|Dan Markingson’s Chart||Another subject’s chart|
Several weeks ago when I read the article about Carl Elliott’s recent findings in the Dan Markingson case, I was at the beach on a notebook computer and unable to upload any graphics. So this is a supplement to living history… and sign up…. As a reminder, in the Dan Markingson case, one central feature was that he was being hospitalized on legal grounds in which the physician in charge had declared him incompetent to make his own decisions, yet he was recruited into a study whose outcome parameter was the length of time the patient continued to take medications. Dan was only allowed to be in the study if he agreed to stay on medications. Huh? No, you’re right. It doesn’t make any sense. Now it appears that there were two consent forms in his chart that looked [exactly] like the one on the left above. Dr. Elliot recently obtained the consent forms from two other patients in the study that were exact copies [one is shown above right]. That is outrageous.
You don’t have to have a CSI or handwriting degree to see that they’re duplicates. Even at the low magnification above, they are identical [click to see the originals]. It’s obvious that some study coordinator just added photocopies to the various charts without even going through the process of actually asking the questions, and recording the individual’s answers. How big a no-no is this in clinical research? Can’t get much bigger unless you make up the subjects altogether.
So we’ve got an acutely delusional and dangerous young man, declared mentally incompetent, who is told that the only way he can get into a less restrictive environment is to be in a drug study, and that taking his medications is a condition of staying in the less restrictive environment. Yet the study’s outcome parameter is how long subjects will voluntarily stay on their medications. Now we learn that the chart has a "dry labbed" [faked] consent form. Add to that his mother’s increasing worry well communicated that he remained intensely psychotic and her concern that he would commit suicide. What could be worse? And so he does kill himself. In a great irony, had he not done that, he would have been considered a treatment success since he continued on the medication [because he had to].
Often on this blog, I talk about over-medication or prolonged medication as bad things. This is an example of something else. Even the most drug averse among us would agree that when someone is as dangerously psychotic as this young man, homicidal and suicidal, you use what you have to use to acutely control the psychotic symptoms and observe him carefully. No one would suggest that you put him on a fixed maintenance dose of one of our softer antipsychotics and move him to a less restrictive environment. No one would have said that he was competent to sign on to a drug study. No one would fake a study consent form. No one would suggest you ignore the family’s input. Yet every one of those things happened presumably because they wanted to get their study done.
As to whether the study [financed and directed by AstraZeneca] was intrinsically rigged, there was a great blog and discussion on Danny Carlat’s blog, with all of the principles weighing in [Was the CAFE study manipulated by AstraZeneca? Maybe Not]. But this kind of thing, where the same photocopied consent form is in multiple charts speaks to something else – study coordinators who are not on top of the conduct of the study or the care of the patients in the study. And that reflects all the way to the top – the local and overall Principle Investigators. People with Dan’s illness are lethal, but in this case, the blame for his death does not fall on Schizophrenia, it rests with his care, and the intrusion of a probably unnecessary clinical trial, designed to neutralize the results of the NIMH CATIE Trial.