Research integrity in Instructions for Authors in Japanese medical journals using ICMJE Recommendations: A descriptive literature study.

BACKGROUND: The International Committee of Medical Journal Editors (ICMJE) has published Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. These provide a global standard for writing and editing medical articles, including research integrity. However, no study has examined the research integrity-related content of Japanese medical journals' Instructions for Authors. We therefore compared research integrity content in ICMJE member journals with those in the English- and Japanese-language journals of the Japanese Association of Medical Sciences (JAMS). MATERIALS AND METHODS: This was a descriptive literature study. We obtained Instructions for Authors from English- and Japanese-language journals listed on the JAMS website and the ICMJE member journals listed on the ICMJE website as of September 1, 2021. We compared the presence of 20 topics (19 in the ICMJE Recommendations plus compliance with ICMJE) in the Instructions for Authors, and analyzed the content of the conflict of interest disclosure. RESULTS: We evaluated 12 ICMJE member journals, and 82 English-language and 99 Japanese-language subcommittee journals. The median number of topics covered was 10.5 for ICMJE member journals, 10 for English-language journals, and three for Japanese-language journals. Compliance with ICMJE was mentioned by 10 (83%) ICMJE member journals, 75 (91%) English-language journals, and 29 (29%) Japanese-language journals. The ICMJE Conflicts of Interest Disclosure Form was requested by seven (64%) ICMJE member journals, 15 (18%) English-language journals, and one (1%) Japanese-language journal. CONCLUSIONS: Although the topics in the JAMS English-language journals resembled those in the ICMJE member journals, the median value of ICMJE-related topic inclusion was approximately one-third lower in JAMS Japanese-language journals than in ICMJE member journals. It is hoped that Japanese-language journals whose conflict of interest disclosure policies differ from ICMJE standards will adopt international standards to deter misconduct and ensure publication quality.

Quantifying Industry Spending on Promotional Events Using Open Payments Data.

Importance: Sponsorship of promotional events for health professionals is a key facet of marketing campaigns for pharmaceuticals and medical devices; however, there appears to be limited transparency regarding the scope and scale of this spending. Objective: To develop a novel method for describing the scope and quantifying the spending by US pharmaceutical and medical companies on industry-sponsored promotional events for particular products. Design and Setting: This was a cross-sectional study using records from the Centers for Medicare & Medicaid's Open Payments database on payments made to prescribing clinicians from January 1 to December 21, 2022. Main Outcomes and Measures: An event-centric approach was used to define sponsored events as groupings of payment records with matching variables. Events were characterized by value (coffee, lunch, dinner, or banquet) and number of attendees (small vs large). To test the method, the number of and total spending for each type of event across professional groups were calculated and used to identify the top 10 products related to dinner events. To validate the method, we extracted all event details advertised on the websites of 4 state-level nurse practitioner associations that regularly hosted industry-sponsored dinner events during 2022 and compared these with events identified in the Open Payments database. Results: A total of 1 154 806 events sponsored by pharmaceutical and medical device companies were identified for 2022. Of these, 1 151 351 (99.7%) had fewer than 20 attendees, and 922 214 (80.0%) were considered to be a lunch ($10-$30 per person). Seven companies sponsored 16 031 dinners for the top 10 products. Of the 227 sponsored in-person dinner events hosted by the 4 state-level nurse practitioner associations, 168 (74.0%) matched events constructed from the Open Payments dataset. Conclusions and Relevance: These findings indicate that an event-centric analysis of Open Payments data is a valid method to understand the scope and quantify spending by pharmaceutical and medical device companies on industry-sponsored promotional events attended by prescribers. Expanding and enforcing the reporting requirements to cover all payments to all registered health professionals would improve the accuracy of estimates of the true extent of all sponsored events and their impact on clinical practice.

Research with Refugee Populations in North America: Applying the NIH Guiding Principles for Ethical Research.

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.

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.

Cross-sectional analysis of pharmaceutical industry payments to authors of clinical practice guidelines for bipolar disorder and major depressive disorder in Japan.

OBJECTIVE: Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan. METHODS: This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020. RESULTS: This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs. CONCLUSIONS: This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.

Conflict of Interest Disclosure in Oncology: Preliminary Insights From the Global ONCOTRUST-1 Cross-Sectional Study.

PURPOSE: Conflicts of interest (COIs) between oncologists and industry might considerably influence how the presentation of the research results is delivered, ultimately affecting clinical decisions and policy-making. Although there are many regulations on reporting COI in high-income countries (HICs), little is known about their reporting in low- and middle-income countries (LMICs). Oncology Transparency Under Scrutiny and Tracking (ONCOTRUST-1) is a pilot global survey to explore the knowledge and perceptions of oncologists regarding COI. MATERIALS AND METHODS: We designed an online 27-question-based survey in the English language to explore the perceptions and knowledge of oncologists regarding COI, with an emphasis on LMICs. Descriptive statistics and the Consensus-Based Checklist for Reporting of Survey Studies guidelines were used to report the findings. RESULTS: ONCOTRUST-1 surveyed 200 oncologists, 70.9% of them practicing in LMICs. Median age of the respondents was 36 (range, 26-84) years; 47.5% of them were women. Of the respondents, 40.5% reported weekly visits by pharmaceutical representatives to their institutions. Regarding oncologists' perceptions of COI that require disclosure, direct financial benefits, such as honoraria, ranked highest (58.5%), followed by gifts from pharmaceutical representatives (50%) and travel grants for attending conferences (44.5%). By contrast, personal or institutional research funding, sample drugs, consulting or advisory board, expert testimony, and food and beverage funded by pharmaceutical industry were less frequently considered as COI. Moreover, only 24% of surveyed oncologists could correctly categorize all situations representing a COI. CONCLUSION: These findings underscore the importance of clear guidelines, education, and transparency in reporting COI in oncology. This hypothesis-generating pilot survey provided the rationale for ONCOTRUST-2 study, which will compare perceptions of COI among oncologists in LMICs and HICs.

Nonfinancial Conflict of Interest in Medical Research: Is Regulation the Right Answer.

Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, conflicts of interest may be financial such as monetary gain, or nonfinancial such as promotion and career advancement. However, with a $1.1 billion median cost of developing a new drug, the focus of these laws was directed towards financial conflicts of interest. But should we expand these laws to include nonfinancial conflicts of interest? This Article highlights prominent arguments in favor of and against the regulation of nonfinancial conflicts of interest in medical research. It further concludes that adequate institutional policies--not additional regulations--strike the right balance between the need to safeguard against the harmful effects of nonfinancial conflicts of interest on the one hand and avoiding the drawbacks of overregulation on the other.

Trends in financial payments from industry to US cancer centers, 2014-2021.

BACKGROUND: Industry payments to US cancer centers are poorly understood. METHODS: US National Cancer Institute (NCI)-designated comprehensive cancer centers were identified (n = 51). Industry payments to NCI-designated comprehensive cancer centers from 2014 to 2021 were obtained from Open Payments and National Institutes of Health (NIH) grant funding from NIH Research Portfolio Online Reporting Tools (RePORT). Given our focus on cancer centers, we measured the subset of industry payments related to cancer drugs specifically and the subset of NIH funding from the NCI. RESULTS: Despite a pandemic-related decline in 2020-2021, cancer-related industry payments to NCI-designated comprehensive cancer centers increased from $482 million in 2014 to $972 million in 2021. Over the same period, NCI research grant funding increased from $2 481  million to $2 724  million. The large majority of nonresearch payments were royalties and licensing payments. CONCLUSION: Industry payments to NCI-designated comprehensive cancer centers increased substantially more than NCI funding in recent years but were also more variable. These trends raise concerns regarding the influence and instability of industry payments.

Emergency Physicians' Ethical Issues with Hospital Business Models.

BACKGROUND: The changing hospital business model has raised ethical issues for emergency physicians (EPs) in a healthcare system that often prioritizes profits over patient welfare. For-profit hospitals, driven by profit motives, may prioritize treating patients with lucrative insurance plans and those who can afford expensive treatments. Private equity investors, who now own many for-profit hospitals, focus on short-term financial gains, leading to cost-cutting measures and pressure on EPs to prioritize financial goals over patient welfare. Nonprofit hospitals, mandated to provide charity care to the underserved, may fail to meet their community service obligations, resulting in disparities in healthcare access. OBJECTIVE: This review examines the ethical challenges faced by emergency physicians (EPs) in response to the evolving hospital business model, which increasingly prioritizes profits over patient welfare. DISCUSSION: Emergency physicians face ethical dilemmas in this changing environment, including conflicts between patient care and financial interests. Upholding professional ethics and the principle of beneficence is essential. Another challenge is equitable access to healthcare, with some nonprofit hospitals reducing charity care, thus exacerbating disparities. EPs must uphold the ethical principle of justice, ensuring quality care for all patients, regardless of financial means. Conflicts of interest may arise when EPs work in hospitals owned by private equity firms or with affiliations with pharmaceutical companies or medical device manufacturers, potentially compromising patient care. CONCLUSION: Emergency physicians must navigate these ethical issues while upholding professional ethics and advocating for patients' best interests. Collaboration with hospital administrators, policymakers, and stakeholders is vital to address these concerns and prioritize patient welfare in healthcare delivery.

Industry Payments to Physicians Endorsing Drugs and Devices on a Social Media Platform.

This study evaluates adherence to industry and professional standards among physicians endorsing drugs and devices on a social media platform.

Reporting Conflicts of Interest and Funding in Health Care Guidelines: The RIGHT-COI&F Checklist.

BACKGROUND: Conflicts of interest (COIs) of contributors to a guideline project and the funding of that project can influence the development of the guideline. Comprehensive reporting of information on COIs and funding is essential for the transparency and credibility of guidelines. OBJECTIVE: To develop an extension of the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement for the reporting of COIs and funding in policy documents of guideline organizations and in guidelines: the RIGHT-COI&F checklist. DESIGN: The recommendations of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network were followed. The process consisted of registration of the project and setting up working groups, generation of the initial list of items, achieving consensus on the items, and formulating and testing the final checklist. SETTING: International collaboration. PARTICIPANTS: 44 experts. MEASUREMENTS: Consensus on checklist items. RESULTS: The checklist contains 27 items: 18 about the COIs of contributors and 9 about the funding of the guideline project. Of the 27 items, 16 are labeled as policy related because they address the reporting of COI and funding policies that apply across an organization's guideline projects. These items should be described ideally in the organization's policy documents, otherwise in the specific guideline. The remaining 11 items are labeled as implementation related and they address the reporting of COIs and funding of the specific guideline. LIMITATION: The RIGHT-COI&F checklist requires testing in real-life use. CONCLUSION: The RIGHT-COI&F checklist can be used to guide the reporting of COIs and funding in guideline development and to assess the completeness of reporting in published guidelines and policy documents. PRIMARY FUNDING SOURCE: The Fundamental Research Funds for the Central Universities of China.

Drug Promotions Between Ethics, Regulations, and Financial Interests.

BACKGROUND: The promotion of the latest medicines produced by the pharmaceutical industry is an important issue both from an ethical point of view (the level of accessibility, the way research is carried out) and from the point of view of marketing and especially from the lobbying issues raised. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the promotion of new drugs revolve between the need to discover new molecules important for treating a wide range of diseases and the need to establish a battery of ethical rules, absolutely necessary for regulations in the field to be compliant with all ethical principles. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) using combinations of keywords, including drugs, medical publicity, and pharma marketing plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The promotion of medicines is governed by advertising laws and regulations in many countries, including at EU level, based on the need for countries to ensure that the promotion and advertising of medicines is truthful, based on information understood by consumers. The ethical analysis of the issues raised is more necessary and complex as the channels used for promotion are more accessible to the population, and the information, easier to obtain, can be the cause of increased self-medication and overeating. Large amounts of money invested in the development of new molecules, but also the risk of scientific fraud through manipulation of data during clinical trials, selective or biased publication of information can have repercussions on the health of the population. CONCLUSIONS: The development of new pharmaceutical molecules is necessary to intervene and treat as many conditions as possible, but marketing must not neglect the observance of ethical principles. The promotion of medicines should be the attribute especially of the medical staff, which should also be a mandatory part of the mechanism for approving the marketing methods and means used by the pharmaceutical companies.

The pharmaceutical company-healthcare relationship: much ado about something.

The relationship between the pharmaceutical companies and the healthcare profession, especially doctors, has always been fraught with conflicts of interest (COI). The publication of the influential The Diagnostic and Statistical Manual for Mental Disorders, Fifth edition, Text Revision (DSM-5-TR), by the American Psychiatric Society (APA) raised concerns that the financial relationships between pharma and members responsible for DSM could result in bias. This resulted in calls for stricter enforcement of controls on financial conflict of interest (FCOI) [1, 2], which could influence the formulation of diagnostic criteria (resulting in more people being "diagnosable as mentally ill"), creating a larger pool of "patients" who "need" pharmaceutical drugs. Knowingly or unknowingly, they would end up serving the pharmaceutical companies' agenda to sell more drugs and drive up profits [2] .

Authorship characteristics of hematology and oncology education chapters: A comprehensive analysis.

INTRODUCTION: Achieving diversity and equity in healthcare, especially within academic and clinical spheres, poses significant challenges. This study aims to evaluate gender representation, geographical diversity among authors, and disclosure of conflicts of interest (COIs) in educational materials published by the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH). MATERIALS AND METHODS: We conducted a comprehensive cross-sectional analysis covering all volumes of ASCO and ASH educational chapters from 2012 to 2022 and 2000 to 2022, respectively. Author data were extracted from the official websites of ASCO and ASH educational books, focusing on names, affiliations, countries of practice, COIs, and publication titles/subjects. RESULTS: Analysis of 2796 articles revealed significant trends in gender representation. Women comprised 44 % of first authors and 38 % of last authors in ASCO educational books, and 39 % of first authors and 39% of last authors in ASH educational books. Notably, there was a marked increase in female first and last authors over time across both ASCO and ASH publications (p < 0.001). Geographical diversity showed disparities, with the majority of authors affiliated with US institutions (72 % of first and last authors). International authors were less represented, with Canada, the UK, and Italy prominent among articles featuring international women authors. A substantial portion of analyzed articles disclosed COIs, mainly research funding, honoraria, and travel expenses. DISCUSSION: Our findings suggest a notable rise in female authorship, potentially reflecting efforts by ASH and ASCO to promote diversity. International authorship remained stable, while COIs were prevalent, primarily involving research funding. Addressing the need for greater international engagement and improving COI reporting quality are crucial to promote inclusivity and transparency in academic publications.

[Interpreting the evidence. Reducing subjectivity in appraising the evidence calls for a return to teaching evidence-based medicine.] / L'interpretazione delle evidenze. Per ridurre la soggettività nella lettura delle prove serve tornare a insegnare l'evidence-based medicine.

The interpretation of clinical research evidence is still characterized by wide subjectivity. This subjectivity is also visible when comparing guidelines and recommendations developed by institutions and learned societies. It is often due to bias and conflicts of interest experienced by the members of guideline panels: thus, the role of editors and publishers of journals and scientific media becomes increasingly important, and they should return to careful oversight of the content of what is published. To address the problem, however, it is necessary to return to teaching evidence-based medicine in order to restore its function as a "North star" in clinical practice and public health decision-making.