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Friday, 28.04.2017

Thomas A. Ban: Conflict of interest – Marketing vs. education
Collated by Thomas A. Ban

 

Edward Shorter’s comment

 

            Tom Ban opens this stimulating exchange with a shot across the bow:  " . . . No clinically effective pharmacological treatment has been developed since the introduction of the first set of therapeutically effective psychotropic drugs in the 1950s."  So true.

            Barry Blackwell replies to this, then Ban emphasizes the cardinal role of what others have called the "Key Opinion Leaders," or "KOLs," basically academics who have sold out to industry for handsome monetary rewards.  Indeed, says Ban, the KOLs have helped enlarge the clinical population with a given diagnosis so greatly that many patients enrolled in trials don't have the disorder in question at all, but will get all of the agent's side effects while reaping none of the benefits.

            Don Klein weighs in:  The real issue is whether academic bias in favor of Pharma has produced a series of unduly favorable trials.  The pathway to answering this question:  We need public access to patient-level trial data.

            Barry Blackwell replies to Klein:  No, the whole enterprise has been corrupted by Pharma.  Academic medical centers have a fiduciary duty to serve the public interest rather than industry.  Such centers often fail in this duty.

            Ban replies to Jose de Leon, who has meanwhile signed in.  Ban reiterates his main point:  There is a conflict between the needs of a marketing department and the duties of the industry and of the academy to educate the public.  One might add that failure to educate the public properly about the role of reuptake in the efficacy of the SSRIs (probably very small) illustrates this conflict.

            Then Ban hammers home the point that RCTs were designed to show efficacy in clinically heterogeneous populations.  This does indeed suggest that marketing needs are in conflict with underlying science ("education").

            Blackwell shoots back with doubts about the prospects of academics agreeing to help make clinical populations homogeneous.

            I have one critical remark:  This fast-moving and thoughtful exchange ignores that the greatest barrier to achieving clinically homogeneous trial populations is not sell-out academics, but the DSM.  Such diagnostic constructs as "major depression" are hopelessly heterogeneous, but it occurs to few academics to unpack this unitary "depression" (or unitary "schizophrenia")  in order to study drug effectiveness properly.  The DSM diagnoses are taken as gospel in other words, and constitute a huge obstacle to drug discovery, on the grounds that "You can't discover drugs for diseases that don't exist."  Why are most academics so resistant to rejigging the DSM diagnoses?  Just sell-outs?  Respect for authority that goes back to the awe-stricken reception of Emil Kraepelin's textbook?  Difficulty of getting grants to study diagnoses outside of the DSM framework?  Whatever the reason, the unwillingness of academic psychiatry to challenge the DSM is really quite striking.

            Don Klein starts to wind things up:  Hey, we should wage a political struggle to get Pharma under control and gain access to patient-level trial data, rather than just fretting about heterogeneity.

            Ban replies, no, the real struggle is intellectual: to define treatment-responsive subgroups.  

            The protagonists end by agreeing, "Let's dump the current model of conducting RCTs."

 

Edward Shorter

April 6, 2017