That happened a long time ago. Nothing to see here. Move along ...

Link to Video 

A Cover-up Culture at the University of Minnesota?

Denial as Administrative Policy?

A story has appeared on KMSP, Channel 9, here in the Twin Cities that has some relevance to the way the University of Minnesota has tried to make the Markingson case go away.

From the KMPSP web-site:

Pam Wheelock, Vice President of University Services at the University of Minnesota:

"I really don't have any comment about something that happened off university property or off university time"

Not according to Hamline University's Professor David Schulz, a nationally recognized expert on government and business ethics:

"This is using your position of authority for purposes of getting something from your subordinates that seems completely illegitimate."

What happened? 

The Standing Rock Reservation is in South Dakota -- 430 miles from the Twin Cities campus, and U officials -- like the vice president of university services -- would very much like to play up that distance.

Back in December of 2011, Louden got slapped with two poaching citations for shooting mule deer out of season on tribal land with someone else's tribal tags -- tags she bought from a guide named Jess Porras, a convicted felon.
When asked whether the Minnesota hunters knew they were using illegal tags, Porras said, "It says right on the tag."

According to federal criminal records, Louden's group took two deer back to a local motel to clean them in the bathtub.

"It wasn't a good idea, 'cause I knew it would be a bloody, bloody mess," Porras said.

Louden pleaded guilty to the two citations. Off campus? Sure -- but very much a university issue because according to an anonymous complaint filed with the U, Louden repeatedly harassed one of her subordinates to take her on the hunting trip in the first place, calling him dozens of times until he relented. He ended up paying a $250 fine for aiding and abetting the illegal hunt.

And yet:

The U says its own internal investigation found no evidence of harassment. They wouldn't say if they checked Louden's phone records -- something they wouldn't turn over to the Fox 9 Investigators, citing privacy.

"That's all the comment I have," Wheelock said. "It was investigated and closed without discipline."

The U also wouldn't tell Fox 9 if they reviewed the poaching criminal file. The Fox 9 Investigators obtained it through the federal Freedom of Information Act. 

Louden's employee told criminal investigators he felt "obligated to take Louden hunting." 

"It's really an abuse of authority," Schultz said.

There's more...

This is not the first complaint Louden has dodged without discipline. In fact, there have been 17 -- 3 times more than anyone else in a similar position. 

What appears to be tiny, toy people scurrying atop a cold, windy roof on the U's East Bank are real bidders taking part in a process that is supposed to be a level playing field. No one company should have an edge in order to protect the taxpayer. 

"Certainly, it sends up the red flags,"Schultz said. 

Yet, anonymous facilities management workers complained that Louden rigged the system, eliminating the competition for a roofing company owned by a guy she's known for a long time. The business is Skyline Building Envelope Consultants, mostly roofing consultants. The man is Rod Schalesky. 

An internal investigation by the university dismissed the complaint after Louden insisted their relationship was purely professional, but the U's own investigation failed to note the following things revealed in e-mails obtained by the Fox 9 Investigators:

1. Schalesky said he would drop proposals at Louden's home for her to review -- a practice that other consultants for several companies in the same business say is unheard of.

2. When Schalesky moved from his home and office, Louden told him in an e-mail, "If you need something, let me know."

3. Twice before, Schalesky's company was to present competitive bids on large products, and he discussed his bids with Louden. This, according to U policy, is supposed to be a confidential process.

4. The university paid Skyline's liability insurance so the company would work on a U project.

U officials say Skyline's work was still a bargain, but the e-mails show that the finance folks -- even Beth Louden's boss, Mike Berthelsen -- didn't like it. Still, the insurance got paid and Skyline got the job.

"I don't believe that violates any policy," Wheelock said repeatedly when asked whether such payments were appropriate.

University investigators dismissed a complaint that Louden appeared to organize the bidding process to minimize the competition for Skyline, but according to e-mails, it appears she and her staff did just that.

Instead of considering the inspection of several buildings as one big project, which would have to be put out for bid, she told them to break up the inspections building by building. That kept prices low enough that Skyline would be given the work without bidding for it. 

A pile of purchase orders show Skyline pulled in hundreds of thousands of dollars over the past 5 years. 

The university investigation concluded in this a from U auditors that "using separate work orders for each building is a direction FM [facilities management] is considering, but the roofing strategy has not been finalized." 

Even so, e-mails show that if anything, people were troubled by that approach. In fact, when people in purchasing objected to breaking up the work building by building, work was delayed. Louden's boss had to weigh in, and Berthelsen approved the system -- but only for a year. The following year, staff went back to a more competitive bidding system. 

"Governmental agencies across the state need to be scrupulous in terms of this process, of people who are making decisions about accepting bids or supervising vendors, to police them for conflicts of interest or self interests," Schultz warned. 

Why would Louden try to give Skyline the edge? Remember, she told university investigators she had a long professional relationship with owner Schalesky. The shiny metal roof on Louden's home wasn't always that way.
A few years back, the Loudens wanted to join a class-action lawsuit against the company that made the old shingles on her house, but before she could, she needed an inspector to sign off that her shingles were bad. A former inspector for Skyline did just that. 

Yet, when asked how much Louden paid for that inspection, Schalesky told Fox 9, "There was no inspection." 

Schalesky owns Skyline, and at first, he denied his company helped Louden with her lawsuit; however, when Fox 9 told him his former inspector had spoken with reporters, Schalesky said, "He went out there and picked up a sample of the shingles that had fallen off the roof." 

The former Inspector said there was more to it than that, and settlement documents appear to confirm it. He says he took three samples from the roof and took photographs before filling out paperwork. Fox 9 checked to see what was actually required for the settlement -- photos and a sample from the roof. 

The inspector said he didn't get paid for what he described as a $200 to $300 job. Why? Schalesky told him Louden was a good customer. Schalesky does not dispute it was done as a favor to Louden. 

"There is no such thing as a small favor," Schultz said. 

Favors? The U's investigation checked out complaints that Louden had employees working on her home or property. She denied it. That was good enough for the U auditors -- but Fox 9 spoke with neighbors who say they've seen university vehicles coming and going from Louden's house during the day. 

Earlier this fall, Wheelock led a campus tour to show people -- especially lawmakers -- just how much money they need. By her own account, they've had to cut the number of custodians and are cleaning university buildings less often. 

"We relied on student tuition increases to meet our programmatic needs across the institution, and we are hitting some real constraints about students being able to manage their debt and the cost of attendance," Wheelock said. 

That's why Fox 9 looked at Louden's spending, too. One of the complaints about her said she spent what she wanted on things like food for meetings and gatherings. Two years of food receipts show the department spent $12,299 on food bought from local business for routine meetings -- most involving Louden or her workers. By way of comparison, the University of Wisconsin's facilities department didn't spend a dime because budgets are just too tight. 

According to a memo written by Louden, she and 9 others planned to head to Las Vegas for what's billed as the largest trade show for custodial supplies in North America. The cost per person to the University was nearly $1,400.
Conference officials say the average size of groups attending was just 5, and none of the Big 10 universities the Fox 9 Investigators checked with -- Wisconsin, Iowa, Ohio State, Illinois, or Michigan -- sent anyone to Vegas this year. Wheelock didn't know the U planned on sending people until Fox 9 told her. 

University officials are looking into the Fox 9 report that Skyline inspected the roof of Louden's home, but the school says Louden is good at her job. The U also provided numbers that they say prove Skyline is cheaper, but those numbers come from the time period after the company was forced to compete against other bids.

In addition to the relevance of this matter to the Markingson case, it should be pointed out that what is going on here is NOT in accord with recent pronouncements on the goals and methods of the Facilities Management operation at the University of Minnesota.

Focusing on service [for Facilities Management] represents a shift away from taking care of the University's buildings and toward caring for the needs of the people and programs in them. This includes focusing on a culture that enhances productivity, demands accountability, and places a premium on clear communication.  

See p. 86 of the 2013 University Plan, Performance and Accountability Report. (emphasis added)

Show me the money - Markingson case

Show me the money!

Dr. Carl Elliot writes on his excellent blog, Fear and Loathing in Bioethics:

(emphasis mine - please see link for complete piece)

"Want information about research deaths? 

Show me the money!"

Have you ever wondered how many patients have died in psychiatric research studies at the University of Minnesota? Or how many patients have been seriously injured? There is a way to find out, under the state’s open records laws. But if you want to make use of that law, you’ll have to send the university a fat check. To be precise: the bill for that information will be $9,720.40, payable in advance.

In October, I filed a number of open records requests asking for information about deaths and injuries in psychiatric clinical trials. Two requests were about antipsychotic studies conducted by Stephen Olson – one for Seroquel, the other for an unapproved drug called bifeprunox. But the largest part of my request consisted of “Serious Adverse Event” reports filed to the Institutional Review Board (IRB) by a number of psychiatric researchers, including Olson and Charles Schulz, the department chair. Researchers are supposed to file these Serious Adverse Event reports whenever a subject dies or is seriously injured in a clinical trial. So in theory, these reports should tell me whether a disproportionate number of psychiatric research subjects are being harmed. (Of course, it is also possible that researchers are hiding deaths and injuries from the IRB, in which case they may not have even filed the Serious Adverse Event reports.)

After five weeks and repeated email reminders, I finally got a reply last week. Susan McKinney, the university records officer, informed me that under Minnesota state law, the university may “require the requesting person to pay the actual costs of searching for and retrieving government data.” She estimated that the cost of my requests will total $9,720.40 and asked me to send a check payable to the University of Minnesota.

Dr. Elliot notes earlier in his piece that his previous requests for information under the open records law were fulfilled without charge, but that this one is somehow different:

"...they have never actually asked me to pay for records -- until I started asking about deaths."

What Margaret Soltan said about #Markingson

What would Dr. Freud say?

Margaret Soltan, a George Washington University English professor, writes on her most excellent blog, University Diaries:

Just below this post is a post about Columbia University’s decision to deal with a now-jailed professor who worked there for twenty years by telling reporters that he hasn’t been around for ten years. True, but he did work there, in an honored, high-profile position, for a long time, and it would be more seemly for Columbia at least to acknowledge that. You don’t want to be like America’s shabbiest campus, Yeshiva University, and pretend Bernard Madoff wasn’t an honored trustee on whom the university depended for financial advice. You want to be better than that.

Similarly, the University of Minnesota seems to think it’s fine to respond to reporters pestering them about a rather smelly clinical trial one of their professors ran by saying fuck you that was years ago. When you simply deny – worse, when you smear reporters for pursuing the story (the university’s communication director recently wondered in an email if a Scientific American reporter was a “wacko”) – the thing you’re denying keeps coming back to haunt you. 

The trial was run by psychiatrists. Surely they’ve read Freud on the way denial works.

Here’s the most recent news report on the escalating Dan Markingson scandal.

=============================================================== 

Margaret's question immediately reminded me of this cartoon:

You see, Doctor, I am a University of Minnesota administrator,

and I have a problem with denial...

Comments on Strib piece: "Send in the wackos..."

Captain, we have a problem...

I've posted a piece on the Markingson case on the Star-Tribune's Community Voices website.

Comments are starting to be posted and I'll give some examples below:

I first saw the piece on Fox last week and was just appalled by the response from the University and especially the comments from the study coordinator. The corrective action she received was a slap on the wrist for her unethical and actually criminal actions. I also found it very misleading on the University's part to claim they've been dealing with this case for almost a decade and there's nothing new. I seriously doubt the UMN would ever have done anything if this poor man's mother had not attempted to hold them accountable. From the records available on-line, that didn't happen until 2008. I would say there is a definite credibility issue with the University.

This case defies logic as to why the University has never simply produced all the documentation that they claim to possess that would provide the credibility that seems to be lacking from all their denial of fault statements. Anyone can view the documents that are now posted that clearly state the Board of Social Work action against the study coordinator, the letter from the Attorney General's Office stating they never investigated this man's death, the Board of Medical Practice letter that states they never investigated the University. What's even more troubling is the fact this man was recruited while being hospitalized at Fairview-Riverside Hospital, the same hospital that was named as having been involved with violating patients privacy rights, and from the Fox report at least one other patient was being harassed the same way.

I think it's high time the state legislators take a serious look into the clinical study practices of the psychiatry department at the University of Minnesota, from approval of nothing but me-too drugs studies, or antipsychotics for "public speaking," or how patients are being recruited or coerced from locked wards, and is the law passed that was named after Dan Markingson being abused at Fairview Riverside and by the research psychiatrists? I can't help but wonder if the PR mouth at the University still has his job after the remark he made regarding Dr. Stone.

It's obvious from the standpoint of message delivered in the Fox 9 report that this scandal is not just simply going to fade away, contrary to the wishes of the University. The comical remark that its been so many years now and we don't care to deal with it says everything that needs to be said concerning the integrity of the University. What isn't clear to me is whether the University really believes the yarns they've spun, or if they have repeated them so often now that there is no dignified way to retract them. As a resident of this state and a U-MN alum, I'm totally ashamed of how the University has handled this entire episode, can't help but think there are many more Dan Markingson's that are yet to be accounted for, and there is a day of reckoning at hand for the University and especially the psychiatry researchers that prey on human subjects.

I'm not typically a Fox News fan, but the report they did regarding this terrible happening was very well presented and clearly indicated that there is a whole lot more to this story and others than the University is willing to admit. I agree with the comment that the U cannot at this point retract or change anything they've said or done and still save face, their only option is to continue the charade of falsehoods and denials and try to browbeat the very people trying to expose the wrongdoings. The psychiatry department at the University of Minnesota has an ugly reputation as far a clinical trial research goes. Garfinkel, Abuzzahab to name just a few, and of course the Strib as well as the Pioneer Press did pieces on Schulz and his AstraZeneca ties and his Haldol/Seroquel presentation that was exposed as being inaccurate and favoring the sponsor's drug Seroquel. Pretty shameful on the part of the University to never have come clean on anything related to psychiatric research without being subpoenaed or some other legal action.

I thought the Fox report to be highly credible and the University's response to be anything but. Exactly what in the Fox piece wasn't reported correctly or accurately ? Seems like more of the same from the University on anything to do with psychiatric research. Violating human subjects rights has never been an obstacle that the University hasn't been able to overcome. Our family hopes the University's reputation never recovers from the Markingson scandal, and for the Dean of the Medical School to stay the course with denials is absolutely pathetic. I also agree with the PR rep at the University should be fired immediately.

Maybe Lori Swanson and her office needs to investigate this case much like they did Fairview and all the issues surrounding harassing patients over medical bills illegally, then the U-Minnesota would have a leg to stand-on with all their claims of being investigated and cleared. The University has become a complete embarrassment over the Markingson case and should be completely ashamed of themselves. Dr. Aaron Friedman is no better than his predecessor, a complete fraud.

It seems to me that Dr. Aaron Friedman's saying the Fox report was "full of inaccuracies and unsubstantiated claims," was speaking about how he and the University have handled this scandal, and not about the allegations made in the report. I'm no attorney, but anyone with half-a-brain can recognize the fact that the University's own general counsel investigating the UMN is liken to the fox guarding the hen house. Absurd to perpetuate the same defense without providing proof of ever having actually done anything internal. Simply stating we have nothing to hide and have been cleared of any wrongdoing isn't the same as providing proof of those statements. The 'wacko' comment was unbelievably inappropriate and unprofessional but right on cue as far as the University has handled this scandal apparently. It certainly appears this mans death and subsequent years of dealing with the aftermath only continue because the University has refused to accept any responsibility for any involvement and that is just ludicrous. At this point I would encourage anyone having any mental health issues with themselves or friends or family go anywhere but the University of Minnesota for help.

I concur with all the statements posted, that the news report was fair and accurate and the University's response immature and substandard. Having personally heard some of the psychiatry department researchers speak at different functions, it's no wonder there is a credibility issue at the University. The statement from the medical dean was par for the course, and thank goodness he's moving on. The University desperately needs to retrain their public relations outlet as the comment about a fellow research doctor who's written a book about conducting clinical trials was so amateurish and rude it is almost unbelievable. It's no wonder the disciplined study coordinator feels secure in making the statements she made in the news report, it must be standard required behavior. The University's handling of the this whole scandal has embarrassed our state beyond repair. But, they could at least try and make amends. Probably not going to happen though until the other scandals hit the wire.

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Send in the wackos... (Markingson case)

KMSP-TV

Send in the wackos - a post on the Star-Tribune Community Voices about the Markingson case 

For the #markingson record: Bigger than Minnesota

bigger than Minnesota…

One Boring Old Man (aka Dr. Mickey Nardo) says what needs to be said:

Posted on Thursday 21 November 2013

The Dan Markingson case is one of those that asks us all to re-examine our beliefs. Such cases can be a screen on which to project our pre-existing thoughts or it can be a new page. Whichever way you take it – the true drama of his suicide, the pictures of his childhood posted on the Internet, the anguish of his mother, the struggles of his champions – all add a layer of reality to the issues often seen from a greater distance. Tueday morning, I worked in a busy clinic seeing patients, and this case was sitting on the side of my mind. I had been trying to focus on what aspect was the most compelling to me. I knew it wasn’t all the major controversies that immediately come to mind, things we could all list. Carl Elliot does a fine job of cataloging them in The Deadly Corruption of Clinical Trials. And it wasn’t the absurdities that I [and everyone else] mentioned; allowing a patient declared incompetent to suddenly become competent to sign on to a trial; putting someone whose mind was filled with the kind of thoughts listed in an earlier post [the rightest of causes…] on a blinded, fixed dose of medication; moving him to a halfway house when there’s no evidence that he was halfway anywhere; ignoring his mother’s concerns; putting him in a study measuring how long people stay on a medication when he was essentially sentenced to keep taking it; etc. Those things are obvious.

Driving home, I was thinking about the  snippets that had stayed with me from reading about Dan again yesterday. One was an AstraZeneca email in Carl’s article that grabbed my attention when I first saw it  [

selling seroquel I: background…]:

Two plus years ago I read that in horror [now, it comes as no surprise at all]. Another thing that lingered was the clip in the video where the clinical coordinator said she "‘didn’t do anything that was wrong or against the law.’ She said Mary Weiss was very controlling. ‘You don’t just kick someone out of a study because the mother wants it to happen.’ Kenny said Dan was doing well. ‘The guy had pretty many stressors going on. Mom was very much interfering with things.’ Kenny said that the fact that Dan committed suicide near Mother’s Day ‘was a really strong message.’" And then there was this remark from the University’s Senior Director of Communication about Scientific American writer Judy Stone, "I looked her up and can’t tell if she’s a whacko or not. I get nervous about anyone who would pay attention to Carl." But this was the loudest thing, "In his deposition, Olson said he saw Dan approximately six times from the date he was admitted in November until he committed suicide in May" followed by "In late April 2004, as Dan’s stay of commitment was about to expire, Olson recommended extending it for another six months — the duration of the CAFE study. He noted that Dan still had ‘little insight into his mental disorder’ and might ‘place himself at risk of harm if he were to terminate his treatment’.’"

It’s the lack of engagement of Dan that haunts me in this story – from AstraZeneca, to Dr. Olson, to the clinical coordinator, to the university – or the implication that his mother was being a royal pain, or that she had something to do with his suicide, or that Judy Stone was a "whacko," or that Carl Elliot doesn’t deserve to be listened to, or even that "it’s a tragedy, not a scandal." Who was engaged with Dan – the young man who was living among telepaths, mind readers, and hybrids, absent emotional attachments?

At the halfway house, Dan often stayed in his room for days. On March 26, 2004 nearly four months after his discharge from Fairview, his thoughts were still "delusional and grandiose," according to a social worker’s note. An occupational-therapy report from April 30 detailed Dan’s condition: "Personal appearance disheveled. Isolated and withdrawn. Poor insight and self-awareness." Entries in a personal journal that Dan kept during this period don’t show any obvious changes, suggesting that he was improving little, if at all…

Mercifully, Dan’s clinical trajectory is uncommon. No matter what you choose to call it, it’s cases like this that lead Emil Kraepelin to the name, Dementia Praecox – a young adult afflicted in the prime of life who was never to be the same and followed a downhill course. We don’t think of things that way anymore. People with this illness used to just disappear into the large sanatoriums – sometimes for life. Now, while there are still controversies aplenty, we have different expectations. And if you’ve been involved in the treatment of these patients, you know that the outcome doesn’t always have a linear relationship to the quality of care.

There are levels of the approach to this mental illness that I thought were best conceptualized in the era of the community mental health movement in terms of prevention. Primary prevention is anything that one does to prevent the development of illness. Don’t smoke. Get immunizations. etc. In the case of psychosis, Patrick McGorry in Australia and others are attempting to identify these patients prior to a psychotic break. It’s a laudable endeavor that’s not ready for prime time. And there’s controversy [as always] about what one would do if you actually could do that. But that’s not to say that it’s not valuable research.

Secondary prevention is efforts to minimize the impact of illness once it appears. With an acute psychotic break, modern treatment involves the use of antipsychotic medication, sometimes protective custody, and psychosocial interventions with an eye always on the future.  The issue of protective custody is primarily in the hands of the legal system. And while the use of medication is the subject of endless armchair debates, it’s pretty standard fare. And it’s a big part of the debate about the case at hand about Dan Markingson.

Tertiary prevention focuses on prevention of recurrence and the prevention of deterioration. When people with psychosis have either a course including recurrent psychotic illness or persistent signs of illness, should they stay on medication all the time, intermittently, not at all? Big controversies, and a factor in the debate are the side effects and potential irreversible long term effects of the drugs. That’s why we were all so hopeful when the atypical antipsychotics appeared: prevention of recurrence? prevention of deterioration? With no down side? That was not to be. And we knew that by the time Dan’s illness came along. So did AstraZeneca – about their own drug Seroquel. They knew it from their own Study 15 that they had already buried:

Clearly, the patients preferred Haldol over Seroquel. It’s clear as a bell. And AstraZeneca knew CATIE was coming and they weren’t going to look good…

… so they had CAFE going in hopes of looking better. But these were maintenance studies – what medication will patients best tolerate long term after responding to acute treatment? It’s hard, from the paucity of information available, to see where Dan had ever responded in the first place:

At the halfway house, Dan often stayed in his room for days. On March 26, 2004 nearly four months after his discharge from Fairview, his thoughts were still "delusional and grandiose," according to a social worker’s note. An occupational-therapy report from April 30 detailed Dan’s condition: "Personal appearance disheveled. Isolated and withdrawn. Poor insight and self-awareness."

The treating psychiatrist even said he hadn’t responded:

"In late April 2004" … "He noted that Dan still had ‘little insight into his mental disorder’ and might ‘place himself at risk of harm if he were to terminate his treatment’."

So:

1. The CAFE Study was driven by commercial interests rather than to gain medical knowledge.
   
   
2. It was a maintenance study for patients who had responded to medications. Dan had been admitted several days before with a florid psychosis of several months’ duration. There is no evidence that he responded to treatment. There was nothing "maintenance" about his case.
   
   
3. He was a success story for the trial because he hadn’t stopped the medication. That was a complete sham, because he couldn’t stop the medication under threat of commitment.
   
   
4. His clinical condition certainly didn’t improve over the ensuing six months. If anything, he was deteriorating.

Those are the things people howl about, and howl they should. But what stayed with me was the lack of genuine engagement of the case by the clinicians involved. The psychiatrist saw him only six times in as many months? The clinical coordinator "said Dan was doing well"? Dan was hardly "doing well." No one was looking.

Psychiatrists and psychiatry take a lot of hits from a lot of places – some deserved, some not so deserved. But the bottom line if you are a psychiatrist is that you become genuinely engaged with the case at hand and you bring everything possible to bear to see that the patient has the best shot at the best recovery that can be achieved, even in the face of persisting disability. This case didn’t even come close to that standard. Dan was pretty disturbed and his recovery was anything but guaranteed, but the care he got didn’t approximate his best shot – not even a good shot. He spent 6 moths languishing in a halfway house on a weak-sister medication that was having, at best, a sub-optimal effect. And he succumbed to a violent psychotic suicide in plain view, a testimony to the inadequacy of the treatment. Such things can happen in the best of circumstances, but this was the nowhere close to the best of circumstances – a patient under care who was neglected.

The term burn-out has become part of our daily conversational lingo. It means that a person who has been doing a difficult job has lost whatever extra drive it takes to keep them at the task. The term actually originated in describing the people who work with chronic psychotic patients. It’s hard work, to say the least, and the rewards are intangible – preventing deterioration, sticking with people through relapses, disillusionment with outcomes. When burnout comes, you can feel it, and the right thing to do is move on. You gave what you had until you couldn’t do it anymore. Good for you. Now go do something else. The alternative is to stay around and develop a kind of hardened indifference you can spot from twenty yards. Most people reading this who are in a mental health field know exactly what I’m talking about from seeing it, and perhaps even living it. But some people are able to keep going without ever burning out. They are amazing – the real saints among us, in my humble opinion.

Often, when something like this happens, we start looking for burnout – people who aren’t engaging because they shouldn’t be doing the job any more [or maybe in the first place]. It’s usually not malice, more something like battle fatigue. Another thing to look for is some hopelessly underfunded, beleaguered system that couldn’t possible do the assigned task. That’s all to frequent in mental health systems. But neither burnout or understaffing appear to be the case here. This is something else that shouldn’t ever be in the mix – corporate greed. And in this case, it filtered down to the people doing the clinical trial itself and resulted in negligence in medical care, failing to engage the case at hand. It is a scandal that deserves full investigation and exposure, at a minimum – and maybe its days in court. Finally, Dan’s Law is bigger than Minnesota…

For the #markingson record: "The rightest of causes"

From One Boring Old Man (aka Dr. Mickey Nardo):

the rightest of causes…

Posted on Monday 18 November 2013

In the summer of 2003, Dan Markingson became intensely psychotic with apocalyptic delusions and the belief that he would be called to become a murderer. After threatening to kill his mother, he was involuntarily hospitalized in the Fall and started on antipsychotic medication [Risperdal]. After several days, he was involuntarily committed to the mental hospital – psychotic, dangerous, and lacked the ability to make decisions regarding his treatment. As you probably know, Dan is the case that Carl Elliot writes about at Fear and Loathing in Bioethics and in his book White Coat, Black Hat: Adventures on the Dark Side of Medicine.

What you might write in a blog post or argue in a comment may be very different from what needs to be done in the very next case you see. Say you are strongly drawn to the point that antipsychotic medicine is toxic and should rarely be used. Further you may be sympathetic to Thomas Szasz’s view that mental illness is a myth and personally opposed to involuntary hospitalization. But then you meet someone like Dan Markingson whose mind is filled with compelling paranoid ideas and who is driven towards violence. It’s the kind of case where acting on your ideology would be in error. Dan’s involuntary hospitalization and medication with an antipsychotic was the only rational choice. Likewise, there’s no algorithm that dictates which medication, or how much, or the duration of his confinement. These are all things contingent on his response, not preconceived ideas based on ideology or guideline.

What happened several days later defies understanding. In Minnesota, committed patients can be offered another option, a stay of commitment, and avoid being confined to a mental institution as long as they agree to comply with the treatment program laid out by their psychiatrist. Dan was offered the stay if he would enroll in the CAFE clinical trial [Comparison of Atypicals in First Episode] in which he would be randomized to take either Seroquel, Zyprexa, or Risperdal. The absurdities were everywhere. He had been declared unable to "make decisions regarding his treatment," yet he was allowed to sign a consent form to be in the study. It was a maintenance study yet Dan had not responded. And he had written those notes above. After a few weeks, he was transferred to a halfway house that hardly addressed his lethality. The outcome parameter of the study was how many patients voluntarily discontinued the medication, yet Dan was court ordered to take the medication as a condition of his stay of commitment.

The treating physician was blinded to his medication, and the protocol didn’t allow for change of medication or dosage – hardly consistent with the needs in this case. Throughout the winter, Dan’s illness persisted and his mother mounted a campaign to get him out of the study without success. In the Spring, Dan killed himself violently with a box cutter leaving a bizarre note, "I left this experience smiling!" [see Carl Elliot's, The Deadly Corruption of Clinical Trials for a more comprehensive history].

Everything’s wrong with this case. The CAFE study was an AstraZeneca experimercial conceived to counter Seroquel’s poor showing in the NIMH CATIE study. The rigid design didn’t allow the flexibility needed in treating first episode psychotic illness, particularly one like Dan’s. Dan was no candidate for the trial on any count for obvious reasons, not the least of which was being required to take a medication in a study measuring patients’ rate of voluntary discontinuation of medication. He’s the kind of case where non-response to a first choice of medication would’ve dictated trying others, adding anxiolytics [forbidden by CAFE protocol], and considering a drug reserved for refractory psychosis. While there’s no guarantee that he would’ve responded, this is the kind of dire mental illness that calls for careful and vigorous treatment, not an unnecessary, fixed treatment, blinded clinical trial.

Carl Elliot, a bioethicist, has mounted a campaign to have this case investigated, so far without success. Most who hear the story or read the book, are horrified by what happened, but it has never become the expected cause célèbre in spite of a herculean effort by Carl and Dan’s friends and family. I have a speculation about why it hasn’t caught on, ignited the fire it deserves. My speculation is based on my own internal response to the case. I think Dan’s care was outrageous, and reaches to the heart of doing clinical trials for pharmaceutical marketing rather than to answer genuine scientific questions. I question whether the trial should’ve been done at all. In the case where it was done, I’m sure that Dan didn’t belong in it. And I can’t get around thinking that his being enrolled was to meet recruitment goals. Had he chosen to stop the medication [the outcome parameter], he faced "recommitment," something he didn’t want. His mother’s desperate attempts to withdraw him were ignored.

But I haven’t written much about it myself, at least as much as I would’ve expected given how I feel about it. I know he shouldn’t have been put into that study, We all know that. I think I’ve been inhibited because what I really think is that he should have been committed involuntarily for as long as it took to treat his severe psychosis. What I think is that in this case, antipsychotic medication should have been pursued vigorously in an effort to get his psychosis under control. What I think is that Benzodiazepines are often important adjuncts in such cases even with their addictive potential. What I think is this is the kind of case where considering the potentially toxic antipsychotic, Clozaril, with careful monitoring would be appropriate. And what I think is that Dan had a Disease. These are not popular things to say, and when I mention them, the comments often fill up with accusations and reminders of the psychiatric abuse of power, and I become the enemy to people whose views I often share. I felt a cringe even writing this paragraph. That probably shouldn’t bother me, but…

So I wonder if Carl Elliot has had difficulty engendering the kind of support he deserves and needs because this case stirs up such conflicted feelings in all of us, feelings that reach into the essential  core of ethics – as his title implies, fear and loathing in bioethics. Ethics are easy when they’re simplified and you’re carrying a banner of truth, justice, and the American way. But they become hard when one is filled with opposing forces and conflicting motivations as is often the case in clinical medicine. I genuinely believe what I said in the last paragraph is the ethical approach to a paranoid, potentially violent, psychotic patient like Dan. In many other psychotic patients, I think an environment with the least possible restraint and the conservative use of medications is the ethical approach. The ethic is determined by careful attention to the human being in front of us,  not by an ideology or some general treatment guideline or algorithm, certainly not by the marketing needs of a drug manufacturer. I’m absolutely sure that including a dangerously ill person needing a flexible vigorous treatment approach in a rigid, superfluous, blinded clinical trial is, by definition, unethical and deserves the most thorough investigation.

I wrote this on receiving an email from a colleague who recently heard Carl speak at the University of Toronto. He was sending it around to drum up support for Carl. When I got it, I wondered why I wasn’t already doing more. The above is what I came up with in reflecting on things. When it’s all said and done, all of the campaigns and activism focused on psychiatry right now are about the same thing – attempts to free us from any considerations or interests that detract from the best individual care of patients that we can muster. I urge you to consider supporting Carl Elliot’s efforts no matter where your opinions fall. He’s going after the rightest of causes…

The Minneapolis Fed and the University of Minnesota

A slightly edited comment on MinnPost:

Quite a complicated story that would make a good CP Snow novel

SUBMITTED BY BILL GLEASON ON NOVEMBER 20, 2013 - 9:34PM.


Some fairly high on the totem pole economists have declared Kocherlakota a hero for having realized his past mistakes and embracing Quantitative Easing enthusiastically.

Others criticize him for frog-marching some dissenting researchers out of the Fed.

The day before this hit the Star-Tribune (Shakeup at the Minneapolis Fed ousts two top economists), the St. Louis economist Steven Williamson had a piece on his blog entitled:

Problems in the Great White North


Williamson is quoted extensively in the Strib piece, but there is additional information in the blog post.

What really caught my eye were the comments on this post, e.g.

"Yes, in the old days there were tremendous rapport between the bank and the University. But the bank has taken over the University since then. Graduate students, who survive with teaching assisantships, have to teach for the professors while the latter can hide themselves at the bank."

"While I am an admirer of both Narayana and the people at the bank, I do think that the Fed has turned into a net negative for the University. If you walk down the halls of the economics department, you seldom see the macro faculty who are being paid hundreds of thousands per year to teach at the U. The teaching of undergraduates is a disgrace to the institution. The faculty seem to think they are above the normal university duties of teaching e.g. a many hundred person undergraduate course is typically staffed by a graduate student. The typical undergraduate never sees a faculty member in a course. Also, faculty are seldom available for graduate students that are not at the Fed. While it may be a loss to the Fed and the research community, one can only hope that the most prominent senior faculty at Minnesota will begin to take their university jobs seriously. It really can't get much worse than the current state of affairs."

"Agree completely."

"Can't agree more. 

I was just wondering will there be a problem if the Dean or even the State Congressman visit the department without notice during the semester and find out almost all macro faculty is not there."

Oouuccchhh!!

Bill Gleason, U of M faculty and alum

The Empire Strikes Back

More Markingson Stonewalling 

I have just received this email.

date:		Tue, Nov 19, 2013 at 10:44 AM
subject:		Important update on recent media coverage

Dear Medical School community,

Over the weekend, our local Fox affiliate ran a story taking yet another look at the case of Dan Markingson, a young man who participated in a clinical drug trial in 2003-2004 before committing suicide in May of 2004.

The story covered no new ground, and unfortunately the piece was full of inaccuracies and unsubstantiated claims. The University provided numerous documents to Fox outlining the facts of the case. These facts were ignored in the Fox report.

As we’ve reiterated in the past, Mr. Markingson’s case has been investigated many times, including reviews and assessments by:


The Food and Drug Administration


Hennepin County District Court


The Board of Medical Practice


The University and its General Counsel’s Office

None of these reports found a link between the clinical drug trial and Dan Markingson’s unfortunate death. None found fault with the University or our faculty. In recent years there have been calls to conduct additional investigations. The matter has been thoroughly investigated. Ten years later, it is time for closure, and time to move forward.

There are many regulatory processes in place at the University to ensure compliance with federal and state laws, to protect patient safety and ensure proper patient care. Beyond that, the University of Minnesota has a deep commitment to conducting high quality, ethical research.

In the area of psychiatric research, Dr. Stephen Olson and Dr. Charles Schultz are two of the nation’s leading experts, looking for new ways to help patients facing severe schizophrenia. This is a difficult illness and it has a high mortality rate, but our researchers are committed to finding new treatments that will save lives.

I remain proud of the work that we do to tackle some of the most difficult health issues and questions of our time. Thank you for your continued pursuit of discovery on behalf of the patients and families we serve.

Sincerely,
Aaron Friedman, M.D.
Dean of the Medical School

$$$

$$

$

KMSP Television Report on Markingson Case

A long habit of not thinking a thing wrong 

gives it a superficial appearance of being right. 

---Thomas Paine 

Television station KMSP broadcast a piece last night on the Markingson case. They've also posted the following story:

MINNEAPOLIS (KMSP) -A petition drive is under way, calling on Gov. Mark Dayton to order an investigation of the University of Minnesota. More than 3,000 people -- including some prominent medical professionals -- have signed it.

The issue? Possible research misconduct by the U's Department of Psychiatry, and Fox 9 Investigator Jeff Baillon looked into the tragic death that set the effort in motion.

Dan Markingson was Mary Weiss' only child, and she still holds onto the recording he left on her voicemail to feel his company -- the message he left a few days before his life came to a horrific end.

"Mary literally collapsed on the floor and just screamed, 'Oh no! Oh no!,'" family friend Mike Howard recalled.

Weiss believed her son had a rage burning within, and her instincts proved to be true. Just before Mother's Day in 2004, Markingson grabbed a box cutter and violently slashed into his chest and neck, nearly decapitating himself.

"He didn't pass away; he was killed," Weiss said in a documentary film. "They let him die, and they need to be held accountable."

Weiss recently suffered a stroke and didn't feel up to an on-camera interview with the Fox 9 Investigators, but she shared her story with filmmakers of "Off Label," who dedicated the film to her.

"Dan became ill, and I got him into Fairview Riverside Hospital," she said in the film.

In the documentary, she described her son's struggle with the onset of a mental illness.

"It was obvious he was deteriorating," she said.

She also explained that he was under a court order to follow the recommendations of his psychiatrist.

"It is an obvious conflict of interest," Weiss contends in the film.Weiss detailed how that psychiatrist was the same University of Minnesota doctor who was conducting a drug study for a pharmaceutical company that paid part of his salary.

"Dan had the choice of either going into the study or going into a mental hospital," she said. "He chose the study."

Markingson signed a consent form, but Weiss believes her son was not in a condition to understand what he was signing up for -- and his condition, she says, only got worse once he started taking the study drug he was assigned."We had tried for everyone to help us, but because Dan was of legal age, I had no way of getting him out of the study other than pleading with the doctors to let him out, which they would not," she said.

For months, Weiss sent letters -- one by certified mail -- and made phone calls to the university. Notes taken by the drug study coordinator show Weiss even left a message saying, "Do we have to wait until he kills himself or someone else before anyone does anything?"

"He was psychotic," Weiss said.

Three weeks later, Markingson's mutilated body was found in the bathroom of a group home.

"I think, at some point in time, the university needs to man-up and say, 'We are going to hold ourselves accountable," Howard said.

Howard has stood with Weiss during her nearly decade-long battle with the U of M. They found an ally in Carl Elliot, a bioethics professor at the U with doctorate degrees in both medicine and philosophy.

"I have never come across a case this egregious," Elliott said.

Elliott has written books on the drug industry.

"When the mother of a research study subject is calling you repeatedly, warning you that she thinks her son is going to commit suicide, you don't simply ignore her," Elliott said.

The University of Minnesota maintains its care of Markingson was appropriate -- that there's no causal link between the drug study and his suicide, and in fact, an investigation by the FDA found "no evidence of misconduct" on the U's part."It is a deeply flawed and incompetent inspection report," Elliott assessed.Elliott is critical of the FDA report, in part, because the inspector never interviewed Weiss.

"So, the only side she got were those from the U of M," Elliott explained.Weiss did file a lawsuit, but a judge dismissed the case on the grounds that, under state statute, the University was immune from being sued. The U turned around and filed a claim for Weiss to pay its $57,000 legal tab, but it dropped the claim after Weiss agreed not to appeal the judge's ruling.

Weiss did proceed with a malpractice suit against Markingson's psychiatrist, Steven Olson -- also the lead investigator of the drug trial. It was settled out of court, and the University would not allow the Fox 9 Investigators to interview Olson.

"I think they're hiding things that were done fraudulently, things that were done sloppily, and they're trying to cover up," Howard said.

Howard points to a report that came out last November as ammunition. The state board of social work issued an "agreement for corrective action" with Jean Kenney, a social worker who was the coordinator of the drug study Markingson was in after the board found Kenney had dispensed medications without a license, signed off on medical charts using the initials of Markingson's psychiatrist and failed to adequately address family concerns that Markingson was in danger of killing himself.

"If you see these things going wrong with the study coordinator, wouldn't you want to step back and say, 'Who was watching her?'" Elliott asked. "'Who was telling her to do these things?'"

Kenney told the Fox 9 Investigators she didn't do anything that was wrong or against the law, and said Weiss was "very controlling" of Markingson's situation.

"You don't just kick someone out of a study because the mother wants it to happen," Kenney said.

Kenney said Markingson "was doing well," but added "the guy had pretty many stressors going on. Mom was very much interfering with things."

Additionally, Kenney said the fact that Markingson committed suicide near Mother's Day "was a really strong message."

"I went to the hospital -- the emergency room -- with symptoms of a mental illness," another study subject who asked that his face and voice be disguised told the Fox 9 Investigators.

This man was recruited for another study the U of M was paid to run for a pharmaceutical company.

"I don't think I was competent to be making that decision," he said. "I wasn't on any medication at all and I was experiencing really bad symptoms of mental illness."

The study subject explained that he signed up because he felt if he didn't, he wouldn't get out of Riverside Hospital.

"You know, when you're locked up in a place, you're very scared and you're willing to do whatever anyone basically suggests," he said.

So, he was put on an experimental drug for schizophrenia that was seeking FDA approval. He said the medication gave him severe headaches, blurred vision and abdominal pain -- so much pain that he admits he thought of committing suicide.

Three months into the study, he called an ambulance to take him back to Riverside Hospital.

"Instead of telling me to immediately stop taking the medication, they told me to cut the pills in half with a butter knife and continue taking them," he recalled.The principal investigator of that drug trial was Dr. Stephen Olson. Via e-mail, he told the Fox 9 Investigators that the patient did not report severe headaches or blurred vision to him. Olson also said he did not tell the man to cut the study medication in half.

Eventually, the man dropped out of the study and went elsewhere to get help."I'm doing a lot better since then," he said.

The development of the test drug he was on was later terminated. It never did get FDA approval. This is the kind of case that troubles Elliott.

"Are there other subjects that are being put in danger?" he asked.

Elliott writes a blog about the Markingson suicide and research ethics. He's been very critical of the university and wants an outside investigation. He's angered many -- including his boss, the medical school Dean, who wrote a scathing op-ed in the newspaper.

"You've been knowingly putting out inaccurate information," the op-ed reads in part. "You're selective and distorted in your narrative about the case. This is a tragedy, not a scandal."

Yet, Elliott disagrees.

"It's a tragedy and a scandal," he said.

Tensions on campus are high. Elliott has moved out of his office in the Academic Health Center, saying "it's gotten uncomfortable."

"It's unpleasant," said Leigh Turner, PhD and professor of bioethics. "There's not much conversation. People are not getting along very well in here."

Turner supports Elliott's call for an investigation.

"I'm in full agreement with his critique," Turner said. "I think this is a major scandal for the University of Minnesota."

Internal university e-mails obtained by the Fox 9 Investigators through the state's open records law show how contentious things are. In March, a writer from "Scientific American" contacted the school for a piece she was doing about the Markingson case.

"I became more and more appalled at errors and breaches in normal research conduct," writer Dr. Judy Stone, MD, said.

The university's senior director of communications sent out an internal message that read in part, "I looked her up and can't tell if she's a wacko or not…. I get nervous about anyone who would pay any attention to Carl."

"I was shocked that the university response to my inquiry was that I'm a wacko," Stone said.

Stone spent 24 years conducting clinical trials and even wrote a book about it. She said she started her reporting on Markingson with no interest on one side or the other, and she has never met Elliott.

"They won't talk to me and have told other faculty also not to talk to me," she said.

In October, a group of nearly 200 scholars from outside Minnesota sent a letter to the U of M Faculty Senate, urging them to request a public inquiry of the Markingson case.

"This is really a case that appears troubling to many specialists in the field," said Trudo Lemmens, with the University of Toronto.

The Fox 9 Investigators also asked the university for an interview. This was the response:

"We're not going to go on the record talking about this. To reiterate, this story is a decade old. We've told this story over and over again in the media, and there is nothing new."

Weiss is now fighting to regain her health after suffering two strokes, but there's a small pouch she wears around her neck which carries some of her son's ashes. Howard says the last 9 years have taken a tremendous toll on his good friend, but she's still determined to see someone be held accountable for her son's death -- and so is Elliott.