How to Get Away with Academic Misconduct at the University of Minnesota

Carl Elliott, M.D., Ph.D.

January 10, 2013

In early 2009, antipsychotic fraud was making headlines.  Eli Lilly had announced in January that it would plead guilty to charges that it had illegally marketed Zyprexa. The company agreed to pay a record-breaking $1.42 billion in penalties. Meanwhile, AstraZeneca was defending itself in federal actions over its own antipsychotic, Seroquel, in which damning internal documents showed that the company had buried and manipulated data to boost sales. In March 2009, articles in the St Paul Pioneer Press and the Minneapolis Star Tribune reported that Charles Schulz, the Chairman of the Department of Psychiatry at the University of Minnesota and a consultant both to Lilly and AstraZeneca, was  implicated in AstraZeneca’s deception.  AstraZeneca would eventually settle the federal investigations for $520 million.

By December 2009, the University of Minnesota’s Board of Regents had received a complaint about Schulz. That complaint came from Mike Howard, a friend of Mary Weiss, whose son, Dan Markingson, had committed suicide in an AstraZeneca-sponsored trial of antipsychotic drugs at the university. Howard’s complaint was not about that trial, however. Rather, it concerned a wide range of questionable activities by Schulz, ranging from his weirdly evasive responses to questions about akathisia in a deposition, to the use of a placebo in a clinical trial involving acutely psychotic patients, to his dubious relationships with the pharmaceutical industry, including his paid presentations about Seroquel. When the university finally responded to Howard’s complaint over a year later, the response came from Mark Rotenberg, the General Counsel for the university, who dismissed the complaint in its entirety. “After careful examination of each allegation,” Rotenberg wrote, “we have found no University policy violations or other improper conduct by Dr. Schulz warranting any University actions against him.”

Given the time it took to prepare, Rotenberg’s defense of Schulz is remarkable not just for its brevity but for the absence of any evidence or argument. For each of the nine allegations that he identifies, Rotenberg simply refers to the findings of the “RIO,” or “Research Integrity Officer.”  The Research Integrity Officer does not speak for herself in the document, nor is she named, but in fact, she is Dr. Frances Lawrenz, the university’s Associate Vice-President for Research.  While all of the issues in Howard’s complaint deserve to be aired, Schulz’s work on behalf of AstraZeneca deserves special scrutiny.

One of the most notorious trials in the AstraZeneca deception was called Study 15, which compared Seroquel to Haldol, an older antipsychotic developed in the 1960s.  Haldol is often chosen as a comparator drug in antipsychotic studies because it is easy to beat. Yet Study 15 had returned some unexpected results. For one thing, it showed that patients on Seroquel gained a significant amount of weight – a fact that AstraZeneca went on to hide for years by burying and spinning its data.  In a 1997 email, for example, AstraZeneca physician Lisa Arvanitis is congratulated on the “great smoke-and-mirrors job” she has done on Study 15. But the weight gain was only one problem.  Study 15 also showed that Seroquel was no more effective than Haldol. In fact, on some measures, it performed worse. This fact had to be hidden as well, which the company accomplished by cherry-picking the results that would be published and those that would be buried. In one email, a company employee named John Tumas identified the buried studies and asked, “How are we going to face the outside world when they accuse us of suppressing data?”

By the time AstraZeneca had recruited Charles Schulz to present a “meta-analysis” of Seroquel studies at the 2000 meeting of the American Psychiatric Association, the company had conducted an internal analysis showing that Seroquel was no more effective than Haldol. (“The data don’t look good,” wrote one company analyst. “In fact, I don’t know how we can get a paper out of this.”) Yet this was not what Schulz told the APA. In his presentation and in press releases, Schulz claimed that Seroquel was “significantly superior” to Haldol. He spoke about the “dramatic benefits” of the drug. Yet in March 2009, when Schulz was caught, the University of Minnesota backed him fully. As the St. Paul Pioneer Press reported, “A U spokesman said that the dean of the medical school, Dr. Deborah Powell, is aware of the controversy over Schulz’s research and has offered him her full support.”

In the university’s reply to Mike Howard, Rotenberg addresses Schulz’s meta-analysis and APA presentation. But Rotenberg’s defense of the meta-analysis makes no sense. According to Rotenberg, the “Research Integrity Officer” – Frances Lawrenz — determined that the presentation did not violate the university academic misconduct policy because it was “based on different data sets and different measures being analyzed and reported.”  But of course, this is exactly what cherry-picking involves. Schulz used the positive data and excluded the negative in order to make Seroquel appear better than Haldol.

Later, in a trial known as Study 41, AstraZeneca compared Seroquel XR – the extended release version of Seroquel – to placebo in patients experiencing acute schizophrenia. The University of Minnesota was one of the study sites, and Charles Schulz was the site investigator. Remarkably, Study 41 showed Seroquel XR performing no better than placebo for schizophrenia.  In emails, AstraZeneca officials refer to Study 41 as a “failed study,” or “code red.” Advisors (such as Schulz) and employees were instructed not to discuss the study. So what did AstraZeneca do? They buried it and tried it again, this time in India, Bulgaria, Romania, the Philippines, Russia, Greece and South Africa. That trial was called Study 132, and it turned out positively. So in 2007 AstraZeneca published that study in the Journal of Clinical Psychiatry. The second author of that study was Charles Schulz, who presented the data at the annual meeting of the American Psychiatric Association and served as the academic point man in company press releases.

Again, in his response to Mike Howard, Rotenberg evades the real issue, which is the role Schulz played in the AstraZeneca spin machine.  Instead, Rotenberg does some spinning of his own.  Schulz wasn’t actually an investigator in Study 41, Rotenberg says – because Schulz never enrolled any subjects.  (Even if this is true — Rotenberg provides no evidence — it would not have prevented Schulz from seeing the negative results, of course.)  And when Schulz cited his own discredited meta-analysis as evidence of Seroquel’s efficacy?  Not a problem, says Rotenberg, because the discredited analysis still showed Seroquel was better than placebo. The charge that AstraZeneca buried the failed Study 41?  Not true, says Rotenberg; AstraZeneca published an abstract. (He does not say where or when that abstract was published.) And the fact that Study 132 produced much better results than Study 41, Rotenberg says, was based on “scientific reasons, such as different study designs.”  (In reality, the study designs are almost exactly the same.)

In fact, Rotenberg’s review doesn’t read anything like a legitimate review. It reads like a contrived defense of Schulz, complete with evasive statements, cherry-picked facts, and technical justifications of academic misconduct.  Actually, not only does it read like a defense of Schulz; it reads like a defense of AstraZeneca, which had already agreed to pay over half a billion dollars to settle federal charges addressing these very issues. All of which raises a number of disturbing questions about officials at the University of Minnesota.  Why is the General Counsel defending the actions of a pharmaceutical company? In fact, why is the General Counsel involved in an academic matter at all?  Why didn’t Frances Lawrenz, the university’s Research Integrity Officer, speak for herself?  Where is the supporting evidence for Rotenberg’s statements? And why isn’t anyone at the university looking into such a clearly deceptive review?

Note: originally posted on Fear and Loathing in Bioethics.

Carl Elliott, M.D., Ph.D.

Enemy of the People: Carl Elliott  is a professor at the Center for Bioethics at the University of Minnesota.  He writes on the medical-industrial complex, and is the author of Better Than Well and and White Coat, Black Hat.  

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4 thoughts on “How to Get Away with Academic Misconduct at the University of Minnesota

  1. What we must be honest about is that almost every psychiatrist, every university, etc. doing these so-called “studies” on how well these toxic drugs work are in bed with Big Pharma. The relationship is so entwined now that it’s too difficult to separate them from one another. No truth, no honesty is to be found in anything that the drug companies state about their products. But the American public keeps right on swallowing everything hook, line, and sinker. And they are screaming now for all of us to be medicated, even if it’s against our will and denies our human and civil rights, for the good of the country and for us!

    One of the sad results is that the integrity of our universities as research facilities is nonexistent at this point. They’ve been willing to compromise themselves to get in on the money being handed around by Big Pharma.

    Everything that Big Pharma has touced is tainted and unreliable in all respects.

  2. Is it normal conduct in a hierarchically structured society? Consider;

    THE KNOWLEDGE ECONOMY?

    Is PhD research into mental health about the livelihood of reseachers, more so, than the mental health of other people?

    In a hiearchically structured society, which group of people does the knowledge economy serve? Like the money markets of the worlds stock exchanges, can knowledge be the basis of a real economy?

    Does higher education provide more perceptive insights than real-life wisdom? Especially in Mental Health where PhD’s always cry, “we need more research?”
    Please consider this important message of hope in Mental Illness Recovery;

    “A Message of Hope in Mental Health Care: There IS an Alternative
    By Sophie Faught, MindFreedom International Communications Coordinator.

    In the previous MindFreedom blog, we presented some data from our Hope in Mental Health Care Survey (download the full survey summary here). This data showed that extremely negative prognoses and messages of hopelessness abound in mental health care. Often, these messages come directly from mental health providers. And very often, these messages turn out to be untrue.

    Across the board for every diagnosis, a majority of respondents to part two of the survey who had received a psychiatric diagnosis and were told by a mental health provider that recovery was impossible described themselves as “recovered” or “fully recovered” (equivalent to a ranking of 8, 9, or 10 on a 10-point recovery scale).

    Furthermore, many individuals who were told by a mental health provider that they would need to be on medications “for the rest of their lives” are currently not taking psychiatric medications. A significant number of them have been off psychiatric medications for at least one year.

    We ask again: why send messages of hopelessness when they are so often untrue?

    There is an alternative to the hopeless prognoses and messages frequently sent by the mental health system to individuals dealing with mental or emotional distress. Recovery is possible, and respondents shared information about the strategies that helped them maintain and achieve recovery:

    Are there really messages of hopelessness coming from our system of higher education, via the academics involved in mental health care? Consider the previous mindfreedom post;

    Where Do Messages of Hopelessness in Mental Health Care Come From?

    Is the real economy about Self-Preservation – Survival?
    Are there uncivil Conflicts of Interest in our hierarchies of Status & Rank, Civil Society?

    “Why would my psychiatrist be interested in curing my mental illness, when I and others like me maintain his lifestyle?” A close friend once asked me, in a very perceptive and equally subtle moment.

    “I’m an identified patient too,” I replied, “It begin in my family and I collude with the good doctor, hoping he will be the good parent of my missing childhood experience. Hoping he can assist in my emotional development.”

    “Your not going to waffle on about the parental nature of society again, are you!” He replied.

    Is the Knowledge Economy deeply conflicted, in the daily reality of Self-Preservation?
    Do we really need “experts” to teach us how to heal ourselves?

    http://bipolarbatesy.blogspot.com.au/2013/01/perception-phds-other-misconceptions.html

  3. Carl Elliot asks, “Why is the General Counsel defending the actions of a pharmaceutical company? In fact, why is the General Counsel involved in an academic matter at all?”

    Because this is the best way to make the complaint go away.

    When you send a complaint through channels, this is one possible result: Bureaucratic stonewalling.

    After this, the next step is to get some prominent person involved and make a big public fuss about it. Behind the scenes, a contact takes the complaint to the university president.

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