Saturday, May 28, 2011

Fairview Layoffs

Did new children's hospital at U of M 

have anything to do with this?


The Minneapolis-based Fairview health system is eliminating 240 jobs because of weak demand for inpatient hospital services.

"We need to reduce our workforce to match the demand for health care services right now, especially on our inpatient side," Davenport [Fairview spokesman] said. "Inpatient volumes have been soft and lower than expected." 

First-quarter revenue was up compared with 2010, but expenses grew even faster with the move into Fairview's new pediatric medical center on the west bank of the University of Minnesota. But one-time expenses for the move as well as a new electronic medical-record system aren't driving the job cuts, Davenport said. 

Last year, Minneapolis-based Children's Hospital & Clinics and Robbinsdale-based North  Memorial announced job cuts. Children's in particular noted a decline in demand for hospital services during 2010. 
Fairview/UofM has recently opened an unnecessary children's hospital at a cost of one million dollars [sic] per bed. In the end this is one of the reasons that health care costs go up. This new hospital is a result of the U of M and Children's hospital not being able to cooperate in cost containment. 


Friday, May 27, 2011

Latest from the University of Minnesota Medical School

All the News That's Fit to Manage?

Very sad example set by the Medical School Dean, Aaron Friedman, MD.

From a blanket email I've just received:

The Med School was featured in a Star Tribune story about the school’s finances. Dean Aaron Friedman, Wes Miller, Medicine, Patrick Schlievert, Microbiology, and Pete Mitsch, Admin, were featured in the story. Read Dean Friedman’s response.
Dishonest and shameful.  Why was the Star-Tribune's response not cited?

Dean Friedman's response is totally bogus and dishonest.

For the Star-Tribune's response to his charges of inaccuracy, please see:

From that document:

The Star Tribune has reviewed your May 5 letter to university colleagues regarding our May 1 news story about the Medical School. We stand behind the accuracy and fairness of that story and we take exception with your misrepresentation of our work. We ask that you set the record straight and remove your letter from any forum at the university and from any public website.
In your letter, you make six accusations that our story made "implications or judgments that are simply wrong and lead to unfair conclusions." Below we respond to each of your six points.
In closing, we want you to know that the Star Tribune often runs corrections. But in this case, we didn't see the need for one. We offer to meet with you to discuss your views of our story. The article was based solely on public documents and interviews with named university officials. Thank you, in advance, for your consideration of this request.

Dr. Friedman, I am very disappointed in you. This kind of behavior is not worthy of the leader of a once proud medical school.  Perhaps you should start by taking your own advice?

"I believe it's critically important that we speak up when statements are made that are unfair or simply wrong, and I also know that our community stands up for what's right. It's what we expect of the students we are sending off into the professions this month, and it's what we should expect of each other."
 If you expect high standards of our students with respect to statements that are unfair or simply wrong, then I believe that you should set a good example yourself in this matter.  Please apologize and withdraw your offensive statement as it dishonors us all.

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.


William B. Gleason

Medical school faculty member and University of Minnesota alumnus

 The Markingson Case at 

the University of  Minnesota

Follow the Money

See: And the Angels wept...  Letter of Dan's mother, Mary Weiss, to University of Minnesota  Research VP

One of the biggest oversights a health writer can make is to cover a scientific study and not talk about its funders.

Funding with strings attached can affect a study’s outcomes. In 2003, a study in the British Medical Journal found that “Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors.”
In October 2009, AstraZeneca agreed to pay $520 million to settle federal investigations and whistle-blower lawsuits over the company’s marketing practices for the antipsychotic drug Seroquel, including allegations that the company had manipulated research data for marketing purposes. As the New York Times wrote at the time, “Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.”

An after-market clinical trial for Seroquel, called the CAFE study, was conducted at the University of Minnesota to prove that Seroquel was better than its competitors, and one of the trial participants, Dan Markingson, killed himself during the trial.
In the late 1990s, a multi-center clinical trial, known as Study 15, failed to show that Seroquel was better than Haldol, or haloperidol, an older antipsychotic that has been on the market since the 1960s. By some measures, Seroquel performed worse than Haldol. Making matters worse, the study showed that Seroquel boosted the risk of weight gain and diabetes. Internal correspondence repeatedly referred to Study 15 as a “failed study,” and company officials discussed ways to spin it or bury it.

In the Seroquel Strategic Plan 1997-2001, the company wrote on Page 17, “With the failure of Study 15, the Strategy Team reevaluated the Phase TUB program and determined that the level of risk had to be reduced, as failure of another large scale trial, eg treatment resistance, would result in significant damage to the brand's market perception if there weren't other trials successfully completed in parallel.”
In November 1997, an AstraZeneca physician wrote an email to a researcher explaining why the company could not fund his study. “R and D is no longer responsible for Seroquel research,” he wrote. “That’s the responsibility of sales and marketing.”  He also noted that funding would be more likely if the study could show a “competitive advantage for Seroquel.”

In a May 1999 email, John Tumas, an AstraZeneca publications manager, wrote that he was worried that the company was “cherry-picking data.”

“We’ve buried trials 15, 31 and 56, and now we’re considering CoStar,” he wrote. “How are we going to face the outside world when they criticize us for suppressing data?”

Apparently looking for new ways to highlight the benefits of Seroquel, the company’s Commercial Support Team performed a meta-analysis of a number of other studies. This meta-analysis did not raise Seroquel’s status over Haldol. 

Instead, the team’s technical document from March 2000 concluded, “In terms of generating positive claims for Seroquel these analyses seem to be somewhat disappointing.”

This analysis came at a very bad time for AstraZeneca. Dr. Charles Schulz at the University of Minnesota was working with the company on preparing a presentation on Seroquel data for the American Psychiatric Association (APA) annual conference in Chicago less than two months later.

 In an email from March 2000, Tumas wrote:

The data don’t look good. I don’t know how we can get a paper out of this. My guess is that we all (including Schulz) saw the good stuff, ie the meta analyses of responder rates that showed we were superior to placebo and haloperidol, and then thought that further analyses would be supportive and a paper was in order. What seems to be the case is that we were highlighting only the good stuff and that our own analysis support the ‘view out there’ that we are less effective than haloperidol and our competitors. Once you get a chance to digest this, let’s get together (or teleconference) and discuss where to go from here. We need to do this quickly, because Schulz needs to get a draft ready for APA and he needs any additional analyses we can give him well before then.

Schulz must have received the data he needed, because he presented a summary of the AstraZeneca data as a poster at the May conference, claiming that Seroquel was “significantly superior” to Haldol.

Documents filed as part of the lawsuits against AstraZeneca suggest that AstraZeneca was hoping to market Seroquel, possibly, off-label, to “first-episode” subjects such as those that the CAFE study enrolled. This group would have included Dan Markingson.

The Seroquel Strategy Summary from 2000 said that the company should establish “Seroquel as atypical of choice in first-episode patients – this has a halo effect as these patients are particularly sensitive to EPS and weight gain.It also listed as an objective broadening “Seroquel use on and off-label. Utilise whole selling team, educational programs to share off-label data.”

In 2007, the American Journal of Psychiatry published the results of the CAFE study, which were positive for Seroquel.

The authors claimed that the CAFE study showed Seroquel to be of “comparable effectiveness” for first-episode patients in comparison to Zyprexa and Risperdal.

Among the 18 “serious adverse events” recorded for the 400 subjects in the study were five suicide attempts, including two completed suicides, both by patients taking Seroquel. One of them was Markingson, although the paper did not name him.

According to the study authors, the suicides occurred “despite the close attention provided in clinical research aftercare programs.”
And the angels wept... 

Sick, just sick...


Are Layoffs at Fairview/University of Minnesota

Completely Unrelated to

Children's Hospital Wars?

 Fairview Health Services said Thursday that it will lay off about 70 workers over the next month.

An additional 170 positions at the Minneapolis-based system of hospitals and clinics either won't get filled or will go dark through attrition, Fairview spokesman Ryan Davenport said.
Fairview made significant investments in its electronic medical records system and in opening the University of Minnesota Amplatz Children's Hospital, but the job losses aren't related to those expected expenses, Davenport said.
According to documents filed with a municipal bond regulatory group, Fairview posted an operating loss of $3.4 million in the three months that ended March 31, compared with a $29 million operating profit in the same period last year.
So what are the expenses in this P/L for the new children's hospital? 

My comment on the Strib web-site:

I cannot let this matter pass without pointing out that Fairview/UofM has recently opened an unnecessary children's hospital at a cost of one million dollars [sic] per bed. In the end this is one of the reasons that health care costs go up. This new hospital is a result of the U of M and Children's hospital not being able to cooperate in cost containment. See "Children as Pawns in the Latest Expensive Healthcare Competition."


Thursday, May 26, 2011

University of Minnesota Medical School 

Dean Aaron Friedman:

Driven to Dissemble?

"I remain deeply concerned that words used in the article imply a situation that's simply not grounded in fact. "
University of Minnesota Medical School Dean Aaron Friedman

Last week, nearly 200 University of Minnesota and community leaders celebrated the groundbreaking for the Cancer/Cardiovascular Research Building, the latest in the university's Biomedical Discovery District.
The event recognized both the legacy and future of our health sciences. It also allowed for reflection on the public and private support that makes our continued success a reality. In April, the new Amplatz Children's Hospital opened its doors.

This month, 1,000 health sciences graduates will be launched into service and practice. These events depict the real story of the university's Medical School. They stand in stark contrast to a Star Tribune article that raised questions about the Medical School's finances ("Money crunch wounds U Medical School,'' May 1). 

I remain deeply concerned that words used in the article imply a situation that's simply not grounded in fact. The university's health sciences represent a $1.44 billion enterprise. Yes, we were affected by the Great Recession.
See the point by point analysis by the Star-Tribune of Friedman's earlier attempt to sweep problems under the rug:


And yes, 15 percent of our budget represents state funding, and promised cuts will lead to another round of difficult decisions for all of us. But we've made the tough decisions necessary to ensure financial stability. Minnesotans have high expectations for our university.

I want to ensure all of them that the Medical School remains on solid financial footing and is positioned to continue its 160-year tradition of educating physicians for our families and communities.


The writer is vice president for health sciences and dean of the University of Minnesota Medical School.

The Markingson Case:

You can run but you can't hide 

at the University of Minnesota

"Faculty members’ rights to study, re-analyze, and publish controversial scholarly materials cannot be abridged," says the report from the UCSD Committee on Academic Freedom. "These rights to academic freedom cannot be administratively revoked to prevent possible future breaching of professional norms. In our view, the campus administration’s fundamental responsibility is precisely to protect the right of faculty members to research and publish scholarly work even when others, on or off campus, find the work or its conclusions controversial or objectionable."

The report goes on to call on the administration "to promptly and publicly accept responsibility for serious errors of judgment in this case" and "to take concrete steps to prevent future violations of academic freedom rights, such as training for all administrators and their staff on these rights, which lie at the very heart of the university."

The dispute at UCSD comes as a controversy with some similar overtones has alarmed some faculty members at the University of Minnesota-Twin Cities. In both cases, administrators have raised questions about faculty critiques of colleagues.

Aftermath in Minnesota

While the nature of the scholarly dispute at UCSD is unclear, that's not the case at Minnesota. There, the question of faculty criticism arose after bioethicists and other professors asked the Board of Regents for an independent review of a death in a clinical trial at the university. The board rejected the request.
Subsequently, Mark Rotenberg, general counsel of the university, posed a series of questions to a faculty committee, including this one: "What is the faculty's collective role in addressing factually incorrect attacks on particular [University of Minnesota] faculty research activities?"

Rotenberg has argued that the question is legitimate, and protects researchers at the university from having their credibility unfairly undermined. And he has denied trying to punish those who have raised questions about the clinical trial.

Many faculty members at the university haven't been reassured, and see the question about "factually incorrect attacks" as an administrator's attempt to declare certain subjects off limits for faculty critiques of colleagues. Some faculty leaders, however, have said that Rotenberg's role has been mischaracterized and that the discussions have not amounted to any effort to limit academic freedom.

In both Minnesota and California, administrators have said that they are in some ways protecting faculty members from unfair or unreasonable criticism from colleagues. 

Those who are upset about the administrators' involvement say that they aren't opposed to civility, just the way it is being promoted.

Nelson of the AAUP said that "I'm a great believer in civility" and that everyone on campus can be a role model in promoting it. But he said that "faculty themselves" need to sort through any problems -- and that research disputes are best left for the market place of ideas to work out.

What if a faculty member complains about a colleague? Nelson said the answer is simple: "The dean should say, 'According to my records, you are both grown-ups and can handle this problem yourselves.'"

Wednesday, May 25, 2011

The Shame of the University of Minnesota..

The Markingson Files: 

Can pressure to recruit patients subvert a clinical trial?

Universities and research organizations set up institutional review boards to make sure research that involves human subjects is safe, among other things.
In the case of the CAFE Study, which measured the benefits of the AstraZeneca drug Seroquel against its competitors, bioethicist and writer Carl Elliott, a University of Minnesota professor, has suggested that one of the trial participants, Dan Markingson, was urged to sign up for the trial, even though his mental illness may have precluded him from making a fully informed consent.
Through the documents referenced below, most of which were filed as part of a lawsuit by Markingson’s mom against the University of Minnesota, you can see how Elliott pieced together a picture of how a research team desperate for patients helped create a pipeline for clinical trial participants by setting up a psychiatric ward.
In an undated letter to CAFE study coordinators, Jeffrey Lieberman of the University of North Carolina, wrote that the study is “behind schedule on enrollment.”
This fact was acknowledged in a September 2002 email from Jean Kenney, the social worker who was coordinating the CAFE study at its Minnesota location. Kenney wrote to Quintiles, the clinical research organization, saying that her team was “definitely struggling to get patients” three months after she had started leading the efforts.
Struggling so hard, apparently, that the University of Minnesota site was put on probation for lack of recruitment.  Kenney mentioned that the study was “on hold/probation” in an email from September 2002. She wrote that she hoped “we can get CAFE up and running again.”
Dr. Charles Schulz, who helped lead the clinical trial at the University of Minnesota, elaborated on this in a deposition for the lawsuit. He said, “My understanding was that Quintiles felt, or indicated that it is expensive to run multiple sites, and that if a site is unable to enter subjects in the study, then what they would prefer to do is work with sites that can.”
In late January 2003, Kenney was still worried about recruitment.  She wrote in an email, “So, some frustration here because we really need to get more enrollees.  We’ve had none for January and that really concerns me.”
She then mentioned that the Department of Psychiatry was planning to open a specialty psychosis inpatient unit in April 2003, which would work as a recruitment vehicle.
She was right.
In a brief prepared for an August 2003 teleconference about the CAFE study, the University of Minnesota team described the establishment of a specialized 16-bed psychosis unit, known as Station 12, which would recruit subjects for the study.  The brief says, “All patients are reviewed for possible research candidacy.  Research staff are in contact with nurses, case managers, and attending psychiatrists daily…  Research staff attend morning report before inpatient rounds take place.  The focus is to identify any possible subjects that may be eligible for studies.”
This focus on recruitment turned things around for the trial.
“One-third of the U's patients for CAFE came from this unit,” wrote Paul Tosto and Jeremy Olson in the St. Paul Pioneer-Press. “By mid-2003, CAFE leaders were praising Olson and his recruiter, Jeannie Kenney, and asking them to share recruiting tips.”
In an email from October 2003, Kenney mentioned the uptick in recruitment.
And, later that month, Dr. Stephen Olson, Markingson’s treating physician and the other lead research for the CAFE study was featured in a webcast for “turning an underperforming site into a well-performing site.”
How many of these recruits – who were supposed to be people experiencing their first schizophrenic episode – were able to fully consent for themselves? And were they, like Markingson, under orders to stay in the trial?
When Markingson was discharged from Fairview Hospital in December 2003, where he had been involuntarily committed, he was told in the discharge documents that if he had to follow the treatment plan, meaning the clinical trial, and that “consequences for not following this plan could result in court commitment to the hospital.”
Another question raised by Elliott is why a clinical trial like this one would have allowed for a patient who was threatening violence. Most studies of antipsychotic drugs exclude subjects who are dangerous to themselves or others. Markingson had told multiple people that he was being ordered by a Satan-worshipping cult to kill people.
Had he talked about suicide – instead of homicide – he likely would have been excluded. The CAFE Study protocol lists among its exclusion criteria subjects at risk of suicide, not subjects who were a danger to others.
This brings us to one of the oddest facts Elliott unearthed.
The director of the University of Minnesota’s IRB overseeing the CAFE Study explained in her deposition that it was not the job of the IRB to protect research subjects. This seems to run counter to the stated purpose of IRBs everywhere, including the University of Minnesota, which states quite clearly on its website (boldface added):
The IRB reviews research projects which involve human subjects to ensure that two broad standards are upheld: first, that subjects are not placed at undue risk; second, that they give uncoerced, informed consent to their participation….The IRB works with investigators to modify projects to ensure adequate protection for its subjects' welfare and right of self-determination. The University's process for protecting human research subjects reflects federal regulations developed in response to such cases as the Public Health Service syphilis study and the U.S. government radiation experiments.
Yet Moira Keane was asked in a sworn deposition, “So it’s not the Institutional Review Board’s purpose to protect clinical trial subjects, is that what you’re saying?”
Her response? “That’s true.”


Wednesday, May 18, 2011

From Fear and Loathing in Bioethics:

The Strib Strikes Back

[Emphasis mine]

On May 1, the Minneapolis Star Tribune published a blistering article about financial mismanagement at the University of Minnesota Medical School, subtitled,"Financial perils follow years of big payouts in pursuit of faculty stars." 
Shortly thereafter, Dr. Aaron Friedman, VP for the Academic Health Center and Dean of Medicine, sent out an email to faculty members, charging that the article was inaccurate and unfair.  Friedman detailed the points he believed were inaccurate and ended by saying, "I believe it's critically important that we speak up when statements are made that are unfair or simply wrong, and I also know that our community stands up for what's right."

Now the Strib has responded to each of his points in detail.  Have a look and judge for yourself.  The response can be found here.

 My view: Dean Friedman should be ashamed of himself. 


Tuesday, May 17, 2011

Star-Tribune Calls Out

University of Minnesota Medical School Dean

On His Response to Star-Tribune Article

[downloadable pdf]

I've posted previously on this matter.  Please see:

May 10, 2011

Aaron Friedman, M.D.
Professor of Pediatrics
Vice President for Health Sciences
Dean of the Medical School
University of Minnesota

Dear Dean Friedman:

The Star Tribune has reviewed your May 5 letter to university colleagues regarding our May 1 news story about the Medical School. We stand behind the accuracy and fairness of that story and we take exception with your misrepresentation of our work. We ask that you set the record straight and remove your letter from any forum at the university and from any public website.

In your letter, you make six accusations that our story made "implications or judgments that are simply wrong and lead to unfair conclusions." Below we respond to each of your six points.

1. You state that we are wrong in reporting that there is no national search in the works right now for a new head of the Department of Medicine because money is too tight.

On the contrary, Medical School Chief Financial Officer Pete Mitsch said in a voice-recorded interview in his office April 15 that a search for a new chairman of the Department of Medicine was started in 2009, but cancelled because the Med School didn't have money to recruit someone to a position of that caliber.

"One of the things you probably read in the financial plan, we are going to have to hire a new Department of Medicine," Mitsch said. "Hiring a head of medicine is a huge issue... We had actually started a search in 2009 and we canceled it because we just didn't have the resources to put on the table to bring in a new head of medicine."

Question: "To recruit and land someone?"
Answer: "Right. That's one of the things as we look forward that we're still trhyng to figure out how we can do that."

Dean, for your information, the CFO complimented Wes Miller, saying the school was lucky to have a "very capable" insider who "agreed to step into that role for three years." The story reflected Miller's important contributions to fixing the financial problem inside his department.

2) You misstate what our story says about federal research funding and ignore a very favorable reference to recent research funding achieved by the Department of Medicine.

The story accurately states your own CFO's calculation that the availability of federal research funding declined in the time period when the Medical School went on its hiring spree. This factor was cited in the story out of fairness to the U as an example of external factors out of the U's control that contributed to the financial crunch. This information came directly from Pete Mitsch.

"The federal budget for research had flattened out and actually was starting to decrease, so all medical schools that are research intensive were running into the same problem of: You've got all of these researchers who have their salaries supported and the pace is occupied by them, et cetera, and that stream of revenue is not increasing certainly. It's starting to go down."

He also said,"We had a squeeze on our research funding."

He also said, "Right about then the federal government started decreasing the amount of research funding that was available and the market for hospitals tightened up. So anyway, the help that we were looking for to hire some of these people didn't materialize.  We brought people in and didn't have the revenue increase that you'd need to support all those new people and so we had to start scaling back a little bit."

Later, again in fairness to the university, our story notes the 30 percent increase in research funding from the National Institutes of Health won by individuals in the Department of Medicine under Wes Miller.

3) You assert that there was no "internal loan."

The Star Tribune had no independent knowledge that the Medical School borrowed funds to cover deficits until CFO Mitsch said so in the April 15 interview in his office. In the voice-recorded interview he used the word "loan" five times to describe the transaction.  Here are some of his descriptions:

"We took an internal loan from the big university of about $16 million...that we are still paying back."

"When we borrowed $16 million from the Big U... it was essentially for six departments and the Dean's Office."

"This was an internal loan to help us cover some deficits.  We are in the second year of our payback."

Mitsch said the payback started in fiscal year 2010 and is being repaid, interest free, at $2 million a year. He later clarified and said that the annual payment was closer to $2.3 million.

Mitsch isn't the only Medical School official to have described the transaction as a loan. Former Dean and AHC Leader Frank Cerra wrote in November 2008 that the Medical school had to cover deficits with an "interest-free loan from the University" to be paid off over seven years.

4.) You take issue with the word "withering" to describe the $10 million structural deficit described in the Medical School's financial plan, published one year ago.

"Withering" is the word we chose to describe a "recurring" deficit of this size. "Recurring" is not our word -- it was chosen one year ago by the Medical School to describe the structural imbalance, or deficit, that was draining the school's finances. The danger of this recurring deficit was described in the financial plan and repeated in the story to bolster our sue of the word, "withering."

"This situation is not sustainable," the report said, "Without aggressive programmatic changes and more careful financial planning the Medical School will be unable to invest in its most important activities or to develop new programs and initiatives."

5) Your opinion doesn't refute or clash with the story.

6) Your opinion that the story involved "second guessing" is not shared by us.

In closing, we want you to know that the Star Tribune often runs corrections. But in this case, we didn't see the need for one. We offer to meet with you to discuss your views of our story. The article was based solely on public documents and interviews with named university officials. Thank you, in advance, for your consideration of this request.


Nancy C. Barnes, Editor and Senior Vice President

Tony Kennedy, News Reporter


Dear Dean Friedman:

"I believe it's critically important that we speak up when statements are made that are unfair or simply wrong, and I also know that our community stands up for what's right. It's what we expect of the students we are sending off into the professions this month, and it's what we should expect of each other."
 If you expect high standards of our students with respect to statements that are unfair or simply wrong, then I believe that you should set a good example yourself in this matter.  Please apologize and withdraw your offensive statement as it dishonors us all.

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.


William B. Gleason

Medical school faculty member and University of Minnesota alumnus


University of Minnesota Dental School Dean

to leave for Ohio State

Patrick Lloyd called his time as dean of the University of Minnesota’s School of Dentistry an “opportunity of a lifetime.”

But after more than seven years in the post, he’s moving on: same job, new state.
Lloyd was named the dean of Ohio State University’s College of Dentistry, the University of Minnesota announced Wednesday. Lloyd will remain at the University until Aug. 1.


Monday, May 16, 2011

Another Recital of the Continuing Disgrace

That is the Markingson Case

at the University of Minnesota 

William Heisel's Antidote: Investigating Untold Health Stories (USC Annenberg School)

[Emphasis mine]
Researchers in any clinical trial want to make sure participants have not been coerced in any way and that they are competent to make the choice to enter the trial. This is standard throughout academia, and most institutional review boards will not approve a project if clinical trial participants are not able to fully understand the risks and potential benefits of the trial and then make the choice to enroll.

This is what has vexed friends and family members of Dan Markingson, who was diagnosed with severe psychiatric disorders and then entered the CAFÉ study. Designed by AstraZeneca and researchers at the University of Minnesota, the study tested the efficacy of the antipsychotic drug Seroquel against its competitors. Markingson ended up killing himself in a brutal fashion.
As Carl Elliott, a University of Minnesota bioethicist and health writer, detailed in Mother Jones how, in the days leading up to Markingson’s enrollment, everyone who examined him said he could not make his own medical decisions. Because of his psychosis, he repeatedly was judged incompetent.  But on the day he was asked to consent to the clinical trial, he was judged competent.
The documents behind this period in the Markingson story raise serious questions not only about Markingson’s competence but about how patients with mental disorders are judged competent in clinical trials all over the world. The documents were filed as part of a lawsuit against the University of Minnesota by Markingson’s mother. Elliott, at Antidote’s request, has posted them online and I will be linking to them in future posts.
On November 14, 2003, Dr. Stephen Olson from the University of Minnesota signed an “Examiner’s Statement,” which is used when committing someone to inpatient psychiatric treatment. The statement says that Markingson believed “he was involved in a Satanic cult that would meet in Duluth soon. He had been chosen to be ‘the One,’ and would be asked to kill others for the greater good. He has threatened to kill his mother.” At the end of the document, Olson recommended that Markingson be treated with neuroleptic (antipsychotic) medication, and he noted that Markingson lacked the capacity to make decisions regarding such treatment because he “does not believe has a mental illness.”
Three days later, on November 17, 2003 a screening team of health professionals also recommended involuntary commitment for Markingson. The team also noted in its report to the court as part of the process of committing him that Markingson had a plan to kill people and said that he thought Angelina Jolie was his sister. Just as Olson had done, the team said that he “did not believe that he had a mental illness.”
The court took Olson and the screening team seriously. On November 19, 2003, a court-appointed clinical psychologist, James L. Jacobson, filed an Examiner’s Report on Markingson. To the question, “Is there a substantial disorder of thought, mood, perception, orientation, memory?” Jacobson replied “Yes.”  Jacobson also noted that Markingson “is believed not to have the capacity to make decisions regarding neuroleptic medication.”
So what did this all add up to? Three different health professionals, including the doctor who had been treating Markingson, ruled that Markingson was not fit to make decisions about his own health, in part because he could not even recognize that he had a mental health problem.
Yet, on November 20, 2003, Olson changed course and asked the court to temporarily suspend the involuntary commitment of Markingson. The next day, Markingson enrolled in the CAFÉ study, of which Olson was one of the lead researchers. When Markingson was asked to give his consent, the CAFÉ study coordinator, a social worker named Jeanne Kenney, judged him competent to consent in her Evaluation to Sign Consent Form.
Elliott has written for the Bioethics Forum that Kenney should not have been allowed to make this call.
First, the final competence assessment was made not by an independent party, but by the study coordinator for the CAFÉ study, Jean Kenney, whose job it was to recruit subjects for the study. 
This is hardly an impartial, disinterested assessment.
Second, Kenney was a social worker, not a psychiatrist or psychologist trained to make competence assessments.
Third, even after Mr. Markingson had been judged competent to consent to the CAFÉ study, his involuntary commitment order was not lifted. This suggests that his mental state had not changed quite so dramatically.
And finally, one of the most persistent features of Markingson’s psychosis was a lack of insight into his condition. Markingson did not believe he had a mental illness. How could he be competent to consent to a study comparing treatments for his mental illness when he would not even acknowledge that he was mentally ill?
The University of Minnesota's official position is that the people involved in this case have been exonerated - whatever that means.  They also claim that it happened a long time ago and that too much money has already been spent on the matter to investigate further.

This entire episode is a disgrace to the medical school, the Academic Health Center, the University of Minnesota, and its Board of Regents. 

I am ashamed of my university's behavior in this matter.


Saturday, May 14, 2011

Persistent Misinformation On the Strib Comments Section

So What Else is New?

This poster should know better:

To the numerous posters who keep linking the money spent in the athletic department to the overall budget at the U, please inform yourself on the actual facts. The U's athletic department is internally funded from ticket revenue, Big Ten revenue sharing, and donations. The buyouts of coaches is paid for by the athletic department, not the U's operating budget. As for TCF Stadium, tuition isn't going to it one bit. Student government voted and approved without dissent to have a $25/year student fee for the stadium (when you use inflation, that is actually less than what the fee was when they had one for Memorial Stadium). The rest is paid for by state bonds and private donations and licensing money. So seriously, stop connecting a line between athletics and the academic budget when the two are not linked at all.
My response:

The athletic department at the U of M continues to receive annual multi-million dollar subsidies from the general fund of the University (the Operations & Maintenance fund). In fiscal year 2010 the subsidy was $8 million; in fiscal year 2011 the subsidy is $7.8 million. pp. 77 & 81 of the U of M budget for fiscal year 2011 (ending June 30, 2011) See:

For further information about University finances, please see: University Inc. Part II


Perhaps Now is the Time for Rethinking

Plans for MoreU Park?


On the Continuing MoreU Park Fiasco Is the University of Minnesota a Land Grant Institution?

Exactly how long is the UMore Park craziness going to continue?

My friend and fellow University of Minnesota alumnus, Michael McNabb, writes:

Recent discussions have confirmed concerns about the UMore Park development.  The gravel pit will be located on land that has been used for agricultural research that has produced hundreds of millions of dollars for the economy of Minnesota.  See the remarks of the professors from the College of Food, Agricultural & Natural Resources Sciences at the April 25, 2011 meeting of the faculty research committee at More On MoreU Park.
In July 2010 the Regents dismissed the concerns expressed by CFANS faculty members about the decision (already made) to transform UMore Park.  At that time the Regents were under the impression that the gravel pit would generate $3 million to $10 million in revenue per year.  That projection by senior administrators was wildly unrealistic.  See Section 1 of University Inc. Part II.
See UMore Park Craziness  for a partial list of the numerous consultants who have received part of the $9.3 million (and counting) that the administration has spent planning the development of UMore Park.  Note that there is not a single consultant from the fields of agriculture or veterinary medicine.  (The Vet School has an entire farm at UMorePark.)  It appears that the senior administrators and the Regents made the decision on UMore Park without consulting either the professors who were engaged in research on the land or any agricultural economists!
The decision of the administration on UMore Park fails to recognize the essential value of agricultural reserach for a land grant university:
“CFANS is a college devoted to solution-driven science; we use critical and innovative thinking plus all the tools of the arts and sciences to make our planet a productive, friendly, and sustainable environment--to solve everyday problems.  We study the health of the land and the health of the living.”
See the message from the Dean at on the University of Minnesota web site. 


 Will no one rid me of this meddlesome doctor?

Effort to Revisit a University of Minnesota  Study That Led to Man's Suicide

Ignites Debate Over Academic Freedom.

[Emphasis mine]
To the University of Minnesota's top lawyer, Mark Rotenberg, it was a reasonable question. To supporters of U bioethicist Carl Elliott, it was a veiled attempt to silence criticism.
Elliott's criticism of two Medical School professors has triggered an escalating debate in academic and legal circles. The latest flashpoint came when Rotenberg posed this question for faculty discussion:
"What is the faculty's collective role in addressing factually incorrect attacks on particular University faculty research activities?"
 Elliott said the question was unfair because it implied inaccuracies, and intimidating because it came from the office that manages the legal force of the university.
Rotenberg said he never intended to threaten Elliott or any faculty member -- and that he drew up the question only because faculty requested his input.
As the fracas grows in faculty committees and on legal blogs, it offers a rare look into the tensions behind academic freedom.
The debate stems from issues surrounding the 2004 death of Dan Markingson -- a mentally ill patient who committed suicide while enrolled in a U study of anti-psychotic drugs.
Elliott wrote a hard-hitting story in the September/October issue of Mother Jones magazine noting that Dr. Stephen C. Olson, an associate professor in the U's psychiatry department, placed Markingson in the study after he landed at Fairview-University Medical Center as a delusional patient who had threatened to kill his mother.
Elliott questioned financial ties between the drugmaker and the researchers. He reported that the department had been struggling to recruit subjects for the study, funded by AstraZeneca, the maker of Seroquel, one of the study drugs. Most studies of anti-psychotic drugs bar researchers from recruiting patients at risk of violence or suicide, Elliott wrote. "Conveniently, however, the [AstraZeneca] study only prohibited patients at risk of suicide, not homicide,'' the story said.
His story noted that the head of psychiatry at the U, Dr. Charles Schulz, had consulting ties to AstraZeneca and a leadership role in the study.
It also quoted four experts who criticized the study as flawed, shallow and driven by marketing purposes.
"It is one thing to ask people to take risks for science, or the common good, or to help other people,'' Elliott wrote. "It is another thing entirely to ask them to risk their lives for the marketing goals of AstraZeneca.''
The Legislature has since adopted "Dan's Law,'' banning patients under civil commitments from being able to consent to medical research without the recommendation of the treating psychiatrist -- who must not be the psychiatrist conducting the drug trial.
When the Board of Regents declined to reopen the Markingson case, it noted that several agencies, including the Food and Drug Administration and the state attorney general's office, found no wrongdoing. Board Chairman Clyde Allen wrote that "at this time, we do not believe further University resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies."
The FDA concluded that there was "no evidence of misconduct or significant violation of the protocol or regulations." The Minnesota Board of Medical Practice also cleared Olson and Schulz after reviewing allegations filed by Markingson's mother, Mary Weiss.
In February, the Faculty Consultative Committee asked Rotenberg to suggest questions for a discussion of issues raised by the Markingson case, e-mails show.
In his reply to the committee, Rotenberg proposed questions about the "risks and challenges posed by increasing reliance on corporate funding'' of university research, among other things. In fiscal 2010, business and industry sponsored $35.4 million in research spending at the U -- 5.4 percent of total research expenditures of $653.6 million.
'Factually incorrect attacks'
But it's his question about "factually incorrect attacks" that has gotten attention.
Rotenberg said that just as his prompt about corporate funding didn't imply that he opposes it, the question about faculty was open-ended. "It's very unreasonable and inaccurate to suggest that I have ever done anything to abridge or restrain Professor Elliott's exercise of freedom to criticize other faculty members," Rotenberg said.
Elliott said the question "tries to discredit my account of the study in which Dan Markingson died.''
Brian Leiter, a University of Chicago law professor and director of the Center for Law, Philosophy & Human Values, said Elliott's article was well within the bounds of fairness.
"He is an expert in this area,'' Leiter said. "It's not like some weird hoby of his.''
Rotenberg's question is out of sync with the moral obligation that universities have to foster and protect academic freedom, Leiter said. The general counsel's office should back faculty research into controversial matters, even when the inquiries allege university wrongdoing, he said.
'Cold climate' on campus?
Faculty leaders have tried to discuss Rotenberg's question broadly, rather than in the context of the Markingson case.
"The intent of the question has been misinterpreted," said Kathryn VandenBosch, chairwoman of the Faculty Consultative Committee. While the question's wording "could have used some editing'' because it speaks to an individual case, she said, it was meant to dig into a broader issue: "Whose responsibility is it to set the record straight?"
Last week the American Society for Bioethics and Humanities issued a statement noting that faculty discussion of Rotenberg's question has "given rise to the public perception that the University has attempted to squelch inquiry.'' Hilde Lindemann, a board member of the society, said the debate itself could create a cold climate for criticism of the university.
Prof. Karen Miksch, co-chairwoman of the U's Academic Freedom and Tenure Committee, said that since the group took up the question, "certainly we've been hearing some concerns" from faculty members worried about the general counsel's intent, she said.
"Myself, I'm always looking for ways for us to make sure we have a climate on campus where a variety of viewpoints can be expressed," she said. "So if people are feeling silenced, that in itself is worrisome."

I suggest that if the Board of Regents and the new president had any sense, they would see that independent inquiry was performed.  It should be obvious by now that ignoring the matter is not going to make it go away.