin Paquette and Brian Lucas
When Justin Paquette, a public relations representative for the University’s Academic Health Center, claimed that Elliott’s “unfounded logic” and “personal crusade against our psychiatry department” amounted to “fiction” motivated by Elliott’s interest in “marketing” his books, bioethicists at the University did not respond to Paquette’s ad hominem attacks. I was among those who should have immediately condemned Paquette’s ugly exercise in character assassination. Faculty members in bioethics also remained silent when Brian Lucas, another public relations employee, speculated about whether Judy Stone, author of numerous pieces critical of the university’s handling of the Markingson case, is “a wacko.”
Aaron Friedman, former dean of the medical school and vice president for health services, has on numerous occasions dismissed Elliott’s concerns and supported Stephen Olson and Charles Schulz, two psychiatrists at the center of allegations of psychiatric research misconduct. In an Op-Ed, Friedman writes, “as Elliot (sic) clamors for more examination, he seems to feel no responsibility to accurately report what has already been done.” Friedman’s commentary accuses Elliott of making “unfounded accusations” and providing a “selective and distorted narrative.” Friedman’s diatribe went unchallenged by faculty members at the bioethics center.
Tim Mulcahy, Aaron Friedman, Mark Rotenberg, and the Academic Freedom and Tenure Committee
In 2011, two University Vice Presidents, Aaron Friedman and Tim Mulcahy, attended a meeting of the Academic Freedom and Tenure Committee and explored ways to silence or challenge Elliott. They were there as a question former General Counsel Mark Rotenberg posed at another committee meeting. “What,” Rotenberg had asked, “is the faculty[’s] collective role in addressing factually-incorrect attacks on particular University faculty research activities?” Minutes from the meeting suggest that the purpose of the vice presidents’ time with the Academic Freedom and Tenure Committee was to explore ways of restricting Elliott’s academic freedom and sanctioning him for making what they alleged were inaccurate claims. I was the only one of Elliott’s colleagues from the Center for Bioethics to attend the committee’s next meeting and ask whether Rotenberg’s comment was a dog whistle call to restrict Elliott’s academic freedom. While Karen-Sue Taussig, an anthropologist, and philosophers Valerie Tiberius, Ken Waters, and Naomi Scheman attended the meeting and offered robust support for Elliott’s academic freedom and right to call for an investigation, despite the principles at stake there was no additional representation from the Center for Bioethics.
Debra DeBruin and Steven Miles
Even when directly asked to investigate, faculty members at the Center have refused to address allegations of psychiatric research misconduct. Debra DeBruin and Steve Miles have both served as directors of the University’s clinical research ethics consultation service. Despite being requested to conduct an inquiry into Markingson’s death and examine the adequacy of human subject protections in the Department of Psychiatry, both DeBruin and Miles refused to investigate.
The Letter to the Board of Regents
The only exception to the collective silence at the Center for Bioethics has been single letter that was sent to the Board of Regents. In November 2010, eight faculty members wrote to the Regents and called for an investigation of the Markingson case. Notably, however, Jeffrey Kahn, then the director of the Center for Bioethics, did not sign the letter. Debra DeBruin, then the associate director and now director of the Center for Bioethics, did not sign the letter. Steven Miles and Susan Wolf, two of the Center’s most senior and prominent bioethicists, did not sign the letter. Throughout a serious research scandal, bioethicists who claim they are concerned with justice, protecting the vulnerable, and responsible governance of human subjects research have remained silent.
The University’s Power Structure
It takes little insight into the power structure of the University to understand why faculty members at the bioethics center remain silent. Anyone paying attention to President Kaler, former Vice President Aaron Friedman, former Vice President Mulcahy, former General Counsel Mark Rotenberg, and current General Counsel William Donohue would have noticed that senior officials all dismiss calls for an investigation of psychiatric research misconduct. To publicly call for an investigation is to swim against the institutional tide. It is much easier to keep quiet than to confront the university’s most powerful administrators.
Silence in the Face of Injustice
When does remaining silent during a research scandal lead to complicity in wrongdoing? Will collective silence from bioethicists prompt blunt questions concerning why the University of Minnesota has a Center for Bioethics? Might collective silence diminish bioethics as an area of study by suggesting that bioethicists, when confronted with allegations of misconduct at their own institution, do little more than defer to authorities? What happens if an investigation at some point determines that serious research misconduct has occurred at the University of Minnesota and most bioethicists at the Center for Bioethics here said and did nothing rather than confront wrongdoing?
Contemporary bioethicists look at the Tuskegee research scandal and question why so many individuals chose to remain silent in the face of wrongdoing. “It was a different time, a different place,” we say, and congratulate ourselves on the progress we assume we’ve made. We look at the past and we think we are distinguishable from people who responded to injustice with silence and indifference. But doesn’t the silence of those who have voices and could choose to use them for good bind past to present and connect us to what we thought we had surpassed?
“The Silence of the Bioethicists”, an earlier version of this post, appeared March 24, 2014 on the blog, Impact Ethics.
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