https://orcid.org/0000-0002-6053-689X
TO THE EDITOR:
Management of conflicts of interest (COI) during the development of clinical practice guidelines is essential. A COI describes a situation in which the judgment of an individual or group is at risk of bias from a secondary interest. COI involve both financial and nonfinancial interests, for example, interests that are academic, personal, political, or social.
There are limited data on how COI actually affect clinical practice guideline recommendations.1 However, bias may be actual or perceived. Actual bias may affect guideline validity, whereas perceived bias may affect credibility. At the same time, survey data show that American Society of Hematology (ASH) members trust guidelines by known experts.2 Such experts, when they have worked for decades in a field of interest, commonly have potential COI, such as conducting research studies funded by industry.
Like most guideline developers, the ASH uses practical policies and procedures to manage both real and perceived COI, with the goal of producing guidelines that health care professionals, patients, and policymakers can trust. In this context, we read with interest the quantification by Jacobs et al of all financial payments by industry to authors of ASH guidelines from 2018 to 2023, using information from the Centers for Medicare and Medicaid Services’ database OpenPayments.3 They report that 77% of US guideline authors received financial payments, with 59% of payments exceeding $5000. The majority of these payments (>90%) were related to research.
There are several limitations to this analysis. First, the completeness, precision, and accuracy of OpenPayments, a publicly accessible database of payments that drug and medical device companies make to US physicians and other health care professionals, has been criticized.4,5 Second, OpenPayments only tracks US-based physicians. As noted by Jacobs et al, fewer than one-third of the authors of the included ASH guidelines were US based. Third, Jacobs et al conflate authors with guideline panelists; under ASH policies, only guideline panelists make decisions about recommendations.
In addition to these obvious limitations, there are logical flaws in the analysis. Most notably, Jacobs et al equate any financial interest reported in OpenPayments with a direct financial payment to a panelist. Both OpenPayments and ASH policies distinguish direct financial interests (eg, payments to an individual for consulting or speaking, equity or ownership, and employment) from indirect financial interests, such as research funding paid to an individual’s institution rather than directly to the individual. Under ASH policies, indirect financial interests are managed differently than direct financial interests (supplemental Appendix).
Furthermore, Jacobs et al give no consideration to how COI may be appropriately managed when judged to be present. ASH policies and procedures around COI are regularly reviewed and revised. They aim for all financial and nonfinancial interests to be transparently disclosed and appropriately managed during the entire guideline development process. ASH’s Guideline Oversight Subcommittee, a group whose mandate is to ensure the rigor and transparency of guidelines, appoints an ex officio member to each guideline panel; this individual’s chief responsibility is to elicit and analyze COI, and ensure ASH policies and processes are being followed. The Society collects interests for potential guideline panelists a priori, sets a threshold beyond which direct interests automatically exclude an individual from panel participation, and encourages open discussion of all interests during guideline panel meetings. For example, on a recommendation-by-recommendation basis, any panelist with a potential conflict of interest may be recused from making judgments about evidence and from making decisions about the direction or strength of the recommendation. All such recusals are then documented within the guidelines. Every published ASH guideline describes all disclosed interests by authors and guideline panelists, the ASH’s judgments about those interests, and specific management strategies taken to mitigate COI; this allows users to develop informed opinions about risk of bias.
In summary, Jacobs et al find that some authors of ASH guidelines have financial relationships with industry. However, they fail to consider how panelist COI were managed, including with recusal. ASH continues to be committed to management of financial and nonfinancial relationships, to promote transparency, equity, and the development of trustworthy guidelines. We welcome additional analysis.
Contribution: M.P., M.B., A.C., R.K., and M.C.C. conceived of and wrote the manuscript; and B.D., J.G., M.S., and D.R.T. critically reviewed and revised the manuscript.
Conflict-of-interest disclosure: M.P. has received honoraria and travel support from Pfizer. A.C. has served as a consultant for MingSight, Pfizer, Sanofi, and Synergy, and has received authorship royalties from UpToDate. M.S. has served as a consultant for BeiGene. R.K. is an employee of the American Society of Hematology (ASH). All authors (except R.K.) are volunteer members of the ASH Guideline Oversight Subcommittee.
Correspondence: Matthew C. Cheung, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Odette Cancer Centre, Toronto, ON M4N3M5, Canada; email: matthew.cheung@sunnybrook.ca.
