Tuesday, June 9, 2015

For the Record: Kaler's compensation: He is not the CEO of a commercial business





From the Star-Tribune
(emphasis mine)


KALER’S COMPENSATION 

He’s overpaid, and attention to this has been underpaid. 
The University of Minnesota president receives an annual salary of $610,000 plus an annual contribution of more than $75,000 to his retirement plan, plus other benefits, including free housing (“6-figure pay to run a public college,” June 8). In 2013, the IRS released its final report on its compliance project on tax-exempt colleges and universities. The average total compensation of presidents of large universities was $399,723, and the median amount was $337,881. 
The U president is not the CEO of a commercial business. He is the head of a nonprofit institution of higher education. The law restricts the pursuit of personal wealth by the leaders of private, tax-exempt organizations. Section 4958 of the Internal Revenue Code imposes an excise tax on excessive compensation paid to senior administrators at private colleges. The section does not apply to public universities, as those institutions are classified as units of government. But we must be concerned with the reasonableness of the compensation of senior administrators at the U — and not simply by comparison to compensation levels at other large public universities. Until recently, no one has been watching the store anywhere in higher education. 
Michael W. McNabb, Lakeville 
• • • 
It’s not U President Eric Kaler’s fault that he measures success by the salary he deserves as the CEO of a $3.5 billion business. He’s been taught, like the rest of us, that money is the barometer of achievement. And it’s not his fault that a tuition hike is needed at the U to cover things such as his $610,000 salary. He runs a large corporation, not a kitchen table where a student and his parents are working out their budget for the fall. And, after all, Kaler is competing with the U’s sports coaches, whose salaries are double and triple his. 
But true success isn’t about money. It’s about assuring that the CEO doesn’t earn more than 20 times the salary of the lowest-paid employee (see Ben & Jerry’s CEOs). It’s about paying your employees for a year when your mill burns down, as Aaron Feuerstein did in 1996 in Massachusetts. Success is about knowing that raising tuition may mean that some students will have to leave college, about knowing that $610,000 is more than you will even need to live well on. Success is about caring more for the world around you than for your ranking in the Big Ten pay scale. 
But then we don’t teach executives to distinguish between success and true success, even in the business ethics courses now springing up in most M.B.A. programs. Shame on us. 
Elaine Frankowski, Minneapolis

Sunday, June 7, 2015

For the Record: Recent U graduate appalled by President Kaler's Counterpoint on Research Ethics


(emphasis mine)
As a 2013 graduate of the University of Minnesota, I was appalled by the May 31 “counterpoint” from university President Eric Kaler. As a student, I was active sharing my comments, concerns and criticisms with Kaler and his staff. I have always believed in the excellence of the University of Minnesota, but that faith does not extend to Kaler, his administration or our Board of Regents. 
Kaler mischaracterized the legislative auditor’s report, the scope of which was on the broad institutional “culture of fear” that systematically ignored “serious ethical issues.” 

The fact that Kaler cited numerous reviews that span a decade highlights continued failure. Further, the report concluded Dr. Stephen Olson’s research had “numerous” conflicts of interest, adding that he had “inappropriately” delegated work in research that involved people’s lives. I wonder then what kind of accountability we are getting when Olson continues to influence students, staff and the department? 
We have yet to see Kaler do more than pay lip service to these issues without demonstrating the courage to act. Yet why would he or the Board of Regents feel compelled to act when there is no accountability? We cannot continue to have good faith in those who have routinely and consistently failed us.

Chris Getowicz, Minneapolis

For the Record: Member of President Kaler's Clinical Research Re-engineering Team Calls Him Out


Professor Naomi Scheman is a member of the group selected by University of Minnesota President Kaler to come forward with new policies to rectify the mess that is clinical research at the University.



From the Sunday Star-Tribune  (emphasis mine)

U RESEARCH ETHICS
Credit Carl Elliott and Leight Turner for prodding people into action 

As a member of the implementation team at the University of Minnesota whose recommendations concerning human subjects protection are being hailed as “Markingson’s legacy” (“The best thing for the U now is to move forward,” May 31), I need to demur. 
While I think our recommendations if seriously implemented will greatly improve human subjects protection, the ground on which that edifice will stand is still problematically unstable. Unanswered questions and failures to hold individuals accountable remain and need to be addressed. Furthermore, credit for what we have accomplished is misplaced. 
Neither the team nor the external review on whose recommendations our work was based would have existed but for the efforts of Carl Elliott and his colleague Leigh Turner. 
Those of us in the Faculty Senate who called for the outside review deserve credit only — and this is no small thing — for refusing to go along with the clear message from successive administrations that Dr. Elliott was not to be taken seriously, and that while academic freedom afforded him some protection from direct retaliation, others’ academic responsibility lay in shunning him. 
The university administration owes Profs. Elliott and Turner an apology and a debt of gratitude, but, most important going forward, it needs to grant them the credibility they have earned. 
Naomi Scheman, St. Paul 
The writer is a professor of philosophy at the University of Minnesota.



Tuesday, June 2, 2015

Setting the Record Straight: Dr. Mickey Nardo does a number on #umn President Kaler


From Dr. Nardo's web-site: 1 Boring Old Man

everything is fine now?…

Posted on Tuesday 2 June 2015

It seems to me that President Kaler at the University of Minnesota thinks if he words things just right, people will believe what he says. So he says the same things over and over in a slightly different way and then seems surprised that we all don’t say, "Oh, I see, everything is fine now" and leave him alone.

Counterpoint from Eric Kaler: U is moving forward on research ethics 
And it is, with an action plan on ethics in research that has the potential to be a national model. 
Minnesota StarTribune
by Eric W. Kaler
May 30, 2015 
Difficult ethical issues are inherent in medical research, especially clinical trials involving human subjects. Research holds the promise of finding lifesaving treatments, but it sometimes depends on the participation of vulnerable patients suffering from serious illnesses. We at the University of Minnesota take seriously our responsibility to patients participating in clinical studies, and our critics are wrong when they assert that we have turned a blind eye to our ethical obligations [Medical research: Honor code still needs strengthening,” a May 27 commentary by U Prof. Carl Elliott]. 
Let me be clear about Dan Markingson’s 2004 death by suicide, which is at the center of much of this conversation. The events have been the subject of many proceedings, including two reviews by the U.S. Food and Drug Administration [2005 and 2015], a lawsuit in Hennepin County District Court [2008], complaints to the Minnesota Board of Medical Practice against two doctors [2009 and 2010], and a review by the legislative auditor [2015]. 
As the legislative auditor concluded, we can never know if Markingson’s tragic death was the result of a clinical study conducted at 26 sites, including the University of Minnesota. However, it is clear we could have done better in our response to the concerns raised about these events. I have apologized to Dan Markingson’s mother, to a legislative committee and at public forums…
In this attempt to deny responsibility, the question is teleported to the clinical study. While the clinical study itself was nothing to write home about, what’s on the table isn’t the clinical study. The Protocol is clear, patients who didn’t respond were to be withdrawn. So a grossly psychotic patient with lethal delusions and disorganized thinking was in full view, not responding to the study medication, and nobody noticed, in spite of being confronted about that by Dan’s mother repeatedly [see making sense…]. Dan wasn’t studied clinically.

To their credit, our university faculty wanted further assurance that our current program was at the highest levels of ethics and science, and in December 2013 the Faculty Senate requested an independent external evaluation of our human subjects protection program…

At the time, the limiting of the investigation to the current program and not the Markingson case per se was Kaler’s idea, not the Senate’s [see the following brief posts with links on Carl Elliot’s Fear and Loathing in Bioethics blog from December 2013]:








Meanwhile, back to President Kaler’s counterpoint. As with many of his statements, Kaler says essentially that everything is fine now and that Carl Elliot et al should be satisfied and move on:

Critics are important voices, but there comes a point at which criticism of past actions stops being a catalyst for reform and, instead, becomes a barrier to necessary change in the future. We can’t change the past, but with vigilance, dedication and integrity, we will move forward. I promise all Minnesotans, our faculty and students, and our future patients and their families that the University of Minnesota’s human subjects research program will soon be a model for other universities.

Other U·of·M Administrative types are accusing Carl of sticking on this issue as résumé padding and book selling COI, this criticism documented by a U·of·M colleague blogging on The Periodic Table [see For the Record: U·of·M faculty member of Academic Freedom and Tenure Committee Steps Over Line? and For the Record: More foolishness from a member of #umn Academic Freedom and Tenure Committee]. Neither passion nor perseverance are conflicts of interest in my book – they’re expressions of interest of the best kind.

Dan Markingson was in the hospital for around six months in 2003/2004. Mary Weiss, his mother, was told that everything is fine now – and it wasn’t. Mary Weiss, Mike Howard, Carl Elliot, Leigh Turner, and all investigators have been repeatedly told that everything is fine now in the decade since – and it wasn’t. So why should they listen to President Kaler’s tired message that everything is fine now? Let’s hope they don’t…


For the Record: More foolishness from a member of #umn Academic Freedom and Tenure Committee



Professor Cohen continues commenting on the Strib. 


In a spectacular example of dunderheadedness we find the following comment in the Star-Tribune from Professor Jerry Cohen, of the University of Minnesota, who is unfortunately a member of our Academic Freedom and Tenure committee

"You miss the point.I think most published works have good and bad reviews and Elliott is a faculty member at a major university.He has credentials, it is not the argument.No matter, if his commentary lacksobjectivity, if he personally benefits by résumé ‘padding, if he basks in the attention, then he has conflicts of interests that need to be considered.Like FOX news, the story may be of an important event, but the bias makes the report suspect.No matter how many liked his book, his lack of objectivity is on the record."

So according to Professor Cohen, Dr. Elliott lacks objectivity, benefits by resume padding, and basks in attention which means he has conflicts of interest?

This man definitely has great potential for administration at the U of M, but not for serving as a member of an academic freedom and tenure committee.


Monday, June 1, 2015

For the Record: U of M faculty member of Academic Freedom and Tenure Committee Steps Over Line?


As I commented to my Academic Senate colleagues:
Carl Elliott apparently feels he has some special insight or unique knowledge of clinical research practice because he repeatedly faults President Kaler for not meeting with him to gain this critical information.His curriculum vitae provides little to warrant this claim.Instead, it shows a significant enhancement of his professional accomplishments attributed to his very public rebukes of this University’s administration by him over the years.His online presence links this activity with advertisements for his book ‘White Coats, Dark Hats’.Similarly, Leigh Turner’s CV is enhanced by almost two pages with 22 items entitled ‘Public service & scholarship requesting an investigation of psychiatric clinical research at the University of Minnesota.’Matthew Lamkin’s CV similarly benefits from such ‘accomplishments’.When, in the course of academic pursuits, does scholarship cross over into vested interests/conflict of interest?
Maybe their expertise into bioethics makes them so insightful into ethical dilemmas that the fact that their actions embellish significantly their own disciplinary credentials is not important and we should remain attuned to their professional demands for righting the university?However, as Sally Satel notes in her review of ‘White Coat, Black Hat’ “…Carl Elliott’s sensational and depressing message, which is that most doctors are dupes and the rest are corrupt” makes one wonder about full objectivity.Ms. Satel notes her concern that ‘The Wild West days of free-ranging drug salesmen, lavish gifts, and pharma-scripted talks are largely over. But Elliott’s book unfortunately keeps alive the impression that corruption, both subtle and overt, is rife.’“Without actually intending it,” Elliott writes, “we have constructed a medical system in which deception is often not just tolerated but rewarded.”Is this, as Ms. Satel seems to imply, sensationalism for the sake of book sales or a committed scholar who fails to recognize change?
Carl Elliott has made us aware of possible motives as he notes in his satirical essay ‘How to be an academic failure: an introduction for beginners’ when he explains prophetically: “If you are feeling a little too comfortable with success, it doesn’t usually take much work to dig up some sort of ethical problem to expose. Conflict of interest, research scandals, malpractice lawsuits in waiting -- any of these will do. Go to a dean or a hospital administrator, kick up a fuss with your Institutional Review Board…” and then he goes on to note “In bioethics, there is always somebody for you to alienate.”As quoted in the Satel review ‘Elliott…dispels any promise of even-handedness: “I do not claim to offer a balanced picture of contemporary American medicine. My interest is in how medicine has gone wrong, not in what there is to admire.”’
It is this lack of any premise of even-handedness along with a clear track of conflict of interest, from resumé padding to book sales, which has me questioning the motivation of these colleagues.As the Rush Limbaughs‎ and Fox News of the world have found, unbalanced pictures of complex situations can make for some handsome rewards.Ethical decisions almost always involve judgments of facts and situations that are subject to various interpretations and influences – judgements that typically are in the gray area without a clear black/white delineation. Lack of objectivity or even the perception of the lost even-handiness can exclude an individual from having their opinions taken seriously.Have these three clearly crossed that line?
As members of the University of Minnesota faculty or its alumnus, these professors have an innate conflict-of-interest when attacks on the university enhance their resumé and thus, as bioethicists, should recuse themselves from active participation.The response of President Kaler and his administration has so far been professional and even-handed, and he has brought outside reasoned analysis of the situation to focus rightly on better ways forward.That way forward to a better future is complex, will require lots of thoughtful deliberation, and is likely to be a rather rocky-road to travel with changes in processes, academic focus and research cultures.This university deserves and hopefully will reap the benefits provided from both continued thoughtful and studied input from outside and informed and debated directions provided best through the processes of faculty governance.
Jerry Cohen, Professor, member of the Faculty Senate and member of the Senate Committee on Academic Freedom and Tenure, University of Minnesota 
===========================
Simply pathetic. 

For the Record: The Silence of the Bioethicist - Markingson




I've posted earlier the commentary by President Kaler in the Star-Tribune which was published yesterday.

In that piece we see the following:

Dr. Steven Miles, a nationally recognized University of Minnesota bioethicist and a member of the team that wrote the report, called this plan “Markingson’s legacy” and said he hopes the plan will be a national model. “Having taught medical ethics now for 34 years, I think … this is possibly the most robust policy I’ve ever seen,” he said.
Of interest are the following comments on the article:


For the Record: Latest Response of President Kaler on Markingson Scandal




Difficult ethical issues are inherent in medical research, especially clinical trials involving human subjects. Research holds the promise of finding lifesaving treatments, but it sometimes depends on the participation of vulnerable patients suffering from serious illnesses.

We at the University of Minnesota take seriously our responsibility to patients participating in clinical studies, and our critics are wrong when they assert that we have turned a blind eye to our ethical obligations (“Medical research: Honor code still needs strengthening,” a May 27 commentary by U Prof. Carl Elliott).

Let me be clear about Dan Markingson’s 2004 death by suicide, which is at the center of much of this conversation. The events have been the subject of many proceedings, including two reviews by the U.S. Food and Drug Administration (2005 and 2015), a lawsuit in Hennepin County District Court (2008), complaints to the Minnesota Board of Medical Practice against two doctors (2009 and 2010), and a review by the legislative auditor (2015).

As the legislative auditor concluded, we can never know if Markingson’s tragic death was the result of a clinical study conducted at 26 sites, including the University of Minnesota. However, it is clear we could have done better in our response to the concerns raised about these events. I have apologized to Dan Markingson’s mother, to a legislative committee and at public forums.

In addition to recognizing and respecting the personal grief of those closest to Mr. Markingson, I believe the most meaningful way for an institution to apologize to the broader Minnesota public is to be better in the future. That is what we are doing as we move forward. The university, the nation’s ninth-most-active public research university, is implementing far-reaching reforms to our human subjects protection program. Our goal is to be a national model, both ethically and operationally. Last week, a faculty-led implementation team produced a 68-page action plan (http://tinyurl.com/l735b3s) to achieve this goal.

This plan reinforces our commitment to an ethical culture, minimizes conflicts of interest, creates more robust institutional review boards and oversight, and vastly improves our approach to research involving people who have impaired decisionmaking capacity.

Dr. Steven Miles, a nationally recognized University of Minnesota bioethicist and a member of the team that wrote the report, called this plan “Markingson’s legacy” and said he hopes the plan will be a national model. “Having taught medical ethics now for 34 years, I think … this is possibly the most robust policy I’ve ever seen,” he said.

I intend to implement this plan fully and with complete transparency, and I encourage you to watch us closely and judge us fairly as we do our work.

When I came to the university in 2011, I reviewed the concerns that some had raised about the Markingson case. I also reviewed investigations of his death from the U.S. Food and Drug Administration, the Board of Medical Practice and the courts. Those are the independent bodies responsible for finding facts and resolving issues in matters such as this, and all of them have affirmed our compliance with laws and regulations.

To their credit, our university faculty wanted further assurance that our current program was at the highest levels of ethics and science, and in December 2013 the Faculty Senate requested an independent external evaluation of our human subjects protection program.

The Board of Regents and I strongly endorsed that recommendation and took immediate action. The panel’s proposals for reform and improvement were so thorough and far-reaching that this spring when the Legislative Auditor issued his review, he adopted the panel’s recommendations in their entirety.

I came to the University of Minnesota less than four years ago, becoming president at a time of enormous change and challenges for all postsecondary institutions. On many fronts, great progress has been made. We renewed our partnership with the state of Minnesota; tuition increases have been reined in; graduation rates are at an all-time high; administrative costs have been reduced substantially, and the quality of much of what we do has been enhanced.

But Minnesotans rightly hold everything done under the name of the “University of Minnesota” to the highest standards of excellence. Minnesotans know that even before there was a state of Minnesota, there was a University of Minnesota. Pride in the university’s legacy and in its importance to all Minnesotans runs deep. I take that very seriously.

Critics are important voices, but there comes a point at which criticism of past actions stops being a catalyst for reform and, instead, becomes a barrier to necessary change in the future. We can’t change the past, but with vigilance, dedication and integrity, we will move forward.

I promise all Minnesotans, our faculty and students, and our future patients and their families that the University of Minnesota’s human subjects research program will soon be a model for other universities.



Eric W. Kaler is president of the University of Minnesota.


Wednesday, May 27, 2015

For the Record: FAQ: U drug trials, patient safety and the death of Dan Markingson




Dan Markingson and his mother, Mary Weiss. 
Weiss was concerned that her son wasn't getting better during his six months in a U of M study. Courtesy Markingson family




Alex Friedrich writes for MPR





More than a decade after the suicide of a patient in a University of Minnesota drug trial, the incident is prompting the university to make some changes to the way it conducts such trials.

The changes are coming about now through the persistence of critics who demanded further investigation into the death of Dan Markingson. After years of little action, the case has generated a flurry of activity in just the last few months — new reports, proposed reforms, staff changes. Here are some of the key points to emerge:

What has all of this been about?

Critics believe some University of Minnesota researchers have coerced vulnerable patients into participating in studies, and then neglected their welfare during the research. Much of the focus has been on a few researchers in the Department of Psychiatry, which often conducts clinical drug trials sponsored by drug companies. Critics say university officials have ignored years of requests to look into the matter.

What prompted it?

It all started with the suicide of a mentally ill man named Dan Markingson over a decade ago. He'd seen Dr. Stephen Olson, a university psychiatrist, who enrolled Markingson in a corporate-sponsored drug trial for an anti-psychotic drug. Markingson's mother, Mary Weiss, believes Olson coerced her son into participating and kept him in the study despite her repeated warnings that he might hurt himself. Markingson's suicide in 2004 prompted her to sue the university in 2007.

A series of articles in 2008 by the St. Paul Pioneer Press brought the case to light.


A court ruled the university was immune to litigation. Weiss later settled with Olson for $75,000.

Was any wrongdoing proven?

The federal and state investigations that Markingson's death sparked have been a subject of contention for years. They included reviews by the university's research oversight panel, the U.S. Food and Drug Administration and the Minnesota Board of Medical Practice.

University officials long said the results exonerated the U.

But the Pioneer Press stories raised the suspicion of U of M bioethicist Carl Elliott. He looked into the case, and began a campaign of articles and letters pointing out what he saw as flaws and inadequacies in the investigations. He pushed the U's top officials to launch another investigation of the case, and their refusal led Elliott to accuse them of a cover-up.

Why did the case make news this year?

The work by Elliott, who was later joined by U of M colleague Leigh Turner, caught the attention of some university faculty, alumni and scholars from around the world, who began pressuring university officials to reopen the case.

Former Gov. Arne Carlson also wrote letters to both regents and lawmakers criticizing the university's actions and asking for another investigation.

After mounting pressure from faculty, President Eric Kaler in December 2013 agreed to launch an outside review of the U's clinical research practices. And in 2014, two leading legislators asked the state legislative auditor to look into the Markingson case specifically.

The results of both cases came out earlier this year, and sparked reaction from both lawmakers and the university.

What did the investigations find?

In February, the external panel hired by the university said the university had weak oversight of research. The reviewers noted that personnel didn't feel the U's leaders were committed to protecting test subjects, and they expressed special concern over a "culture of fear" in the psychiatry department they said kept people from raising safety concerns. It suggested dozens of reforms.

In March, Minnesota Legislative Auditor Jim Nobles criticized the U for its handling of the Markingson case.
Nobles said it was impossible to link Markingson's death to the drug study, but said he found "serious ethical issues and numerous conflicts of interest." He said the conditions under which researchers recruited Markingson were potentially coercive, and that researchers ignored repeated warnings about Markingson's deteriorating condition.

The report noted multiple potential conflicts of interest among the researchers and subsequent investigators. Nobles said the FDA investigation had been "limited," and that the U's own investigation had been "superficial." He said university leaders had repeatedly made misleading statements about the thoroughness of past reviews, and that they'd damaged the university's reputation by rejecting calls for further investigation.

Since those reports, more information about university researchers has surfaced.
This month, an internal review found some Fairview Health Services personnel held a "profound" distrust of some U of M psychiatric researchers working there, and it blamed leadership at Fairview and the U for ignoring it.
In a separate case this month, the university wrote a letter of apology to a former test subject, saying researchers had failed to follow several safety procedures during a 2007 university drug trial he participated in. The U issued the letter after an outside consulting firm said Olson and his staff had made the mistakes, calling two of them "serious."

However, the report rejected the patient's claims that Olson and his staff had coerced him into participating.

How has the U reacted to all of this?

Although Kaler said he didn't agree with all of the findings in March's legislative audit, he accepted it, as well as the findings of February's external review.

Kaler said he thought the medical school was doing better than it was in protecting test subjects, and called it "worrisome that we have such a distance to go to reach the very highest standards."

He apologized to Markingson's family "for his death under our care." He also apologized for the university's prior misleading statements on the matter, saying they were not meant to mislead and that he'd relied on investigations he thought were credible.

Kaler suspended patient enrollment in 17 active and pending drug studies until they're reviewed by an outside firm, and ordered an action plan to carry out the reforms.

What's changing?

According to the draft plan the university released Monday, it will add personnel, boost training and increase oversight in an attempt to make sure a case like Markingson's doesn't happen again.

Many of the changes focus on strengthening oversight panels so the U can make sure researchers in all departments are conducting their experiments appropriately. It's instituting a tougher patient consent process, and is giving researchers more training so they can better judge whether patients are mentally capable of consenting to a study. The U will also work to curb conflicts of interest among researchers and drug companies.

Campus leaders say they're trying to change the research culture by injecting more checks and balances into the power structure, and enable those who are not physicians to have more say in the research process. And the U will be offering physicians more education and training in ethics and the new standards.

Has anyone been disciplined as a result of all this?

Not publicly, at least.

However, last month Dr. Charles Schulz, who was a co-researcher with Olson in the Markingson study and led the psychiatry department at the time, resigned his leadership of the department. Recently, he said he'd also agreed to step down as executive medical director of behavioral health services at the university hospital.

What happens now?

The public has through June 1 to comment on the reform plan, which regents are expected to vote on next month. Medical School Dean Brooks Jackson said he hopes to see most reforms in place within nine months. Legislative auditor Nobles says he'll return late this fall to see check on the U's progress, and wants to follow up several times in the next few years.

Nobles called the reform plan "very encouraging," and university leaders say elements go far beyond what other institutions do. Some critics say it does have the potential to improve things, but remain skeptical that it will bring about significant change.

Meanwhile, Nobles hopes to release in the next few weeks the results of his review of the past decade of university drug trials. He's trying to determine whether the university's files contain more cases such as Markingson's or other major mishaps.

How has all of this affected the U?

Its reputation has taken a beating, and multiple colleges in the U.S and abroad use the Markingson case as a study in how not to conduct research and handle criticism.

Meanwhile, drug studies remain suspended as an outside consultant reviews them.

The reforms will cost the university lots of paperwork and millions of dollars to carry out — all during a time when it's trying to boost its national ranking as a major medical research institution.

Jackson said in an email, however, that higher rankings and protecting subjects "are not mutually exclusive." He acknowledges that some reforms could increase red tape, but said others could actually make some studies get started more quickly.

"Expansion of research should in no way come at the expense of patient safety," he said, "so we don't anticipate these reforms impeding us as we look to grow our research portfolio."


For the Record: How others see us. Recent comments in NYT about #umn



Carl Elliot has recently written a piece in the New York Times. (link)


Here are some comments on the piece:
(not #umn proud ...)


Thank you Dr. Elliott for blowing the whistle loudly and clearly. This mistreatment of the participants in these drug studies is appalling, if not criminal. As a person who conducts research with human subjects, I consider the treatment of each individual to be sacrosanct and if there are researchers who are mistreating their subjects they should be banned from conducting research. 

It's sad that at the same time the university officials were hiding the internal investigation, they were piously preaching the principles of academic honesty to their undergraduates and threatening them with expulsion. What a sham! 

Dr. Elliot appears to be calling for greater power for IRBs to regulate, or a greater role within the institution, but I fear his concerns may be applicable only to the University of Minnesota, which by his description, is seriously flawed. Any researcher (Principal Investigator or Co-I) who broke IRB rules where I've worked was fined, placed on administrative leave, or fired. My experience is that IRBs exist less to protect subjects and more to protect the institutions with which researchers are affiliated. Maybe the issue isn't the lack of power within the IRB, but the lack of will at Univ. of Minn to confront the culture within the department of Psychiatry within the college of Medicine. Its easy to blame a body with oversight duties for the failings of a research culture that reside within the college of medicine.

As taxpayer contribution to biomedical research dwindle (NIH budget adjusted for inflation keeps coming down year after year) universities and medical schools are depending more and more from pharmaceuticals and biotech companies to keep research going. There is an obvious conflict of interest between reporting unbiased scientific facts and a company need to hype their products. Thus, an increase in cases of unethical or questionable research is to be expected. At the end you get what you pay for and the companies that fund research certainly want something in return.

IRBs have the right to monitor research and the consent process. They have the right to impose restrictions and suspend research protocols. The fact that the UM IRB did not perform its duties is not a reason to do away with the IRB system; it is a call for the UM IRB to function as it is supposed to function. Unfortunately, institutional support is essential to the proper functioning of an IRB. Clearly that institutional support was completely missing here.

It is quite possible to have adequate review and protection using the IRB model, IF the university's administration is willing to support the IRB's efforts, administratively and financially. At the institution where I chaired the IRB we had a major scandal, not unlike what occurred at Minnesota. It did serve as a wake-up call for the school. The President and the deans provided facilities and funds for an infrastructure that not only enhanced initial review but follow-up reviews and announced and unannounced audits of the studies.

This is a remarkable article. Those of us who have been medical practitioners know how rare it is and how risky for a reputable clinician to come forward, stating that scandalous behavior by physicians both persists and is minimized by a University administration. "Go along to get along" has been an expectation among physicians. Consider that there are students within the University of Minnesota Department of Psychiatry, residents fellows. Their training there may now raise some eyebrows, to be sure, but what about their attitudes and values, learned from the behavior of their mentors?

Wow, I bet the author is about as welcome as a case of hives around the Center for Bioethics these days. I adore people who can and will speak courageously and with little regard for their own security.

Several questions come to mind: Have there been, or will there be, any criminal charges filed against any of the "researchers," particularly in the case of the young man's death? And how will the University punish you, Dr. Elliott, for your unusual honesty? Never mind the ethics code; you have broken the code of silence.

I am ashamed of my specialty of psychiatry. All too often, our leaders prostitute themselves to Big Pharma. Even our diagnostic manual (the "DSM") is influenced by the pharmaceutical industry, which promotes the lie that psychiatric illnesses are purely "brain diseases," along with downplaying the important psychological dimensions of these illnesses.
Clinical Professor of Psychiatry, Georgetown University School of Medicine


I applaud the bravery of Dr. Elliot for writing this piece. Ethics in research is becoming a scarce commodity. Simultaneously, more and more professionals of every stripe are parroting the phrase "evidence-based," which is truly meaningless in the way it is being used. It will take more people like Dr. Elliot, willing to stand up and speak the truth, because we can no longer rely on self-regulation.

It is important is to find better ways to distinguish the risk level of different studies. I have submitted studies at my current and other R1 universities. IRBs vary, but I have found an extraordinary amount of scrutiny for voluntary survey research on healthy, non-incarcerated adults (e.g. low risk). Every line of a recruitment email is scrutinized and it can take months for a very simple study to be approved. If similar rigor is applied to high risk studies (e.g. where a substance is ingested, or medical procedure, or a high risk population), it is shocking to me that the studies described here were approved.

At the U, there have been other whistle-blowers, including a dear friend whose career was all but destroyed because she chose to speak up. While Carl Elliot's remarks are most welcome and so necessary, they are too long in coming.

Thank you very much Dr. Elliot. Some things seem never to change. More than 40 years ago I was placed in the U of M hospital after complaining about depression. As part of an experimental program, I was given a powerful anti-psychotic medication (though there were no signs of psychosis) with almost nothing in the way of explanation. Long story short, I was extremely lucky to have survived and did so only by leaving the facility against the will of the doctor conducting the study who threatened me with "commitment" for leaving the program against his wishes. It appears that someone has finally summoned the courage to stand up to the Department of Psychiatry at the University of Minnesota.

This article is a textbook example of the importance of tenure. Dr. Elliott has made a valuable contribution to cleaning up the mess of scientific research. No doubt he will pay a price for it, but if he has tenure, his job won't be at stake. And he is an example of the importance of professional ethics, and the need to teach every emerging professional about ethical professional behavior.

"A great grey mediocrity" it was call by Dean of the Institute of Technology Athelstan Spilhaus, The university has alway been a mess. I have little interest in going back there as an alum. There was much to be said for the quality of the staff and the overall experience, yet it was dumbed down by bureaucracy. Evidently not much has changed.

This is not a new problem for the department of psychiatry at Minnesota. Nearly 20 years ago as a graduate student, I reported several very serious instances of fraud and misconduct by a principal researcher, to the chair of the department. Despite the fact that I had concrete evidence (from a paper trail) all that every came of it was a severe lecture to me about the immorality of going behind said researcher's back. I was never allowed to conduct research at that department again. 

Congratulations to Dr. Elliott for his years of work in shining light on these abuses, and much more difficult, actually moving the institution to action. In the past few weeks the New England Journal of Medicine published a series of articles defending financial compensation of academic physicians by drug companies. The author asked for instances of harm stemming from such relationships. The U of Minn provides plenty, and I supplied more in a blog last week: http://www.healthnewsreview.org/2015/05/responding-to-parts-2-3-of-new-e...

If you talk to doctors in the Twin Cities, you sense they believe the Minnesota medical school is in a state of decline.

Tenure protects Professor Elliott from reprisal from his institution. Another reason to reinforce that safeguard for critics. There are too few who feel safe enough to speak truth to money.

The morning I arrived for an academic urology job at the Minneapolis V.A. in the low '90's, the Chairman of Urology resigned under pressure from the student newspaper. They had found questionable accounting in the Dept. of Urology. At the same time, the Chairman of Surgery was under indictment by the FDA for selling a drug across interstate lines without FDA approval. He was acquitted. The board of trustees had approved the business plan and there was a resignation there. So, the problems at U. Minn. Dept. of Psychiatry are not new.

Aren't the University of Minnesota hospitals owned by a Corporation, Fairview Health Services? Does Fairview have a direct say in the acceptance and oversight of research studies? Do its attorneys determine how to respond to potential scandal? If yes, are Fairview attorney responses similar to that of similar non- profit Medical Centers?

The instances--especially the horrific death of Mr. Markingson--of failures in his department at the U of M are shocking to me because of the violations of trust between patients and researchers. His anger and strong language about the violations of the I.R.B.s and its "honor code" while apparently not new to others doing research are not able to rouse me to action since the control is totally within the research community and not sensitive to public pressure. If I agree to be a participant in any future studies, I will certainly ask more questions, but that seems to be all I can do.

The instances--especially the horrific death of Mr. Markingson--of failures in his department at the U of M are shocking to me because of the violations of trust between patients and researchers. His anger and strong language about the violations of the I.R.B.s and its "honor code" while apparently not new to others doing research are not able to rouse me to action since the control is totally within the research community and not sensitive to public pressure. If I agree to be a participant in any future studies, I will certainly ask more questions, but that seems to be all I can do.

Both for his book and this column, Dr. Elliot should be lauded most vigorously. His concerns are completely relevant to this situation in which Big Pharma will do most anything to get positive research-study outcomes for its new products. Starting with Vioxx, there are numerous examples of the failure of this model to account for the complexity of human physiology, where side-effects are the rule rather than the exception.

The author fails to cite the fact that the University of Minnesota was placed on the NIH "exceptional institutions" list in 1997 (not a good thing) for their failures to monitor Dr. John Najarian"s research and clinical trials on organ transplant drugs for immunosuppression. The University supposedly recruited a senior official to oversee clinical research. We can see how successful these efforts were.

as an alum of U of M, and someone who knows the byzantine waysmof university cultures, I would suggest that the only hope for change comes not from the top ranks who have denied, lied and hidden, but from the bottom up -- faculty, students, alumni and DONORS -- unified and individually demanding that the governing Boatd and the governor mandate change. Those who spent years hiding are not the ones who will now suddenly see the light and change their ways. U of M's destruction of its reputation affects all of us at the grass roots, and the taxpayers of Minnesota as well. The masses must speak.



For the Record: Carl Elliot in NYT: University of Minnesota’s Medical Research Mess



From the New York Times

MINNEAPOLIS — IF you want to see just how long an academic institution can tolerate a string of slow, festering research scandals, let me invite you to the University of Minnesota, where I teach medical ethics.

Over the past 25 years, our department of psychiatry has been party to the following disgraces: a felony conviction and a Food and Drug Administration research disqualification for a psychiatrist guilty of fraud in a drug study; the F.D.A. disqualification of another psychiatrist, for enrolling illiterate Hmong refugees in a drug study without their consent; the suspended license of yet another psychiatrist, who was charged with “reckless, if not willful, disregard” for dozens of patients; and, in 2004, the discovery, in a halfway house bathroom, of the near-decapitated corpse of Dan Markingson, a seriously mentally ill young man under an involuntary commitment order who committed suicide after enrolling, over the objections of his mother, in an industry-funded antipsychotic study run by members of the department.

And those, unfortunately, are just the highlights.

The problem extends well beyond the department of psychiatry and into the university administration. Rather than dealing forthrightly with these ethical breaches, university officials have seemed more interested in covering up wrongdoing with a variety of underhanded tactics. Reporting in The Star Tribune discovered, for example, that in the felony case, university officials hid an internal investigation of the fraud from federal investigators for nearly four years.

I hope that the situation at the University of Minnesota is exceptional. But I know that at least one underlying cause of our problems is not limited to us: namely, the antiquated bureaucratic apparatus of institutional review boards, or I.R.B.s, which are supposed to protect subjects of medical experimentation. Indeed, whether other institutions have seen the kinds of abuses that have emerged at the University of Minnesota is difficult to know, precisely because the current research oversight system is inadequate to detect them.

The current I.R.B. system of research protection arose in the 1970s. At the time, many reformers believed the main threat to research subjects came from overambitious government and university researchers who might be tempted to overlook the welfare of research subjects.

As a result, the scheme put in place for protecting subjects was not a formal regulatory system but essentially an honor code. Under the I.R.B. system, medical research studies are evaluated — on paper — by a panel of academic volunteers. I.R.B.s do not usually monitor research as it is taking place. They rarely see a research subject or even a researcher face to face. Instead, they simply trust researchers to tell the truth, report mishaps honestly and conduct their studies in the way that they claim to be conducting them.

These days, of course, medical research is not just a scholarly affair. It is also a global, multibillion-dollar business enterprise, powered by the pharmaceutical and medical-device industries. The ethical problem today is not merely that these corporations have plenty of money to grease the wheels of university research. It’s also that researchers themselves are often given powerful financial incentives to do unethical things: pressure vulnerable subjects to enroll in studies, fudge diagnoses to recruit otherwise ineligible subjects and keep subjects in studies even when they are doing poorly.

In what other potentially dangerous industry do we rely on an honor code to keep people safe? Imagine if inspectors never actually set foot in meatpacking plants or coal mines, but gave approvals based entirely on paperwork filled out by the owners.

With so much money at stake in drug research, research subjects need a full-blown regulatory system. I.R.B.s should be replaced with oversight bodies that are fully independent — both financially and institutionally — of the research they are overseeing. These bodies must have the staffing and the authority to monitor research on the ground. And they must have the power to punish researchers who break the rules and institutions that cover up wrongdoing.

Here at the University of Minnesota, we have reached a critical point. Two months ago, after two blistering external investigations, university officials finally agreed to suspend recruitment for psychiatric drug studies. Yet they still refuse to admit any serious wrongdoing.

An honor code is a fragile thing. All the parts have to be in place: pride in the integrity of an institution, vigilant self-policing, a collective sense of shame when the code is violated and a willingness to punish those who break it. At the University of Minnesota, we have very few of those things. And so without sustained, relentless pressure from the outside, I am afraid we are doomed to more of the same.


Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota, is the author of “White Coat, Black Hat: Adventures on the Dark Side of Medicine.”


Sunday, May 17, 2015

For the Record: Former U of Minnesota Doc: What Did They Do To My U?


Former Minnesota Medical School cardiologist: What did they do to my U?

Under poor management, the school has turned into the equivalent of a junior-varsity team. Unfortunately, it produces the bulk of the state’s doctors.


From the Star-Tribune:

(Emphasis added.)

When I joined the faculty of the University of Minnesota Medical School as a junior cardiologist in 1986, it was vibrant and highly ranked nationally. Now it is ranked in the second tier of schools for research. Its main hospital, the University of Minnesota Medical Center, was then among the top in the country. Now it is ranked by U.S. News and World Report as third in the metro area, behind Abbott Northwestern in Minneapolis and Mercy Hospital in Coon Rapids.

How could this happen? And why hasn’t it been a subject of alarm for our Board of Regents or for university administration?

Over the last two decades, the Medical School has been rocked by successive ethical scandals. Poor financial management led the Board of Regents in 1996 to sell the university hospital to Fairview, a community hospital chain with an average reputation in health care. Since then, review after review has found a lackluster record of achievement; a loss of important faculty members, and inept, bloated administrative functions.

All of this prompted the dean of the University of Michigan Medical School (who is a University of Minnesota graduate) to tell the Michigan Daily about his once-great alma mater: “They have disassembled the whole enterprise … and they’ll never recover from it.”

When I recently talked to a few regents about how this could happen, I got a similar story. They did not feel capable of managing a health care enterprise, so they relied on the university administration to keep them informed and take care of business. That apparently did not happen. Few of them were informed about the fall in rankings. Most claimed to be surprised by each scandal.

In the Navy, they say, “When there is trouble on the deck, look to the bridge.” In this case, the bridge was asleep.

Why should this matter to Minnesota? After all, we have the Mayo Clinic. It could be Minnesota’s varsity health care organization, and the U could be a nice JV team.

The problem is that the U produces the vast majority of the doctors for this state. If you want a JV doctor in 10 years, then that is a good approach. If you want the best for our state, the U matters.

In addition, JV teams do not generate economic activity. The U Medical School is responsible for a great deal of the medical-device industry in Minnesota. We would not likely have a medical-device industry without the medical school that we created in the 1950s and ’60s. Imagine Minnesota without Medtronic and St. Jude Medical (not to mention more than 100 other businesses that sprang from the Medical School).

Gov. Mark Dayton recently got the message and created a blue-ribbon commission to study the problem. The commission’s decision was to throw money at the school. That is a good start, but it does not address the root cause of the problem. Compared with other public medical schools, the U med school has been relatively well-funded (not great, but in line).
The U med school, however, has lacked vision and leadership. Its goal is to be top decile in clinical care. What is that? Top 10 percent of all hospitals — one of the top 500? Wow.

As discussed by former Gov. Arne Carlson (“U can’t regain trust under its current leadership,” April 12), the administration is plagued by cronyism and conflicts of interest. There are legitimate questions about the transparency and truthfulness of its leaders. Poor leadership is how we got to where we are, not lack of money.
In addition to the leadership issues, there is an elephant in the room: Fairview. To its credit, Fairview restored the financial performance of the university hospital; the U accounts for half of the net margin of the entire Fairview chain. But Fairview has taken its toll. The hospital it manages, and the one where most of Minnesota’s doctors are trained and where research is done, has become a B-level facility. Fairview’s contribution of profits to the Medical School is meager compared with other university hospitals in the country.

There is no way to have a great medical school without a great hospital. Unless the Fairview problem is solved, we are destined to have a B-level medical school and a JV team.

After 27 years, I left my position at the U at the end of 2013 because, like the dean of the Michigan Medical School, I just did not see any hope that the U med school would turn around. I’m seeing a glimmer of hope with former Gov. Carlson’s commentary several weeks ago. The light shown on the lackluster administrative culture by the Dan Markingson case external review and legislative auditor’s report validate the problems. Gov. Dayton seems engaged. The regents may be waking up. Sunshine may be the best antiseptic.

Let’s hope that the Medical School responds with new, clean growth instead of withering in the light.


Robert F. Wilson is former chief of clinical cardiology at the University of Minnesota.