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"Dean of the University of Minnesota's medical school Aaron Friedman

put his head in his hands..." 

(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 and qualification 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."

Two points:

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."

Finally:

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.

For example:

(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. 

Source

Author of the higher education bill, Rep. Gene Pelowski, DFL-Winona

A recent editorial in the Star Tribune accused the state legislature of a power grab in attempting to set tuition rates for both the University of Minnesota system and MNSCU.

They opined that politicians were not the best option for balancing price (tuition) and quality for our higher education systems.

There were a large number of questionable arguments and statements made in that editorial, but today I would like to address only one, briefly.

Specifically:

"The Senate amendment tacitly acknowledges that the Legislature has limited ability to tread on the Board of Regents' constitutionally protected turf. But the House seeks to coerce the regents to do the Legislature's bidding by directing state officials to refuse to release funds to the university if a tuition freeze is not adopted."

First, it should be noted that it was the University that asked the legislature to provide funds specifically for keeping tuition frozen. This was a pre-emptive strike since the general public is furious because of the level of tuition and consequent student debt load. 

And second, after bringing the question of constitutional autonomy up, we find later in the same editorial this:

The Senate's omnibus high-education bill is on the right track in making five percent of the state's 2014-15 appropriations to the two systems contingent on meeting at least three of five performance goals.

So, how does this work?  A little coercion is acceptable to the Star Tribune but a lot is not?  Where exactly is this line to be drawn?

One of the reasons why the U is in such bad odour with the public is the perception of arrogance in the matter of constituional autonomy. You can't tell us what to do, please hand over the money.  In thinking about why the Legislature has not been generous to the U in the last ten years, is it possible that this perceived arrogance had anything to do with funding levels?

There are of course ways to fix the constitutional autonomy problem, but hopefully President Kaler is more sensitive to the matter than was his predecessor. The current General Counsel is about to leave town for a new job. One of his claims to fame has been as a fierce defender of the University's constitutional autonomy. Hopefully his successor will be a little more sensitive in this matter.

 [Added later]

Although the issue of constitutional autonomy was not intended to be a major focus of these brief remarks, some gentle readers may wish more information on the topic.

"The study shows that Michigan, California, and Minnesota continue as the states with the most substantial legal recognition of constitutional autonomy."

"In these states, independent constitutional authority for public colleges and universities is meant to limit exessive political inteference from other parts of the state government." 

Source: A comparative Legal Analysis of State Constitutional Autonomy Provisions for Public Colleges and Universities

 Photo Credit: Star-Tribune

Skewed U 

[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.

See pp. 17-18 of the 2002 U of M annual financial report and pp. 14-15 of the 2012 U of M annual financial report.

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
 

[Update: The petition mentioned in this post has now been signed by more than 1,000 people including three former editors of the New England Journal of Medicine. An article has also appeared in the Star-Tribune that gives the University of Minnesota's response to the most recent developments. Please see comments on the article.] 

 From my friend Mike Howard:

 "In November 2003, psychiatrists at the University of Minnesota used the threat of involuntary commitment to force a mentally ill young man named Dan Markingson into a very profitable, industry-funded study of antipsychotic drugs. Dan was enrolled in the study over the objections of his mother, Mary Weiss. For months Mary tried desperately to get him out of the study, warning the psychiatrists that Dan’s condition was deteriorating and that he was in danger of killing himself. The psychiatrists refused to listen to her. On May 8, 2004, Dan committed suicide, and Mary lost her only child." 

As of this writing nearly six hundred people have signed a petition to Governor Dayton, including 70 scholars in bioethics/health law/medical humanities.  The group includes a former editor of the New England Journal of Medicine. 

The petition calls for an outside investigation without involvement of the University of Minnesota, especially its General Counsel who suffers from a severe conflict of interest.

For example:

As former Health Ombudsman in New Zealand (Health and Disability Commissioner, 2000-10) I am deeply disturbed to read of unethical behaviour by researchers and psychiatrists who enrolled Dan Markinson in a trial of antipsychotic drugs, when he was not competent to consent. It appears that evidence about potential harmful side effects of the prescribed drugs was suppressed. Dan's suicide may well be linked to the effect of the drugs he was prescribed, yet no one listened to his mother's cries for help to prevent the harm that ultimately ensued. It is now too late for Dan, but the University of Minnesota owes it to him and his mother to investigate what happened and put safeguards in places to prevent a similar tragedy happening again. 

As a Senior Associate Dean for Academic Affairs at a Big Ten medical school and a practicing physician, I think medical researchers and their sponsoring institutions should be held to a high standard of ethical behavior and transparency.

As the leading institution for higher learning in the state, the University of Minnesota can, and should, do better.

The coverage of this case in the Minneapolis Star-Tribune and elsewhere generates reason to be deeply worried about possible research misconduct at the University of Minnesota. The potential misconduct appears to be serious enough that an independent investigation, located outside the university, is necessary.

Because I have worked in Psychiatric Research for close to 30 years and I find the response from UM and the sponsor to be unacceptable.

I have followed this particular case since it piqued my interested back a few years ago with an article in the Pioneer Press from St Paul. I have tried to keep an open mind and understand the University's denials of any wrongdoing. From everything I have been able to gather researching this I've come to the same conclusion over and over again. The UMN is wrong and they know it. Their repeated steps to block any type of independent investigation is disgusting. The University is acting exactly like the pharmaceutical company, if we can control the data then we can control the outcome. As I see it, Governor Dayton has no option but to order an investigation.

I teach biomedical ethics, and every student ever to take my class could tell you why this study design was profoundly immoral.

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.

A modified version of this piece was originally posted on the Chronicle of Higher Education Brainstorm Blog.