Ethics guidelines for environmental epidemiologists: 2023 revision.

Recognition of the importance to environmental epidemiology of ethical and philosophical deliberation led, in 1996, to the establishment of Ethics Guidelines for the profession. In 1999, these guidelines were adopted by the International Society for Environmental Epidemiology. The guidelines were revised in 2012 and again in 2023 to ensure continued relevance to the major issues facing the field. Comprising normative standards of professional conduct, the guidelines are structured into four subsections: (1) obligations to individuals and communities who participate in research; (2) obligations to society; (3) obligations regarding funders/sponsors and employers; and (4) obligations to colleagues. Through the 2023 revision of the Ethics Guidelines, the International Society for Environmental Epidemiology seeks to ensure the highest possible standards of transparency and accountability for the ethical conduct of environmental epidemiologists engaged in research and public health practice.

"Caught In Each Other's Traps": Factors Perpetuating Incentive-Linked Prescribing Deals Between Physicians and the Pharmaceutical Industry.

BACKGROUND: Despite known adverse impacts on patients and health systems, 'incentive-linked prescribing', which describes the prescribing of medicines that result in personal benefits for the prescriber, remains a widespread and hidden impediment to quality of healthcare. We investigated factors perpetuating incentive-linked prescribing among primary care physicians in for-profit practices (referred to as private doctors), using Pakistan as a case study. METHODS: Our mixed-methods study synthesised insights from a survey of 419 systematically samples private doctors and 68 semi-structured interviews with private doctors (n=28), pharmaceutical sales representatives (n=12), and provincial and national policy actors (n=28). For the survey, we built a verified database of all registered private doctors within Karachi, Pakistan's most populous city, administered an electronic questionnaire in-person and descriptively analysed the data. Semi-structured interviews incorporated a vignette-based exercise and data was analysed using an interpretive approach. RESULTS: Our survey showed that 90% of private doctors met pharmaceutical sales representatives weekly. Three interlinked factors perpetuating incentive-linked prescribing we identified were: gaps in understanding of conflicts of interest and loss of values among doctors; financial pressures on doctors operating in a (largely) privately financed health-system, exacerbated by competition with unqualified healthcare providers; and aggressive incentivisation by pharmaceutical companies, linked to low political will to regulate and an over-saturated pharmaceutical market. CONCLUSION: Regular interactions between pharmaceutical companies and private doctors are normalised in our study setting, and progress on regulating these is hindered by the substantial role of incentive-linked prescribing in the financial success of physicians and the pharmaceutical industry employees. A first step towards addressing the entrenchment of incentive-linked prescribing may be to reduce opposition to restrictions on incentivisation of physicians from stakeholders within the pharmaceutical industry, physicians themselves, and policymakers concerned about curtailing growth of the pharmaceutical industry.

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.

ChatGPT for Automated Cross-Checking of Authors' Conflicts of Interest Against Industry Payments.

OBJECTIVE: The Centers for Medicare & Medicaid Services "OpenPayments" database tracks industry payments to US physicians to improve research conflicts of interest (COIs) transparency, but manual cross-checking of articles' authors against this database is labor-intensive. This study aims to assess the potential of large language models (LLMs) like ChatGPT to automate COI data analysis in medical publications. STUDY DESIGN: An observational study analyzing the accuracy of ChatGPT in automating the cross-checking of COI disclosures in medical research articles against the OpenPayments database. SETTING: Publications regarding Food and Drug Administration-approved biologics for chronic rhinosinusitis with nasal polyposis: omalizumab, mepolizumab, and dupilumab. METHODS: First, ChatGPT evaluated author affiliations from PubMed to identify those based in the United States. Second, for author names matching 1 or multiple payment recipients in OpenPayments, ChatGPT undertook a comparative analysis between author affiliation and OpenPayments recipient metadata. Third, ChatGPT scrutinized full article COI statements, producing an intricate matrix of disclosures for each author against each relevant company (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline). A random subset of responses was manually checked for accuracy. RESULTS: In total, 78 relevant articles and 294 unique US authors were included, leading to 980 LLM queries. Manual verification showed accuracies of 100% (200/200; 95% confidence interval [CI]: 98.1%-100%) for country analysis, 97.4% (113/116; 95% CI: 92.7%-99.1%) for matching author affiliations with OpenPayments metadata, and 99.2% (1091/1100; 95% CI: 98.5%-99.6%) for COI statement data extraction. CONCLUSION: LLMs have robust potential to automate author-company-specific COI cross-checking against the OpenPayments database. Our findings pave the way for streamlined, efficient, and accurate COI assessment that could be widely employed across medical research.

Assessing conflict of interest reporting and quality of clinical trials on infant formula: a systematic review.

OBJECTIVES: This study aims to assess the quality, risk of bias, and conflicts of interest (COIs) of clinical trials conducted on the effects of fortified infant formula. STUDY DESIGN AND SETTTING: Systematic review including all randomized clinical trials targeting healthy children and using three arms: fortified infant formula; standard formula; and breastfeeding. We performed a descriptive analysis of the studies reviewed, assessed their quality using the "Risk of Bias 2- RoB 2" tool, and identified COIs. RESULTS: A total of 40 studies were included. All showed a high overall risk of bias, with this being especially noteworthy in the "deviations from intention to treat" and "missing outcome data" domains. Of the total included studies, 29 reported conclusions in favor of the fortified formula; 15 studies reported multiple conclusions that were either contradictory or not in line with the results. COIs with industry were identified in 33 studies, and in 17 studies, these conflicts were not declared in the appropriate section. CONCLUSION: From a methodological perspective, studies on fortified infant formula display low quality, made evident by the high risk of bias. Additionally, there are frequent COIs. These aspects must be considered by health professionals and the population when drawing up recommendations for the use of this product.

Addressing misinformation about the Dietary Guidelines for Americans.

The Dietary Guidelines for Americans (DGA) provides science-based advice on dietary intake to promote health, reduce risk of chronic disease, and meet nutrient needs. It is jointly published by the United States Departments of Health and Human Services and Agriculture (USDA) every 5 y. As chronic diseases continue to rise to pervasive levels, helping the United States population follow the DGA is especially important for improving the health of our nation. The DGA is developed using a rigorous and transparent scientific process, and with the advice of an independent, external committee of leading scientists. Career federal nutrition scientists who manage the process ensure that the methods used to develop the DGA remain state of the art. Unfortunately, misinformation about the scientific basis, transparency, and relevance of the DGA for the United States population threatens its credibility. The main objective of this article is to correct this misinformation with factual information about the process used to develop the DGA. The DGA provides guidelines for the general public, and its primary audience includes policymakers and nutrition and health professionals who help individuals and families consume a healthy dietary pattern. Providing accurate information may bolster trust in the recommendations among these audiences while improving implementation across sectors to promote better adherence to the DGA, thereby improving diet quality among the United States population.

Development of a Medical Social Media Ethics Scale and Assessment of #IRad, #CardioTwitter, and #MedTwitter Posts: Mixed Methods Study.

BACKGROUND: Social media posts by clinicians are not bound by the same rules as peer-reviewed publications, raising ethical concerns that have not been extensively characterized or quantified. OBJECTIVE: We aim to develop a scale to assess ethical issues on medical social media (SoMe) and use it to determine the prevalence of these issues among posts with 3 different hashtags: #MedTwitter, #IRad, and #CardioTwitter. METHODS: A scale was developed based on previous descriptions of professionalism and validated via semistructured cognitive interviewing with a sample of 11 clinicians and trainees, interrater agreement, and correlation of 100 posts. The final scale assessed social media posts in 6 domains. This was used to analyze 1500 Twitter posts, 500 each from the 3 hashtags. Analysis of posts was limited to original Twitter posts in English made by health care professionals in North America. The prevalence of potential issues was determined using descriptive statistics and compared across hashtags using the Fisher exact and χ2 tests with Yates correction. RESULTS: The final scale was considered reflective of potential ethical issues of SoMe by participants. There was good interrater agreement (Cohen κ=0.620, P<.01) and moderate to strong positive interrater correlation (=0.602, P<.001). The 6 scale domains showed minimal to no interrelation (Cronbach α=0.206). Ethical concerns across all hashtags had a prevalence of 1.5% or less except the conflict of interest concerns on #IRad, which had a prevalence of 3.6% (n=18). Compared to #MedTwitter, posts with specialty-specific hashtags had more patient privacy and conflict of interest concerns. CONCLUSIONS: The SoMe professionalism scale we developed reliably reflects potential ethical issues. Ethical issues on SoMe are rare but important and vary in prevalence across medical communities.

Perspectives on the role of industry in informatics research and authorship.

OBJECTIVES: Advances in informatics research come from academic, nonprofit, and for-profit industry organizations, and from academic-industry partnerships. While scientific studies of commercial products may offer critical lessons for the field, manuscripts authored by industry scientists are sometimes categorically rejected. We review historical context, community perceptions, and guidelines on informatics authorship. PROCESS: We convened an expert panel at the American Medical Informatics Association 2022 Annual Symposium to explore the role of industry in informatics research and authorship with community input. The panel summarized session themes and prepared recommendations. CONCLUSIONS: Authorship for informatics research, regardless of affiliation, should be determined by International Committee of Medical Journal Editors uniform requirements for authorship. All authors meeting criteria should be included, and categorical rejection based on author affiliation is unethical. Informatics research should be evaluated based on its scientific rigor; all sources of bias and conflicts of interest should be addressed through disclosure and, when possible, methodological mitigation.

Financial Conflicts of Interest and Industry Funding are Associated With Conclusions Favorable to New Technologies: A Review of Published Economic Analyses in Hip and Knee Arthroplasty.

BACKGROUND: New technologies in hip and knee arthroplasty are commonly evaluated using cost-effectiveness analyses and similar economic assessments. There is a wide variation in the methodology of these studies, introducing the potential for bias. The purpose of this study was to evaluate associations between potential financial conflicts of interest (COI) and the outcomes of economic analyses. We hypothesized that authors' COI and industry funding would be associated with conclusions favorable to a new technology. METHODS: Economic analyses making cost-effectiveness or economic implementation claims on patient-specific instrumentation, robotics, and implants used in hip and knee arthroplasty published from 2010 to 2022 were identified. Papers were evaluated to determine if conclusions were favorable to the new technology being studied. Fisher's exact test was utilized to determine the relationship between the presence of COI and an article's conclusions. RESULTS: Of 43 eligible articles, 76.7% were cost-effectiveness analyses, 23.2% were cost analyses, and 67.4% of articles had conclusions favorable to a technology. Of the 29 articles with favorable conclusions, 26 had an author with a financial COI (89.7%), and 14 had industry funding (48.3%). Of the 33 articles with a financial COI, 26 (78.8%) had favorable conclusions, and of the 16 articles with industry funding, 14 (87.5%) had favorable conclusions. Fisher's exact test revealed a statistically significant association between an article having favorable conclusions and the presence of an author's COI or industry funding (odds ratio, 13.5; 95% CI [confidence interval], 2.3 to 79.9; P = .003). CONCLUSIONS: Financial COIs were present in 79.1% of lower extremity arthroplasty economic analyses on technologies and were associated with an article having conclusions favorable to the new technology. Surgeons and decision-makers should be aware of the variability and assumptions in these studies and the potential bias of the conclusions.

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.

Responding to research misconduct allegations brought against top university officials.

Investigating research misconduct allegations against top officials can create significant conflicts of interest (COIs) for universities that may require changes to existing oversight frameworks. One way of addressing some of these challenges is to develop policies and procedures that specifically address investigation of allegations of misconduct involving top university officials. Steps can also be taken now regardless of whether such a body is created. Federal and university research misconduct regulations and policies may need to be revised to provide institutions with clearer guidance on how to deal with misconduct allegations against top officials. For their part, institutions may benefit from proactively creating and transparently disclosing their own processes for independent investigation of research misconduct allegations against senior officials.

Financial conflicts of interest among presenters, panellists and moderators at haematology and oncology FDA workshops.

OBJECTIVE: To assess the characteristics and financial conflicts of interest of presenters, panellists and moderators at haematology and oncology workshops held jointly with or hosted by the US FDA. SETTING: We included information on all publicly available haematology or oncology FDA workshop agendas held between 1 January 2018 and 31 December 2022. EXPOSURE: General and research payments reported on Open Payments, industry funding to patient advocacy organizations reported on their webpages or 990 tax forms and employment in both pharmaceutical and regulatory settings. RESULTS: Among physicians eligible for payments, 78% received at least one payment from the industry between 2017 and 2021. The mean general payment amount was $82,170 for all years ($16,434 per year) and the median was $14,906 for all years ($2981 per year). Sixty-nine per cent of patient advocacy speakers were representing organizations that received financial support from the pharmaceutical industry. Among those representing regulatory agencies or pharmaceutical companies, 16% had worked in both settings during their careers. CONCLUSIONS AND RELEVANCE: Our findings in this cross-sectional study show a majority of US-based physician presenters at haematology and oncology workshops held jointly with members of the US FDA have some financial conflict of interest with the pharmaceutical industry. These findings support the need for clear disclosures and suggest that a more balanced selection of presenters with fewer conflicts may help to limit bias in discussions between multiple stakeholders.

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.

Chymotrypsin and Trypsin Inhibitory Activity of Some Medicinal Plants Collected from Rize (Türkiye).

In this research, the evaluation of in vitro chymotrypsin and trypsin inhibitory activities of ten plant species collected from Rize were aimed, and fractions that showed strong activity were analyzed through HPLC. Daphne pontica L. and Mentha longifolia (L.) L. were found to have the highest chymotrypsin inhibitory activities (87.75 and 84.24 % inhibition). Similarly, the highest trypsin inhibitory activity was observed in D. pontica (%99.93 inhibition), followed by Sambucus ebulus L. flowers (87.47 % inhibition). Extracts showing strong enzyme inhibition were fractioned and subjected to activity tests. The highest chymotrypsin inhibitory activity was observed in the n-hexane fraction of D. pontica (%80.70 inhibition), while the highest trypsin inhibitory activity was found in the n-butanol fraction of S. ebulus (%86.81 inhibition). HPLC studies determined that the 80 % ethanol extract of D. pontica and its dichloromethane and ethyl acetate fractions contained umbelliferone. It was found that chlorogenic acid was present in the 80 % ethanol extracts of S. ebulus flowers. M. longifolia was found to contain chlorogenic acid, caffeic acid, luteolin-7-glucoside, and rosmarinic acid. M. longifolia has been identified as the plant exhibiting the highest antioxidant activity in ABTS and CUPRAC tests, consistent with its high phenolic and flavonoid content.

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.

Conflict of interest policies at Australian medical schools.

BACKGROUND: Pharmaceutical industry exposure is widespread during medical training and may affect education and clinical decision-making. Medical faculties' conflict of interest (COI) policies help to limit this exposure and protect students against commercial influence. AIMS: Our aim was to investigate the prevalence, content and strength of COI policies at Australian medical schools and changes since a previous assessment conducted in 2009. METHODS: We identified policies by searching medical school and host university websites in January 2021, and contacted deans to identify any missed policies. We applied a modified version of a scorecard developed in previous studies to examine the content of COI policies. All data were coded in duplicate. COI policies were rated on a scale from 0 (no policy) to 2 (strong policy) across 11 items per medical school. Oversight mechanisms and sanctions were also assessed, and current policies were compared with the 2009 study. RESULTS: Of 155 potentially relevant policies, 153 were university-wide and two were specific to medical schools. No policies covered sales representatives, on-site sponsored education or free samples. Oversight of consultancies had improved substantially, with 76% of schools requiring preapproval. Disclosure policies, while usually present, were weak, with no public disclosure required. CONCLUSION: We found little indication that Australian medical students are protected from commercial influence on medical education, and there has been limited COI policy development within the past decade. More attention is needed to ensure the independence of medical education in Australia.