Summary of principal findings
This comprehensive longitudinal cross-sectional study scrutinized the financial relationships between pharmaceutical companies and all allergists certified by the Japanese Society of Allergology for non-research activities from 2016 to 2020. To the best of our knowledge, this research is the first study to assess the scale and trends of non-research reimbursements to physicians from pharmaceutical companies for services such as lecturing, consulting, and manuscript drafting in the Japanese discipline of allergology and clinical immunology. The analysis revealed that 60.8% of all allergists received non-research payments totaling $43.4 million (over 4.6 billion yen) across the five-year span. Notably, these payments escalated annually by more than 7% in the pre-pandemic era, with the largest contributions stemming from companies that manufacture and distribute medications for allergic conditions including allergic rhinitis, asthma, and atopic dermatitis within Japan.
Comparison with previous studies
This investigation discerned that approximately 40% of allergists received annual non-research payments, with over 60% compensated across a five-year period for activities such as lecturing, consulting, and drafting. These percentages are consistent with prior research conducted within Japan. The lowest annual proportions of physicians receiving such payments were reported among otolaryngologists (24.3% to 26.0%) and the highest among rheumatologists (49.8% to 52.5%) across 10 clinical specialties previously documented[6-10,12,28,29,31,37]. Concurrently, the annual median payments received by allergists ($1,332 to $1,526) fell within the range reported for other internal medicine subspecialties. For example, gastroenterologists received $829 to $946[8], pulmonologists $1085 to $1428[10], hematologists $1241 to $1629[31], infectious disease specialists $1430 to $1737[9], and rheumatologists $1544 to $1635 annually[6]. Thus, the financial engagements between the pharmaceutical industry and board-certified allergists do not appear to be markedly distinct when compared to other medical fields.
The analysis revealed that annual non-research payments to allergists ranged from $7.8 million to $10.0 million. In comparison, the United States recorded annual payments between $10.6 million and $18.8 million for similar non-research activities among allergists and clinical immunologists[20,21]. Considering the healthcare expenditure of approximately $4.3 trillion in the United States against Japan’s $403.4 billion, the non-research payments to Japanese allergists for activities such as lecturing, consulting, and drafting appear relatively substantial. This disparity may be attributed to the high prevalence of allergic diseases in Japan, estimated at 49.2% for allergic rhinitis[38], compared to 15%-30% in the United States [39-41].
Additionally, the period between 2014 and 2018 saw the approval of several novel drugs for allergic rhinitis in Japan. For instance, Kyorin Pharmaceutical, ranking fourth among the top payers, released desloratadine (Desalex) in 2016. Additionally, four out of the top ten payers introduced new second-generation antihistamines—rupatadine fumarate (Rupafin by Mitsubishi Tanabe Pharma, approved in 2017), bilastine (Bilanoa by Taiho Pharmaceutical, approved in 2016), and fexofenadine hydrochloride/pseudoephedrine hydrochloride (Dellegra by Sanofi, approved in 2012). The first sublingual immunotherapy product for cedar pollen allergy, Cedartolen by Torii Pharmaceutical, received approval in 2014 for patients aged 12 years and older. Following suit, Miticure, another product by Torii Pharmaceutical for dust mite allergy, was initially approved in 2015 for patients over 12 years and later extended for younger patients in 2018[42]. The introduction of these novel drugs and the expansion of treatment options for allergic rhinitis likely contributed to the high volume of payments and the ascending trend observed from 2016 to 2019.
The investigation also revealed that a disproportionate amount of non-research payments was concentrated among the small number of allergists. This finding is also consistent with previous research across specialties[1,6-9,16,20,29]. Pharmaceutical companies often engage and make payments to physicians who are well-recognized for their clinical expertise and research contributions to deliver lectures to their peers. These leading physicians, often referred to as key opinion leaders, received substantial amounts of non-research payments as reimbursements of giving lectures, consultations, and drafting manuscripts and pamphlets[43-45]. While the collaboration between leading physicians and pharmaceutical companies can be instrumental in advancing drug and medical product development, such significant financial ties may pose conflict of interest concerns. This is particularly true for physicians holding positions that demand high ethical standards, such as board members of professional medical societies[5,8,18,46], editors of medical journals[47-49], authors of clinical guidelines[11,33,50-54], and members of governmental advisory boards[55-59]. Conflicts of interest in these influential roles may introduce bias in decision-making, potentially compromising the quality of patient care[60,61]. Future research should aim to scrutinize the characteristics of the allergists receiving the most considerable payments and examine how these financial associations influence their clinical and policy decisions.
The study identified a notable reduction in non-research payments to allergists in Japan in 2020, coinciding with the onset of the COVID-19 pandemic. Payments to allergists declined by over 20% in terms of amounts per allergist during this year. Comparative studies in the United States documented a significant drop in non-research payments across various specialties[13-15,25-27,34,36,62-65], while research payments remained unaffected during the pandemic[13,25-27,36,66-69]. Notably, to mitigate the spread of COVID-19, numerous academic conferences were either canceled or deferred, and the activities of pharmaceutical representatives were considerably curtailed within healthcare facilities in Japan. To our knowledge, this investigation is the inaugural study to demonstrate the pandemic’s impact on the financial dynamics between physicians and the pharmaceutical industry in Japan, supported by a substantial dataset. Nonetheless, the implications of this significant decline in financial payments on the influence of the industry over physicians’ clinical decisions remain unclear. Previous studies have indicated associations between payments to allergists and their prescribing behaviors[69-75], particularly for new asthma biologics in the United States[69]. It is imperative for future research to delve into the relationship between physician payments and clinical practice, as well as to assess how the pandemic has affected the pharmaceutical industry’s influence on clinical practice in Japan.
This study has several limitations. Firstly, the analysis was confined to payment data from JPMA-affiliated pharmaceutical companies, potentially overlooking financial relationships between allergists and non-member companies. However, it is important to note that JPMA-affiliated companies represent over 80% of the market share for drugs and medical products in Japan[76]. Additionally, non-member companies do not publicly disclose payment information to allergists. Consequently, the impact of undisclosed financial relationships with non-member companies is likely minimal. Secondly, the payment data are self-reported by the companies in compliance with JPMA guidelines, which do not impose penalties for non-adherence, raising concerns about the accuracy of the disclosed data. Thirdly, the Japanese Society of Allergology publishes only the most recent list of board-certified allergists; therefore, the study may include some allergists who were not board-certified during the payment period.