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.
(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.
Photo Credit: Star-Tribune
[Note: There has been considerable controversy over former Governor Arne Carlson's suggestion that the University of Minnesota suffers from a bloated administration. He has made this charge on his own blog as well as on the Star-Tribune commentary section. This piece was answered by the Chairman of the Board of Regents, Ms. Linda Cohen. Some further information about this dispute is offered below by my friend and fellow U of M alum, Mr. Michael McNabb. I hope readers will find it informative.]
In a guest column in the April 10 Star Tribune the chair of the Board of Regents responds to the criticism of excessive costs of administration at the U of M by Governor Carlson in his April 7 Star Tribune guest column.
Here is "the rest of the story" to the response of the Regents.
(1) "The university has realized millions of dollars of savings . . . . "
In January 2013 the U of M chief financial officer told state legislators that the administration has cut $228 million since 2006. See the January 31 Star Tribune report. From fiscal year 2007 through fiscal year 2012 the total operating expenses for the University were just under $17 billion. See the U of M financial reports. So the cuts amount to 1.3% of the total operating expenses. Does the administration view this as making tough choices? Or making a serious effort to control costs and tuition?
(2) "As part of our legislative request this year we have pledged to freeze Minnesota resident undergraduate tuition for two years . . . ."
The administration proposes to freeze tuition on the condition that the legislature increases state appropriations by $91.6 million for the next two years. See the September 14, 2012 Pioneer Press report.
The freeze would be limited to undergraduate tuition only (and to Minnesota residents only). The tuition for students (both resident and non-resident) in graduate and professional programs is what really compounds the crushing debt on young persons. See Whose Fault--Crushing Student Debt.
(3) "The Twin Cities campus has a lower net price (tuition, fees, room and board minus financial aid) than any other four year college in the state--public or private."
Net price does not provide any relief to the students because the administration classifies student loans as "financial aid." The Minnesota Daily describes this argument of the administration as cynical and deceptive. See Driven To Deception.
(4) "The board and the Kaler administration undertook an aggressive internal review to study . . . its administrative costs."
The Regents fail to mention that the internal study showed that the total cost of administration for fiscal year 2012 exceeded $852 million (or 28% of the total expenditures of the University). See On The Cost of Administration Part III. So their proposed $28 million reduction in administrative costs over the next two years does not make much of a dent in administrative overhead.
(5) "The column suggests that the university can operate outside the marketplace for faculty and staff salaries. . . ."
Governor Carlson limited his criticism to the compensation of administrators. He noted that universities "compare their rising costs with those of other spiraling systems and proclaim this to be the market."
The Regents should know that the law restricts the pursuit of personal wealth by the leaders of tax exempt organizations. See the Postscript to $tate of the University--A Parent's Perspective.
Society grants tax exemptions to non-profit institutions of higher education in order to promote the common good and not to enrich administrators. If the motivation of the administrators is to accumulate personal wealth, then they should seek those riches in for-profit organizations. See The Cost of "Top Talent" and The Cost of "Top Talent" Part III.
(6) "This argument ignores a reality that was unmentioned: a $140 million reduction in annual state support to the university since 2008."
Over the past decade the U of M administration has increased spending by $1 billion--despite a reduction in state appropriations. In fiscal year 2002 the total operating expenses for the University were $2,005,138,000. In fiscal year 2012 the total operating expenses were $2,948,366,000.
The fuel for this billion dollar explosion was skyrocketing tuition. In fiscal year 2002 the administration collected a net amount (after scholarships and grants) of $293,127,000 in tuition and fees. In fiscal year 2012 the net amount of tuition and fees collected was $696,278,000.
The senior administrators and the Regents have shown no mercy to the students (and their parents). This skyrocketing tuition far exceeded the reduction in state appropriations. In fiscal year 2002 the University received $643,088,000 in state appropriations. In fiscal year 2012 the amount was $572,075,000.
If the Regents are unwilling or unable to make substantial reductions in the cost of administration, then the legislature will do so for them.
Michael W. McNabb
University of Minnesota B.A. 1971; J.D.1974
University of Minnesota Alumni Association life member
Photo Credit: Pizza Luce - Seward
Whenever I go to local restaurants, I always try to strike up a conversation with the server. Here in Minneapolis, many servers are students at our numerous colleges and universities. Having worked at a restaurant while in college, I have a lot of empathy for these folks.
Sometimes I get a big surprise. This happened recently with a server who attended MCAD—the Minneapolis College of Art and Design. When he learned that I did some polymer chemistry, he asked if I knew about the male contraceptive system, being developed in India, that was polymer based. Never heard of it. One of my colleagues, the medicinal chemist Gunda Georg, has been working in this area for some time, so I try to follow the topic. Of course, it is a very important one.
So what’s this about? A quick check revealed a very interesting story. A maverick Indian scientist, S.K. Guha is finally getting attention. He even scored a $100,00 grant from the Gates Foundation. This injectable polymeric system—styrene/maleic anhydride—is referred to by the acronym RISUG, short for Reversible Inhibition of Sperm Under Guidance. The polymer coats the interior of the vas deferens and inactivates sperm as they pass by. The method seems to work for ten years and a reversal procedure is available. According to malecontraceptives.org: “Our research has convinced us that RISUG is the most promising of the potential male contraceptives.”
So what’s the problem here? Do the clinical trials, make sure the method is safe and Bob’s your uncle? Not so fast there, pardner.
“We had no support from industry,” said Guha. As Elaine Lisser, a San Francisco activist for male contraception put it: “To men, an ideal method would be cheap and long-lasting. To company shareholders, an ideal method would be expensive and temporary.”
Now I’m not trying to push some great conspiracy theory about Big Pharm. We’ve heard it all before. They HAVE a cure for x, or y, or z, but they are not revealing it because they can make more money from selling drugs to treat the disease.
But in some public health matters there is no economic incentive for pharma to step in because they cannot make the kind of money they need to operate from something like RISUG. Another recent example of a rather simple approach to a serious problem that will probably not be too popular with pharma is the diagnosis of pre-cancerous cervical lesions with vinegar. See the New York Times article: Fighting Cervical Cancer with Vinegar and Ingenuity.
When vinegar is applied to the cervix, white spots may become visible. These resemble warts and may be removed by cryotherapy—freezing—using a metal probe cooled by a tank of carbon dioxide. Where there’s Coke, there’s CO2. This method has the potential to do for underdeveloped countries what the PAP smear has done for countries like the U.S. The death rate for cervical cancer worldwide is about 250,000. The vast majority occurring where PAP smears are not readily available to a poor population.
Intelligent use of foreign aid, Gates money, and public health research may yield more benefit than higher-tech approaches that pharma necessarily pursues.
I thank Guy Wagner, server at Pizza Luce, for calling this topic to my attention.
People who work with crystals have received an inordinate number of Nobel Prizes. Some of them receive the prize because of the importance of the compounds they have worked on. Protein crystallographers have helped to unravel the mysteries of such things as photosynthesis and how hemoglobin transports oxygen. The Protein Data Bank (PDB) is a treasure trove of interesting and useful results from crystallographic experiments. The prize has also been awarded to people who have invented new methods for the determination of structures from crystallographic data.
Usually, like most scientists, I read the news reports of the science prizes and try to understand what the winners did and why it is important. In this particular case, I saw most of the action as it developed.
Shechtman obtained experimental evidence – a diffraction pattern – for five-fold symmetry in what later came to be known as quasi-crystals. This is not supposed to happen. He realized the importance of this observation and proceeded to publish and defend it. According to a detailed scientific description of the work released by the Nobel folks: “The achievement of Daniel Shechtman is clearly not only the discovery of quasicrystals, but the realization of the importance of this result and the determination to communicate it to a skeptical scientific community.”
His jaw-dropping discovery was initially greeted with skepticism, for example:
“When Shechtman told scientists about his discovery, he was faced with complete opposition, and some colleagues even resorted to ridicule. Many claimed that what he had observed was in fact a twin crystal. The head of the laboratory gave him a textbook of crystallography and suggested he should read it … All the commotion finally led his boss to ask him to leave the research group, as Shechtman himself recalled later.”
And the most influential twin proponent at that time was Nobel laureate Linus Pauling. I consider the late chemist to be one of the greatest scientists alive then. The twin theory or model explains the experimental data by “twinning” or the interpenetration of two – at least – separate crystals. It is a well known phenomenon that can lead to very strange diffraction patterns. I heard Pauling give a talk on his twinning theory that I found absolutely convincing. But then, I was a fan. Pauling later had to amend his initial twinning model, but by that time the evidence had mounted – from all over the world – that the quasi-crystal phenomenon could not be explained simply by twinning.
Upon first making his observation, Shechtman reports saying to himself: “Eyn chaya kazo” (Hebrew for: “There can be no such creature”). No doubt he realized the heat he would take for reporting this discovery.
מזל טוב, Professor Shechtman.
This piece was originally posted on the Chronicle of HIgher Education Brainstorm Blog and is used with permission.
Figure used with permission of the University of Minnesota Bioethics Center.
I didn’t want to attend this conference because I knew that it would be difficult and painful. Like having your wisdom teeth pulled without anesthesia.
As my colleague, bioethicist Carl Elliot, put it: “Only 16 percent of academic health centers in this country will pay the medical bills for research subjects who are injured in clinical trials. None will pay for lost wages and suffering. And an ethicist is arguing that we all have a duty to sign up for these trials? Give me a break.”
But Carl was not able to attend this conference and I knew that Mary Weiss, the mother of Dan Markingson, would be there. Her son died in connection with a clinical trial at the University of Minnesota that has become notorious. I wanted to offer moral support. I met her – for the first time – before the start of the conference. She seemed in control, and we had a pleasant conversation, but I was concerned. After the first talk, on the pro side, she had to leave. I could understand why.
My original intention was to try to present a dispassionate description here of the pros/cons of the question outlining the case made by each side. But I can’t. At first I was offended that my university would put on such a conference given our terrible record with clinical trials in the past. It seemed hypocritical. But in retrospect, I thank the Center for Bioethics for broaching the subject. During the conference most of the points that needed to be made came out. Professor Joan Liashenko did the heavy lifting of organizing and running the conference.
I was particularly impressed by two African-American women who persistently questioned the claim that treating research participation as a moral obligation would actually help the minority community. Henrietta Lacks came up during the discussion. I later learned that one of these women is a bioethicist and the other the president of the Minnesota Black Nurse’s Association.
Which brings me to the first problem I have with the title proposition. Cui bono? And I maintain that the answer is overwhelmingly the pharmaceutical industry. This proposition finds support in the Lysaught presentation cited below.
But what really frosted me was the “moral obligation” business. Thou shalt not steal, thou shalt not kill, thou shalt not covet thy neighbor’s wife, thou shalt participate in clinical research?
The argument that it’s just like paying taxes or giving to charity seems absurd to me. As one of the participants put it, the consequences of paying taxes are not nearly as great as losing one’s life, or being blinded. And for what? Mostly to justify supposedly new clinical therapies for pharma?
And as for charity… Most of us believe, even if we don’t believe in a God, that we are our brother’s and sister’s keepers. When we give to charity, if we are so inclined, we can do a little investigation. We can find, if we wish, something about the percent of money that actually goes to use in a charity and how much goes to administration.
Most patients are not capable of making scientific judgments about whether a clinical trial is worthwhile. Many doctors and people who sit on institutional review boards are not. To claim that people should risk themselves, out of beneficence, to participate in a clinical trial is unreasonable. Certainly to declare it to be a moral obligation is wrong.
I was upset by the use of the term “moral obligation” because I think this means something far beyond “this would be a good idea.” I don’t think there is support for the proposition in the works of, for example, Kant or John Stuart Mill. But these arguments are dense and not easily capsulized for this forum.
I did find a wonderful talk by Professor Susan Wolf of the University of North Carolina, who gave the Frumke lecture at NYU entitled: “Moral Obligations and Social Commands.” This talk examines the concept of what a moral obligation is and gives examples. To claim that participation in research is a moral obligation does not seem to pass the Wolf Test. This outstanding lecture is available in hard copy here and even, mirabile dictu, on YouTube.
It was an exhausting day. Certainly caused a Brainstorm. I drove one of the speakers to the airport and came home. Took three beers to return to earth.
This piece originally appeared in the Chronicle of Higher Education. For those interested in more details, that version includes some references and links to the slides used by the conference speakers.