Wednesday, May 4, 2016

For the Record: Bioethicist Dr. Steven Miles to take Voltaire's advice: "We must cultivate our garden."






From the Minnesota Daily:


After almost 35 years at the University of Minnesota, Medicine Professor Dr. Steven Miles announced Sunday to medical school leaders that he plans to retire after the 2016-17 school year. 


While his peers have praised Miles’ work for human rights at the University’s Bioethics Center, some in the center say they worry they’ll continue to lose administration support following his departure.


In a letter to administrators and department heads, Miles highlighted his accomplishments at the University, including changes in patients’ end-of-life care and ending the use of restraints in nursing homes. 


He also noted his work involving short-course tuberculosis therapy in open refugee camps, writing the standard interpretation of the Hippocratic Oath and “accurately excavating United States military medicine’s complicity with torture during the war on terror,” among others. 


Miles served on the center for Victims of Torture board for several years, which CVT Executive Director Curt Goering said was an asset because of his international reputation and knowledge of medical ethics. 


“I would be hard-pressed to find someone who’s had more of an impact,” Goering said. 


In his letter, Miles pointed to the importance of the Bioethics Center in the wake of several ethical controversies at the University involving research practices. 


In the past 15 years, Miles said, these controversies have led to government hearings, criminal trials, huge University allocations of staff time and National Institutes of Health sanctions. 


“All of these have arisen at the nexus of powerful faculty, commercial funding and advances in research,” Miles wrote, adding that only one of the University’s scandals has been brought into the public light by faculty at the Bioethics Center.


The center’s long-term operations under interim and year-to-year directors, as well as the University’s denial to conduct a national search to replace faculty, has contributed to its difficulties, Miles said in the statement. 


The center’s plight has also drawn the attention of the legislative auditor’s office in the aftermath of the 2004 death of Dan Markingson, who committed suicide after being recruited into a University drug trial. 


In a report last year that raised questions about research practices at the University, auditors questioned why University officials did not include the Bioethics Center in research ethics discussions. 


“It leaves us wondering why the University of Minnesota has a Center for Bioethics when University officials will not meet with the center’s faculty to discuss the very real and important bioethical questions the Markingson case raised,” the report said.


Miles wrote that in the past decade other academic health centers “established and fortified their medical and bioethics centers,” but the University has moved in the opposite direction. 


When bioethics professor Carl Elliott came to the University in 1997, he said the Center for Bioethics was viewed as one of the best bioethics units in the world. But in the wake of multiple ethical concerns regarding the University’s research practices, faculty members now run thin. 


“Now, all that’s left is a skeleton crew.” Elliott said. “The administration has decided that the solution to 25 years of scandals in the medical school is to asphyxiate the center quietly and relentlessly, making the bioethicists so miserable that they leave. It has been a brilliant strategy.” 


Miles expressed a similar concern and wrote, “The attrition of the depth and breadth of Bioethics expertise at the AHC is counter to the University’s interests.”


Miles said he plans to spend his retirement traveling and gardening. 


“I love the University of Minnesota and am proud of, and have enjoyed, nearly 35 years on the faculty,” he said. “I just finished a chapter and am going out to garden now.”


Friday, April 8, 2016

For the Record: U of Minnesota Faculty Consultative Committee - member calls administration handling of psychiatry scandal "sickening"




From the  16 March Faculty Consultative Committee Minutes:

Members of the committee proceeded to have a very candid discussion about the issues surrounding the Department of Psychiatry, the consultant’s report and the management plan. Themes that came out of this discussion included:

• Disappointment in how the administration is handling this controversy with a member going so far as to characterize it as “sickening.”

• The alleged conduct in the Department of Psychiatry goes so far beyond the level of responsible conduct that it calls into question how the University could have recruited, trained and sustained people who would act this way. What kind of environment allowed this to happened? It would be naïve to believe this is the only place in the University where these kinds of things are occurring. How can the precursors be identified before something like this happens again?

• The administration is taking a very defensive posture/position by categorically denying allegations in the report rather than taking responsibility and being accountable. If the University is going to spend the money to hire an outside consultant, it needs to accept the findings, even when they are findings the administration does not want to hear. This speaks to the credibility of the institution, and minimizes the trust employees and students have in the institution. What can faculty do to hold the administration accountable? A number of faculty are not necessarily behind the administration. What should the faculty response be given there is so much distrust.

• The administration continues to operate in crisis and damage control mode, and fails to see the underlying issues that caused the problems in the first place, which are often structural and systemic, e.g., the environment and culture. A culture change needs to happen; it is difficult to overcome administrative practices and procedures that are in place that do not foster a culture where people feel they can speak up without being retaliated against.

• There exists a lack of consultation on the part of the administration. It is not uncommon for the administration to make important decisions without proper consultation.

• Serious misconduct can lead to federal consequences. Should certain lines of work be discontinued in order to restore the University’s reputation? There is a serious accountability problem for those on the front line and up the hierarchy as well. Violators should be subject to greater scrutiny going forward.

• The institution as a whole has a culture of non-compliance, which, at least in part, is due to a lack of institutional commitment to ensuring compliance occurs and because there are so many rules it makes it hard to get anything done. The University makes it hard to do the right thing, and easy to not do the right thing. Studies should be systematically or randomly audited. More auditors need to be hired. Taking a course on research ethics does not make a person ethical unless the person really works on ethical reasoning. 

• The administration is not forthcoming with information and gives it too late, e.g., timing of distribution of the report.

• The institution should function as one university and not the AHC and everyone else. Breaking down the boundaries will be critical if the University going to do well. 

[I thank my colleague, Carl Elliott, for calling this link to my attention.]

For the Record: University of Minnesota's new psychiatry head seeks to heal wounds with families



Dr. Sophia Vinogradov will become head of the psychiatry department in August.


In her first visit since being picked to lead the University of Minnesota’s embattled Psychiatry Department, Dr. Sophia Vinogradov spent an hour this week with a relative of Dan Markingson, who died by suicide in 2004 amid complaints that he had been coerced into a U schizophrenia drug study.

“I intend to have a full and open dialogue with every single person that I possibly can,” Vinogradov said in a phone interview Thursday after returning to the University of California-San Francisco, where she teaches in the medical school.

“I see a place [in the U] that has just incredible potential, both for me as an individual researcher who is interested in serious mental illnesses and in nonpharmacological approaches,” she said, “but also as someone who has been developing ideas and visions about where the future of psychiatry needs to go.”
On Tuesday, Vinogradov met with Mike Howard, a close friend of the Markingson family, and offered him a spot on a consumer advisory counsel intended to keep researchers honest regarding the needs and concerns of patients and their families. A similar council at the VA hospital in San Francisco has been meaningful in her work, she added.
They also discussed the possibility of an annual research ethics lecture in Markingson’s memory, according to Howard, who said he was impressed by Vinogradov’s commitment to “learn from this and never repeat the same mistakes.”

Friday, April 1, 2016

For the Record: Costs in coaching contracts are hardly where the troubles end at University of Minnesota





[The following letter appeared in the Star-Tribune today. Regular readers will recognize that the author, Mr. Michael McNabb, is a regular and valued contributor to this blog.]


UNIVERSITY OF MINNESOTA

Costs in coaching contracts are hardly where the troubles end. 
In questioning the $7 million buyout provision for the University of Minnesota basketball coach, the two newest regents refer to “a university bubble where logic doesn’t quite look the same as it does for the rest of us.” (“Change is urged on big U coaching deals,” March 31). 
This should be just the beginning of such questions. The 2015 administrative cost report includes some astounding total amounts in several general categories, such as $80.3 million for “leadership,” $77.5 million for consulting and professional services for “mission,” and $66.1 million for consulting and professional services for “mission support.” 
The March 31 issue of the Star Tribune also includes a report on student loan debt (“Tales of student debt aired at Capitol,” March 31). There is a connection here. 
Just as Wall Street bankers created a housing bubble using other people’s money, the senior administrators and the older regents have created a higher-education bubble using student loan debt. When this budget balloon bursts, they will walk away unscathed, just as the investment bankers did. The students (and their parents) will suffer harm from the student loan debt that inflated the balloon. They will be shackled with that debt for many years. 
Michael W. McNabb, Lakeville

Friday, February 19, 2016

For the Record: Signatories to “University of Minnesota research lapses show self-reform is failing," Minneapolis Star Tribune, February 18, 2016







Professor Carl Elliott has kindly provided me a copy of his article (with professor Matt Lamkin, U Tulsa Law School) which appeared in the Star-Tribune recently

Another year, another day, another damning indictment of the University of Minnesota’s Department of Psychiatry. If anyone was surprised by last week’s blistering assessment of psychiatric research at the university (“New lapses in U psych studies,” Feb. 12), they probably weren’t paying attention to the previous five. Those reviews found evidence of coerced study recruitment, troubling conflicts of interest, shoddy scientific review, deep mistrust of U leaders, and a climate of fear and intimidation in the Psychiatry Department. The difference with this latest review is that it comes nearly a year after U leaders solemnly promised the people of Minnesota that they were finally going to clean up the mess. 
For more than a decade, U leaders brushed aside revelations that their Psychiatry Department was mistreating vulnerable patients, including Dan Markingson, a mentally ill young man under a civil commitment order who killed himself while in a U drug study. Last year, the state’s legislative auditor released a scathing report that not only confirmed these research abuses, but laid bare the U’s strategy for avoiding responsibility for its misdeeds. U leaders “have made misleading statements about previous reviews and been consistently unwilling to discuss or even acknowledge that serious ethical issues and conflicts are involved,” the legislative auditor wrote. “This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation.”

This latest debacle shows the administration falling back on the same old playbook. When Jan Dugas, the external consultant hired by the U, reported alarming problems in Psychiatry Department studies, the acting department chair responded, “This is nothing new; it happens all over the university.” On two occasions, Dugas said, she was intimidated and “verbally abused” by department faculty members. The director of the Human Research Protection Program refused to let Dugas see study records.

When Dugas uncovered more than 40 “critical or major” safety problems, legal violations and incidents of unethical conduct in just three weeks, officials abruptly pulled the plug on her investigation, saying it was no longer necessary. Leaders of the Clinical and Translational Science Institute told her “not to write a report” of her findings. When she was finally allowed to produce a report, she was told that no one else would be allowed to see it. U officials kept the report on ice for more than a month, stonewalling open-records requests while they prepared to spin its findings (now conveniently relabeled “allegations”). It is not clear when the report would have been released had it not been leaked to the news media last week. At that point, U President Eric Kaler explained: “We wanted to clarify the record before we released the report.”

It is understandable why U leaders did not want anyone to see the report. Research in the Psychiatry Department is portrayed as a dangerous, disorganized mess: unlicensed study personnel operating MRI and TMS machines; children approached for research studies without the permission of their parents; urine specimens collected from patients in fast-food restaurants and coffee shops.

Last summer, only two months after U leaders announced a reform plan they called “Markingson’s legacy,” a faculty member in the Psychiatry Department was found to have forged federal research documents. Now we learn that research personnel admitted to altering study documents when they prepared for audits. “We go behind the scenes and fix things up,” one interviewee said. “What people don’t know won’t hurt them.”

The response of U leaders has been utterly predictable. Just as before, they have disputed the consultant’s findings, minimized the significance of the report, and cloaked their response in a bureaucratic fog of euphemism and circumlocution. But no amount of double talk can hide the report’s main conclusion: “Practices in the Department of Psychiatry demonstrate a profound lack of knowledge about how to conduct clinical research and an intentional lack of adherence to requirements.”

This latest fiasco makes clear that the pathology at the University of Minnesota lies not just in the Department of Psychiatry, but in an administration whose overriding goal is to avoid accountability. The Board of Regents has responded to this latest scandal exactly as it has responded to all of the others — with a shrug. The U’s dysfunctional culture can’t be reformed by the same people who created and sustained it over so many years. The question now is: when will the Legislature bring the U’s leadership to heel?

Matt Lamkin is a professor at the University of Tulsa College of Law. Carl Elliott is a professor at the Center for Bioethics at the University of Minnesota. The views expressed here are their own. This article was submitted on behalf of a group of 83 University of Minnesota alumni and scholars in health law, bioethics, psychiatry and medicine.



Thursday, February 18, 2016

For the Record: Chad Hartman talks with Former Gov Arne Carlson on WCCO. Carlson is critical of the U of M President & Regents.




The original posting - see above - contains about twice the material where Governor Carlson was interviewed.


The full link to the above page is here.  


The video below contains only the relevant discussion between Carlson and Hartman:










Sunday, February 14, 2016

Tuesday, February 9, 2016

Tone Deaf at the U of M?




Rising Temperature


As a result of all this, we now have a reading of the American political temperature.  What we've learned is that it's burning a lot hotter at the grass roots than either party's leadership seems capable of understanding.
The Talk of the Town at p. 35 of the February 8, 2016 issue of The New Yorker magazine.


I'm not going to tell [my children] that college will eventually become affordable without a political revolution to change this ghastly situation. . . . I'm not because it's delusional to believe otherwise.
Letter to the Editor in the February 5, 2016 issue of the Star Tribune.

The high tuition high financial aid experiment has failed a vast  majority of students and their parents.  In 2014 65% of U of M graduates had student debt.  The median debt was $24,728.  Then there is the unconscionable economic burden placed on students in the professional schools.  In 2014 88% of the graduates from the U of M professional schools had student loan debt.  The median debt was $152,793.  See pp. 15, 21 of the October 2015 Minnesota Higher Education Report on Cumulative Student Loan Debt in Minnesota.

Tone deaf remarks about student loan debt ("less than a new car") by the U of M president and the 2014 chair of the Board of Regents demonstrate a failure to acknowledge the overall cost of a college education and a remarkable lack of empathy for the students and parents struggling to pay that cost. 

The senior administrators and the Regents responsible for a decade of skyrocketing tuition in 2002--2012 never had to deal with that financial burden when they were starting their careers and their families after graduation.  How much different would their lives have been if they had been shackled by student debt?

Just as the Wall Street bankers created a housing bubble using other people's money, the senior administrators and the Regents at the U of M have created a higher education bubble using both student loan debt and institutional debt.  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 harm from the student loan debt that inflated the balloon.  They will be shackled with that debt for many years (or even decades for many students in the professional schools).  And the citizens of Minnesota will pick up the tab for the huge institutional debt.   


Michael W. McNabb

University of Minnesota B.A. 1971; J.D. 1974

University of Minnesota Alumni Association life member