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Psychedelics are a group of psychoactive substances which produce complex and subjective changes to consciousness and carry unique safety considerations. There is a growing body of work investigating the use of psychedelics for mental health treatment alongside increasing socio-cultural and political acceptance. This rapid evolution has prompted corporations to fund psychedelic clinical trials, leading to a potential rise in conflicts of interest in relevant studies and publications. However, the body of evidence for the safety and efficacy of psychedelic-assisted psychotherapy for psychiatric illnesses is early. There is concern regarding the introduction of bias in psychedelic clinical trials and the selective reporting of results amidst and beyond corporate involvement. At a crucial time in psychedelic drug reform, this paper explores the safety concerns associated with psychedelics, the potential influences of financial stakeholders on safety outcome reporting and the importance of balanced science communication in maintaining public health and safety.
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BACKGROUND: The integrity of medical research reporting in online news publications is crucial for informed healthcare decisions and public health discourse. However, omissions, lack of transparency, and the rapid spread of misinformation on digital and social media platforms can lead to an incomplete or inaccurate understanding of research findings. This study aims to analyze the fidelity of online news in reporting medical research findings, focusing on conflicts of interest, study limitations, statistical data, and research conclusions. METHODS: Fifty randomized controlled trials published in major medical journals and their corresponding news reports were evaluated for the inclusion of conflicts of interest, study limitations, and inferential statistics in the news reports. The alignment of conclusions was evaluated. A binomial test with a Bonferroni correction was used to assess the inclusion rate of these variables against a 90% threshold. RESULTS: Conflicts of interest were reported in 10 (20%) of news reports, study limitations in 14 (28%), and inferential statistics in 19 (38%). These rates were significantly lower than the 90% threshold (p<0.001). Research conclusions aligned in 43 (86%) cases, which was not significantly different from 90% (p=0.230). Misaligned conclusions resulted from overstating claims. CONCLUSION: Significant gaps exist in the reporting of critical contextual information in medical news articles. Adopting a structured reporting format could enhance the quality and transparency of medical research communication. Collaboration among journalists, news organizations, and medical researchers is crucial for establishing and promoting best practices, fostering informed public discourse, and better health outcomes.
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BACKGROUND: Alcohol industry organisations occupy a prominent position in UK alcohol policy, but their involvement has been contested by public health bodies on the basis that a conflict of interest (COI) exists between their economic objectives and those of public health. There are ongoing debates in the research literature about how to conceptualise COI and mitigate this in health research and practise. However, less attention has been paid to these issues in relation to the alcohol industry specifically. This article explores similarities and differences in beliefs among alcohol policy actors regarding COI and the implications of engagement with the alcohol industry in the context of UK public health policy. METHODS: Semi-structured interviews with a range of policy actors (n=26) including medical professionals, parliamentarians, civil servants, academic researchers, health campaigners, and alcohol industry representatives. Interviews with alcohol industry representatives were supplemented with an analysis of industry responses to a public consultation. All data was thematically coded using NVivo software. RESULTS: Two competing "coalitions" were identified, expressing beliefs about COI linked to alcohol industry engagement. Both divergent and convergent beliefs were expressed by the two coalitions in relation to the type of industry actor, form of engagement, the policy issue under discussion and the stage of policy process. CONCLUSION: Alcohol policy is a complex and contested space in which policy actors have differing, nuanced and contingent understandings of COI and identify varying risks associated with alcohol industry engagement. In identifying the areas of convergence and diversion in both understanding and evaluation of COI in alcohol-specific settings, these findings will assist both decision-makers and non-governmental actors in developing policies and guidelines to manage potential COI in future.
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Conflito de Interesses , Política Pública , Humanos , Etanol , Saúde Pública , Reino UnidoRESUMO
BACKGROUND: Conflicts of interest inherent in industry funding can bias medical research methods, outcomes, reporting and clinical applications. This study explored the extent of funding provided to American physician researchers studying surgical mesh used to treat uterine prolapse or stress urinary incontinence, and whether that funding was declared by researchers or influenced the ethical integrity of resulting publications in peer reviewed journals. METHODS: Publications identified via a Pubmed search (2014-2021) of the terms mesh and pelvic organ prolapse or stress urinary incontinence and with at least one US physician author were reviewed. Using the CMS Open Payments database industry funding received by those MDs in the year before, of and after publication was recorded, as were each study's declarations of funding and 14 quality measures. RESULTS: Fifty-three of the 56 studies reviewed had at least one American MD author who received industry funding in the year of, or one year before or after publication. For 47 articles this funding was not declared. Of 247 physician authors, 60% received > $100 while 13% received $100,000-$1,000,000 of which approximately 60% was undeclared. While 57% of the studies reviewed explicitly concluded that mesh was safe, only 39% of outcomes supported this. Neither the quality indicator of follow-up duration nor overall statements as to mesh safety varied with declaration status. CONCLUSIONS: Journal editors' guidelines re declaring conflicts of interest are not being followed. Financial involvement of industry in mesh research is extensive, often undeclared, and may shape the quality of, and conclusions drawn, resulting in overstated benefit and overuse of pelvic mesh in clinical practice.
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The objective of this scoping review was to systematically review the literature on how non-financial conflicts of interest (nfCOI) are defined and evaluated, and the strategies suggested for their management in health-related and biomedical journals. PubMed, Embase, Scopus and Web of Science were searched for peer reviewed studies published in English between 1970 and December 2023 that addressed at least one of the following: the definition, evaluation, or management of non-financial conflicts of interest. From 658 studies, 190 studies were included in the review. nfCOI were discussed most commonly in empirical (22%; 42/190), theoretical (15%; 29/190) and "other" studies (18%; 34/190) - including commentary, perspective, and opinion articles. nfCOI were addressed frequently in the research domain (36%; 68/190), publication domain (29%; 55/190) and clinical practice domain (17%; 32/190). Attitudes toward nfCOI and their management were divided into two distinct groups. The first larger group claimed that nfCOI were problematic and required some form of management, whereas the second group argued that nfCOI were not problematic, and therefore, did not require management. Despite ongoing debates about the nature, definition, and management of nfCOI, many articles included in this review agreed that serious consideration needs to be given to the prevalence, impact and optimal mitigation of non-financial COI.
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In the ever-evolving landscape of biomedical research and publishing, the International Committee of Medical Journal Editors recommendations serve as a critical framework for maintaining ethical standards. By providing a framework that adapts to technological advancements, the International Committee of Medical Journal Editors recommendations actively shape responsible and transparent practices, ensuring the integrity of scientific inquiry and fostering global collaboration in the ever-evolving landscape of medical publishing. This editorial delves into key aspects of the latest changes in the International Committee of Medical Journal Editors recommendations, focusing on authorship, conflict of interest disclosure, data sharing and reproducibility, medical publishing and carbon emissions, the use of artificial intelligence, and the challenges posed by predatory journals within the realm of open access. It emphasizes the importance of new recommendations, which represent a beacon of ethical guidance in the ever-evolving domain of biomedical research and publishing.
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Nudging, a controversial technique for modifying people's behavior in a predictable way, is claimed to preserve freedom of choice while simultaneously influencing it. Nudging had been largely confined to situations such as promoting healthy eating choices but has been employed in the coronavirus disease 2019 (COVID-19) crisis in a shift towards measures that involve significantly less choice, such as shoves and behavioral prods. Shared decision making (SDM), a method for direct involvement and autonomy, is an alternative approach to communicate risk. Predominantly peer-reviewed scientific publications from standard literature databases like PubMed, PsycInfo, and Psyndex were evaluated in a narrative review. The so-called fear nudges, as well as the dissemination of strongly emotionalizing or moralizing messages can lead to intense psycho-physical stress. The use of these nudges by specialized units during the COVID-19 pandemic generated a societal atmosphere of fear that precipitated a deterioration of the mental and physical health of the population. Major recommendations of the German COVID-19 Snapshot Monitoring (COSMO) study, which are based on elements of nudging and coercive measures, do not comply with ethical principles, basic psychological principles, or evidence-based data. SDM was misused in the COVID-19 crisis, which helped to achieve one-sided goals of governments. The emphasis on utilitarian thinking is criticized and the unethical behavior of decision makers is explained by both using the concept of moral disengagement and the maturity level of coping strategies. There should be a return to an open-ended, democratic, and pluralistic scientific debate without using nudges. It is therefore necessary to return to the origins of SDM.
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Background: Robotic total knee arthroplasty (R-TKA) utilization and marketing continue to rise. We examined the marketing on surgeon websites regarding R-TKA benefits and sought to determine if the claims were supported by existing literature. Methods: A Google search identified 10 physician websites from each of the 5 largest U.S. markets by population with the term "robotic total knee arthroplasty city, state." Claims on websites about R-TKA were categorized. Literature from 2012-2022 was reviewed for data "for" or "against" each claim. Level of evidence for each publication was collected. Results: Fifty websites were captured that included 59 surgeons. A specific R-TKA platform was mentioned on 68% of websites. Website claims about robotics were placed into 8 major categories. Literature review supported the claims of more precise/accurate, reduced injury to tissue, and less pain with more literature "for" than "against" the claims. Conclusions: Claims made on physician websites regarding the benefits of R-TKA are variable and not definitively supported by existing literature. Most available data can be categorized into levels of evidence III, IV, and V. There is a paucity of level I evidence to support the various marketing statements. Physicians should be cognizant of both the claims made on their websites and the literature that could be used to support or refute those specific claims.
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AIMS: We have previously described the European Medicines Agency's (EMA) and the US Food and Drug Administration's guidelines, each for a specific psychiatric indication, on how to design pivotal drug trials used in new drug applications. Here, we report on our efforts over 3 years to retrieve conflicts of interest declarations from EMA. We wanted to assess potential internal industry influence judged as the proportion of guideline committee members with industry conflicts of interest. METHODS: We submitted Freedom of Information requests in February 2020 to access EMA's lists of committee members (and their declared conflicts of interest) involved in drafting the 13 'Clinical efficacy and safety' guidelines available on EMA's website pertaining to psychiatric indications. In our request, we did not specify the exact EMA committees. Here, we describe the received documents and report the proportion of members with industry interests (i.e. defined as any financial industry relationship). It is a follow-up paper to our first report (http://doi.org/10.1017/S2045796021000147). RESULTS: After 2 years and 9 months (November 2022), the EMA sent us member lists and corresponding conflicts of interest declarations from the Committee for Medicinal Products for Human use (CHMP) from 2012, 2013 and 2017. These member lists pertained to 3 of the 13 requested guidelines (schizophrenia, depression and autism spectrum disorder). The 10 remaining guidelines were published before 2011 and EMA stated that they needed to require permission from their expert members (with unknown retrieval rate) and foresaw excessive workload and long wait. Therefore, we withdrew our request. The CHMPs from 2012, 2013 and 2017 had from 34 to 36 members; 39%-44% declared any interests and we judged 14%-18% as having industry interests. For the schizophrenia guideline, we identified two members with industry interests to companies who submitted feedback on the guideline. We did not receive declarations from the Central Nervous System (CNS) Working Party, the CHMP appointed expert group responsible for drafting and incorporating feedback into the guidelines. CONCLUSIONS: After almost 3 years, we received information, which only partly addressed our request. We recommend EMA to improve transparency by publishing the author names and their corresponding conflicts of interest declarations directly in the 'Clinical efficacy and safety' guidelines and to not remove conflicts of interest declarations after 1 year from their website to reduce the risk of stealth corporate influence during the development of these influential guidelines.
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Transtorno do Espectro Autista , Conflito de Interesses , Humanos , Seguimentos , Preparações FarmacêuticasRESUMO
BACKGROUND: Financial interactions between pharmaceutical companies and physicians lead to conflicts of interest. This study examines the extent and trends of non-research payments made by pharmaceutical companies to board-certified allergists in Japan between 2016 and 2020. METHODS: A retrospective analysis of disclosed payment data from pharmaceutical companies affiliated with the Japanese Pharmaceutical Manufacturers Association was conducted. The study focused on non-research payments for lecturing, consulting, and manuscript drafting made to board-certified allergists from 2016 to 2020. We performed descriptive analyses on payment data. Trends were analyzed using generalized estimating equation models. RESULTS: Of the 3,943 board-certified allergists, 2,398 (60.8%) received non-research payments totaling $43.4 million over five years. Lecturing fees comprised 85.7% ($37.2 million) of the total payment amounts. For allergists who received at least one payment, the median amount per allergist was $3,106 (interquartile range: $966 - $12,124), in contrast to a mean of $18,092 (standard deviation: $49,233) over the five-year span. The top 1% and 10% of these allergists accounted for 20.8% and 68.8% of all non-research payments, respectively. The annual payment amounts significantly increased by 7.2% annual increase (95% CI: 4.4 - 10.0%, p < 0.001) each year until 2019, but saw a significant decrease in 2020 amid the COVID-19 pandemic. CONCLUSION: The majority of allergists received non-research payments, with a notable concentration among a small group. Payments increased annually until the pandemic's onset, which coincided with a substantial decrease. Further research is needed to explore the implications of these financial interactions on clinical practice and patient care in Japan.
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Alergistas , Pandemias , Humanos , Estudos Transversais , Japão , Estudos Retrospectivos , Indústria Farmacêutica , Preparações Farmacêuticas , Conflito de Interesses , RevelaçãoRESUMO
Financial interactions between healthcare industry and pediatric hematologist/oncologists (PHOs) could be conflicts of interest. Nevertheless, little is known about financial relationships between healthcare industry and PHOs. This cross-sectional analysis of the Open Payments Database examined general and research payments to PHOs from healthcare industry in the United States between 2013 and 2021. Payments to the PHOs were analyzed descriptively. Trends in payments were assessed using generalized estimating equation models. Of 2784 PHOs, 2142 (76.9%) PHOs received payments totaling $187.3 million from the healthcare industry between 2013 and 2021. Approximately, $46.3 million (24.8%) were general payments and $137.7 million (73.5%) were funding for research where PHOs served as principal investigators (associated research funding). Both general payments and associated research funding considerably increased between 2014 and 2019. The number of PHOs receiving general payments and associated research funding annually increased by 2.2% (95% CI: 1.2-3.3%, p < .001) and 5.0% (95% CI: 3.3-6.8%, p < .001) between 2014 and 2019, respectively.
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Conflito de Interesses , Hematologia , Humanos , Estados Unidos , Conflito de Interesses/economia , Estudos Transversais , Hematologia/economia , Oncologistas/estatística & dados numéricos , Oncologistas/economia , Pesquisa Biomédica/economia , Apoio à Pesquisa como Assunto/economia , Pediatria/economia , Pediatria/tendências , Pediatria/estatística & dados numéricos , Setor de Assistência à Saúde/economia , História do Século XXIRESUMO
AIM: To investigate the association between industry-sponsored meal payments and the prescribing patterns of brand-name colchicines, namely Colcrys and Mitigare, among Medicare beneficiaries in the United States from 2014 to 2021. METHODS: This cross-sectional study utilized data from the Open Payments Database and Medicare Part D covering the years 2014 to 2021. The study included 54 836 physicians who submitted more than 10 colchicine claims. Exposure was defined as the receipt of one or more industry-sponsored meals from the manufacturers of Colcrys or Mitigare. The primary outcomes included the likelihood of prescribing Colcrys and Mitigare, as well as the associated number of claims and Medicare expenditures. RESULTS: Among 54 836 eligible physicians, 44.9% received meal payments from the Colcrys manufacturer, and 8.0% from the Mitigare manufacturer, over the eight-year study period. The average meal payment value was $14.9 for Colcrys and $15.1 for Mitigare. The receipt of meal payments was significantly associated with an increased likelihood of prescribing Colcrys (odds ratio: 1.24 [95% CI: 1.21-1.27], p < .001) and Mitigare (odds ratio: 3.54 [95% CI: 2.98-4.20], p < .001). Each additional meal payment corresponded with a significant increase in Medicare expenditures: $55.4 (95% CI: $48.3-$62.5, p < .001) for Colcrys and $153.7 (95% CI: $17.7-$289.6, p = .03) for Mitigare. These associations remained consistent across different specialties and genders. CONCLUSION: This study reveals that receipt of meal payments from manufacturers of brand-name colchicine was significantly associated with an increased rate of prescriptions for these brand-name drugs, leading to higher Medicare expenditures in the United States.
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Medicare Part D , Medicamentos sob Prescrição , Idoso , Humanos , Estados Unidos , Masculino , Feminino , Colchicina , Gastos em Saúde , Estudos Transversais , Padrões de Prática Médica , Prescrições , Indústria FarmacêuticaRESUMO
RATIONALE: Healthcare industry sometimes make large marketing payments to physicians. Previous studies have demonstrated that there are significant associations between industry marketing practices and physicians' prescribing behaviours in several specialties. Given the current increasing introduction of many novel biologics for atopic dermatitis and increasing payments to dermatologists, the industry payments to dermatologists for atopic dermatitis drugs could be associated with their prescribing patterns in the United States. AIMS AND OBJECTIVES: This study aims to evaluate association between dermatologists' dupilumab prescription behaviours and manufacturer's sponsored meal payments to dermatologists in the United States. METHOD: Using the Centers for Medicare and Medicaid Services and the Open Payments Database, this cross-sectional analysis evaluated associations between manufacturer's sponsored meal payments to dermatologists related to dupilumab and dermatologists' dupilumab prescriptions between 2017 and 2021. Associations were evaluated using logistic generalised estimating equations (GEE) and negative binomial regression GEE models at individual dermatologist level. RESULTS: Among 2852 dermatologists prescribing dupilumab, 74.5% received meal payments amounting to $1,083,919 between 2017 and 2021. Dermatologists receiving meal payments were more likely to prescribe dupilumab (odds ratio 1.50, 95% confidence interval [CI]: 1.37-1.65). There were also consistent dose-response associations between meal payments and total claims as well as Medicare spending. Dermatologists who received 1, 2-5, 6-10, and 11-15 meal payments per year reported 1.13 (95% CI: 1.03-1.24, p < 0.05), 1.35 (95% CI: 1.24-1.46, p < 0.001), 1.64 (95% CI: 1.48-1.82, p < 0.001), and 2.10 (95% CI: 1.78-2.47, p < 0.001) times more dupilumab-related claims in the year when they received the payments than those who did not receive the payments, respectively. CONCLUSION: This study found that significant associations between industry-sponsored meal payments and increased dupilumab prescriptions, shedding light on the potential influence of financial relationships on clinical practice. The findings call for heightened awareness among dermatologists, patients, and policymakers regarding the impact of these relationships on healthcare expenditures and decision-making in the United States. Future research is warranted to further explore these associations longitudinally.
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Anticorpos Monoclonais Humanizados , Dermatite Atópica , Medicare , Idoso , Estados Unidos , Humanos , Dermatologistas , Estudos Transversais , Dermatite Atópica/tratamento farmacológico , Prescrições , Indústria Farmacêutica , Padrões de Prática MédicaRESUMO
Aim This cross-sectional study aimed to examine the scale and trends of industry-sponsored research payments to gastroenterologists and hepatologists in the United States from 2014 to 2021. Methods Using the Open Payments Database and the National Plan and Provider Enumeration System (NPPES), the study analyzed both grant and research payments made to individual gastroenterologists and associated payments made for research where gastroenterologists and hepatologists served as principal investigators. Results After adjusting for inflation, the study found that a total of $1.5 billion was allocated to gastroenterologists by 284 companies during this period. Only 15.9% of the 20,986 gastroenterologists received at least one research payment, with associated research payments accounting for 97.6% of all payments. The study also revealed a significant increase in the number of gastroenterologists receiving associated research payments and a more than twofold increase in payments for registered clinical trials from 2014 to 2021. Conclusion The healthcare industry allocated large amounts of research funding to gastroenterologists and hepatologists. The study underscores the critical role of industry-sponsored clinical trials in advancing gastroenterological research and treatments.
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Background: Rational drug prescription (RDP) is one of the main components of the healthcare systems. Irrational prescribing can bring about numerous negative consequences for the patients and governmental agencies. This study aims to analyze the involvement of stakeholders in rational drug prescribing, their position (opponent or proponent), and the rationale behind it. Methods: This was a qualitative study conducted in 2019. Semi-structured face-to-face interviews were conducted with 40 stakeholders. Purposive and snowball sampling techniques with maximum heterogeneity were adopted to select the interviewees. Data was analyzed by MAXQDA software using thematic approach. Results: Iranian Food and Drug Administration employs the highest authority on the rational prescribing policy. Although the Ministry of Health and Medical Education, the Social Security Organization as one of the main health insurance organizations, pharmaceutical companies, and the Medical Council of the Islamic Republic of Iran, are among agencies that have great authority to improve rational prescribing, they fail to act professionally as they have conflicting interests. Remarkably, the Iran Food and Drug Administration, insurance organizations, family physicians, and patients, highly support the rational prescribing policy while the pharmaceutical companies display the least support for it. Conclusions: To make the prescription and using drugs more rational, policy makers should focus on different sources of conflicts of interest that different actors have. They should devise legal, behavior and financial policies accordingly to lessen or at least neutralize these conflicting interests, otherwise achieving RDP would be impossible in short and long terms.
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Conflito de Interesses , Países em Desenvolvimento , Prescrições de Medicamentos , Humanos , Atenção à Saúde , Irã (Geográfico) , Preparações Farmacêuticas , Saúde PúblicaRESUMO
Accurate disclosure of financial conflicts of interest (COI) among clinical practice guideline (CPG) developers is critical to ensure the quality of CPGs. However, there is limited evidence on the impact of underreporting COIs on the quality of CPGs. This study aimed to examine the proportion of underreported COI disclosures in the development of Japanese CPGs and to estimate the association between underreported COIs and CPG quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II. Twenty-three Japanese CPGs published in 2019 and their 1114 developers were included in the study. The results show that underreporting of COIs occurred in 52% of the included CPGs and 8% of all CPG developers. Underreporting COI disclosures was negatively associated with low-quality CPG (Odds ratio [OR], 0.57; 95% confidence interval [CI]: 0.11, 3.04). On the other hand, CPGs that had more than 13% of CPG developers with voting rights on recommendation decisions and underreporting of COI disclosures were positively associated with low quality (OR, 1.78; 95% CI: 0.25, 12.45). For individual CPG developers with voting rights for recommendation decisions, the presence of a COI was positively associated with low quality (OR, 1.11; 95% CI: 0.71, 1.75). This study demonstrates that the involvement and underreporting of COIs did not seriously distort the CPG development process. However, the COI-related factors of CPG developers with voting rights for recommendation decisions may be associated with low CPG quality.
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Financial relationships between physicians and the health care industry sometimes lead to conflicts of interest and need to be properly managed. Using the Open Payments Database between 2013 and 2021, this cross-sectional analysis examined the industry payments made to physicians whose primary specialty was pediatrics. Descriptive analyses were performed for the payment data overall and other pediatrician demographics. Of 99 764 eligible pediatricians, 59 984 (60.1%) received a total of $297 million (12.8%) in general and $2 billion in research payments over the 9 years. Median 9-year per-physician payments were $288 (interquartile range [IQR]: $88-$958) in general and $65 343 (IQR: $16 763-$255 208) in research payments. Male pediatricians were 1.06 (95% CI: 1.05-1.09, P < .001) and 1.56 (95% CI: 1.49-1.65, P < .001) times more likely to receive general and associated research payments than female pediatricians, respectively. The number of pediatricians receiving general payments annually decreased by 1.5% (95% CI: -1.7% to -1.4%, P < .001).
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Objective To assess the financial relationships between pharmaceutical companies and authors of the 2020 Japan College of Rheumatology Clinical Practice Guidelines (CPG) for the Management of Rheumatoid Arthritis and to evaluate the quality of evidence supporting the guideline recommendations. Methods This retrospective study evaluated financial relationships between all 27 authors of the CPG and pharmaceutical companies in Japan. Personal payments from pharmaceutical companies to these authors between 2016 and 2020 were extracted from publicly disclosed databases for each pharmaceutical company. The quality of the evidence supporting the CPG recommendations was also assessed. Results All 27 authors received personal payments from pharmaceutical companies, totaling $3,683,048 over five years. The median and mean payments per author were $101,624 and $136,409, respectively. Speaking compensations accounted for more than 80% of all personal payments. More than 77.8% (21 authors), 66.7% (18 authors), and 51.9% (14 authors) received more than $10,000, $50,000, and $100,000 in total payments over the five years, respectively. Nevertheless, these financial relationships between the CPG authors and pharmaceutical companies were not disclosed. More than 81.8% of the CPG recommendations were supported by low- or very-low-quality evidence. Of the strong recommendations, 66.7% were supported by low- or very-low-quality evidence. Conclusion Even though all CPG authors received substantial amounts of personal payments from pharmaceutical companies, these conflicts of interest (COIs) were not disclosed in the CPG. These findings underscore the urgent need for policy interventions to enhance transparency, integrity, and reliability in the development of CPGs in Japan.