Minnesota Environmental Partnership

Weighs In On

University of Minnesota's Pulling Plug

On Controversial Film

Kudos to the Morrill Hall Gang for another pr disaster...

Troubled Waters - Troubled U

When the Daily Planet revealed this week that the U of M has pulled the plug on the premiere of an important film about farming and the Mississippi River, it wasn’t just another hint that corporate powers are calling the shots at the state’s ag college. It was also a troubling peek into just how willing some officials are to allow those shots to be called, perhaps even before the trigger’s been pulled.

I viewed a near-finished version of the film last spring, and was extremely impressed. It did an excellent job of laying out the problem and then showing how average people—farmers as well as the general public—can use a combination of innovative production systems, good policy and creative market forces to fix something that is causing major problems both here and a thousand miles downstream.

As a result, the film’s producers bent over backwards—almost to a fault—to make the film as fair and scientifically accurate as possible. McPhee is no amateur on a mission. She’s done work for, among others, NOVA and National Geographic Explorer, entities known for their strict adherence to scientific standards.

Troubled Waters is not an anti-farmer screed. In fact, it carries a very positive message: that farmers are part of the solution right here in our own back yard.

Why was the film’s release blocked at the last minute? The official word via spokespeople statements and press releases is that the film needed “further scientific review” because it’s an LCCMR-funded project. When reporters at the Daily Planet, Star Tribune, St. Paul Pioneer Press and Minnesota Public Radio asked for specifics about what was scientifically wrong with the film, they were met with a lot of double talk, “I don’t knows” and plain old stony silence. (Molly Priesmeyer has written an excellent follow-up article in the Daily Planet on how the LCCMR is being kept in the dark by U officials on the future of the film as well; apparently being a legislative commission doesn’t gain you any more respect from certain U officials than being a member of the press or general public).

As one Minnesota farmer (and U of M grad) said after learning of the film-yanking: “Show the film and let the people of Minnesota decide. What are they afraid of?” Maybe they’re afraid the public will learn there’s a difference between what farmers think about the environment, and what corporate ag thinks. They aren’t one and the same...

Remember, the U of M may own the rights to the film, but we all have ownership in the U. That means we have a right to see Troubled Waters.

In the frenzy of media coverage that’s emerged since the original Daily Planet story broke (by the way, what a relief to learn that investigative journalism is not dead in Minnesota), everyone from Daniel Wolters to John Himle has claimed that there was no outside pressure to cancel the premiere. If that’s true, then it’s even more frightening—that means University officials censored an important documentary of their own accord.

Insiders who have worked with the University’s public relations arm say that during the past four years this particular division has taken unprecedented steps to control the flow of information that comes out of classrooms, laboratories and test plots. University Relations seems to utilize one simple criteria for whether U information is released to the public: “Will it please or upset large corporations?” That criteria may be appropriate at Cargill or General Mills, but it doesn’t belong at a land grant institution that serves the people of Minnesota.

Given that, perhaps Big Ag didn’t even have to lift a finger when it came to Troubled Waters—maybe certain decision makers within the U took the initiative to kill the messenger themselves. Self-censorship is the worst kind of censorship.

Whatever the source of the squashing—inside, outside or in the middle—this is an embarrassment for a world-class public institution. This smells like a rat, and in order for our University of Minnesota to clear the air, it needs to come clean. That begins with answering some key questions:

• Who ultimately made the decision to yank the premiere, and why was it done at such a late date?

• What were the specific “scientific questions” that prompted a call for a review?

• Who raised these questions?

• The Bell has announced that “qualified faculty” will review the film.

Why weren’t the previous reviewers qualified?

Who decided they weren’t “qualified”?

Who will pick the new reviewers?

Contact U of M President Robert Bruininks and tell him the way this whole situation has been handled is unacceptable, and the only way to start making things right is by answering the above questions in a forthright manner.

He can be contacted at UPres@umn.edu or 612-626-1616.

+

Curiouser and Curiouser...

Who threw the overalls in Mrs. Murphy's chowder?

(or who pulled the plug on the U of M's Mississippi River
Documentary and Why?)

Molly Priesmeyer reports:

The University of Minnesota looks to be getting itself into deeper hot water.

...University Relations sent out a statement late yesterday asserting that University officials were reviewing the film to see if it "meets the specifications of the legislative appropriation to the University." The documentary was funded in large part by the Legislative Citizen Commission on Minnesota Resources (LCCMR) through the Minnesota Environment and Natural Resources Trust Fund.

However, Michael Banker, communications manager for LCCMR, said that, while the University has the authority for determining whether the film meets University standards, "the authority to determine whether the project meets the language of the appropriation and LCCMR-approved work program is the responsibility of LCCMR and the legislature."

Karen Himle, the VP of University Relations, yanked the film from TPT more than a week ago. Banker said he can't explain why because the University has yet to give LCCMR any specifics.

[I have yet to see it established that Karen Himle "yanked" the film. Full disclosure: I consider KH to be a good person and a friend...]

"I made a request to Karen Himle on September 16th to provide us with documentations of concerns so we can consider them within our own review," Banker said. "I was informed that the documentation did not exist at the time."

Banker said that, so far, Himle is the only one to talk with LCCMR about her concerns, and none of them are rooted in specifics. "To the best of my knowledge, it appears that the concerns and requests to halt the film rose from the Office of University Relations," he said. "So far, Karen Himle is the only one who has been in communication with LCCMR about concerns."

Still, the question is whether Karen Himle's connection to Himle Horner and the Minnesota Agri-Growth Council, a proponent of ethanol and industrial agriculture, poses a serious conflict of interest for the University. Dan Wolter, the director of News Service in the Office of University Relations, has yet to respond to questions raised by TC Daily Planet about issues of conflict of interest.

"We still don't know what specific concerns the University has," Banker said. "But because the University raised concerns, we are in the process of extensively reviewing the film to see if it meets the appropriation language. However, we are still waiting to hear what their specific concerns are so we can better make that determination."

Other funders, including the McKnight Foundation and the Mississippi River Fund told the Star Tribune that they were troubled by the decision and waiting for an explanation from the University of Minnesota.

[I don't like it, but I won't say why?]

.

Question: Legal But Unethical, Who Works On That?

Answer: The University of Minnesota

For some background, please see: We're Not Violating a Legal Statute...

From the Hastings Center Bioethics Forum:

Alice Dreger (a professor of clinical medical humanities and bioethics at Northwestern University’s Feinberg School of Medicine)

It’s hard to say what is most horrifying in Carl Elliott’s report in the current issue of Mother Jones of a young man who died caught up in a pharma study run out of the University of Minnesota.

That a man considered mentally ill enough to be facing involuntary commitment was considered well enough to consent to a blinded study of antipsychotic drugs?

That apparently the young man was given to understand that he could not leave the study without being involuntarily committed?

That research subjects like this are being used in drug trials whose real aim is production of marketing materials, and not “genuine scientific knowledge”?

That big pharma is using academic doctors to turn patients like this man into lucrative guinea pigs?

That the university’s IRB director testified in a lawsuit that the IRB’s purpose is not to protect clinical trial subjects?

Or that, according to Elliott, after the man’s mother unsuccessfully sued the University of Minnesota (where Elliott himself works), the university “filed a legal action against [her], demanding that she pay the university $57,000 to cover its legal expenses”?

Elliott’s hair-raising account, along with my own work in the history of medicine and in patient advocacy, has led me to a troubling meditation, one that goes roughly like this:

A medical ethics travesty occurs, and people yell, “There oughta be a law.” So, if things go right, a new law or regulation goes into place to try to protect patients and research subjects from repetition of the horror that occurred.

But then those people charged with watching out for the rights of patients and research subjects – people who increasingly tend to be lawyers who pragmatically treat things like IRBs as liability shields for their institutions – stick as closely to the laws and regulations as possible.

They do not worry about the gray zone of questionable practices that remains between patients and the law; they worry about following the law. They worry about protecting the institution from illegal behavior, not protecting the patients or research subjects. Subtle but key difference, one made vivid in Elliott’s article.

Then if someone – say, Elliott – tries to say, “But this particular practice is unethical in the way it treats patients or subjects,” the response is, “But it isn’t illegal.” As if to say to us, “If you really think it’s so bad, go get the law changed, and until you do so, don’t bother us with your worried little heads.”

In other words, the new law or regulation is really meant to make the system more expansively ethical. But by forever being read as a constriction of what we’re allowed, effectively, to worry about, it does the opposite: it restricts what counts as a behavior you can prohibit or stop. It seems to restrict what you can even worry about.

Now, if the systems we set up to protect people are not only inadequate to protect people, but in fact are used to constrict concerns about protection – how do we really protect people in medicine and medical research? (Especially when the laws are used to protect an institution, and not a seriously mentally ill man caught in a research study, or his mother.) Who will do the real work of medical ethics, and how?

The University of Minnesota has issued a statement on this story.

Predictably, it comes from the general counsel, and attempts to undermine the power of Elliott’s criticisms through legalistic meandering.

The statement also seems to contain two basic misrepresentations.

When I put those possible misrepresentations to the university spokesman named on the statement’s Web page, he responded that “Because this is a closed legal case[,] there is much I’m simply unable to discuss openly and on the record.”

His e-mail signature line contained the University of Minnesota’s slogan: “Driven to Discover.”

[Driven to Discover what? Mr. Rotenberg? President Bruininks?]

-

Troubled Mississippi Waters Flow By

The University of Minnesota

Proof that NewScut is not just interested in the pornographic beavers of Bemidji?

From MPR

Want to see the definition of a heck of a story? Read the Twin Cities Daily Planet's report into why a University of Minnesota-funded documentary about the Mississippi River got pulled shortly before it was to premiere. It focuses on agriculture, pollution, and sustainable solutions.

The suggestion in the story -- impossible to prove because the people who could clear up the controversy either aren't talking, appear to fibbing a bit, or don't seem to know answers to legitimate questions -- is that the university didn't want to upset ties to big agriculture. The few people at the U who are talking say the Bell Museum wanted a scientific review of the project, but the show's producer says that's not true.

Now, according to reporter Molly Priesmeyer, there's another angle that's surfaced on the "isn't it a coincidence?" list ... Priesmeyer doesn't have the smoking gun, but she's at the very least got circumstantial evidence that could only be explained away by the university fully explaining why it pulled the documentary at the last minute.


The (Morrill Hall) Gang that couldn't shoot straight misfires again?

University of Minnesota Pulls Plug on Bell Museum

Movie Premiere... Why?

(Film pulled by University Relations!)

The fickle finger of Mr. Wolter?


From the TwinCities Daily Planet:

Troubled Waters: A Mississippi River Story has been nearly four years in the making. A team of researchers, filmmakers, and scientists have been up and down the Mississippi River, knee deep in swamps and icy waters, and elbow deep in footage and research. The film, by the U of M's Bell Museum of Natural History, focuses on agriculture, pollution, and sustainable solutions. Now, suddenly, its premiere has been cancelled, and no one can say exactly why.

The film was also scheduled to broadcast on TPT on October 5.

But on September 7th, just as invitations to the premiere were sliding into mailboxes, the U of M pulled the plug on the event and the TPT airing. According to Barbara Coffin, coordinator of public programs at the Bell and executive producer of Troubled Waters, the film was pulled from TPT by University Relations.

The producers at the U's Bell Museum were informed that morning in a letter sent from University Relations: The film would not air on TPT and the party and premiere were shuttered. Later that week the Facebook invite for the premiere was updated to say the release was postponed "to allow time for a review of the film's scientific content."

But insiders believe someone is putting pressure on the University to pull the film--and no one within the University has a convincing story about who was responsible for pulling the film for "scientific review."

According to University News Service director Daniel Wolter, the Bell Museum, which is part of the College of Food, Agricultural, and Natural Resource Sciences, is responsible for halting the release. "It was determined by the Bell Museum director and producer of the production," he says. "We are an academic and science-based institution, and we want to ensure a production like this is scientifically sound."

However, the film's director, Larkin McPhee, said she never delayed the release or called for a scientific review. "I do not understand why the University postponed the film's broadcast," she said via email. "I am, along with many others, awaiting explanation from the U."

What's more, she and assistant producer Shanai Matteson, who also serves as community program specialist at the Bell Museum, contend that the film did undergo a scientific review and was extensively fact-checked to "NOVA standards."

"We verified every fact with at least three independent sources," Matteson says of the documentary project.

Matteson says that the film was also reviewed by as many as 12 prominent university scientists, including Jon Foley and David Tilman (both from the of U of M's Ecology, Evolution, and Behavior department); Robert Diaz, a professor of marine science at the Virginia Institute of Marine Science and an expert on "dead zone" issues in the Gulf of Mexico; Eugene Turner, a zoologist at Louisiana State University who has done extensive research on wetland pollution and coastal erosion; and Nancy Rabalias, another LSU professor whose research has dealt extensively with pollution issues in the Gulf of Mexico.

[But apparently these folks aren't sufficient

to check the science, Mr. Wolter?]

When asked what aspect of the film raised red flags for "scientific review," Wolter says he doesn't know. "I am not sure there is much more I can say there ... it just has been postponed."

As a land-grant institution, the U of M is under increasing pressure to maintain its mission to serve farmers, a policy that has been in place since long before small farmers were supplanted by corporate entities. When asked if the film's "controversial" subject matter--how corporate farming contributes to pollution--raised red flags, Wolter said this was an internal decision. "This is just an internal review process that the Bell called."

["the Bell called for?" Who, exactly, is the Bell, Mr. Wolter]

And when asked what other scientists are going to be part of the second review panel, Wolter also was unsure. "I don't know," he said. "My understanding was the Bell Museum would be responsible for that."

[Again, who is the Bell, Mr. Wolter?]

However, the filmmakers say this isn't true. "Shanai Matteson is correct in stating that the film already underwent scientific review," McPhee says. "As with all my work, I am proud of this production and was honored to collaborate with so many researchers and scientists at the University. I look forward to having Troubled Waters: A Mississippi River Story reach the public as soon as possible."

Obvious question:

What the hell does chief U of M flack, Daniel Wolter,

have to do with

pulling the plug on this film?

Once again, the University of Minnesota emerges from another bad bout of egg-in-face. No doubt the Morrill Hall Gang had a lot to do with this, because Mr. Wolter does not make decisions like this on his own. He is but the chief flack catcher, pushed to the front to deal with the evil media. If things don't work out right, others can step out of Morrill Hall to 'splain how Mr. Wolter got it wrong...

Recall the famous words of OurLeader cited above: "Everything we do at the University of Minnesota is out in the open."

When will this be true, Mr. President?

+++

QS World University Rankings

University of Minnesota

#96

"ambitious aspirations to be one of the top three public universities in the world [sic]" (within the decade, i.e. 2014)

The clock is ticking...

Source:

1 Cambridge
4. University College London
6. Oxford
7. Imperial Collge London

15. Michigan

18. ETH
19. McGill
20. Australian National University
21. King's College
22. University of Edinburgh
23. Hong Kong Uninversity
24. Tokyo University
25. Kyoto University
26. Bristol University

28. UC - Berkeley

29. Toronto
30. Manchester
31 Singapore
32 Ecole Polytechnique - Lausanne
33. Ecole Normal - Paris

35. UCLA

36. Ecole Polytechnique - Paris
37. Syndney
38. Melbourne
40 Hong Kong U of Science and Tech
42. Chinese U. of Hong Kong
43. Queensland
44. British Columbia
45. Copenhagen
46. University of New South Wales
47. Peking

48. Wisconsin

49. Osaka
50. Seoul
51. Heidelburg
52. Trinity College - Dublin
53. Warwick
54. Tsinghua

55. University of Washington

56. Amsterdam

57. North Carolina

58. Technical University, Munich
59. Birmingham
60 Tokyo Institute of Tech
61 Monash
62 Uppsala

63. Illinois

65. UCSD

66. Ludwig Maximilian - Munich

67. Texas

68. Auckland
69. Sheffield
70. Free University Berlin
71. Geneva
72. Lund
73. Nottingham
74. Nayang Tech - Singapore
75. Helsinki
77. Glasgow
78. Alberta
79. Korea Advanced Inst. of Sci and Tech
80. London School of Economics
81. Southhampton
82. Leiden
83. Utrecht
84. Aarhus
85. Leeds

87. Purdue

88. York
89. University of West. Austalia
91. Nagoya
92. Durham
93. Moscow State
94. National Taiwan University
95. St. Andrews

96. University of Minnesota

We aren't even in the top ten publics in the US according to this ranking.

The hubris of the "in the world" part of our president and provost's boast is readily apparent. Perhaps this kind of thing sells to the Board of Regents, and to some students and faculty, but a boast like this continues to make us look both arrogant and stupid.

+++

Times Higher Education

World University Rankings

2010-2011

University of Minnesota Weighs in at #52.

"Ambitious aspiration to be one of the top three public research universities in the world..." (within the decade, i.e. 2014)

Some work to do, Provost Sullivan and President Bruininks?

Publics in the Top 200

Global

6. Cambridge
7. Oxford

8. Berkeley

9. Imperial College London

11. UCLA

15. Swiss Federal Institute of Technology

15. University of Michigan

17. University of Toronto
21. University of Hong Kong
22. University College London

23. University of Washington

26. University of Tokyo

27. Georgia Tech

28. Pohang University (Korea)

29. UC - Santa Barbara

30. University of British Columbia

30. University of North Carolina
32. UC - San Diego
33. University of Illinois

34. National University of Singapore
35. McGill University
36. University of Melbourne
37. Peking University
39. Ecole Polytechnic
40. University of Edinburgh
41. Hong King University
42. Ecole Normale Superiure
43. Australian National University
43. Gottingen University
43. Karolinska Institute

43. University of Wisconsin

48. Ecole Polytechnique Federal (Lausanne)
49. University of Science and Technology of China

49. UC - Irvine

52. University of Minnesota

Looks like they've done a decent job, further analysis coming.

Time for some honesty at the University of Minnesota about the Strategic Propaganda Initiative?

+++

The Secret Lives

of

Pharma's Thought Leaders

Carl Elliott is at it again:
(from the Chronicle of Higher Education)

... If medicine were simple and transparent, pretending to be a medical expert would be very difficult. An audience could spot incompetence right away. Pretending to be a medical expert is possible precisely because medical knowledge is so specialized and opaque. These days an ordinary doctor can no more expect to understand the intricacies of specialized medical research than the driveway mechanic who tinkered with his Volkswagen in 1962 can expect to fully understand the complex, computerized automobiles on the road today..."

The phrase "opinion leader" was made familiar by the sociologists Paul Lazarsfeld and Elihu Katz in their 1955 book, Personal Influence, where they used the term to explain the way that media messages were filtered and spread by personal, face-to-face contact with influential people. Today the pharmaceutical industry uses the terms "thought leader" or "key opinion leader"—KOL for short—to refer to influential physicians, often academic researchers, who are especially effective at transmitting messages to their peers.

The KOL is a combination of celebrity spokesperson, neighborhood gossip, and the popular kid in high school. KOL's do not exactly endorse drugs, at least not in ways that are too obvious, but their opinions can be used to market them—sometimes by word of mouth, but more often by quasi-academic activities, such as grand-rounds lectures, sponsored symposia, or articles in medical journals (which may be ghostwritten by hired medical writers).

Most marketers would like to have a convincing, influential, and apparently independent expert who will deliver the text that they give him.

"It strokes your narcissism," says Erick Turner, a psychiatrist at the Oregon Health and Science University. There is the money, of course, which is no small matter. Some high-level KOL's make more money consulting for the pharmaceutical industry than they get from their academic institutions. Academic physicians talk about the experience of being a KOL the way others might talk about being admitted to a selective fraternity or an exclusive New York dance club. "You get to hobnob with these mega-thought leaders and these aspiring thought leaders," Turner says. "They make you feel like you're special."

Turner is a former drug reviewer for the Food and Drug Administration.

But if you are involved with the rollout of a company's new drug, you are really in on the action. "The first thing they do is ferry you to a really nice hotel. And sometimes they pick you up in a limo, and you feel very important, and they have really, really good food. And they make you sign a confidentiality agreement and say you need to sign this if you want to get paid." The meetings Turner attended featured what he calls the "mega-thought leaders," the recognized leaders in the field, who gave presentations to a group of people like him—the second-tier "little thought leaders."The companies will also offer these aspiring thought leaders media training and advice on public speaking. "They give you slides that you will probably be speaking from, and you'll be in a room with about a dozen other people," Turner says. "

It is an article of faith among pharmaceutical executives that KOL's are a critical part of any marketing plan. According to a 2004 study of the 15 largest pharmaceutical companies, the industry spends just under a third of its total marketing expenditures on KOL's.

If a company can manage the discourse effectively, it can establish the desperate need for its drug, spin clinical-trial results to its advantage, downplay the side effects of a drug, neutralize its critics, and play up the drug's off-label uses. Virtually all physicians are on the receiving end of this communication, but only a relatively few deliver it. If the industry can influence those few, then it can also influence the rest.

Naturally, some lower-level pharmaceutical employees resent the KOL's they are expected to flatter and serve. A medical writer I spoke with compares thought leadership to a cult, or maybe the priesthood. "At meetings they get big fancy badges, like generals with their medals," he says.

Perhaps the most remarkable recent exchange with a KOL emerged in an investigation of Joseph Biederman, a child psychiatrist at Harvard University. In a lawsuit against Johnson & Johnson, Biederman was accused of promising positive research results to the company in exchange for funding. A hint of Biederman's self-opinion emerged in a deposition, where a lawyer asked him about his academic ranking.

Biederman: "To move in the ranks from one rank, for example, at Harvard, there is instructor, from instructor you move to assistant professor, from assistant professor you move to associate professor, from associate professor you move to full professor."

Lawyer: "Full professor?"

Biederman: "Mm-hmm."

Lawyer: "What rank are you?"

Biederman: "Full professor."

Lawyer: "What's after that?"

Biederman: "God."

Lawyer: "Did you say God?"

Biederman: "Yeah."

The status of being a KOL carries a certain irony. It is a hunger for status that motivates many academic physicians to work for industry, yet in order to preserve their status, those physicians must also cultivate the perception of independence. As Erick Turner asks, "Is it worth it, feeling like you are a robot, just speaking from a prefab slide set?"

For the past several years, Sen. Charles E. Grassley of Iowa, the ranking minority member of the Senate Finance Committee, has made it his mission to investigate and expose the conflicts of interest generated when KOL's work for the pharmaceutical and medical-device industries. His investigations have targeted prominent academic physicians at Harvard, Stanford, Emory, Wisconsin, and Minnesota, among other universities.

Mere disclosure is unlikely to fix the problem, however. Minnesota, where some of the most egregious offenses have occurred, has had a similar "sunshine law" since the mid-90s, to little effect.

What is more, empirical research in psychology suggests that, contrary to conventional wisdom, people who disclose their conflicts of interest make judgments that are more biased, not less.

If the aim of disclosure is to shame KOL's into giving up their industry relationships, it is based on a faulty premise; the most prominent KOL's often announce their industry relationships with something close to pride. And why shouldn't they? If the very reason scholars work with industry is the status confirmed by the relationship, then asking KOL's to reveal their industry ties is not much different from asking them to reveal their honors and prizes.

Universities could easily clean up the problem, simply by banning or capping industry payments to faculty members, but that is unlikely to happen. Not just because academic physicians would object, but also because many high-level university administrators have lucrative corporate relationships of their own. (For instance, the president of the University of Michigan sits on the Board of Directors of Johnson & Johnson, while the president of Brown University sat on the boards of Pfizer and Goldman Sachs.) As universities have come to look more like businesses, competing for funding and prestige in a consumer marketplace, industry relationships have become a lucrative perk of many university jobs.

David Healy, a psychiatrist at Cardiff University, in Wales, and a prominent industry critic: "If you look at the opinion leaders, the guys in the field are not stellar geniuses. The field moves forward by virtue of the fact that people cooperate. It's not that anybody has a particularly brilliant insight, or that these guys are really awfully bright, but the opinion leaders who work with pharma are actually the least bright. These guys get made by industry. They get money, they get status, and they knew they wouldn't be anything if it weren't for this."

My brother Hal, a psychiatrist at Wake Forest University, used to work as a KOL for GlaxoSmithKline. Hal calls this his moment of understanding, after which he never gave another industry-funded talk. Up to that point, he had imagined himself as a high-powered academic physician bringing the latest university research to doctors out in the community. Standing next to the drug rep, however, Hal understood how the community of doctors saw him. To them, Hal was a drug-company shill. "I was literally standing in the drug-rep spot begging for a minute of this doctor's time, like a cocker spaniel begging for a leftover piece of meat from the table," he says. It was no wonder the doctors saw little difference between Hal and the rep. "It was like I had become a psychiatric call boy," he says. "I might as well have just said, 'Hi, I'm Hal. The company sent me to make sure you all have a good time."

And so it goes...

Lawyers, Drugs, and Money

Is Medical Research

at the University of Minnesota

Compromised

From City Pages:

In a damning new article in the latest issue of Mother Jones magazine, Dr. Carl Elliott, a professor at the University of Minnesota's Center for Bioethics, argues that the university's system of clinical research "has been so thoroughly co-opted by market forces that many studies have become little more than covert instruments for promoting drugs." Because of the large sums of money pharmaceutical companies are paying the university, Elliott writes, the institution is too often turning a blind eye to glaring conflicts of interest and serious ethical lapses. In one instance, Elliott contends it may even have lead to the death of a study's subject,

What's been the reaction of your peers to this article?

Well, outside the medical school, and outside the university as a whole: lots of support for me personally, and, as you'd expect, shock that this could happen here. Inside the medical school: silence.

One should perhaps no longer be surprised to find pharmaceutical companies suppressing unfavorable data and manipulating studies to get the results they desire, but to read in your piece that a respected medical institution like the university may be aiding that deception is stunning.

Why would the university risk its reputation?

Pharmaceutical industry funding is the norm for academic health centers, not the exception. In academic medicine, working for them is not seen as shameful; it is seen as a mark of status. For a lot of academic physicians, being chosen by a drug company to work as a paid consultant or speaker is like being admitted to an elite private club.

But when the head of your university's psychiatric department, for instance, is a well-paid consultant for a pharmaceutical company, and that company, in the interest of increasing profits, fudges results and hides unfavorable data, why wouldn't top officials at the U of M sound the alarm?

You could ask the same question about any of a number of scandals at the university. A couple of years ago, the Star Tribune discovered that Leo Furcht, the co-chair of an ethics task force at the U working on a new conflict-of-interest policy, had steered a $501,000 pharma grant into a firm he owned and which he later sold for $9.5 million in stock. When the Star Tribune asked Deborah Powell, the dean of the medical school, why she had appointed Furcht to chair the ethics task force, she said it was because of his "extensive experience" devising conflict-of-interest rules. Furcht remains chair of the Department of Laboratory Medicine and Pathology.

You point out that in one case, a 26-year-old man named Dan Markingson was used in a psychiatric drug study after being diagnosed as psychotic. He committed suicide during this study. His mother begged university researchers not to place her son in the study. She believes carelessness on their part led directly to his death.

Do you believe this?

I asked this question of my brother, a psychiatrist on the faculty at Wake Forest University. He said, "Look, if a mentally ill young man's mother keeps calling, begging you to take her son out of a study because she thinks he is going to commit suicide, you don't just ignore her. You call 911."

Did the drug given to Dan in the study cause the suicide?

That's impossible to say; you never know whether a suicide is linked to a drug or the underlying mental illness. Did Dan get poor treatment during the study? Yes. Were there financial incentives to enroll him in the study and keep him in? Yes. I asked Jerome Kassirer, the former editor of the New England Journal of Medicine, to comment on the case for my article, and here's what he said:

"The conflict of interest is disgusting, and it seems quite likely that the boy's death was an indirect consequence of the financial inducements of the study. At the very least, the university should have appointed an independent review board, dismissed all the hospital charges, and paid the boy's mother damages."

Do you have any support, inside the medical school, calling for some new approach to medical research?

There are a few people concerned about conflicts of interest, but most of them seem afraid to say much. They prefer to keep their thoughts to themselves. As my brother says, "Doctors fear drug companies like bookies fear the mob."

More On Continuing Disgrace of

the University of Minnesota

and Drug Trials

From Covering Health, Keeping Health Care Journalists Informed and Connected:

Writing for Mother Jones, University of Minnesota medical ethics professor Carl Elliott digs into the Dan Markingson story first covered by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto. Elliott works at the same institution as the physicians who who administered a Seroquel trial that the 26-year-old was enrolled in when he committed suicide.

Given his teaching field and institution, it’s not surprising that Elliot couldn’t stay away from the Markingson story.

…the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.

Elliot goes after the idea that the new wave of anti-psychotics was any safer than its predecessors, then explains the clinical trial manipulations he says were used to claim they were.

From there, Elliot takes on the use of clinical trials for marketing purposes. Clinical trials can be dangerous, which is theoretically acceptable if they have the potential to advance medical care. But what if patients are just being exposed to those dangers in an effort to sell more drugs?

The Gang That Can't Shoot Straight

Provides Further Evidence:

University of Minnesota Sues

Mary Weiss

From the Daily:

Troubling Loss of Mary Weiss

Her son committed suicide in a clinical trial that deserves scrutiny.

Mary Weiss says she wasn’t surprised when her lawyer called notifying her that the University of Minnesota was seeking about $57,000 in legal fees. It had already put her through enough after her son, Dan Markingson, 26, stabbed himself to death while enrolled in a clinical trial for an anti-psychotic medication here in 2004, a trial she didn’t want him in.

In 2008, a Hennepin County Court dismissed the case she brought against the University and the University settled with her, agreeing to drop the legal fees so long as she doesn’t appeal. That’s exactly why the case deserves continued public scrutiny, not only about the actions of the researchers carrying out the University’s mission, but about whether the University’s research mission itself favors public good over profit.

A recent article in Mother Jones Magazine by University bioethics professor Carl Elliott details possible oversights in this so-called 2003 Café study lead by Dr. Stephen Olson and sponsored by AstraZeneca. Throughout the six-month study, Weiss says she had warned researchers that she was concerned for Dan’s well-being. She got little response.

The University is quick to point out that a Food and Drug Administration investigation into the case found no wrongdoing on behalf of the researchers in the Café study and that the court established no causal link between Seroquel, AstraZeneca’s medication that Dan was taking, and his suicide. But how could it?

That’s no assurance for Weiss, who says she noticed troubling signs in Dan, like rage and withdrawal, while he was in the study. Nor should that be enough for researchers and their overseers, the University’s Institutional Review Board, to conduct trials on at-risk populations which shouldn’t have to worry that their doctors are also beholden to the profit motives of Big Parma.

So who's responsible for this ham-handed attempt to silence Mary Weiss? Mr. Rotenberg? President Bruininks?

I've posted a lot on this matter, for a few examples, please see:

More on Dan Markingson Case at the University of Minnesota from Hooked: Ethics, Medicine & Pharma

A Clinical Trial, A Suicide, And Patient Safety

On Carl Elliott's Making a Killing

Chickens Coming Home to Roost at the University of Minnesota

Hazards of Market Driven Research - A Look at the Ethical Quagmire that is the University of Minnesota

Premack Award to Pioneer Press Journos for "The Death of Patient 13"

etc., etc., etc...

+++

Top 25 Recruiter Picks

Wall Street Journal

(Publics kick butt, but not U of M - why?)

From the Wall Street Journal:

1. Pennsylvania State University

2. Texas A&M

3. University of Illinois

4. Purdue

5. Arizona State

6. Michigan

7. Georgia Tech

8. Maryland

9. Florida

10 Carnegie Mellon

11. BYU

12. Ohio State

13. VPI

14. Cornell

15. Berkeley

16. Wisconsin

17. UCLA

18. Texas Tech

19. North Carolina St.

19. Virginia

21. Rutgers

22. Notre Dame

23. MIT

24. Southern Cal

25. Washington St.

25. North Carolina

Most of these schools aren't interested in becoming one of the third greatest public research universities in the world... Where are our priorities at the University of Minnesota, President Bruininks?

As in athletics, where we talk about the Rose Bowl, and get beaten by South Dakota?

+++

Succession Problems at the University of Minnesota

"If we upset Southern California, people will quickly forget this game," Bruininks said."That's a tall order, but I think we can do it." 9/11/2010

"Starting in 2004, the University began the first comprehensive strategic planning process it had undergone in almost 15 years. Under the leadership of Provost Sullivan, the University community articulated an ambitious aspiration for the University—to be one of the top three public research universities in the world [sic] within a decade."

"Serving Minnesota Through World Class Greatness"

Which is more delusional?

The latest mess at the House that Bob Built (aka TCF stadium or the House of Pain) concerns firing Coach Brewster now or later. In either case the AD, Joel Maturi, would presumably do the search for a new coach.

[I suppose the President could fire Maturi, but then HE'D have to come up with a new AD and PresB is what is delicately referred to as a lame duck. Full disclosure: Overall Maturi has done a good job n my opinion.]

So, let's see. Maturi picks a new coach, and a new President comes in and he wants his own AD. Good-bye Joel, your contract is up. New AD did not pick football coach...

I think the problem is obvious and could have been prevented if there were any stray brain cells running around in Morril Hall.

Which brings me to an even bigger problem - the U of M presidential search which has all the earmarks of a disaster. How long did the BoRe know that the prez was going to be gone? And when did they start the search? And how likely is it that they can come up with a good candidate from outside? And was this maybe the idea?

Looks like we'll have to pick another insider again. The leading apparent inside candidate would be a disaster. There are others further down the pecking order who MIGHT do a decent job, but unfortunately the overwhelming number of possibles below the provost level would also be disasters.

Looks good for neither Gopher athletics nor Gopher academics...

Sad.

Telling Comment on President Bruininks

(University of Minnesota)

in the Star-Tribune

Upset fan on Bruininks:

Actually, Bruininks has failed in almost everything

I'd be curious as to what the "very strong things" Bruininks has done academically might be.

Tuition for Minnesota residents has soared while he expanded the number of vice-presidents earning six-figure salaries, there aren't enough TAs to grade papers, his Driven to Discover campaign has done nothing to improve the U's national ranking - in fact it dropped this past year - and the U's own measure of the caliber of its students places it near the bottom of like-universities in median SAT scores and top 10% of high school graduating classes.

What Bruininks has done is invest a great deal of time and political capital into getting the new TCF Bank stadium built.

Yet for all the political and real capital expended, we're left with a stadium that isn't full at game time and a team that is a joke.

At the same time, the U men's hockey team has declined significantly while the men's basketball team seems to have topped out at good-but-not-great play under a national champion coach. From where I stand the administration has failed in both academics and athletics, some of the non-revenue sports notwithstanding.

Under a "condition of financial stringency"

the University of Minnesota pours more

sand down the Driven to Discover Rathole

From the Faculty for the Renewal of Public Educaton - Reclaim the University of Minnesota - site:

Driven to Distraction

FRPE has long been critical of the U's Driven to Discover PR campaign. Wasteful in good times, spending obscene amounts of money on a PR campaign borders on criminal when deep cuts are being made to instructional budgets. It perfectly illustrates the misplaced priorities of our leadership. STRIB reporter Jenna Ross attended this month's Regents meeting and Tweeted that "U of M will restart 'Driven to Discover' TV ads Sept. 27. Survey presenters warning that when that campaign stopped, public opinion dropped."

http://twitter.com/ByJenna/status/23940516562

Looks like this will be the ad (warning: grab a bucket first because watching it will make you sick to your stomach):

http://mediamill.cla.umn.edu/mediamill/display/78681

How much was spent on creating this 3 minutes of baloney? And how much more will be flushed down the toilet on the television campaign?

University of Minnesota

Presidential Search

Will History Repeat Itself?

From the web-site of FRPE - Faculty for the Renewal of Public Education, Reclaim the University of Minnesota:

The University of Minnesota is searching for a new president. The 12-person advisory search committee is hard at work assembling a slate of finalists.

In 2002, the Board of Regents tossed out the list of candidates prepared by the search committee and instead, after a series of closed meetings, chose to appoint interim president Robert Bruininks as the next president of the University of Minnesota.

The University only released the names of the finalists after being sued.

Will this year's search culminate in another inside job?

Will the Regents continue to act like a junta that can make decisions behind closed doors, appointing insiders and perpetuating the cycle of incest?

Most of our peer institutions appoint people from outside their institutions, and for good reason.

An individual who has participated in leading an institution down a questionable path is unlikely to make radical changes.

We need new blood that will bring a more inclusive and daring vision for our land grant institution, one that values intellectual inquiry and the public good over revenue generation and private profit.

For additional commentary on the presidential search see:

http://ptable.blogspot.com/2010/09/search-for-new-president-of-university.html#links

Recent Daily reporting on the search:

http://www.mndaily.com/2010/09/08/search-next-u-president-picks-speed

Search For A New President

of

The University of Minnesota

A day late, a dollar short, and a stacked deck...

The Daily has an article on this situation.

My comments on the Daily site:

About time.

We've know for quite a while that PresB was going to be gone. Waiting until this late in the game to start looking was not very smart. Now we are under pressure to do this quickly because we need a person on board NOW. Not smart, not smart at all... Recall the fiasco when the current president was hired? Much chest-beating, no suitable candidates could be found, supposedly, and the present occupant was installed. What if this happens again? I hope that it doesn't, but it might. Not smart to take a chance on our future with so much at stake.


While foot dragging has gone on here, two pretty good people have been available with BigTen connections who would have made excellent presidents. Within the last month, Wallace Loh has gone from provost at Iowa to the chancellor of the University of Maryland. He has a PhD and law degree and an excellent understanding of the academic side of the university unlike the run of the mill law school dean. He also has experience at a University with an excellent medical school and academic health center. He has been doing an excellent job at Iowa, despite a cheap shot by one of the Morill Hall Gang. Because Iowa has had terrible financial experiences lately, he would have been an excellent, experienced, and knowledgeable leader, unlike the current situation in Morrill Hall.

The new president of Illinois, Mike Hogan, previously UConn pres, was previously a provost at Iowa. He would also have made an outstanding president.

Question: Why do provosts at Iowa go elsewhere as president and this doesn't seem to happen here? Is it the quality of the administrators or is it parochialism?

Questions: Why do all the BigTen schools but two (Minnesota and Michigan State) have presidents who came from outside? Does it have anything to do with the stature or rank of the institution? Do insiders make middle management (vice presidents..) at Minnesota uncomfortable? Perhaps this would be a good thing.

I hope the next president is the equal of the new presidents at Illinois or Maryland. But starting this late in the game is going to make it tough to get a good candidate from outside.

Maybe that was the idea?

Emmer Caught Crunching Numbers on Laptop

From the Strib:

Republican gubernatorial candidate Tom Emmer has tried to beat back criticism for not releasing a full budget plan by attacking his rivals for not running their budget numbers through the Minnesota Department of Revenue the way he did.

The problem is, Revenue Department officials said they never officially reviewed the plan.

At a Monday news conference where he released $626 million in proposed business tax cuts and incentives, Emmer told reporters, "I went to the Department of Revenue and I said, 'Please run these numbers and tell me what they are going to be.'"

At a debate Tuesday, he stepped up the pressure on rivals to do the same: "Will you guys agree -- just commit today -- that you'll take your plan, just like we took ours, take it to the people that have the computer-modeling capabilities and show everybody?"

But Emmer's proposal never got vetted by number-crunching computers, according to the Revenue Department.

My comment:

Emmer is simply a buffoon and this is becoming more and more obvious.

There is no excuse for him not having put a serious proposal on the table by now so that all can make a judgment about whether his proposed cuts - what are they? - will solve our problems. This is unconscionable.

He has also played fast and loose with the truth, his claim of having had his budget vetted by the Minnesota Department of Revenue being just the latest example. He has weaseled on many other important issues.

Maybe the GOP should get another candidate or we should all start thinking about whether the Dayton or the Horner option is better.

Emmer is dangerous and an obvious loser. We can't afford to take another chance after the TeaPaw fiasco.

Risperdal - An Antipsychotic

Isn't it sweet of Pharma to provide these nice legos...

Child’s Ordeal Shows Risks of Psychosis Drugs for Young

From the New York Times

At 18 months, Kyle Warren started taking a daily antipsychotic drug on the orders of a pediatrician trying to quell the boy’s severe temper tantrums.

Thus began a troubled toddler’s journey from one doctor to another, from one diagnosis to another, involving even more drugs. Autism, bipolar disorder, hyperactivity, insomnia, oppositional defiant disorder. The boy’s daily pill regimen multiplied: the antipsychotic Risperdal, the antidepressant Prozac, two sleeping medicines and one for attention-deficit disorder. All by the time he was 3.

He was sedated, drooling and overweight from the side effects of the antipsychotic medicine. Although his mother, Brandy Warren, had been at her “wit’s end” when she resorted to the drug treatment, she began to worry about Kyle’s altered personality. “All I had was a medicated little boy,” Ms. Warren said. “I didn’t have my son. It’s like, you’d look into his eyes and you would just see just blankness.”

Today, 6-year-old Kyle is in his fourth week of first grade, scoring high marks on his first tests. He is rambunctious and much thinner. Weaned off the drugs through a program affiliated with Tulane University that is aimed at helping low-income families whose children have mental health problems, Kyle now laughs easily and teases his family.

Ms. Warren and Kyle’s new doctors point to his remarkable progress — and a more common diagnosis for children of attention-deficit hyperactivity disorder — as proof that he should have never been prescribed such powerful drugs in the first place.

Even the most reluctant prescribers encounter a marketing juggernaut that has made antipsychotics the nation’s top-selling class of drugs by revenue, $14.6 billion last year, with prominent promotions aimed at treating children. In the waiting room of Kyle’s original child psychiatrist, children played with Legos stamped with the word Risperdal, made by Johnson & Johnson. It has since lost its patent on the drug and stopped handing out the toys.

Greg Panico, a company spokesman, said the Legos were not intended for children to play with — only as a promotional item.

Dr. Mary Margaret Gleason, a professor of pediatrics and child psychiatry at Tulane who treated Kyle from ages 3 to 5 as he was weaned off the heavy medications, said there was no valid medical reason to give antipsychotic drugs to the boy, or virtually any other 2-year-old. “It’s disturbing,” she said.

Dr. Gleason says Kyle’s current status proves he probably never had bipolar disorder, autism or psychosis. His doctors now say Kyle’s tantrums arose from family turmoil and language delays, not any of the diagnoses used to justify antipsychotics.

There's more here, but I don't have the heart to read it...

(I am not related to Dr. Mary Margaret Gleason.)

Hat tip to Margaret Soltan.