Abstract
Clinical practice guidelines (CPGs) are important in advancing the quality of medical care. Financial relationships between physicians and pharmaceutical companies may influence clinical practice. In accordance with the Japan Pharmaceutical Manufacturers Association guidelines for transparency, pharmaceutical company payments to physicians have been disclosed since 2013. The distribution of pharmaceutical company payments among CPG authors in Japan has not been studied. To determine the characteristics and distribution of payments made by pharmaceutical companies to authors of oncologic CPGs in Japan and to assess the transparency of policies associated with conflict of interest (COI) disclosures in CPGs. This retrospective cross-sectional study of 326 authors from 6 prominent oncologic CPGs from Japan included annual payment data for 2016 from 78 pharmaceutical companies during varying times from January 1, 2016, through September 30, 2017. Amount and proportion of payments made by pharmaceutical companies to the authors; amount and proportion of payments made to the authors of each guideline; and information on policies for disclosing COIs in CPGs (Japanese yen were converted to US dollars based on the February 20, 2019 exchange rate of 110 yen per 1 US dollar). Of 326 eligible authors, 255 (78.2%) received payments from pharmaceutical companies in 2016. The total number of payments was 3947, and the total amount was $3 444 193 (¥378 861 220), including $2 696 777 for speaking, $181 944 for writing, $554 381 for consulting, and $11 091 for unclear fees. The median payment amount was $3233 (interquartile range [IQR], $506-$10 873), and the mean (SD) payment amount was $10 565 ($20 059); 84 authors (25.8%) received more than $10 000. The largest proportions of CPG authors receiving at least 1 payment were those for gastric carcinoma (92%) and colorectal carcinoma (92%). The median payment was highest for authors of colorectal carcinoma guidelines ($7781; IQR, $2506-$18 633), whereas it was lowest for authors of pancreatic carcinoma guidelines ($2207; IQR, $304-$9240). Only breast carcinoma CPGs published the authors' individual COI disclosure in an identifiable matter; guidelines for lung, colorectal, pancreatic, and hepatocellular carcinomas disclosed the financial relationships between the authors and companies anonymously; and the gastric carcinoma CPGs did not have a COI disclosure section. Most oncologic CPG authors received payments from pharmaceutical companies, and COI disclosure methods appeared to be insufficient. Given the possibility of bias in guideline content if authors have any financial relationships with pharmaceutical companies, CPGs from Japan may require improved transparency.
Highlights
There is an increasing focus on transparency in the financial relationships between the pharmaceutical industry and physicians worldwide because such financial relationships can bias physicians’ decision making[1,2,3,4,5] and a large amount of payments has been made for promotional purposes
To determine the characteristics and distribution of payments made by pharmaceutical companies to authors of oncologic Clinical practice guidelines (CPGs) in Japan and to assess the transparency of policies associated with conflict of interest (COI) disclosures in CPGs
The largest proportions of CPG authors receiving at least 1 payment were those for gastric carcinoma (92%) and colorectal carcinoma (92%)
Summary
There is an increasing focus on transparency in the financial relationships between the pharmaceutical industry and physicians worldwide because such financial relationships can bias physicians’ decision making[1,2,3,4,5] and a large amount of payments has been made for promotional purposes. Among various types of representatives in medical fields, CPG authors exert some of the largest influences on clinical practice[14] because they present recommendations for drugs and other treatment modalities for specific disorders. CPG authors may be prime targets for pharmaceutical company payments used for promotional purposes despite self-regulation and other policies; this could be true in oncology. A single administration of tisagenlecleucel, a recently approved chimeric, antigen-receptor T-cell immunotherapy treatment manufactured by Novartis Pharma reportedly costs US $475 000.15,16
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