Article Text

Original research
Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study
  1. Maryam Mooghali1,2,
  2. Laura Glick3,
  3. Reshma Ramachandran2,4,
  4. Joseph S Ross3,5
  1. 1General Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
  2. 2Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, Connecticut, USA
  3. 3Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
  4. 4Internal Medicine, Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
  5. 5Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut, USA
  1. Correspondence to Dr Joseph S Ross; joseph.ross{at}yale.edu

Abstract

Objective To evaluate the prevalence and accuracy of industry-related financial conflict of interest (COI) disclosures among US physician guideline authors.

Design Cross-sectional study.

Setting Clinical practice guidelines published by the Council of Medical Specialty Societies in 2020.

Participants US physician guideline authors.

Main outcome measures Financial COI disclosures, both self-reported and determined using Open Payments data.

Results Among 270 US physician authors of 20 clinical practice guidelines, 101 (37.4%) disclosed industry-related financial COIs, whereas 199 (73.7%) were found to have received payments from industry when accounting for payments disclosed through Open Payments. The median payments received by authors during the 3-year period was US$27 451 (IQR, US$1385–US$254 677). Comparing authors’ self-disclosures with Open Payments, 72 (26.7%) of the authors accurately disclosed their financial COIs, including 68 (25.2%) accurately disclosing no financial COIs and 4 (1.5%) accurately disclosing a financial COI. In contrast, 101 (37.4%) disclosed no financial COIs and were found to have received payments from industry, 23 (8.5%) disclosed a financial COI but had under-reported payments received from industry, 14 (5.2%) disclosed a financial COI but had over-reported payments received from industry and 60 (22.2%) disclosed a financial COI but were found to have both under-reported and over-reported payments received from industry. We found that inaccurate COI disclosure was more frequent among professors compared with non-professors (81.9% vs 63.5%; p<0.001) and among males compared with females (77.7% vs 64.8%; p=0.02). The accuracy of disclosures also varied among medical professional societies (p<0.001).

Conclusions Financial relationships with industry are common among US physician authors of clinical practice guidelines and are often not accurately disclosed. To ensure high-quality guidelines and unbiased recommendations, more effort is needed to minimise existing COIs and improve disclosure accuracy among panel members.

  • Protocols & guidelines
  • MEDICAL ETHICS
  • Quality in health care

Data availability statement

Data are available upon reasonable request. Relevant data are available on reasonable request from the corresponding author.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Data availability statement

Data are available upon reasonable request. Relevant data are available on reasonable request from the corresponding author.

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Footnotes

  • Twitter @reshmagar

  • Contributors MM, LG and JSR conceived of and designed the study. MM and LG collected the data. MM led the data analysis and drafted the first version of the manuscript. MM, LG, RR and JSR reviewed and interpreted the data, read the manuscript and provided critical feedback for important intellectual content. JSR provided supervision. MM, LG, RR and JSR approved the submission of the current version of the manuscript. MM accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests MM, RR and JSR currently receive research support through Yale University from Arnold Ventures. RR currently receives research support through Yale Law School from the Stavros Niarchos Foundation for a project focused on public R&D and manufacturing for enabling equitable access to medical technologies. She also serves as a consultant to the ReAct-Action on Antibiotic Resistance Strategic Policy Program based out of Johns Hopkins Bloomberg School of Public Health, which is funded by the Swedish International Development and Cooperation Agency (Sida). JSR currently receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882) and from the National Heart, Lung and Blood Institute of the National Institutes of Health (R01HS025164, R01HL144644); in addition, JSR is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.