COI in medicine: the pharisees exposed!

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Irvine Page’s 1987 medical textbook Hypertension Mechanisms begins with the following acknowledgment:

My special thanks are due to the Ciba-Geigy Company, who not only has contributed generously to the financing of this book, but who–over the years and more than any corporation–has recognized and encouraged the development of research in hypertension

The famed Cleveland Clinic physician-scientist, who died 4 years after the book was published, would not live long enough to have to apologize publicly for this colossal evidence of conflict of interest (COI).  It would take a few more years and a few scandals to set into motion the current phobia against industry influence.  In fact, Page would undoubtedly be stupefied by the rituals we now go through to show that our research and opinions are unblemished by the taint of for-profit corporations.

Back in his days, as can be seen from the statement, a relationship of confluence of interest was something to embrace: patients needed treatments for lethal diseases, physicians needed funds for research and education, pharmaceutical companies needed physicians to prescribe drugs.  It seemed obvious that there would be collective benefit in a close collaboration.

Today, however, to hold such a consideration publicly is to invite the wrath of a sect of pharisees who encourage cleansing rituals to protect our medical knowledge from any contagion or impurity.  Disclosures of any and all potential sources of industry influence must be rendered with religious reverence at medical conferences, in medical journals, in the proceedings of scientific and regulatory meetings, and even at poorly attended and meagerly catered hospital lunches that still occasionally serve as an opportunity for medical education.  If a breach of protocol is ever discovered, chest beatings with mea culpas may not be enough.  Heads must roll or reputations must be ruined.

Fortunately for Page, his contribution to the field of hypertension has not yet been posthumously subjected to revision, and his plainly evident COI has not yet cast doubt on the value of angiotensin inhibition or on the existence of serotonin, which he had co-discovered.  Could it be that the religious fervor against conflicts of interest is beginning to wane?

A 3-part series of articles, authored by Harvard cardiologist Lisa Rosenbaum and just published in the New England Journal of Medicine, seem to indicate as much.  In her lengthy dissertation, Rosenbaum aptly points out that anti-COI zeal can hardly be justified on reasonable grounds.  She thus directly attacks a doctrine dominant since Arnold Relman published the first condemnation of the “medical-industrial complex” in the same national beacon of medical orthodoxy some 35 years ago.

Rosenbaum argues several important points:  The correlation between industry ties and patient harm is not subject to easy analysis.  The social science of bias suggests that such influences are far more nuanced than the vituperations against COI otherwise indicate. The highly emotional invectives of the “pharmascolds” inhibit a reasoned appraisal of any given situation and is detrimental to the overall goal of promoting innovative research.  A culture of moral outrage has permeated the medical community to such an extent the new “sacred values” promote their own conflicts of interest and “blind spot biases” favorable to those who hold them.  The chance of ruining the reputation of honest physicians and scientists is rising, and so is the chance of depriving patients of helpful therapy.

I applaud Rosenbaum for the courage to speak out against the established order.  Undoubtedly, she will suffer consequences for voicing such a challenging viewpoint.  (The rebukes, in fact, have already begun.)

To Rosenbaum’s arguments I’d like to add a few additional considerations:

1. The private sector has been the sole target of the anti-COI campaign, yet the public sector is not immune from wrongdoing. After all, the most horrendous instance of COI leading to direct abuse of and harm to innocent patients was conducted by none other that the US Public Health Service.

Today, a number of highly influential “apostles of less-is-more” serve as consultants for government health care programs and hold positions on key policy-making committees.  These leaders and influencers invariably disclose “No COI” when they issue recommendations for health care austerity.  Is there any justification to give a free pass to those who may be subject to COI stemming from public sector interactions?

2. There is no argument that potential for COI arises when industry money finds its way into the pocket of physician-scientists who may have influence over the course of patient care.  But ordinary physicians have the most direct influence on patient care.  A fortiori, potential for COI exists when ordinary physicians depend entirely on third-party payers for their livelihood.  This financial arrangement may lead to systematic distortions in the way patients are tested or treated, yet the third-party payment arrangement per se is hardly ever subject to criticism or moral outrage.

3. Is it so wise to have a regulatory system so centralized that a handful of FDA advisers and guideline writers hold in their hand the fate of a drug or device for 300 million Americans?  Doesn’t such a system invite the kind of troubles that have played out in the scandals of the last 30 years?

Conflicts of interest are of great concern not because greed has all of sudden become a popular vice for doctors and scientists, but because the American health care system is dominated by a single government entity that spends billions of dollars a year on drugs and devices.  This entity relies on a priestly caste of medical technocrats who wield enormous influence over the fate of the entire nation and are therefore set up for very powerful temptations.

Our faith in the system may demand from us public confessions and ablutions while wearing white garments to indicate our cleanliness, but to think that such rituals will diminish undue influence on patient care is dubious.  Instead, the ridiculous protocols are keeping medical progress under tight wraps of red tape, which can only serve to advance the cause of the Evil One: keeping physicians from doing their job and patients from receiving the care they need.

I thank Lisa Rosenbaum for challenging the false doctrine of the medical pharisees.

Update: A follow-up post addresses another aspect of this topic brought up by Austin Frakt from the Incidental Economist.