Interactions between Australian cancer physicians and the pharmaceutical industry: a qualitative study.

OBJECTIVES: To understand how and why Australian cancer physicians interact with the pharmaceutical industry. DESIGN: Qualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes. SETTING: Given the evidence on industry influences on clinical practice and the importance to the market of oncology drugs, we sought to better understand cancer physicians' experiences. Practising consultant medical oncologists and clinical haematologists from four Australian states were interviewed over Zoom. PARTICIPANTS: 16 cancer physicians were interviewed between November 2021 and March 2022, from 37 invited (response rate 43%). Most were medical oncologists (n=12 of 16, 75%) and male (n=9 of 16, 56%). OUTCOME MEASURES: The analysis of all interviews was based on grounded theory. Transcripts were coded and then codes formed into themes with supporting quotes. The themes were then placed into categories, used to describe the broad areas into which the themes could be grouped. RESULTS: Six themes were identified that fell within two broad categories: cancer physicians' views and experiences of interactions and management of these interactions. Views and experiences included: the transactional nature of relationships, risks of research dependence, ethical challenges and varied attitudes based on interaction type. Management themes included: lack of useful guidance and reduced interactions during the COVID-19 pandemic. These led to an overarching seventh theme, on the desire for a 'middle road'. Cancer physicians identified the transactional nature of industry relationships and felt uncomfortable with several types of interactions, including those with sales representatives. Most wanted less contact with industry, and the forced separation that occurred with the COVID-19 pandemic was generally welcome. CONCLUSIONS: Cancer physicians may have difficulty balancing the perceived need to interact with industry in modern cancer care while maintaining distance to minimise conflicts of interest. Further research is needed to assess management strategies in this area.

Industry Payments to Radiologists During the Last 5 Years and Impact of COVID-19 Pandemic.

OBJECTIVE: The aim of this study is to assess the trends in industry payments to radiologists and the impact of the COVID-19 pandemic, including trends in different categories of payments. METHODS: The Open Payments Database from CMS was accessed and analyzed for the period from January 1, 2016, to December 31, 2021. Payments were grouped into six categories: consulting fees, education, gifts, research, speaker fees, and royalties or ownership. The total number, value, and types of industry payments to radiologists were subsequently determined and compared pre- and postpandemic from 2016 to 2021. RESULTS: The total number of industry payments and the number of radiologists receiving these payments dropped by 50% and 32%, respectively, between 2019 and 2020, with only partial recovery in 2021. However, the mean payment value and total payment value increased by 177% and 37%, respectively, between 2019 and 2020. Gifts and speaker fees experienced the largest decreases between 2019 and 2020 (54% and 63%, respectively). Research and education grants were also disrupted, with the number of payments decreasing by 37% and 36% and payment value decreasing by 37% and 25%, respectively. However, royalty or ownership increased during the first year of the pandemic (8% for number of payments and 345% for value of payments). CONCLUSIONS: There was significant decline in overall industry payments coinciding with the COVID-19 pandemic, with biggest declines in gifts and speaker fees. The impact on the different categories of payments and recovery in the last 2 years has been heterogeneous.

Cannabis companies and the sponsorship of scientific research: A cross-sectional Canadian case study.

Corporations across sectors engage in the conduct, sponsorship, and dissemination of scientific research. Industry sponsorship of research, however, is associated with research agendas, outcomes, and conclusions that are favourable to the sponsor. The legalization of cannabis in Canada provides a useful case study to understand the nature and extent of the nascent cannabis industry's involvement in the production of scientific evidence as well as broader impacts on equity-oriented research agendas. We conducted a cross-sectional, descriptive, meta-research study to describe the characteristics of research that reports funding from, or author conflicts of interest with, Canadian cannabis companies. From May to August 2021, we sampled licensed, prominent Canadian cannabis companies, identified their subsidiaries, and searched each company name in the PubMed conflict of interest statement search interface. Authors of included articles disclosed research support from, or conflicts of interest with, Canadian cannabis companies. We included 156 articles: 82% included at least one author with a conflict of interest and 1/3 reported study support from a Canadian cannabis company. More than half of the sampled articles were not cannabis focused, however, a cannabis company was listed amongst other biomedical companies in the author disclosure statement. For articles with a cannabis focus, prevalent topics included cannabis as a treatment for a range of conditions (15/72, 21%), particularly chronic pain (6/72, 8%); as a tool in harm reduction related to other substance use (10/72, 14%); product safety (10/72, 14%); and preclinical animal studies (6/72, 8%). Demographics were underreported in empirical studies with human participants, but most included adults (76/84, 90%) and, where reported, predominantly white (32/39, 82%) and male (49/83, 59%) participants. The cannabis company-funded studies included people who used drugs (37%) and people prescribed medical cannabis (22%). Canadian cannabis companies may be analogous to peer industries such as pharmaceuticals, alcohol, tobacco, and food in the following three ways: sponsoring research related to product development, expanding indications of use, and supporting key opinion leaders. Given the recent legalization of cannabis in Canada, there is ample opportunity to create a policy climate that can mitigate the harms of criminalization as well as impacts of the "funding effect" on research integrity, research agendas, and the evidence base available for decision-making, while promoting high-priority and equity-oriented independent research.

The new Italian National Immunization Technical Advisory Group (NITAG) and its commitment to endorse a new efficient National Immunization Plan in COVID-19 times.

Among the objectives of the WHO Global Vaccination Action Plan 2020-2025, there is the establishment, in all countries, of a National Immunization Technical Advisory Group (NITAG), an independent body with the aim of supporting and harmonising vaccination policies. Italy firstly established a NITAG in 2017; it contributed to the nation's immunization policies but fell short of its goal of becoming a true reference group. The newly appointed NITAG, made up of 28 independent experts, has the ambitious goal to promote the new National Immunization Prevention Plan (PNPV), to harmonise the current vaccination schedule with the anti-COVID-19 campaign, and to recover the vaccination coverage decline that occurred during the pandemic. The contact with the ECDC EU/EEA, the WHO Global NITAG networks, and all the national stakeholders needs to be reinforced in order to accomplish these aims. This paper describes the structure, organisation, and strategy of the new Italian NITAG.

Observational study of financial and non-financial conflicts of interest among the Japanese government advisory board members concerning coronavirus disease 2019.

This cross-sectional analysis aimed to assess the extent of conflicts of interest among the Japanese government coronavirus disease 2019 (COVID-19) advisory board members and elucidate the accuracy of conflicts of interest (COI) disclosure and management strategies. Using the payment data from all 79 pharmaceutical companies in Japan between 2017 and 2019 and direct research grants from the Japanese government between 2019 and 2020, we evaluated the extent of financial and non-financial COI among all 20 Japanese government COVID-19 advisory board members. The Ethic Committee of the Medical Governance Research Institute approved this study. Japanese government COVID-19 advisory board members were predominantly male (75.0%) and physicians (50.0%). Between 2019 and 2020, 2 members (10.0%) received a total of $819,244 in government research funding. Another 5 members (25.0%) received $532,127 in payments, including $276,722 in personal fees, from 31 pharmaceutical companies between 2017 and 2019. The average value of the pharmaceutical payments was $9155 (standard deviation: $12,975). Furthermore, neither the Ministry of Health, Labor, and Welfare nor the Japanese Cabinet Secretariat disclosed financial or non-financial COI with industry. Additionally, the government had no policies for managing COI among advisory board members. This study found that the Japanese government COVID-19 advisory board had financial and non-financial COI with pharmaceutical companies and the government. Furthermore, personal communication received as part of this research indicated that there were no rigorous COI management strategies for the COVID-19 advisory board members. Any government must ensure the independence of scientific advisory boards by implementing more rigorous and transparent management strategies that require the declaration and public disclosure of all COI.

A meta-epidemiological assessment of transparency indicators of infectious disease models.

Mathematical models have become very influential, especially during the COVID-19 pandemic. Data and code sharing are indispensable for reproducing them, protocol registration may be useful sometimes, and declarations of conflicts of interest (COIs) and of funding are quintessential for transparency. Here, we evaluated these features in publications of infectious disease-related models and assessed whether there were differences before and during the COVID-19 pandemic and for COVID-19 models versus models for other diseases. We analysed all PubMed Central open access publications of infectious disease models published in 2019 and 2021 using previously validated text mining algorithms of transparency indicators. We evaluated 1338 articles: 216 from 2019 and 1122 from 2021 (of which 818 were on COVID-19); almost a six-fold increase in publications within the field. 511 (39.2%) were compartmental models, 337 (25.2%) were time series, 279 (20.9%) were spatiotemporal, 186 (13.9%) were agent-based and 25 (1.9%) contained multiple model types. 288 (21.5%) articles shared code, 332 (24.8%) shared data, 6 (0.4%) were registered, and 1197 (89.5%) and 1109 (82.9%) contained COI and funding statements, respectively. There was no major changes in transparency indicators between 2019 and 2021. COVID-19 articles were less likely to have funding statements and more likely to share code. Further validation was performed by manual assessment of 10% of the articles identified by text mining as fulfilling transparency indicators and of 10% of the articles lacking them. Correcting estimates for validation performance, 26.0% of papers shared code and 41.1% shared data. On manual assessment, 5/6 articles identified as registered had indeed been registered. Of articles containing COI and funding statements, 95.8% disclosed no conflict and 11.7% reported no funding. Transparency in infectious disease modelling is relatively low, especially for data and code sharing. This is concerning, considering the nature of this research and the heightened influence it has acquired.

Trend in industry payments to infectious disease physicians in the United States: a seven-year analysis of nonresearch payments from the Open Payments Database between 2014 and 2020.

OBJECTIVE: To evaluate the trend in nonresearch payments made by the industries to the infectious disease physicians in the United States since the launch of the Open Payments Database and during the COVID-19 pandemic. METHODS: Descriptive analysis was performed for the nonresearch payments made to all infectious disease physicians listed in the Open Payments Database between 2014 and 2020. Using the generalized estimating equation models with panel data of monthly and yearly payment per physician, the payment trend since the inception of the Open Payments Database and during the early stage of the COVID-19 pandemic were evaluated. RESULTS: A total of 7901 (81.5%) infectious disease physicians received $156 837 987 in nonresearch payments between 2014 and 2020. Median annual payments were $197 to $220. Monthly nonresearch per-physician payments and number of physicians with payments rapidly decreased by 58.6% (95% CI: 49.7%‒65.9%, p < 0.001) and by 54.4% (95% CI: 52.7%‒56.1%, p < 0.001) at the beginning of the COVID-19 pandemic, respectively. However, the per-physician payments and number of physicians with payments slightly increased every month right after onset of the pandemic. Both per-physician payments and the number of physicians with payments decreased by 2.6% (95% CI: 0.45‒4.7, p 0.018) and 2.0% (95% CI: 1.6%‒2.4%, p < 0.001) since the inception of the Open Payments Database, respectively. DISCUSSION: The nonresearch payments and number of infectious disease physicians accepting payments had decreased since the inception of the Open Payments Database. Furthermore, the non-research payments to infectious disease physicians suddenly decreased by more than half due to the COVID-19 pandemic.

Reporting of funding and conflicts of interest improved from preprints to peer-reviewed publications of biomedical research.

BACKGROUND AND OBJECTIVES: To assess changes in the reporting of funding and conflicts of interest (COI) in biomedical research between preprint server publications and their corresponding versions in peer-reviewed journals. METHODS: We selected preprint servers publishing exclusively biomedical research. From these, we screened articles by order of publication date and identified 200 preprints first published in 2020 with subsequent versions in peer-reviewed journals. We judged eligibility and extracted data about authorship, funding, and COI in duplicate and independently. We performed descriptive statistics. RESULTS: A quarter of the studies added at least one author to the peer-reviewed version. Most studies reported funding in both versions (87%), and a quarter of these added at least one funder to the peer-reviewed version. Eighteen studies (9%) reported funding only in the peer-reviewed version. A majority of studies reported COI in both versions (69%) and 5% of these had authors reporting more COI in the peer-reviewed version. A minority of studies (23%) reported COI only in the peer-reviewed version. None of the studies justified any changes in authorship, funding, or COI. CONCLUSION: Reporting of funding and COI improved in peer-reviewed versions. However, substantive percentages of studies added authors, funders, and COI disclosures in their peer-reviewed versions.

COVID-19 Vaccine Task Force and Conflicts of Interest.

Early in the COVID-19 pandemic, the federal government established a COVID-19 Vaccine Task Force to provide it with recommendations on a wide variety of issues related to vaccines. This article explores how the conflicts of interest of the Task Force members are declared and managed and what the implications are for the advice that they offer to the government. The Canadian government needs to go beyond just managing conflicts and work toward eliminating them on the Task Force.

Commentary - From Transparency to Accountability: Finding Ways to Make Expert Advice Trustworthy.

Declining public trust in government and expert advice is a public health priority, given its impact on vaccination uptake, adherence to guidelines and social cohesion. In the context of the COVID-19 Vaccine Task Force, conflicts of interest that can threaten public trust are handled primarily through disclosures. However, this places the onus on the public to discern the relevance, severity and impact of these conflicts and does little to address whose interests guide decision making. Alternatively, expert advisory committees should adopt more trustworthy strategies, including promoting independence from commercial and political interests.

Intraorganization conflicts of interest in hospitals adapting to a changing ecosystem.

PURPOSE: Health systems function in an ecosystem that is turbulent and competitive because of demographic, economic, political, technological and lifestyle changes and sociopolitical influences, requiring hospitals to adopt comprehensive business strategies. Failure to do so may result in duplication, waste and deficits. This original article uses the prism of agency theory to examine differences in approach at two levels of hospital management and the consequent problems in the incorporation of necessary changes. Agency theory posits an inherent conflict of interest in organizations, including health organizations: the managers (agents) always aim to maximize their profit or personal interest instead of that of the owner or organization (principal), potentially causing difficulty in managing the organization. The aim is to generate recommendations for policymakers. DESIGN/METHODOLOGY/APPROACH: The study is based on 30 semi-structured, in-depth interviews with key figures in the health system and on two levels of hospital management: senior managers and heads of selected departments. The analysis used a categorical qualitative methodology. FINDINGS: The main findings are five key themes: views of business behavior, asymmetry of interests, asymmetry of information, transparency and cooperation between various levels of management and ambivalence toward business in hospitals. The two levels of management are clearly divided in terms of interests, information and activity, leading to difficulty in cooperation, efficiency and achievement of organizational goals. ORIGINALITY/VALUE: Using agency theory, this study provides a systemic and organizational view of hospitals' management and environmental adaptation. Understanding the processes and increasing cooperation at various managerial levels can help make the system more efficient and ensure its survival in a dynamic market.

Toolkit for detecting misused epidemiological methods.

BACKGROUND: Critical knowledge of what we know about health and disease, risk factors, causation, prevention, and treatment, derives from epidemiology. Unfortunately, its methods and language can be misused and improperly applied. A repertoire of methods, techniques, arguments, and tactics are used by some people to manipulate science, usually in the service of powerful interests, and particularly those with a financial stake related to toxic agents. Such interests work to foment uncertainty, cast doubt, and mislead decision makers by seeding confusion about cause-and-effect relating to population health. We have compiled a toolkit of the methods used by those whose interests are not aligned with the public health sciences. Professional epidemiologists, as well as those who rely on their work, will thereby be more readily equipped to detect bias and flaws resulting from financial conflict-of-interest, improper study design, data collection, analysis, or interpretation, bringing greater clarity-not only to the advancement of knowledge, but, more immediately, to policy debates. METHODS: The summary of techniques used to manipulate epidemiological findings, compiled as part of the 2020 Position Statement of the International Network for Epidemiology in Policy (INEP) entitled Conflict-of-Interest and Disclosure in Epidemiology, has been expanded and further elucidated in this commentary. RESULTS: Some level of uncertainty is inherent in science. However, corrupted and incomplete literature contributes to confuse, foment further uncertainty, and cast doubt about the evidence under consideration. Confusion delays scientific advancement and leads to the inability of policymakers to make changes that, if enacted, would-supported by the body of valid evidence-protect, maintain, and improve public health. An accessible toolkit is provided that brings attention to the misuse of the methods of epidemiology. Its usefulness is as a compendium of what those trained in epidemiology, as well as those reviewing epidemiological studies, should identify methodologically when assessing the transparency and validity of any epidemiological inquiry, evaluation, or argument. The problems resulting from financial conflicting interests and the misuse of scientific methods, in conjunction with the strategies that can be used to safeguard public health against them, apply not only to epidemiologists, but also to other public health professionals. CONCLUSIONS: This novel toolkit is for use in protecting the public. It is provided to assist public health professionals as gatekeepers of their respective specialty and subspecialty disciplines whose mission includes protecting, maintaining, and improving the public's health. It is intended to serve our roles as educators, reviewers, and researchers.

The Development of Living, Rapid Practice Points: Summary of Methods From the Scientific Medical Policy Committee of the American College of Physicians.

In response to the COVID-19 pandemic, the Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) began developing "practice points" to provide clinical advice based on the best available evidence for the public, patients, clinicians, and public health professionals. As one of the first organizations in the United States to develop evidence-based clinical guidelines, ACP continues to lead and advance the science of evidence-based medicine by implementing new methods to rapidly publish practice points and maintain them as living advice that regularly assesses and incorporates new evidence. The overarching aim of practice points is to answer targeted key questions for which there is a timely need to synthesize evidence for decision making. The SMPC believes these methods can potentially be adapted to address various clinical and public health topics beyond the COVID-19 pandemic. This article presents an overview of the SMPC's living, rapid practice points development process, which includes a rapid systematic review, use of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method, use of stringent policies on the disclosure of interests and management of conflicts of interest, incorporating a public (nonclinician) perspective, and maintenance of the documents as living through ongoing surveillance and synthesis of new evidence as it emerges.