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.
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.
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:
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…
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.
… 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.
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.