Disclose or not disclose – COIs mismanagement erodes public trust

ESMO
  • Dario Trapani
Unsustainable

Dario Trapani

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There is a broader negligence of the public health consequences of individual actions among the health providers

In my previous column piece, I explained why COIs might not influence a physician’s career. However, the mismanagement of COIs can go to public health detriment. For instance, the so-called opioid crisis due to misuse or abuse of this drug class has its roots in the mismanagement of COIs when developing guidelines for non-cancer pain management. This story recalls the efforts of the tobacco industry to disguise health threats of tobacco smoking by having key opinion leaders “on board”: similar elements are identified in these narratives, i.e., control of the public opinion via echo chambers, media hype and rewarded experts.

May any one of us be immune from the influence of such a powerful industry, when there is reward? It is not hard to believe that the enthusiasm generated by the sense of “playing a role” (while your impact on decision-makers is very limited in everyday practice), the sense of power (while your institutional role is marginal), added to financial benefits may result in over-enthusiastic recommendations of a medical product and indulge in narratives that you were asked (indirectly?) to pursue for.

In most cases when COIs are mis-managed, I think there is not a deliberate will to harm, rather there is what I call social (ir)responsibility: a broader negligence of the public health consequences of individual actions among the health providers. It is not something “you feel”, it is something a health leader must be trained in, to deliver for impact.

Governance matters

I have learnt from the International Organization of Public Health and from some governments I have served, that the problem is not all in the existence of the COIs, but in how you manage the COIs. Every person is an island of greed and fear, but no person can exploit conflicts in an island entire of itself. The only way to enforce public trust in healthcare and ensure the best outcomes, is to improve the governance of the COIs.

A robust framework for the management of the COIs has been adopted by the World Health Organization (WHO) in 2016: the so called “WHO Framework of Engagement with Non-State Actors (FENSA)”. The FENSA is the austere chimera that aims at protecting the development of norms and guidance from undue influence, to deliver integrity, independence and credibility. As a clinician and cancer researcher involved in public health and collaborating with international agencies, scientific societies and governmental bodies, I am convinced that the transparent management of the COIs should be the only way to produce evidence, comment on data, shape science. Let’s be clear: it is far from me to believe that private partners are all evil whereas public institutions are all good, nor do I demonize the public-private partnerships. Great progress in science and some of the efforts in implementing medical services at population level have relied on public-private interchained interests, mixing expertise, investing on pathways or ideas and maximizing outcomes ultimately. But much of all good has been delivered fairly under robust governance, regulations and policies. I cannot recall many examples of private interests delivering solidarity and population health benefits under fragile public governance.

The governance for the management of the COI should be based on the transparency principle. I believe that acknowledgment of the COIs is not commonly enough. Who cares if an entire panel of experts is highly conflicted with a single company, when the only “management” of the COIs consists in the disclosure of the COIs? It is tautology. In some panels I have been involved to formulate recommendations, stakeholders bringing specific COIs usually disclose the COIs and abstain from voting on all the products object of the COIs.

This could be a good start: change the narrative of advertisements through marketing-devoted financial COIs by limiting the influence of conflicted stakeholders in the formulation of recommendations.

Moving beyond the “speciality bias”

I do not see any meaningful point to disclose long lists of past COIs, often with no sense of the magnitude of the revenues and the nature of the consultancies if there is no limit in the capacity to polarise, mislead and influence medical recommendations. A common procedure from public engagement with experts is to document disclosures and track the voting process, guaranteeing avoidance of influence on decisions. In other words, I am saying that you can get all the COIs you want, provided they do not make the recommendation I will use to base my decisions. This is part of the social responsibilities that health leaders should be aware of for the public well-being.

It is said that experts carrying more COIs are opinion leaders, and that their contribution is critical to dissect the knowledge and give deepest insights on a specific matter. The only way to get expertise in medical research is to take money from companies, to advertise their products. This is the quintessence of the “specialty bias”: the idea that greater trust and greater persuasion are driven by the disclosure of a long list of COIs is just a common bias, generated by the same marketing approach where COIs themselves belong to. That is why The Nobel Prize Assembly at Karolinska Institute is now evaluating to include the magnitude of the COIs as a parameter to select Nobel Price nominees in physiology/medicine (note: they are not really).

In conclusion, disclosing the COIs is just insufficient.

What we need more is to manage COIs to ensure harm is minimized, and transparency, independence and integrity are maximized in the formulation of health recommendations. To me, this is first an educational principle, then a best practice for clinical and research conduct. It is the only guiding principle of illuminated health leaders who aim at delivering for population health impact and public trust, serving people, including outside of the perimeter of their fancy, trusted clubs.

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