Indignation Bias

"Moral indignation in most cases is 2% moral, 48% indignation, and 50% envy." - Vittorio De Sica


The New England Journal of Medicine has started a new series on conflicts of interest that should prove to be enlightening if the rest of the articles are as good as the first one.  In this article, Lisa Rosenbaum, MD  takes on typical cases that appear to be straightforward conflict of interest cases and thoroughly debunks the common thought process.  She provides a clear link between the outrage over the behavior of the pharmaceutical industry and an indignation based approach to regulation and conflict of interest considerations.

In the first example she looks at the issue of the 2013 cholesterol guidelines and the expansion of the target population for statin therapy.  There was the standard New York Times editorial by two physicians who concluded that the guideline "would benefit the pharmaceutical industry more than anyone else."  They referenced an article by one of the authors on the frequency of statin side effects that was later withdrawn due to an overestimate of the frequency of side effects.  They challenged the credibility of  the guideline writers suggesting that they needed to be free from "influence, conscious or unconscious".  Rosenbaum reviews the checks and balances in place for the writing of this guideline in a manner reminiscent of my analysis of a Washington Post commentary on the DSM-5 diagnosis of depression.  In both cases, the safeguards in place are overlooked, the benefit to the pharmaceutical industry  overestimated, and the authors of these critical articles are never challenged.  She asks the important question: "So why the rush to conclude that the guidelines were an industry plot?"  It is also interesting from the perspective of psychiatry where the field would never get that kind of break.  The question for psychiatry is:  "Why the rush to judgment to conclude that the guidelines were a plot between psychiatrists everywhere and industry?"

The Jesse Gelsinger case was examined next.  Mr. Gelsinger was an 18 year old man with ornithine transcarbamylase deficiency.  He volunteered for a research protocol examining gene therapy for the disorder.  The ethical considerations included the fact that the researchers were advised that it was not ethical for them to test the protocol in affected babies who might benefit if it was successful because that would be considered coercion.  There was also an issue relating to the reporting of a complication of the therapy by basic science researchers.  Rosenbaum points out that after Jesse Gelsigner's death due to the research, the popular explanation for what happened was that the lead researcher had an equity position in a gene-therapy company.  There were numerous safeguards in place including a lack of a direct connection between sponsorship of the trial, a university prohibition of the lead researcher in patient enrollment or interaction,  and that same researcher asking a colleague to be the lead investigator in that trial.  The research had also been approved by more than one Institutional Review Board (IRB).  Most IRBs require a review of the scientific merit of the research before considering it on ethical grounds.   Since this was a protocol for the first human experiment in gene therapy, the vetting was unusually rigorous:

"The OTCD gene therapy protocol and the associated consent document underwent extensive review including IRBs at three institutions, the Recombinant DNA Advisory Committee, the Oversight Committee of the General Clinical Research Center of the University of Pennsylvania, and the FDA."  (reference 2)

 Please read the entire paper on line for the complexities of this case.  For the purpose of the NEJM article the relevant section had to do with Wilson recommendations of why the appearance of conflict of interest maybe all that counts.  After disclosing everything that he did  to minimize financial conflicts of interest Wilson concludes:

"I conclude that it is impossible to manage perceptions of conflicts of interest in the context of highly scrutinized clinical trials, particularly where there is a tragic outcome....." (reference 2, p 155).

That is where Rosenbaum's article gets interesting.  She introduces a concept that gets very little play in clinical medicine and one that has not had much play in psychology until the past decade and that is emotional reasoning.  There are physiological and evolutionary reasons why emotions play a large role in day to day reasoning.  In patients with a pathological loss of emotional reasoning there are significant problems in day-to-day decision making.  Diagnostic reasoning in medicine on the other hand is often described as a purely intellectual  process.  Psychiatrists  encounter this in our colleagues.  I can recall for example, confronting a Cardiology resident with the fact that her agitated patient did not have an acute exacerbation of bipolar disorder like she suspected and  did not need transfer to Psychiatry, but in fact had just had a stroke and was aphasic.  "What the hell do you know about strokes?  What do psychiatrists know about neurology?"  she stated forcefully as she rapidly escalated herself.   I calmly back pedaled and said: "Get your attending to confirm the findings and the diagnosis and if he doesn't - call me back.  But right now your patient has aphasia and has right upper extremity weakness and needs to go to the Neurology service."  Within an hour that patient was under the care of the Neurology service.  My point being that level of emotion or in this case emotional biasing really doesn't show up in any of the case records or diagnostic reasoning in the New England Journal of Medicine.  Everything is cool, dry, and pure Bayesian analysis.

Rosenbaum likes the work of a social psychologist Robert Zajonc who was one of the pioneers in this area.  If most decisions begin with a feeling, what persisting feeling may be there in the case of decisions about conflict of interest.  She had previously cited numerous legal infractions and penalties against most of the major pharmaceutical manufacturers.  It should not be surprising that the persistent emotional decision making involving that industry is going to be rather negative and miss the complexities and information that runs counter to that emotion.  I think back to one of the basic admonitions of grandmothers everywhere from my generation: "If there is one thing I can't stand it is a liar!"  I reflected on that over the course of my years in medicine as I realized that the reality is that everybody lies and they lie all the time.  But if you are indoctrinated to that rule and you have a definite emotion associated with it, you should be able to predict the direction of the decision.  You only have to look as far as Cognitive Appraisal Theory (4) for the predictable results when anger is that emotion.  To make it real, in the case of ongoing problem with the pharmaceutical industry you will see their responsibility as high and any adverse outcomes as being totally in their control.  You will be very certain about your decision, irrespective of what the reality is.  One example previously mentioned is the idea that the new cholesterol guidelines would be a windfall for the pharmaceutical industry when the vast majority of the prescriptions are for generic statins.  There will be a contamination effect on everyone associated with those companies and as long as the underlying emotion persists the associates will be predictably condemned with the same level of certainty and any negative events will be perceived as being under the complete control of the individuals involved.  There can be no unanticipated adverse outcomes or complications.        

The most concerning aspect of this kind of emotional bias is that people seem to be completely unaware of the fact that they have been swept up in it.  To them, their decisions all seem reality based.  The biasing effect in emotional reasoning has the same predictable effect in paranoid psychotic states, road rage, and Little League parents.  It is certainly alive and well in practically all aspects of public opinion when it comes to psychiatry.  Many blogs and Internet sites seem nothing more than a lens to focus rageful commentary against the profession, and further indignation if any psychiatrist dares to speak out against many of these practices.

I think indignation bias explains a lot, particularly attitudes toward psychiatry but also overly rigid thinking in the case of complex decisions and unpredictable negative outcomes.  It has allowed an irrational connection between Big Pharma and psychiatry and for many people to profit from focusing anger against the profession.  And per Dr. Rosenfeld it is not conducive to rational regulations of the industry, but it seems that at least the marketing end of those businesses seem content to see their "pushback" as being the cost of doing business.  Even marketers could benefit from educating themselves about the negative future effects of emotional decision-making against their industry.


George Dawson, MD, DFAPA


References:


1:  Rosenbaum L. Reconnecting the Dots - Reinterpreting Industry-Physician Relations. N Engl J Med. 2015 May 7;372(19):1860-1864. PubMed PMID: 25946288.

2:  Wilson JM. Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency. Mol Genet Metab. 2009 Apr;96(4):151-7. doi: 10.1016/j.ymgme.2008.12.016. Epub 2009 Feb 10. PubMed PMID: 19211285.

3:  Lerner JS, Li Y, Valdesolo P, Kassam KS. Emotion and decision making. Annu RevPsychol. 2015 Jan 3;66:799-823. doi: 10.1146/annurev-psych-010213-115043. Epub 2014 Sep 22. PubMed PMID: 25251484.

4:  Lerner JS, Keltner D. 2000. Beyond valence: toward a model of emotion-specific influences on judgment and choice. Cogn. Emot. 14(4):479.



Supplementary 1:  According to UpToDate, the gene therapy trial mentioned in the above reference was cancelled after the death of Jesse Gelsinger.  He was the 19th patient in the trial and metabolic correction of the other 18 patients did not occur.  (Topic 2923)

Supplementary 2:  Image used at the top of this post is a Shutterstock standard license download.

Supplementary 3:  Quote from Vittorio De Sica is from Stereophile June 2015, p 125.