For the Record: More #umn alums blast admin for #markingson denial

From the Star-Tribune:

Will the U review or whitewash a research subject's death?

The Dan Markingson case, involving a drug trial, has been a self-perpetuated cloud over the school for a decade.

As scholars of medical ethics and proud alumni of the University of Minnesota, we have been pained by the cloud that has hung over our alma mater in the decade since Dan Markingson killed himself while enrolled in a university-sponsored drug trial.

Many prominent voices have called for an independent investigation into Markingson’s death, including editors of the world’s most prestigious medical journals and more than 250 other ethicists, physicians and scholars.
Unfortunately, rather than working to be accountable and transparent, the university administration has taken a relentlessly defensive posture — hiding behind its lawyers, targeting its critics and distorting the facts.

Most notably, the administration has dismissed the need for an independent investigation by claiming that the university’s treatment of Markingson “has been exhaustively reviewed by federal, state and academic bodies since 2004,” in the words of the university’s general counsel. However, some of these claimed reviews simply did not occur, while others did not examine the most troubling aspects of the Markingson case. For example, the administration has repeatedly claimed that the Hennepin County District Court exonerated the university in a lawsuit brought by Markingson’s mother. In fact, the university convinced the court that it had legal immunity from the suit and could not be held liable no matter how badly it may have treated Markingson.

The administration’s refusal to commission an independent investigation of the Markingson case has tainted the university for far too long. That began to change recently when the Faculty Senate responded to a letter signed by more than 175 scholars asking for an external, independent investigation into the Markingson case. By an overwhelming margin, the Faculty Senate voted to approve a “Resolution on the Matter of the Markingson case” and endorse an inquiry into clinical research practices at the university.

Yet University of Minnesota President Eric Kaler appears intent on continuing the university’s efforts to avoid scrutiny. In a recent interview with the Minnesota Daily, Kaler said that the inquiry will not look at Markingson’s death at all, but rather will focus solely on “what we are doing now and what we’re going to do moving forward.”

Such a limited inquiry would defeat the purposes of the Senate’s action. Although the resolution does call for an inquiry into the university’s current practices, the Senate left no doubt that the aims of that investigation included resolving “questions [that] continue to be raised about the policies and procedures followed in the Markingson case” and addressing the harm to the university’s reputation “in consequence of this tragic case and its aftermath.”

Any inquiry that merely considers the university’s forms and policies without examining the experiences of actual research subjects would only further erode confidence in the institution and compound the harm to its reputation.
In addition to seeking to limit the scope of the investigation, Kaler seems intent on handpicking the investigators. Any involvement by the administration in selecting the members of the investigative panel would destroy the body’s credibility. The offices of the president, the general counsel and the Academic Health Center are all important players in the Markingson controversy whose roles must be examined by the investigative panel. It would be a clear conflict of interest for the targets of this inquiry to select their own investigators.

Finally, the investigative body must be given the legal authority it needs to conduct a thorough investigation. It must be empowered to look at financial records, to obtain internal e-mails and communications, to give legal protection to whistleblowers, and to interview former patients and research subjects and protect them from retaliation. For example, the panel should have the authority to waive confidentiality agreements that former patients and their family members may have signed as part of legal settlements with the university.

The Faculty Senate’s resolution presents an excellent opportunity to bring closure to a tragic case that has sullied our university for far too long. But this can only happen if the investigation is thorough, broad and independent, rather than carefully managed by the administration.

Matt Lamkin is an assistant professor at the University of Tulsa College of Law.

This article was also submitted on behalf of 

Emily Smith Beitiks, deputy director of the Longmore Institute on Disability at San Francisco State University; 

Joseph E. Davis, director of research at the Institute for Advanced Studies in Culture, University of Virginia; 

Alicia Hall, assistant professor of philosophy, University of Alaska, Fairbanks; 

Susan Hawthorne, assistant professor of philosophy, St. Catherine University; 

James Harold, associate professor of philosophy at Mount Holyoke College; 

Ramona Illea, associate professor and chair, Department of Philosophy, Pacific University; 

Monica Greenwell Janzen, faculty member, Hennepin Technical College; 

Greg Kaebnick, editor, The Hastings Center Report; 

Barton Moffatt, assistant professor of philosophy, Mississippi State University; 

Susan Parry, philosophy instructor, Hennepin Technical College; 

Elita Poplavska, assistant professor, Riga Stradins University, 

and Maran Wolston, Philosophy Department faculty member, Minneapolis Community and Technical College.

From comments posted on this piece:

I'm certain President Kaler would like to continue to bury the details of this case. Hopefully more ethical officials at the university will prevail.

Excellent article. If Kaler actually thinks the Markingson case was simply a one-of-kind tragedy at the U-MN he's beyond help. Wake-up Mr. Kaler, your psychiatry department has ruined many lives.

This egregious and disgusting behavior by the University's president has to come to a halt. This man and his ideas and morals are certainly part of the problem not part of the solution. We have lost all respect for the University over this scandal and the others that have been kept in the dark. Shame on Mr. Kaler and either do the right and ethical thing and step aside, or resign. It's apparent you are not able to lead this university with integrity and truthfulness.

At the very least, everyone involved at the U of M in the epic and continuous fumbling of the PR on this episode should be fired.

It seems that the University must be afraid that many more Markingson's will appear if such an investigation takes place. There is no other logical explanation for all the repeated statements of no-wrongdoing from the administration. Had this been case, the University would simply have produced all the documents that prove their claims and this case would have ended. That has never happened and agree with the fact that the PR representatives at the U that have been allowed to speak or answer inquires are some of the worst in their field.

I can appreciate the fact that many years have past since this young mans death, what I don't understand though is why the UMN has repeatedly offered up the same excuses time after time trying to defend themselves. And they are just that, excuses, not credible documentation that they looked into this death and how and why it happened, and any steps they've taken to prevent something as tragic as this from happening again. It isn't so much the act of suicide here from an obviously unbalanced young man, but the enabling to cover it's tracks afterwards by the University's top officials and legal team of any violations of human rights or human subject's protection. A totally independent investigation is long overdue, and if/when other such cases surface, the University has to be transparent in their handling of such tragedy's. Until that happens, I have lost all respect for research at the UMN.

It would be fitting of President Kaler to demonstrate the same amount of enthusiasm for seeking the truth about not only the Markingson case, but for the others the University is aware of or have taken great pains to avoid, as he displays on the football sidelines during gophers games. To have ignored this scandal for so long is such an embarrassment for the University as well as the state.

We are witnessing an abdication of responsibility on the part of University President Kaler. He has positioned himself as an executive unaccountable to anyone but himself. He must have been made fully aware of the Markingson scandal and agreed beforehand to staying on the University’s road of denial as a condition of his employment. It’s not rocket science folks, the University simply cannot allow a totally independent investigation conducted by qualified unattached investigators, knowing full-well what that investigation will reveal. How many more abused human subjects are there that the University knows about and have also tried to stifle? Hint: There are numerous. I’m old enough to recall Nixon raising his two fingers above his head and claiming that he’s not a crook following Watergate…The University by their denials are simply mimicking that disgusting behavior.

As a U-alum I am ashamed of this total disregard of responsibility from President Kaler. This scandal has hung like a cloud over the university for years and finally Kaler was given an opportunity to save face and claim he was just acting on the vote from the Faculty Senate and appoint an independent investigation of not only the Markingson case, but of the others that exist. President Kaler has a responsibility to answer to everyone and not just his immediate conspirators in cover-up mode. I was once proud of the reputation of the University of Minnesota's Medical School, and all of it's accomplishments. That pride has really taken a hit over this episode.

Agree with almost all of the posts. For Dr. Kaler to not recognize the fact that there are more human subjects and their families that have had research violation issues with the department of psychiatry is just ludicrous. The recent Fox News report showed another individual, and it's 100% guaranteed that there are many more such patients that were taken advantaged of, or had their rights abused by researchers at the University's psychiatry clinic's and hospital wards. I know personally of three such individuals.

It's quite amusing to think that the state's Attorney General's Office prosecuted Accretive for violating 100's if not thousands of patients protective health records at Fairview, and yet Kaler and University want everyone to accept and believe that nothing like that occurred with mentally ill patients within the two University controlled wards at Fairview? Having had a family member that worked on those and other mental health wards at Fairview, she was disgusted and alarmed on a regular basis over the violations occurring by research psychiatrists or their staff. For Kaler to insinuate that those incidents didn't take place on a regular basis is just ridiculous. To claim that all is 'today' without recognizing and admitting the the wrongs from the past just invites more of the same in the future.

Latest #markingson post on Star-Tribune Community Voices

Wackos roll off the line in a seemingly never ending stream

Source: Flickr

Latest #markingson post on Star-Tribune site: 

Those pesky wackos are back again ... 

Finally time to do the right thing?

Time to do the right thing at the University of Minnesota? #Markingson

 Da Mayor: "Doctor, always do the right thing."

Link to Youtube movie trailer

The time is always right to do the right thing.   Martin Luther King 

Do the right thing, even when it is hard.  Joel Osteeen

Do the right thing because it is right. W. Clement Stone 

Sometimes it is better to lose, and do the right thing... Tony Blair 

Leaders are people who do the right thing. Warren Bennis 

In plain Texas talk: It's do the right thing. Ross Perot 

You do the right thing, even if it makes you feel bad. The purpose of life is not to be happy but to be worthy of happiness. Tracy Kidder

Or, as Mark Yudof said in his inaugural address as president of the University of Minnesota:

"Minnesotans expect us to be fair in providing access to the University for their sons and daughters. If we do not provide reasonable access--including access for those who are underprepared and historically underrepresented in higher education and in the upper levels of our socioeconomic life, the taxpayers and state government of Minnesota will turn their backs on our graduate, research, and outreach functions. Simply stated, it is imperative that we continue to embrace our land-grant roots if we are to thrive."

"The need for integrity permeates every aspect of the University. The education mission of the University must be taken seriously--not just the way to get state funding."

"Administrators should tell the truth, keep their word, implement what they promise, and not dissemble. My point is plain enough: Without integrity, the phrase higher education is an oxymoron."

"When making decisions, I view shared governance and consultation with constituent groups as only fair because of the enormous stake they have in the University. Without fairness there is no legitimacy and no buy in to the institutional vision." 

"At the crossroads of expectation and reality, human fallibility and aspiration, individual will and institutional inertia, I hope that you will forgive my inevitable lapses, take joint responsibility for the nurturing of values and goals, and find comfort in the progress we make together."

"God bless all of you and God bless the University of Minnesota."

 Mark Yudof handled a horrible scandal in the athletic department with grace and dignity,  with no excuses and no dissembling. I have been very disappointed with the University of Minnesota administration since his presidency. Yudof fired people (the athletic director as well as coaches and support staff) and had Tonya Moten Brown essentially take over the athletic department. And his humility was not false.

The time for stonewalling has passed. Trying to dodge the issues inherent in the Markingson case is a fool's game. A university without integrity is not really a university. Bread and circuses do not a great university make, nor idle chatter about the infamous third greatest public research university in the world.

Time to walk the talk, President Kaler.  Otherwise,  disappointed  University of Minnesota alums will have to take a hike from their alma mater.  In the Twin Cities alone there are plenty of places for higher education philanthropy besides the University of Minnesota - Augsburg and Macalester colleges being two examples. Note that at these two schools the student debt at graduation is lower than that at the public University of Minnesota, to our everlasting disgrace.  I hope not.

One might whine that Mac is a school for the rich, a terrible and untrue argument, but such a charge is obviously not credible for Augsburg College with its much more modest endowment. When Auggie, as it is familiarly known,  got donor money of questionable provenance, they gave it back. This is what doing the right thing means.  And the education available at Auggie is hardly for chumps. An Auggie, Peter Agre, recently won a Nobel Prize in chemistry. Nice ROI on that, I'd say. Kudos, Auggie, a Minnesota school that makes me proud. Macalester is also in this category as well as many other fine Minnesota  small liberal arts colleges, or SLACs to use au courant higher ed jargon.

Our recent University of Minnestoa debt-saddled alums and their parents are none too happy with the performance of our university. Nor are our state legislators who are heartsick and bewildered by the fact that we are one of the leaders in the country - for student debt. Perhaps the plan is to salvage our position with sports dollars? I understand that Louie Nanne has been charged with raising two hundred million dollars for our athletics program. Under the present circumstances of crushing debt for our students, this is pathetic.

And of course if one desires to contribute money for medical research, there is always the Mayo. What's been going on at Fairview-University hospital lately does not exactly inspire warm and fuzzy feelings in the hearts of the populace. People will vote on the University's performance with their feet and their checkbooks. This goes also for the people in the state legislature.

If the University wants to see private philanthropic support, perhaps they should give us something to be proud of? Manufactured hash tags like #umnproud will not suffice.

Is it finally time to do the right thing in the Markingson matter? More evasion will only serve to further erode our reputation in the real world. Out there where recent University of Minnesota administrations apparently would prefer not to go.

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Latest Carl Elliot post about #markingson

Yesterday I put up a "for the record" post on an interview with President Kaler that appeared in the Minnesota Daily.

When I use this phrase, I try to put up the original material without highlights, emphasis change, or comments so that the readers may decide for themselves what they think about the document or statement.

Usually I intend to follow up with a reaction to the "for the record" post. But in this case, Dr. Carl Elliot has already done the job and I re-post his comments (with permission):



Kaler on Faculty Senate resolution: "It’s not a review of the Markingson case"

I think we're getting a pretty good idea of where the University of Minnesota administration plans to take the "independent review" endorsed by the Faculty Senate last week.  This interview with President Kaler appears in today's Minnesota Daily:

The Faculty Senate just passed its resolution to create an independent, external panel to investigate how the institution conducts clinical research on human subjects. What do you think of the most recent developments in the Dan Markingson case?

I’m a big believer in shared governance, and so I’m willing to take the advice of the Senate and the panel. ... I think they will find that our review processes are robust and that we do, in fact, protect patients in clinical trials, but there’s been concern raised in how we do that, and so our goal is to air out clearly and very publicly what we do and have a panel of external experts validate that and be sure we are doing this absolutely as well as can be done.

It’s certainly resulted as a consequence of a lot of repetitive publicity about the Markingson case, but it’s not a review of the Markingson case; it’s a review of what we are doing now and what we’re going to do moving forward.

This is something that began before you were president. What do you see as your role?

My role is to look forward, and as I said, that will be the charge of the panel.

And just to reinforce the point, the Daily editorial staff writes:

Though some, including University bioethicists and professors, may want more answers involving Markingson’s death, we should focus on avoiding potential tragedies and unethical behavior in the future.

The resolution passed by the Faculty Senate responded to an international call for an investigation into the death of Dan Markingson.  How would an investigation that avoids the Markingson case do anything to restore confidence in the university?

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For the Record: Kaler talks external review - not a review of #Markingson case

Kaler talks Markingson case

From the Minnesota Daily:


The Faculty Senate just passed its resolution to create an independent, external panel to investigate how the institution conducts clinical research on human subjects. What do you think of the most recent developments in the Dan Markingson case?

I’m a big believer in shared governance, and so I’m willing to take the advice of the Senate and the panel. ... I think they will find that our review processes are robust and that we do, in fact, protect patients in clinical trials, but there’s been concern raised in how we do that, and so our goal is to air out clearly and very publicly what we do and have a panel of external experts validate that and be sure we are doing this absolutely as well as can be done.

It’s certainly resulted as a consequence of a lot of repetitive publicity about the Markingson case, but it’s not a review of the Markingson case; it’s a review of what we are doing now and what we’re going to do moving forward.

This is something that began before you were president. What do you see as your role?

My role is to look forward, and as I said, that will be the charge of the panel.

The Daily weighs in on the #Markingson "investigation"

My question: Will the University of Minnesota Face Up To Ethical Responsibilities or Continue In Denial and Evasion?

Faculty push for independent research review

The Faculty Senate wants an outside panel to examine clinical trials.
By Kia Farhang Marion Renault December 09, 2013

The University of Minnesota Faculty Senate is calling for an independent, external panel to examine how the University does clinical research on human subjects.

The measure passed in a 67-23 vote Thursday after renewed calls from scholars and bioethicists to re-examine the 2004 suicide of Dan Markingson, a 26-year-old who participated in a clinical drug trial 10 years ago at the University of Minnesota Medical Center, Fairview.

Since Markingson’s suicide, many within and outside the University have raised questions about the CAFE study, the psychiatric drug trial he participated in and the University’s standards for ethical research.

An international group of bioethicists wrote to University President Eric Kaler and the Faculty Senate in October asking for an independent investigation of issues arising from the CAFE study.

The measure calls for a look at current human research practices at the University, not an investigation of the Markingson case.

The resolution that passed Thursday isn’t binding, said Eva von Dassow, Faculty Senate vice chair and associate classical and near Eastern studies professor.

But Kaler, who chairs the Faculty Senate, told reporters after the meeting that he’s moving forward with the recommendation.

University officials will begin scouting nationwide early next year for experts to conduct the review, Kaler said, but no timeline is set for when the evaluation would be completed.

Kaler said he thinks the investigation will show that the University’s current research policies are “in very good shape.”

The Faculty Senate made three amendments to the original proposal, including one that requires the results of the inquiry to be reported back to the Senate for discussion.

The other two amendments added more details about Markingson to the resolution and struck the word “investigative” from the panel’s definition.

Markingson case lingers

While Thursday’s resolution doesn’t call for an investigation into the Markingson case, several faculty members said lingering questions from the incident have clouded the University’s reputation as a premier research institution.

Multiple reviews of the Markingson case at the University, state and national levels found no wrongdoing in the CAFE study. The only official finding of wrongdoing was a corrective action agreement for a study coordinator from a Minnesota Board of Social Work investigation last fall.

But several prominent scholars don’t believe past inquiries into the case were credible, said philosophy professor Naomi Scheman.

“We do have a good reputation, and we’ve worked hard to earn that reputation,” she said, “but it’s crumbling before our eyes.”

Others, like public health professor Dr. Russell Luepker, said at the meeting that the investigations into the Markingson case have been sufficient. He said documents questioning those past investigations contain a “number of half-truths and distortions.”

But Luepker said he supports a review of the University’s ethics procedures and practices despite his qualms about the proposal’s origins.

“The issue here, I think, is not a 10-year-old case of a tragedy that occurred, which has been investigated thoroughly, and nothing has been found,” he said, “but we should never stop from asking questions and review such a critical area.”

Cultural studies and comparative literature professor Cesare Casarino said the full truth of the Markingson case still needs to come out.

When it comes to determining whether there was any wrongdoing in the case, the burden of proof is on the University, Casarino said.

Dr. Stephen Olson, the CAFE study’s lead psychiatrist, told reporters after the meeting that he welcomes any investigation into the Markingson case.

“I’ve got nothing to hide,” he said. “We didn’t do anything wrong.”

He said at the meeting that Markingson’s suicide was tragic but unsurprising.

“Cancer patients die in cancer studies all the time,” he said, “and it’s not a surprise that people with mental illness will die in a trial of mental illness.”

Olson said he and his colleagues involved with the study haven’t been able to fully defend themselves because they don’t have the legal right to release Markingson’s medical records.

For Mike Howard, a representative for Markingson’s mother, Mary Weiss, the Faculty Senate’s action Thursday was “a huge vindication.”

‘This cloud hangs over us’

The University already has channels set in place, like the Institutional Review Board, that hold it to “rigorous standards of ethics,” pediatrics professor Dr. Sue Berry said at the meeting.

But William Durfee, a mechanical engineering professor and Faculty Consultative Committee chair, said while the University passes those voluntary accreditation processes with “flying colors,” it might not be enough.

“There’s a sense … as faculty that we almost want to hold the University to a higher standard than that,” he said.

Sociology professor David Pellow said he’s been through the IRB process at five different research universities and found the University of Minnesota’s to be the most “rigorous,” “comprehensive” and “impressive.”

But Pellow said his confidence has faltered and he feels the University should respond to “a growing and global call” for an external review.

Not conducting the review, he said, could be dangerous for the University as a whole.

“As scholars around the nation, and indeed the world, look askance and wearily at our perceived troublesome practices … [they will] likely discourage their students and colleagues from studying here, working here and collaborating with faculty here,” Pellow said.

Anthropology professor Karen-Sue Taussig said the University needs to show its commitment to research ethics, especially to the 175 international bioethicists and scholars who signed the October letter to the Faculty Senate, many of whom are renowned in their fields.

“The fact that this cloud hangs over us in the way that it does shows that we are not being successful in demonstrating that to the public and our colleagues elsewhere,” she said.

=============End of Daily Article

To try to evade looking into what happened in the Markingson case is a very bad strategy for the university, painful as it may be after many years of denial that anything was wrong.

I've written about this on the Star-Tribune Community Blogs website:

Markingson Case: Has the Gordian Knot puzzle been solved at the University of Minnesota?

A short excerpt:

The Gordian Knot of the Markingson matter can be solved, crudely speaking, in two ways. One is the "Alexandrine solution." [cutting the knot in half with a sword]

 But simply "give them an investigation of things as they are now" may solve the problem at one level, but will it will simply intensify questioning and even outrage at another. The time for stonewalling is over.

 The alternative is to take the knot apart. Follow the unravelled rope from one end - the Markingson case - to the other end: clincal practices in the present.  What was wrong - if anything - in the Markingson case?  What has changed as a result of it - for example Dan's Law? And where do we stand now, has anything actually changed? Is there a difference between what is ethical and what is legal?  Are we now following clinical practices in accord with  the highest ethical standards not just the law? 

 "Profiles in courage" should not only be an exemplar for politicians. It is time for the University of Minnesota administration to step up to the plate and demonstrate some courage.

I'll write again as things develop. We all love our university. Some day I'd like to be #umnproud again. 

For the Record: #Markingson resolution as amended and passed at University of Minnesota Faculty Senate

Source

Approved by the:

Faculty Senate - December 5, 2013 Administration - PENDING Board of Regents - no action required

Issues Arising from the CAFE Study

 and the Suicide of Dan Markingson 

PREAMBLE:

In May 2004, Dan Markingson, while enrolled in a clinical trial of an antipsychotic drug (the CAFE study) at the University of Minnesota, committed suicide. Since then individuals and groups within and outside the University have raised questions about the study, how Markingson was recruited into it, his treatment during the study, and the circumstances of his suicide.

On October 21, 2013, a letter co-authored by six bioethicists from outside the University, with 175 co-signatories, was addressed to President Eric Kaler and Professor Eva von Dassow, as chair and vice-chair (respectively) of the Faculty Senate, and to members of the University of Minnesota Senate. The letter asked the Senate to endorse and request an independent investigation of the issues arising from the Markingson case and the CAFE study. That letter is available at:

http://www1.umn.edu/usenate/fsenate/docs/131205toronto_letter.pdf.

The list of additional co-signatories is available at:

 http://www1.umn.edu/usenate/fsenate/docs/131205toronoto_signatures.pdf.

On November 20, 2013, fourteen faculty senators co-signed a request to the Faculty Consultative Committee to place this matter on the agenda of the December 5 Faculty Senate meeting for discussion, and further requesting that a resolution calling for an independent investigation be presented for discussion and action. That letter is available at:

http://www1.umn.edu/usenate/fsenate/docs/131205letter_to_fcc.pdf.


The FCC discussed the letter and the issues it raises at its meetings on Oct. 24, Nov. 14, and Nov. 21. While these discussions have not reached a conclusion, and members of the FCC have varying views, a consensus emerged that it is appropriate to bring the matter before the Faculty Senate at this time. The FCC wishes to emphasize the following points.

First, it is important that those participating in decisions about this matter familiarize themselves, with the history of the case and investigations conducted to date.

Second, as the FCC studied this issue, two things became clear: that the Markingson tragedy specifically had been investigated several times from different perspectives, and that those investigations did not address the broader question of whether the University's current policies, procedures and practices, some of them changed since the Markingson case, reflect both best practices in clinical research on human subjects and the faculty's high ambitions for ethical behavior. Members of the FCC also recognize that external evaluations can have the advantage of fresh perspectives not biased by familiarity with current practice, and are a way for the public to have the utmost confidence in the integrity of the research conducted at the University of Minnesota.

For this reason, the FCC feels that the way forward is to recommend that an independent and transparent examination be undertaken to evaluate the University's procedures, practices, and policies governing clinical research on human subjects, and in particular clinical research involving adult participants with diminished functional abilities. While the specific charge for such an examination requires further work, FCC believes issues to address may include investigator conflict of interest, institutional conflict of interest, consent policies and procedures, case management of enrolled participants, mechanisms for overseeing such research and mechanisms for addressing adverse events.

Therefore, the FCC suggests to the Faculty Senate the following resolution:

Resolution on the matter of the Markingson case

WHEREAS the faculty of the University of Minnesota are committed to upholding high ethical standards in the conduct of research;

WHEREAS questions continue to be raised about the policies and procedures followed in the case of Dan Markingson, a 26-year-old participant in a clinical trial who committed suicide in 2004;

WHEREAS the University has suffered reputational harm in consequence of this tragic case and its aftermath;

WHEREAS the faculty seek to ensure through independent evaluation that the University's ethical standards for clinical research on human subjects meet or surpass the norm,


BE IT RESOLVED that a panel external to and independent from the University of Minnesota be constituted for the purpose of conducting an inquiry examining current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities. The administration, in collaboration with appropriate faculty governance committees, shall initiate the constitution of such an independent panel and shall support its inquiry. The panel shall have authority to obtain any records it deems necessary for a thorough inquiry, to the extent consistent with applicable law. At the conclusion of the inquiry, the panel shall issue a report that will be made publicly available, within the limitations of regulations governing the protection and privacy of individuals, including research participants, and the results will be reported back to the Faculty Senate so that senators have an opportunity to ask questions and discuss the report.

Farewell to University of Minnesota Medical School Dean Friedman

But first, this may be painful and require  anesthesia, 
so please click the play button above for some 
soothing music while you read.
Primum non nocere and all that...

When our beloved General Counsel, Mark Rotenberg, moved on to greener pastures at Hopkins, I thought he deserved a suitable send-off given his contributions to the University.  See my post:

Farewell to Mark Rotenberg, University of Minnesota General Counsel

Although Dean Friedman in only three years has had nowhere near the time in which to do similar damage, I believe that he also richly deserves a tribute. 

In my time as a faculty member at the U, I have  seen the following Medical School Deans in action and inaction:

Dr. David Brown - he of the scandal that cost the U of M $32 million for abuses in the medical school. 

Dr. Frank Cerra - he of the foot-dragging performance in reforming conflict of interest rules at the University of Minnesota. Pay special attention to the unofficial medical school anthem at this link. 

We had two insiders during this time.  Dr. Al Michaels and Dr. Shelly Chu held the fort while numerous outside searches failed. Both were reputed to be good people. I have no evidence to the contrary.

And then there was... Dr. Deborah Powell.  I don't even know where to go with this, but here is a start: "The Ethically Challenged U of M Medical School Administration"  Among other highly questionable moves, Dr. Powell put Dr. Leo Furcht into a position of leading a group to redo conflict of interest policies at the University without informing committee members that he had been involved in quite a conflict of interest himself.   Nice, huh?

Eventually, Dr. Powell was unhorsed in mid-stream by Dr. Frank Cerra in his administrative position as Vice President for the Academic Health Center and replaced as dean by...

Dr. Frank Cerra!

The mind reels.

And when Dr Cerra stepped down as VP/Dean, he was replaced by today's celebrant, Dr. Friedman.

So what to say about Dr. Friedman?  I'll keep it simple and just post about a  few of the preposterous things he has written, no doubt aided and abetted by people in the U of M's PR department, people like Justin Paquette whose modus operandi  is obvious from this post. 

So here are just a few links in tribute to our latest about to be emeritus dean. May he live long and prosper.

1. University of Minnesota Medical School Dean and Academic Health Center Vice President Dr. Aaron Friedman to Step Down  Good overall summary - if I do say so.

Note especially the pathetic defense of homeopathy written, nominally, by two medical school deans, Friedman and Cerra. Don't all doctors take chemistry as undergrads? I guess a few of them don't remember much chemistry - at least the concepts of dilution to infinity and Avogadro's number.

2. http://ptable.blogspot.com/2013/05/for-record-dollop-of-bluster-on-usual.html

Dr. Friedman's pitiful attempt to defame Dr. Carl Elliot: "We hope Star Tribune readers won’t allow Elliott’s campaign to cloud reality." Dr. Friedman's Star-Tribune commentary was shredded in the comments that are included in the link.


3. Latest from the University of Minnesota Medical School: All the News That's Fit to Manage?

"To complain internally to the university community about the unfairness of the press after having dissembled as outlined above is not worthy of a University of Minnesota medical school dean."

4. University of Minnesota Medical School Dean Aaron Friedman: Driven to Dissemble?

There is, unfortunately, more. But the point is made.

Needless to say, I will not be attending the big shindig scheduled to celebrate Dr. Friedman's stepping down, nor did I attend Mr. Rotenberg's bon voyage party.


To give a certain symmetry to this post, I'll end with a final celebratory interlude. Those of you who have done your link homework will recognize it as the unofficial anthem of the University of Minnesota Medical School.  Let's hope that changes in the future.

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#Markingson Case: Has the Gordian Knot puzzle been solved at the University of Minnesota

I've put up a new post on the Star-Tribune Community Voices site.

KMSP-9 Video: U faculty call for outside review #markingson

KMSP-9 has graciously allowed embedding of their video report on this matter. It should be noted that their recent work  has contributed greatly to progress in the Markingson case. Kudos.

KMSP-TV

KMSP-9 Reports on #markingson resolution vote at U of M Faculty Senate

INVESTIGATORS: U of M Senate resolves to review human research

MINNEAPOLIS (KMSP) -

For nearly 10 years, family and friends of Dan Markingson have pushed for an outside investigation of his death after he violently took his own life while enrolled in a drug study at the University of Minnesota.

On Thursday, the University of Minnesota's Faculty Senate took a bold step, passing a resolution that calls for outside experts to review how the school conducts research on human subjects.

"We are all of us under this cloud, and it has to be removed," Professor Naomi Scheman contended.

Markingson was mentally ill when he was recruited to sign up for the study. His psychiatrist, Steven Olson, was the principal investigator, and part of his salary was being paid by the drug maker.

Mary Weiss, Markingson's mother, repeatedly complained to the U that her son's condition was worsening, and she feared he would kill himself.

"He didn't pass away, he was killed," Weiss said. "They let him die."

Weiss, who is recovering from a stroke, was unable to attend the faculty Senate meeting, but a close family friend called the results of the vote "overwhelming."

"I never thought it would come to this, speaking on behalf of Mary Weiss," Mike Howard said. "Thank you."

Now, it's up to University of Minnesota President Eric Kaler to decide what happens next.

"I'll consult with experts on campus to identify external people who have the expertise necessary to make an evaluation," Kaler said. "We'll invite them to come review what we do and we'll report the result."

Kaler does have the option to do nothing. The university has long maintained that the death of Markingson was a tragedy, but not the fault of researchers.

An investigation by the FDA found no evidence of misconduct, but critics say that review was incomplete and they have been pushing for a far more in-depth investigation.

"I welcome any investigation," Olson said. "I've got nothing to hide. We didn't do anything wrong."

More than 3,000 people, many of them medical professionals, have also signed a petition calling on the governor to get involved in the Markingson case. That petition was delivered to Gov. Mark Dayton's office on Thursday morning. His staff says he will have a response soon.

Star-Tribune on #Markingson by Jeremy Olson

Faculty Senate Meeting on #Markingson

Resolution for Investigation Approved

Some Uncertainty About What This Means

Jeremy Olson is quite a good reporter who has been in on the Markingson situation for quite some time. At his previous job with the St. Paul Pioneer Press, he and Paul Tosto received the Primack Award from the U of M for their investigative journalism on this and related cases. I'll tidy up this paragraph with links later.

But for now, from the Strib:

Nearly a decade after Dan Markingson died by suicide while participating in a U of M drug trial for schizophrenics, the U’s Faculty Senate raised his death as a reason to re-examine their institution’s handling of vulnerable research subjects.

At a meeting Thursday, the senate voted 67-23 to ask the university for a review of how the university recruits and protects people in clinical trials.

Questions have emerged in recent years about whether U psychiatry researchers coerced the young, delusional Markingson into a drug study that he didn’t fully understand and his mother didn’t want for him. Most recently, a petition by more than 180 leading researchers and ethicists asked the university to review its conduct.

“These are not random cranks out there,” said Karen-Sue Taussig, a Faculty Senate member and liberal arts professor. “These are people who are really quite eminent in their field.”

Faculty members at Thursday’s meeting expressed different views on the issue — some questioning whether the U put research goals ahead of Markingson, who died at age 26, and others believing the institution did everything it could to protect him. The psychiatrist who treated and recruited Markingson to the so-called CAFE study, which was funded by drugmaker AstraZeneca to compare three antipsychotic drugs, even made a rare public defense of his research.

But most faculty members agreed that the university’s credibility in the research world has been damaged by a decade of unresolved questions over Markingson’s death, and that an independent, external review could help rebuild its reputation.

“We are all of us under this cloud and this cloud needs to be removed,” said Naomi Scheman, a philosophy professor and Faculty Senate member.

Whether the vote called for a broad look only at the university’s research practices, or a specific examination of the Markingson case, was a matter of dispute after the vote.

U bioethicist Carl Elliott, who has been a leading critic of the university’s conduct in the study, said it will have to address Markingson’s death in some meaningful way. “If anyone wants this investigation to clear the name of the university — as a lot of people said they do — then it will have to deal with Dan,” he said.

After Markingson’s death at a halfway house in May 2004, a review by the U.S. Food and Drug Administration found no wrongdoing by the university.

However, the state mental health ombudsman did raise concerns that Markingson was recruited by a psychiatrist, Dr. Stephen Olson, who also could advise a judge on whether his patient should be committed to a state mental health hospital. And state legislation has since outlawed doctors from recruiting their own patients into psychiatric drug studies because of that risk of coercion.

Olson told the Faculty Senate that he felt badly for the loss of Markingson but that he did not coerce him into the study and that the call for an investigation was prompted by mistruths.

“Cancer patients die in cancer studies all the time,” he said, “and it’s not a surprise that people with mental illness will die in a trial of mental illness.”

U of Minnesota President agrees to outside review #markingson

UMN president agrees to outside review 

of clinical research practices

Report from On Campus:

University of Minnesota President Eric Kaler says he will form an outside panel to review how the U treats human subjects in clinical trials.

 His announcement followed a faculty resolution today requesting a review of the U’s practices. 

The panel is a response to the 2004 death of patient Dan Markingson, who killed himself while enrolled in a clinical drug study at the U. 

Faculty leader Naomi Scheman says lingering questions over his death have put the U’s reputation under a cloud.

“It’s not going away because — despite the university’s insistence that it has been adequately investigated — very credible, serious, thoughtful, fair-minded people do not find those investigations genuinely to be credible.” 

Kaler says he welcomes the review, saying it would put to rest any doubts over how the U handles people in clinical research.

“Let’s look at what we’re doing now, currently. I have a great deal of confidence in what we’re doing, and I think an external validation of that — which is what I expect it to be — will close the chapters.”

Kaler said he will form the panel early next year.

Carl Elliott, who has been one of the main scholars raising questions — and who has called for an outside investigation into Markingson’s death — says he’s trying to stay optimistic:

“It all depends on who picks the panel, what they’re allowed to look at, and what kind of access and power they have to get at records, to get at court documents, to get at finances, to interview people who have been involved in clinical care as patients and research subjects that were in the department of psychiatry. All that stuff is going to be important .. for whoever sets up this panel to make sure they’re given the tools and expertise to do their job.” 

This morning, a friend of the Markingson family, Mike Howard, delivered a petition with almost 3,500 signatures to Gov. Mark Dayton’s office asking for “an external panel of experts to investigate ethical wrongdoing in psychiatric research at the University of Minnesota, including the circumstances surrounding Dan’s death.”

He later [called] Kaler’s announcement of the panel “a tremendous first step.”

He added:

“The records will speak for themselves. … It does restore some faith that there is some honesty and integrity at the University. Because for a long time, it has been held in a closet. And today is the first day it came out.”

Minnesota Daily writes about #markingson

Added later, Daily IT probs fixed. This link should work to give you formatted Daily report.

--------------------below was posted to make article available
while IT fixes underway. --------------------------------------

This has just come out. 

Formatting on Daily site via web is strange.

So here it is:

December 05, 2013

The University of Minnesota Faculty Senate will discuss a resolution Thursday to create an independent, external panel to investigate how the institution conducts clinical research on human subjects.

The Faculty Consultative Committee is recommending that the full Senate approve the resolution in order to ensure the University is meeting ethical standards.

The proposed resolution stems from the years-old controversy surrounding University drug trial participant Dan Markingson, who committed suicide six months after joining the study in 2003.

Markingson participated in the CAFE study, a psychiatric drug trial sponsored by AstraZeneca and run by University professors.

In October, a group of bioethicists from around the world wrote a letter to the Faculty Senate asking for an outside investigation of the case. The group raised concerns about previous action on the case, including a Minnesota Board of Social Work investigation and a lawsuit filed against the University by Markingson’s mother, Mary Weiss.

“We are aware that officials within your university have suggested that various investigations have already taken place,” the letter said. “However, such claims hold only at the most superficial level.”

Some researchers say an investigation will find more cases like Markingson’s.

Trudo Lemmens, a University of Toronto professor and one of the letter’s key authors, said part of its intent was to show that concerns about the Markingson case aren’t unique to researchers in Minnesota.

“The external academic community is really worried about what is happening at the University of Minnesota,” he said.

The proposed investigation wouldn’t consider past research like the CAFE study. But the resolution says it would examine “current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities.”

Multiple reviews of the Markingson case — from University, state and national bodies — found no wrongdoing in the CAFE study. The only official finding of wrongdoing was a corrective action agreement from a Minnesota Board of Social Work investigation last fall.

The board’s investigation found that study coordinator Jean Kenney made repeated errors in documentation, performed tasks beyond her expertise and didn’t adequately address family concerns over how Markingson was treated.

Associate professor in bioethics and public health Leigh Turner, who arrived at the University in 2008, said his colleagues have been concerned about the CAFE study as long as he’s been on campus.

“It’s just something that needs to be addressed, and it needs to be addressed in a definitive way,” he said.

Mechanical engineering professor William Durfee, chairman for the University’s Faculty Consultative Committee, said psychiatric clinical trials involving human test subjects are a highly sensitive area of research.

The panel’s investigation could provide reassurance that University research practices meet ethical standards, he said.

“You need to do the research to get ahead,” he said, “but you need to be exceptionally careful that you’re following best practices in terms of enrollment and managing subjects all the way.”

But Mike Howard, a close friend to Weiss who has been involved with the Markingson case, said he thinks it’s unlikely an investigation would find no wrongdoing, and he thinks there are other “victims” like Markingson.

“I find it hard to believe that they would not find anything wrong,” Howard said.

Issues with the University’s research practices in the Markingson case have lingered for years, Turner said.

Though much discussion of research misconduct focuses on the CAFE study, Turner said, one important question remains:

“Is Dan Markingson part of a larger community of research subjects that’ve been harmed by research studies here?”

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

(my apologies for formatting inconsistencies-early Thursday morning)

Faculty Consultative Committee

Thursday, November 14, 2013

4.    Committee Business

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

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

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

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

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

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

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

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

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

Faculty Consultative Committee

Thursday, November 21, 2013

3.    Faculty Senate Docket

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

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

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

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

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

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

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

    Professor Ranelli said the matter should be on the docket.

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

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

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

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

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

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

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

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

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

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

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

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

4.    Discussion with President Kaler

    Professor Durfee welcomed the president to the meeting.  

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

    Professor von Dassow commented that letter sent by Trudo Lemmens, et al. talks about the Markingson case because that case was the subject of a lawsuit and is a matter of public knowledge, but the concern is that similar problems exist in other cases as well and that they may represent systemic problems; she noted the criticisms of the reviews of this case that had taken place; she suggested that the University is obligated to examine how research is conducted, and in a public way; she said an independent inquiry could clear things up and provide a public benefit for the University, so it should resolve that there be one.

    

    Professor Ben-Ner said that if there is a problem with IRB procedures, they should be addressed; if the rules appear to allow conflicts of interest, they should be addressed; if all drug companies participate in research, that should be addressed; if there is a problem with faculty members, it should be addressed.  But it does not make sense to re-open all the details of this particular case.

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

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

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

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

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

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

3.    Faculty Senate Docket, cont.

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

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

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

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

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

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

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