Running title: COIs in Japanese neurology guidelinesAuthors: Anju Murayama1,2*; Yuki Senoo, MD3

CorrespondenceAnju MurayamaSchool of Medicine, Tohoku University, 2-1 Seiryo-machi, Aoba ward, Sendai City, Miyagi, 980-0872, JapanTelephone: 81-22-717-8006Email address: [email protected]

Evaluation of Industry Payments to Allergists and Clinical Immunologists in the United States during the COVID-19 pandemic: A Seven-year analysis of the Open Payments Database from 2014 to 2020Anju Murayama1,*, Sae Kamamoto2; Hanano Mamada3

Rationale, aims and objectives Financial conflicts of interest (FCOI) between pharmaceutical companies (Pharma) and healthcare domains may unduly influence physician-led clinical practice and patient-centered care. However, the extent of awareness and perceptions of FCOI among Japanese cancer patients remains unclear. This study aimed to assess these factors and their impacts on physician trustworthiness among Japanese cancer patients. Methods A cross-sectional study using self-administered surveys was conducted on a Japanese cancer patient advocacy group with 800 registered members from January to February 2019. Main outcome measures included awareness and perceptions of physician-Pharma interactions, their impact on physician trustworthiness, and attitudes towards FCOI among professions. We also performed thematic analyses on additional comments responders provided in the surveys. Results Among the 524 invited members, 96 (18.3%) completed the questionnaire. Of these, 69 (77.5%) were cancer patients. The proportion of participants aware of such interactions ranged from 2.1% to 65.3%, depending on the interaction type. Participants were generally neutral on how the interactions would affect physician trustworthiness. A large proportion of participants agreed that these interactions were unethical, could influence physicians’ prescribing behavior leading to unnecessary prescriptions, and negatively affect physician trustworthiness. Qualitative responses (n=56) indicated that patients expected physicians to use sound ethical judgment and avoid accepting incentives. Participants were also concerned about their treatment and the undue influence of FCOI on physicians. Conclusion Most participants were aware of at least one FCOI between Pharma and physicians and perceived them negatively. Further efforts to regulate FCOI appear necessary to protect patient-centered care.

Anju Murayama1,2*; Kenichi Higuchi1; Yuki Senoo, MD, MUDr3

Financial relationships between board-certified neurologists and pharmaceutical industry in Japan Anju Murayama1,2*; Kenichi Higuchi1; Yuki Senoo, MD, MUDr3

Anju Murayama1,2*; Yuki Senoo, MD, MUDr3

Anju Murayama1*

Anju Murayama1,*Affiliations:1 School of Medicine, Tohoku University, Sendai City, Miyagi, Japan*Correspondence:Anju MurayamaTohoku University School of Medicine, 2-1 Seiryo machi, Aoba Ward, Sendai, Miyagi 980-0872, JapanTelephone: +81-22-717-8006Email address:[email protected] summaryUsing the 2014-2022 Open Payments Database, this study found 50.5% to 68.0% of endocrinologists in the US received general payments from the healthcare industry each year.AbstractObjective: This study aimed to evaluate industry payments to endocrinologists and their institutions between 2014 and 2022.Research Design and Methods: This serial cross-sectional study examined general and research payments (direct to individuals or associated research payments to institutions) made to endocrinologists registered in the National Plan and Provider Enumeration System in the United States, using the Open Payments Database between 2014 and 2022. Payment data were analyzed descriptively. Trends were evaluated by generalized estimating equations.Results: Among 8002 active endocrinologists, 50.5% to 68.0% annually received general payments excluding those for ownership interests and royalties (GPEOR) between 2014 and 2022. The annual median GPEOR per physician declined from $984 in 2014 to $438 in 2022. Only top 10% of endocrinologists annually received 90.0% to 94.4% of all GPEOR. Despite 68.5% of all payments being for research, only 1.6% to 3.0% of endocrinologists directly received these annually, while 6.0% to 9.3% did through their institutions. Per-physician GPEOR decreased between 2014 and 2019, with a relative annual change of -4.4% (95% confidence interval [CI]: -5.7% to -3.3%). The number of endocrinologists receiving research payments decreased by 3.5% (95% CI: -4.8% to -2.2%) between 2014 and 2019. Both GPEOR and research payments were significantly lower in 2020-2022 compared to 2014-2019 in the number of endocrinologists receiving payments and/or payment amounts.Conclusions: Majority of endocrinologists accepted general payments from the healthcare industry, while less than 10% of endocrinologists received research payments (personally or to their institution) in the United States.Highlights• This study examined industry payments to endocrinologists and their institutions using the Open Payments Database from 2014 to 2022.• Findings showed that 50.5%-68.0% of endocrinologists accepted non-research payments each year between 2014 and 2022, while less than 10% of endocrinologists received research payments annually.• Median per-physician annual payments varied, with $438-$984 in general, $1710-$4956 in direct research, and $40,300-$73,161 in associated research.• There was a decreasing trend in per-physician general payments between 2014 and 2019, with a relative annual change of -4.4% (95% confidence interval: -5.7% to -3.3%, p<0.001).IntroductionFinancial collaborations between physicians and the healthcare industry can improve patient care through developing and implementing novel medications and medical devices and fostering research to combat diseases (1). However, these relationships might also negatively impact patient care, as evidenced by various medical scandals involving clinical trials and guideline recommendations (2,3). Increasing public demand for greater transparency in physician-industry relationships led the United States (US) to enact the 2010 Physician Payment Sunshine Act (4), mandating that pharmaceutical and medical device companies report all financial transfers made to physicians and teaching hospitals since 2013. The reported data is publicly disclosed under a federal transparency database, the Open Payments Database.Endocrinology attracts substantial attention from pharmaceutical and medical device manufacturers due to the large and growing population of persons with obesity and diabetes (5,6), the development of novel medications for diabetes and endocrinological diseases, and expansion of indications for certain of these medications over the last decade (7).Conflicts of interest are common among the Endocrine Society guideline authors (8). Irwig et al. reported that 74.3% of the Society’s clinical-practice guideline authors received about $5.5 and $30.9 million in general and research payments, respectively, from pharmaceutical companies. Liu et al. reported that in 2014 the editors of Diabetes Care, an official journal of the American Diabetes Association, received the highest median personal payments from healthcare industries ($19,618) of 52 US medical journals (9). While editors must declare any financial conflicts of interest, to the American Diabetes Association and their academic institutions, that information may not be readily available to the public. Studies have identified positive associations between payment amounts from pharmaceutical companies marketing diabetes medications and increases in physicians’ prescriptions in the US and other developed countries (10-12).Prior studies have not investigated the overall picture of financial relationships between the healthcare industry and endocrinologists since the establishment of the Open Payments Database in the US. This study aimed to shed light on the magnitude, prevalence, and trends in physician-industry financial relationships in endocrinology in the US.Research Design and Methods

Authors: Anju Murayama1,2*

ObjectiveThere are widespread financial relationships between journal editors and healthcare industry in the United States (US) across specialties. These relationships could be conflicts of interest among editors: however, no studies have been assessed the extent of the relationships in infectious diseases.MethodsUsing the Open Payments Database between 2014 and 2022, financial relationships between the healthcare industry and all US-based physician editors of the six clinical infectious disease journals with the highest impact factors were evaluated. Proportion of the editors with payments and payment amounts to the editors were calculated.ResultsOf the 82 eligible US physician editors, 61 (74.4%) and 45 (54.9%) received non-research payments from the healthcare industry for the periods 2014-2022 and 2020-2022, respectively. Meanwhile, 22.4% and 40.3% received direct research payments and associated research funding over the nine years. The total payment amounts to the editors were $3,996,131 in non-research payments, $933,813 in direct research payments, and $39,394,410 in associated research funding. The majority of US physician editors received non-research payments between 2020 and 2022 in the Clinical Microbiology and Infection, Clinical Infections Diseases, Journal of Travel Medicine, and Journal of Infectious Diseases. Only two journals had conflicts of interest policies for their journal editors available on the journal webpage. Additionally, none of the journals disclosed the editors’ conflicts of interest.ConclusionsThis study found that the majority of the US-based physician editors of high-impact infectious disease journals received payments from the healthcare industry. Additionally, these financial conflicts of interest among the editors were not publicly disclosed.

Objective: To evaluate the financial and non-financial conflicts of interest (COI) among authors of Clinical Practice Guideline for Obstetrics 2020 (OBCPG) and Clinical Practice Guideline for Outpatient Gynecology 2020 (GYNCPG), relationship between quality of evidence and strength of recommendations, and COI policies. Design: Cross-sectional study Setting & Populations: All 103 guideline authors of OBCPG and GYNCPG published by Japan Society of Obstetrics and Gynecology (JSOG) in 2020. Methods: Descriptive analysis and multivariate negative binomial regression analysis. Main Outcome Measures: Personal payment data from 92 major pharmaceutical companies to the OBCPG and GYNCPG authors between 2016 and 2019; and quality of evidence and strength of recommendations underlying the guideline. Results: The 66.0% of the authors received personal payments of $1,174,508 in total from 60 pharmaceutical companies between 2016 and 2019. The four-year combined average payment per author was $11,403 (standard deviation: $22,056) and the median was $2,010 (interquartile range: $0‒$8,902). For analysis of references and recommendation, a total of 50.2% of references were low quality of evidence. Only 21.4% of references were high quality of evidence. Conclusions: This study found that the 66.0% of Japanese obstetric and gynecologic CPG authors received personal payments at least once during the CPG development period. 50.2% of evidence supporting Japanese obstetric and gynecologic CPG were low quality of evidence. There were no sufficient COI policies in JSOG, as well as ACOG, comparing to the global standard COI policies for CPG development. Funding: This study was funded in part by the Medical Governance Research Institute.