Discussion
The present study aimed to investigate the financial conflicts of interest among authors of the 2020 Japan College of Rheumatology Clinical Practice Guideline for the Management of Rheumatoid Arthritis. To the best of our knowledge, this study is the first to evaluate the prevalence and magnitude of financial relationships between CPG authors and pharmaceutical companies in Japan in the field of rheumatology. Remarkably, all 27 authors received personal payments from pharmaceutical companies between 2016 and 2020, totaling $3,683,048. The median and mean payments per author were substantial, and one author received as much as $686,024 over the five years. These findings raise ethical concerns, especially considering that the COI information was not publicly disclosed in the CPG or on the JCR’s website. Additionally, more than 80% of recommendations were supported by low or very low-quality evidence, including single observational studies, case reports, and the opinions of the CPG authors.
The high prevalence of financial COIs among the authors in our study aligns with previous research, albeit with a higher percentage. This could indicate a field-specific vulnerability to financial COIs, particularly in the realm of rheumatology in Japan. For example, we previously reported that the prevalence of CPG authors receiving personal payments from pharmaceutical companies was 87.0% in infectious diseases [24], 88% in nephrology [11], 88.2% in gastroenterology [23], 88.6% in urology [25], 90.6% in dermatology [18], 91.3% in psoriatic arthritis [10], 94.6% in hematology [26], 96.3% in otolaryngology [12], and 100% in hepatology [27] and esophageal cancer [28]. Additionally, the mean annual payment of $29,000 was larger than those to CPG authors in most previously reported specialties [8,18,23-25,28]. We also previously found that the mean annual personal payments to general rheumatologists were $4,882–$5,673 [16]. These findings support our hypothesis that pharmaceutical companies concentrate their payments significantly on rheumatology CPG authors in Japan, even compared to other specialties.
Our study also evaluated the strength and quality of the CPG recommendations. A significant majority (81.8%) of the recommendations were supported by low or very low-quality evidence. This is particularly concerning given that the majority of strong recommendations were supported by low-quality evidence, such as case reports and opinions of experts with insufficient COI management, as seen in previous studies [3,11,29]. The incongruence between the strength of recommendations and the quality of evidence underscores the need for more rigorous evidence-based approaches in guideline development in Japan.
Nevertheless, these financial relationships between the CPG authors and the pharmaceutical companies were managed within the JCR and not publicly disclosed to the CPG readers. Although almost all CPGs published by US and European medical societies have publicly disclosed their authors’ COI information and emphasized the importance of transparency in financial relationships [2,6,7,30], non-disclosure of financial COI among CPG authors is commonly reported in Japan [11,12,18,24,25,28]. In some cases, significant amounts of payments and a large number of CPG authors under-declared their COI status to the public in Japan [10,23,28]. This study highlights an urgent need for transparency and reform in the development of clinical practice guidelines in Japan, particularly in the field of rheumatology. The undisclosed financial COIs and the low quality of evidence supporting the recommendations have far-reaching ethical and clinical implications. They not only compromise the integrity of the guidelines but also risk skewing treatment paradigms towards less evidence-based treatments. This is particularly relevant in a field like rheumatology, where treatment decisions have long-term consequences for patients.