Wednesday, 01.12.2021

Michael Godberg’s Commentary

Barry Blackwell: Corporate Corruption in the Psychopharmaceutical Industry - Revised

 

            As a clinical pharmacologist who is wrapping up an industrial career, I cannot in good conscience pass this work on as I think it is overly one-sided.   As a generalist, I have worked on drugs in multiple classes some of which went on to provide patient benefit according to standards defined by FDA and the achievement of real patient outcomes (Admittedly, some circularity resides in application of these standards.  However, the emphasis on safety implicit to these trials must also be considered as a check on achieving a certain level of patient protection, albeit, as mentioned, imperfect.)  My main psychopharmacological experience is as a collaborator in my work as a clinical pharmacologist and as a patient whose career was sustained and supported by the careful use of an MAOI and other agents for severe atypical depression. 

            My thoughts are mainly informed by personal experience, and are not as well documented as the citations in the Essay.  Clearly, the current quagmire has been contributed to majorly by various activities of the pharmaceutical industry.  But, other factors must be considered which I will list as concisely as possible:

1.  Patients want to not feel bad and the "medicine man" in all his manifestations has been (for centuries) and is a cultural iconic role, even if his tools are imperfect to various degrees.

2.  In contrast to recent developments in oncology, the ability to individualize psychiatric treatment beyond certain examples (e.g., narcotics for pain, MAOIs, at least in my case) has not, to my knowledge, been achieved beyond a crude system of classification and treatment modalities.  Much of the basic research, while targeted to that which is "hot" in some cases, has been conducted or supported by Industry, viz. advances in functional and anatomic imaging.

3.  The charge to FDA to allow only allow "safe and effective" medications to be marketed has been a major driver to the business of clinical trials.  This results in multiple drivers to the cost of drug development.

4.  Rare events occur rarely (unless a named individual is impacted) and current standards do not allow such events to be detected reliably, except in retrospect.  This is not to say that signals have not been missed, but the specialization of physicians and infrequency of some events makes the initial generation of safety hypotheses a challenge when a trial or practicing physician (who is a specialist in a different field) observes single patients experiencing poor outcomes which are not uncommon in the demographic group being treated.  There have been bad outcomes which have been missed except, as with rofecoxib, hypotheses have been tested in adequately sized studies.

5.  It is intrinsic to the nature of our capitalistic system that multiple pharmaceutical companies exist, with variation among them in their values and how they do their work.

            In conclusion, the relief of suffering is a significant challenge and there have been multiple examples where the achievement of this goal has both occurred, and gone astray.  However, to put all the blame for bad actions on the pharmaceutical industry and individuals associated with industry is simplistic.  As one of my former professors of cardiology taught us, "For bad things to happen to a patient, both the seed and the soil must interact."  The genetic revolution has shown us that examination of this soil has identified risks/seeds not previously identified as pathophysiologic factors in the etiology of many diseases. Then, the patient plays a role via his/her individual lifestyle and ensuing non-genetic risk factors. The analogy also applies to individual and societal suffering, our cultural/economic norms and mechanisms of abuse by imperfect institutions and individuals.

            I trust these remarks will provide additional perspective as methods to address the imperfections of the pharmaceutical industry are considered.

 

July 20, 2017