Confronting Conflict: Addressing Institutional Conflicts of Interest in Academic Medical Centers
Liang, Bryan A., Mackey, Tim, American Journal of Law & Medicine
Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest ("ICOIs") in academic medical centers ("AMCs") engaged in research and clinical care-have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a "Centralized System" model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant finding. The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education-academic detailing-in place of current marketing-focused "education." Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.
Academic Medical Centers ("AMCs") have become the front line for the conflict between scientific integrity in medicine and corporate interests. Conflicts of interest occur on a daily basis in the practice decisions made by individual physicians, which have been well recognized in a variety of settings.1 However, importantly, they also occur at the institutional, AMC level. These conflicts have created significant concerns regarding what approaches should be adopted to ensure that clinical and research decisions are made with social concerns foremost, rather than institutional selfinterest.2
Conflicts frequently arise when pharmaceutical companies and AMCs wish to share in lucrative business arrangements originating from research underwritten by corporate funds performed at the AMC and the products arising therefrom.3 The issues implicated by this conflict encompass patients and their safety, trust in physicians and medical institutions, the overall economie cost through increased health care expenditures, and academic and scientific integrity.4
Industry involvement and support of AMCs may nevertheless be acceptable if conducted in an appropriate manner. However, industry relationships with AMCs that give rise to conflicts of interest pose a significant concern and challenge to AMCs. Those relationships have the potential to compromise the integrity of an institution and undermine the public's trust in the medical and research community. Further, these conflicts can endanger patient lives with little or no benefit to the individual patient or society. These problems are analogous to similar concerns regarding individual and institutional conflicts of interest by lenders and universities which participate in federal government student loan programs.5
Unfortunately, AMCs have not substantively addressed institutional conflicts of interests ("ICOIs"), nor do they see it as a major concern. The limitations of the current framework have been illustrated by an analysis that found substantial variation in policies adopted by AMCs governing conflicts of interest, one-fourth of investigators had industry affiliations, two-thirds of academic institutions had equity holdings representing the presence of an ICOI, and management of conflicts of interest and enforcement or sanctions for failure to disclose were almost universally discretionary. …