Abstract
Background
Monoclonal antibody drugs are widely used, highly marketed, expensive compounds. Relationships between these drug manufacturers and physicians may increase the potential for bias in relevant studies.
Objective
The aim of this study is to determine the rate of disclosures among physicians receiving compensations for monoclonal antibody drugs (MAbDs).
Design
This is a retrospective, population-based, cross-sectional study.
Participants
The 50 physicians who received the highest financial compensation for selected MAbDs from 2016 to 2020 were included.
Main Measures
Payment data were obtained from the Open Payments Database, bibliometric data were obtained from SCOPUS, and disclosure data were obtained from relevant publications found in PubMed. The primary outcome was rate of disclosure concordance between self-declared conflict-of-interest and industry-reported payments documented in the Open Payments Database.
Key Results
Of the 50 physicians examined, 74% (N = 37) had publications examined. A cumulative 6170 payments totaling $18,484,228 were analyzed. A total of 418 relevant papers were reviewed. The rate of full disclosure (all relevant financial relationships disclosed) was 39.5%, partial disclosure (some but not all financial relationships disclosed) was 28.0%, and no disclosure was 26.3%. 6.2% did not require disclosure. Publications authored by dermatologists had the highest rate of full disclosure at 49.3%. There was no association between h-index and disclosure rate. Practice guidelines had the highest rate of full disclosure at 69.2% while basic science papers had the lowest (0%). Lastly, substantial variations in specific journal disclosure policies were found.
Conclusions
Substantial inconsistencies were found between self-reported disclosures and the Open Payments Database among physicians receiving high compensation for MAbDs. A policy of full disclosure for all publications should be adopted.
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Acknowledgements
This study would not have been possible without research support from Julianna Brouwer, M.P.H. M.H. is supported by an NIH NIDCD Ruth L. Kirschstein Predoctoral Individual NRSA grant award number F30DC017658 and an MSTP grant from the National Institute of General Medical Sciences of the NIH under award number T32GM007739 to the Weill Cornell/Rockefeller/Sloan Kettering Tri-Institutional MD-PhD Program.
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Dr. Alessio Pigazzi has received compensation and/or consulting fees from Intuitive, Ethicon, Covidien, Medtronic, Colospan, and Vioptix, honoraria from Xodus, and education and food/beverage fees under the sum of $200 from Coloplast and AcelRx. Dr. Jafari has received compensation and/or consulting fees from Intuitive, Covidien, Erbe, Merz, and AcelRx and is a course director for Medtronic. Dr. Jafari has received consulting fees from Intuitive, Covidien, Erbe, Merz, AcelRx, and Karl Storz and is a course director for Medtronic. Dr. Herre became an employee of Regeneron Pharmaceuticals during completion of the manuscript. The remainder of the authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article.
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These data were presented at the 2022 Fall Scientific Session for the New York Surgical Society
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Mesiti, A., Herre, M., Jafari, M.D. et al. Discrepancies in Conflict-of-Interest Disclosures Among Physicians Receiving Compensation for Monoclonal Antibody Drugs. J GEN INTERN MED 39, 1135–1141 (2024). https://doi.org/10.1007/s11606-023-08523-7
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DOI: https://doi.org/10.1007/s11606-023-08523-7