by Judith Curry
The term conflict of interest is pejorative. It is confrontational and presumptive of inappropriate behavior. – Anne Cappola and Garret FitzGerald
Kip Hansen pointed me to this article in the current issue of the Journal of the American Medical Association (JAMA) [link], extended excerpts provided below:
Confluence, Not Conflict of Interest. Name Change Necessary
Anne R. Cappola and Garret A. FitzGerald
The primary interest of the biomedical scientific endeavor is to benefit patients and society. Frequently, this primary interest coincides with secondary interests, most commonly financial in nature, at the interface of the investigator’s relationship with a private sponsor, typically a drug or device company or, increasingly, venture capital firms. Academia and the public have become sensitive to how such a secondary interest might be unduly influential, biasing the interpretation of results, exposing patients to harm, and damaging the reputation of an institution and investigator. This concern has prompted efforts to minimize or “manage” such “conflicts of interest” resulting in a plethora of policies at both the local and national level.
First, the term conflict of interest is pejorative. It is confrontational and presumptive of inappropriate behavior. Rather, 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 the risk of bias. A better term—indicative of the objective—would be confluence of interest, implying an alignment of primary and secondary interests. In this regard, the individuals and entities liable to bias extend far beyond the investigator and the sponsor; they include departments, research institutes, and universities. The potential for bias also extends to nonprofit funders, such as the National Institutes of Health and foundations, as well as to journals that might, for example, generate advertising revenue from sponsors.
JC comment: I am so pleased to see someone make this point. At Georgia Tech, my company CFAN has been the source of many concerns about ‘conflicts of interest’ that need to be ‘managed.’ I am made to feel like a criminal through all this, when it was Georgia Tech that encouraged me to start a company in 2006 and compete for SBIR/STTR grants, and entrepreneurship is a major part of Georgia Tech’s strategic plan (not to mention the fact that I have not done anything ‘wrong’). That said, I know that Georgia Tech is better than most universities in this regard, in terms of encouraging entrepreneurship.
Second, disclosure policies have focused on financial gain. However, in academia, the prospect of fame may be even more seductive than fortune. Thus, the outcome of a study may influence publication in a high-impact journal, invitations to speak at conferences, promotion, salary, and space.
JC comment: Most researchers that I know are driven much more by fame than by personal ‘fortune’ (Shukla seems to be an exception.) Most academic researchers could make much more money in the private sector.
Estimation of how fame—which again may apply to institutions, funders, and journals—might introduce bias is a considerable challenge. However, even in the case of monetary gain, which can be readily quantitated, bias is complex. A possible strategy is to consider a terrain-mapping approach to potential sources of bias. 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. Disclosure of such information on institutional websites and its provision in consent forms to participants in trials would help the public to visualize the complexity of such relationships and aid individuals and institutions to promote confluence of primary and secondary interests with the objective of minimizing bias. Irrespective of such efforts, disclosure is necessary but insufficient; it can serve to mitigate, but not to avoid bias.
JC comment: the fame-fortune terrain mapping idea is a fascinating one. Calling David Wojick . . .
Fourth, 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. Institutions also have an obligation to be governed by their mission, rather than profit, and maximizing profit may not always serve that mission.
Fifth, Academic institutions have a particular responsibility to inculcate, promote, and reward intellectual honesty in ways more imaginative and effective than in the past. Just as scientific discovery is celebrated by prizes and awards and election to societies and organizations, academia needs to celebrate examples of moral courage in the scientific endeavor. These might include predicting and revealing adverse events concealed or denied by industry sponsors or publicly disclosing inappropriate behavior by investigators or institutions. Faculty should be repeatedly educated in their ethical responsibilities, not just to their patients, but also to their students, their colleagues, and their institutions to minimize bias and to serve the primary interest of biomedical research. This might occur as part of the online requirements necessary to retain credentials to function as an academic investigator.
JC comment: Researchers employed at universities most definitely do NOT get rewarded for moral courage in the scientific endeavor. Instead, they are rewarded for ‘playing the game.’ I recall, about 5 years ago, talking to a senior administrator at Georgia Tech, informally at a social function. The words that stuck in my mind are these: “Judith, you need to learn how to play the game.” Sorry, no ‘game playing’ for me.
Confluence of interest represents a complex ecosystem that requires development of a uniform approach to minimize bias in clinical research across the academic sector. 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.
JC reflections
Once again, the field of medical research provides some important insights into conflicts of interests; for specific concerns related to climate science, see these two previous posts:
I found particularly interest the Conflict of Interest Disclosure made by the authors, Cappola and FitzGerald:
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Cappola reports receiving consulting fees from Biomarin, Mannkind Corporation, and Takeda. Dr FitzGerald reports being the McNeil Professor of Translational Medicine and Therapeutics, a council member of the American Association for the Advancement of Science, and a member of the National Academy of Medicine biomarker committee; receiving a stipend for being co-chair of the advisory board for Science Translational Medicine; grants from the Harrington Family Foundation and Eli Lilly; consulting fees from Calico and Pfizer, Eli Lilly, Glenmark Pharmaceuticals, and New Haven Pharmaceuticals; serving as chair for the Burroughs Wellcome Foundation review group on regulatory science awards, the Helmholtz Foundation advisory board for the network of cardiovascular science centers, and the PhD program committee of the Wellcome Trust, a section committee of the Royal Society; and serving on the advisory boards of the Oklahoma Medical Research Foundation and King’s Health Partners in London. He also serves on the advisory boards of the Clinical and Translational Science Awards held by the University of Connecticut, Harvard, the Medical University of South Carolina, Duke University, and the University of California at San Francisco.
Funding/Support: This work is supported by a grant (UL1 TR000003) from the National Institutes of Health.
Role of the Funder/Sponsor: The National Institutes of Health had no role in the preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Note the distinction between source of funding, and the conflict of interests. I totally agree that it is appropriate to separate these two items.
I don’t recall ever seeing a conflict of interest disclosure like this attached to a journal article, although I don’t read many articles in medical journals (well, I suppose if you are writing an article about conflict of interest, you had better scrupulously document your own COIs). Such a ‘core dump’ is an interesting approach to take regarding COI disclosure; any potential source of genuine conflict is lost in a large list of affiliations and the large list puts the potential conflict (funding or otherwise) into perspective.
I totally agree that serving on advisory boards reflects a conflict — oops, a ‘confluence’ – of interest. Recall a previous post
A scientist serving on the advisory board of a green advocacy group, or a libertarian think tank, reflects a confluence of interest with that group. Which is the chicken and which is the egg in causing a ‘conflict’ is not clear. By the same token, a scientist who is offered research funding from an industrial source is viewed as having a confluence of interest with that source.
So, do all these disclosures eliminate bias? I doubt it, but it can help identify bias. If you are going to enforce disclosure, I strongly support the manner of disclosure reflected in the JAMA article – separating conflicts of interest and funding disclosures.
Filed under: Ethics, Sociology of science