Discussions about the role of conflict of interest (COI) in medicine persist and are characterized by confusion, frustration, and debate over appropriate COI management. In my last column, I introduced the topic of COI by focusing on the importance of disclosure in the process. Although the column focused on COI in clinical care, the process is conceptually similar to the process for COI disclosure in research and continuing medical education. In this column, I discuss why, when, and how to manage COI.
A COI in clinical care refers to instances in which physician judgment regarding a patient’s well-being is at risk of being biased by a secondary interest (like financial compensation) that can harm patients.1 A COI does not require that a patient be harmed or that it be proved a physician’s professional judgment is or was biased. COI only requires that the judgment regarding a patient’s well-being is at risk of being biased by a secondary interest. Disclosure of and managing COI is vital to establishing and maintaining the integrity of the medical profession and public trust. If patients are not confident that their healthcare professionals are putting their interests first, then patients are likely to mistrust them.2
Unintended consequences
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Despite the laudable goal of avoiding COI in medicine, debate remains about potential negative unintended consequences of COI disclosure. For example, critics of broad COI disclosure policies argue that such practices disrespect physicians by encouraging the public to assume that industry ties are always problematic.3 At the same time, empirical data suggest that other unintended consequences are not significant. A recent study demonstrated that an author’s disclosure of a COI in academic publications did not affect peer reviewers’ assessment of the manuscript as high quality or appropriate for publication.4
Ethical principles both underlie and guide the COI process by helping to evaluate and balance the risks and benefits of relationships between physicians and industry. Partnerships between physicians and industry are common and may occur in a variety of settings, such as when pharmaceutical companies collaborate with physicians to participate in community-based research; when physicians are solicited to serve on speaker bureaus; when physicians accept small or large gifts from a company, including meals or medication samples; when physicians have a financial stake in a healthcare facility; when a physician is involved in device or other medical product development or when they have a financial interest in the company; or self-referral. Some of these relationships may present valuable opportunities to advance medical knowledge and even the quality of patient care. In other cases, however, these relationships may establish a secondary financial interest that introduces conscious or unconscious bias into clinical decision making and thus potentially adversely affect patient care. Balancing the potential risks and expected benefits of relationships with industry is critical to managing this problem and maintaining public trust. Avoiding, disclosing, and/or managing COI then enables the medical profession to safeguard patient interests patients while allowing for reasonable financial relationships with industry.
Organization policies
Depending on a physicians’ professional setting, there may be a policy or multiple policies that circumscribe acceptable practices regarding COI. These could include COI policies from physicians’ local medical institutions or professional societies, medical journals, state or federal employers, or grant funders. Broadly speaking, COI policies guide acceptable practices for how COI should be disclosed, which relationships should be prohibited or avoided, and, if not avoidable, how they can be managed appropriately. From a policy perspective, disclosure is a central part of the process and should include information about “the nature, scope, duration, and monetary value of relationship to allow institutions to assess the risk that secondary interests might unduly influence judgments about research, clinical care, education, or other primary interests.”2 Although disclosure is critical, it is not necessarily sufficient to protect patient interests.
Restricting involvement
Managing COI is necessary when disclosure alone is insufficient to protect patient interests but eliminating or avoiding COI is not possible or reasonable. What does managing COI look like? Depending on the circumstances, this requires that some aspect of the potentially problematic relationship be addressed so that the primary interests of patients are maintained. A physician who has a COI because of financial compensation from a device manufacturer should forgo membership on his hospital’s surgical device committee because that committee approves contracts between the hospital and device manufacturers. Physicians have a COI because they sit on the board of a start-up medical services company competing for business at the hospital where they work. If eliminating the relationship entirely is impossible or impractical, restricting physicians’ involvement may help to manage the conflict. This might mean having the physicians serve only in a non-voting role on the company board, or recusing themselves from hospital deliberations that relate to the conflict.
COI will continue to be debated. Promoting patients’ interests and advancing productive collaboration with industry are both important goals. For the debate to be productive, physicians should recognize the real ethical concerns raised and how they can affect patient care and professional integrity. At the same time, demanding good empirical data will help inform the debate by ensuring that arguments are not simply opinion, but grounded in science.
David J. Alfandre MD, MSPH, is a healthcare ethicist for the National Center for Ethics in Health Care (NCEHC) at the Department of Veterans Affairs (VA) and an Associate Professor in the Department of Medicine and the Department of Population Health at the NYU School of Medicine in New York. The views expressed in this article are those of the author and do not necessarily reflect the position or policy of the NCEHC or the VA.
References
- McCoy M, Emanuel E. Why there are no “potential” conflicts of interest. JAMA. 2017;317:1721-1722.
- Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press, 2009.
- Stossel TP 2008. Has the hunt for conflicts of interest gone too far? Yes. BMJ. 2008;336(7642):476.
- John LK, Loewenstein G, Marder A, Callaham ML. Effect of revealing authors’ conflicts of interests in peer review: randomized controlled trial. BMJ. 2019;367:15896.
