Most professional medical societies sponsor clinical practice guidelines (CPGs) relevant to their clinical specialty. Previous studies report that physicians selected to serve as CPG authors have considerable industry relationships.1,2 In the field of neurosurgery, where evidence suggests that industry-funded neurosurgery trials are more likely to produce favorable results than non–industry-funded trials,3 the extent of financial conflict of interest (FCOI) among guideline authors remains unknown. In this investigation, we examined payments from medical device and pharmaceutical companies compiled in the Open Payments Database (OPD) to physician-authors of the Congress of Neurological Surgery’s (CNS) internally produced and endorsed CPGs a year before and after the CPG publication date. We also identified the portion of undisclosed payments made to authors for medications and devices relevant to CPGs.
The CPGs were required to be published after August 2014, chosen to allow 1 year prior to CPG publication to evaluate authors’ FCOI (OPD began cataloging data in August 2013). According to CNS policy, CPG authors should report all possible FCOIs for 1 year before guideline work, including potential FCOIs unrelated to guideline topics.4 Four payment categories are available in OPD: general, research, associated research, and ownership. For general payments, we excluded food and beverage payments. For each author, 2 investigators (B.S.J. and C.G.W.) extracted payments cataloged in OPD 1 year prior to and 1 year after the CPG publication date. Because no CPG start date could be identified, we used publication date and 12 months prior as a proxy for start date, consistent with previous investigations.1,5 One investigator (S.D.), a board-certified neurosurgeon, evaluated each payment for guideline relevance. The institutional review board at Oklahoma State University determined that this study was exempted from review, and no informed consent was needed because there were no study participants. Analysis began July 2019 and ended May 2020.
We found 1723 individual payments to 60 physician-authors totaling $7 154 943. Only 24.4% ($1 746 276 of $7 154 943) of total payments were included for analysis of relevant payments because OPD does not always include the drug or device name. Based on these $1 746 276 in payments, 23.8% ($415 725 of $1 746 276) were guideline relevant. Of the 60 authors, 50 (83.3%) received payments totaling $5 526 966 prior to publication. These 50 authors received a median (interquartile range) of $16 392 ($822-$53 180) the year prior to publication. Only 20.3% ($1 119 757 of $5 526 966) of the money received before guideline publication were disclosed by the author. Three of 6 guidelines (50%) reported that all authors had no FCOI to disclose; however, 22 authors received payments totaling $1 072 989. Only 3 of 41 relevant payments (7.3%) received prior to guideline publication were disclosed by the author. The remaining $1 627 977 was received by 50 authors (83.3%) after guideline publication. These 50 authors received a median (interquartile range) of $11 748 ($991-$36 833) in the 1 year following publication (Table 1). Thirteen authors received relevant payments totaling $182 469, representing 11.2% ($182 469 of $1 627 977) of all payments received after guideline publication. These relevant payments represent 43.9% ($182 469 of $415 725) of the total relevant dollars received in this study. These 13 authors received a median (interquartile range) of $3571 ($2390-$9337) of relevant money in the year following guideline publication (Table 2).
In summary, many CNS guideline authors did not disclose payments. These undisclosed payments totaled $4.4 million, encompassing almost 80% of payments received prior to guideline development. These results are similar to those for numerous other professional societies.1,2,5 Two CNS CPG authors received nearly $20 000 in undisclosed, relevant general payments in the year prior to guideline publication. These CPG-relevant and undisclosed payments are 6 to 7 times larger than the median total of general payments received by all authors prior to publication. This example is concerning because of the magnitude of influence such payments may have on authors and because the public would have never known this relationship existed otherwise. To promote transparency, decrease bias, and gain the trust of patients and physicians, we recommend the CNS amend CPG policies to include broad concepts, such as verifying author disclosure statements, including more conflict-free authors, and requiring longer conflict-free periods. A degree of subjectivity may exist when determining relevance of payments, such that another expert may determine relevance differently. To mitigate this subjectivity, we applied a narrower definition of relevance than described by the International Committee of Medical Journal Editors.6
Corresponding Author: Bradley S. Johnson, MA, Oklahoma State University Center for Health Sciences, 1111 W 17th St, Tulsa, OK 74107 (bradley.johnson11@okstate.edu).
Accepted for Publication: May 16, 2020.
Published Online: October 14, 2020. doi:10.1001/jamasurg.2020.3515
Author Contributions: Dr Vassar had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Walters, Wayant, Vassar.
Acquisition, analysis, or interpretation of data: Johnson, Walters, Wayant, Dull.
Drafting of the manuscript: Johnson, Walters, Wayant.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Johnson, Walters.
Administrative, technical, or material support: Vassar.
Supervision: Wayant, Vassar.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was sponsored by an Oklahoma State University Presidential Grant.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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