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1.  Global Health Governance and the Commercial Sector: A Documentary Analysis of Tobacco Company Strategies to Influence the WHO Framework Convention on Tobacco Control 
PLoS Medicine  2012;9(6):e1001249.
Heide Weishaar and colleagues did an analysis of internal tobacco industry documents together with other data and describe the industry's strategic response to the proposed World Health Organization Framework Convention on Tobacco Control.
Background
In successfully negotiating the Framework Convention on Tobacco Control (FCTC), the World Health Organization (WHO) has led a significant innovation in global health governance, helping to transform international tobacco control. This article provides the first comprehensive review of the diverse campaign initiated by transnational tobacco corporations (TTCs) to try to undermine the proposed convention.
Methods and Findings
The article is primarily based on an analysis of internal tobacco industry documents made public through litigation, triangulated with data from official documentation relating to the FCTC process and websites of relevant organisations. It is also informed by a comprehensive review of previous studies concerning tobacco industry efforts to influence the FCTC. The findings demonstrate that the industry's strategic response to the proposed WHO convention was two-fold. First, arguments and frames were developed to challenge the FCTC, including: claiming there would be damaging economic consequences; depicting tobacco control as an agenda promoted by high-income countries; alleging the treaty conflicted with trade agreements, “good governance,” and national sovereignty; questioning WHO's mandate; claiming the FCTC would set a precedent for issues beyond tobacco; and presenting corporate social responsibility (CSR) as an alternative. Second, multiple tactics were employed to promote and increase the impact of these arguments, including: directly targeting FCTC delegations and relevant political actors, enlisting diverse allies (e.g., mass media outlets and scientists), and using stakeholder consultation to delay decisions and secure industry participation.
Conclusions
TTCs' efforts to undermine the FCTC were comprehensive, demonstrating the global application of tactics that TTCs have previously been found to have employed nationally and further included arguments against the FCTC as a key initiative in global health governance. Awareness of these strategies can help guard against industry efforts to disrupt the implementation of the FCTC and support the development of future, comparable initiatives in global health.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die worldwide from tobacco-related causes and, if current trends continue, annual deaths from tobacco-related causes will increase to 10 million by 2030. In response to this global tobacco epidemic, the World Health Organization (WHO) has developed an international instrument for tobacco control called the Framework Convention on Tobacco Control (FCTC). Negotiations on the FCTC began in 1999, and the international treaty—the first to be negotiated under the auspices of WHO—entered into force on 27 February 2005. To date, 174 countries have become parties to the FCTC. As such, they agree to implement comprehensive bans on tobacco advertising, promotion, and sponsorship; to ban misleading and deceptive terms on cigarette packaging; to implement health warnings on tobacco packaging; to protect people from tobacco smoke exposure in public spaces and indoor workplaces; to implement taxation policies aimed at reducing tobacco consumption; and to combat illicit trade in tobacco products.
Why Was This Study Done?
Transnational tobacco corporations (TTCs) are sometimes described as “vectors” of the global tobacco epidemic because of their drive to maximize shareholder value and tobacco consumption. Just like conventional disease vectors (agents that carry or transmit infectious organisms), TTCs employ a variety of tactics to ensure the spread of tobacco consumption. For example, various studies have shown that TTCs have developed strategies that attempt to limit the impact of tobacco control measures such as the FCTC. However, to date, studies investigating the influence of TTCs on the FCTC have concentrated on specific countries or documented specific tactics. Here, the researchers undertake a comprehensive review of the diverse tactics employed by TTCs to undermine the development of the FCTC. Such a review is important because its results should facilitate the effective implementation of FCTC measures and could support the development of future tobacco control initiatives and of global initiatives designed to control alcohol-related and food-related disease and death.
What Did the Researchers Do and Find?
The researchers analyzed documents retrieved from the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) dealing with the strategies employed by TTCs to influence the FCTC alongside data from the websites of industry, consultancy, and other organizations cited in the documents; the official records of the FCTC process; and previous studies of tobacco industry efforts to influence the FCTC. Their analysis reveals that the strategic response of the major TTCs to the proposed FCTC was two-fold. First, the TTCs developed a series of arguments and “frames” (beliefs and ideas that provide a framework for thinking about an issue) to challenge the FCTC. Core frames included claiming that the FCTC would have damaging economic consequences, questioning WHO's mandate to develop a legally binding international treaty by claiming that tobacco was not a cross-border problem, and presenting corporate social responsibility (the commitment by business to affect the environment, consumers, employees, and society positively in addition to making money for shareholders) as an alternative to the FCTC. Second, the TTCs employed multiple strategies to promote and increase the impact of these arguments and frames, such as targeting FCTC delegations and enlisting the help of diverse allies including media outlets and scientists.
What Do These Findings Mean?
These findings illustrate the variety and complexity of the tobacco industry's efforts to undermine the FCTC and show the extent to which TTCs combined and coordinated tactics on a global stage that they had previously used on a national stage. Indeed, “the comprehensiveness and scale of the tobacco industry's response to the FCTC suggests that it is reasonable to speak of a ‘globalisation of tobacco industry strategy’ in combating the development of effective tobacco control policies,” write the researchers. Awareness of the strategies employed by TTCs to influence the FCTC should help guard against industry efforts to disrupt the implementation of the FCTC and should support the development of future global tobacco control initiatives. More generally, these findings should support the development of global health initiatives designed to tackle cardiovascular disease, cancer, chronic respiratory diseases and diabetes – non-communicable diseases that together account for 60% of global deaths and are partly driven by the commercial activities of food, alcohol, and tobacco corporations.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001249.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control
For information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
The Framework Convention Alliance provides more information about the FCTC
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking and not start again
doi:10.1371/journal.pmed.1001249
PMCID: PMC3383743  PMID: 22745607
2.  The use and misuse of health research by parliamentary politicians during the development of a national smokefree law 
Background
We investigated the ways in which research evidence about the health effects from secondhand smoke (SHS) and smokefree policies was publicly used or regarded by New Zealand parliamentary politicians, during efforts to strengthen a smokefree law (ie, from 1997 to 2005).
Methods
A documentary case study used published and unpublished material recording the use of research evidence by politicians. The material was collected for the period 1997–2005 from the parliamentary record, media and other databases. Additional searches were made to provide context for the politicians who used research.
Results
Major themes identified included: (a) the employment of local estimates of SHS mortality, (b) linking specific health effects (eg, cancer) to SHS exposure, (c) a focus on the use of research relevant to bar workers, and (d) the use of research to downgrade the health effects, and attacks on the credibility of research showing health effects from SHS. Almost half of the 21 Members of Parliament (MPs), who spoke in parliament about SHS research during 2000–2005, denied or were sceptical about SHS harm. At least five MPs used tobacco industry funded or disseminated versions of research. There was some indirect evidence that the degree of exposure to the health sector, or the tobacco industry and its allies, may have been factors in the use by MPs of the research.
Policy implications
The willingness of some of this group of politicians to adopt tobacco industry arguments suggests possible options within health promotion. These include the better enforcement of consumer protection laws (preventing deceptive information by the tobacco industry and its allies), and the adoption of an increased focus on tobacco industry behaviour within tobacco control efforts. These moves may have beneficial effects for the use of research in public health policymaking. The strengthening by the health sector of its advocacy capacity and effectiveness may also be a crucial step in the better use of research by politicians in the policymaking process.
doi:10.1186/1743-8462-4-24
PMCID: PMC2235868  PMID: 18062819
3.  Corporate Social Responsibility and Access to Policy Élites: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2011;8(8):e1001076.
Gary Fooks and colleagues undertook a review of tobacco industry documents and show that policies on corporate social responsibility can enable access to and dialogue with policymakers at the highest level.
Background
Recent attempts by large tobacco companies to represent themselves as socially responsible have been widely dismissed as image management. Existing research supports such claims by pointing to the failings and misleading nature of corporate social responsibility (CSR) initiatives. However, few studies have focused in depth on what tobacco companies hoped to achieve through CSR or reflected on the extent to which these ambitions have been realised.
Methods and Findings
Iterative searching relating to CSR strategies was undertaken of internal British American Tobacco (BAT) documents, released through litigation in the US. Relevant documents (764) were indexed and qualitatively analysed. In the past decade, BAT has actively developed a wide-ranging CSR programme. Company documents indicate that one of the key aims of this programme was to help the company secure access to policymakers and, thereby, increase the company's chances of influencing policy decisions. Taking the UK as a case study, this paper demonstrates the way in which CSR can be used to renew and maintain dialogue with policymakers, even in ostensibly unreceptive political contexts. In practice, the impact of this political use of CSR is likely to be context specific; depending on factors such as policy élites' understanding of the credibility of companies as a reliable source of information.
Conclusions
The findings suggest that tobacco company CSR strategies can enable access to and dialogue with policymakers and provide opportunities for issue definition. CSR should therefore be seen as a form of corporate political activity. This underlines the need for broad implementation of Article 5.3 of the Framework Convention on Tobacco Control. Measures are needed to ensure transparency of interactions between all parts of government and the tobacco industry and for policy makers to be made more aware of what companies hope to achieve through CSR.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In the past, companies and multinational corporations were judged on the profits they made. Nowadays, though, much is made of corporate social responsibility (CSR). CSR is the commitment by business to behave ethically and to contribute to economic development while improving the quality of life of the workforce, their families, the local community, and society at large. Put simply, companies and corporations now endeavor to show that they have a positive impact on the environment, consumers, employees, and society in addition to making money for their shareholders. Large tobacco companies are no exception. British American Tobacco (BAT, the world's second largest publicly traded tobacco company), for example, began working on a wide-ranging CSR program more than a decade ago. Given that tobacco is responsible for an estimated 5.4 million deaths worldwide annually, this program was initially met with hostility and dismissed as an image management exercise. However, large parts of the investment and CSR communities now approve of BAT's CSR program, which has won numerous awards.
Why Was This Study Done?
But what do BAT and other tobacco companies actually hope to achieve through their CSR initiatives and how successful have they been in achieving these aims? Few studies have addressed these important questions. In particular, there has been little research into the extent to which tobacco companies use CSR initiatives as a form of corporate political activity that can help them gain “access” to policymakers and define the legitimate concerns and optimal alternatives of public policy (“issue definition”). Access is defined as taking place when policymakers consider the views of policy advocates such as tobacco company employees and is a crucial component of issue definition, which refers to the strategies adopted by bodies such as multinational corporations to influence the policy agenda by defining what issues public policy should concern itself with and how it should approach them. In this case study, the researchers explore whether BAT's CSR program works as a form of corporate political activity by systematically examining internal BAT documents made publicly available as a result of US litigation. Specifically, the researchers examine BAT's efforts through its CSR program to reestablish access with the UK Department of Health following the department's decision in the late 1990s to restrict contact with major tobacco companies.
What Did the Researchers Do and Find?
Using iterative searching, the researchers identified 764 documents in the Legacy Tobacco Documents Library (a large collection of internal tobacco company documents released as a result of US litigation cases) that contain information relevant to BAT's CSR strategies. Their analysis of these documents indicates that one of the key aims of the CSR program actively developed over the past decade by BAT was to help secure access to policymakers and shows how BAT used CSR to renew and maintain dialogue with policymakers at a time when contact between government and tobacco companies was extremely restricted. The documents also show that BAT employees used CSR initiatives as a means of issue definition to both optimize the probability of subsequent discussions taking place and to frame their content. Finally, the documents illustrate how BAT used its CSR program to expand the number of access points across government, thereby providing BAT with more opportunities to meet and talk to officials.
What Do These Findings Mean?
These findings suggest that CSR is a form of corporate political activity that potentially has important implications for public health given the documented impact of the political activity of tobacco companies in delaying and blocking health-related tobacco control policies. In practice, the impact of the political use of CSR is likely to be context specific and will depend on factors such as whether senior policymakers regard companies as reliable sources of information. Importantly, these findings underline the need for broad implementation of Article 5.3 of the World Health Organization's Framework Convention on Tobacco Control (FCTC), an international treaty that calls for the introduction of multiple measures to reduce tobacco consumption, including tobacco advertizing bans and relevant taxation policies. Article 5.3 aims to protect public-health policies on tobacco control from tobacco industry influence. The findings of this study indicate that implementation of Article 5.3 will require measures that ensure transparency in interactions between all parts of government and the tobacco industry and will need an increased awareness across government of what tobacco companies hope to achieve through CSR.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001076.
The Corporate Responsibility (CORE) coalition, an alliance of voluntary organizations, trade unions, and companies, maintains a Web site that contains useful material on corporate social responsibility
The European Coalition for Corporate Justice (ECCJ) promotes corporate accountability by bringing together national platforms of civil society organizations (including NGOs, trade unions, consumer advocacy groups, and academic institutions) from all over Europe
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages), details of the Framework Convention on Tobacco Control (in several languages), and guidelines for the implementation of Article 5.3 of the FCTC
The Framework Convention Alliance provides more information about the FCTC
For information about tobacco industry influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
doi:10.1371/journal.pmed.1001076
PMCID: PMC3160341  PMID: 21886485
4.  “The law was actually drafted by us but the Government is to be congratulated on its wise actions”: British American Tobacco and public policy in Kenya 
Tobacco Control  2007;16(1):1-8.
Background and objective
British American Tobacco (BAT) has historically enjoyed a monopoly position in Kenya. Analysis of recent tobacco control debates and a case study of BAT's response to the emergence of competition in Kenya are used to explore the company's ability to shape public policy and its treatment of tobacco farmers.
Design
Analysis of internal industry documents from BAT's Guildford depository, other relevant data and interviews with key informants.
Results
BAT enjoys extensive high‐level political connections in Kenya, including close relationships with successive Kenyan presidents. Such links seems to have been used to influence public policy. Health legislation has been diluted and delayed, and when a competitor emerged in the market, BAT used its contacts to have the government pass legislation drafted by BAT that compelled farmers to sell tobacco to BAT rather than to its competitor. BAT was already paying farmers less than any other African leaf‐growing company, and the legislation entrenched poor pay and a quasi‐feudal relationship. BAT's public relation's response to the threat of competition and the ministers' public statements extolling the economic importance of tobacco growing suggest that BAT has manipulated tobacco farming as a political issue.
Conclusions
The extent of BAT's influence over public policy is consistent with the observations that, despite ratifying the Framework Convention on Tobacco Control, progress in implementing tobacco control measures in Kenya has been limited. The benefits of tobacco farming seem to be deliberately exaggerated, and an analysis of its true cost benefits is urgently needed. Tobacco farmers must be protected against BAT's predatory practices and fully informed about its activities to help them have an informed role in policy debates. As image, particularly around the importance of tobacco farming, seems key to BAT's ability to influence policy, the truth about its treatment of farmers must be publicised.
doi:10.1136/tc.2006.016071
PMCID: PMC2598451  PMID: 17297056
5.  Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation 
PLoS Medicine  2013;10(5):e1001450.
Stanton Glantz and colleagues investigate efforts by tobacco companies to influence Clearing the Smoke, a 2001 Institute of Medicine report on harm reduction tobacco products.
Please see later in the article for the Editors' Summary
Background
Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report.
Methods and Findings
We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalence”) without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act.
Conclusions
Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Up to half of tobacco users will die of cancer, lung disease, heart disease, stroke, or another tobacco-related disease. Cigarettes and other tobacco products cause disease because they expose their users to nicotine and numerous other toxic chemicals. Tobacco companies have been working to develop a “safe” cigarette for more than half a century. Initially, their attention focused on cigarettes that produced lower tar and nicotine yields in machine-smoking tests. These products were perceived as “safer” products by the public and scientists for many years, but it is now known that the use of low-yield cigarettes can actually expose smokers to higher levels of toxins than standard cigarettes. More recently, the tobacco companies have developed other products (for example, products that heat aerosols of nicotine, rather than burning the tobacco) that claim to reduce harm and the risk of tobacco-related disease, but they can only market these modified risk tobacco products in the US after obtaining Food and Drug Administration (FDA) approval. In 1999, the FDA commissioned the US Institute of Medicine (IOM, an influential source of independent expert advice on medical issues) to assess the science base for tobacco “harm reduction.” In 2001, the IOM published its report Clearing the Smoke: Assessing the Science Base for Tobacco Harm and Reduction, which, although controversial, set the tone for the development and regulation of tobacco products in the US, particularly those claiming to be less dangerous, in subsequent years.
Why Was This Study Done?
Tobacco companies have a long history of working to shape scientific discussions and agendas. For example, they have produced research results designed to “create controversy” about the dangers of smoking and secondhand smoke. In this study, the researchers investigate how tobacco companies organized to try to influence the IOM committee that prepared the Clearing the Smoke report on modified risk tobacco products by analyzing tobacco industry and IOM documents.
What Did the Researchers Do and Find?
The researchers searched the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) for documents outlining how tobacco companies tried to influence the IOM Committee to Assess the Science Base for Tobacco Harm Reduction and created a timeline of events from the 1,000 or so documents they retrieved. They confirmed and supplemented this timeline using information in 80 files that detailed written interactions between the tobacco companies and the IOM committee, which they obtained through a public records access request. Analysis of these documents indicates that the tobacco companies considered the IOM report to have important regulatory implications, that they developed and implemented strategies with consulting and legal firms to access the IOM proceedings, and that tobacco company lawyers, consultants, and regulatory staff shaped presentations to the IOM committee by company scientists on various aspects of tobacco harm reduction products. The analysis also shows that tobacco companies were pleased with the final report, particularly its recommendation that tobacco products can be marketed with exposure or risk reduction claims provided the products substantially reduce exposure and provided the behavioral and health consequences of these products are determined in post-marketing surveillance and epidemiological studies (“tiered testing”) and its recommendation that, provided no claim of reduced exposure or risk is made, new products comparable to existing conventional cigarettes (“substantial equivalence”) can be marketed without prior regulatory approval.
What Do These Findings Mean?
These findings suggest that tobacco companies used their legal and regulatory staff to access the IOM committee that advised the FDA on modified risk tobacco products and that they used this access to deliver specific, carefully formulated messages designed to serve their business interests. Although these findings provide no evidence that the efforts of tobacco companies influenced the IOM committee in any way, they show that the companies were satisfied with the final IOM report and its recommendations, some of which have policy implications that continue to reverberate today. The researchers therefore call for the FDA and other regulatory bodies to remember that they are dealing with companies with a long history of intentionally misleading the public when assessing the information presented by tobacco companies as part of the regulatory process and to actively protect their public-health policies from the commercial interests of the tobacco industry.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001450.
This study is further discussed in a PLOS Medicine Perspective by Thomas Novotny
The World Health Organization provides information about the dangers of tobacco (in several languages); for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
A PLOS Medicine Research Article by Heide Weishaar and colleagues describes tobacco company efforts to undermine the Framework Convention on Tobacco Control, an international instrument for tobacco control
Wikipedia has a page on tobacco harm reduction (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The IOM report Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction is available to read online
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The University of California, San Francisco Center for Tobacco Control Research and Education is the focal point for University of California, San Francisco (UCSF) scientists in disciplines ranging from the molecular biology of nicotine addiction through political science who combine their efforts to eradicate the use of tobacco and tobacco-induced cancer and other diseases worldwide
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001450
PMCID: PMC3665841  PMID: 23723740
6.  The development of Tobacco Harm Prevention Law in Vietnam: stakeholder tensions over tobacco control legislation in a state owned industry 
Background
Building on its National Tobacco Control Policy initiated in 2000, Vietnam is currently considering introducing a comprehensive law to strengthen the implementation of tobacco control policy. This study analyses the positions of key stakeholders in the development of tobacco control legislation in the context of a largely state-owned industry, and discusses their implications for the policy process.
Methods
Several qualitative methods were employed for the study including: literature review and documentary analysis; key informant interview; focus groups discussion; and key stakeholders survey.
Findings
The Ministry of Health, Ministry of Trade and Industry, and Ministry of Finance are key players in the tobacco control policy and legislation, representing competing bureaucratic interests over health, macro-economy and revenue. High-ranking officials, including the Communist Party and National Assembly members, take a rather relaxed position reflecting the low political stakes placed on tobacco issues. The state-owned tobacco industry is regarded as an important contributor to the government revenue and gross domestic product, and the relative weight on health and socioeconomic issues placed by stakeholders determine their positions on tobacco control. Overall, short-term economic interests have more immediate influence in setting policy directions, with the consequences of health gains perceived as relegated to a distant future. This was reflected in the position of tobacco control advocates, including MOH, that presented with reluctance in insisting on some tobacco control strategies revealing a mixture attitude of concessions to the socioeconomic uncertainties and a sense of bargaining to win the strategies that are more likely to be accepted.
Conclusion
The state-ownership of tobacco industry poses a major paradox within the government that benefits from manufacturing of tobacco products and is also responsible for controlling tobacco consumption. The perceptions of negative implications on government revenue and the macro-economy, coupled with the reluctance to challenge these issues from health perspective too directly, means that tobacco control has yet to secure itself a place on the priority policy agenda. The overall policy environment will shift in favour of tobacco control only if the economic framing can be challenged.
doi:10.1186/1747-597X-6-24
PMCID: PMC3191345  PMID: 21923945
7.  “A Good Personal Scientific Relationship”: Philip Morris Scientists and the Chulabhorn Research Institute, Bangkok 
PLoS Medicine  2008;5(12):e238.
Background
This paper examines the efforts of consultants affiliated with Philip Morris (PM), the world's leading transnational tobacco corporation, to influence scientific research and training in Thailand via the Chulabhorn Research Institute (CRI). A leading Southeast Asian institute for environmental health science, the CRI is headed by Professor Dr. Her Royal Highness Princess Chulabhorn, the daughter of the King of Thailand, and it has assumed international significance via its designation as a World Health Organization (WHO) Collaborating Centre in December 2005.
Methods and Findings
This paper analyses previously confidential tobacco industry documents that were made publicly available following litigation in the United States. PM documents reveal that ostensibly independent overseas scientists, now identified as industry consultants, were able to gain access to the Thai scientific community. Most significantly, PM scientist Roger Walk has established close connections with the CRI. Documents indicate that Walk was able to use such links to influence the study and teaching of environmental toxicology in the institute and to develop relations with key officials and local scientists so as to advance the interests of PM within Thailand and across Asia. While sensitivities surrounding royal patronage of the CRI make public criticism extremely difficult, indications of ongoing involvement by tobacco industry consultants suggest the need for detailed scrutiny of such relationships.
Conclusions
The establishment of close links with the CRI advances industry strategies to influence scientific research and debate around tobacco and health, particularly regarding secondhand smoke, to link with academic institutions, and to build relationships with national elites. Such strategies assume particular significance in the national and regional contexts presented here amid the globalisation of the tobacco pandemic. From an international perspective, particular concern is raised by the CRI's recently awarded status as a WHO Collaborating Centre. Since the network of WHO Collaborating Centres rests on the principle of “using national institutions for international purposes,” the documents presented below suggest that more rigorous safeguards are required to ensure that such use advances public health goals rather than the objectives of transnational corporations.
Jeff Collin and Ross MacKenzie analyze tobacco industry documents and find that Philip Morris consultants were able to gain access to a Thai research institute that is a WHO Collaborating Centre.
Editors' Summary
Background.
Tobacco use kills 5.4 million people a year (one person every six seconds) and accounts for one in ten adult deaths worldwide. Globally, the use of tobacco is on the rise, especially in developing countries, which have become a major target for tobacco industry marketing. The tobacco industry has worked hard to try and influence public perceptions about the risks of smoking and the risk of inhaling secondhand smoke (passive smoking). The industry has used a variety of tactics to downplay the health hazards of smoking or inhaling secondhand smoke—two examples are publishing articles casting doubts about the health hazards of tobacco and funding research that is biased toward giving pro-industry results. Another tactic is for tobacco industry consultants to try and gain entry to universities and other academic centers to see if they can influence research and teaching activities.
Why Was This Study Done?
The researchers were concerned that consultants from the tobacco company Philip Morris had gained access to an academic research center in Thailand called the Chulabhorn Research Institute (CRI). The CRI is an internationally renowned teaching institution for a variety of scientific disciplines, including environmental toxicology (the study of how chemicals in the environment, such as tobacco smoke, can affect human health), biomedicine, and biotechnology. The institute has secured funding from the Thai government, the Association of Southeast Nations and the United Nations Development Programme. In 2005 the institute's environmental toxicology unit was designated a World Health Organization (WHO) Collaborating Centre. WHO Collaborating Centres are “institutions such as research institutes, parts of universities or academies, that are designated by the Director-General of the WHO to carry out activities in support of the WHO's programs” (http://www.who.int/collaboratingcentres/en/). The researchers were concerned that Philip Morris consultants had been able to develop relationships with the CRI to help advance the company's interests.
What Did the Researchers Do and Find?
The researchers analyzed previously confidential tobacco industry documents that were made publicly available online following litigation in the United States. They searched two online collections of industry documents—the Legacy Tobacco Documents Library and Tobacco Documents Online—as well as the online collections operated by US-based tobacco companies. They found that consultants to Philip Morris were able to gain access to the scientific community in Thailand. A Philip Morris scientist named Roger Walk was able to establish close connections to the CRI, and he used these connections to influence research and teaching activities at the CRI on environmental toxicology. Walk was also able to build relationships with government officials and scientists in Thailand to help advance the interests of Philip Morris in the country and across Asia.
What Do these Findings Mean?
This study provides evidence that the tobacco industry has established close links with a research institute in Thailand that collaborates with the WHO, and has been able to influence the institute's teaching curriculum and research. Such links are of great concern to the public health community, which is working hard to reduce deaths and disease due to tobacco. These links raise the possibility that the tobacco industry is managing to influence medical research and teaching at academic institutions. The WHO has stated that a firewall is in place between itself and the tobacco industry—but the study authors argue, based on their findings, that “this firewall is not impenetrable.” The study findings, they conclude, highlight a challenge posed to international tobacco control efforts, especially with respect to Article 5.3 of an international treaty called the WHO Framework Convention on Tobacco Control; Article 5.3 addresses the need to protect public health policies from the vested interests of the tobacco industry. The authors say that better safeguards must be put in place to prevent tobacco companies from thwarting public health goals.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050238.
The Legacy Tobacco Documents Library contains over 9.7 million documents created by tobacco companies
Tobacco Documents Online contains over 4 million tobacco industry documents
Over 900 WHO Collaborating Centres are at work in 99 Member States on many health disciplines
The WHO held an inquiry in 2000 into possible tobacco industry influence over the organization (and over other UN agencies), and has published its recommendations in response to this inquiry
The WHO Framework Convention on Tobacco Control is an international treaty on controlling tobacco
doi:10.1371/journal.pmed.0050238
PMCID: PMC2605886  PMID: 19108600
8.  A pilot qualitative study of New Zealand policymakers' knowledge of, and attitudes to, the tobacco industry 
Background
The actions of policymakers are critical to advancing tobacco control. To evaluate the feasibility of using anonymous in-depth interviews to ascertain policymakers' knowledge about, and attitudes to, the tobacco industry, we undertook a pilot study involving New Zealand policymakers.
Methods
Five politicians (from different political parties) and five senior officials, who were involved in tobacco control policy, were recruited for semi-structured, anonymous, face-to-face interviews.
Results
Recruitment of appropriate senior policymakers was found to be possible. Interviewees were willing to answer questions fully and frankly about their knowledge and views of the tobacco industry.
The preliminary data from this pilot suggest that some New Zealand politicians appeared to see contact with the industry as similar to contact with other groups, whereas the officials indicated at least a different style of relationship. Only one politician knew if their party accepted funding from tobacco companies. All but one of the interviewees thought that promotion of tobacco to under-16 s still occurs, albeit indirectly. The interviewees' knowledge of the investment in tobacco industries by New Zealand government agencies was low or absent.
While most of those interviewed showed scepticism about tobacco company public relations efforts, this was absent in some cases. There was a wide understanding that the tobacco industry will use many tactics in the pursuit of profit, and to counteract government efforts to reduce the harm from smoking.
Conclusion
In-depth anonymous interviews appear to be feasible and can be productive for exploring sensitive tobacco-related policy issues with policymakers. The preliminary data from this group of New Zealand policymakers suggest important knowledge gaps, but also general distrust of this industry. From a tobacco control perspective, the results may suggest a greater focus by advocates on the funding of political parties by the tobacco industry, and on government agency investment in the tobacco industry.
doi:10.1186/1743-8462-4-17
PMCID: PMC2042493  PMID: 17651500
9.  Tobacco Industry Manipulation of Tobacco Excise and Tobacco Advertising Policies in the Czech Republic: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2012;9(6):e1001248.
Risako Shirane and colleagues examined the the Legacy Tobacco Documents Library and found evidence of transnational tobacco company influence over tobacco advertising and excise policy in the Czech Republic, a country with one of the poorest tobacco control records in Europe.
Background
The Czech Republic has one of the poorest tobacco control records in Europe. This paper examines transnational tobacco companies' (TTCs') efforts to influence policy there, paying particular attention to excise policies, as high taxes are one of the most effective means of reducing tobacco consumption, and tax structures are an important aspect of TTC competitiveness.
Methods and Findings
TTC documents dating from 1989 to 2004/5 were retrieved from the Legacy Tobacco Documents Library website, analysed using a socio-historical approach, and triangulated with key informant interviews and secondary data. The documents demonstrate significant industry influence over tobacco control policy. Philip Morris (PM) ignored, overturned, and weakened various attempts to restrict tobacco advertising, promoting voluntary approaches as an alternative to binding legislation. PM and British American Tobacco (BAT) lobbied separately on tobacco tax structures, each seeking to implement the structure that benefitted its own brand portfolio over that of its competitors, and enjoying success in turn. On excise levels, the different companies took a far more collaborative approach, seeking to keep tobacco taxes low and specifically to prevent any large tax increases. Collective lobbying, using a variety of arguments, was successful in delaying the tax increases required via European Union accession. Contrary to industry arguments, data show that cigarettes became more affordable post-accession and that TTCs have taken advantage of low excise duties by raising prices. Interview data suggest that TTCs enjoy high-level political support and continue to actively attempt to influence policy.
Conclusion
There is clear evidence of past and ongoing TTC influence over tobacco advertising and excise policy. We conclude that this helps explain the country's weak tobacco control record. The findings suggest there is significant scope for tobacco tax increases in the Czech Republic and that large (rather than small, incremental) increases are most effective in reducing smoking.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to 10 million by 2030. Faced with this global tobacco epidemic, national and international bodies have drawn up conventions and directives designed to control tobacco. For example, European Union (EU) Directives on tobacco control call for member states to ban tobacco advertising, promotion, and sponsorship and to adopt taxation policies (for example, high levels of tobacco excise tax) aimed at reducing tobacco consumption. Within the EU, implementation of tobacco control policies varies widely but the Czech Republic, which was formed in 1993 when Czechoslovakia split following the 1989 collapse of communism, has a particularly poor record. The Czech Republic, which joined the EU in 2004, is the only EU Member State not to have ratified the World Health Organization's Framework Convention on Tobacco Control, which entered into force in 2005, and its tobacco control policies were the fourth least effective in Europe in 2010.
Why Was This Study Done?
During the communist era, state-run tobacco monopolies controlled the supply of cigarettes and other tobacco products in Czechoslovakia. Privatization of these monopolies began in 1991 and several transnational tobacco companies (TTCs)—in particular, Philip Morris and British American Tobacco—entered the tobacco market in what was to become the Czech Republic. In this socio-historical study, which aims to improve understanding of both effective tobacco excise policy and the ways in which TTCs seek to influence policy in emerging markets, the researchers analyze publically available internal TTC documents and interview key informants to examine efforts made by TTCs to influence tobacco advertising and tobacco excise tax policies in the Czech Republic. A socio-historical study examines the interactions between individuals and groups in a historical context.
What Did the Researchers Do and Find?
The researchers analyzed 511 documents (dated 1989 onwards) in the Legacy Tobacco Documents Library website (a collection of internal tobacco industry documents released through US litigation cases) that mentioned tobacco control policies in the Czech Republic. They also analyzed information obtained from sources such as tobacco industry journals and data obtained in 2010 in interviews with key Czech informants (including a tobacco industry representative and a politician). The researchers' analysis of the industry documents indicates that Philip Morris ignored, overturned, and weakened attempts to restrict tobacco advertising and promoted voluntary approaches as an alternative to binding legislation. Importantly, while the internal documents show that Philip Morris lobbied for a specific excise tax (a fixed amount of tax per cigarette, a tax structure that favors the expensive brands that Philip Morris mainly markets), the European strategy employed at that time by British American Tobacco was to lobby for a mixed excise structure that combined an “ad valorem” tax (a tax levied as a proportion of price) and a specific tax, an approach that favors a mixed portfolio of tobacco brands. By contrast, the documents show that TTCs collaborated in trying to keep tobacco taxes low and in trying to prevent any large tax increases. This collective lobbying successfully delayed the tobacco tax increases required as a condition of the Czech Republic's accession to the EU. Finally, the interview data suggest that TTCs had high-level political support in the Czech Republic and continue actively to attempt to influence policy.
What Do These Findings Mean?
These findings provide clear evidence that Philip Morris and British American Tobacco (the two TTCs that have dominated the Czech market since privatization of the tobacco industry) have significantly influenced tobacco advertising and excise policy in the Czech Republic since 1989. The findings, which also suggest that this influence is ongoing, help to explain the Czech Republic's poor tobacco control record, which was reflected in a fall in the real price of cigarettes between 1990 and 2000. More generally, this study provides valuable insight into how TTCs might try to influence policy in other emerging markets. Improvements in global tobacco control, the researchers conclude, will be possible only if efforts are made to protect tobacco control policies from the vested interests of the tobacco industry, a principle enshrined in the WHO Framework Convention on Tobacco control, and if public and political attitudes to the industry shift.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001248.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about its Framework Convention on Tobacco Control
For information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
The Framework Convention Alliance more information about the FCTC
Details of European Union legislation on excise duty applied to manufactured tobacco and on the manufacture, presentation and sale of tobacco products are available (in several languages)
The Legacy Tobacco Documents Library is a searchable public database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking and not start again
doi:10.1371/journal.pmed.1001248
PMCID: PMC3383744  PMID: 22745606
10.  Print media coverage of California's smokefree bar law 
Tobacco Control  2001;10(2):154-160.
OBJECTIVE—To assess the print media coverage of California's smokefree bar law in the state of California.
DESIGN—Content analysis of newspaper, trade journal, and magazine items.
SUBJECTS—Items regarding the smokefree bar law published seven months before and one year following the implementation of the smokefree bar law (June 1997 to December 1998). Items consisted of news articles (n = 446), opinion editorials (n = 31), editorials (n = 104), letters to the editor (n = 240), and cartoons (n = 10).
MAIN OUTCOME MEASURES—Number and timing of publication of items, presence of tobacco industry arguments or public health arguments regarding law, positive, negative, and neutral views of opinion items published.
RESULTS—53% of items published concerning the smokefree bar law were news articles, 47% were opinion items. 45% of items regarding the smokefree bar law were published during the first month of implementation. The tobacco industry dominated coverage in most categories (economics, choice, enforcement, ventilation, legislation, individual quotes), except for categories public health used the most frequently (government role, tactics, organisational quotes). Anti-law editorials and letters to the editor were published more than pro-law editorials and letters. Region of the state, paper size, presence of local clean indoor air legislation, and voting on tobacco related ballot initiatives did not have an impact on the presence of opinion items.
CONCLUSIONS—The tobacco industry succeeded in obtaining more coverage of the smokefree bar law, both in news items and opinion items. The tobacco industry used historical arguments of restricting freedom of choice and economic ramifications in fighting the smokefree bar law, while public health groups focused on the worker protection issue, and exposed tobacco industry tactics. Despite the skewed coverage, public health groups obtained adequate attention to their arguments to keep the law in effect.


Keywords: content analysis; politics; passive smoking; smokefree bar law; California
doi:10.1136/tc.10.2.154
PMCID: PMC1747550  PMID: 11387536
11.  “Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents 
PLoS Medicine  2010;7(1):e1000202.
Katherine Smith and colleagues investigate the ways in which British American Tobacco influenced the European Union Treaty so that new EU policies advance the interests of major corporations, including those that produce products damaging to health.
Background
Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA.
Methods and Findings
In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost–benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health.
Conclusions
Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The primary goal of public health, the branch of medicine concerned with the health of communities, is to improve lives by preventing disease. Public-health groups do this by assessing and monitoring the health of communities, by ensuring that populations have access to appropriate and cost-effective health care, and by helping to formulate public policies that safeguard human health. Until recently, most of the world's major public-health concerns related to infectious diseases. Nowadays, however, many major public-health concerns are linked to the goods made and marketed by large corporations such as fast food, alcohol, tobacco, and chemicals. In Europe, these corporations are regulated by policies drawn up both by member states and by the European Commission, the executive organ of the European Union (EU; an economic and political partnership among 27 democratic European countries). Thus, for example, the tobacco industry, which is widely recognized as a driver of the smoking epidemic, is regulated by Europe-wide tobacco control policies and member state level policies.
Why Was This Study Done?
Since 1997, the European Commission has been required by law to assess the economic, social (including health), and environmental consequences of new policy initiatives using a process called an “impact assessment” (IA). Because different types of IA examine the likely effects of policies on different aspects of daily life—a health impact assessment, for example, focuses on a policy's effect on health—the choice of IA can lead to different decisions being taken about new policies. Although the IA tool adopted by the European Commission aims to assess economic, environmental and social impacts, independent experts suggest this tool does not adequately assess health impacts. Instead, economic impacts receive the most attention, a situation that may favour the interests of large businesses. In this study, the researchers seek to identify how and why the EU's approach to IA developed. More specifically, the researchers analyze internal documents from British American Tobacco (BAT), which have been disclosed because of US litigation cases, to find out whether industry has played a role in promoting the EU's system of IA.
What Did the Researchers Do and Find?
The researchers analyzed 714 BAT internal documents (identified by searching the Legacy Tobacco Documents Library, which contains more than 10 million internal tobacco company documents) that concerned attempts made by BAT to influence regulatory reforms in Europe. They also analyzed related literature from other sources (for example, academic publications) and interviewed 16 relevant people (including people who had worked at the European Commission). This analysis shows that from 1995, BAT worked with other businesses to promote European regulatory reforms (in particular, the establishment of a business-orientated form of IA) that favor large corporations. A lobbying campaign, initiated by BAT but involving a “policy network” of other companies, first helped to secure binding changes to the EU Treaty that require policymakers to minimize legislative burdens on businesses. The analysis shows that after achieving this goal, which BAT described as an “important victory,” further lobbying ensured that these treaty changes were translated into the implementation of a business-orientated form of IA within the EU. Both the tobacco industry and the chemical industry, the researchers argue, have since used the IA to delay and/or weaken EU legislation intended to protect public health.
What Do These Findings Mean?
These findings suggest that BAT and its corporate allies have fundamentally altered the way in which EU policy is made by ensuring that all significant EU policy decisions have to be assessed using a business-orientated IA. As the authors note, this situation increases the likelihood that the EU will produce policies that favor big business rather than the health of its citizens. Furthermore, these findings suggest that by establishing a network of other industries to help in lobbying for EU Treaty changes, BAT was able to distance itself from the push to establish a business-orientated IA to the extent that Commission officials were unaware of the involvement of the tobacco industry in campaigns for IA. Thus, in future, to safeguard public health, policymakers and public-health groups must pay more attention to corporate efforts to shape decision-making processes. In addition, public-health groups must take account of the ways in which IA can be used to undermine as well as support effective public-health policies and they must collaborate more closely in their efforts to ensure effective national and international policy.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/0.1371/journal.pmed.1000202.
Wikipedia has a page on public health (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
More information on the European Union (in several languages), on public health in the European Union, and on impact assessment by the European Commission is available
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages)
The Smoke Free Partnership contains more information about smoking prevalence in Europe and about European policies to tackle the public health issues associated with tobacco use
For more information about tobacco industry influence on policy see the 2009 World Health Organization report on tobacco industry interference with tobacco control
doi:10.1371/journal.pmed.1000202
PMCID: PMC2797088  PMID: 20084098
12.  Representation and Misrepresentation of Scientific Evidence in Contemporary Tobacco Regulation: A Review of Tobacco Industry Submissions to the UK Government Consultation on Standardised Packaging 
PLoS Medicine  2014;11(3):e1001629.
Selda Ulucanlar and colleagues analyze submissions by two tobacco companies to the UK government consultation on standardized packaging.
Please see later in the article for the Editors' Summary
Background
Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for ‘more evidence’, but four months later a second ‘independent review’ was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP.
Methods and Findings
We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, ‘mimicked scientific critique’ was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in ‘evidential landscaping’, promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach.
Conclusions
The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 6 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to more than 8 million by 2030. To reduce this loss of life, national and international bodies have drawn up various conventions and directives designed to implement tobacco control measures such as the adoption of taxation policies aimed at reducing tobacco consumption and bans on tobacco advertising, promotion, and sponsorship. One innovative but largely unused tobacco control measure is standardised packaging of tobacco products. Standardised packaging aims to prevent the use of packaging as a marketing tool by removing all brand imagery and text (other than name) and by introducing packs of a standard shape and colour that include prominent pictorial health warnings. Standardised packaging was first suggested as a tobacco control measure in 1986 but has been consistently opposed by the tobacco industry.
Why Was This Study Done?
The UK is currently considering standardised packaging of tobacco products. In the UK, Better Regulation guidance obliges officials to seek the views of stakeholders, including corporations, on the government's cost and benefit estimates of regulatory measures such as standardised packaging and on the evidence underlying these estimates. In response to a public consultation about standardised packaging in July 2013, which considered submissions from several transnational tobacco companies (TTCs), the UK government announced that it would wait for the results of the standardised packaging legislation that Australia adopted in December 2012 before making its final decision about this tobacco control measure. Parliamentary debates and media statements have suggested that doubt over the adequacy of the evidence was the main reason for this ‘wait and see’ decision. Notably, TTCs have a history of manufacturing uncertainty about the scientific evidence related to the harms of tobacco. Given the centrality of evidence to the debate about standardised packaging, in this study, the researchers analyse submissions made by two TTCs, British American Tobacco (BAT) and Japan Tobacco International (JTI), to the first UK consultation on standardised packaging (a second review is currently underway and will report shortly) to examine how TTCs used evidence to oppose standardised packaging.
What Did the Researchers Do and Find?
The researchers analysed sub-sections of two of the four TTC submissions (those submitted by BAT and JTI) made to the public consultation using verification-oriented cross-documentary analysis, which compared references made to published sources with the original sources to ascertain how these sources had been used, and interpretative analysis to examine the conceptual significance of TTC critiques of the evidence on standardised packaging. The researchers report that the companies' overall argument was that the evidence base in support of standardised packaging was seriously flawed and did not warrant the introduction of such packaging. The researchers identified three ways in which the TTC reports misrepresented the evidence base. First, the TTCs misquoted published studies, thereby distorting the main messages of these studies. For example, the TTCs sometimes omitted important qualifying information when quoting from published studies. Second, the TTCs undermined evidence by employing experts to review published studies for methodological rigor and value in ways that did not conform to normal scientific critique approaches (‘mimicked scientific critique’). So, for example, the experts considered each piece of evidence in isolation for its ability to support standardised packaging rather than considering the cumulative weight of the evidence. Finally, the TTCs engaged in ‘evidential landscaping’. That is, they promoted research that deflected attention from standardised packaging (for example, research into social explanations of smoking behaviour) and omitted internal industry research on the role of packaging in marketing.
What Do These Findings Mean?
These findings suggest that the TTC critique of the evidence in favour of standardised packaging that was presented to the UK public consultation on this tobacco control measure is highly misleading. However, because the researchers' analysis only considered subsections of the submissions from two TTCs, these findings may not be applicable to the other submissions or to other TTCs. Moreover, their analysis only considered the efforts made by TTCs to influence public health policy and not the effectiveness of these efforts. Nevertheless, these findings suggest that the claim of TTCs that standardised packaging will not lead to public health benefits is largely without foundation. More generally, these findings highlight the possibility that the tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for wealthy corporations to slow, weaken, or prevent the implementation of public health policies.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001629.
The World Health Organization provides information about the dangers of tobacco (in several languages) and an article about first experiences with Australia's tobacco plain packaging law; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report ‘Tobacco industry interference with tobacco control’
A UK parliamentary briefing on standardised packaging of tobacco products, a press release about the consultation, and a summary report of the consultation are available; the ideas behind the UK's Better Regulation guidance are described in a leaflet produced by the Better Regulation Task Force
Cancer Research UK (CRUK) has a web page with information on standardised packaging and includes videos
Wikipedia has a page on standardised packaging of tobacco products (note: Wikipedia is a free online encyclopaedia that anyone can edit; available in several languages)
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and the tactics it uses to influence tobacco regulation
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001629
PMCID: PMC3965396  PMID: 24667150
13.  Impediments to the enforcement of youth access laws 
Tobacco Control  1999;8(2):152-155.
OBJECTIVE—To recognise obstacles to the implementation of the effective enforcement of tobacco sales laws and to identify measures that could be taken to overcome these obstacles.
DESIGN—Interviews were conducted with health department officials in Massachusetts communities to determine why their efforts to prevent illegal sales of tobacco to minors had been only partially successful.
SETTING—Urban, suburban, and rural communities in Massachusetts, USA.
RESULTS—Organisational problems, court challenges to citations, budgetary threats, and political pressure all combined to reduce the frequency of enforcement inspections to half the intended rate. Political pressure resulted in the exclusion of older youths from compliance tests, further undermining enforcement efficacy.
CONCLUSIONS—Suggestions for addressing the problems include obtaining support from the community, keeping elected and court officials informed about plans for merchant education and law enforcement, using efficient enforcement protocols, setting merchant compliance goals, and advising the public and government officials about progress towards those goals, using older youths to make purchase attempts, and testing all merchants frequently.


Keywords: tobacco sales; access laws; adolescents
PMCID: PMC1759707  PMID: 10478398
14.  “Efforts to Reprioritise the Agenda” in China: British American Tobacco's Efforts to Influence Public Policy on Secondhand Smoke in China 
PLoS Medicine  2008;5(12):e251.
Background
Each year, 540 million Chinese are exposed to secondhand smoke (SHS), resulting in more than 100,000 deaths. Smoke-free policies have been demonstrated to decrease overall cigarette consumption, encourage smokers to quit, and protect the health of nonsmokers. However, restrictions on smoking in China remain limited and ineffective. Internal tobacco industry documents show that transnational tobacco companies (TTCs) have pursued a multifaceted strategy for undermining the adoption of restrictions on smoking in many countries.
Methods and Findings
To understand company activities in China related to SHS, we analyzed British American Tobacco's (BAT's) internal corporate documents produced in response to litigation against the major cigarette manufacturers to understand company activities in China related to SHS. BAT has carried out an extensive strategy to undermine the health policy agenda on SHS in China by attempting to divert public attention from SHS issues towards liver disease prevention, pushing the so-called “resocialisation of smoking” accommodation principles, and providing “training” for industry, public officials, and the media based on BAT's corporate agenda that SHS is an insignificant contributor to the larger issue of air pollution.
Conclusions
The public health community in China should be aware of the tactics previously used by TTCs, including efforts by the tobacco industry to co-opt prominent Chinese benevolent organizations, when seeking to enact stronger restrictions on smoking in public places.
Monique Muggli and colleagues study British American Tobacco (BAT) internal documents and find that from the mid 1990s BAT pursued a strategy aimed at influencing the public debate on secondhand smoke in China.
Editors' Summary
Background.
Each year, about one million people die in China from tobacco-caused diseases, including cancer, heart disease, and lung disease. Although most of these deaths occur among smokers—300 million people smoke in China, accounting for one-third of the global “consumption” of cigarettes—more than 100,000 deaths from tobacco-related causes occur annually among the 540 million Chinese people who are exposed to secondhand smoke. Tobacco smoke contains 4,000 known chemicals, 69 of which are known or probable carcinogens, and, when it is produced in enclosed spaces, both smokers and nonsmokers are exposed to its harmful effects. The only effective way to reduce tobacco smoke exposure indoors to acceptable levels is to implement 100% smoke-free environments—ventilation, filtration, and the provision of segregated areas for smokers and nonsmokers are insufficient. Importantly, as well as protecting nonsmokers from secondhand smoke, the implementation of smoke-free public places also reduces the number of cigarettes smoked among continuing smokers, increases the likelihood of smokers quitting, and reduces the chances of young people taking up smoking.
Why Was This Study Done?
Article 8 of the World Health Organization's Framework Convention on Tobacco Control (FCTC; an international public-health treaty that seeks to reduce tobacco-caused death and disease) calls on countries party to the treaty to protect their citizens from secondhand smoke exposure. China became a party to the FCTC in 2005 but restrictions on smoking in public places in China remain limited and ineffective. Previous analyses of internal tobacco industry documents have revealed that transnational tobacco companies (TTCs) have used a multifaceted approach to undermine the adoption of restrictions on smoking in many countries. TTCs have been shown to influence media coverage of secondhand smoke issues and to promote ineffective ventilation and separate smoking and nonsmoking areas in restaurants, bars, and hotels (so-called “resocalization of smoking” accommodation principles) with the aim of undermining smoke-free legislation. In addition, TTCs have created organizations interested in non-tobacco-related diseases to draw attention away from the public-health implications of secondhand smoke. In this study, the researchers ask whether TTCs have used a similar approach to undermine the adoption of restrictions on smoking in China, one of the most coveted cigarette markets in the world by the major TTCs.
What Did the Researchers Do and Find?
The researchers analyzed internal corporate documents produced by British American Tobacco (BAT; the predominant TTC in China) in response to litigation against major cigarette manufacturers stored in document depositories in Minnesota, USA and Guildford, UK. Among these documents, they found evidence that BAT had attempted to divert attention from secondhand smoke issues toward liver disease prevention by funding the Beijing Liver Foundation (BFL) from its inception in 1997 until at least 2002 (the most recent year that BAT's corporate records are available for public review). The researchers also found evidence that BAT had promoted “resocialization of smoking” accommodation principles as a “route to avoid smoking bans” and pushed ventilation and air filtration in airports and in establishments serving food and drink. Finally, the researchers found evidence that BAT had sought to “present the message that ‘tobacco smoke is just one of the sources of air polution [sic] and a very insignificant one compared with other pollutants'” through presentations given to the Chinese tobacco industry and media seminars aimed at Chinese journalists.
What Do These Findings Mean?
These findings indicate that, beginning in the mid 1990s and continuing until at least 2002, BAT has followed an intensive, multi-pronged strategy designed to undermine the health policy agenda on secondhand smoke in China. Given their findings, the researchers suggest that BFL and other charitable organizations in China must be wary of accepting tobacco money and that measures must be taken to improve the transparency and accountability of these and other public organizations. To meet FCTC obligations under Article 5.3 (industry interference), policy makers in China, they suggest, must be made aware of how BAT and other TTCs have repeatedly sought to influence health policy in China by focusing attention toward the adoption of ineffective air filtration and ventilation systems in hospitality venues rather than the implementation of 100% smoke-free environments. Finally, Chinese policy makers and the media need to be better informed about BAT's long-standing attempts to communicate misleading messages to them about the health effects of secondhand smoke.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050251.
The World Health Organization's Regional Office for the Western Pacific provides smoking statistics for China and other countries in the region
The World Health Organization provides information on the health problems associated with secondhand smoke, about its Tobacco Free Initiative (available in several languages), and about the Framework Convention on Tobacco Control (also available in several languages)
MedlinePlus provides links to information about the dangers of secondhand smoke (available in English and Spanish)
The UK National Health Service Smokefree Web site provides information about the advantages of giving up smoking, how to give up smoking, and the dangers associated with secondhand smoke
British American Tobacco documents stored in the Minnesota and Guildford Depositories, including those analyzed in this study, can be searched through the British American Tobacco Documents Archive
doi:10.1371/journal.pmed.0050251
PMCID: PMC2605899  PMID: 19108603
15.  Transnational Tobacco Company Interests in Smokeless Tobacco in Europe: Analysis of Internal Industry Documents and Contemporary Industry Materials 
PLoS Medicine  2013;10(9):e1001506.
In light lobbying by transnational tobacco companies to remove the European Union ban on the sale of snus (a smokeless tobacco product), Silvy Peeters and Anna Gilmore explore the motivation behind tobacco companies' interests in smokeless tobacco products in Europe.
Please see later in the article for the Editors' Summary
Background
European Union (EU) legislation bans the sale of snus, a smokeless tobacco (SLT) which is considerably less harmful than smoking, in all EU countries other than Sweden. To inform the current review of this legislation, this paper aims to explore transnational tobacco company (TTC) interests in SLT and pure nicotine in Europe from the 1970s to the present, comparing them with TTCs' public claims of support for harm reduction.
Methods and Results
Internal tobacco industry documents (in total 416 documents dating from 1971 to 2009), obtained via searching the online Legacy Tobacco Documents Library, were analysed using a hermeneutic approach. This library comprises documents obtained via litigation in the US and does not include documents from Imperial Tobacco, Japan Tobacco International, or Swedish Match. To help overcome this limitation and provide more recent data, we triangulated our documentary findings with contemporary documentation including TTC investor presentations. The analysis demonstrates that British American Tobacco explored SLT opportunities in Europe from 1971 driven by regulatory threats and health concerns, both likely to impact cigarette sales negatively, and the potential to create a new form of tobacco use among those no longer interested in taking up smoking. Young people were a key target. TTCs did not, however, make SLT investments until 2002, a time when EU cigarette volumes started declining, smoke-free legislation was being introduced, and public health became interested in harm reduction. All TTCs have now invested in snus (and recently in pure nicotine), yet both early and recent snus test markets appear to have failed, and little evidence was found in TTCs' corporate materials that snus is central to their business strategy.
Conclusions
There is clear evidence that BAT's early interest in introducing SLT in Europe was based on the potential for creating an alternative form of tobacco use in light of declining cigarette sales and social restrictions on smoking, with young people a key target. We conclude that by investing in snus, and recently nicotine, TTCs have eliminated competition between cigarettes and lower-risk products, thus helping maintain the current market balance in favour of (highly profitable) cigarettes while ensuring TTCs' long-term future should cigarette sales decline further and profit margins be eroded.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die from cancer, heart disease, and other tobacco-related diseases. In recent years, to reduce this growing loss of life, international and national bodies have drawn up various tobacco control conventions and directives. For example, the European Union (EU) Directives on tobacco control call for member states to ban tobacco advertising, promotion, and sponsorship and to adopt taxation policies aimed at reducing tobacco consumption. The 2001 EU Tobacco Products Directive also bans the sale of snus, a form of smokeless tobacco (SLT), in all EU countries except Sweden. Snus, which originated in Sweden in the early 19th century, is a moist tobacco product that is placed under the upper lip. Although snus is considerably less harmful than smoking, the sale of snus was banned in the EU in 1992 because of fears that it might cause cancer and was being marketed to young people. When Sweden joined the EU in 1994, exemption from the ban was made a condition of the membership treaty.
Why Was This Study Done?
Transnational tobacco companies (TTCs) have been investing in European snus manufacturers since 2002 and more recently in pure nicotine products, and it has been suggested that, faced with declining cigarette markets in Europe and elsewhere, TTCs are preparing for a “post-cigarette era”. Since 2008, TTCs have been lobbying EU member states and the European Commission to remove the ban on snus sales, arguing that public health would be improved if governments allowed potentially reduced-harm products like snus onto the market. At the end of 2012, however, the European Commission proposed that the ban on snus sales should be continued. Here, to help inform this controversial policy debate, the researchers explore the interest of TTCs in SLT and pure nicotine in Europe from the 1970s to the present by examining internal tobacco documents and compare these interests with public claims of support for harm reduction made by TTCs.
What Did the Researchers Do and Find?
By searching the Legacy Tobacco Documents Library (internal tobacco industry documents released following US litigation cases), the researchers identified 416 documents that detail the historical interest of TTCs in SLT and pure nicotine and their efforts to enter European markets, and to influence national and EU public-health policy. The researchers analyzed these documents using a “hermeneutic” approach—methodical reading and re-reading of the documents to identify themes and sub-themes. Finally, they used TTC investor presentations and other documents to confirm these themes and to provide recent data on TTC investment in SLT. British American Tobacco (BAT) explored the opportunities for marketing SLT products in Europe from 1971 onwards. This exploration was driven by regulatory threats and health concerns, both of which were likely to impact tobacco sales, and by the potential to create a new form of tobacco use among people no longer interested in taking up smoking. TTCs did not begin to invest in SLT, however, until 2002, a time when EU cigarette sale volumes started to decline, smoke-free legislation was being introduced, and tobacco harm reduction first became a major public-health issue. All the TTCs have now invested in snus even though snus test markets appear to have failed and even though there is little evidence in corporate materials that snus is central to the business strategy of TTCs.
What Do These Findings Mean?
These findings suggest that BAT's early interest in SLT in Europe was driven by business concerns and was based on the potential for creating an alternative form of tobacco use among people—particularly young people—who would no longer take up smoking because of health concerns. They also suggest that TTC investments in snus were defensive—by buying up snus manufacturers and more recently nicotine producers, TTCs have eliminated competition between cigarettes and lower-risk products, thereby helping to maintain the current market balance in favor of cigarettes while ensuring the long-term future of TTCs should cigarette sales decline further. Although these findings are limited by the possibility that some relevant documents may have been omitted from this analysis, they nevertheless raise the concern that, if TTC investment in SLT continues, competition between cigarettes and SLT will reduce the potential for harm reduction to benefit public health. Legalization of snus sales in the European Union may therefore have considerably less benefit than envisaged.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001506.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control, an international treaty for tobacco control; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
Details of European Union legislation on the manufacture, presentation, and sale of tobacco products is available (in several languages)
Wikipedia has pages on tobacco harm reduction and on snus (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The Legacy Tobacco Documents Library is a searchable public database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and their tactics to influence tobacco regulation
doi:10.1371/journal.pmed.1001506
PMCID: PMC3769209  PMID: 24058299
16.  The Toxic Effects of Cigarette Additives. Philip Morris' Project Mix Reconsidered: An Analysis of Documents Released through Litigation 
PLoS Medicine  2011;8(12):e1001145.
Stanton Glantz and colleagues analyzed previously secret tobacco industry documents and peer-reviewed published results of Philip Morris' Project MIX about research on cigarette additives, and show that this research on the use of cigarette additives cannot be taken at face value.
Background
In 2009, the promulgation of US Food and Drug Administration (FDA) tobacco regulation focused attention on cigarette flavor additives. The tobacco industry had prepared for this eventuality by initiating a research program focusing on additive toxicity. The objective of this study was to analyze Philip Morris' Project MIX as a case study of tobacco industry scientific research being positioned strategically to prevent anticipated tobacco control regulations.
Methods and Findings
We analyzed previously secret tobacco industry documents to identify internal strategies for research on cigarette additives and reanalyzed tobacco industry peer-reviewed published results of this research. We focused on the key group of studies conducted by Phillip Morris in a coordinated effort known as “Project MIX.” Documents showed that Project MIX subsumed the study of various combinations of 333 cigarette additives. In addition to multiple internal reports, this work also led to four peer-reviewed publications (published in 2001). These papers concluded that there was no evidence of substantial toxicity attributable to the cigarette additives studied. Internal documents revealed post hoc changes in analytical protocols after initial statistical findings indicated an additive-associated increase in cigarette toxicity as well as increased total particulate matter (TPM) concentrations in additive-modified cigarette smoke. By expressing the data adjusted by TPM concentration, the published papers obscured this underlying toxicity and particulate increase. The animal toxicology results were based on a small number of rats in each experiment, raising the possibility that the failure to detect statistically significant changes in the end points was due to underpowering the experiments rather than lack of a real effect.
Conclusion
The case study of Project MIX shows tobacco industry scientific research on the use of cigarette additives cannot be taken at face value. The results demonstrate that toxins in cigarette smoke increase substantially when additives are put in cigarettes, including the level of TPM. In particular, regulatory authorities, including the FDA and similar agencies elsewhere, could use the Project MIX data to eliminate the use of these 333 additives (including menthol) from cigarettes.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The tobacco industry in the United States has recognized that regulation of its products was inevitable as early as 1963 and devoted increasing attention to the likelihood of regulation by the US Food and Drug Administration in the mid-1990s, which finally became law in 2009. In addition, the World Health Organization (WHO) Framework Convention on Tobacco Control (WHO FCTC), which came into force in June 2003, includes provisions addressing the regulation of the contents of tobacco products and the regulation of tobacco product disclosures. Although these steps represent progress in tobacco control, the events of the past few decades show the determination of the tobacco industry to avoid regulation, including the regulation of additives. In the United States, executives of the tobacco company Philip Morris (PM) recognized the inevitability of regulation and responded by initiating efforts to shape legislation and regulation by reorganizing its internal scientific activities and conducting scientific research that could be used to shape any proposed regulations. For example, the company conducted “Project MIX,” a study of chemical constituents in and toxicity of smoke produced by burning cigarettes containing three different combinations of 333 cigarette additives that “were constructed to resemble typical commercial blended cigarettes.” The resulting four papers published in Food and Chemical Toxicology in January 2002 concluded that there was no evidence of substantial toxicity attributable to the cigarette additives studied.
Why Was This Study Done?
The use of cigarette additives is an important concern of the WHO, FDA, and similar national regulatory bodies around the world. Philip Morris has used the published Project MIX papers to assert the safety of individual additives and other cigarette companies have done similar studies that reached similar conclusions. In this study, the researchers used documents made public as a result of litigation against the tobacco industry to investigate the origins and design of Project MIX and to conduct their own analyses of the results to assess the reliability of the conclusions in the papers published in Food and Chemical Toxicology.
What Did the Researchers Do and Find?
The researchers systematically examined tobacco industry documents in the University of California San Francisco Legacy Tobacco Documents Library (then about 60 million pages made publicly available as a result of litigation) and used an iterative process of searching, analyzing, and refining to identify and review in detail 500 relevant documents.
The researchers found that in the original Project MIX analysis, the published papers obscured findings of toxicity by adjusting the data by total particulate matter (TPM) concentration. When the researchers conducted their own analysis by studying additives per cigarette (as was specified in the original Project MIX protocol), they found that 15 carcinogenic chemicals increased by 20%. The researchers also reported that, for unexplained reasons, Philip Morris deemphasized 19 of the 51 chemicals tested in the presentation of results, including nine that were substantially increased in smoke on a per cigarette basis of additive-added cigarettes, compared to smoke of control cigarettes.
The researchers explored the possibility that the failure of Project MIX to detect statistically significant changes in the toxicity of the smoke from cigarettes containing the additives was due to underpowered experiments rather than lack of a real effect by conducting their own statistical analysis. This analysis suggests that a better powered study would have detected a much broader range of biological effects associated with the additives than was identified in Philip Morris' published paper, suggesting that it substantially underestimated the toxic potential of cigarette smoke and additives.
The researchers also found that Food and Chemical Toxicology, the journal in which the four Project MIX papers were published, had an editor and 11 of its International Editorial Board with documented links to the tobacco industry. The scientist and leader of Project MIX Edward Carmines described the process of publication as “an inside job.”
What Do These Findings Mean?
These findings show that the tobacco industry scientific research on the use of cigarette additives cannot be taken at face value: the results demonstrate that toxins in cigarette smoke increase substantially when additives are put in cigarettes. In addition, better powered studies would probably have detected a much broader range of adverse biological effects associated with the additives than identified to those identified in PM's published papers suggesting that the published papers substantially underestimate the toxic potential combination of cigarette smoke and additives.
Regulatory authorities, including the FDA and similar agencies elsewhere who are implementing WHO FCTC, should conduct their own independent analysis of Project MIX data, which, analyzed correctly, could provide a strong evidence base for the elimination of the use of the studied additives (including menthol) in cigarettes on public health grounds.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001145.
For PLoS Medicine's own policy on publishing papers sponsored by the tobacco industry see http://www.plosmedicine.org/static/policies.action#funders
The World Health Organization (WHO) provides information on the Framework Convention on Tobacco Control (FCTC)
The documents that the researchers reviewed in this paper can be found at the Legacy Tobacco Documents Library
doi:10.1371/journal.pmed.1001145
PMCID: PMC3243707  PMID: 22205885
17.  Political dynamics promoting the incremental regulation of secondhand smoke: a case study of New South Wales, Australia 
BMC Public Health  2006;6:192.
Background
The history of governmental responses to the accumulation of scientific evidence about the harms of secondhand smoke (SHS) presents an intriguing case study of incremental public health policy development. Australia has long been considered a world-leader in progressive tobacco control policies, but in the last decade has fallen behind other jurisdictions in introducing SHS legislation that protects all workers. Bars, clubs and pubs remain the only public indoor spaces where smoking is legally permitted, despite SHS exposure in the hospitality industry being higher and affecting more people than in any other setting after domestic exposure. This paper examines the political dynamics that have shaped this incremental approach to SHS.
Methods
In-depth interviews with 21 key stakeholders in the state of New South Wales (NSW), including politicians, their advisors, health officials and tobacco control advocates, were conducted and subjected to thematic content analysis. Interviewees' comments provided insights into the dynamics surrounding the debates and outcomes of SHS legislative attempts and the current political environment, and about how to progress SHS legislation.
Results
SHS restrictions have been delayed by several broad factors: the influence of industry groups successfully opposing regulation; issue wear-out; and political perceptions that there is not a salient constituency demanding that smoking be banned in bars and clubs. Interviewees also provided suggestions of strategies that advocates might utilise to best overcome the current political inertia of incremental compromises and achieve timely comprehensive smoking bans.
Conclusion
Advocates concerned to shorten the duration of incremental endgames must continue to insist that governments address SHS fundamentally as a health issue rather than making political concessions to industry groups, and should broaden and amplify community voices calling on governments to finish the job. Publicity to the growing number of state and national governments that have successfully implemented total bans over the past decade is likely to make incrementalism an increasingly unattractive political option.
doi:10.1186/1471-2458-6-192
PMCID: PMC1560380  PMID: 16859560
18.  International trade law, plain packaging and tobacco industry political activity: the Trans-Pacific Partnership 
Tobacco Control  2013;23(1):e1.
Tobacco companies are increasingly turning to trade and investment agreements to challenge measures aimed at reducing tobacco use. This study examines their efforts to influence the Trans-Pacific Partnership (TPP), a major trade and investment agreement which may eventually cover 40% of the world's population; focusing on how these efforts might enhance the industry's power to challenge the introduction of plain packaging. Specifically, the paper discusses the implications for public health regulation of Philip Morris International's interest in using the TPP to: shape the bureaucratic structures and decision-making processes of business regulation at the national level; introduce a higher standard of protection for trademarks than is currently provided under the Agreement on Trade Related Aspects of Intellectual Property Rights; and expand the coverage of Investor-State Dispute Settlement which empowers corporations to litigate directly against governments where they are deemed to be in breach of investment agreements. The large number of countries involved in the TPP underlines its risk to the development of tobacco regulation globally.
doi:10.1136/tobaccocontrol-2012-050869
PMCID: PMC3888632  PMID: 23788606
Global health; Tobacco industry; Public policy; Packaging and Labelling; Globalisation
19.  Effect of the California Tobacco Control Program on Personal Health Care Expenditures 
PLoS Medicine  2008;5(8):e178.
Background
Large state tobacco control programs have been shown to reduce smoking and would be expected to affect health care costs. We investigate the effect of California's large-scale tobacco control program on aggregate personal health care expenditures in the state.
Methods and Findings
Cointegrating regressions were used to predict (1) the difference in per capita cigarette consumption between California and 38 control states as a function of the difference in cumulative expenditures of the California and control state tobacco control programs, and (2) the relationship between the difference in cigarette consumption and the difference in per capita personal health expenditures between the control states and California between 1980 and 2004. Between 1989 (when it started) and 2004, the California program was associated with $86 billion (2004 US dollars) (95% confidence interval [CI] $28 billion to $151 billion) lower health care expenditures than would have been expected without the program. This reduction grew over time, reaching 7.3% (95% CI 2.7%–12.1%) of total health care expenditures in 2004.
Conclusions
A strong tobacco control program is not only associated with reduced smoking, but also with reductions in health care expenditures.
Stanton Glantz and colleagues find that the California state tobacco control program is associated not only with reduced smoking, but with reductions in health care costs as well.
Editors' Summary
Background
According to the World Health Organization (WHO), tobacco causes 1 in 10 adult deaths worldwide and is the leading preventable cause of death in the world. In 2005, tobacco caused 5.4 million deaths, which amounts to one death every 6 seconds. It is estimated that by 2030, annual deaths from tobacco use will be 8 million worldwide. Eighty percent of these deaths will occur in the developing world.
Exposure to secondhand tobacco smoke is also a major health concern, as it can cause cancer, heart disease, and respiratory illness. An estimated 200,000 workers die annually from exposure to smoke at work, according to the International Labour Organization.
In 2008, the WHO released a report on the global tobacco epidemic, which provided a comprehensive analysis of tobacco use and control efforts. It revealed that not a single country fully implements all key tobacco control measures. The report also stated that governments around the world collect 500 times more money in tobacco taxes each year than they spend on anti-tobacco efforts.
The California Tobacco Control Program (CTCP) is a state-funded public policy intervention established in 1989. Its goal is to decrease tobacco-related diseases and deaths in California by reducing tobacco use across the state. The program is focused on adults and social norm change rather than on adolescent tobacco use prevention, on the premise that the “next generation cannot be saved without changing the generations who have already reached adulthood.”
Why Was This Study Done?
The success of large public health programs, especially those that counter the tactics of powerful industries such as the tobacco industry, require funding. The justification of public spending on these initiatives should be evidence driven. While the success of the CTCP in reducing smoking was known, it was not yet clear whether the program had reduced health care costs. The researchers investigated the effect of the CTCP on personal health care expenditures in the state. Their findings can provide useful information for the development of other tobacco control initiatives.
What Did the Researchers Do and Find?
Using the statistical approach of cointegrating regressions, the researchers modeled the relationships between per capita tobacco control expenditures, per capita cigarette consumption, and health care expenditures. They analyzed data from 1980 and 2004 on smoking, health care expenditures, and exposure to a tobacco control educational program in California and compared them to a group of 38 control states. Control states were those without comprehensive tobacco control programs prior to 2000 or cigarette tax increases of $0.50 or more per pack over the study period. This comparison allowed the researchers to assess the effect of the CTCP on total personal health care spending.
The researchers found that US$86 billion (95% CI $28 billion to $151 billion) were saved in personal health care expenditure between 1989, the start of the program, and 2004. This generally grew over time, reaching 7.3% of the total in 2003–2004. The personal health care expenditure savings represented about a 50-fold return on the $1.8 billion spent on the program during the same period (all 2004 US dollars).
The researchers report that 3.6 billion (95% CI 1.5 billion to 5.9 billion) fewer packs of cigarettes were sold between 1989–1990 and 2003–2004. This represents a loss of $9.2 billion (95% CI $3.8 billion to $14.7 billion) to the tobacco industry in pre-tax cigarette sales.
These cost savings occurred despite the substantial diversion of funding and decreased purchasing power experienced by the CTCP, particularly in the mid-1990s. (The program was funded with a constant tax of $0.05 per pack, despite inflation). The researchers estimated that if the funding, and thus purchasing power, had been maintained, total savings in personal health expenditures would have increased to $156 billion with an additional $70 billion in health cost savings. Cigarette consumption would have dropped to an estimated 6.6 billion packs.
What Do These Findings Mean?
The CTCP has been successful in reducing smoking in California in comparison to other states, and has reduced personal health care expenditures. These cost reductions were substantial, rapid, and grew over time. The researchers contend that the CTCP's focus on social norm change among adults, not primarily on youth prevention, is responsible for such rapid and large reductions in disease and the associated health care costs. They state that a program focused on primary prevention of smoking among adolescents would take decades to have any impact on tobacco-induced diseases, which rarely manifest among adolescents or even young adults. These researcher's findings support the establishment of strong tobacco control programs in other settings: they not only reduce smoking, prevent disease, and save lives, but also represent an important way to curb rapidly increasing health care expenditures in the short term.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050178.
The California Tobacco Control Program provides information about its social change approach
The WHO MPOWER strategy, detailed in the 2008 Report on the Global Tobacco Epidemic, outlines the six most effective policies to help curb the epidemic
Resources to help people quit smoking can be obtained through the US Centers for Disease Control and the UK National Health Service
doi:10.1371/journal.pmed.0050178
PMCID: PMC2522256  PMID: 18752344
20.  Public health foundations and the tobacco industry: lessons from Minnesota 
Tobacco Control  2004;13(3):228-236.
Objective: To investigate whether private foundations can be created in a way that will insulate them from attacks by the tobacco industry, using the Minnesota Partnership for Action Against Tobacco (MPAAT) as a case study.
Design: Information was collected from internal tobacco industry documents, court documents, newspapers, and interviews with health advocates and elected officials.
Results: The creation of MPAAT as an independent foundation did not insulate it from attacks by tobacco industry allies. During 2001–2002, MPAAT was repeatedly attacked by Attorney General Mike Hatch and major media, using standard tobacco industry rhetoric. This strategy of attack and demands for information were reminiscent of previous attacks on Minnesota's Plan for Nonsmoking and Health and the American Stop Smoking Intervention Study (ASSIST). MPAAT was ultimately forced to restructure its programme to abandon effective community norm change interventions around smoke-free policies and replace them with less effective individual cessation interventions. Neither MPAAT nor other health advocates mounted an effective public response to these attacks, instead relying on the insider strategy of responding in court.
Conclusion: It is not possible to avoid attacks by the tobacco industry or its political allies. Like programmes administered by government agencies, tobacco control foundations must be prepared for these attacks, including a proactive plan to educate the public about the principles of community based tobacco control. Public health advocates also need to be willing to take prompt action to defend these programmes and hold public officials who attack tobacco control programmes accountable for their actions.
doi:10.1136/tc.2003.006866
PMCID: PMC1747907  PMID: 15333877
21.  “Key to the Future”: British American Tobacco and Cigarette Smuggling in China 
PLoS Medicine  2006;3(7):e228.
Background
Cigarette smuggling is a major public health issue, stimulating increased tobacco consumption and undermining tobacco control measures. China is the ultimate prize among tobacco's emerging markets, and is also believed to have the world's largest cigarette smuggling problem. Previous work has demonstrated the complicity of British American Tobacco (BAT) in this illicit trade within Asia and the former Soviet Union.
Methods and Findings
This paper analyses internal documents of BAT available on site from the Guildford Depository and online from the BAT Document Archive. Documents dating from the early 1900s to 2003 were searched and indexed on a specially designed project database to enable the construction of an historical narrative. Document analysis incorporated several validation techniques within a hermeneutic process. This paper describes the huge scale of this illicit trade in China, amounting to billions of (United States) dollars in sales, and the key supply routes by which it has been conducted. It examines BAT's efforts to optimise earnings by restructuring operations, and controlling the supply chain and pricing of smuggled cigarettes.
Conclusions
Our research shows that smuggling has been strategically critical to BAT's ongoing efforts to penetrate the Chinese market, and to its overall goal to become the leading company within an increasingly global industry. These findings support the need for concerted efforts to strengthen global collaboration to combat cigarette smuggling.
Editors' Summary
Background.
Smoking tobacco kills about 5 million people around the world every year, and according to the World Health Organization, half of the people who smoke will eventually die as a result. The habit is in decline in most of the world's richer nations, but it is growing in developing countries. Governments can control consumption, and raise substantial tax revenues, by levying high taxes on tobacco. However, this is undermined when tobacco is smuggled into the country and sold illegally. Smuggling makes cigarettes more affordable, thus stimulating consumption, and undermines efforts to reduce smoking rates.
  British American Tobacco (BAT) is one of the largest international tobacco companies. Following a legal case in the United States, millions of pages of BAT internal documents (dating back to the early 1900s) have been made public. They are held in a depository in the United Kingdom, and most can now be seen online. Researchers have already undertaken wide-ranging studies of these documents and have drawn conclusions about the way BAT has sought to enter emerging markets throughout the world.
Why Was This Study Done?
Previously published studies have concluded that BAT has been “complicit” in large-scale cigarette smuggling, described in documents by the euphemisms “transit,” “general trade” (“GT”), “duty not paid” (“DNP”), and “free market.” This study focuses on such activities in China, which is believed to have the world's biggest tobacco smuggling problem. China is a key market for BAT and other tobacco companies because of the size of its population, high smoking prevalence, and rapidly growing economy. The development of effective tobacco control policy in China constitutes one of the greatest opportunities to advance global health. The State Tobacco Monopoly Administration is the only agency legally allowed to trade in tobacco in China.
What Did the Researchers Do and Find?
The authors have put together an account of the company's trading in China in the period from 1986 to 1999. They begin by describing the scale on which tobacco was smuggled into China and the main supply routes through which tobacco entered the country. They found evidence that smuggling increased considerably during the period.
  The researchers found that BAT's own documents describe the company's efforts to improve its earnings from China by restructuring operations and controlling the supply chain—that is, how cigarettes are manufactured and legally exported, are handled by various “agents” or middlemen, and then are sold illicitly as contraband. The title of this article is taken from one BAT document that states that exports from Hong Kong to China are the “key to the future” of the company's planned growth. The researchers say that this can be taken to mean smuggling, and that BAT's documents indicate that the company benefited from, encouraged, and attempted to control the smuggling of tobacco into China.
What Do These Findings Mean?
BAT has stated publicly that it does not approve of smuggling. However, from the researchers' analysis of the information in the internal papers, they conclude that “the documents demonstrate that contraband has been a hugely profitable and integral part of BAT operations in China over the past two decades.” They estimate that the value of the illicit trade amounts to billions of (United States) dollars and go on to say that “for the Chinese government, this illicit trade undermined restrictions on imports, represented an enormous loss of tax revenue, and stimulated demand for premium brand cigarettes.” The researchers argue that action should be taken internationally to reduce tobacco smuggling.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030228.
• Most of the documents used in this paper can be found at the British American Tobacco Documents Archive created by public health researchers (the Web site also contains useful information on tobacco document research)
• The Tobacco Free Initiative, based at the World Health Organization, provides information on the global scale of the tobacco problem, and about efforts to combat the situation
• Many countries have national anti-smoking organizations; the United Kingdom charity Action on Smoking and Health has a useful list of these
• Information about the dangers of smoking to personal health and advice on giving up the habit are available from the Web sites of the American Academy of Family Physicians and NHS Direct (United Kingdom National Health Service)
Internal documents from British American Tobacco demonstrate the scale of tobacco smuggling into China and show that this illicit trade has been a critical factor in BAT's expansion in this market.
doi:10.1371/journal.pmed.0030228
PMCID: PMC1502159  PMID: 16834455
22.  A Comprehensive Review of State Laws Governing Internet and Other Delivery Sales of Cigarettes in the USA 
All U.S. states regulate face-to-face tobacco sales at retail outlets. However, the recent growth of delivery sales of tobacco products by Internet and mail order vendors has prompted new state regulations focused on preventing youth access and tax evasion. To date, there are no comprehensive and systematic analyses of these laws. The objectives of this study were to: (1) document the historical enactment of the laws; (2) assess the nature and extent of the laws; and (3) conduct preliminary analyses to examine the relationship between states with laws and other factors that might predict enactment of or be impacted by these laws. Between 1995 and 2006, thirty-four states (67%) enacted a relevant law, with 23 states’ laws (45%) enacted between 2003 and 2006. Four states banned direct-to-consumer shipment of cigarettes. The remaining 30 states’ laws included a combination of requirements addressing minimum age/ID, payment issues, shipping, vendor licensure and related issues, tax collection/remittance, and penalties/enforcement. States with delivery sales laws also have stronger state excise tax rates, youth access to tobacco policies, and state tobacco control environments as well as higher cigarette excise tax revenue, past month cigarette use rates, and perceptions of risk of use by adolescents. This paper provides the policy context for understanding Internet and other cigarette delivery sales laws in the U.S. It also provides a systematic framework for ongoing policy surveillance and will contribute to future analyses of the impact of these laws on successfully reducing youth access to cigarettes and preventing tax evasion.
doi:10.1080/14622200701838232
PMCID: PMC4263913  PMID: 18236290
23.  Offshore Finfish Aquaculture in the United States: An Examination of Federal Laws That Could be Used to Address Environmental and Occupational Public Health Risks 
Half of the world’s edible seafood comes from aquaculture, and the United States (US) government is working to develop an offshore finfish aquaculture industry in federal waters. To date, US aquaculture has largely been regulated at the state level, and creating an offshore aquaculture industry will require the development of a new regulatory structure. Some aquaculture practices involve hazardous working conditions and the use of veterinary drugs, agrochemicals, and questionable farming methods, which could raise environmental and occupational public health concerns if these methods are employed in the offshore finfish industry in the US. This policy analysis aims to inform public health professionals and other stakeholders in the policy debate regarding how offshore finfish aquaculture should be regulated in the US to protect human health; previous policy analyses on this topic have focused on environmental impacts. We identified 20 federal laws related to offshore finfish aquaculture, including 11 that are relevant to preventing, controlling, or monitoring potential public health risks. Given the novelty of the industry in the US, myriad relevant laws, and jurisdictional issues in an offshore setting, federal agencies need to work collaboratively and transparently to ensure that a comprehensive and functional regulatory structure is established that addresses the potential public health risks associated with this type of food production.
doi:10.3390/ijerph111111964
PMCID: PMC4245654  PMID: 25415208
Exclusive Economic Zone; federal regulations; fish farming; food production; food safety; occupational health; ocean policy; offshore aquaculture; public health; seafood
24.  Development and destruction of the first state funded anti-smoking campaign in the USA 
Tobacco Control  2003;12(2):214-220.
Background: Minnesota was the first state in the USA to implement a large state funded tobacco control programme (in 1985). Despite evidence of effectiveness, it was dismantled in 1993.
Objective: To describe and analyse how and why these events transpired and identify lessons for tobacco control advocates facing similar challenges in the 21st century.
Design: Case study based on previously secret tobacco industry documents, news reports, research reports, official documents, and interviews with health advocates and state government officials.
Results: Unable to defeat funding for this campaign in 1985, the tobacco industry organised groups which eliminated it later. Despite the programme's documented effectiveness, it was dismantled based on claims of fiscal crisis. These claims were not true; the real debate was what to do with the state's surplus. Health advocates failed to challenge the claim of fiscal crisis or mobilise public support for the programme.
Conclusions: Simply quoting evidence that a tobacco control programme is effective does not ensure its continuing survival. Claims of fiscal crisis are an effective cover for tobacco industry efforts to dismantle successful programmes, particularly if health advocates accept these claims and fail to mobilise political pressure to defend the programme.
doi:10.1136/tc.12.2.214
PMCID: PMC1747722  PMID: 12773734
25.  State Foodborne Illness Surveillance and Response Laws: Compilation and Analysis 
Objective
To document and assess the variation in state legislation relating to foodborne disease surveillance and outbreak response for all 50 states and the District of Columbia by creating a database and appendix of laws and regulations that will be made available to researchers and policymakers.
Introduction
Foodborne illnesses sicken 48 million and kill 3,000 Americans every year, presenting an enduring threat to the public’s health. In just the past three years alone, the United States has experienced at least four major multistate outbreaks in food. Despite this growing problem, efforts to prevent foodborne illness pose a particular public health challenge due in part to the widely variable laws governing foodborne illness surveillance and outbreak response. The recent passage of the Food Safety Modernization Act (FSMA) presents an opportunity for researchers, program managers, and policy makers to assess and correct the legal barriers that may hinder states in effectively implementing the FSMA’s vision with regard to increased state and local capacity for surveillance and outbreak response.
Methods
We conducted a systematic review and analysis of laws and regulations relating to foodborne illness surveillance and outbreak response in all 50 states and the District of Columbia, using the following methods: (1) we created a database to record state laws and regulations relating to foodborne illness surveillance and outbreak response in all 50 states and the District of Columbia; (2) we conducted a basic gap analysis of state foodborne illness surveillance and outbreak response laws and policies collected in the database; and (3) we conducted case study analyses of previous multistate outbreaks from 2008–2011.
Results
Through compilation of the state foodborne illness surveillance and outbreak response laws and regulations and analysis of previous multistate outbreaks, we are able to present trends, variations, and gaps in the legislation that directly impacts the ability of public health officials to conduct foodborne outbreak investigations. We also present policy recommendations for strengthening state laws and regulations.
PMCID: PMC3692918
Surveillance; Foodborne disease; Outbreak response; Public health law; Legal preparedness

Results 1-25 (1304951)