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.