Wendy Lipworth: COI conflicts

WHILE medicines play an important role in ensuring the health of Australians, the pharmaceutical companies that produce them have been the focus of sustained and fervent criticism.

Those who receive financial support from the pharmaceutical industry are also subject to criticism — the main concern being that receiving support from industry creates “conflicts of interest” (COI) that render professionals less willing or able to fulfill their primary responsibilities to produce knowledge, make policy, or care for patients.

Over the years, critics of biomedicine have identified a seemingly endless array of potentially “corruptogenic” industry influences. Some of these — such as industry influence over clinical research, policy making and prescribing — are well characterised.

Other types of industry influence, such as that over basic scientists, pharmacists and charity groups, are newer and not yet fully understood.

While these cases of industry influence arise in different contexts, there is a clear pattern to the discourse that emerges when a potential conflict of interest is identified. First, someone tells the world about the previously hidden or ignored influential relationship. Second, the potential for a harmful conflict of interest is noted. Third, the credibility of the professionals involved is questioned. Finally, there are calls for greater transparency and/or more stringent regulation of industry and professional activities.

This pattern can be illustrated clearly in the discourse that is currently unfolding about relationships between the pharmaceutical industry and the medical communication companies (MCCs) that produce continuing medical education (CME) activities.

A study conducted by researchers from Columbia University and reported recently in JAMA revealed that MCCs receive the lion’s share of pharmaceutical company grants. Pharmaceutical companies are not obliged by industry codes of conduct to disclose their payments to MCCs, and the MCCs are not obliged to tell doctors about their receipt of industry funding.

In keeping with the pattern described above, the study was accompanied by an editorial which argued that “[t]he obvious concern is conflict of interest”, which has the potential to lead companies to feel “pressure to present their clients’ products in the best light”.

Dissenting views have begun to emerge, with claims that the JAMA study was flawed, but these have not stopped critics demanding greater disclosure and regulation of industry payments to communications companies.

What is interesting about this discourse (and the many others like it) is that there tends to be a particular emphasis on calls for disclosure and/or regulation of potentially suspect activities. There is, however, little (if any) discussion of whether these are adequate response to actual or perceived conflicts of interest.

This is a problem for two reasons. First, transparency is not a panacea. It does not necessarily change behaviour or prevent harm, and it can have unexpected negative consequences such as discouraging further ethical conduct, discouraging further critique of professionals, or distracting people from more important issues.

Regulation can also backfire if those involved do not genuinely support it.

Second, a reflexive reliance on transparency and piecemeal regulation might lead us to underplay the seriousness of the problem of COI in biomedicine. The JAMA article highlights the myriad ways in which medicine and industry are entangled, and simply exposing or regulating one type of COI at a time might obscure the fact that COI is a systemic problem in need of far more than disclosure and fragmented regulatory responses.

There is also the possibility that the significance of some kinds of COI will be overplayed, leading to understandable resentment on the part of the professionals concerned.

Those with an interest in the probity and integrity of biomedicine therefore need to step back from the current habitual approach to COI, and develop a framework that is sophisticated enough to account for the complexities and realities of contemporary biomedicine, and that is more likely to be accepted and integrated into practice.

This might include taking steps to determine which COIs are actually harmful, and which are not; boosting existing systems of professional self-regulation; and demanding redress for any harm that arises as a result of a COI.

If the decision is made to demand greater transparency or external regulation, then those instituting these measures should explain to the professionals concerned why they are warranted. They should also educate the public, so that people can understand and respond appropriately to disclosures, and ensure that regulatory measures and public registers are themselves instituted transparently and do not unfairly single out particular professionals.
 

Dr Wendy Lipworth is an NHMRC postdoctoral research fellow in bioethics at the Centre for Clinical Governance Research in Health, Australian Institute of Health Innovation, Faculty of Medicine at the University of NSW.