Inside "Operation Change Agent": Mallinckrodt's Plan for Capturing the Opioid Market.

CONTEXT: The United States is deeply entangled in an opioid crisis that began with the overuse of prescription painkillers. At the height of the prescription opioid crisis (2006-2012), Mallinckrodt Pharmaceuticals was the largest opioid manufacturer. This study explores Mallinckrodt strategies to expand its market share by promoting a new opioid. METHODS: Using the Opioids Industry Document Archive, we analyzed the incentive structures, sales contests, and rhetorical strategy behind Mallinckrodt's "Operation Change Agent," a campaign to switch patients from OxyContin to Mallinckrodt-branded painkillers. A structured search of the archive in October 2022 retrieved 464 documents dated between 2010 and 2020. FINDINGS: We identified a range of sales force motivational techniques, including hypertargeting high-decile prescribers, the provision of free trial kits, using emotion-based language to connect with prescribers, and strategies to oppose prescriber resistance. Throughout, managers used specific incentivization metaphors to frame strategies through sport and ultramarathons. CONCLUSIONS: This research on internal corporate strategy adds to growing challenges to industry claims that opioid sales teams simply educated providers and helped fill existing demand for their products. Moreover, this research has important implications for regulatory policy and consumer protections that can better protect health in the face of competitive market forces.

Corporate Political Activity: Taxonomies and Model of Corporate Influence on Public Policy.

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.

Distilling the curriculum: An analysis of alcohol industry-funded school-based youth education programmes.

BACKGROUND AND AIM: For decades, corporations such as the tobacco and fossil fuel industries have used youth education programmes and schools to disseminate discourses, ideas and values favourable to their positions, and to pre-empt regulation that threatens profits. However, there is no systematic research into alcohol industry-funded youth education programmes. This article serves to address this important gap in the literature. METHODS: Using a discourse theoretical approach informed by poststructural discourse theory and critical discourse analysis, we analysed teaching materials from three school-based youth education initiatives which focus on alcohol consumption and health harms: Drinkaware for Education, The Smashed Project (funded by Diageo), and Talk About Alcohol (Alcohol Education Trust). These materials, some of which are disseminated internationally, are provided to schools through intermediary bodies in receipt of alcohol industry funding. FINDINGS: The analysis found that these materials drew from and presented discourses of personal responsibility, moderate alcohol consumption, and involved a narrowing of the problem definition and causes. The locus of the problem is located by the discourses within individuals including youth, with causes of youth alcohol consumption repeatedly presented as peer pressure and 'poor choices', with little or no mention of alcohol industry marketing or other practices. All programmes promoted familiarisation and normalisation of alcohol as a 'normal' adult consumer product which children must learn about and master how to use responsibly when older. The discourses constructed in these materials closely align with those of other alcohol industry corporate social responsibility discourses which employ selective presentation of harms, including misinformation about cancer, and ambiguous terms such as "responsible drinking". Furthermore, the role of alcohol price, availability and access, and the impacts of alcohol and the industry on inequities were not articulated within the discourses. The research was limited to an analysis of teaching materials and further research is needed to explore their impact on youth, teachers and wider discourses and social norms. CONCLUSION: Alcohol industry-sponsored youth education programmes serve industry interests and promote moderate consumption while purportedly educating children about harms and influences of alcohol use. There are considerable conflicts of interest in the delivery of alcohol education programmes funded by the alcohol industry and intermediary bodies in receipt of such funding. Alcohol education materials should be developed independent from industry, including funding, and should empower children and young people to understand and think critically about alcohol, including harms and drivers of consumption, and effective interventions needed to protect them and others from alcohol-related harms. Independent organisations can use this analysis to critique their materials to strengthen alignment with meeting student and public health interests. The ongoing exposure of children and young people to such conflicted and misleading materials needs urgent attention from policymakers, practitioners, teachers and parents, and resources dependent on industry support should cease being used in schools.

Framing tobacco control: the case of the Nigerian tobacco tax debates.

Studies have shown that the tobacco industry exerts significant policy-framing efforts to undermine tobacco control (TC) policies. However, most of this evidence is from high-income settings. This study applies framing analysis to the debate surrounding the 2016 tobacco import duty raise in Nigeria and subsequent rise in excise duty on tobacco, alcohol and selected food products in 2018 to understand why policy changes occurred. Print media documents and relevant actor publications published between 2016 and 2018 were analysed interpretively to identify key actors and arguments for and against the tax raise. Key opponents included tobacco companies, trade groups and allies. In contrast, the Ministries of Health and Finance, non-governmental organizations and international bodies like the World Health Organization advocated for the policy. The framing efforts of opponents were largely coordinated with significant alcohol industry involvement, while TC advocates lacked a unified front. Actors on both sides of the debate predominantly focused on economic and 'global ranking' arguments, and advocates also employed health and 'vulnerable groups' framing among others. The tax policy was sustained despite the framing and litigation efforts of opponents, and this is attributed principally to economic factors. The findings also suggest that tobacco is grouped with less harmful products, and advocates need to intensify efforts to diminish this legitimacy in low- and middle-income country settings. Additionally, there may be some benefits to jointly addressing alcohol and TC in this setting. Summarily, it is recommended that public health advocates coordinate their framing efforts to better articulate clear policy positions to the government, gain public support and ensure full Framework Convention on Tobacco Control compliance.

The case for developing a cohesive systems approach to research across unhealthy commodity industries.

OBJECTIVES: Most non-communicable diseases are preventable and largely driven by the consumption of harmful products, such as tobacco, alcohol, gambling and ultra-processed food and drink products, collectively termed unhealthy commodities. This paper explores the links between unhealthy commodity industries (UCIs), analyses the extent of alignment across their corporate political strategies, and proposes a cohesive systems approach to research across UCIs. METHODS: We held an expert consultation on analysing the involvement of UCIs in public health policy, conducted an analysis of business links across UCIs, and employed taxonomies of corporate political activity to collate, compare and illustrate strategies employed by the alcohol, ultra-processed food and drink products, tobacco and gambling industries. RESULTS: There are clear commonalities across UCIs' strategies in shaping evidence, employing narratives and framing techniques, constituency building and policy substitution. There is also consistent evidence of business links between UCIs, as well as complex relationships with government agencies, often allowing UCIs to engage in policy-making forums. This knowledge indicates that the role of all UCIs in public health policy would benefit from a common approach to analysis. This enables the development of a theoretical framework for understanding how UCIs influence the policy process. It highlights the need for a deeper and broader understanding of conflicts of interests and how to avoid them; and a broader conception of what constitutes strong evidence generated by a wider range of research types. CONCLUSION: UCIs employ shared strategies to shape public health policy, protecting business interests, and thereby contributing to the perpetuation of non-communicable diseases. A cohesive systems approach to research across UCIs is required to deepen shared understanding of this complex and interconnected area and also to inform a more effective and coherent response.

Transnational Tobacco Companies and New Nicotine Delivery Systems.

While the public health community has focused on the harm-reduction potential of new nicotine delivery systems (NNDSs) and, conversely, their potential for impeding overall efforts to prevent and reduce tobacco use, limited analysis has been conducted on the role of leading transnational tobacco companies (TTCs) in this rapidly growing market. Following aborted efforts during the 1980s and 1990s to develop reduced-risk products, TTCs have heavily invested in selected NNDS products since 2010 via acquisitions and internal research and development. This article catalogs and analyzes the patterns of investment in NNDSs by leading TTCs over time, and identifies differences in the companies' approaches to NNDS product acquisition and development in specific markets globally. This analysis raises important questions regarding the companies' intent, which appears to be to sustain, rather than replace, cigarette sales, and to increase their influence and credibility with respect to NNDS policy and regulation. We identify the need for greater public health vigilance and research to understand and respond to the increasingly significant role of NNDSs in TTCs' global business strategies, to ensure that NNDSs advance, rather than hinder, tobacco control efforts.

Mapping discourse coalitions in the minimum unit pricing for alcohol debate: a discourse network analysis of UK newspaper coverage.

BACKGROUND AND AIMS: Minimum unit pricing (MUP) for alcohol was introduced in Scotland on 1 May 2018, and is now on the policy agenda in other devolved administrations and at Westminster. Previous research has explored the arguments deployed for and against MUP, but the congruence between actors in the MUP debate has not been sufficiently examined. This study identified and mapped the discourse coalitions that emerged in the UK MUP debate through an analysis of actors' use of arguments in media coverage of the policy debates. DESIGN: A sample of print media coverage of MUP was obtained from the LexisNexis newspaper database. The resulting sample was imported into discourse network analysis (DNA) software for coding and subsequent visualization of actor networks. SETTING: United Kingdom. OBSERVATIONS: A total of 348 articles from eight UK-wide and three Scottish newspapers from an 18-month period, ending in November 2012, were analysed. MEASUREMENTS: Actors' arguments were coded to generate structured data for conversion into a weighted actor network where ties represent similarities among actors in terms of arguments in support of or opposition to MUP. FINDINGS: Two polarized discourse coalitions, Opponents and Proponents of MUP, emerged in media coverage. The Proponents coalition consisted mainly of health advocacy groups, charities, political parties and academic institutions. In the Opponents coalition, the networks were formed of key alcohol manufacturers and economic think-tanks. While producer organizations were central to the Opponents coalition, some commercial actors were more favourable to MUP, highlighting divisions within the industry overall. CONCLUSIONS: Media coverage of minimum unit pricing (MUP) in Scotland from June 2011 to November 2012 showed alignment between the policy positions of (1) alcohol producers and think-tanks opposed to MUP; and (2) public health advocates and health charities in favour of the policy. Some alcohol industry actors were supportive of MUP indicating divisions among the industry. Discourse network analysis may be usefully applied to study other highly contested policy issues in health and beyond.

Alcohol industry involvement in policymaking: a systematic review.

AIMS: To summarize the substantive findings of studies of alcohol industry involvement in national or supranational policymaking, and to produce a new synthesis of current evidence. METHODS: This study examined peer-reviewed journal reports published in the English language between 1980 and 2016 of studies of alcohol industry involvement in policymaking. Included studies were required to provide information on data collection and analysis and to have sought explicitly to investigate interventions by alcohol industry actors within the process of public policymaking. Eight electronic databases were searched on 27 February 2017. The methodological strengths and limitations of individual studies and the literature as a whole were examined. A thematic synthesis using an inductive approach to the generation of themes was guided by the research aims and objectives. RESULTS: Twenty reports drawn from 15 documentary and interview studies identify the pervasive influence of alcohol industry actors in policymaking. This evidence synthesis indicates that industry actors seek to influence policy in two principal ways by: (1) framing policy debates in a cogent and internally consistent manner, which excludes from policy agendas issues that are contrary to commercial interests; and (2) adopting short- and long-term approaches to managing threats to commercial interests within the policy arena by building relationships with key actors using a variety of different organizational forms. This review pools findings from existing studies on the range of observed impacts on national alcohol policy decision-making throughout the world. CONCLUSIONS: Alcohol industry actors are highly strategic, rhetorically sophisticated and well organized in influencing national policymaking.

Waterpipe product packaging and labelling at the 3rd international Hookah Fair; does it comply with Article 11 of the Framework Convention on Tobacco Control?

We assessed compliance of waterpipe product packaging and labelling with the Framework Convention on Tobacco Control's Article 11. We evaluated samples collected at a trade fair against ten domains: health warning location, size, use of pictorials, use of colour, and packaging information on constituents and emissions. We also evaluated waterpipe accessories (e.g., charcoal) for misleading claims. Ten of 15 tobacco products had health warnings on their principal display areas, covering a median of 22.4 per cent (interquartile range 19.4-27.4 per cent) of those areas. Three had pictorial, in-colour health warnings. We judged all packaging information on constituents and emissions to be misleading. Eight of 13 charcoal products displayed environmentally friendly descriptors and/or claims of reduced harm that we judged to be misleading. Increased compliance with waterpipe tobacco regulation is warranted. An improved policy framework for waterpipe tobacco should also consider regulation of accessories such as charcoal products.

Agenda setting and framing of gender-based violence in Nepal: how it became a health issue.

Gender-based violence (GBV) has been addressed as a policy issue in Nepal since the mid 1990s, yet it was only in 2010 that Nepal developed a legal and policy framework to combat GBV. This article draws on the concepts of agenda setting and framing to analyse the historical processes by which GBV became legitimized as a health policy issue in Nepal and explored factors that facilitated and constrained the opening and closing of windows of opportunity. The results presented are based on a document analysis of the policy and regulatory framework around GBV in Nepal. A content analysis was undertaken. Agenda setting for GBV policies in Nepal evolved over many years and was characterized by the interplay of political context factors, actors and multiple frames. The way the issue was depicted at different times and by different actors played a key role in the delay in bringing health onto the policy agenda. Women's groups and less powerful Ministries developed gender equity and development frames, but it was only when the more powerful human rights frame was promoted by the country's new Constitution and the Office of the Prime Minister that legislation on GBV was achieved and a domestic violence bill was adopted, followed by a National Plan of Action. This eventually enabled the health frame to converge around the development of implementation policies that incorporated health service responses. Our explicit incorporation of framing within the Kindgon model has illustrated how important it is for understanding the emergence of policy issues, and the subsequent debates about their resolution. The framing of a policy problem by certain policy actors, affects the development of each of the three policy streams, and may facilitate or constrain their convergence. The concept of framing therefore lends an additional depth of understanding to the Kindgon agenda setting model.

Gaining Insights Into the Waterpipe Tobacco Industry: Participant Observation and a Cross-Sectional Survey of Products at a Trade Exhibition.

INTRODUCTION: The rise in waterpipe tobacco smoking has been accompanied by the emergence of a diverse range of products, such as "herbal" waterpipe tobacco substitutes and electronic waterpipes. The aims of this study were to assess the extent to which emerging waterpipe products are being developed by waterpipe tobacco companies themselves, to understand the key characteristics of the main market players, and to examine the connections between producers of different product categories. METHODS: In 2014, one researcher attended an international waterpipe trade exhibition in Germany, conducting a survey of products at exhibition stands, and gathering qualitative data on exhibitors and products using participant observation. Cross-tabulations and chi-square tests identified the association between waterpipe tobacco, waterpipe tobacco substitutes, and electronic waterpipe products. We thematically analyzed field notes into information about exhibitors and products. RESULTS: Of 97 exhibitors, 55 displayed waterpipe-related products. Of these, nearly half (45%) displayed electronic waterpipe products, 38% displayed waterpipe tobacco and 23% displayed waterpipe tobacco substitutes. There was an inverse association between the display of waterpipe tobacco and electronic waterpipe products, and a positive association between the display of waterpipe tobacco and waterpipe tobacco substitutes. We found that Japan Tobacco Inc, Philip Morris, and British American Tobacco were partnered or affiliated with exhibitors displaying waterpipe-related products. CONCLUSIONS: Electronic waterpipe products were the main feature of this exhibition. Waterpipe tobacco substitutes are likely to be produced by the waterpipe tobacco industry whereas electronic waterpipes are not. There is a developing interest in waterpipe-related products by transnational tobacco corporations. Further industry surveillance is warranted.

Waterpipe industry products and marketing strategies: analysis of an industry trade exhibition.

INTRODUCTION: Understanding product development and marketing strategies of transnational tobacco companies (TTCs) has been of vital importance in developing an effective tobacco control policy. However, comparatively little is known of the waterpipe tobacco industry, which TTCs have recently entered. This study aimed to gain an understanding of waterpipe tobacco products and marketing strategies by visiting a waterpipe trade exhibition. METHODS: In April 2014, the first author attended an international waterpipe trade exhibition, recording descriptions of products and collecting all available marketing items. We described the purpose and function of all products, and performed a thematic analysis of messages in marketing material. RESULTS: We classified waterpipe products into four categories and noted product variation within categories. Electronic waterpipe products (which mimic electronic cigarettes) rarely appeared on waterpipe tobacco marketing material, but were displayed just as widely. Claims of reduced harm, safety and quality were paramount on marketing materials, regardless of whether they were promoting consumption products (tobacco, tobacco substitutes), electronic waterpipes or accessories. CONCLUSIONS: Waterpipe products are diverse in nature and are marketed as healthy and safe products. Furthermore, the development of electronic waterpipe products appears to be closely connected with the electronic cigarette industry, rather than the waterpipe tobacco manufacturers. Tobacco control policy must evolve to take account of the vast and expanding array of waterpipe products, and potentially also charcoal products developed for waterpipe smokers. We recommend that tobacco substitutes be classified as tobacco products. Continued surveillance of the waterpipe industry is warranted.

Be aware of Drinkaware.

In 2006, Drinkaware was established as a charity in the United Kingdom following a memorandum of understanding between the Portman Group and various UK government agencies. This debate piece briefly reviews the international literature on industry social aspects organizations, examines the nature of Drinkaware's activities and considers how the public health community should respond. Although the British addiction field and the wider public health community have distanced themselves from the Portman Group, they have not done so from Drinkaware, even though Drinkaware was devised by the Portman Group to serve industry interests. Both long-standing and more recent developments indicate very high levels of industry influence on British alcohol policy, and Drinkaware provides one mechanism of influence. We suggest that working with, and for, industry bodies such as Drinkaware helps disguise fundamental conflicts of interest and serves only to legitimize corporate efforts to promote partnership as a means of averting evidence-based alcohol policies. We invite vigorous debate on these internationally significant issues and propose that similar industry bodies should be carefully studied in other countries.

Industry use of evidence to influence alcohol policy: a case study of submissions to the 2008 Scottish government consultation.

Jim McCambridge and colleagues analyze industry submissions to a Scottish Government consultation on whole-population approaches to alcohol policy.