There were several comments on our recent post on guidelines about the murky world of conflict of interest. As former journal editors, this is something we discussed at length at numerous meetings and dealt with on a regular basis with authors, editors, and peer reviewers. Indeed, JAMA had an entire theme issue focused on COI (JAMA, May 2017). In addition, as authors, we have completed many COI forms, and as faculty members at two institutions, we are aware of the complexity of these issues for hospitals and universities.
In 2009, the Institute of Medicine, now the National Academy of Medicine, defined conflict of interest “as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.” The IOM focused on financial COI, although since then additional attention has focused on non-financial COI, which is often defined as a particular relationship that might influence a decision. Bero and Grundy have argued that it is important to distinguish between non-financial COI and interest alone, arguing that, for example, personal experiences, religious background, or training are interests but not non-financial COI, because they can never be eliminated. The distinction between interest and conflict of interest is challenging whether it be selecting grant reviewers, guideline panel members, or editorialists. For example, whether anyone who has expressed strongly held, or fixed beliefs should ever serve on a guideline panel seems inconsistent with a fair assessment of evidence.
Over the past few decades, there has been a change in how academic institutions, societies, and journals deal with COI. They have moved toward greater transparency in requiring the reporting of financial COI but have moved away from requiring disclosures of the amount of money (or stock, or other financial compensation) that is involved in various relationships. Many individuals have a standard set of disclosures which they use for all required COI statements, regardless of whether they are true conflicts in each specific instance. This renders such disclosures less meaningful. Two recent examples, one an opinion piece and one a research report, highlight how difficult it is to understand COI statements, with authors in both papers reporting dozens of relationships, making it difficult to determine those that are relevant.
One of the challenges for journals is whether the common approach that is now used – a list of all potential COIs, which can often be long, with no details about why a particular relationship is a COI or the amount of money involved - serves the public good. Speaking and consulting fees can be in the tens of thousands of dollars, and stock options even more, although their value can be very difficult to estimate. We believe that most clinicians and the public would want to know about and would distinguish between a $25 lunch, a $10,000 speaking fee, and $100,000 in stock options. For authors of guidelines, besides ongoing consultant relationships, whether a company or organization has supported or is supporting the research of an author should also be declared. Although this support may not directly impact the salary of that author, any research support is financially beneficial.
In scientific journals, who supports the study is usually reported, but who has control of the data and conducts the analysis is often less clear. We applaud journals that have added a detailed description of many of these issues to their methods section. For example, the role of the study sponsor in design, data collection, analysis, writing the report, and the decision to submit for publication are now required and included by some journals in the methods section of manuscripts. We believe that particularly for RCTs of drugs and devices, which often change practice and fuel the rise in health care costs, other journals should follow this model.
There can be COIs for clinicians who have relationships with drug or device manufacturers, or own, or have consultant arrangements with ambulatory services, like radiology, emergency medicine, and orthopedics. What should they tell patients? For example, if a physician recommends a particular device (or their institution uses a particular device) should that person disclose that they have a financial relationship with that company? If an institution manufactures CAR T-cells, and that is recommended as treatment, should that be disclosed? Virtually no disclosures are ever made in clinical care, with patients trusting that clinicians (and their institutions) will make decisions that are in the best interest of patients. If the institution has safeguards in place – for example, clinicians with a financial relationship with a particular drug or device manufacturer cannot decide which drug or device is used at their institution, or if treatments that are recommended directly benefit the institution, there is an independent review of the treatment -- then we are not sure if any additional disclosure is necessary. That said, it is likely that some patients would want to know about such COI.
One additional area deserves comment. Many journals now have regular podcasts, often with an editor interviewing an author, or a well-known physician, scientist, or policymaker. Yet, we are unaware of any podcast hosted by a journal that reports COI. Given the increasing and ubiquitous nature of podcasts, “published” and distributed by journals that maintain careful COI policies for written material, we believe it is time for them to consider COI policies for podcasts. Given the various possible COIs of both editors and the people they interview, listeners, similar to written articles that are published, hosted, and distributed by journals, should be aware of COIs.
The world of COI will remain murky – it is all around and comes in many sizes and shapes. It is not clear to us that the current approach – full disclosure, but without the type and amount of the relationships – enables public trust. Perhaps it is time to re-introduce financial categories of support (1 -<10K; 2-10-25K; 3->25-50, 4 >50-100K, 5 >100K). At a time of waning trust in medicine and science, a renewed effort to improve meaningful financial disclosure is necessary.
Declaration of COI:
Bauchner – Consultant to Vivli (Data Sharing Platform, Category 1); Medeloop (Data Repository and AI Agentic, Category 2); Paper-Wizard (AI Review of Manuscripts, Category 2); CBMRT (Null-Hypothesis Champion, Category 2)
Rivara – Funding from NIH; consultant for Career Physicians (Category 1)
Howard Bauchner, MD, is a Professor of Pediatrics and Public Health at the Boston University Chobanian & Avedisian School of Medicine. He is also a Visiting Scholar at the National University of Singapore. Dr. Bauchner is also the former Editor-in-Chief of JAMA and the JAMA Network (2011-2021) and Archives of Disease in Childhood (2004-2011).
Frederick P Rivara, MD, MPH, is Professor of Pediatrics and Adjunct Professor of Epidemiology at the University of Washington. He is also the former Editor-in-Chief of JAMA Pediatrics (2000-2017) and JAMA Network Open (2018-2024). He continues as an active clinician, mentor, and investigator.
Photo by Arnold Antoo on Unsplash
Too little, too late
Great read. Good clarifications. Personally Would rather just see dollar amount range rather than category as I think it’s more transparent. Thanks for your time.