Mary Guan1, Michael Pillinger2 and Aryeh Abeles3, 1New York University Grossman School of Medicine, Brooklyn, NY, 2NYU Grossman School of Medicine, New York, NY, 3New York University Grossman School of Medicine, Wallingford, CT
Background/Purpose: Prior studies demonstrated that authors of publications may not accurately disclose their financial relationships with industry. One recent study reported that among authors of American College of Rheumatology Clinical Practice Guidelines 35% of total payments from industry sources were incompletely disclosed. Accurate disclosure is intended to minimize bias and ensure transparency for readers who depend on the impartiality of recommendations. We assessed the discrepancy between payments reported in the Open Payments Database (OPD) and those disclosed by authors of clinical research papers in the three top-ranked (by impact factor) American-based general rheumatology journals.
Methods: We are reviewing all disclosures provided by first, second, and last authors of the first 50 clinical research papers and editorials published beginning in January 2019 in the journals Arthritis and Rheumatology, Arthritis Care & Research and Seminars in Arthritis & Rheumatism. Basic science research and letters were excluded. Only US-based physician authors who were searchable on OPD were included. For each author, we extracted payment reports from the OPD related to consulting fees, honoraria and speaker or faculty compensation. Research payments, education, grants, food and travel and lodging were excluded. We defined a potential conflict of interest (PCOI) as a payment received from a company with an ongoing Phase 2 or 3 clinical trial, or with a medication on the market, related to the published manuscript's clinical topic. A comparative analysis was conducted for each author to determine if reported disclosures matched PCOI from OPD. Additionally we determined under-reported company financial relationships and amount of compensation ( > or < $10000).
Results: 75 papers have been analyzed to date. Of these, 60 of 75 were deemed appropriate for inclusion. Among these 60 manuscripts, 46 included ≥1 inaccuracy in the authors' declared PCOI.
Of 164 authors assessed, 61 resided outside the US or were not medical doctors and therefore not included in the OPD. Among 103 US-based physician authors, 35 received no payments from the pharmaceutical industry. Of 68 authors receiving at least one payment from industry, 53 (78%) reported inaccurately. 47 authors (69%) failed to disclose ≥1 PCOI, and 21 (31%) under-disclosed the amount of money received. 15 authors (22%) had both undisclosed PCOI and under-disclosed payments. Among the manuscripts reviewed, 12 papers reported the results of clinical trials, all of which had disclosure inaccuracies, with 17 of 20 (85%) OPD-eligible authors reporting inaccurately. Overall, 305 of 411 (74%) PCOI were declared. Of 72 instances of under-reporting, the mean dollar amount under-reported was $33,126/occurrence (median = $17,438).
Conclusion: Inaccurate and under-reporting of financial disclosures by authors remain an issue in clinical studies published in top rheumatology journals. Improved community education and firmer enforcement of expectations would allow readers to better assess the possible impact of PCOI on publications. Accuracy of financial disclosures in published clinical research papers in top-ranked (by impact factor) American-based Rheumatology journals.
Accuracy of financial disclosures by authors with financial ties to industry in top-ranked Rheumatology journals. Both undisclosed and under-disclosed potential conflicts of interest (PCOI) are reported below. Disclosures: M. Guan, None; M. Pillinger, Horizon Therapeutics, Sobi, Fortress Bioscience, Hikma; A. Abeles, Janssen.