What you might write in a blog post or argue in a comment may be very different from what needs to be done in the very next case you see. Say you are strongly drawn to the point that antipsychotic medicine is toxic and should rarely be used. Further you may be sympathetic to Thomas Szasz’s view that mental illness is a myth and personally opposed to involuntary hospitalization. But then you meet someone like Dan Markingson whose mind is filled with compelling paranoid ideas and who is driven towards violence. It’s the kind of case where acting on your ideology would be in error. Dan’s involuntary hospitalization and medication with an antipsychotic was the only rational choice. Likewise, there’s no algorithm that dictates which medication, or how much, or the duration of his confinement. These are all things contingent on his response, not preconceived ideas based on ideology or guideline.
What happened several days later defies understanding. In Minnesota, committed patients can be offered another option, a stay of commitment, and avoid being confined to a mental institution as long as they agree to comply with the treatment program laid out by their psychiatrist. Dan was offered the stay if he would enroll in the CAFE clinical trial [Comparison of Atypicals in First Episode] in which he would be randomized to take either Seroquel, Zyprexa, or Risperdal. The absurdities were everywhere. He had been declared unable to "make decisions regarding his treatment," yet he was allowed to sign a consent form to be in the study. It was a maintenance study yet Dan had not responded. And he had written those notes above. After a few weeks, he was transferred to a halfway house that hardly addressed his lethality. The outcome parameter of the study was how many patients voluntarily discontinued the medication, yet Dan was court ordered to take the medication as a condition of his stay of commitment.
The treating physician was blinded to his medication, and the protocol didn’t allow for change of medication or dosage – hardly consistent with the needs in this case. Throughout the winter, Dan’s illness persisted and his mother mounted a campaign to get him out of the study without success. In the Spring, Dan killed himself violently with a box cutter leaving a bizarre note, "I left this experience smiling!" [see Carl Elliot’s, The Deadly Corruption of Clinical Trials for a more comprehensive history].
Everything’s wrong with this case. The CAFE study was an AstraZeneca experimercial conceived to counter Seroquel’s poor showing in the NIMH CATIE study. The rigid design didn’t allow the flexability needed in treating first episode psychotic illness, particularly one like Dan’s. Dan was no candidate for the trial on any count for obvious reasons, not the least of which was being required to take a medication in a study measuring patients’ rate of voluntary discontinuation of medication. He’s the kind of case where non-response to a first choice of medication would’ve dictated trying others, adding anxiolytics [forbidden by CAFE protocol], and considering a drug reserved for refractory psychosis. While there’s no guarantee that he would’ve responded, this is the kind of dire mental illness that calls for careful and vigorous treatment, not an unnecessary, fixed treatment, blinded clinical trial.
Carl Elliot, a bioethicist, has mounted a campaign to have this case investigated, so far without success. Most who hear the story or read the book, are horrified by what happened, but it has never become the expected cause célèbre in spite of a herculean effort by Carl and Dan’s friends and family. I have a speculation about why it hasn’t caught on, ignited the fire it deserves. My speculation is based on my own internal response to the case. I think Dan’s care was outrageous, and reaches to the heart of doing clinical trials for pharmaceutical marketing rather than to answer genuine scientific questions. I question whether the trial should’ve been done at all. In the case where it was done, I’m sure that Dan didn’t belong in it. And I can’t get around thinking that his being enrolled was to meet recruitment goals. Had he chosen to stop the medication [the outcome parameter], he faced "recommitment," something he didn’t want. His mother’s desperate attempts to withdraw him were ignored.
But I haven’t written much about it myself, at least as much as I would’ve expected given how I feel about it. I know he shouldn’t have been put into that study, We all know that. I think I’ve been inhibited because what I really think is that he should have been committed involuntarily for as long as it took to treat his severe psychosis. What I think is that in this case, antipsychotic medication should have been pursued vigorously in an effort to get his psychosis under control. What I think is that Benzodiazepines are often important adjuncts in such cases even with their addictive potential. What I think is this is the kind of case where considering the potentially toxic antipsychotic, Clozaril, with careful monitoring would be appropriate. And what I think is that Dan had a Disease. These are not popular things to say, and when I mention them, the comments often fill up with accusations and reminders of the psychiatric abuse of power, and I become the enemy to people whose views I often share. I felt a cringe even writing this paragraph. That probably shouldn’t bother me, but…
So I wonder if Carl Elliot has had difficulty engendering the kind of support he deserves and needs because this case stirs up such conflicted feelings in all of us, feelings that reach into the essential core of ethics – as his title implies, fear and loathing in bioethics. Ethics are easy when they’re simplified and you’re carrying a banner of truth, justice, and the American way. But they become hard when one is filled with opposing forces and conflicting motivations as is often the case in clinical medicine. I genuinely believe what I said in the last paragraph is the ethical approach to a paranoid, potentially violent, psychotic patient like Dan. In many other psychotic patients, I think an environment with the least possible restraint and the conservative use of medications is the ethical approach. The ethic is determined by careful attention to the human being in front of us, not by an ideology or some general treatment guideline or algorithm, certainly not by the marketing needs of a drug manufacturer. I’m absolutely sure that including a dangerously ill person needing a flexible vigorous treatment approach in a rigid, superfluous, blinded clinical trial is, by definition, unethical and deserves the most thorough investigation.
who was the authority who supervised the agreement and was expected to enforce it by coming for dan and returning him to the hospital?
Sadly, both here and abroad, we find that only through the legal system do we find any type of control. The loss of life seems to be the trigger for any action. The only question is when will we in the US become so irate about cases like this that we see controls put in place to safe guard the participants?
http://www.newscientist.com/article/dn24421-badly-run-trials-behind-indian-drug-testing-freeze.html?cmpid=RSS|NSNS|2012-GLOBAL|online-news#.UmAZQ9KTjno
Steve Lucas
Whether Dan Markingson’s deterioration into psychosis was caused by a Disease or his life’s mix of bio-psych-social forces, I do not know, as I do not know all the whys of my gifted, peaceloving son’s decent into psychosis and crisis.
I wish there had been a dr Nardo up the road to consult, and a dr Tom Andersen and Jaakko Seikkula system of Open Dialogue,in place to minimize fear and the potential for harm – being with the suffering person first and foremost, administering toxic substances only as last resort, preferably the least harmful – “the best individual care of patients that we can muster”. denied Dan Markingson and so many other vulnerable people because of rampant corruption in medicine, business, academia.
Carl Elliot’s and Mrs Markingson’s struggle for truth and justice is heroic.
I certainly agree with you, Mickey, that he should have been receiving treatment for his psychosis so that he could stabilize, and that the use of drugs was appropriate.
The field of psychiatry has influence over the law that is out of proportion with its reliability. Drug companies have so much influence over clinicians, that Markingson could be forced into a drug study, that was, as you say, an “infomercial” is evidence that the whole field has crossed so many lines that it needs desperately to be reigned in.
That the field is treating so many people as if they were as psychotic and dangerous as Markingson illustrates how indiscriminate the field has become.
People who need psychiatry, hospitalization, and meds (temporarily or otherwise) the most who are often being denied appropriate care and being put out on their own, while— I suspect, people with much more benign conditions are being over-treated and hospitalized according to their insurance coverage, over-diagnoses, and the sadly mistaken belief that the field understands “mental illness” on the whole, and how best to treat it.
Treating the floridly and dangerously psychotic as if they have a “disease” that can be successfully treated with medication in such a glib way that a man in the throes of psychosis can safely be put into a study in which he is randomly assigned a drug, is toying with psychosis. It seems that the professionals in this instance did not take themselves anymore seriously than they did this patient.
“It seems that the professionals in this instance did not take themselves anymore seriously than they did this patient.”
Amen…
I would say you made some very keen observations regarding Dan’s state of mind as well as the greed and ego driven obsessions of the PI. And it should be noted that as a direct result of the circumstances of Dan’s enrollment by the coerced actions of his treating physician whom just happened to be the PI in the CAFE’ study, Minnesota passed Dan’s Law unanimously, which now prohibits the deplorable behavior of the treating physician.
That’s good news, Mike Howard. The tide is turning against a lot of resistance. I cannot but hope that these victories will reach critical mass in order to usher in an age of reform in the field of psychiatry that asks more and better questions, to reflect the humility that the human prospect and human mind deserves.
Mary Weiss, Dan Markingson’s mother. Her name surfaced from the dark well of my subconcious in the middle of the night. Checking, I also found that Carl Elliot now is a Network Fellow at the Safra Center of Ethics at Harvard University, Their admirable struggle is a tale of how deep professionals can let themselves sink when business interests are dominant instead of the patient’s best interests, and a tale of love and integrity.
Oh dear.
“you may be sympathetic to Thomas Szasz’s view that mental illness is a myth”
Whenever I read this soundbite I cringe. What does Szasz mean by a myth? In the words of Gilbert Ryle “A myth is, of course, not a fairy story. It is the presentation of facts belonging to one category in the idioms appropriate to another. To explode a myth is accordingly not to deny the facts but to re-allocate them.” Szasz does not say that the conditions that are called ‘mental illness do not exist but shows that the continual attempts by society to explain away morally bad or deviant behaviour as the result of a medical disease is a category error. A myth.
“Dan’s involuntary hospitalization and medication with an antipsychotic was the only rational choice.”
First of all, the threat of murder is a criminal offence and so incarceration is a rule of law and not a medical decision. Forced ‘treatment’ with ‘antipsychotics’ is a human rights abuse. Read what Carl Elliot has to say about them. These are brain disabling toxic chemicals – the name is supposed to reflect antibiotics – a true medical treatment, and demonstrates the rhetoric of psychiatry attempting to be accepted as a scientific medical discipline which it is not. There are many studies, Mosher for example, that show that treatment with drugs have worse outcomes.
“And what I think is that Dan had a Disease.”
And your scientific evidence is? Anecdote?
Sorry Mickey, but you have succumbed to the ‘myth’ of mental disease.
Unfortunately we have little knowledge of thought processes involved.
“I’m aware that people can cast spells that can hurt you at a distance”
This makes sense to me. Memes can be seen of as ‘spells’ that can hurt people at a distance. Think of Hitler’s ideas.
” I’m aware that some people can read minds.”
Well this may also be possible. Psychiatry itself attempts to read other people’s minds and attempts to ‘rectify’ deviant thoughts.
” I’m aware that some people might actually be ‘hybrids’ and not altogether human.”
When I look at history, in particular, trying to understand why millions of people have been slaughtered in the past hundred years… I tend to get the feeling that some people are not altogether human.
“I’m especially eager to attend this storm and SLAY those who deserve slaying. I will choose victims immediately…
I HAVE NO EMOTIONAL ATTACHMENTS. I KILL FOR FUN!!”
Well many political leaders seem to share this idea which is why we go to war. What we do not know is why he held these beliefs or what had happened in his life that such views came to be held. Psychologists such as Richard Bentall have attempted to define what ‘delusional thinking’ is and have not succeeded. It is possible that all human being suffer from delusional thinking but only the acceptable thoughts, shared by that particular culture and society are acceptable. Other delusions, not shared by popular thinking are then considered the result of a disease – which is an ‘insane’ logical proposition. The Manufacture of Madness by Dr. Szasz attempts to explain why society requires the function of state psychiatry.
And lastly, what one believes is what one sees – and not the other way round!
What does Jeffrey Lieberman have to say about the Dan Markingson case? He was the Principal Investigator on the CAFE study. Judy Stone wants to know http://blogs.scientificamerican.com/molecules-to-medicine/2013/05/24/anti-psychiatry-prejudice-a-response-to-dr-lieberman/
Wiley, you state: The tide is turning against a lot of resistance. I cannot but hope that these victories will reach critical mass in order to usher in an age of reform in the field of psychiatry . . .the field of psychiatry is NOT the lone malefactor in medicine. Let’s hope the tide turns against a lot of KOLs whose greed aligns with those of BigPharma, and have only marginal consideration at the humans affected by their paid-for endorsements.
Carl Elliott is a crusader and I believe this story has been around for so long people have stopped listening to the atrocity that happened to Dan and his mother. Dan’s mother has worn herself out trying to expose this tragedy and hold UMN accountable for which she will have lost everything. UMN has no moral compass or business ethic moral compass. The mere fact that a social worker was in charge of the medications in a drug trial should freak everyone out! add to that, AstraZeneca’s lawsuits, Seroquel’s damage done to tens of thousands and counting! What price does one have to pay to seek the truth?
Carl Elliott’s “crusade” is for ALL people. UMN, Big Pharma, all of them are in lockstep, and the almighty dollar rules and directs their corporate compass.
Carl’s speaking out to fight on for Mary Weiss should be commended and in my opinion should hold the same esteem here and elsewhere as there was for Allen Jones, whistleblower.
Fight on, Carl!