“My point here is that when discussing an actual case, the ideological wars melt and people from multiple sides of a debate can usually agree. "Clinician trumps Ideology."
From 1BOM March 30, 2015 post.
Not sure that I follow that line of thinking. That has not been my experience in psychiatry or any other medical specialty. There is plenty of ideology and a lack of technology across the board. There is also the dirty little word that nobody likes to see affiliated with medicine and that is politics. As far as I can tell a lot of the ethical debates in medicine are all politics. I can point out several on this blog.
There is also the question of uncertainty. I can recall being a grunt in a new drug protocol that I will not name but I will say it is in a therapeutic class almost never prescribed by psychiatrists. My job was to do the medical and psychiatric evaluations and assure that the patients were medically fit to continue the protocol. Part of the weekly screening was an ECG. I looked at this patient’s ECG, determined it had been changed and told the monitor that I was stopping the protocol. The monitor got very angry at me because the patient was 2/3 of the way through the protocol and would not count as a completed patient. I referred the patient immediately to a medicine clinic and they agreed the ECG was changed. The patient was advised to come back for routine follow up care. They could not comment on the study drug and they did not recommend any acute care. The monitor remained angry, but I stood my ground and the patient was taken out of the study and referred back to medicine.
A week later the patient had a major medical complication and ended up in the ICU. The monitor and the chief investigator both thanked me for taking the patient out of the protocol at that time – one week later. The monitor apologized for getting irate with me.
So the rub is – am I more “ethical” than the monitor (who was not an MD) or am I just lucky? Uncertainty certainly can make you look like a hero or a zero in a hurry in medicine. In this case an internist did not have any reason for concern even though the ECG was clearly different. Was the ECG change causally connected to the ICU incident? Was it casually connected to the study medication? Or was the decision to stop the protocol more related to my blue-collar anti authoritarian roots? To this day nobody knows (but as I age I am more inclined to credit the roots).
And what if I had no markers and the person had stayed in the protocol and ended up in the ICU on the study medication? Certainly the company and the FDA would have investigated the study and me and my methods. Would I have been vilified as just another researcher working in the interest of a pharmaceutical company? Would it have been good press for somebody trying to benefit at my expense? My only thoughts at the time were in the interests of the patient. But that difference in course could have been career changing for me, despite the fact that my only interest then and in the past 30 years has been patient safety.
Situations like this are easily politicized and there is a very porous boundary between politics and ethics.
Not sure that I follow that line of thinking. That has not been my experience in psychiatry or any other medical specialty. There is plenty of ideology and a lack of technology across the board. There is also the dirty little word that nobody likes to see affiliated with medicine and that is politics. As far as I can tell a lot of the ethical debates in medicine are all politics. I can point out several on this blog.
There is also the question of uncertainty. I can recall being a grunt in a new drug protocol that I will not name but I will say it is in a therapeutic class almost never prescribed by psychiatrists. My job was to do the medical and psychiatric evaluations and assure that the patients were medically fit to continue the protocol. Part of the weekly screening was an ECG. I looked at this patient’s ECG, determined it had been changed and told the monitor that I was stopping the protocol. The monitor got very angry at me because the patient was 2/3 of the way through the protocol and would not count as a completed patient. I referred the patient immediately to a medicine clinic and they agreed the ECG was changed. The patient was advised to come back for routine follow up care. They could not comment on the study drug and they did not recommend any acute care. The monitor remained angry, but I stood my ground and the patient was taken out of the study and referred back to medicine.
A week later the patient had a major medical complication and ended up in the ICU. The monitor and the chief investigator both thanked me for taking the patient out of the protocol at that time – one week later. The monitor apologized for getting irate with me.
So the rub is – am I more “ethical” than the monitor (who was not an MD) or am I just lucky? Uncertainty certainly can make you look like a hero or a zero in a hurry in medicine. In this case an internist did not have any reason for concern even though the ECG was clearly different. Was the ECG change causally connected to the ICU incident? Was it casually connected to the study medication? Or was the decision to stop the protocol more related to my blue-collar anti authoritarian roots? To this day nobody knows (but as I age I am more inclined to credit the roots).
And what if I had no markers and the person had stayed in the protocol and ended up in the ICU on the study medication? Certainly the company and the FDA would have investigated the study and me and my methods. Would I have been vilified as just another researcher working in the interest of a pharmaceutical company? Would it have been good press for somebody trying to benefit at my expense? My only thoughts at the time were in the interests of the patient. But that difference in course could have been career changing for me, despite the fact that my only interest then and in the past 30 years has been patient safety.
Situations like this are easily politicized and there is a very porous boundary between politics and ethics.
George Dawson, MD, DFAPA
