Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Miyagi, Japan.
Medical Governance Research Institute, Shinagawa, Tokyo, Japan.
JAMA Netw Open. 2019 Apr 5;2(4):e192834. doi: 10.1001/jamanetworkopen.2019.2834.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
临床实践指南（CPG）对于提高医疗质量非常重要。医生与制药公司之间的财务关系可能会影响临床实践。根据日本制药商协会的透明度准则，自 2013 年以来，已披露制药公司向医生支付的款项。日本 CPG 作者之间制药公司支付款项的分布情况尚未研究。
确定日本肿瘤 CPG 作者从制药公司获得的付款的特征和分布，并评估与利益冲突（COI）披露相关的政策的透明度。
设计、设置和参与者：这项对来自日本 6 种主要肿瘤 CPG 的 326 名作者的回顾性横断面研究包括 2016 年来自 78 家制药公司的年度付款数据，时间范围从 2016 年 1 月 1 日至 2017 年 9 月 30 日不等。
制药公司向作者支付的款项金额和比例；每位指南作者收到的付款金额和比例；以及 CPG 中披露 COI 政策的信息（根据 2019 年 2 月 20 日 110 日元兑 1 美元的汇率，将日元转换为美元）。
在 326 名符合条件的作者中，255 名（78.2%）在 2016 年收到了制药公司的付款。总付款数为 3947 笔，总额为 3444193 美元（378861220 日元），其中包括演讲费 2696777 美元、写作费 181944 美元、咨询费 554381 美元和不明费用 11091 美元。中位付款金额为 3233 美元（四分位距 [IQR]，506-10873 美元），平均（SD）付款金额为 10565 美元（20059 美元）；84 名作者（25.8%）收到的款项超过 10000 美元。收到至少 1 笔付款的 CPG 作者中，胃癌（92%）和结直肠癌（92%）的比例最大。结直肠癌指南作者的中位付款最高（7781 美元；IQR，2506-18633 美元），而胰腺癌指南作者的付款最低（2207 美元；IQR，304-9240 美元）。只有乳腺癌 CPG 以可识别的方式公布了作者的个人 COI 披露；肺癌、结直肠癌、胰腺癌和肝细胞癌指南匿名披露了作者与公司之间的财务关系；胃癌 CPG 没有 COI 披露部分。
大多数肿瘤 CPG 作者都从制药公司获得了报酬，而且 COI 披露方法似乎还不够。如果作者与制药公司有任何财务关系，可能会影响指南内容的偏差，因此日本的 CPG 可能需要提高透明度。
