Research on commercial milk formulas for young children: A scoping review.

A scoping review of publications about commercial milk formulas intended for or consumed by children 12-36 months (CMF 12-36) was conducted. This review aimed to comprehensively map the existing literature, identify key concepts in the field and understand its evolution through time. A total of 3329 articles were screened and 220 were included, published between 1986 and 2024. Most works were published after 2016 (70.0%) and in high-income countries (71.8%). Original studies were the vast majority (81.8%) of publications. Most publications dealt with feeding practices or analysed the composition and/or contamination of specific products (44.1% and 35.9%), but since the late 2000s, publications about marketing, policy, legislation, and consumer perception started to appear. Most published works (65.5%) did not focus exclusively on CMF 12-36 and included formulas for other demographics or other foods. About half of the works (55.5%) did not consider CMF 12-36 to be a breast milk substitute. We found 81 distinct product denominations used to refer to CMF 12-36, Growing Up Milk was the most common (25.9%). CMF industry was involved in 41.8% of all analysed works, and industry participation and funding were not always clearly informed (22.5% lacked a conflict of interest statement, and 25.5% did not present any information about funding). In the last decade, publications about CMF 12-36 have increased in volume and diversified in scope and subject matter. CMF-industry participation has always been and still is present in the field, so possible vested interests should be taken into account when appreciating the literature.

Sample Size Considerations for Fine-Tuning Large Language Models for Named Entity Recognition Tasks: Methodological Study.

BACKGROUND: Large language models (LLMs) have the potential to support promising new applications in health informatics. However, practical data on sample size considerations for fine-tuning LLMs to perform specific tasks in biomedical and health policy contexts are lacking. OBJECTIVE: This study aims to evaluate sample size and sample selection techniques for fine-tuning LLMs to support improved named entity recognition (NER) for a custom data set of conflicts of interest disclosure statements. METHODS: A random sample of 200 disclosure statements was prepared for annotation. All "PERSON" and "ORG" entities were identified by each of the 2 raters, and once appropriate agreement was established, the annotators independently annotated an additional 290 disclosure statements. From the 490 annotated documents, 2500 stratified random samples in different size ranges were drawn. The 2500 training set subsamples were used to fine-tune a selection of language models across 2 model architectures (Bidirectional Encoder Representations from Transformers [BERT] and Generative Pre-trained Transformer [GPT]) for improved NER, and multiple regression was used to assess the relationship between sample size (sentences), entity density (entities per sentence [EPS]), and trained model performance (F1-score). Additionally, single-predictor threshold regression models were used to evaluate the possibility of diminishing marginal returns from increased sample size or entity density. RESULTS: Fine-tuned models ranged in topline NER performance from F1-score=0.79 to F1-score=0.96 across architectures. Two-predictor multiple linear regression models were statistically significant with multiple R2 ranging from 0.6057 to 0.7896 (all P<.001). EPS and the number of sentences were significant predictors of F1-scores in all cases ( P<.001), except for the GPT-2_large model, where EPS was not a significant predictor (P=.184). Model thresholds indicate points of diminishing marginal return from increased training data set sample size measured by the number of sentences, with point estimates ranging from 439 sentences for RoBERTa_large to 527 sentences for GPT-2_large. Likewise, the threshold regression models indicate a diminishing marginal return for EPS with point estimates between 1.36 and 1.38. CONCLUSIONS: Relatively modest sample sizes can be used to fine-tune LLMs for NER tasks applied to biomedical text, and training data entity density should representatively approximate entity density in production data. Training data quality and a model architecture's intended use (text generation vs text processing or classification) may be as, or more, important as training data volume and model parameter size.

Randomised study of the effects of sense of entitlement and conflict of interest contrarianism on researcher decision-making to work with the alcohol industry.

BACKGROUND: It is well established that the tobacco industry used research funding as a deliberate tactic to subvert science. There has been little wider attention to how researchers think about accepting industry funding. We developed, then tested, hypotheses about two psychological constructs, namely, entitlement and conflict of interest contrarianism (CoI-C) among alcohol researchers who had previously received industry funding. METHODS: A mixed-methods pilot study involved construct and instrument development, followed by an online survey and nested 3-arm randomised trial. We randomly allocated alcohol industry funding recipients to one of three conditions. In two experimental conditions we asked participants questions to remind them (and thus increase the salience) of their sense of entitlement or CoI-C. We compared these groups with a control group who did not receive any reminder. The outcome was a composite measure of openness to working with the alcohol industry. RESULTS: 133 researchers were randomised of whom 79 completed the experiment. The posterior distribution over effect estimates revealed that there was a 94.8% probability that reminding researchers of their CoI-C led them to self-report being more receptive to industry funding, whereas the probability was 68.1% that reminding them of their sense of entitlement did so. Biomedical researchers reported being more open to working with industry than did psychosocial researchers. CONCLUSION: Holding contrarian views on conflict of interest could make researchers more open to working with industry. This study shows how it is possible to study researcher decision-making using quantitative experimental methods.

Pharmaceutical company funding of cancer patient advocacy organizations in the Netherlands.

BACKGROUND: Financial conflicts of interest (FCOI) of medical professionals and associated organizations with pharmaceutical companies (pharma) might contribute to the use of low value oncological treatments. Value criteria for oncological drug approvals in the Netherlands have recently become more stringent leading to objections by cancer patient advocacy organizations (cPAOs). Considering the importance of cPAOs input in cancer patient care we analyzed whether pharma funding of cPAOs occurs in the Netherlands. METHODS: The cPAO websites and available annual reports were evaluated for disclosure of pharma funding for the years 2021 and 2022. Also, data from the Dutch Healthcare Transparency Registry (DHTR) were extracted. RESULTS: Twenty-one of 34 (61.8 %) cPAOs received pharma funding (with 20 registered in the DHTR), and for 13 (29.4 %) cPAOs no reporting of pharma funding could be found. Three of the cPAOs disclosed pharma funding directly on their main website. Online educational material was available from 22 cPAOs on their websites with pharma funding disclosed on the educational material in 5. The total registered amount of pharmaceutical funding was €667,232.00 in 2021 and €536,098.00 in 2022. The median (and interquartile ranges) DHTR registered amount of support per cPAO that received funding in the studied period was €23,799.50 (14,823.75-84,663.30). The most common funding category as defined in the DHTR was project sponsorship. CONCLUSIONS: Financial support by the pharmaceutical industry is common for Dutch cPAOs. Given the importance of cPAOs and their objective input in the societal debate on the availability of cancer drugs, the potential influence of pharma sponsoring should be critically evaluated.

Funding of evidence included within public comments submitted to inform Medicare national coverage determinations.

The Centers for Medicare & Medicaid Services (CMS) relies on public comments submitted in response to proposed national coverage determinations to assist the agency in determining the coverage of items and services for Medicare beneficiaries. In a cross-sectional study, we characterized the cited evidence and what funding supported the cited evidence submitted in public comments to CMS for all therapeutic medical device national coverage determinations finalized between June 2019 and June 2022. Of 681 public comments, 159 (23%) cited at least 1 identifiable published scientific journal article. Within these 159 public comments, 198 unique articles were cited, 170 (86%) of which included funding statements or author disclosures. Among these, 96 (56%) disclosed funding from manufacturers that would benefit from Medicare coverage and/or were written by author(s) who received funding from these manufacturers. In summary, most public commenters for national coverage determinations did not cite published scientific journal articles to support their positions. Among those who did, more than half of articles were directly funded by manufacturers that would benefit from coverage. Greater funding of independent, non-industry-supported research may help provide unbiased evaluations of benefits and harms to support Medicare coverage decisions.

[What does Harm Reduction in Tobacco Use means to Public Health]. / Reducción de daños en tabaquismo desde la Salud Pública.

Harm reduction is a classic Public Health concept to refer to the reduction of the negative effect of drug use/abuse with a focus on justice and human rights, but the tobacco industry has been perverting this concept for years and using it as a tool for its own marketing. This publication details what real harm reduction action on tobacco use would be, when it should be implemented, and what pillars it should be based on. Different methods of reducing the harmful effects of tobacco and nicotine have been tried and tested over time, but the results have been poor; therefore, smoking cessation by the various officially recognised methods is recommended as a priority objective, using the tools that are truly supported by science. In contrast, it also explains the strategies developed by the industry to manipulate consumers and make them dependent on products that can eventually kill them: from the development of filtered cigarettes to light cigarettes, and from menthol to flavoured vapes. In all cases, they have falsely led people to believe that they were developing less toxic products when they were not. Nowadays, both light and menthol cigarettes are banned in Spain, filters have not reduced risk but increased the use, and vapes try to replace cigarettes with their attractive flavours and their false legend of healthier products when what they are really doing is maintaining the same addiction by changing the object, encouraging dual use, and attracting younger and younger non-smokers. At the same time, a strategy of dividing the opinion of health professionals has been developed, using medical doctors and researchers with recognised conflicts of interest but who manage to confuse consumers. In conclusion, we consider that, although nicotine releasing devices may be useful elements in some particular cases, they are not recommended at the population level as they can promote onset, prevent cessation, as well as maintaining the addictive capacity. The only nicotine products that are recommended are those of pharmacological use approved for the case and provided they are used as a transitional tool to complete cessation.

La reducción de daños es un concepto clásico de la Salud Pública para referirse a la reducción del impacto negativo del consumo de drogas con un enfoque de justicia y derechos humanos, pero la industria tabacalera lleva años pervirtiendo este concepto y utilizándolo como una herramienta de su propio marketing. La presente publicación detalla qué sería una verdadera acción de reducción de daños en tabaquismo, cuándo debería aplicarse y en qué pilares debería sostenerse. A lo largo del tiempo se han probado distintos métodos de minorar los efectos perjudiciales del tabaco y de la nicotina, si bien los resultados han sido escasos; así pues, se propone como objetivo prioritario la cesación tabáquica por los distintos métodos reconocidos, utilizando como herramientas las verdaderamente amparadas por la Ciencia. En contraste, se explican también las estrategias desarrolladas por la industria para manipular a los consumidores y hacerles dependientes de unos productos que eventualmente pueden acabar con sus vidas: desde el desarrollo de los cigarrillos con filtro a los light, y de los mentolados a los vapers de sabores. En todos los casos han hecho creer falsamente que desarrollaban productos menos tóxicos cuando no era así. Hoy en día, tanto los cigarrillos light como los mentolados están prohibidos en España, los filtros no han conseguido una disminución del riesgo y sí un aumento del consumo, y los vapers intentan sustituir a los cigarrillos con sus aromas atractivos y su falsa leyenda de productos más sanos cuando lo que están haciendo en realidad es mantener la misma adicción cambiando el objeto, fomentando el consumo dual, y atrayendo a consumidores no-fumadores previos cada vez más jóvenes. Paralelamente, se ha desarrollado una estrategia de división de la opinión de los profesionales sanitarios, con médicos e investigadores con reconocidos conflictos de interés pero que logran confundir al consumidor. Como conclusión consideramos que, si bien en algún caso particular los DSLN (dispositivos susceptibles de liberar nicotina) puedan ser elementos útiles, no son recomendables a nivel poblacional ya que pueden promover el inicio del consumo e impedir la cesación, además de mantener la capacidad adictógena. Los únicos productos de nicotina que se recomiendan son aquellos de uso farmacológico aprobados para el caso y siempre que se usen como herramienta transitoria para la cesación completa.

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.

Attitudes Towards Conflicts of Interest in Medical Research: A Survey of US Medical Students.

Industry funds nearly two-thirds of US healthcare research, and industry-sponsorship may produce more favorable research results and conclusions. Medical students report feeling inadequately prepared to avoid negative industry influence. Research of educational interventions that educate students on the potential effects of industry influence is lacking, and no interventions have demonstrated long-term benefit. Surveying and assessing student opinions of the relationship between industry and research may help improve future educational interventions. We surveyed preclinical and clinical students at seven US medical schools regarding their attitudes towards industry conflicts of interest (COIs) in medical research. A total of 466 medical students including 232 preclinical and 234 clinical students completed the survey. Of those who had research experience, clinical students were more likely than preclinical students to look for COIs (62.0% v 45.9%, p = .014) and to consider whether author COIs are pertinent to the article (68.1% v 54.1%, p = .023). Many disagreed that they felt adequately educated on the issue of COIs (42.7%), but most agreed that medical school should take a role in guiding student interactions with industry (65.0%). Students responded that all listed financial relationships between industry and investigator, except for providing food and/or beverage, would likely bias the investigator's research. Many students feel inadequately educated on industry issues in biomedical research, and most believe medical schools should help guide interactions with industry. Our findings support further development of educational interventions that prepare students to navigate the relationship between industry and medical research during and after medical school.

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.

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.

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.