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Background: Non-communicable diseases (NCDs) kill 41 million people a year. The products and services of unhealthy commodity industries (UCIs) such as tobacco, alcohol, ultra-processed foods and beverages and gambling are responsible for much of this health burden. While effective public health policies are available to address this, UCIs have consistently sought to stop governments and global organisations adopting such policies through what is known as corporate political activity (CPA). We aimed to contribute to the study of CPA and development of effective counter-measures by formulating a model and evidence-informed taxonomies of UCI political activity. Methods: We used five complementary methods: critical interpretive synthesis of the conceptual CPA literature; brief interviews; expert co-author knowledge; stakeholder workshops; testing against the literature. Results: We found 11 original conceptualisations of CPA; four had been used by other researchers and reported in 24 additional review papers. Combining an interpretive synthesis of all these papers and feedback from users, we developed two taxonomies – one on framing strategies and one on action strategies. The former identified three frames (policy actors, problem, and solutions) and the latter six strategies (access and influence policy-making, use the law, manufacture support for industry, shape evidence to manufacture doubt, displace, and usurp public health, manage reputations to industry’s advantage). We also offer an analysis of the strengths and weaknesses of UCI strategies and a model that situates industry CPA in the wider social, political, and economic context. Conclusion: Our work confirms the similarity of CPA across UCIs and demonstrates its extensive and multi-faceted nature, the disproportionate power of corporations in policy spaces and the unacceptable conflicts of interest that characterise their engagement with policy-making. We suggest that industry CPA is recognised as a corruption of democracy, not an element of participatory democracy. Our taxonomies and model provide a starting point for developing effective solutions.

Background Systematic reviews, which assess the risk of bias in included studies, are increasingly used to develop environmental hazard assessments and public health guidelines. These research areas typically rely on evidence from human observational studies of exposures, yet there are currently no universally accepted standards for assessing risk of bias in such studies. The risk of bias in non-randomised studies of exposures (ROBINS-E) tool has been developed by building upon tools for risk of bias assessment of randomised trials, diagnostic test accuracy studies and observational studies of interventions. This paper reports our experience with the application of the ROBINS-E tool. Methods We applied ROBINS-E to 74 exposure studies (60 cohort studies, 14 case-control studies) in 3 areas: environmental risk, dietary exposure and drug harm. All investigators provided written feedback, and we documented verbal discussion of the tool. We inductively and iteratively classified the feedback into 7 themes based on commonalities and differences until all the feedback was accounted for in the themes. We present a description of each theme. Results We identified practical concerns with the premise that ROBINS-E is a structured comparison of the observational study being rated to the ‘ideal’ randomised controlled trial. ROBINS-E assesses 7 domains of bias, but relevant questions related to some critical sources of bias, such as exposure and funding source, are not assessed. ROBINS-E fails to discriminate between studies with a single risk of bias or multiple risks of bias. ROBINS-E is severely limited at determining whether confounders will bias study outcomes. The construct of co-exposures was difficult to distinguish from confounders. Applying ROBINS-E was time-consuming and confusing. Conclusions Our experience suggests that the ROBINS-E tool does not meet the need for an international standard for evaluating human observational studies for questions of harm relevant to public and environmental health. We propose that a simpler tool, based on empirical evidence of bias, would provide accurate measures of risk of bias and is more likely to meet the needs of the environmental and public health community.

Context Participatory systems mapping is increasingly used to gain insight into the complex systems surrounding non-communicable diseases (NCDs) and their risk factors. Objectives To identify and synthesize studies that used participatory systems mapping in the context of non-communicable diseases. Design Scoping review. Eligibility criteria Peer-reviewed studies published between 2000 and 2022. Study selection Studies that focused on NCDs and/or related risk factors, and included participants at any stage of their system’s mapping process, were included. Categories for analysis The main categories for analysis were: (1) problem definition and goal-setting, (2) participant involvement, (3) structure of the mapping process, (4) validation of the systems map, and (5) evaluation of the mapping process. Results We identified 57 studies that used participatory systems mapping for a variety of purposes, including to inform or evaluate policies or interventions and to identify potential leverage points within a system. The number of participants ranged from 6 to 590. While policymakers and professionals were the stakeholder groups most often included, some studies described significant added value from including marginalized communities. There was a general lack of formal evaluation in most studies. However, reported benefits related mostly to individual and group learning, whereas limitations described included a lack of concrete actions following from systems mapping exercises. Conclusions Based on the findings of this review, we argue that research using participatory systems mapping would benefit from considering three different but intertwined actions: explicitly considering how different participants and the power imbalances between them may influence the participatory process, considering how the results from a systems mapping exercise may effectively inform policy or translate into action, and including and reporting on evaluation and outcomes of the process, wherever possible.

Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we collected information from each disclosure policy/code on: target industries, categories of healthcare professionals covered, scope of payments included, location and searchability of the disclosed data. Our analysis shows that although important improvements have been put in place in the past few years, significant gaps remain in disclosure requirements and their implementation. The situation differs substantially from country to country and the most striking differences are between governmental and self-regulatory approaches, especially with regard to the comprehensiveness of the disclosed data. In many cases, individuals can still opt out and reporting is incomplete, with common influential gifts such as food and drink excluded. Finally, in several countries data are only available as separate PDFs from companies, thus making the payment reports difficult to access and analyse. In order to overcome these gaps, minimum standards for disclosures should be implemented across Europe. All payments to healthcare professionals and organizations should be included, all health-related industries should be required to submit reports, and usability of disclosed data should be guaranteed.

Background: This systematic review aims to estimate the proportion of medical schools and teaching hospitals with conflicts of interest (COI) policies for health research and education, to describe the provisions included in the policies and their impact on research outputs and educational quality or content. Methods: Experimental and observational studies reporting at least one of the above mentioned aims were included irrespective of language, publication type or geographical setting. MEDLINE, Scopus, Embase and the Cochrane Methodology Register were searched from inception to March 2020. Methodological study quality was assessed using an amended version of the Joanna Briggs Institute’s checklist for prevalence studies. Results: Twenty-two cross-sectional studies were included; all were conducted in high-income countries. Of these, 20 studies estimated the prevalence of COI policies, which ranged from 5% to 100% (median: 85%). Twenty studies assessed the provisions included in COI policies with different assessment methods. Of these, nine analysed the strength of the content of medical schools’ COI policies using various assessment tools that looked at a range of policy domains. The mean standardised summary score of policy strength ranged from 2% to 73% (median: 30%), with a low score indicating a weak policy. North American institutions more frequently had COI policies and their content was rated as stronger than policies from European institutions. None of the included studies assessed the impact of COI policies on research outputs or educational quality or content. Conclusion: Prevalence of COI policies at medical schools and teaching hospitals varied greatly in high-income countries. No studies estimated the prevalence of policies in low to middle-income countries. The content of COI policies varied widely and while most European institutions ranked poorly, in North America more medical schools had strong policies. No studies were identified on impact of COI policies on research outputs and educational quality or content.

ObjectivesTo study how patient groups that accept pharmaceutical industry money perceive and manage the risk of undue influence from their sponsors.DesignEmpirical ethics approach using a qualitative interview study.SettingThe Australian patient group sector.Participants27 participants from 23 patient groups, purposively recruited for diversity of group characteristics (degree of pharmaceutical industry funding, health focus, location) and participant role (staff, board members).AnalysisInterview data were transcribed and read repeatedly to identify concepts and patterns in the data. These were grouped into conceptual categories that described and explained the findings. We used an inductive analytical approach to identify important themes and concepts in the data.ResultsParticipants in this study described how the patient group sector receives pressure from pharmaceutical company funders to act in ways that prioritise company interests. Groups worked to try and protect their credibility and ability to act in ways of their own choosing using practical rules or ‘lines in the sand’ about industry funding activities. They were grouped around the dominant topics of: sponsor exclusivity, brand marketing, agenda setting, advocacy and content of group activities. Lines in the sand were largely experience-driven and ethically informed; they varied between groups. There was also variable transparency among groups about financial interactions with pharmaceutical companies.ConclusionsIt is important to know about patient group practices around pharmaceutical industry funders as this allows public scrutiny about the adequacy of such practices. Inadequate strategies may mean that funders can influence patient groups activities in ways that do not necessarily prioritise the interests of members. We found that groups differed in their approach, with little independent external guidance to inform responses to commonly encountered types of influence. Inadequate transparency limits the ability of the public to make informed assessments about the risk of bias over the activities of groups that accept industry funding.

ObjectivesTo evaluate workshops delivered to citizen health advocates about financial conflicts of interest in healthcare, transparency databases which disclose industry payments in the USA and Australia and the pros and cons of advocacy groups accepting industry sponsorship.DesignThematic analysis of workshop participant recorded discussions, and pre, post and 3-month follow-up questionnaires on confidence and knowledge about financial conflicts of interest, transparency databases and the merits of advocacy organisations accepting industry sponsorship.Participants and setting48 citizen health advocates participated in a half-day workshop, held in four Australian cities, which ended with a 1-hour recorded discussion. Participants were recruited with assistance from leading state-based health advocacy organisations.ResultsThe thematic analysis of the recorded discussions revealed two major themes, (i) transparency and (ii) relationships with industry; and three minor themes: a lack of awareness about conflicts of interest and transparency, issues relating to trust and next steps in terms of potential reforms. In relation to transparency, participants felt strong support for transparency, strongly favouring the mandatory, extensive and accessible US Open Payments over the self-regulatory Australian model. Participants also noted that transparency had limitations, including the utility of disclosed information. In relation to industry sponsorship of advocacy groups, some participants expressed an openness to and support for accepting sponsorship, while many expressed a caution around potential downsides. Questionnaire results showed increases in both confidence and knowledge after the workshop, though only 23 of 48 participants returned the 3-month follow-up questionnaire.ConclusionsFollowing a half-day workshop, citizen health advocates recruited by leading health advocacy organisations expressed strong support for tough transparency rules, and mixed feelings about advocacy groups accepting sponsorship from industry. Study limitations include a non-representative sample and a large drop-out at the 3-month post-workshop follow-up.

Background Concerns around staffs’ and students’ interactions with commercial entities, for example drug companies, have led several North American medical schools to implement conflict of interest (COI) policies. However, little is known about COI policies at European medical schools. We analysed the content and strength of COI policies at Scandinavian medical schools. Methods We searched the websites of medical schools in Denmark, Norway, and Sweden and emailed the Deans for additional information. Using comparable methodology to previous studies, the strength of the COI policies was rated on a scale from 0 to 2 across 11 items (higher score more restrictive); we also assessed the presence of oversight mechanisms and sanctions. Results We identified 77 unique policies for 15 medical schools (range 2–8 per school). Most of the policies ( n  = 72; 94%) were University wide and only five (6%) were specific for the medical schools. For six of eleven items one or more schools had a restrictive policy (score of two). None of the schools had a restrictive policy for the five additional items (speaking relationships, sales representatives, on-site education activities, medical school curriculum, and drug samples). Honoraria was the item with the highest score, with eight of the 15 schools having a score of two. Thirteen of the 15 schools had policies that identified a party responsible for policy oversight and mentioned sanctions for non-compliance. Conclusion Our study provides the first evaluation of all Scandinavian medical schools’ COI policies. We found that the content of COI policies varies widely and still has shortcomings. We encourage Scandinavian medical schools to develop more stringent COI policies to regulate industry interactions with both faculty and students.

Industry influence still threatens the integrity of healthcare and harms patients