Discussion
This study demonstrates that a minority but large number of
otorhinolaryngologists received personal payments from pharmaceutical
companies for the reimbursement of lecturing, consulting, and writing in
Japan. Large amounts of these personal payments were significantly
concentrated on a small number of otorhinolaryngologists with leading
positions such as clinical practice guideline authors, society board
members, and academic journal editors in the field of
otorhinolaryngology. We observed that the personal financial
relationships between the otorhinolaryngologists and pharmaceutical
companies had remained stable over the four years in Japan. Our findings
show significant similarities and differences compared to previous
studies assessing this issue in Japan and other developed countries.
First, this large sample-sized longitudinal observational study
elucidated that 44.8 % of all board-certified otorhinolaryngologists
received a median personal payment of $1,022 from the pharmaceutical
companies. Previous studies in Japan reported that there was an
increasing trend in physicians receiving payments from pharmaceutical
companies in terms of the number of physicians with payments and
payments per physician.[7, 8, 29, 34] Proportion of physicians with
payments and median four-year personal payments were from 62.0% in
pulmonology[34] to 70.6% in medical oncology[8] and $2,210 in
pulmonology[34] to $3,183 in infectious diseases,
respectively.[29] Smaller payments made to otorhinolaryngologists
observed in this study were consistent with many previous studies in the
United States.[9-11, 14, 35] Pathak et al. found that US
otorhinolaryngologists received the second lowest personal payments in
surgical specialties between 2014 and 2015.[11] Cvetanovich et
al.[35] and Rathi et al.[9] reported that the trend of lowest
payments made to the otorhinolaryngologists persisted since the launch
of the Open Payments Program in 2013. Fewer expensive and novel drugs
and the large number of otorhinolaryngologists could contribute to the
lower payment values both in Japan and the US.
Second, we observed that the personal financial relationships between
the otorhinolaryngologists and pharmaceutical companies remained stable
over the four years at both low monetary payment values and number of
otorhinolaryngologists with payments. In contrast to our findings, Morse
et al. previously observed that there was an increasing trend in
personal payments among the US otorhinolaryngologists between 2014 and
2016,[10] while the increasing trend was not observed in
2017.[12] Meanwhile, even lower personal payments to
otorhinolaryngologists significantly influence otorhinolaryngologists’
clinical practice, such as increasing brand-name prescriptions,[36]
prescribing more brand-name intranasal corticosteroids over generic
alternatives,[37] and performing more controversial treatment, sinus
balloon catheter dilation.[38, 39] Accumulating evidence strongly
suggests that personal payments made by pharmaceutical companies
significantly distort physicians’ prescribing patterns which were
potentially harmful to patients,[36, 38, 40-46] increase healthcare
costs,[40, 47, 48] and lower patients’ trust in
physicians,[49-51] while many physicians have denied the influence
and justified their personal financial relationships with
industries.[52-54]
In addition, our study directly demonstrated that large amounts of
personal payments significantly concentrated on only a small number of
otorhinolaryngologists positioned in authoritative and public roles,
such as clinical practice guideline authors, society board members, and
academic journal editors. High concentration of payments on leading
physicians, namely key opinion leaders, are pervading in medicine
worldwide.[22-24, 26, 28] Moynihan et al. elucidated that 72% of
board members of ten US professional medical societies in the highest
financial burden disease areas accepted a median of $6,026 in personal
payments from pharmaceutical and medical devices companies between 2013
and 2018.[23] Similarly, Saito et al. reported that 86.9% of the
board member from 19 major Japanese professional medical societies
received a median per-physician payment of $7,486 in in 2016.[25]
Also, there are prevalent and large FCOIs among clinical practice
guideline authors and journal editors in many developed countries.[4,
6, 55-63] Furthermore, many of these financial relationships between
leading physicians and pharmaceutical companies are undisclosed to the
public and underreported,[5, 23, 30, 61, 64, 65] as we found that
the JSO-HNS did not disclose FCOIs among the board members and academic
journal editors. Unlike leading physicians conducting clinical trials
and research sponsored by the industry, such leading physicians as
clinical practice guideline authors, society board members, and academic
journal editors are necessary to manage and, if possible, be free from
financial interest with the industry, as their financial interest with
industry conflict with their primary interest. Currently, FCOIs among
clinical practice guideline authors are strictly managed by many
guideline developing organizations: minority of guideline authors with
FCOIs involve in guideline development, all FCOIs for the past three
years are declared and disclosed by guideline authors, and the guideline
chairperson is required to be free from any FCOIs with
industry.[66-68] Several academic journals such as the Annals
of Emergency Medicine , the official journal of the American College of
Emergency Physicians, and Journal of Urology , the official
journal of the American Urological Association, disclose the editors’
FCOIs on journal webpages.[61] Transparency and rigorous managements
are necessary in financial relationships between pharmaceutical
companies and leading otorhinolaryngologists with authoritative and
public positions.