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.

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.

[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.

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] .

Trends in Industry-Sponsored Research Payments to Physician Principal Investigators.

This cohort study investigates trends in total and per-physician industry-sponsored research payments to physician principal investigators from 2015 to 2022.

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.

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.

Cross-sectional examination of commercial milk formula industry funding of international, regional and national healthcare professional associations: protocol.

INTRODUCTION: Commercial milk formula manufacturers often emphasise their role in supporting infant and young child nutrition and breastfeeding, but their commercial goals to increase volume and profit margin of formula sales conflict with these declarations. Healthcare professional associations have an important role in healthcare worker education, shaping clinical practice. When healthcare professional associations enter into financial relationships with formula manufacturers, conflicts of interest arise, which may undermine education and practice that promotes optimal infant and young child feeding. The World Health Assembly calls on all parties to avoid such conflicts of interest, but it is uncertain how often this recommendation is followed. This protocol documents a systematic method to identify funding from the commercial milk formula industry among international, regional and national associations of healthcare professionals. METHODS AND ANALYSIS: Using systematic search strategies in the Gale Directory Library and Google, we will identify international healthcare professional associations relevant to maternal and child health. Data regarding funding relationships with the commercial milk formula industry over the past 24 months will be extracted from the official websites or, in their absence, social media accounts by two independent analysts. The analysis will focus on the presence of conflict of interest or sponsorship policies and type of funding, such as sponsorship or payment for services. ETHICS AND DISSEMINATION: This study does not require ethical approval and will use data available in the public domain. The results will be disseminated through peer-reviewed journal articles, at conferences and among the healthcare professional associations.

Physician's perceptions regarding the pharmaceutical industry: a Brazilian national study.

OBJECTIVE: The objective of this study was to investigate the newly graduated physicians' attitudes and perceptions regarding the medical relationship with the pharmaceutical industry and identify the sociodemographic patterns related to such thinking. METHODS: A structured questionnaire was administered to 4,601 participants selected from a pool of 16,323 physicians who were registered with one of the 27 Regional Medical Councils of Brazil in 2015. Answers were analyzed using two stratification variables: type of medical school (public vs. private) and the sex of the respondents. RESULTS: Out of the participants, 61.8% believed that industry funding could support medical conferences and education, and 48.4% felt that small gifts and conference travel funding were acceptable. Conversely, 64.7% disagreed with industry-sponsored social events. Views on whether pharmaceutical representatives' visits influenced prescriptions were divided. Statistically significant differences were observed between genders and medical school types, with men and private school graduates being more accepting of certain industry interactions. CONCLUSION: The study highlights the nuanced attitudes of new doctors toward industry relationships, indicating the need for clearer ethical guidelines and education in medical schools to align practice with evolving societal values.

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.

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.

Hepatic Ablation Technology: Assessment of Conflicts of Interest in Recent Literature.

INTRODUCTION: Collaboration between the health care industry and surgeons is critical in modern medicine. Conflict of interest (COI) has the risk of introducing bias into research studies. We investigated the accuracy of self-disclosed COI for studies that researched the use of microwave ablation for liver metastasis. METHODS: A literature search identified studies that investigated the use of microwave ablation for liver cancer between 2016 and 2022. We utilized the Open Payments Database to query individual authors' financial contributions from the industry. The accuracy of the disclosure statement and financial contribution for each study and author was calculated. We compared the amount of financial contribution authors received based on the accuracy of their COI statement. RESULTS: Twenty-five studies of interest were identified. The mean number of authors was 8.24. A disclosure statement was present in 52% of studies. Of those, 28% had an incongruent disclosure statement. 9/25 (36%) of studies had a conflict of interest based on financial payments provided by industry. Overall, authors received an average of $440,483.41 (SD $1,889,375.34). We did not find a difference in the financial contribution's value based on the disclosure statement's accuracy (P = .55). CONCLUSIONS: Over a quarter of studies in our review of microwave ablation literature had discrepancies in the reporting of conflicts of interest, highlighting the need for improved reporting of potential conflicts of interest to protect the integrity of clinical research. Compared to other fields of surgery, we found a lower rate of undisclosed COI, suggesting that the scope of cancer-directed surgery may be more resistant to industry influence.

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.