Monday, March 30, 2015

The Luck Of The Ethical Researcher

“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.

George Dawson,  MD, DFAPA

Supplementary 1:  For the whole story go to the 1BOM blog and start reading at the link.


  1. What do you mean when you use the word politics?

    Is it politics in support of an ideology or politics in support of a person's career, ego, income or something else?

  2. I'm still not sure what you mean by politics although I get that they are all a single entity as far as you're concerned.

    However, this statement of yours tells me all I need to know of your "ethics".

    "My only thoughts at the time were in the interests of the patient."

    But, this doesn't mean I excuse someone for a poor outcome just because they had good intentions. What it means is that as far as I'm concerned, whether they were ignorant, led astray by the latest pseudo-science or a trusted colleague, lack of ethics was not the problem.

    1. "What it means is that as far as I'm concerned, whether they were ignorant, led astray by the latest pseudo-science or a trusted colleague, lack of ethics was not the problem."

      And that is precisely where politics comes in.

      My whole point in posting this vignette is to illustrate how easily you can be scapegoated with the best of intentions. All it takes is a bad outcome.

      At the national level there is even a lower standard. All it takes is the appearance of conflict of interest. That is the battle cry of every self righteous blogger, politician, and administrator out there. Thousands of people essentially persecuted on the appearance of conflict of interest and the hope that they may have done something that violated their employment rules so that they could really be made to look bad.

      No proof whatsoever that there actually was a conflict of interest.

      That's what the big drug company payment database is all about.