I don’t know much about Dr. Charles Schultz and his research on Schizophrenia, but we all know that he and Dr. Stephen Olson were co-investigators for the Minnesota arm of the CAFE study, a Clinical Trial funded by Astra-Zeneca to compare maintenance antipsychotics in first-break Schizophrenia. We also know the Dan Markingson was inappropriately recruited and included in this study, and killed himself some six months into the one year trial [see
Fear and Loathing in Bioethics<\/a>]. <\/div>\nThe 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.<\/p>\n
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.<\/p>\n
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<\/em> – not what happened then<\/em>. 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.<\/p>\nThere’s another part to this story that isn’t the stuff of courtrooms or investigations. Dan Markingson was an Object<\/em>, not an encountered person – a Subject<\/em>. He was a Schizophrenia Object<\/em> for the study. He was a Dangerous Person Object<\/em> 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<\/em> 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. <\/p>\nSo there are two issues in this story: an egregious and concrete violation of research ethics that was likely a factor in Dan’s suicide; and an absence of an essential something that’s hard to measure, but when it’s missing, it’s too loud to ignore. It’s too late for Dan and his mother. But the case deserves a full hearing and investigation because of its bearing on future research at this center and elsewhere. But, secondly, it deserves a full hearing at large because of what was missing. There are countless future medical workers who need the case of Dan Markingson in the back of their minds throughout their subsequent careers to remind them of what really matters about what they do. There is certainly no call for a celebrity award anywhere in this story…<\/div>\n","protected":false},"excerpt":{"rendered":"
Psychiatry head to receive major award University of Minnesota Medical School News by Sarah Hansen 04\/15\/2013 S. 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 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-45601","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/45601","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=45601"}],"version-history":[{"count":16,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/45601\/revisions"}],"predecessor-version":[{"id":45617,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/45601\/revisions\/45617"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=45601"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=45601"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=45601"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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