Life Science Compliance Update

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September 28, 2015

“Confluence, Not Conflict of Interest: Name Change Necessary”


Last week, the Journal of the American Medical Association (JAMA) released an editorial entitled “Confluence, Not Conflict of Interest: Name Change Necessary.” In it, the authors make a number of important points about certain problems with the “conflicts of interest” label that they feel has been misused. Anne Cappola and Garret Fitzgerald, both of the Institute for Translational Medicine and Therapeutics (ITMAT) at the University of Pennsylvania, note that their editorial reflects themes that emerged from a recently convened international meeting on conflicts of interests.

The authors’ first disagreement stems from the phrase itself—“conflict of interest is pejorative” they write, and “confrontational and presumptive of inappropriate behavior.” The authors argue that better terms would be “confluence of interest,” and “the focus should be on the objective, which is to align secondary interests with the primary objective of the endeavor—to benefit patients and society—in a way that minimizes risk of bias.” The term “confluence of interest” expands the individuals who could be liable to bias beyond just the investigator and sponsor to include departments, research institutions, universities, and out to nonprofit funders, the National Institutes of Health, and journals, which the authors state “generate advertising revenue from sponsors.”

Their second point is that up to now, clinical research disclosure policies have focused on financial disclosure. The authors provide their views that money is only one part of the picture. “[I]n academia, the prospect of fame may be even more seductive than fortune,” they write. Bias may be stronger for a researcher who may benefit from the outcome of a study by having the study published in a prestigious journal, receiving invitations to speak at conferences, and even enjoying promotions or higher salary. “Even though an investigator may publicly eschew any direct financial reward from a sponsor, such fiscal and professional benefits may accrue to them indirectly from the institution, if they attract clinical trials with their attendant indirect costs,” the authors write.

They offer an idea on how to potentially track this: “Much like a heat map of gene expression, a dashboard would express and give weight to elements of fame and fortune on the y-axis, charted against individuals and entities on the x-axis that are likely to gain from the endeavor,” they write.

The authors next discuss another theme that emerged during their Conflicts of Interest meeting—that inventors of medicine or devices may have “a highly restricted skill set necessary to advance translation of the discovery from ‘bench to bedside.’” Despite the potential for bias, the authors note that there has been “a move away from blanket exclusion to permitting engagement by the inventor in clinical development, conditional on additional oversight, to assure the public and to mitigate bias.”

The article also notes that despite the benefits of public private partnership, the interests of these parties may sometimes diverge. “Just as universities foster relationships of their faculty with industry, their responsibility to the public interest behooves them to protect and ensure the independence of their faculty to disseminate the full spectrum of their discoveries, even when they may include uncomfortable truths for the sponsor,” the authors write. “Institutions also have an obligation to be governed by their mission, rather than profit, and maximizing profit may not always serve that mission.”

Finally, the authors place a high level important on education. “Education of trainees, investigators, administrators, funders, publishers, politicians, and the public—is essential for progress,” they state. “Academic institutions have a particular responsibility to inculcate, promote, and reward intellectual honesty in ways more imaginative and effective than in the past.”

 “Confluence of interest represents a complex ecosystem that requires development of a uniform approach to minimize bias in clinical research across the academic sector,” the authors conclude. “Such a policy must be at once simple and accessible, capturing the complexity of the relationships while being sufficiently flexible at the individual level not to intrude on the process of innovation.”

This article gives us a hint that there may be a change in the editorial direction at JAMA, earlier this year a competing journal the New England Journal of Medicine also ran a series of articles questioning the burden that the conflict of interest movement has had on medicine.

View the article in JAMA here

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