Letter to the editor: Are clinical practice guidelines for hepatitis C by the American Association for the Study of Liver Diseases and Infectious Diseases Society of America evidence based? Financial conflicts of interest and assessment of quality of evidence and strength of recommendations

Abstract

Funding informationSupported, in part, by the Medical Governance Research Institute. This nonprofit enterprise receives donations from pharmaceutical companies, including Ain Pharmacies, Inc., other organizations, and private persons. None of the entities providing financial support for this study contributed to the design, execution, data analyses, or interpretation of study findings and the drafting of this article To the editor, Financial conflicts of interest (FCOIs) of physicians could bias the tones of recommendations in clinical practice guidelines (CPGs) in the way to benefit commercial entities rather than patients. The USA CPGs for hepatitis C by the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) are known for rigorous control of CPG development, although Jefferson et al. reported several discrepancies between the authors’ self‐reported FCOIs in the CPGs and their articles.[1] Here, we examined recommendations of the AASLD/IDSA CPGs for hepatitis C and FCOIs of the authors. We considered all CPG authors of AASLD/IDSA CPGs for hepatitis C published on September 29, 2021[2] and extracted data on author names, their FCOIs, level of evidence (LOE), strength of recommendation (SOR), and tone of recommendation (TOR) from the AASLD/IDSA CPGs and webpage as of September 30, 2021. For the USA‐based CPG physician author, all categories of payments were extracted from the USA Open Payments Data database from 2014 to 2020. The CPGs categorized LOE into three groups: LOE A (multiple randomized clinical trials and meta‐analysis); LOE B (a single randomized trial and nonrandomized studies); and LOE C (expert opinions and case studies). According to recommendation statements, TORs were classified into three types: positive (e.g., “recommend” or “should”); neutral (e.g., recommendation concerning patients eligible for specific treatment); and negative (e.g., “not recommend” or “should not”). SOR was converted into two types: strong (Class I and III SOR) and weak recommendations (Class II, IIa, and IIb SOR). Then, a descriptive analysis was performed for the payment data and recommendations as described.[3,4] The Ethics Committee of the Medical Governance Research Institute approved this study and waived to gain informed consent from study participants because all data in this study were publicly available. We identified 23 authors; 14 (60.9%) had self‐reported FCOI, either personally or institutionally, and 18 (78.3%) were eligible for the payment analysis using Open Payments Data. Among them, 15 (83.3%) received $35,264,631 in total for the 7 years combined (Table 1). No authors received ownership payments. As for the latest 3‐year payments, 12 (67.7%) received $7,314,280 in total and $406,349 per author on average. Furthermore, 11 (61.1%) received average general payments of $7042 (SD, $12,080). There were four CPG chairs; 3 (75.0%) received at least one payment, and 1 (25.0%) had $402,244 for the past 3 years. Although the prevalence of the CPG authors with payments remained the same, annual payments to the CPG authors in all categories had decreased since 2018, which was 1 year after publication of the article by Jefferson et al.[1] TABLE 1 - FCOIs with pharmaceutical companies among the authors of the AASLD and IDSA guidelines for hepatitis C between 2014 and 2020 Total from 2014 to 2020 Total for the last 3 years (from 2018 to 2020) USA open payments data–based FCOI Total by category, US$ General 990,298 126,762 Associate research 27,071,696 7,179,326 Research 23,311 8192 All categories 28,085,305 7,314,280 Average (SD) by category, US$ General 55,017 (94,494) 7042 (12,080) Associate research 1,503,983 (2,232,470) 398,851 (654,113) Research 1295 (2175) 455 (1,482) All categories 1,560,295 (2,319,003) 406,349 (658,850) Author with payment, n (%) General 15 (83.3) 11 (61.1) Associate research 11 (61.1) 9 (50.0) Research 9 (50.0) 2 (11.1) All categories 15 (83.3) 12 (66.7) Chair with payment, n (%) General 4 (100) 2 (50.0) Associate research 2 (50.0) 2 (50.0) Research 2 (50.0) 0 (0) All categories 4 (100) 3 (75.0) Authors’ self‐reported FCOI (since October 2013), n (%) Personal FCOI 8/23 (34.8) — Institutional FCOI 13/23 (56.5) — All 14/23 (60.9) — We identified 212 recommendations, with 54 (25.5%) and 75 (35.4%) being classified as LOE A and C, respectively. Of 150 (70.8%) recommendations categorized as strong, 53 (35.3%) and 44 (29.3%) were based on LOE B and C, respectively. Overall, 90.1% of the recommendations were positive, recommending a conduct of treatment or intervention (Supporting Information S1). This study found that 83.3% of USA hepatitis C CPG authors had FCOIs with pharmaceutical companies. Furthermore, a majority of recommendations were strongly and positively stated with low quality of evidence. Furthermore, the latest AASLD/IDSA CPGs still deviated from the standards suggested 4 years ago,[1] as evidenced by the fact that the majority of authors and 75.0% of chairs received payments from pharmaceutical companies. Currently, several professional societies have taken more rigorous methodology for CPG development, such as using the Open Payments Data database for FCOI disclosure by the American Society of Clinical Oncology[5] and disclosure of non‐FCOIs and rigorous recommendation grading by the American College of Chest Physicians.[6] Given that the current disclosure policy of the AASLD/IDSA CPGs focused on only direct FCOIs with pharmaceutical companies, they should reform the COI policy and CPG development procedure for further improvement. CONFLICT OF INTEREST Dr. Saito received personal fees from TAIHO pharmaceutical company. Dr. Ozaki consults for MNES. Dr. Tanimoto received compensation from MNES and Bionics. AUTHOR CONTRIBUTIONS Anju Murayama: Study concept and design, statistical analysis, and drafting of the manuscript. Akihiko Ozaki: Study concept and design, statistical analysis, drafting of the manuscript, and study supervision. Hiroaki Saito: Study concept and design, drafting of the manuscript. Toyoaki Sawano: Study concept and design, drafting of the manuscript. Tetsuya Tanimoto: Study concept and design, drafting of the manuscript, and study supervision. All authors 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.

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