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Figure.  Payments Received by Authors of Clinical Practice Guidelines (CPGs) Recommending High-Revenue Medications
Payments Received by Authors of Clinical Practice Guidelines (CPGs) Recommending High-Revenue Medications

Data are stratified by payment type. CMS-OP indicates Centers for Medicare & Medicaid Services Open Payments.

Table.  Characteristics of Clinical Practice Guidelines
Characteristics of Clinical Practice Guidelines
1.
Sox  HC.  Conflict of interest in practice guidelines panels.  JAMA. 2017;317(17):1739-1740. doi:10.1001/jama.2017.2701PubMedGoogle ScholarCrossref
2.
Neuman  J, Korenstein  D, Ross  JS, Keyhani  S.  Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study.  BMJ. 2011;343:d5621. doi:10.1136/bmj.d5621PubMedGoogle ScholarCrossref
3.
Graham  R, Mancher  M, Wolman  DM.  Clinical Practice Guidelines We Can Trust. Washington, DC: Institute of Medicine; 2011.
4.
Kornfield  R, Donohue  J, Berndt  ER, Alexander  GC.  Promotion of prescription drugs to consumers and providers, 2001-2010.  PLoS One. 2013;8(3):e55504. doi:10.1371/journal.pone.0055504PubMedGoogle ScholarCrossref
5.
Brax  H, Fadlallah  R, Al-Khaled  L,  et al.  Association between physicians’ interaction with pharmaceutical companies and their clinical practices: a systematic review and meta-analysis.  PLoS One. 2017;12(4):e0175493. doi:10.1371/journal.pone.0175493PubMedGoogle ScholarCrossref
6.
Santhakumar  S, Adashi  EY.  The Physician Payment Sunshine Act: testing the value of transparency.  JAMA. 2015;313(1):23-24. doi:10.1001/jama.2014.15472PubMedGoogle ScholarCrossref
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    Research Letter
    December 2018

    Prevalence of Financial Conflicts of Interest Among Authors of Clinical Guidelines Related to High-Revenue Medications

    Author Affiliations
    • 1Division of Gastroenterology, St Michael’s Hospital, Toronto, Ontario, Canada
    • 2Department of Medicine, University of Toronto, Toronto, Ontario, Canada
    JAMA Intern Med. 2018;178(12):1712-1715. doi:10.1001/jamainternmed.2018.5106

    The presence of financial conflicts of interest in clinical practice guidelines (CPGs) may affect the objectivity of these documents. Although the National Academy of Medicine has created policies to limit industry influence on the development of CPGs, guidelines rarely adhere to these policies.1 Moreover, CPG authors may have undeclared financial conflicts of interest.2 We hypothesized that undeclared industry payments would be highly prevalent among authors of CPGs related to high-revenue medications, and we quantified the presence and extent of these payments.

    Methods

    In this study, conducted from January 1, 2013, to December 31, 2017, we identified the top 10 revenue medications of 2016 using the pharmaceutical information website PharmaCompass (https://www.pharmacompass.com/) and verified this information with Securities and Exchange Commission documents and company reports. We identified CPGs through the National Guideline Clearinghouse based on clinical indications for medications and selected CPGs endorsed by a national organization based in the United States and published from 2013 to 2017. For each author, we categorized financial conflicts of interest based on the Centers for Medicare & Medicaid Services Open Payments (CMS-OP) definitions of general (eg, consulting fees) or research payments (https://www.cms.gov/OpenPayments/About/Natures-of-Payment.html). The CMS-OP website publishes payments made by pharmaceutical companies to US-based physicians. This study used publicly available data. A waiver of approval was provided by the St Michael’s Hospital Research Ethics Board.

    We searched for authors on the CMS-OP website to identify payments not declared in the CPG. We only included US-based physicians in our study sample, defined as authors with CMS-OP profiles. We limited our search to the CPG publication year and the year prior. We assessed each guideline for adherence to 3 National Academy of Medicine standards: written disclosure of all potential financial conflicts of interest; appointing committee chairs with no financial conflicts of interest; and limiting guideline authors with financial conflicts of interest to less than 50% of the panel.3

    Results

    We identified 18 CPGs that provided recommendations for 10 high-revenue medications, written by 160 authors who were US-based physicians (Table). A total of 79 authors (49.4%) declared receipt of a payment in the CPG or supplemental materials, with 50 (31.3%) declaring receipt of payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPG. An additional 41 authors (25.6%) were found to have received but not disclosed receipt of payments from companies marketing 1 of the 10 high-revenue medications recommended within the CPGs. Thus, in total, 91 authors (56.9%) were found to have financial conflicts of interest (Figure).

    Among all authors, the median value of undeclared payments from companies marketing 1 of the 10 high-revenue medications recommended in the CPGs was $522 (interquartile range, $0-$40 444) from 2 companies (interquartile range, 0-4). With respect to adherence to National Academy of Medicine standards, no CPGs had complete written disclosure of all potential financial conflicts of interest, 4 appointed chairs without financial conflicts of interest, and 8 limited authors with financial conflicts of interest to less than 50% of the panel.

    Discussion

    Authors of CPGs related to high-revenue medications have a substantial number of undeclared payments from industry, including those from pharmaceutical companies that market the medications recommended in those CPGs. In addition, most guidelines fail to adhere to national standards for financial conflicts of interest in CPGs. Guidelines related to high-revenue medications may be at especially high risk of having authors with financial conflicts of interest because pharmaceutical companies expend considerable resources marketing their top products.4 This marketing may take the form of payments to physicians, which have been shown to affect clinical decision making.5

    This study is limited by potential inaccuracies in CMS-OP reporting, which are rarely corrected,6 and lack of generalizability outside the United States. In addition, the CMS-OP website began publishing data from mid-2013. Since we collected only several months of CMS-OP data for guidelines published in 2013, we may have underestimated the financial conflicts of interest for these guidelines. Finally, we did not have access to guideline voting records and thus did not know when conflicted panel members recommended against a medication or recused themselves from voting.

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    Article Information

    Accepted for Publication: August 4, 2018.

    Corresponding Author: Samir C. Grover, MD, MEd, FRCPC, Division of Gastroenterology, St Michael’s Hospital, Department of Medicine, University of Toronto, 30 Bond St, 16-036 Cardinal Carter Wing, Toronto, ON M5B 1W8, Canada (samir.grover@utoronto.ca).

    Published Online: October 29, 2018. doi:10.1001/jamainternmed.2018.5106

    Author Contributions: Mr Khan and Dr Grover had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Messrs Khan and Scaffidi contributed equally.

    Concept and design: Khan, Scaffidi, Rumman, Plener, Grover.

    Acquisition, analysis, or interpretation of data: All authors.

    Drafting of the manuscript: Khan, Scaffidi, Rumman, Grindal, Grover.

    Critical revision of the manuscript for important intellectual content: All authors.

    Statistical analysis: Khan, Scaffidi, Rumman, Grindal.

    Administrative, technical, or material support: Grover.

    Supervision: Grover.

    Conflict of Interest Disclosures: Mr Khan reported receiving research funding from AbbVie and Ferring Pharmaceuticals. Dr Grover reported receiving grants from AbbVie and Janssen and personal fees from AbbVie, Takeda, and Ferring and being owner of and holding shares in Volō Healthcare.

    Additional Contributions: Kaitlin Fuller, MLIS, Gerstein Science Information Centre, University of Toronto, assisted in formatting the search strategy. She was not compensated for her contribution.

    References
    1.
    Sox  HC.  Conflict of interest in practice guidelines panels.  JAMA. 2017;317(17):1739-1740. doi:10.1001/jama.2017.2701PubMedGoogle ScholarCrossref
    2.
    Neuman  J, Korenstein  D, Ross  JS, Keyhani  S.  Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study.  BMJ. 2011;343:d5621. doi:10.1136/bmj.d5621PubMedGoogle ScholarCrossref
    3.
    Graham  R, Mancher  M, Wolman  DM.  Clinical Practice Guidelines We Can Trust. Washington, DC: Institute of Medicine; 2011.
    4.
    Kornfield  R, Donohue  J, Berndt  ER, Alexander  GC.  Promotion of prescription drugs to consumers and providers, 2001-2010.  PLoS One. 2013;8(3):e55504. doi:10.1371/journal.pone.0055504PubMedGoogle ScholarCrossref
    5.
    Brax  H, Fadlallah  R, Al-Khaled  L,  et al.  Association between physicians’ interaction with pharmaceutical companies and their clinical practices: a systematic review and meta-analysis.  PLoS One. 2017;12(4):e0175493. doi:10.1371/journal.pone.0175493PubMedGoogle ScholarCrossref
    6.
    Santhakumar  S, Adashi  EY.  The Physician Payment Sunshine Act: testing the value of transparency.  JAMA. 2015;313(1):23-24. doi:10.1001/jama.2014.15472PubMedGoogle ScholarCrossref
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