"Turn him to any cause of policy,
The Gordian Knot of it he will unloose,
Familiar as his garter"
Henry V, I-1 45-47
Background (Short Version)
Dan Markingson died by committing suicide in a clinical trial at the University of Minnesota approximately ten years ago. The university has steadfastly maintained that there was no wrongdoing, that the matter has been thoroughly investigated, and that whiners and complainers should please go away.
The University of Minnesota Faculty Senate last Thursday afternoon passed a resolution (by a vote of 67-23) that an outside investigation of clinical research at the university should be done.
Not coincidentally, a petition was delivered Thursday morning to the office of Minnesota Governor Dayton (endorsed by approximately 3500 people) that the Markingson situation should be investigated by an outside body.
For those wishing to read more, I suggest:
1. Send in the Wackos - my Community Voices post of two weeks ago
2. Jeremy Olson's excellent, fair, and balanced piece in the Star-Tribune: U faculty calls for investigative review of controversial drug study.
It should be noted that Jeremy Olson and Paul Tosto received the University of Minnesota Premack award for investigative journalism for their work in this area while both were at the Pioneer Press. This is an example of why I am such a fan of real journalists.
3. Susan Perry's excellent and fair summary on MinnPost: Faculty Senate votes for inquiry into U's clinical-trial practices
In summary: after years of trying to avoid an outside review of clinical trial practices at the University of Minnesota, the faculty stimulated administration has agreed to an outside review. This is definitely progress and something those of us who have been pushing for it are deeply gratified by. I checked Markingson on my blog, and note that I found 87 posts on it dating back to 2009. Others, especially Drs. Carl Elliot and Leigh Turner have far more time invested as has Mike Howard, Mary Weiss's friend.
At this point what will happen next remains a matter of conjecture. Technically this is in the hands of the President Eric Kahler. The governor may - or may not - respond to the petition since the president has agreed to an inquiry.
But apparently the university administration would like to restrict the investigation to present day cinical practices and would prefer not to go into the Markingson matter. Calling the proceedings the Markingson investigation induces bad vibrations in the administration.
There is also the usual question at the university of conflict of interest. Should someone who's possible negligence in stonewalling an earlier investigation be involved in both charging and selecting panelists for an inquiry?
I've made a suggestion for one panelist, Dr. Atul Gawande, a Harvard faculty member who is a surgeon, a McArthur foundation fellow and an author of several books that have been influential in the medical profession. As far as I know, he has taken no position on the Markingson matter. He is a down in the trenches doc, with both humanity and empathy. Truly the kind of doc we'd like our sons and daughers to be. For more information about Dr. Gawande please see his biography.
By an odd coincidence an extremely interesting interview of Gawande has been posted just today. See: Atul Gawande on the Secrets of a Puzzle-Filled Career (Medscape).
Now Dr. Gawande is a busy man. He very well might decline to participate for a variety of reasons. But he is the kind of man or woman we need. We should invite someone like him to head the outside investigation and allow him to pick anyone he likes to assist in this matter.
The Gordian Knot of the Markingson matter can be solved, crudely speaking, in two ways. One is the "Alexandrine solution."
But simply "give them an investigation of things as they are now" may solve the problem at one level, but will it will simply intensify questioning and even outrage at another. The time for stonewalling is over.
The alternative is to take the knot apart. Follow the unravelled rope from one end - the Markingson case - to the other end: clincal practices in the present. What was wrong - if anything - in the Markingson case? What has changed as a result of it - for example Dan's Law? And where do we stand now, has anything actually changed? Is there a difference between what is ethical and what is legal? Are we now following clinical practices in accord with the highest ethical standards not just the law?
"Profiles in courage" should not only be an exemplar for politicians. It is time for the University of Minnesota administration to step up to the plate and demonstrate some courage.
I'll write again as things develop. We all love our university. Some day I'd like to be #umnproud again.
U of M faculty and alum
KMSP-TV has been punching above its weight lately. First they did a story on the Markingson case that I commented on earlier on Community Voices. See: "Send in the Wackos..." Their latest effort in the Investigators series is quite good and thought provoking. Long time newsies will recognize the narrator for this piece, the excellent Trish Van Pilsum.
This new piece is titled "U Insider" where insider is being used in the same way that it is used in the phrase "insider trading." I'd encourage those interested to watch the video - link given above - or at the same location the case is outlined in text form. I've also put up most of the report on my blog The Periodic Table with highlighting of the very best parts...
So what's the short version? (source of all quotations)
1. A university employee was allegedly harrassed into taking a supervisor on an illegal mule deer hunt on a reservation in South Dakota. She was cited, admitted guilt, and paid a fine.
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.
"I really don't have any comment about something that happened off university property or off university time," Vice President of University Services Pam Wheelock told Fox 9.
Louden pleaded guilty to the two citations. Off campus? Sure -- but very much a universtiy 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.
Professor David Schultz, a nationally recognized expert on business ethics at Hamline University, had this to say:
That seems perfectly inappropriate. "This is using your position of authority for purposes of getting something from your subordinates that seems completely illegitimate."
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.
2. A University of Minnesota supervisor apparently rigged bids for a contractor friend.
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:
Unfortunately for that claim, e-mail records obtained by the KMPSP investigators revealed that:
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.
The university apparently dismissed a complaint that the bidding was organized to favor the bidding by the company Skyline owned by Loudon's friend Schalesky:
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.
So why would UofM supervisor Louden try to give Skyline/Schalesky the edge?
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.
But according to Professor Schulz:
"There is no such thing as a small favor."
3. Have "favors" been done by University of Minnesota employees at the Loudon residence?
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.
4. Complaints were made about unnecessary spending
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.
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.
So there you have it...
Nothing to see here, move along?
This situation certainly reminds me of the way the U of M has handled the Markingson case. But of course the death of a clinical trials patient is a much more serious matter.
But as an indicator of the institutional culture at the U, this case speaks volumes. The discrepancy between words and actions is obvious. Most of us can recognize why the situation described above is wrong and have witnessed similar behavior in our own lives. To the lay person the Markingson case may at first seem complicated and beyond comprehension, because who is to decide when doctors disagree?
This is but one more example of why an outside investigation of the Markingson case is necessary.
KMSP has recently called attention to the scandal and tragedy of the Markingson case in which a young man committed suicide while enrolled in a clinical trial at the University of Minnesota. The position of the university is that nothing wrong has been done by the U, the matter has been thoroughly investigated, nothing to see here. Move along.
If you have some time and have not already seen it, I'd urge readers to click the link above and have a look at the KMSP video.
Of course the university immediately tried to brush the matter off. As a recent post in MinnPost put it:
In a letter sent Tuesday to the U of M's medical community, Dr. Aaron Friedman, the dean of the university's medical school, said Baillon's report was "full of inaccuracies and unsubstantiated claims," although he did not detail them.
This is of course standard operating procedure by now at the U. What exactly were the inaccuracies and unsubstantiated claims? These blanket denials are insufficient given the evidence in the record.
One of the claims that the U has used many times is that sufficient investigation has already done that has exonerated the U of M. This claim has been demolished by Professor Trudo Lemmens, a faculty member in the law school at the University of Toronto. In an excellent summary Professor Lemmens has taken each of the proceedings the U claims has exonerated them and illustrates why this is not the case. I strongly recommend that anyone with an interest have a look at this summary on ScribD. (Unfortunately because of the way it is formatted and the length, it would be difficult to summarize here.)
I've posted before on the Markingson case at the University of Minnesota. See for example:
May 20, 2013: The Markingson Case: A Tragedy But Not A Scandal?
"It is critical for the University of Minnesota to regain its good name and to take steps to see that something like this never happens again.
To defend the behavior of the University in the Markingson case is a fool's errand."
June 5, 2013: Response to University of Minnesota President's Letter
I am perplexed as to how the president could make the claim that the actions of the University did not "in any way" contribute to the death of Mr. Markingson.
Even a small sampling of the events that occurred makes this claim very difficult to back up. The fact that the General Counsel at the University of Minnesota did an investigation means exactly nothing. He is the University's mouthpiece and the results of his supposed investigation were never made public.
So why is the University of Minnesota so afraid of an unbiased, outside, investigation? If it is true that the U has done nothing wrong, why not do it? The fact that a large number of people both inside and outside the University have asked that this be done is of no consequence? Many of these people are alums, faculty, and citizens of the state of Minnesota.
Send in the wackos...
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.
And for a supposed senior director of communications at the U to make the statement:
"I looked her up and can't tell if she's a wacko or not..."
is both outrageous and incompetent. It takes a simple Google search to discover that not only does Dr. Stone have experience in clinical trials, she has also written a highly regarded book on that topic that is rated at 4.8/5 stars on Amazon. I will not further embarrass the director of communications by quoting from the many laudatory reviews of this well regarded book on clinical trials.
So the other pernicious and disturbing aspect of this case is the implication that anyone who would pay attention to Carl Elliot is a wacko. This is outrageous.
So 3,413 people who signed a petition for an independent investigation of the matter are wackos? Including practicing psychiatrists, medical ethicists, medical journal editors, U of M alumni, and citizens of the state?
A link to the institutional affiliations of the 170 scholars may be found here. The qualifications of some of the petitioners may be found here. To dismiss the opinion of these people because they "pay attention to Carl" beggars belief.
As the highly regarded psychiatrist and psychoanalyst Dr. Mickey Nardo put it:
...the care [Markingson] got didn’t approximate his best shot – not even a good shot. He spent 6 months 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.
...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.
What EXACTLY is it going to take for my university to step forward, take responsibility, and see that things like this don't happen again?
I am not #umnproud. I am #umn ashamed, sorry to say.
William B. Gleason
University of Minnesota faculty and alum
[It isn't the wackos that are the problem here, it's the clowns.]
(AP Photo/The Star Tribune, Renee Jones Schneider)
For some background on this matter please see my earlier post on the petition to Governor Dayton calling for an independent investigation of the suicide of Dan Markingson.
Since that time more than 2500 people have signed the petition including citizens of Minnesota, and students, faculty, and alumni of the University of MInnesota.
Also among the signers are three former editors of the highly regarded New England Journal of Medicine; the editor of the Lancet - a highly respected British medical journal, a former editor of the British Medical Journal and the former health and disability commissioner of New Zealand as well as more than 200 experts in medical ethics and related disciplines. Others include a medical historian with expertise in the Guatemala syphilis studies, which resulted in an apology by President Obama in 2010, and one with expertise in the infamous Tuskegee experiments.
In his recent opinion piece on the Star-Tribune, Dean Friedman hypothesizes that "The University of Minnesota research case is not a scandal."
The first thing that pops up on the web for a definition of scandal is:
scandal (noun): An action or event regarded as morally or legally wrong and causing general public outratge.
synonyms: disgrace, shame
Based on the signatures, qualification, and comments of those calling for an independent investigation, I'd say that this situation qualifies eminently as a scandal.
The fact that the Dean starts his piece with this semantic argument indicates how weak his case really is.
But there is more...
Dr. Friedman states:
"The story may be familiar to some readers. For years, Elliot has focused his energy on this single issue. Yet as Elliot clamors for more examination, he seems to feel no responsibility to accurately report what has already been done."
a) Dr. Elliot has contributed greatly to our understanding of what I will delicately call the academic-medical-pharmaceutical complex using the Markingson case as well as many others to make major contributions to the medical ethics field. To belittle his efforts is unworthy of a medical school dean.
b) "accurately report what has already been done" This statement is almost laughable. Dr. Elliot has published copious documentation in this case on ScribD, as well as on his website. All we have gotten from the university is the same boilerplate denials. The tactic is simply to deny and stall and then to claim: "well that happened a long time ago."
In Dr. Friedman's own words:
"Nine years later, it is time to stop blaming our university and our researchers."
What really galls me is the following statement by Dean Friedman:
"Judge the university not on unfounded accusations, but on careful examination of the facts surrounding this case, and on the scale of the groundbreaking advancements taking place across our campuses every day."
I've already indicated who has carefully examined the facts (Elliot) and who is in denial of them (Dean Friedman) but this final argument that we should just forget about the Markingson scandal because of the "groundbreaking advancements taking place across our campuses every day" is preposterous.
Because advances are made we should ignore the plight of mistreated clinical trials patients. They are just so much broken crockery to sweep away?
And what is even worse about this argument - Dan Markingson did not die on the altar of "groundbreaking advancements" but in the service of a pharma sponsored trial of a drug (Seroquel) that can only be described as a marketing study.
For more information, gentle readers might want to consult the artlcle by the Strib's Maura Lerner and Janet Moore. There they will learn that in 2009, documents revealed in litigation against AstraZeneca illustrated that Dr. Charles Schulz, head of the U of M's psychiatry department and a highly paid Astra Zeneca consultant had inaccurately represented the benefits of Seroquel in both research presentations and press releases. The groundbreaking work of Dr. Schulz actually established that Seroquel was no more effective than older, existing drugs such as Haldol (haloperidol).
Someone seems to have forgotten about first, do no harm and other ethical matters, Dr. Friedman.
It is critical for the University of MInnesota to regain its good name and to take steps to see that something like this never happens again.
To defend the behavior of the University in the Markingson case is a fool's errand.
Many years ago I was lucky enough to have summer jobs working as a busboy in the Park Schenley restaurant in Pittsburgh. This summer job allowed me to earn the $600 necessary - with generous financial aid - to attend Northwestern University for my undergraduate degree. It was a tough job. On Satudays we started set-up at 10 am and were not finished until clean-up at 2 am Sunday morning. There was a break from 3pm-5pm when I took a nap in the Carnegie public library.
Good times. And I was very fortunate because at that time the unemployment rate in Pittsburgh was about 25%.
Fast forward to the present. I've been going to Zipp's liquors for many years and have been very impressed by the hard work put in by Andrew and Jennifer Schoenzeit, a brother and sister team who are the owners of Zipp's, a liquor store on Franklin Avenue in the Seward neighborhood. Zipp's is an excellent example of a locally owned community business. Their prices are reasonable, they have a decent selection of wines, and trustworthy people to help you in selecting the right wine.
I have been rather confused lately in trying to figure out what would be the actual effect of the proposed increase in alcohol tax being discussed at the state capitol. Some say that it will only be seven cents per glass of beer, but others claim that it will be a lot more. When I asked about this Ms. Schoenzeit provided me with some information that is quite striking concerning current alcohol taxes in Minnesota and in other US locations.
(Used with permission)
The striking thing about this illustration is the high penalty that alcohol vendors in Minneapolis pay compared to the rest of the state. But even the tax outside of Minneapolis is quite high compared to our neighbors and places in the rest of the country.
(used with permission)
So my point is: the taxes paid on alcohol are ALREADY higher in Minnesota than in other locations. Any further increase should be very small and that does not appear to be the case.
Some other things to consider include whether a tax is progressive or not. If you can afford Veauve Clicquot the additional cost of the tax is probably not going to affect your decision to purchase it. However, if you are a beer drinker of modest means an increase in cost of, say, two dollars for a twelve pack may change your choice of beer brand. That is why in graduate school, I drank Buckhorn, the absolutely cheapest beer available at the time. Nowadays, my favorite is Summit.
The great increase in quality of craft beers like Summit has been a boon to new businesses including breweries in the state. Even local restaurants like the Birchwood now serve beer and wine. And I have yet to see anyone in the Birchwood who had too much to drink.
So I hope that our state legislators and the Governor will keep these points in mind while trying to decide what taxes they raise. Unintended consequences of this action may have a devastating effect on businesses that depend on alcoholic beverages as part or all of their revenue.