Conflicts of Interest Among Cardiology Clinical Practice Guideline Authors in Japan.

BACKGROUND: Clinical practice guidelines (CPGs) offer disease management recommendations based on scientific evidence. However, financial conflicts of interest between CPG developers and the pharmaceutical industry could bias these recommendations, potentially affecting patient care. Proper management of these conflicts of interest is particularly crucial for maintaining the integrity of CPGs. The study aimed to evaluate the extent of financial relationships between the pharmaceutical industry and authors of CPGs for cardiovascular diseases in Japan. METHODS AND RESULTS: The study analyzed personal payments from the pharmaceutical industry to authors of cardiovascular disease CPGs published by the Japanese Circulation Society from January 2015 to December 2022. Payment data, including speaking, consultancy, and writing fees from 2016 to 2020, were extracted from a publicly available database containing personal payments disclosed by all major pharmaceutical companies. A total of 929 unique authors from 37 eligible Japanese Circulation Society CPGs were identified. Notably, 94.4% of these authors received personal payments from pharmaceutical companies, totaling >US $70.8 million. The mean±SD payment per author was US $76 314±138 663) and the median payment per author was US $20 792 (interquartile range: US $4262-US $76 998) over the 5-year period. Chairs of CPGs received significantly higher payments than other authors. More than 80% of authors in each CPG received personal payments. CONCLUSIONS: The study elucidated that there were considerable financial relationships between pharmaceutical companies and cardiology CPG authors in Japan. This finding deviates from international conflict of interest management policies, suggesting the need for more stringent conflict of interest management strategies by the Japanese Circulation Society to ensure the development of trustworthy and evidence-based CPGs.

Policy Actors' Perceptions of Conflicts of Interest and Alcohol Industry Engagement in UK Policy Processes.

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.

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status.

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.

Bias and Conflict of Interest in the Underreporting of Sexual Abuse in Competitive Sports: A Literature Review.

ABSTRACT: The prevalence of sexual abuse in competitive sports is increasing worldwide and requires a united call to action. The underreporting of such abuses gained media attention resulting from recent high-profile cases. In this article, we report the results of a systematic literature review, identifying root causes of underreporting sexual abuse in competitive sports. We identify that biases and conflicts of interest work against effective reporting of abuse by athletes at the individual, organizational, and cultural levels. We offer conflict of interest and bias mitigation approaches from the social science, law, business, research, and diagnostic error literature that may apply. Competitive sports organizations may use this analysis to identify barriers and improve the effective reporting of sexual abuse.

Opposing life history strategies allow grass shrimp parasites to avoid a conflict of interest.

A conflict of interest occurs when parasites manipulate the behavior of their host in contradictory ways to achieve different goals. In grass shrimp (Palaemonetes pugio), trematode parasites that use shrimp as an intermediate host cause the shrimp to be more active than usual around predators, whereas bopyrid isopod parasites that use shrimp as a final host elicit the opposite response. Since these parasites are altering the host's behavior in opposing directions, a conflict of interest would occur in co-infected shrimp. Natural selection should favor attempts to resolve this conflict through avoidance, killing, or sabotage. In a field survey of shrimp populations in four tidal creeks in the Cape Fear River, we found a significant negative association between the two parasites. Parasite abundance was negatively correlated in differently sized hosts, suggesting avoidance as a mechanism. Subsequent mortality experiments showed no evidence of early death of co-infected hosts. In behavior trials, co-infected shrimp did not show significantly different behavior from singly infected or uninfected shrimp, suggesting that neither parasite sabotages the manipulation of the other. Taken together, our results suggest that rather than sabotaging or killing one another, bopyrid and trematode parasites tend to infect differently sized hosts, thus avoiding a conflict and confirming the importance of testing assumptions in natural contexts.

Cross-sectional analysis of financial relationships between board certified allergists and the pharmaceutical industry in Japan.

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.

Conflict of interest disclosure by US cardiothoracic surgeons.

BACKGROUND: Surgeon-industry collaboration is a key driver of advancement in surgical technology and practice. Disclosures of financial relationships between investigators and industries are important to ensure transparent and critical evaluation of literature. METHODS: All American cardiothoracic (CT) surgeons who published in three major CT surgery journals in 2019 were identified. Whether these surgeons disclosed any conflicts of interest was recorded and compared to actual payments received within 5 years of publication as reported by the Centers for Medicare and Medicaid Services data. RESULTS: In the study period, there were 1079 unique manuscripts involving 885 American CT surgeons as authors, which combined for 2719 author instances. Of these, 96.2% of authors (851 of 885) received payments from companies. The authors who received payments produced 2651 author instances (97.4%). Financial disclosure was reported in only 11.4% (301 of 2651) of these instances. In total, 851 surgeons received more than $187 million over 5 years, with the highest-paid surgeon receiving an average of over $5.9 million per year. The largest individual payments were from "Associated Research Funding," with over $115 million being paid to 277 surgeons over 5 years. The top paying company issued over $96.5 million to American CT surgeons over 5 years. CONCLUSIONS: Nearly all the reviewed publications in three top CT surgery journals were by surgeons who received payments from companies, but very few of these payments were recorded as potential conflicts of interest. A more consistent and robust policy of COI disclosure is needed to reduce perceptions of bias.

A Nine-Year Investigation of Industry Research and Nonresearch Payments to Emergency Physicians in the United States Between 2014 and 2022.

BACKGROUND: Financial relationships between physicians and the health care industry are common in the United States. Yet, there are limited data on payments to emergency physicians since the 2014 launch of the Open Payments Database. OBJECTIVES: To analyze the trends and characteristics of industry payments to U.S. emergency physicians from 2014 to 2022. METHODS: This retrospective study used the Open Payments Database to examine all general and research payments to all active emergency physicians. Descriptive statistics and generalized estimating equations were employed. RESULTS: Between 2014 and 2022, 50.1% (33,021) of emergency physicians received $640.1 million in payments. Of these, 50.1% received general payments, and 1.2% received research payments. General payments constituted 18.7% ($119.7 million) of the overall industry payments. Median general and research payments were $149 ($49-$401) and $72,083 ($13,903-$370,142), respectively. Compared with other specialties, fewer emergency physicians received general payments, and the amounts were lower. The top 1% of emergency physicians received 80.5% of the general payments. No significant trends in payment amounts were observed from 2014 to 2019, but there was a significant decrease in both types of payments in 2020 due to the COVID-19 pandemic. CONCLUSIONS: The majority of emergency physicians received payments from the health care industry, although these payments were typically minimal compared with other specialties. Payment trends remained consistent from 2014 to 2019, with a notable decrease in 2020 due to the pandemic.

Japanese physicians' perceptions of conflicts of interest with pharmaceutical companies: Estimating two different questioning approaches.

Despite being one of the world's largest pharmaceutical markets, interactions between Japanese physicians and pharmaceutical companies often remain opaque. Importantly, potential conflicts of interest associated with these interactions can compromise patient care and increase costs. We conducted an online survey of Japanese physicians to elucidate perspectives on pharmaceutical company promotional activities and how these influence physician prescribing patterns. Anticipating that physicians might downplay their reliance on, or the value of, pharmaceutical company-provided information, the survey incorporated a direct questioning method and an unmatched count technique (UCT) to identify hidden perceptions on factors likely to influence prescribing. Overall, 1080 eligible physicians participated. Of these, 105 (9.7%) self-identified as hospital directors or managers. Surprisingly, nearly twice as many participants responding to direct questioning (18.9%) versus those responding to the UCT (10.1%) asserted that information provided by pharmaceutical companies was important when prescribing medicine. Hospital directors or managers (adjusted odds ratio [adjOR] 2.56, 95% confidence interval [95% CI]: 1.00-6.54, reference = physician without title) and frequent interactions with pharmaceutical sales representatives (adjOR 5.96, 95% CI: 1.88-18.9, reference = rare interaction) significantly valued the information from sales representatives and sponsored lectures when considering prescribing decisions. Additionally, 77.1% of respondents believed that sales representatives provide fair, neutral, or relatively honest and unbiased information about their products. Few Japanese physicians acknowledged the influence of industry-provided information on prescribing patterns. Our study uniquely applies two distinct question formats, providing a novel approach to understanding the depth of physician-industry relationships and the effectiveness of various survey methodologies.

Undisclosed financial conflicts of interest in DSM-5-TR: cross sectional analysis.

OBJECTIVE: To assess the extent and types of financial ties to industry of panel and task force members of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision (DSM-5-TR), published in 2022. DESIGN: Cross sectional analysis. SETTING: Open Payments database, USA. PARTICIPANTS: 92 physicians based in the US who served as members of either a panel (n=86) or task force (n=6) on the DSM-5-TR with information recorded in the Centers for Medicare and Medicaid Services Open Payments database during 2016-19. This period was chosen to include the year that development of the DSM-5-TR began and the three years preceding, a time consistent with previous research on conflicts of interest and consistent with the American Psychiatric Association's disclosure requirements for the fifth revision (DSM-5) of the manual. MAIN OUTCOME MEASURES: Type and amount of compensation the panel and task force members of DSM-5-TR received during 2016-19. RESULTS: After duplicate names had been removed, 168 individuals were identified who served as either panel or task force members of the DSM-5-TR. 92 met the inclusion criteria of being a physician who was based in the US and therefore could be included in Open Payments. Of these 92 individuals, 55 (60%) received payments from industry. Collectively, these panel members received a total of $14.2m (£11.2m; €13m). One third (33.3%) of the task force members had payments reported in Open Payments. CONCLUSIONS: Conflicts of interest among panel members of DSM-5-TR were prevalent. Because of the enormous influence of diagnostic and treatment guidelines, the standards for participation on a guideline development panel should be high. A rebuttable presumption should exist for the Diagnostic and Statistical Manual of Mental Disorders to prohibit conflicts of interest among its panel and task force members. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the panels, but they should not have decision making authority on revisions or the inclusion of new disorders.