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| 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.
How can we ever expect things to change in the direction of ethical consumer oriented care….when the wolves are running the chicken coup…Dan is just one very sad and disturbing example of an institutional problem that is adversely effecting many millions… http://www.guardian.co.uk/commentisfree/2012/dec/05/obamacare-fowler-lobbyist-industry1
Let no one forget that Charles Schulz who headed the corrupt Seroquel studies at U of M is still a paid professor and head of the University of Minnesota Medical School Department of Psychiatry. He was cleared of all wrong doing by the University in a cover up & white wash of historic proportions.. just to powerful to be held accountable is the constant theme played out over and over again as the incestuous relationship between Corporate Dollars and University Benefactors continues unabated to this day… http://blogs.citypages.com/blotter/2011/02/charles_schulz_cleared_u_of_m_investigation.php
Stan,
As you say, “cover-up” and “white-wash” – tragic…
The thing to realize is what Dan’s death signifies, That is, what it says about the nature of medical research in psycho-pharmacology’ and the lack of regard some “professionals” have for psychiatric patients. As casually as this homicide was “whitewashed” and “covered up,” truly speaks a truth about the type of behavior that is, not exactly acceptable, yet it is accepted—covered up and white washed by others as well as the perpetrators. In the intro to White Coat Black Hat Carl shares a an observation made by his brother Hal; I believe it to contain a grain of truth, “…being a narcissistic sociopath is kind of a prerequisite for medical school.” The way we train doctors basically sets them up to make errors–all humans make errors when deprived of sleep and working in an environment which also requires them to develop alliances in order to fit into the medico-political system and become successful doctors. It is this professional camaraderie steeped within an adversarial competitive system that breeds the social conditions which enable individuals to passively accept, and even to justify becoming passively or actively involved in a cover up.
The profession of medicine has undermined its very foundation – the trust of patients and of the larger public – by way of the all too common sins of personal ambition and greed. Its bio-psychiatric branch may bank on futuristic technologies and cures, unwilling to admit sins of commission, corruption and omission, of which those honest doctors there are, risk being tainted too, unless you take part in the ongoing public fight for transparency, accountablility and responsibility for patients and the common good, as I am glad to see in these pages. CUDOS!
More mothers will – hopefully – follow the good example set by Dan Markingson’s grieving, angry mother. Many are betrayed when entrusting children to psychiatrists, and more will die young if Big Pharma et al are allowed to continue to “white-wash and cover-up” to make tons of money, global sales soon expected to rise to trillions of dollars, of which psychopharmaceuticals are among the most profitable, according to IMS Health.
Becky’s point is good. Systems attracting/ producing so much callousness are deeply flawed, demonstrated time and again, also by Philip Zimbardo in The Lucifer Effect. We must stop it, as Zimbardo’s wife-to-be did when she saw the goings-on in the Stanford prison experiment, and keep telling it to the world!
Becky, I was just thinking about that last week— residency is a long hazing ritual.
Psychiatry has entirely too much power, too little self-policing, and too much money gained through corruption and the exploitation of those they label as mentally ill.
It seems that in the process of denying all contributors to mental disorder and mental distress but genetics and brain flaws, that psychiatry has failed to take into account that the practice of psychiatric treatment itself may be disheartening, denigrating, degrading, distressing, and disordering.
Like the LAPD, psychiatry is saying that they can’t have hurt these people— they’re mentally ill— their statements can’t be taken at face value, ever. The patient is an unreliable witness to his or her own pain. Everything about a mental patient is a matter of interpretation by a professional psychiatrist, because the patients lack insight, so what they say and feel doesn’t matter— it’s all in their disordered little heads.
What a vulnerable person needs, apparently, is to be so completely stripped of power and agency so that they can’t claim their own experience and can’t do anything to better it. What a person who has been labeled “mentally ill” really needs is to be dissed.
Compliance is everything. Resistance is futile. Submit.
Two more words then I’ll be quiet about this one—
negligent homicide
The evidence for fraudulent consent forms is irrefutable. So how did these guys get cleared????
Thank you wiley and berit bj for your feedback. To clarify how I became interested in this whole mess: my son was used in drug trials as a minor without consent—in spite of my vehement protests. He will be 25 this month, I am not only his mother, I am his caretaker. My son is a victim of crime(s) http://involuntarytransformation.blogspot.com/2011/12/jon-mcclellans-testimony-to-us-senate.html
If the consent forms are indeed fraudulent, that is probably a criminal act, and the state attorney general needs to be involved.
Anon
I think that’s where they are headed…