Academic·Industrial·Complex I…

Posted on Saturday 18 April 2015

Now that the case of Dan Markingson’s 2004 suicide is no longer in the realm of unacknowledged tragedy, moved into the public domain by two recent reports villifying the University of Minnesota’s Administration and Clinical Trials program for its handling of the case throughout, we can begin to think about what it all means.  The implication in many of the discussions of the case is that the Department of Psychiatry’s Clinical Trials program is more revenue generator than a scientific enterprise, and that Markingson’s case is just the tip of the iceberg large enough to sink the Titanic. And speaking of icebergs, there’s the broader question of the involvement of many other Departments of Psychiatry in churning out industry sponsored [and industry controlled] studies of commercial products with results tipped  towards the needs of these sponsor’s products.

I recall being told as a Medicine Resident in Memphis Tennessee in the late 1960s that the "Biological" Psychiatry programs were the ones "along the Mississippi River." Well the Mississippi River arises in Minnesota and ends in New Orleans Louisiana, and looking along its course, that generalization seems to be true. In 1980, the year of the DSM-III "revolution," Paula Clayton moved from Washington University in Saint Louis [the epicenter of "Biological" Psychiatry] to become Chairman at UMn. She was replaced in 1999 by Charles Schulz in 1999, who stayed until last week. By the time he arrived, psychiatry in the US was "Biological" in general. There’s a long interview of Dr. Schulz done in 2010 as part of an oral history project [Interview with S. Charles Schulz, M.D.] where he lays out the plan he had he had when he left Case Western Reserve in 1999 to become Chairman at Minnesota – Neuroimaging [Minnesota had a state-of-the-art Neuroimaging Center], Genetics, and Drug Trials. In fact, in laying out his plan, he’s defining the story of academic psychiatry in the modern era – research as fund-raising:
In the number of visits I made to come here, learn about what was here, talk with Dean Michael, administrators, faculty, Apostolos, etc., I developed an idea to focus our academics on imaging, genetics, and clinical trial research, and the rationale for that being we had one of the greatest imaging centers and that’s what the NIH wanted to do. Genetics were emerging. There hadn’t been a person imaged in CMRR, there hadn’t been a blood drawn for genotyping in the department, and I said – We have to get going in these areas. Both of those areas, I thought, could interact with doing very good clinical trial studies, and I felt a university department was very important for the faculty involved in what was the latest things happening. My experience at Case, especially working with Herb [Meltzer] and with Joe Calabrese, were that the participation in the clinical trials of new compounds led our faculty to be expert in them, basically the day they were approved. I thought also that by doing very good clinical trials, we could use those results in an interface with imaging and in genetics. So, like Dr. [David] Mrazek at Mayo says – "Let’s draw your blood and find out what’s going on in your serotonin or your transporter genes or your metabolic genes and that’ll help us with your treatment. The same is also true for imaging, where we’re now imaging at baseline, giving them medicine, imaging after the study is over, and seeing where does the drug act in the brain. Or, can we tell who’s going to respond and who’s not going to respond. So the interplay was actually more important than the three items of imaging, genes, and clinical trials.
I don’t particularly like that kind of talk either, but having been an administrator in an academic department being pushed [kicking and screaming] in that academic direction, I know the pressures on a medical department chair to raise money to run a department. Academic Medical Education is funded by… the Academics. That’s just life. If you do heart surgery, the money pours in from the faculty’s work. If you do psychiatry, welcome to the Sahara Desert – there’s no free lunch. So I can live with Schulz’s profiteering, or at least understand it. But the fulcrum is on the two meanings of the words «very good clinical trials».

  1. One meaning of «very good clinical trials» is "trials that add something to the body of medical/psychiatric knowledge" [rather than experimercials being financed by the drug companies for commercial reasons]. In the modern era, that’s not such an easy task. Remember, this is AstraZeneca, maker of Seroquel®, and we recall this famous memo [November 1997] making it very clear what kinds of things AstraZeneca might be willing to fund:
    click image for the source
  2. The second meaning of «very good clinical trials» is "doing the clinical trials well" – ethically, humanely, carefully, honestly, etc.  And the whole reason we’re talking about this is the Dan Markingson case. It’s unlikely anyone reading this is going to say that this case is an example of doing anything well
So here is the core structure and the core problem of the Academic·Industrial·Complex that grew in psychiatry in the 1970s, 1980s, and 1990s as the funding from government sources dried up [along with the private sources]. All of Academic Medicine has to struggle with these forces, but psychiatry was hit with a perfect storm because of the decimating impact of Managed Care on psychiatry specifically thrown into the mix. In this example, uncovered by the suicide of Dan Markingson, we have a window into how widely its impact was felt. As a matter of fact, in the interview, Dr. Schulz is asked about Conflicts of Interest [here]. Here are a few quotes from his response:
A difficult and challenging topic, and I think I mentioned earlier that when I came and drew up a strategic plan for our department and worked with Dr. Cerra at the AHC [Academic Health Center] and with Al Michael, I strongly felt that a Department of Psychiatry should be able to be involved in clinical trials to advance treatment and to be very familiar with medicines as they came out. I felt that patients need to be well cared for and highly respected, so with Dr. Cerra and Dr. Michael, I was able to get as part of my package to come here the resources to build the ambulatory research center. And this is in our professional building, it’s 5,000 square feet of space devoted to clinical trials, to assessment for imaging studies, etc. The interview rooms are nice, they have a window, etc. There’s a wonderful reception area and each person who comes to be in the research, is greeted by a person. They have a little area for children to sit if they are going to be in the clinical trial, etc. Exam rooms, conference rooms, the whole thing.
On arrival, he had his Clinical Trial program set up and ready to go. He goes on to talk about Conflicts of Interest in other areas of Medicine – Orthopedic Surgery [artificial joints], Cardiology [stents], etc. But then the wheels start coming off the wagon, or at least start getting very loose…
… but psychiatry, boy … front page in the New York Times for even the president of the American Psychiatric Association – grilling, nasty things. His university investigated him thoroughly, and he had done nothing wrong. As a matter of fact, what he had done is he had done exactly what the president of Stanford had asked him to do, Dr. Schatzberg. So, in my impression, looking at this, there probably are some instances of the high-flying industry utilizing academia in ways that was not fully appropriate, that the new guidelines for managing conflicts of interest and improving transparency are very, very appropriate in my mind. I think they, if followed in the way that I think our university has put forward and the way Dr. Cerra has expressed his wish, he, from the first day I met him to now, has said – I want us to be able to collaborate with industry, whether it is pharmaceutical or device, or whatever; but, let’s make it real clear what we’re doing. I think we can move ahead with this. And our conflict of interest policy here at the University is really pretty much that way. Not pretty much, very much – it’s actually as strict as any conflict of interest in the US.
…and then he starts talking about the Markingson case and the impact of UMn Bioethicist Carl Elliot‘s campaign on his grand scheme. I’ll leave that to you to read. His reference to Dr. Schatzberg is to Senator Grassley’s investigation of academic psychiatrists not reporting personal income from drug companies. He’s claiming that academic psychiatry was unfairly persecuted [many of us think otherwise – not only were they not falsely persecuted, we wish they’d been truly prosecuted].

But that’s enough for one post. Carl Elliot and colleague Leigh Turner have felt all along that this case was indicative of a problem that had wide implications. After all, Carl’s first article was entitled "The Deadly Corruption of Clinical Trials", not "The Deadly Corruption of a single Clinical Trial". And yesterday’s New York Times has another case from a Cliinical Trial done in Minnesota [A Drug Trial’s Frayed Promise], obviously pursuing the idea that the Markingson case was just a loud example of something generally rotten in the state of Minnesota.

There’s little question about what the next post is going to address…
    Mike Howard
    April 19, 2015 | 7:13 AM

    The first time I read this interview between Schulz and the Minnesota Psychiatric Assoc I almost gagged. Schulz must have selective memory syndrome or is actually so far gone that he can hide his own Easter eggs every year. He talks about Dr Dunner as his best buddy who offered to endorse him for the chair position at the UMN, and who also is at Schulz’s wedding. Well, in his sworn testimony during the Markingson case when asked if he knows any of the expert witness’s (hired guns) that his attorneys acquired he comments that he barely knows of Dunner, may have spoken once in the hall of some APA convention. When the topic of conversation turns to the Markingson case, Schulz states that Dan Markingson was living in a residential “treatment center” at the time of his suicide. Um-he was living in a group home with a couple of other residents..Schulz states that the lawsuit was so weak that the court judge would not allow an appeal of the verdict..Um- there was no verdict beyond the court granting the UMN immunity from being sued. These are just a few of the “whoppers” as Governor Arne Carlson calls them that Schulz spits out on a regular basis. Just the kind of honesty and moral integrity that one would expect from the chair of a department at a major university. Gag

    Sandra Steingard
    April 19, 2015 | 9:11 AM

    The link to the full interview does not seem to be working. And thanks again for another great post.

    April 19, 2015 | 10:39 AM

    Thanks for the link. How some of us came to 2010 (and 2015) with such different views of both the history and promise of psychiatry is an ongoing topic of (sad) fascination for me. By 2010 (really by 2000), there was already so much reason to be worried about what had transpired and to reflect in a less defensive way. I look forward to reading more from you.

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