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.