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.