Sometimes, frustration and impossibility are necessary components of learning. Try looking around on the Internet for something that captures the essence of the difference between legal and ethical, between the Rule[s] of Law and a Code of Ethics. There’s plenty to find, sure enough, but something about the last thing I found isn’t quite it, so I return to the search. As in the phrase, the letter of the Law, Laws cover a minimal definable and enforceable standard of behavior derived from Ethics, which are more felt than written, more the difference between wrong and not right. So it’s little wonder that the Case of Dan Markingson is finally being decided by a faculty senate, a panel from an accrediting agency, and a legislative body, instead of in a Court of Law. Equally telling, it has become a cause célèbre through the efforts of an academic department of bioethics.
It’s hard to imagine reading the details of Dan’s story without seeing how not right it was from day one to its tragic ending. In the narratives of most other problematic Clinical Trials, the misrepresented efficacy or de-emphasized patient harms are experience distant from the trial itself, showing up as impersonal statistics from later users of the drug. In this case, it was the conduct of the trial itself that did the damage, not just some mathematical trick in the analysis or sleight of hand in the presentation of the study’s outcome. This case is also unique in that the role of the particular academic institution involved is central to the publicity – the Department of Psychiatry, the Institutional Review Board, the Clinical Research Center, and the Administration at the University of Minnesota. And this story is populated – Charles Schultz, Stephen Olson, Eric Kaler, Dan Markingson, Mary Weiss, Carl Elliot, Leigh Turner, Mike Howard – actual people make the story more real. And of course, the fact that Dan killed himself in an altered state [making sense…] some six months after he was placed in this Clinical Trial is an indelible marker of its not rightness – un·ethical.
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When his mother visited him in California June 2003, he was floridly delusional, yet was still able to convince the police that he was fine [see The Deadly Corruption of Clinical Trials].
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His September emails were again quite delusional, as was his presentation in Minnesota in November. But again, after 12 days on Risperdal®, he seemed to have cleared [see Study Visits p. 5], passing of his former symptoms as "lack of sleep." yet, whistleblower Nikki Gjere said that he was "too sick to be in the study" at that time [a paradigm…., INVESTIGATORS: Nurse questions integrity of U of M drug researchers].
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Notes from various sources and Dan’s journal suggest that for the last several months of his life, he was getting worse [making sense…]. From the journal:Mar 23, 2004: "world walking, you were at a farm house and we’re getting presents from dogs who had presents fastened in plastic bags to their snouts… in the gloaming and breening, you were thinking of naming it gloaming and greening or gloam-green. That was someone brings a snowslide in summer or midsummer. It has been left behind…" [Olson 2007 p. 467].But from what I can find, it certainly appears that Dan was very ill either on-and-off or throughout the study.
I posted my response on my blog. If interested it is here:
http://real-psychiatry.blogspot.com/2015/03/the-luck-of-ethical-researcher.html
This issue of ethics versus legalism has been around a long time. Many of the scandals in psychiatry over the past 20 years have turned on the failure to make this very distinction. Here is a discussion from a few years ago on the Health Care Renewal blog. Impeachments at Minnesota, anybody?
I’m disappointed an intelligent discussion based on KNOWN facts regarding antidepressants and behaviors cannot be had on this blog of all places. This proves, in my opinion, that psychiatry is fully entrenched with the one and only treatment paradigm that western medicine embraces and pharma fully funds! there will never be a day when we –the ones who have seen horrors first hand as a result of drug induced behaviors—will stop being called antipsychiatrists–and such by DOCTORS THEMSELVES. Such as “therapy first” Dr Hassman. I wonder when human beings will stop being guinea pigs for pharma and doctors, when the results are shown over and over again that people CAN have adverse and negative reactions to these meds!
Re flying and the copilot– wait for a tox report for that evidence or deal with the facts that the youth who was not even 30 yrs old drove the plane into a mountain–his weapon was not unlike a mall shooter–he just used a plane. Sometimes there are no answers to tragic events!
I’m disappointed an intelligent discussion based on KNOWN facts regarding antidepressants and behaviors cannot be had on this blog of all places. This proves, in my opinion, that psychiatry is fully entrenched with the one and only treatment paradigm that western medicine embraces and pharma fully funds! there will never be a day when we –the ones who have seen horrors first hand as a result of drug induced behaviors—will stop being called antipsychiatrists–and such by DOCTORS THEMSELVES. Such as “therapy first” Dr Hassman. I wonder when human beings will stop being guinea pigs for pharma and doctors, when the results are shown over and over again that people CAN have adverse and negative reactions to these meds!
Re flying and the copilot– wait for a tox report for that evidence or deal with the facts that the youth who was not even 30 yrs old drove the plane into a mountain–his weapon was not unlike a mall shooter–he just used a plane. Sometimes there are no answers to tragic events!