MinnPostBy Leigh Turner03/11/2014In yet another twist to the University of Minnesota’s longstanding refusal to investigate alleged research misconduct in the Department of Psychiatry, university officials, instead of asking for a credible inquiry, are soliciting “bids” from prospective contractors interested in reviewing “current policies, practices, and oversight of clinical research on human subjects.” This limited review is both absurd and fully consistent with the decade-long refusal by university administrators to promote anything resembling a legitimate inquiry into possible research misconduct involving vulnerable patients with mental illnesses.
The latest episode began in December, when the University of Minnesota Faculty Senate approved a measure titled “Resolution on the matter of the Markingson case.” Dan Markingson was an acutely psychotic young man who was recruited into a psychiatric clinical trial while under a civil commitment order. His psychiatrists kept him in the trial despite the desperate pleas of his mother, Mary Weiss. Markingson stayed in the study until he committed suicide by nearly severing his head with a box-cutter.
In the years since then, many critical questions about the circumstances surrounding his death have remained unanswered or contested: whether Markingson was coerced into the trial, whether he was enrolled without having the capacity to provide informed consent, whether he was given inadequate care by psychiatrists with significant financial conflicts of interest, and whether his privacy rights were violated. Last fall, a group of 181 professors from outside the university wrote to the Faculty Senate, asking it to endorse an investigation of the circumstances surrounding Markingson’s death. The Senate passed a resolution by a vote of 67 to 23; its preamble noted the reputational harm the university has suffered "in consequence of this tragic case and its aftermath," as well as the many unanswered questions raised by Markingson’s death.
Still, university officials continue to dodge a legitimate inquiry. Instead of asking for an investigation by a panel of independent experts in research ethics or a law-enforcement body, university officials have posted a request for proposal [RFP] to the MBid System on the university’s Purchasing Services website. This is the website ordinarily used to solicit bids for services such as furniture reupholstery contracts and laboratory supplies. Unless the Presidential Commission for the Study of Bioethical Issues routinely trolls for contracts on the MBid website, it is unlikely that the kind of organization that registers with MBid is going to have the expertise, credibility, investigative powers, and forensic skills needed to conduct a thorough investigation of possible psychiatric research misconduct. Even if a credible body with relevant expertise receives the contract, it is being given the wrong mandate. According to the RFP:
The intent of this review is to ensure that the University’s processes for clinical research on human subjects meet or surpass the established best practices and norms and to instill confidence among faculty and the public that the University of Minnesota research is beyond reproach. It is to be forward looking, productive, transparent and independent review of current practice by an external expert panel.Setting aside the suggestion that the primary mandate of the contractor is to engage in a public-relations exercise for the university by “instilling confidence” that research conducted at the University of Minnesota is “beyond reproach,” the emphasis on being “forward looking” while examining only “current” policies, practices, and oversight of clinical research is profoundly disturbing. I believe the purpose of an investigation should not be limited to reviewing current policies, but must also include a careful investigation of past conduct — including alleged misconduct in the Markingson case…
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Inadequate therapeutic effect [requiring alternative treatment]…
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Unacceptable side effects
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Patient decision…
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Administrative…"
Unlike the usual complaints of over-medication and unnecessary restraint, Markingson was inadequately medicated and placed in an environment that did not offer appropriate restraint. The magnitude of his impairment was neglected in the service of the clinical trial – an unnecessary trial of the expirimercial variety. The absurdity is that until he killed himself, he was on the road to being declared a treatment success since he was still taking the study medicine [albeit anything but voluntarily]. In a more reasonable world, one would expect the Sponsor [AstraZeneca], the Principle Investigator [Jeffrey Lieberman, current APA President], and the organization actually running the trial [Quintiles] to have some interest in knowing what went wrong in their study.
If the story is actually as I have just told it, it is an example of clinical neglect leading to a fatality in the service of performing an unnecessary clinical trial for marketing purposes. At this point, only an outside, unbiased investigation can determine the truth. The Study Coordinator has already been censured by her professional organization for her part in the story, but the University administration has hindered any further general probe. This current tack of limiting the investigation to current conditions, leaving Markingson’s out of the investigation, and putting it out for bidding along with office furniture on a request for proposal site can only be seen as deliberate obstruction of the faculty senate mandate – and a direct insult.
May I have permission to post this entire article on my web-site? The address is above, as is my email.
Thank you for your consideration of this request.
Bill Gleason – U Minnesota faculty (med school)
I grew up in a town with Big U. There was always some scandal being covered up by the university. Professors involved with 18 year old girls were common with the answer always being the girl was 18, and an affair was part of the college experience.
Jobs and contracts being given to family and friends were also common.
The solution to these and other problems was to always keep it “internal.” Keep quiet and nobody will know.
The problem is this concept has moved out into the world of the clergy. My denomination now follows this practice feeling that if they ignore problems they will not be held liable. Staff involved with young girls are only required to make sure they are 18. The whole concept of unreasonable influence is ignored.
Clergy have taken the position that like a college professor they are somehow tenured and cannot be removed for performance once they have been hired. Hired without a full disclosure by the denomination of past employment problems, or full disclosure by their past church in an effort to move this person along without a court battle.
After a year of pointing out a minister’s many references to psychological counseling, being “unchained” from conventional social norms, his interest in violent movies and TV shows, and declarations of superiority I had a letter returned unopened.
The concept that if I ignore you, you will go away, combined with if I do not speak to you, you have nothing to use to sue me is alive and well in a number of institutions.
The Markingson case is tragic, but this is not an unusual response by an academic institution. One that is mimicked by others who feel they are above those who ask questions or point out: The Emperor has no cloths.
Steve Lucas
To use – “adding insult to injury” as a verb….
To further a loss with mockery or indignity; to worsen an unfavourable situation
fits the U-MN to a tee.
The University of Minnesota, among the 25 largest public research universities in the USA, according to Wikipedia, its leading administrators instilling confidence and trust by dodging the utterly shameful research scandal responsible for the death of young, vulnerable Dan Markingson?? The only honourable option is an independent, competent, transparently honest investigation and settlement.
Another convoluted tale is the aftermath of the Sandy Hook tragedy, where politicians and professionals try to keep the lid on the mental health treatments (medications) of young Adam Lanza, see http://www.ablechild.org
The stink warrants a root cleaning, and the addition to the university’s honour roll of Carl Elliot.
Many years ago I moved to my wife’s home town and away from Big U. There were a couple of small colleges, one of which became a university in an attempt to attract international students. A community college that has never stopped expanding as the need for cost effective education continues to be an issue.
Up the road is one Big U who is currently looking for a new president. Under consideration is a former football coach at an even larger university. This university has come under criticism for a low graduation rate and excessive student loans. They have chosen to charge students the transaction cost of using a credit card when paying their tuition.
Then we have the other Big U, more sophisticated with a PBS station and national reputation. They are also looking for a new president. The past president was sued by the state for wanting to add a “student” charge to all of those enrolled that had no relationship to classes or hours taken. He also wanted to dot the campus with cranes due to his concept of a new campus with new buildings.
Today I open the paper and find the outgoing president has been give $100,000 plus as a bonus for his performance. The paper asks why and is told that is private.
The paper has also asked about the large fees paid to a search company, and they are told this is private. The criteria used in the search? Private. The other candidates? Private All of this information is private and most likely destroyed, since it was a private search company with no ties to the university.
Along with announcing all of the information is private, Big U did announce that almost all of the fees and tuition charged will increase the by state maximum. The only thing that is transparent is the additional money students will pay to attend.
Steve Lucas