Saturday, February 28, 2015

For the Record: Outside review faults University of Minnesota on research ethics

From the Star-Tribune

By Jeremy Olson (with Paul Tosto, Primack Award winners from the University of Minnesota for investigative journalism)

Safeguards for human subjects are inadequate, according to review that spun off patient’s death in ’04.

The University of Minnesota needs stronger measures to protect people participating in its scientific research, according to an outside review that found “inconsistent and inadequate” practices to prevent vulnerable patients from being coerced into clinical studies.

The review, released Friday, strikes at the same issues critics raised about the recruitment of Dan Markingson, a man with schizophrenia who died by suicide in 2004 while participating in a U drug study. Markingson was enrolled by a psychiatrist who had been treating him and advising a judge whether the young man needed to be committed to an institution.

The report, paid for by the university and conducted by the Association for the Accreditation of Human Research Protection Programs, found that the university’s lapses had left research subjects “susceptible to risks that otherwise would be avoidable.”

“Some research subjects, by virtue of impairment or incapacity, may be unable to fully protect their own interests at the point of study enrollment and during the course of research participation,” according to the review. The university, it said, gave “inadequate attention” to the issue.

Researchers were poorly equipped to deal with unstable patients whose ability to consent to research fluctuated, for example. The researchers also were inconsistent in determining when guardians or others could consent on patients’ behalf.

The report did credit the university for a “thoughtful” overhaul of the policies and training for its Institutional Review Boards, which oversee the safety and appropriateness of research involving humans. But it recommended the use of clinical gatekeepers who could provide unbiased, hands-on observation to make sure patients are safe.

In a letter also released Friday, University President Eric Kaler and vice president for research Brian Herman said the U would assemble a plan for responding to the report within 60 days.

“Measuring the difference between our current research program and our commitment to becoming beyond reproach was the charge given to the independent review panel,” they said. “Now, we will be accountable for taking action.”

In an interview, Herman pledged an immediate correction to one finding — that subordinates in some cases are reviewing the soundness and safety of their boss’ research. Reviewers found five instances, which they described as conflicts.

‘A cloud’

The review was commissioned by the U’s Faculty Senate in late 2013 following media coverage of Markingson’s recruitment into the so-called CAFE study, which was funded by drugmaker AstraZeneca to compare three antipsychotic drugs, and his subsequent death.

Many believed that lingering questions from the Markingson case had harmed faculty recruitment and retention.

“Frankly, the whole reason we pressed so hard for this, is we feel like there is a cloud over the university that affects all of us who work there,” said Karen-Sue Taussig, an anthropology professor.

Relatives blamed the university for recruiting Markingson when he was delusional. They argued that a psychiatrist, Dr. Stephen Olson, held too much sway as both a recruiter and caregiver, and that the doctor was unmoved when the family said Markingson was getting worse during the study and needed to be withdrawn from it.

The Legislature has since made it unlawful for doctors to recruit their own patients into their own drug studies.

Carl Elliott, a U bioethics professor and outspoken critic of the school’s conduct in the Markingson case, said the review vindicates his concerns. “The PR line of the university has always been that this is an old case. We’ve been cleared repeatedly, and we’ve fixed everything. Now it turns out they haven’t fixed anything.”

The Psychiatry Department received stinging criticism, including that its human subjects protections do “not reflect the best efforts of a University of this caliber.” Fairview Health clinical staff members also told the reviewers privately that they lacked trust in two U psychiatrists and worried that research recruiting tactics were too aggressive.

The doctors’ names were redacted from the public version of the review, which recommended that one receive supervision and training in leadership and in protecting human subjects.

University officials have been incredulous over the continued attention to the Markingson case, which was reviewed years ago by the U.S. Food and Drug Administration (FDA) and Minnesota’s mental health ombudsman. The university also was excused from a lawsuit by Markingson’s mother; Olson, the psychiatrist, settled the case.

More attention is coming. A preliminary investigation by Minnesota’s legislative auditor is due in March, and one lawmaker recommended delaying regent appointments until then. Former Gov. Arne Carlson has pressed for legislative hearings, accusing university officials of “concocting fiction” that the Markingson case was thoroughly reviewed.

“Nobody has pressed them to tell when, where and how these investigations were conducted,” he said. “And where are your findings?”

University officials recently acknowledged that FDA investigators were back on campus last fall, meeting with Olson, though the precise subject wasn’t disclosed.

Some comments from the Star-Tribune web site.

It just sickens me to read that the University will not publicly come out and admit what they have known all along, that there human subject research program is broken and has never been held accountable as far as the department of psychiatry is concerned.  I would hope that after the next report is made public from the auditors office that the chair of psychiatry and his unnamed rogue investigator are fired.   

What a disappointing comments section. I was expecting to find the usual defenses we've seen over the last several years, saying that the U had been exonerated over and over, and that this whole thing was the private obsession of one or two faculty on some rogue crusade: "Why can't we just fire this guy?"  and so on.  I guess that approach is losing currency now?

Thanks, I was looking for the same ignorant comments from a few UMN plants or department of psychiatry paid lobbyist.  meegwich brought up the medical school deans and their attempts over the years whether on the radio or within the Strib to discredit bioethics professors from their own university for having done their job that they were hired to do, and apparently did it too well as they exposed the very findings within this report.  Just a couple of weeks ago I listened to Dean Brooks Jackson on MPR radio make the comment that this report would put to bed the harsh criticism of the medical school and the psychiatry department in particular.  Dr. Jackson has no clue what he is talking about or has been seriously mislead.  If the upcoming report from the legislative auditor is anything close to this report there should be more than a few people at the university looking for new jobs.

Let me try again with proper prose.  The full report, which is easy to find with any major search engine, is  very revealing.  It has a section concerning "vulnerability to coercion or undue influence".  The first two paragraphs in that section made interesting reading, at least for me, because it seems this distinguished review panel has stated they have found no evidence of active compliance with a Mn State Law at UM.  A later section suggests some 'retraining' and, between the lines, some housecleaning in one of UM's distinguished medical departments. What will be, will be...... 

I just don't understand why the university thinks they are now going to be able to be above reproach by simply making a few token changes.  This report indicates a continuance of the despicable behavior that they have exhibited for years and years when it revolves around their psychiatric research program.  I have to agree with why did it take so long and an outside investigation for the university to even admit they have a problem?  They have no one to blame but themselves for a tarnished reputation and public perception that the department of psychiatry is poorly run and managed, and has direct causation to numerous instances of patients being harm or mistreated.  Shame of the university.

My opinion after reading the article and report is that neither come anywhere close enough to exposing the corrupt manner in which psychiatric researchers at the U have ignored or blatantly disregarded vulnerable patients basic civil rights, and I am speaking specifically about PHI and or HIPAA.  Having had a family member hospitalized at Fairview-Riverside and then hounded and hounded by her own psychiatrist and his study staff to enroll into a study was just outrageous.    Total disregard for HIPAA rights as she had never even been approached to sign a release and yet multiple staff came at her night and day citing her personal information like no big deal.  I am quite sure the redacted psychiatrist's name is the same individual behind harassing our family member.  

Missing in nearly every article related to the Markingson case is attention to the greatest breach of medical care ethics, involuntary commitment. Under legal coercion, which made any research ethics and human subject protection breaches particularly acute, the physician ordered participation in the study. The foundational problem here is the involuntary commitment. If not itself, then in the court order that specified that Markingson was to follow the specific treatment plan of his physician rather than simply requiring him to follow a plan by a physician, with the ability for himself (or guardian if appropriate) to choose treatment and physician.

With science everyone is a guinea pig.  Nobody cares about the person, it is all about meeting the goals of the researches outcome.  Also who is behind this and funding it.  They have motives to reach a certain outcome. This isn't about careing for people in the study, it is about how much money will we make with the desired outcome.  All these big drug companies bringing in their poison to test on vulnerable people is sick and immoral.
I cannot speak on behalf of the psychiatric researchers or the present psychiatry chairman but there have been considerable efforts to ensure that clinical research research is carried at the highest level possible at the University of Minnesota starting with study coordinators and investigators and that the IRB has not ignored this matter. Dr. Elliott continues to state that nothing has been fixed - may be what he is saying is that certain individuals should terminated or something be done in the department of psychiatry and we will see what comes of this from the new Dean. To taint the whole University on this tragedy and to claim the AHC needs to be fixed is to neglect to see the fine work of many being spoiled by a few.
I guess all those claims by the administration over the years citing all is well in University-Land were not exactly truthful.  Seems like first Aaron Friedman and now Brooks Jackson can't seem to understand what a scandal is, and their repeated lines that we've investigated ourselves and found nothing wrong just got shot out the window.  The Legislative Auditors report should be the final nail that drives some sweeping changes in personnel within the department of psychiatry and the academic health center, otherwise it's just more of the same with Kaler who doesn't seem capable of walking the walking...
 I think you've hit the nail on the head.  Very disturbing for me to read the statement from Mr. Kaler that now we can be accountable going forward ! My god, why hasn't the U been held accountable before now?  Why did it take this outside investigation, paid for by taxpayers, to inform both the public and the U that there are serious on-going problems within the department of psychiatry and their researchers and failing's to protect a very vulnerable population.  I read through the report and it's very alarming, and the Minnesota chapter of NAMI should be ashamed of themselves.  Their endorsement of the department of psychiatry's sitting chair is shameful considering some of the most critical aspects of the report deal solely with the department of psychiatry.  NAMI has lost credibility  over the years and now I believe they have gone over the edge and lost all of it. 

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