University of MinnesotaMedical School Newsby Sarah Hansen04/15/2013S. Charles Schulz, M.D., head of the Department of Psychiatry, will receive the esteemed Stanley Dean Award for Research in Schizophrenia in 2014. For more than 50 years, The American College of Psychiatrists [ACP] has issued this award to “a group or individual that has made a major contribution to the treatment of schizophrenic disorders.” The award will be presented at the next annual meeting of the ACP in February 2014. As part of the award ceremony, Schulz has also been asked to present a brief lecture on his work.
Schulz is the founder of the Schizophrenia Program at the Medical College of Virginia and, previous to his coming to the University of Minnesota, was the Medical Director of the Schizophrenia Module at University of Pittsburgh. He has contributed to the National Plan on Schizophrenia Research and with his colleague Dr. Carol Tamminga, started the International Congress on Schizophrenia Research. Schulz was featured as an expert in the 2011 Academic Health Center informational video The Value of Academic Medicine: Confronting Psychiatric Illness. Watch to see him discuss relevant psychiatric issues including schizophrenia.hat tip to altostrata…
The outcome variable in the study was voluntary continuation of medications. Patients with a diagnosis of Schizophrenia regularly stop their medications. The CATIE and CAFE studies hypothesized that the side effect profiles of the drugs were a major factor in the poor adherence rates, thus the outcome variable. In truth, side effect profiles are only one of many factors involved in this complex issue, and the naive notion that these drugs are the solution to the problem of Schizophrenia for either patients or society has long passed. But those larger questions aside, in this case there was ample evidence of fundamental research misconduct. Dan Markingson’s adherence to medication was not a function of side effects – it was legal repercussions. His semi-freedom to live outside an institution was predicated on staying on the medication.
There is another underlying assumption in such studies. The "non-compliance" is viewed as a paradox. Here is a medication that can rid the patient of psychotic thinking and symptoms, yet they stop taking it. How-come is that? While it’s another naive question, in Dan’s case, there’s none of the usual evidence that it helped him in any way. We’ve not seen a detailed case report [if there is one], but the observations of his mother and the staff at the Halfway House don’t confirm that it was helping. He was seclusive, grandiose, remaining in his private world that we don’t know about. If anything, the outside view suggests continued psychotic processes. The point being, there’s no concrete evidence that suggests that he responded to the medication in the first place.
A research program that condones or allows that kind of recruitment and inclusion deserves thorough investigation, and perhaps shutting down. The University wants to limit the investigation they have been forced into to remain limited to the program now – not what happened then. That allows Dr. Olson to continue to aver that they did "nothing wrong" and Dr. Schultz to make tapes like the one above selling that academic programs [his academic program] as the right places to do clinical trials. That should be true, but in this case, it wasn’t. This was not research misconduct lite – this was the real deal and what has been happening is, by any measure, a cover-up extraordinaire.
There’s another part to this story that isn’t the stuff of courtrooms or investigations. Dan Markingson was an Object, not an encountered person – a Subject. He was a Schizophrenia Object for the study. He was a Dangerous Person Object for the courts. He was a young adult taken out of the course of his life by a show-stopping illness we’ve known since the dawn of time. There’s no guarantee that he could have been helped, but if that had been possible [and it often is], it would require that the Subject Dan Markingson be encountered. Anyone who has ever worked with these patients knows that with such cases, that’s not always easy, and sometimes impossible. But in this case, it doesn’t seem that anyone gave it a shot. They didn’t even seem to register how sick he remained during the six plus months he was in their care.
dr mickey,
were the pills provided “on the house”, courtesy of AZ? i.e. when the patients were “on” their medication, was it an AZ branded pharmaceutical?
Gagan,
It was a blinded study, meaning his medication was either Seroqel, Risperdal, or Zyprexa, and the pills are made to all look the same. It was “double blinded,” meaning that neither he nor his doctors knew what he was taking. He was on Seroquel, but that wasn’t known until after his death.
in Canada they’ve apparently been using seroquel to sedate patients with dementia– to the tune of 200m dollars! (us canadians are quite shocked). http://www.thestar.com/news/canada/2014/04/12/star_obtains_list_of_redflagged_drugs.html
i can only imagine the kind of havoc this medication has wreaked on people’s lives.
i wonder what A-Z got out of conducting this study. this is why i asked if they were the manufacturers for all three drugs used in the trial, because i would think schulz/olson’s “materials” (pills?) were by A-Z (“on the house”, they are a pharma company after all).
the risk and danger involved in this sort of study makes me wonder just how foolish A-Z was/is, because they must have expected positive results. i do not see any other reason to conduct such a high risk study, given the *very* apparent intersubject variabilities in responding to these medications. there is just so much can go wrong (like dan markingson’s suicide).
i mean, of course there are going to be high risk studies in psychiatry, but these studies sure seemed premature (to say the least).
nonetheless, i digress. all we can do is fix the present and look to the future.
Dr. Mickey, I liked your object-subject discussion. We might even go further and say that Dan Markingson was viewed as a commodity and a means to obtain funding. Meeting the protocol conditions took precedence over sensible clinical decisions… it’s not as though there were no warning signs leading up to his death.
As for gagan’s question about what was the point of the CAFE trial, it was a pure experimercial – a cost is no object exercise designed to promote a product in a market niche. It had no redeeming scientific value. Folks may want to review the discussion of this on Danny Carlat’s blog back in 2010.
Great take on Schulz. It’s amazing to me that the moron has held his chair position after watching him squirm and weasel his entire way through the questioning thrown at him in his deposition in the Markingson case. He blatantly lies, deceives, can’t remember, or just plain refuses to answer certain questions. If telling the truth is never having to remember what you’ve said, Schulz can feign amnesia for the rest of his life. Giving him any award beyond jerk of the month is a complete waste of time. Not that anyone cares at the U of M, but he’s never authored an original paper, he’s never conducted any kind of cutting edge research, he’s never done anything but been a pharma puppet…and for that I guess you get an award. What a piece of work he is!!
Ideally, when something goes amiss in either clinical care or research, it should prompt both introspection and outside scrutiny to ask how things can be done better going forward. This is true whether the sentinel misadventure involved misconduct or not. When the University has resisted this sort of review (presumably out of concern for liability risk and unseemly discovery), it has also resisted the call to behave responsibly as an academic entity.
Ethical codes since the 1931 Reichsgesundheitsrat Circular have called for special protections of vulnerable subjects, and such protections are requirements for approval under both DHHS and FDA regulations. It’s hard to see how that requirement was met here, and an examination of what SHOULD be done is sorely needed. At a certain level, I find this one of the more disturbing aspects. Even if one does not wish to assign blame (or thinks that the time for that has passed), can we not learn from this?
Ironically, if the University is trying to prevent unseemly discovery, it’s tarnishing its image at least as badly by being unwilling to be examined. If it has nothing to hide, why hide what it has?
DEH
Awards are often the self flagellating of the elitists who just don’t have long enough arms to strongly pat themselves on the back loudly.
Oh, I thought they were ministrations by minions to another body part entirely.
You write, “I don’t know much about Dr. Charles Schultz and his research on Schizophrenia”. Actually, I think you do.