The Markingson Files: University of Minnesota dallies on clinical trial documentation

Published on
June 24, 2011

Markingson Files, Carl Elliott, University of Minnesota, William Heisel, Antidote blogIn March, Antidote asked Dr. Charles Schulz at the University of Minnesota for an interview about a clinical trial he had overseen in which a patient had killed himself.

The suicide of Dan Markingson has been the subject of numerous stories, including an in-depth piece by University of Minnesota bioethicist Carl Elliott.

Schulz did not respond. Dr. Stephen Olson, who was the co-investigator on the clinical trial, did not respond to a similar request. But I did receive a very candid email from the public relations manager for the Academic Health Center, Justin Paquette, who has been cordial in every exchange:

First and foremost, the topic sounds interesting and we very much appreciate the opportunity to discuss this case, but I'd like to decline – and here's our reasoning. Our University has been dealing with Carl Elliott's personal crusade against our psychiatry department (and Drs. Schulz & Olson specifically) for a number of years.  Unfortunately, lost in the marketing around Carl's books and the articles he authors is the fact that the multiple bodies who have examined this case (and the University's role in it) have never found a connection between Dan Markingson's unfortunate suicide and this clinical trial.

I'm unsure how one man's opinion has been positioned above the findings of the federal government, state reviews, the courts and our own University's review boards, but such has been the case. And just in the past few months, you can now add our Board of Regents to the list of reviewers who haven't found any connection between the CAFÉ trial or Seroquel and Dan's death. I can appreciate the beliefs of Dan's mother, and I can see where Carl's interests lie – but the facts simply point a different direction.

While I would never imply the media coverage has been unfair, I would say that it's been unfortunate that one man has been given such a voice when the facts prove his logic is unfounded. I understand that fiction is sometimes more interesting than the facts, but it's been frustrating for our University to see media coverage that borders on editorial or opinion positioned as news online and in some print sources. However, I would also say that the major news media in our area has not covered this since the original story broke years ago, which may further prove that there is simply nothing new to discuss. This is essentially a long-winded way of saying that I'm unsure it makes sense for our University to continue discussing this through the media. We appreciate you reaching out.

Crusade? Fiction? Unfounded logic? These are phrases that perk up a reporter's ears. I wanted to see for myself how all of these independent investigations had exonerated the university, so I asked for an interview with someone at the university who could talk about the importance of conducting clinical trial research while maintaining clear standards for patient protection. I wrote on March 17:

It's difficult, though, to separate clinically sound decision-making from the needs of a pharmaceutical company to establish a case for its product. So, whether Dan Markingson died because of the trial is just part of the larger question that Dr. Elliott raises of whether these trials are more beneficial to the companies than they are to the trial participants and future patients. That's really the important question. Do you know of anyone who might be able to talk with me about that larger question?

Paquette said he would try to find someone for me to interview.

I like to think that I'm a patient person. I know that the Markingson case has been a pain for the University of Minnesota and that Paquette and his colleagues have a lot of other projects that deserve attention, including research into a vaccine for cytomegalovirus and a new Cardiovascular and Cancer Research center.

I did not write Paquette again until May 3, when I said:

I would appreciate it if you could provide some documents for some of the things that you mentioned above. It would be great to post some documents about the federal reviews, the state reviews, the court reviews, the multiple University reviews and the Board of Regents reviews. My intention is to walk people through the documents and explain how they relate to the case.

Paquette wrote back:

Let me pass this request upward. I know the Regents response, etc., should be easy enough to pass along b/c it was recent. The other parts may be more challenging.

There must have been significant challenges somewhere up the authority chain, because by May 11, I still had not been given a response. I bugged Paquette again, and he wrote back on May 16:

Was told that most of the documents you referenced pertaining to the exhaustive investigations around this case years ago (and most recently from our Regents) is all a matter of public record. If you want the U of M to provide them you can put in an official request that I can forward to the general counsel's office, but it wouldn't be an immediate turnaround. Also, my initial assumption was confirmed – administrators within the University don't see the need to comment on this case further. Carl will likely continue on his own personal path with regards to this case, but the U of M won't discuss it any more.

Confused by why I would need to make an "official request" beyond what I had already requested, I asked:

I'm not sure what you mean by an official request. Is there a template that the university requires people to follow?

That was more than one month ago. I have yet to receive any documents.

Meanwhile, Elliott has been asking the university for the same records, and the school finally provided some documentation to him. I will go over the records and what they mean in upcoming posts.

To see more posts from the Markingson Files, click here.