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The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States

  • Deepa V. Cherla
  • Cristina P. Viso
  • Julie L. Holihan
  • Karla Bernardi
  • Maya L. Moses
  • Krislynn M. Mueck
  • Oscar A. Olavarria
  • Juan R. Flores-Gonzalez
  • Courtney J. Balentine
  • Tien C. Ko
  • Sasha D. Adams
  • Claudia Pedroza
  • Lillian S. Kao
  • Mike K. Liang
Original Research

Abstract

Background

Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report of these conflicts of interest (COIs).

Objective

Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI.

Design

In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed.

Main Measures

Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability.

Key Results

A 69% discordance rate existed between industry and self-report in COI disclosure.

When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p = < 0.001). On univariate (any COI 74% versus no COI 62%, RR 1.11, p = < 0.001) and multivariable analyses, any COI was associated with favorability.

Conclusions

All financial COIs (disclosed or undisclosed, relevant or not relevant, research or non-research) influence whether studies report findings favorable to industry sponsors.

KEY WORDS

ethics medical education-professionalism research Design 

Notes

Acknowledgments

This work was supported by the Center for Clinical and Translational Sciences, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences. Dr. Balentine is supported by a mentored career development award from the Agency for Healthcare Research and Quality (K12 HS023009-03).

Compliance with Ethical Standards

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Conflict of Interest

The authors declare that they do not have a conflict of interest.

Supplementary material

11606_2018_4784_MOESM1_ESM.docx (17 kb)
ESM 1 (DOCX 17 kb)

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Copyright information

© Society of General Internal Medicine 2019

Authors and Affiliations

  • Deepa V. Cherla
    • 1
    • 2
  • Cristina P. Viso
    • 1
  • Julie L. Holihan
    • 1
    • 2
  • Karla Bernardi
    • 1
    • 2
    • 3
  • Maya L. Moses
    • 1
  • Krislynn M. Mueck
    • 1
    • 2
  • Oscar A. Olavarria
    • 1
  • Juan R. Flores-Gonzalez
    • 1
  • Courtney J. Balentine
    • 4
  • Tien C. Ko
    • 1
  • Sasha D. Adams
    • 1
  • Claudia Pedroza
    • 1
    • 5
  • Lillian S. Kao
    • 1
    • 2
  • Mike K. Liang
    • 1
    • 2
  1. 1.Department of Surgery, McGovern Medical SchoolUniversity of Texas Health Science Center at HoustonHoustonUSA
  2. 2.Center for Surgical Trials and Evidence-Based Practice (C-STEP), McGovern Medical SchoolUniversity of Texas Health Science Center at HoustonHoustonUSA
  3. 3.Department of Surgery General Surgery Clinical Research FellowHoustonUSA
  4. 4.Department of Surgery & Institute for Cancer Outcomes and SurvivorshipUniversity of Alabama at BirminghamBirminghamUSA
  5. 5.Center for Clinical Research and Evidence-Based Medicine, McGovern Medical SchoolUniversity of Texas Health Science Center at HoustonHoustonUSA

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