Changing the Tobacco Use Management System - Wiley Online Library

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Changing the Tobacco Use Management System: Blending Systems Thinking with Actor–Network Theory 550

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David Young Cancer Council Victoria Ron Borland Cancer Council Victoria Ken Coghill Monash University Abstract Managing “wicked” issues like the tobacco epidemic is addressed using a combination of Open Systems Thinking (OST) and Actor–Network Theory (ANT). OST was used to construct a model of the tobacco problem as a management system acting in a broader environment. This highlighted several problems with the current system but provided no mechanism for reform. ANT, the “sociology of translation,” was used for understanding how change occurs. Unlike systems thinking, ANT focuses the contest for change on heterogeneous networks of human and nonhuman actors that must be constructed through a process of defining and defending models of change, building alliances, gaining public acceptance, and finally achieving institutional acceptance of the reform (or of some compromise). We then show how this dual approach can shed light on a current challenge in controlling tobacco, the issue of product regulation, and the broader issue of harm reduction versus harm elimination. KEY WORDS: health policy, tobacco control, systems thinking, actor–network theory, public health

Introduction

The late 20th century and early 21st century have been characterized by the recognition of issues and problems, sometimes called “wicked” problems (Rittel & Webber, 1973), that cannot be managed by a single organization, jurisdiction, or domain. Governments (e.g., Commonwealth of Australia, 2007; which specifically identifies the tobacco control harm reduction debate as a wicked problem) and other decision-making systems are beginning to realize that these problems require new management strategies. Apart from aspects of tobacco control, other wicked problems include management of the global carbon cycle in the face of climate change and impending resource constraints, management of global financial systems, and management of global security. Wicked problems are hard to solve, at least in part, because optimal solutions for one set of interests threaten the interests of others, and being multifaceted, no simple solution will suffice. In fact, solving a wicked problem is an iterative process, Funding Information This project is was primarily funded by the inaugural Sally Birch Fellowship in Cancer Control, offered under the auspices of The Cancer Council Australia. It also received funding from the Australian Research Council Linkage Project LP0669043 conducted by Monash University in partnership with The Cancer Council Victoria.

Review of Policy Research, Volume 29, Number 2 (2012) 10.1111/j.1541-1338.2011.00550.x © 2012 by The Policy Studies Organization. All rights reserved.

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where early “solutions” are best treated as opportunities to more fully understand the complexity of the problem, rather than definitive answers. If, initially, a simple solution offers itself, it is almost certainly wrong. The capacity for human action to resolve these problems is a function of the extent to which human choice contributes to the causal processes involved, our capacity to envisage possible solutions, and the number of systems that need to be engaged with in order to deliver the solutions. Problems like cigarette consumption, which are only embedded in a relatively small number of systems, may be among those that are easier to resolve and could thus serve as a model for tackling even more complex problems. The globalization of the mass production and marketing of cigarettes has led to the situation where about 30 percent of the global population over 15 years of age smokes, with over 80 percent of these smokers in developing economies, countries that lack the infrastructure to either resist, or treat the victims (World Health Organisation, 2006a). Smoking is also associated with disadvantage within countries. For example, in developed countries, the smoking rates among disadvantaged groups can be as much as three times higher than those found among professionals (Smith & Leggat, 2007). Tobacco use has created an enormous health problem. In 2006, it was estimated that cigarettes killed five million people (World Health Organisation, 2006a), and if current trends persist, they will kill ten million people per year by 2020, with 70 percent of those deaths in developing countries (Mackay, Eriksen, & Shafey, 2006). The pioneering studies of the effects of tobacco on human health were conducted mainly in the 1950s (Doll & Hill, 1954; Wynder, 1997), and by the 1960s, it had been established that tobacco use is the largest single preventable cause of premature mortality around the world, increasing the risk of cancer, emphysema, heart disease, stroke, and other diseases (Boyle, Gray, Henningfield, Seffrin, & Zatonski, 2004). While there have been significant advances in tobacco control in the past two decades, especially in developed countries (Boyle et al., 2004), for almost every action taken by public health authorities and tobacco control organizations, there has been resistance from forces aligned with the tobacco industry (McDaniel, Intinarelli, & Malone, 2008). The tobacco industry operates internationally, and while it modifies its approach as needed to adapt to local conditions, many of its strategies span national boundaries. Therefore, for countries to implement effective tobacco control strategies nationally, there is a clear need for international cooperation: to do what they cannot do alone (e.g., confront smuggling), to facilitate knowledge transfer, and to set up surveillance systems to enable interventions (e.g., cessation programs) to be monitored and comparisons to be made. Since the 1990s, there has been progress in the global management of the problem. For example, since 1993, it has been World Bank policy not to lend money for tobacco production or marketing, but it will do so for antitobacco activities (World Bank, 1993). In 2005, the World Health Organization (WHO) “Framework Convention on Tobacco Control” (FCTC, 2003) came into force (World Health Organisation, 2007a). This is the first international law from the WHO, and among its many articles, the Framework Convention on Tobacco Control (FCTC) requires parties to impose policies with demonstrated effectiveness, including restrictions on advertising, sponsorship, and promotion; regulation of the packaging and labeling

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of tobacco products; establishment of smoke-free regulations for indoor public spaces (e.g., work-places, restaurants, public transport, and bars); and strengthening legislation to limit smuggling. It is explicitly an evidence-based treaty. The FCTC also includes a strong role for input from civil society, particularly through a group called the Framework Convention Alliance, a coalition of nongovernmental organizations (NGOs) with an interest in health that has influenced both the form and implementation of the convention. The focus the FCTC has brought to the problem, and its ramifications in developing countries, has excited interest from philanthropists, e.g., the philanthropic Bloomberg “Worldwide Stop Smoking Initiative” (WHO, 2006b), the largest ever injection of funds into tobacco control. As of October 2010, 172 countries, representing over 80 percent of the world’s population, had ratified the FCTC (World Health Organisation, 2010). The convention provides an international coordinating mechanism for national tobacco control initiatives and an indication of direction for those initiatives but is not a mechanism for the “central management” of tobacco control. While the FCTC is expressed as a set of obligations, because countries can choose to opt out, or not sign new protocols (obligations), the ultimate jurisdiction remains with sovereign states. Furthermore, even when implementing agreed policies, each national jurisdiction still brings its local interpretations and practices to bear. In order to understand the challenges of managing tobacco use, a framework is required that begins with an acceptance of these fundamentally decentralized decision-making processes and how they are facilitated, and to some degree coordinated, by the FCTC guidelines and protocols. This article builds on work reported in Borland, Young, Coghill, and Zhang (2010) and Young, Borland, and Coghill (2010). It outlines a strategic framework for the management of the global tobacco problem, focusing on the policy innovations required to address the problem more effectively. In the next section, a social-ecology or open systems (Trist, Emery, & Murray, 1997) analysis of tobacco control is used to define the system–environment boundary, describe the component subsystems and key external forces that will codetermine the system’s future, and identify systemic problems. Following that, we employ Actor–Network Theory (ANT) (Latour, 2005), also known as The Sociology of Translation (Callon, 1986), to elaborate strategies for gaining acceptance for, and implementing, new tobacco control initiatives. We then combine systems thinking and ANT to suggest strategies for managing an intensely contested issue within tobacco control; the balance between harm reduction and cessation of use/harm removal. Where relevant, the applicability of this approach to other complex global issues is highlighted. A Socio-Ecological Framework The need for a systems approach to tobacco control has been recognized for some years (e.g., National Cancer Institute, 2007). We agree and have operationalized the main elements of tobacco control as an open system (Borland et al., 2010). From a systems perspective, aggregate tobacco use is the outcome of complex interactions between forces aimed at increasing use, and those aimed at decreasing use; the balance of which can be influenced by the policy framework provided by governments. The existence of policies to control tobacco, and programs to constrain its use, makes it useful to characterize the resultant complex of activities as a Tobacco

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TOBACCO USE MANAGEMENT SYSTEM Tobacco Use Control Sub-System

Nature of Tobacco Use Control Sub-System (e.g., well integrated, multi-level networks, population focus, mobilization of research )

System Rules

Activities of Tobacco Use Control Sub-System (e.g., quit-lines, nicotine replacement therapy, social marketing, policy advocacy to decision makers, scientific research about tobacco use)

Externalities Death Disease Health costs Tax revenues

System Constraints

Environment Whole of government at various levels (National, State, Local) Other supra-systems: especially Public Health, Economic/Commercial systems Mediating Systems Communications/media Science and scientific culture Broader social, political, technological, ecological dynamics

Regulatory Sub-System Functions of Regulatory Sub-System Currently compliance focused

Individuals Enacted Tobacco Control Instruments (e.g., smoke-free laws, health warnings, advertising bans, policy statements, taxation levels, age restrictions)

Tobacco Use (e.g., quit, cut down, attempt quit, change to other forms of nicotine, acquire knowledge about tobacco, effect of prices, effects of smokefree rules,)

Human Nature (e.g., social animal, with receptors for nicotine)

System Rules System Constraints Nature of Tobacco Industry Sub-System (e.g., a profit seeking, oligopoly, selling addictive substance, subject to corporations law, also growers, retailers, & those who benefit from tobacco use; casino operators, some bar owners )

Nature of the Product

Actions of Tobacco Industry Sub-System (e.g., selling tobacco, switch from cigarettes to other products, find allies, covert/ viral marketing, pay taxes, invest in tobacco friendly events & movies)

Tobacco Industry Sub-System

Figure 1. The Tobacco Use Management System in Context: A Framework for Investigating the Social Ecology of Tobacco Use

Use Management System (TUMS) (Borland et al., 2010). A management system is one that has a set of dynamically interrelated elements and a framework of processes and structures to constrain its activities toward an espoused goal; in this case, reducing the level of tobacco use, and/or the level of harm caused by use. It does this by a combination of constraints on the tobacco industry, such as restrictions on advertising and other forms of promotion; by acting directly on smokers, via taxes and laws to restrict where they can smoke; and indirectly through supporting such things as social marketing programs and cessation assistance. All management systems are open systems. They both influence, and are influenced by, external forces. In addition, the espoused goals of most complex systems are often vague and difficult to translate into meaningful performance measures (e.g., Is the goal of tobacco control harm minimization or use minimization? What precisely is it about global warming that we need to stop?). This lack of system specificity to achieve espoused goals and/or ambiguity over what constitutes the attainment of the espoused goals are characteristics of wicked problems. Figure 1 offers a description of how the TUMS operates. The outputs (actions/ behavior) of each subsystem are driven (or motivated) by three kinds of processes: • inputs from broader external (or environmental) influences;


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• the outputs of other subsystems; and • processes intrinsic to the nature of each subsystem, which can both motivate action independently and/or moderate the effects of inputs. These intrinsic processes are, currently, largely determined from outside the TUMS. Regulatory mechanisms can change the operations of systems in two ways: first, structural or process changes (changing how they do, what they do; changing or constraining the way they operate); and second, functional changes (changing what they do; changing their role, and/or their products). Systems can only change themselves within limits defined by their response repertoire, which also indicates the extent to which they are self-regulating. Furthermore, this repertoire becomes more limited as the system optimizes its capacity around responses that have proved successful in the past (Wilden, 1972, pp. 205–207). Where capacity does not exist, or has become limited, external forces are needed for system reform, either by imposing external solutions to solve a problem, and/or by making the system more dynamically adaptive. As presently constituted in all countries, the TUMS has very limited dynamic control (governance) of its internal functioning, this power being retained by central government that operates as an external influence and not as a part of the system. Evaluating a management system involves identifying the problems that contribute to gaps between the espoused goals of the system and its actual performance. In earlier work (Borland et al., 2010), an analysis of the TUMS identified two fundamental problems that jointly make the tobacco problem difficult (wicked): Humans are susceptible to nicotine addiction, and the most attractive form of nicotine delivery to users, the modern cigarette, is also the most harmful. Five systemic problems that constrain the effective management of tobacco use today were also identified. These are, at least in principle, amenable to resolution, but until potential solutions emerge, they may need to be accepted as ongoing and thus managed. People using tobacco products constitute the core of the TUMS. Their primary associations are with the tobacco industry (or their agents), and the number and strength of these associations, largely represented in tobacco use, defines the state of the system at any time. Addicted smokers are unable to act rationally with regard to the harms (Borland, 1997), and smokers weave smoking into everyday cultural practices and rituals thereby reinforcing the addiction, something exploited by industry marketing strategies (Martini & Sulistyowati, 2005; Reid, 2005; Young, Wilson, Edwards, Weerasekera, & Borland, 2010). This all means that it is self-deluding to frame the tobacco problem as a consequence of choices autonomous individuals make (choosing harmful products); rather it needs to be framed, at least in part, as an industry issue (supplying harmful products). The failure of the system of users and suppliers to act in the long-term interests of users provides the main rationale for external intervention by governments. Smokers, at least, seem to realize that they are stuck with a problem that is beyond their volitional control; they support further regulation (Young et al., 2007), even though this support is almost entirely passive. The tobacco industry subsystem currently retains a dynamic capacity to shape the tobacco market and its future. In most countries, it is dominated by a small

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group of cigarette companies, including Philip Morris (PM) and British American Tobacco. As commercial enterprises, they are motivated to maximize value to their shareholders, typically by maximizing profits through increased sales of their products, something diametrically opposed to the espoused goal of the TUMS. This incompatibility of goals means their public positioning is constrained because they cannot be seen to openly pursue their real goal. They are left to obfuscate, to delay action as long as possible, to undermine what they think will work, and to “responsibly” support tobacco control actions that they believe will be ineffective. They are not motivated to harm their customers; this is against their long-term interests. However, they need to attract and retain customers, so if the harm is far enough in the future (to allow time for a profit to be made), this is “acceptable” to them if the alternative is not having customers in the first place. The problems caused by the interaction between product “attractiveness” (i.e., addictiveness) and product harmfulness are massively amplified when they, in turn, interact with the corporate profit motive in a globalized market (systemic problem #1). This is an especially “wicked” confluence and as such is likely only to be broken by forceful external intervention. Until recently, the epidemiology of nicotine use has focused on the absolute harmfulness of tobacco, particularly cigarettes, rather than on relative harmfulness of nicotine delivery methods. However, experience in Sweden (in particular) has changed that (Foulds, Ramstrom, Burke, & Fagerström, 2003). It is now recognized that smokeless tobacco can be made far less harmful than smoked tobacco (Broadstock, 2007; Levy et al., 2004; Royal College of Physicians, 2007). The tobacco industry has now largely accepted that smoking is unacceptably harmful (Winston-Salem Journal, 2008, p. 1) and therefore, to be accepted as responsible marketers, they need to be seen to be working toward reducing the harmfulness of their products. Phillip Morris actively supported U.S. Food and Drug Administration (FDA) regulation of tobacco while concomitantly lobbying for restrictions on those powers (Benson, 2008; McDaniel, Smith, & Malone, 2006). Cigarette companies are also actively experimenting with less harmful alternatives, including buying up or partnering with smokeless tobacco companies (Craver, 2009). Concomitantly, driven by their need to maximize profit, they all continue to sell as many cigarettes as they can, especially in less developed countries without well-developed tobacco control infrastructure. The tobacco use control subsystem emerged as a foil to the tobacco industry. It does this primarily by providing interventions that help smokers to quit (information and cessation services) and nonsmokers to avoid starting. It began within not-for-profit organizations and governments but has now been joined in a loose alliance by pharmaceutical companies marketing cessation medications and purveyors of other cessation aids. It has limited capacity to respond adaptively to ongoing activities from the other subsystems and the external environment, and hence, its capacity to control tobacco use is constrained. Nevertheless, in many countries, its power has increased to the point where it has the capacity to reach smokers proactively through the mass media (National Cancer Institute, 2008) as well as offering an increasing range of cessation aids and vehicles for delivering them. This increase in functional capacity, from a reactive focus on individuals to a more proactive focus on populations, is the one area of tobacco control where


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functional change has been widely adopted. However, it remains fundamentally constrained by lack of resources. Tobacco control infrastructure, apart from that created through the sale of cessation aids and health insurance policies, relies on government support, but this support is typically not tied to achievements (systemic problem #2). The health costs of smoking and the savings from effective control are treated as externalities and do not feed back into resources for prevention. In some jurisdictions, this structural problem has been at least partly addressed by linking resourcing of tobacco control to the estimated reduction in health-care costs produced through prevention of smoking and/or encouragement of cessation, e.g., via Health Maintenance Organizations in the United States, or the recent Council of Australian Governments agreement to link health funding to the achievement of tobacco prevalence reductions. The other role assumed by the tobacco control subsystem is to advocate for rules to further constrain the industry. This oppositional role tends to produce a strong “them and us” framing epitomized by “the scream test” (Chapman, 2007): the idea that if the industry screams, then the initiative must be worthwhile; and if they do not (or even worse, if they support a policy), it must be flawed. While this may help keep the diverse coalition of interests together, it can become problematic as anti-tobacco forces and the industry are, in truth, interdependent, and interdependent subsystems need to be able to switch between cooperation and competition as the situation requires. Newton (2002) makes a similar point about the environment movement. When regulators begin to consider policies that address functional changes (in addition to the traditional structural interventions) that would necessitate dialogue with the industry, such as product regulation, tobacco control networks are caught in a quandary (systemic problem #3). Traditionally, the response has been to stalemate any attempts to change rules around product modification for fear of the industry benefiting. One symptom of stalemated systems is that there is a remorseless focus on means (structures/ processes) at the almost complete expense of ends (functions), something Maruyama (1982) refers to as a “goal moratorium.” This phenomenon has been documented within the tobacco control subsystem by Sweanor (2008) and Young, Borland, and colleagues (2010). In most countries, governance lies outside the TUMS. Indeed, in many, responsibility for implementing the various pieces of tobacco control legislation/regulation is not located in one central agency (systemic problem #4). In most places, governments are reliant on advocacy from within the tobacco control subsystem to identify areas where they need to act, as there is inadequate capacity within their rudimentary regulatory arms. This is beginning to change. In 2009, the U.S. Food and Drug Administration (FDA) was given regulatory control over tobacco products, and some aspects of marketing, to add to its role controlling cessation medications. This is an important step, but it has no capacity to change the nature of the industry nor to coordinate prevention and cessation efforts. It remains to be seen as to whether it will be able to develop the strategic capacity it needs to provide direction for the TUMS. The interaction between a powerful, profit-driven tobacco industry, on the one hand, and on the other, a relatively weak tobacco control subsystem and a regulatory structure reliant on sections of the tobacco control subsystem to initiate

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strategic thinking creates a climate of mutual distrust, limiting capacity to find any common ground. Regulatory agencies require the capacity to strategically analyze the system they control and the problem it is designed to manage, with an evaluation capacity that feeds back progress into the development of new solutions (e.g., International Agency for Research on Cancer [IARC], 2008). Ideally, regulators should have the powers to do all that is necessary to achieve the system goals. However, governments have a broader responsibility to other social values that are as highly, or more highly, valued (e.g., economic stability), and they need to ensure that the TUMS is constrained from acting in ways that threaten these values. Like all open systems, the actions of the TUMS are codetermined by external forces, including key suprasystems within which parts of the TUMS are embedded. The two main ones are the public health system, which sets higher-order goals for the tobacco use control subsystem, and the economic system, which largely determines the goals of the tobacco industry and also has a significant influence on overall government policy. Currently, both would need to be engaged in attempts to change the TUMS in any fundamental way but because neither is fully engaged by the issue and they have incommensurable goals, gaining consensus can be difficult. Other suprasystems can become involved in specific issues. For example, to address the issue of tobacco smuggling (FCTC Article 16), members of the TUMS will need to engage with the Customs and Excise function of the justice suprasystem. Managing the broader dynamics is difficult. The relevant agents (systems) need to be brought together and consensus achieved for changes in fundamental system properties to occur. This can be easier to achieve when there is a crisis (e.g., the current realignment of the rules for global finance). However, the slow, complex, process being followed in the pursuit of effective tobacco control, or climate change management, reveals just how difficult is the task of engaging adaptively with these forces because of their competing priorities and the different perspectives they bring. The tension between the interests of suprasystems interacts with the lack of self-regulatory capacity in the TUMS to create conditions where endemic stalemate for enacting functional change is likely at both system and governmental levels (systemic problem #5). The unwillingness of governments to delegate appropriate agency to the TUMS means it is unable to act in a concerted manner to achieve its stated objectives. There are other forms of external influence on the TUMS that include “mediating systems” such as the media and science, which provide tools used by the system, and broader external trends (social, political, technological, ecological, and so on) that all systems are subject to. These can change existing balances, for example, the Internet and other means of transnational communication have allowed the industry to exploit new promotional opportunities in countries where many other means have been effectively prohibited and, as we shall see, our changing understanding of how tobacco causes its harms is transforming the way the tobacco industry operates. As noted earlier, tobacco use produces externalities (e.g., disease and death and tax revenue) that are not managed by the TUMS. This decoupling allows tobacco companies to profit from selling tobacco and to avoid paying for the longer term


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health costs. While health costs are being creatively linked to the tobacco control subsystem in some places, thereby providing a framework for accessing resources, a major ongoing challenge is to find ways to reshape the TUMS at a system level so that it can effectively manage these externalities. Producing change in such a wicked system is complex. The systems approach is good for problem diagnosis and the identification of possible solutions through the analysis of a system in context. The first and most critical step in system reform is to identify the goals the system needs to pursue (including new or revised ones) and to work out what systemic changes are required to most effectively achieve the most ambitious goals. This search should be wary of simple solutions (either prohibition, or leaving the problem to “market forces”) as they can actually be counterproductive. The search also requires analyzing the implications that both goals and mechanisms have for interdependent interests, e.g., the impact on employment in the tobacco industry, impacts on tax revenues, and the changed amenity value of smoke-free places. Truly adaptive systems should have an inbuilt and dynamic capacity to produce the internal changes that are needed to achieve their goals (i.e., they should be autopoietic). Our analysis demonstrates that fundamental changes are needed in all three subsystems of the TUMS for it to achieve its goals more effectively. It is reasonable to seek, or accept, compromise only after what is in principle achievable has been worked out because only then can one assess what opportunities are being foregone. However, this approach does not provide any real insight as to why the theoretically ideal solution is not the one that is always adopted. Negotiating a solution via policy innovations and other forms of adaptive change (as opposed to reactive change) cannot be accommodated by traditional systems approaches. Adaptive system change is the outcome of a social process, within which a range of heterogenous elements (e.g., human actors, resources, institutions, and instruments of authority) are “translated” (Callon, 1986; Latour, 2005, pp. 106–109) away from their formal subsystem roles and realigned with, or entrained on, a socio-ecological (system-in-context) strategy. It also involves partial engagement (“weak links”; Newton, 2002) with an even wider range of external actors, including other organizations, groups, institutions, and publics that have sufficient interest in the outcome to become involved. In the next section, a framework for enacting adaptive change (ANT, or The Sociology of Translation) is outlined. Actor–Network Theory Actor–Network Theory (Latour, 1999, 2005; Law, 1992; Law & Hassard, 1999) provides a comprehensive model of innovation processes, and it can be used to help us understand how systems make both structural and functional changes as well as overcome stalemates and system rigidity. We have argued that system change necessarily involves, first, going beyond system boundaries and, second, dealing with a heterogeneous range of actors/stakeholders. ANT is the framework for doing this. It is noteworthy that definitions of wicked problems (Commonwealth of Australia, 2007; Rittel & Webber, 1973) also identify these two prerequisites for dealing with such problems. ANT is the only integrated framework that we are aware of that

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enables these requirements to be met as a matter of course as well as being the most comprehensive in its coverage of the policy innovation process. Therefore, we have chosen to use it, as opposed to other extant frameworks. ANT has a distinctive ontology (Harman, 2009) that it claims resolves the longstanding “wars” between agency (actor) and structure (network), micro and macro (actor–network), nature and culture (through the concept of hybrid objects; Latour, 1988) and, most strikingly, human and nonhuman. In the case of this latter resolution, which has not gone unchallenged, ANT’s semiotic roots are reflected in the concept of the actant, a relationally defined role, that both human actors and nonhuman entities (e.g., financial resources, instruments of power, scientific evidence) play in the propagation of actor–networks. This ability to account for the many and varied elements contributing to successful innovation makes it easier to evaluate why success and failure emerge in different settings. ANT is also a planning tool, providing a framework to go beyond systems thinking and work out how to negotiate the necessary change and/or some acceptable compromise. However, ANT is not a predictive tool; while it can help identify opportunities for progress, it cannot be used to predict outcomes. From an ANT perspective, producing effective tobacco control policies, or any novel intervention, is an innovation process that requires engagement with all the interests directly involved as well as with other affected groups. This engagement does not necessarily (or usually) map onto the roles actors play within systems (the TUMS in this case) or suprasystems. Young, Borland, and colleagues (2010) provide a detailed analysis of how this works with regard to the smoke-free places policy contest. An actor–network begins with the pursuit of a new goal (one that does not yet have an institutionalized system in place to deliver it) and evolves as it seeks to enroll others as participating actants. Where the new goal threatens existing groups, it almost always stimulates the development of counter networks or “anti programs” (Akrich, 1992; Latour, 1991) that seek to block the goal being sought and/or pursue alternative goals and/or solutions. The contesting networks then compete for allies, institutional sanction, public support, and both tangible and intangible resources until a stable resolution is achieved. As conceived by Latour (2005), the actor–network evolves and acts as a whole to produce the innovation (in this case a policy innovation). It is this integration of human and nonhuman agency into heterogeneous networks that can survive (or not) via ongoing translation and replication (and thereby become structures) that makes ANT so distinctive and where it adds significantly to a systemic understanding. One aspect of the ANT framework is schematized in Figure 2 (after Latour, 1999, pp. 99–111). The central core is referred to as “links and knots” because it represents the actants (knots) and the set of relationships between them (links) that first initiate the innovation, and then act to organize, and hold in place, all the activities along four “loops” (actually, engagements) that reach out into the broader context. In Latour’s original framework, the upper loop in Figure 2 is “mobilisation of the world” and refers to the requirement for the embryonic actor–network to link with, and mobilize, a whole range of nonhuman resources (e.g., intangible resources like scientific evidence and supporting theories, and tangible resources like technologies, money, and venues) in order to produce an innovation. Mobilization represents “all


Mobilization of Instruments, Evidence & Framings of the Issue

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Links and Knots

Autonomization of the Issue & its Framing, Institutionalization of Solutions

Public Opinion: Level of Social Acceptance

Competition for Allies

Figure 2. The Key Processes in an Actor–Network Theory Analysis

the means by which non-humans are progressively loaded into discourse.” (Latour, 1999, p. 90) For the management of systemic issues such as tobacco control and climate change, the key resources are: knowledge about the problem (particularly scientific evidence), the frameworks (theories/ideas) that make sense of the evidence, and the technologies or processes that could be used to assess and/or solve the problem. The evidence and ideas mobilized understandably reflect the interests of the protagonists and are mobilized consistent with their priorities. The mobilization process becomes a dynamic interplay between evidence and arguments in ways that constrain which arguments will come to dominate the discourse and, consequently, how actions/solutions (including the prospective innovation or the successful prevention of it) are framed. The resolution of the arguments is not completely determined by their internal coherence and the evidence but is codetermined by the relative persistence and power of the actors engaged in the contest. Competing priorities for what is mobilized emerge out of the different values/ goals of the competing networks (e.g., tobacco control versus the industry), and this leads to the development of different narratives or stories. These competing stories are tightly woven webs of research findings, ideas, theories, and values directed at providing an understanding of the nature of the problem in ways that justify the proffered solutions. Their relative credibility is a function of: their internal coher-

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ence; the perspective from which they view the problem (which determines which issues are seen as critical); the quality of the science that can be mobilized and embedded within them (indicating truth value); and their capacity to engage potential audiences. Each protagonist in the battle will attempt to shape and or gather evidence to support their position, and this includes framing the issue in ways that make evidence supporting their narrative more central and evidence to the contrary less so. Sometimes the value of an innovation to a broader systemic issue can influence choice of solution over what might be adequate as a local solution. Thus, in the case of second-hand smoke (SHS), the tobacco control subsystem was attracted to solutions that had the greatest capacity to reduce active smoking as well, so bans on smoking in enclosed spaces was preferred to ventilation (a priori). The net contribution of science to the management of complex problems is a function of certainty and generalizability: Certainty (“immutability” in ANT terms) refers to the definitiveness of the science. Are there plausible alternative explanations of the facts? If real, is the problem significant enough to require new interventions and/or new approaches? Are there plausible alternative solutions that have not been adequately evaluated? Generalizability (“mobility” in ANT terms) addresses the question of whether the science applies here, or are “we” different? Context has a significant influence on both the amount, and the focus, of the science that is mobilized, and jurisdictional powers are often a constraint on generalizability. For example, where environmental law was the mechanism for implementing smoke-free rules, the focus could be on protecting everybody, whereas where occupational health and safety laws were used, the focus had to be on workers, so the health of people in general was no longer central. Cultural issues may also be important here. For example, Ireland, the first country to go completely smoke-free in public indoor places, did not rely on local science, being able to mobilize scientific evidence from other jurisdictions (Howell & Allwright, 2007). By contrast, the German scientific and political establishment perceives itself as unique and expects local evidence, thus constraining the introduction of external innovations until they are locally authenticated (Grning, Strnck, & Gilmore, 2008). The bottom loop, “alliance building” refers to the process by which a policy innovation is linked with allies who can weave it into extended networks (and their resources), while rejecting alliances with those likely to detract from its credibility and power, or who value competing outcomes. All innovation involves contests: over claims, diagnoses, responses and, importantly, over alliance partners. As allies are added, and others avoided, these links are loaded into the developing discourse about the innovation. Members of an alliance jointly determine its goals, and as alliances grow, the diversity of individual goals grows, so there is greater potential for compromise over solutions. This means there is a dynamic tension between having an alliance that may be strong enough to achieve its members’ goals and increasing its power with new members with the attendant risk that this could lead to compromises that might not be as desirable to the original members.


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Parallel with this, systems tend to be inherently conservative and will generally act to limit changes to those that are minimally disruptive to their own interests. Particular strategies may be seen as precedents for actions in other areas that the government may not want to contemplate (e.g., calls for parallel actions to control alcohol use; or support for toxin-reduced oral tobacco as a part of a harm minimization strategy that may conflict with broader ideological positions espoused by governments, like “zero tolerance” in drug control). Sometimes the ideal innovation is not pursued because of a reluctance to engage overlapping suprasystems that could successfully contest the change. The change that is pursued is thus limited to areas within the sphere of influence of supportive societal forces. Finding the right balance between breadth of solution and adequacy of support is always a challenge. Power within alliances is partly determined by how central each group is to the implementation of proposed solutions. Groups whose interests are peripheral to the specific focus of the changes being negotiated are vulnerable, as they cannot easily become lead negotiators and their interests may be compromised by focal groups whose key interests are different, even if marginally so. If the perceived impacts on the interests of central parties can be changed by arguments and/or evidence, then the allegiance of those parties is likely to shift, thus changing the balance of power. For example, in the fight for smoke-free recreational venues, the tobacco industry, which had a lot to lose, was marginalized, and they needed to find allies (e.g., bar/restaurant associations) who would act in their interests. However, once evidence was mobilized indicating that the fears of these groups were largely illusory, their initial support diminished, leaving the industry isolated. Strategically, this exemplified an indirect attack by the tobacco control subsystem on the industry’s weak flank (the alliance between the tobacco and hospitality industries). The “balance of opinion” loop is about gaining acceptance by individuals potentially affected; first, that a problem or issue exists, and second, that the putative innovation represents a desirable and feasible solution to the problem, or the best way of managing the issue. If the putative solution is not obviously and immediately a plus for all, then it has to be justified on a balance of interests (e.g., the “right to clean air” versus “the right to smoke”). Innovations will not succeed without acceptance, and in so far as policies are concerned, governments generally require some level of public acceptance before they are prepared to act. Alliances often expend considerable resources trying to market their positions to the public. The impacts on the public of early attempts at solutions are critical: positive effects in one place strengthens arguments for implementation elsewhere (and vice versa). Aspects of an innovation that arouse public concern include the implications for them and the perceived equity of the solution (Thrasher, Boado, Sebrié, & Bianco, 2009). Where public support translates into active support for coalitions (e.g., joining a group) and/or taking other actions (e.g., threatening to vote against a government), it will have a much stronger impact on decision makers than passive support, almost regardless of poll results. One feature of tobacco control is the lack of active engagement by tobacco users in policy debates. The final loop, “autonomization” and “institutionalization” refers to the process by which authoritative acceptance of, and institutional support for, an innovation emerges. Young, Borland, and colleagues (2010) identified three major phases of innovative policy change: acceptance of the issue—that there is a problem and what

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it is (autonomization); the fight to establish the appropriate solution (or set of solutions); and the fight to institutionalize the agreed solution. The establishment of laws, regulations, and programs reflects institutionalization of solutions. These stages may feed back dynamically on each other before the innovation is fully institutionalized; for example, where initial attempts at solutions do not work as intended, things need to be rethought. The stage of the innovation strongly influences the sorts of ideas and evidence that need to be mobilized. Some issues come preautonomized because they are of obvious concern (e.g., road accidents and alcohol abuse). However, others like tobacco and global warming only become problems after science (epidemiology in this case) has identified the problem and brought it to public attention. Autonomization involves the process of convincing opinion leaders and relevant authorities that it is real (Reid, 2005). Successful policy innovation requires having a viable solution and then targeting the appropriate autonomizing and institutionalizing agents, which, in turn, requires a well-developed understanding of local, social, professional, and political norms. Simple innovations are easier to sell and institutionalize than more complex ones. Institutions seek the smallest possible change to minimize disruption, and hence they tend to do the minimum they think necessary to achieve the agreed goal. Accepting a compromised innovation that might corrupt its coherence is a risk: it may not work and/or it may lead to unintended complications (BBC News Europe, 2008; Grning et al., 2008). On the other hand, it may be necessary to gain sufficient support for the innovation to be accepted at all and may facilitate incremental progress toward more substantial change. Decision makers, especially in government, are more likely to autonomize problems, and institutionalize solutions, when they can see a critical mass of stakeholders being engaged by a specific solution, and alternatives have been marginalized. Governments are also more likely to support solutions that do not open up conflicts between important portfolios (e.g., between the health and economic portfolios), or threaten their ideological underpinnings (e.g., individual autonomy). Governments are also influenced by the science and public opinion, and when all these forces have “converged” (Newton, 2002), success becomes almost inevitable. In summary, for successful innovations, the interactions between the “links and knots” and the four loops need to produce a cascade of positive feedback toward the ultimate end point (Kenneth Arrow’s “Law of Increasing Returns” as cited in Arthur, 1994, p. 12), although it is often not the initial goal, but some transformed version of it, that becomes institutionalized. In the case of smoke-free places, the mobilization of scientific results and concepts into credible narratives reinforced the autonomization of SHS, establishing it as a problem requiring action and increasing public expectations of smoke-free conditions. This made the formation of powerful cross-sectoral alliances more likely (while weakening pro tobacco alliances), enabling powerful social marketing campaigns that helped to gradually denormalize public smoking; and leading to the establishment of some smoke-free places, which, in turn, stimulated more research which, when mobilized, motivated the institutionalization of comprehensive smoke-free conditions, and so on. Whenever a system is manifestly not achieving its espoused goals, actor–networks will try to reshape the system so it is more likely to achieve their version of its ultimate goal(s). The networks will not only include actors from within the sub-


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systems themselves (e.g., from the tobacco control subsystem developing a consensus around smoke-free regulations and mobilizing research that supports this consensus; from the tobacco industry subsystem attempting to develop consumeracceptable reduced harm products) but also networks of external actors (e.g., from whole of government, health and/or economic suprasystems) attempting to engineer changes in the structure or function of the system. The networks will also include actors from within subsystems but who are acting outside of their formal roles (e.g., from the tobacco control and industry sub-systems, see below). This is almost inevitable where functional change is concerned. The interaction of these competitive and cooperative (i.e., interdependent) forces determines which changes, if any, are ultimately institutionalized.

The Challenge of Harm Reduction In this section, Systems Thinking and ANT are used to organize our thinking about harm reduction. Within tobacco control, the issue has been autonomized for about 50 years but has been subject to as much controversy as within the broader drug control domain. In the years after smoking became established as a major health hazard (Royal College of Physicians, 1962; U.S. Surgeon General, 1964), there was some focus on the product and on efforts to reduce the level of toxins it delivered (Gray, 2000; King & Borland, 2004). It is now known that these early actions achieved little or nothing for health (National Cancer Institute, 2001, 2004). The industry rapidly discovered that when tar and nicotine levels dropped too far, smokers lost interest. Instead of accepting this, the industry adopted filter ventilation, an engineering technique that produced low tar and nicotine readings using standard machine-based testing but made it easy for users to compensate by smoking in a way that enabled them to get the levels of nicotine they craved, regardless of machine-tested yields (Koslowski, Frecker, Khouw, & Pope, 1980). To date, the TUMS has been unable to drive the development and sale of progressively less harmful tobacco products, a clear case of system failure. The “low tar”/“lights” convergence failed, in part, because it tried to reduce nicotine and other toxins in parallel, and smokers, seeking nicotine, rejected genuinely low tar products because they were also low in nicotine (Gray, 2000). Partly because of the failure of this attempt, partly because of the failure of the industry to come up with demonstrably less harmful cigarettes (that people would smoke), and partly because of a focus on the goal of gradual elimination, the tobacco control community lost interest in product regulation. The harm reduction actor–network collapsed. Over the past decade or so, there has been a renewed interest in product regulation for a variety of reasons including a desire to correct the errors of the “lights” fiasco, research showing that nicotine is only a minor contributor to the harms of tobacco use (Gray, 2008), an acceptance by some that tobacco use is going to be with us for longer than we had hoped, and the emergence of a range of new or modified alternative nicotine products (Lewis, 2009; Warner, 2005). This refocusing on products and harm reduction has generated significant friction within tobacco control networks (Warner, 2005), reinforcing polarization, and hence stalemate, over harm reduction. However, it is necessary to find a way forward.

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Any systematic harm reduction strategy for tobacco requires an effective system of product regulation, with the capacity to set yield limits on products and/or alter incentives in favor of less harmful alternatives (Britton & Edwards, 2008). This, in turn, requires standardized assessment measures that have a meaningful association with actual human exposures and comprehensive disclosure of product characteristics. Ideally, it should also have the capacity to control communications about relative harms and have control over product features that might mislead consumers into holding false harm-related beliefs (although this is likely to be limited). Consequently, it would be able to influence product marketing and to either phase out or actively discourage more harmful products in favor of less harmful ones. In most countries, the TUMS has little, if any, of this capacity. There are four important interrelated sets of product-related developments that are changing the context within which the TUMS operates, highlighting the need for reform. First, there is considerable variation in cigarette toxin levels so, clearly, some are higher in toxins than can be achieved (World Health Organisation, 2007b). An expert group at WHO (World Health Organisation, 2007b) has put forward a proposal to downregulate several of the main toxins, assessing toxin delivery per milligram of nicotine delivered, to deal with smokers titrating their dose. This measure, although not perfect (Hammond et al., 2007), is likely to be a reasonably accurate indicator of human intakes. To achieve such a progressive reduction in toxin levels would require a dynamic regulatory mechanism within the TUMS to monitor compliance and ensure the gradual reduction occurred. Second, some smokeless tobacco products, the best known of which is Swedish “snus” (Swedish for “snuff”), contain lower toxin levels than traditional forms (Hatsukami, Ebbert, Feuer, Stepanov, & Hecht, 2007). These smokeless products are far less harmful than cigarettes, or other smoked tobacco products, with this demonstrated for long-term use of Swedish snus (Broadstock, 2007; Levy et al., 2004; Martinet, Bohadana, & Fagerström, 2007). However, they are not harmless (Dachille & McNamara, 2008; Rodu & Jansson, 2004), and switching to them from cigarettes, instead of quitting, results in less health benefit than stopping nicotine use altogether (Tomar, Fox, & Severson, 2009). Snus has replaced smoking as the main nicotine delivery system among Swedish men but not women, and when it is added to smoked tobacco, tobacco use among Swedish men is much greater than in comparable countries (Foulds et al., 2003), so it seems that the availability of snus has increased total tobacco use. However, disease rates in Sweden are consistent with the level of cigarette use, not with total tobacco use. The Swedish gender difference in smokeless use is probably cultural because it is the preferred form of tobacco by women in South Asia and parts of Africa (Anderson, 2006). Third, products that vaporize nicotine without combustion, thus allowing it to be inhaled into the lungs in a relatively pure form, are being developed and marketed. These products remain largely untested in terms of toxicity and other effects (Laugesen, 2008) and are being banned in some countries, even though they are likely to be harm-reduced alternatives. Fourth, jurisdictions are increasing the range of approved uses of therapeutic nicotine replacement products (e.g., nicotine gum). These products are now available over the counter in many countries so there is no effective control over what users actually do with them. Even though they have been engineered to minimize


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consumer appeal, these products are now being used by a minority long term to help them stay off cigarettes, and/or because they are now dependent on this form of nicotine. Paradoxically, this class of products is more tightly regulated than cigarettes, so under current rules they need to demonstrate smoking cessation capacity before being allowed on the market, making this costly (Gray, 2008). These developments open up the possibility of smoked tobacco products being made somewhat less harmful, or even replaced by significantly less harmful nicotine products (Hall & Gartner, 2008; Royal College of Physicians, 2007; Warner, 2005), but the achievement of maximum public health benefit requires the TUMS to manage it appropriately. The U.S. legislation giving its FDA regulatory jurisdiction over tobacco is the most important response to date. Importantly, it resulted in part because actors from ostensibly competitive subsystems recognized their interdependency and cooperated to achieve a mutually acceptable compromise. In ANT terms, the FDA legislation represents the black-boxing (Latour, 1988) of a large actor–network into an institutionalized format. The United States is not the first country to legislate powers to regulate tobacco products, but it is the one most likely to have the capacity to use these powers to drive large-scale change. The new powers mean that in the United States, at least, the debate has shifted from: “do we need regulatory controls” to “does the legislation provide the powers needed to achieve the system goals.” The new debate requires an analysis of the constraints that remain and the potential for the newly dynamic system to work within those constraints. The new powers give the FDA some of the capacity needed to act as the regulatory subsystem of the TUMS. However, it does not fully engage the tobacco use control subsystem, and its powers over products are constrained by a focus on legality (allowing or prohibiting), rather than one that can vary incentives to shift use (e.g., through price). While the formal goals (i.e., the functions) of U.S. product regulation are specified by the FDA legislation, there is currently considerable uncertainty about how these goals will be realized, about the outcomes that will actually be produced, and about the broader implications for the TUMS as a whole. There is also uncertainty about the implications for other countries. This all means different outcomes are evoked in the minds of interested parties, and there is currently a battle going on over whose interests will dominate the translation process. For the FDA to get widespread support from the tobacco use control subsystem and its allies, these uncertainties will need to be addressed. However, before considering this, the tobacco industry’s response needs to be understood. Product regulation represents a threat to any tobacco company that cannot simultaneously comply with new regulations and maintain consumer demand for their products. Given this, some may well chose to resist any new rules for as long as they can, while those who can will adapt their portfolio toward less harmful options and away from products that will be aggressively discouraged (or eventually prohibited). Major cigarette companies have recently bought up smokeless tobacco companies (Rossel, 2009), or are developing strategic alliances with them (Craver, 2009). The then chief executive of Altria (PM’s parent company) Michael Szymanczyk told shareholders in May 2008 that, while Altria will still aim to build market share in a declining cigarette business, future success will depend on developing alternative products that will satisfy consumers and reduce health risks:

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As the company looks to the future, it has clear recognition of the fact that conventional cigarettes are harmful in society, and we’d like to make some progress on improving that situation. (Winston-Salem Journal, 2008, p. 1)

He clarified this statement by stating that PM USA will deal with fewer cigarette sales by capitalizing on its Marlboro brand and selling more smokeless products that it is now trying to do under the Marlboro brand. PM also made a public proposal forwarded to the U.S. Surgeon General regarding smokeless tobacco. Pointedly, the covering letter made the following claim: Members of the scientific, medical and public health communities in the United States and abroad have concluded, with increasing frequency, that the health risks of using smokeless tobacco, particularly low-nitrosamine smokeless tobacco (hereinafter “LN-SLT”) are substantially lower than the health risks of cigarette smoking with respect to lung cancer, chronic obstructive pulmonary disease, oral cancer, and other serious diseases. Philip Morris USA . . . therefore respectfully requests that the Office of the Surgeon General examine the applicable science discussed below and communicate to the public the relative health risks from the use of LN-SLT products compared to the health risks from smoking cigarettes. (Philip Morris, 2008, p. 2)

This is clever strategic positioning by PM. They can be seen as socially responsible by supporting regulation, while situating themselves to be competitive if, and when, fundamental change occurs. This is a lower-risk strategy for them than for other U.S. cigarette companies because they are the market leaders, and the FDA legislation is likely to effectively freeze the market in its current state until specific product regulations can be agreed on. As part of this repositioning, PM spun off its international arm. This allows for the continuation of its traditional behavior (i.e., selling cigarettes) in countries where product regulation is not on the agenda, without complicating their position where it is. This better positions PM to make the kind of functional changes that would enable it to compete in a harm reduction environment in the West, complemented by its potent armory of research and development resources. It enables them to construct a strategic framework within which the nicotine delivery mechanism can be translated differently (as a key actant in the reduced harm network and as the dominant actant in the aggressively expanding “business as usual” network) and in a way that maximally favors their interests (also see Gilmore, Britton, Arnott, Ashcroft, & Jarvis, 2008). It seems likely that PM’s active participation in the FDA legislation led to compromises that suited its interests (e.g., powers to ban flavorings are framed so as to make it more difficult to ban menthol). By contributing, PM has also made another strategic move, attempting to position its approach to tobacco use management as an obligatory passage point (OPP) (Latour, 1988, p. 43). In ANT parlance, any compulsory action (e.g., having to deal with PM in any negotiations concerning the regulation of tobacco), definition (e.g., defining “harm reduced” nicotine in ways that favor their product initiatives), or exclusion (e.g., menthol) is called an OPP, and as other actants move through, or to, the OPP, they effectively become allied with the key protagonist, and their network becomes more resilient, routine like, and durable. In this case, PM has defined an OPP around product attributes, not industry attributes, an outcome that clearly favors its position. Any actant that can successfully define and then control an OPP thereby becomes increasingly powerful


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and, eventually, indispensable. Creating an OPP is dependent on the ability of the key protagonist to enroll and persuade other actants, especially institutionalizing actants (e.g., governments, professional colleges), of the necessity/validity of the OPP. During the early unsuccessful attempts to engineer a “safer” (i.e., low tar) cigarette, the standard used was not a useful indicator of human exposure (Koslowski et al., 1980), but this was ignored, enabling what is now known as the ISO standard (ISO:TC126) to become an OPP. Debate therefore revolved around what levels of machine, not human, exposure were acceptable, resulting in the problem we have today. However, during the SHS debate, the tobacco use control subsystem’s response to SHS emerged as the OPP. Their framing of the possible solution was smoke-free conditions in public spaces. Other possible responses (enhanced ventilation, smoking areas, and “mutual respect”) were sidelined, and any negotiation invariably started from this point; the only variable was the question of degree. The debate about consequences was forced into a debate about the outcomes of this option, and once it was demonstrated that this option did not have the economic consequences that the industry predicted, the alliance between it and the recreation sector was decisively undermined, and the balance of power shifted comprehensively (and nonlinearly). The new industry positioning on harm reduction means that tobacco control networks now have even more reason to ask the question “where is tobacco control going?” and to respond with a comprehensive analysis and plan of their own, otherwise they are in danger of being rendered irrelevant as an alternative actor– network develops around PM’s initiatives. Any effective plan is likely to involve engagement with the industry, as they have some of the knowledge and resources (capacity to produce products) that may be essential for progress, a conclusion drawn by Nigel Gray, one of the elder statesmen of tobacco control (Gray, 2008), among others. This will require the establishment of what ANT calls “weak links” with the tobacco industry. This is a concept that transcends the simple dichotomy of either “getting into bed with the enemy” (common parlance for strong links) or “don’t give an inch” (implacable opposition). Newton (2002, p. 15), employing ANT to examine the present state, and the future, of the climate change issue argues that progress in the construction of “greening” networks, under the aegis of the Kyoto process, will be characterized by the development of weak links between some key actors who have, up to now, taken an oppositional stance. However, this collaborative position is incompatible with the use reduction/ “zero-tolerance” narrative that dominates tobacco control discourse. It tells of a heroic, David and Goliath war, between forces supporting human health and an irredeemably evil tobacco industry that will only be won when there is no more tobacco, and by implication, no more industry. In most countries, the tobacco industry is still controlled by the same companies that caused the problem, and collaborated in its perpetuation (Francey & Chapman, 2000), and any engagement with the industry is seen as a form of treachery. Concern also comes partly from a belief that the industry should be punished for their past conduct and a fear that once again (as with the low-tar fiasco) tobacco control forces will be misled, and thereby tricked into a solution aligned with tobacco industry goals, not those of public health. While tobacco companies should be punished for past

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wrongs, the risk of deception can be managed through strong disclosure requirements and ensuring nonindustry groups have the technical expertise necessary to evaluate industry claims. The harm reduction narrative is a story of transformation, rather than warfare, a nonzero-sum framing of tobacco control. Current tobacco companies or other entities with similar capacities will need to make the new products, and this alone will require a more dynamic relationship between regulators and the industry than currently exists. In order to resolve the conflict between these two perspectives and harness the energies of the entire movement around an effective actor–network to counter the one being constructed by PM, the subsystem will need to develop and articulate goals that can act as coordinating mechanisms. This was easy to do with SHS because the goal did not threaten to open up the fissure we have described above and was therefore not stalemated. However, in this case, the tobacco control movement will not only have to manage the proximal fissure, but also the underlying one that is increasingly evident between tobacco control and nicotine control; some key actors are committed to reducing/removing nicotine addiction, regardless of the delivery mechanism. This provides a double constraint on the formation of an effective regulation actor–network centered on actors from the tobacco use control subsystem; actor–networks must have a common espoused goal, and in this case powerful actors within the sub-system have different goals, and these differences have become central as the focus of regulation has turned to the product itself. Even if an effective strategy was developed in the United States and similar countries, effective product regulation can only occur where the industry and the government (through whatever regulatory agency it delegates responsibility to) both have the capability to act. There is a risk that movement toward harm reduction in countries like India, if successful, would effectively destroy most of the local industry (which lacks the technical capacity to comply), leaving the market open to sophisticated multinational companies that might be able to drive up demand in ways that would eliminate, or even reverse, any potential gains of reduced toxin products. Thus, for the foreseeable future, a prime focus on harm reduction should be restricted to those countries prepared, and able, to invest in the necessary product regulation infrastructure. This could be done either alone, or collectively, through mechanisms being developed by WHO to support the FCTC. A harm reduction agenda reduces concerns from outside the health suprasystem. A more managed approach to nicotine use reduces the immediate economic threat to those who are dependent on tobacco economically, including governments that in most countries reap large net tax excesses over identified tobacco-related costs. Even in countries where the capacity for product regulation exists, concerns remain about harm reduction strategies from within the health suprasystem. One set of concerns is that harm reduction moves the focus of tobacco control efforts from the distant goal of eliminating tobacco use to an acceptance of continued use for the foreseeable future (else why make products less harmful). It also complicates policy making because the lower harm products such as smokeless tobacco and new products like electronic cigarettes, while still being unacceptable longer term, may be encouraged short term. This also runs the risk that governments will be seen as endorsing products that are still harmful, as safe. Related to this, health professionals feel reluctant to endorse nontherapeutic products unless they can be considered


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completely safe. To avoid giving the impression that some forms of tobacco use are acceptable, it will be necessary to strengthen capacity to communicate the harmfulness of all long-term use to the public and to support cessation for all products the user needs help to stop using. Other concerns reflect deeply held values about ends, and therefore focus on future scenarios. Some think a focus on harm-reduced products might slow progress toward harm elimination. One argument is that “we are making progress doing what we are doing; all we need is more of the same and tobacco use will eventually die out, so why get distracted by a problem as difficult as harmminimization.” Furthermore, changing the focus to harm reduction could be interpreted as a recognition that current efforts have been inadequate (or at least represent only part of the solution), something that many find unpalatable. A stronger version of this argument is that “the solution” might make the problem worse. There is a scenario where the introduction of less harmful products leads to more overall nicotine use (probable), and this acts as a conduit to increased use of the most harmful (tobacco) products (unlikely), thereby increasing overall harm. In Sweden, at least, there has been net movement away from more harmful to less harmful forms (Foulds et al., 2003); however, this might not reflect what has been happening in the United States (Zhu et al., 2009). The probability of potential adverse effects is likely to be a function of users’ beliefs about the various products and incentives to use (e.g., differential taxation rates and/or marketing rules), both of which will be influenced by the specific form of product and industry regulation. Resolution of all these concerns, and agreement on outcomes, will not occur overnight. It will require coherent arguments, grounded and shaped by good evidence. This could be hastened by well-designed deliberative processes (Donahue, 2004; Hajer & Wagener, 2003; Salmon, 2007) that can be especially effective in cases where the mobilization of science is critical to decision making (Stern & Fineberg, 1996). Such an approach is widely adopted in the Nordic countries and recommended by the U.S. National Research Council (Stern & Fineberg, 1996). Addressing wicked problems inevitably involves collaboration (e.g., between governments, tobacco controllers, and those with the technical capacities to produce nicotine delivery products) and more effective regulatory frameworks for wicked problems could be developed by institutionalizing collaborative processes. The key questions to answer are: what is the highest priority for minimizing tobacco-related harms, how can this be achieved, and what can readily be achieved sufficiently close to the ideal to seed the “links and knots” of a successful policy/ regulatory innovation? There are three sets of issues that need to be resolved to work out how, and in what form, a harm-reduction agenda could be pursued, all affecting its potential viability. First, should the focus be on reducing the harmfulness of tobacco products as a whole, or should there be separate strategies for smoked and smokeless products? The latter would try to downregulate toxins in each class separately, while the former would imply attempts to move users toward nonsmoked forms of tobacco, as these are almost invariably less toxic than smoked forms. Related to this is the question of whether smokeless tobacco is a necessary part of the solution, or could the same outcome be achieved by restricting the options to medical quality nicotine products? The key here is the extent to which smokeless products can be established

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as feasible alternatives to smoked tobacco and under what circumstances. If they are always to be treated as separate types of products, then the strategy of using smokeless as an intermediate step will not be viable. The TUMS needs to be kept open to both kinds of approaches until the evidence is clear. Perhaps the Swedes should be encouraged to more strongly push snus as an alternative to cigarettes, as this is the country best placed to achieve it, if it is possible. The issue can be reduced to: what form, or forms, of reduced harm nicotine products, if any, can a critical mass of actors be aligned with, and assuming enough would, would this lead to better outcomes than alternative strategies? Second, the future form of the tobacco industry requires thought. Even though the industry subsystem lies at the heart of the problem, efforts to date have focused on constraining its activities (initially, mainly focused on marketing, and now with an increased focus on product attributes) but not on changing its nature. There is no a priori reason why the industry needs to continue in its current form; alternative models have been suggested (Borland, 2003, 2006; Callard, Thompson, & Collishaw, 2005) such as restricting tobacco to not-for-profit organizations. In countries where the government owns the tobacco industry, this could be done relatively easily by changing the charter of the industry to harm reduction. Where for-profit companies dominate the market, such changes will be more difficult to achieve. They are likely to be strongly resisted by the tobacco industry, so strong alliances from outside the TUMS, both from parallel systems and suprasystems, would be required to bring them to fruition. While it is patently obvious that the current mechanism for marketing nicotine in most countries (i.e., for-profit corporations) is inconsistent with the public health goals of minimizing harm and/or use, governments (and most tobacco control advocates) have not believed that changing the system was feasible; rather, they have tried to patch it up and seek progress despite it. However, in the context of a reconsideration of the merits of unrestrained markets, following the recent financial crisis, more and more people are looking for models of fundamental change, not for all corporations, but certainly for those that (potentially) do harm as a consequence of how they currently operate. Tobacco control advocates will need to continue to lead the development of better regulation and to work with national (e.g., FDA) or international (e.g., WHO) agencies to drive the necessary reforms. However, given the animosity that influential sections of the movement have exhibited toward these efforts, the capacity of tobacco control advocates to come up with a consensus position will be difficult. There is another reason for taking the issue of industry regulation seriously; PM’s success at making its own definition of the issue, and its position, an OPP that shifts the focus of the debate (understandably) away from the industry in general and onto specific products. Reenergizing the industry regulation issue would enable the tobacco use control subsystem to redefine the debate as one that concerns the end-to-end tobacco use process and to argue that reducing, or even removing the harm currently caused by tobacco must, of necessity, involve engagement with, and regulation of, the entire process. One of the appeals of restricting any substitution strategy to medical quality nicotine is the assumption that this would restrict potential negotiating partners to the pharmaceutical industry. However, this superficially appealing option may be


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flawed. If current therapeutic nicotine products are not attractive enough to replace cigarettes, innovation will be required to make more attractive ones. Work is happening in this regard, but it is not restricted to pharmaceutical companies. Furthermore, if nicotine were positioned as a recreational product (a substitute for cigarettes), rather than as a cessation aid, then different kinds of companies would seek to market it. Pharmaceutical companies would need to transform, or sell to other companies (most probably tobacco companies), who are prepared to compete for the consumer market, as nicotine would no longer be marketed as a medical product. The third main area requiring reform is the nature of the TUMS itself. Its form will be in part determined by decisions on the earlier two issues. For example, it will need less compliance infrastructure if the industry could be transformed to a more cooperative structural form. In employing the kinds of collaborative processes identified above to plan the future of the TUMS, consistent with moving users from the most harmful to the least harmful systems (in countries with the requisite capability), the following broad outcomes would be sought: a regulatory subsystem that is more than just a dynamic product regulatory regime for monitoring and standard setting. It needs to encompass the full functional potential of the TUMS (e.g., by coordinating product regulation, demand-shaping, counter-marketing, marketing and promotional restrictions, pricing (to the degree it has influence), cessation, prevention and, even, industry reorganization), while ensuring the system is adequately resourced. This necessitates coordination of the tobacco use control subsystem’s activities so they integrate with product regulation activities. There is currently a real possibility that product regulation could operate in isolation from the tobacco use control subsystem, which would not only limit integration, but also increase the risk of regulatory capture, or at least concern about it happening. Having tobacco use control interests actively engaged in regulatory decisions will be critical to the long-term success of any harm-reduction strategy. We accept that, given the large excise contribution to consolidated revenue in many countries, the TUMS could never have full control over tobacco pricing. Consequently, decisions about tax rates would not be a systemic responsibility, and influencing them will continue to require cross-boundary (ANT) processes. Finding an acceptable way forward will require that all actors (interests) be brought to the table. However, actors whose goals are intrinsically antithetical to problem definition (let alone solution development) may need to be kept at arm’s length from specific elements of the process. For example, in considering further constraints on product marketing, the tobacco industry may need to remain outside the process, as their goals are diametrically opposed to those of the society as a whole. However, in the case of product regulation to reduce harmfulness, the partial convergence of interests can provide the basis for progress. The importance of key players having options that allow them to participate is illustrated by the success of the Montreal Protocol negotiations (UNEP, 2000). A key determinant was that the patent holders of the Chlorofluorocarbons (CFCs) that caused ozone depletion also held the patents on the Hydrofluorocarbons (HFCs) that were to be employed to solve the problem. Thus, they could compromise without major loss. The tobacco industry is reshaping itself to be in a similar position regarding harm reduction for nicotine, at least in the United States.

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While the existing TUMS (or any system) is inadequate to solve the problem it is designed to manage, an external mechanism is required to drive the case for change. For tobacco, key elements of the actor network leading the advocacy for change and driving the research to support change come from either within the tobacco use control subsystem or are closely aligned with it (including the authors of this article). It is essential that this expertise is harnessed in any strategic dialogue, along with the inputs of other interests both within and external to the TUMS. Conclusions Functional and/or contested change is inevitably a negotiated process, and this requires leadership. The key role for leadership from or on behalf of a system is to establish an OPP for the negotiations that will avoid two managerial pathologies that wicked problems provoke: to limit the scope of changes to the minimum necessary to achieve consensus, an approach that runs the risk of being inadequate, and/or to stalemate until conditions change to allow a “pain-free” solution to emerge. An innovative technology (e.g., new nicotine delivery devices) or a new understanding of consequences, such as the emerging knowledge on relative product risks, can, of itself, provide the seed for change by tilting the balance within systems. However, because such changes do not oblige reconsideration of goals/functions, they are normally treated as part of the context for the ongoing management of the system, in order to achieve a predefined function. Functional change also requires leadership, rather than management, because it inevitably involves action outside of the system’s formal management structure. Nevertheless, the leaders must include people who understand the nature of the system that has to implement the changes to ensure it has the required capacity. Generating the political space for fundamental reform to occur where new knowledge fails to motivate change from within the system often requires an external “ambush,” or some crisis that challenges the value of managerial caution. Current economic conditions may offer a “once in a generation” crisis, heralded by the failings of current orthodoxies, and the search for new solutions for organizing the worlds’ institutions, including placing further responsibilities on for-profit corporations. Finding solutions to the tobacco problem, and other seemingly intractable problems, could become much easier in this environment. To implement change, leaders need to have sufficient power over the subsystems they are responsible for to act unilaterally in the interests of the broader system. Where they cannot, or where they operate outside the systems managerial structures, they must have the skills to negotiate with representatives of suprasystems and to build coalitions/alliances. Leadership from representatives of civil society (e.g., NGOs), concerned about the problem, but not institutionalized within current management systems, can play a critical role. They can act both to mobilize scientific knowledge in pursuit of solutions and build coalitions/alliances to influence and support the relevant institutionalizing agencies (national and/or transnational) to take the necessary actions. Where such institutions do not exist, they can coordinate lobbying for their creation. The analysis presented here on the tobacco problem has clear parallels with other issues, such as other lifestyle problems (e.g., the obesity epidemic), and


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environmental issues, such as climate change. Climate change is currently at a point where there is now a consensus that there is a problem (autonomization has occurred), and majority support (but not consensus) about some macro-level aspects of the solution (stabilizing atmospheric CO2 levels), but not about how to achieve this. When dealing with complex, transnational issues and problems of the kind discussed here, the social-ecological systems framework provides a comprehensive approach to define the issue or problem, to highlight the causal relationships that coproduce the problem, to proffer solutions based on this analysis, and to identify the key autonomizing and institutionalizing agents. Without using the social-ecology approach for problem definition and analysis, we are collectively limited to traversing furrows that have been imprinted on the social landscape by previous successes and failures; the scope for developing truly creative innovations is fundamentally constrained. Systems thinking helps us analyze the problem and work out what we need to do to manage it more effectively. However, systems analysis does not tell us how to get from where we are to where we need to be because this involves stepping outside the focal systems and violating internal and external boundaries because of the heterogeneous actants that need to be identified and engaged. This is not a managerial process; it is a leadership process (Bennis & Nanus, 1985). Solutions typically have different winners and losers, and the way the forces competing for their solutions operate to determine which solution is adopted (or whether action is stalemated), requires a different way of thinking. ANT provides a comprehensive map of the actants, and actions, involved in negotiating a solution. The common activity that links both frameworks is scientific research; first into the “what” (to underpin the socio-ecological analysis), then into the “how” (to underpin the ANT analysis), and finally into the “how well” (in order to underpin evaluation of the solution). By making these links, science also contributes to the kind of value directed stories, described above, that can play a critical role in justifying and explicating change. ANT is a less constrained mode of analysis than Systems Theory, which in turn, is less constrained than classical linear causal analysis. This means ANT can cast light on the messy, complex interactions that characterize situated change. ANT helps us understand the heterogeneous mechanics of successful and unsuccessful initiatives for implementing change and avoids the risks inherent in accepting “best practice” summaries emerging from single jurisdictions, single disciplines, and/or single systems. Understanding change as the operation of an actor–network enables us to extract trans-disciplinary, trans-system, and trans-subsystem learning from the network building processes involved, and then focus this learning on how a new actor–network can be best engineered to facilitate the solution sought. By explicitly identifying the competing needs and values, it also allows for negotiation about solutions that are sensitive to these issues, without compromising the integrity of the systemic change required. About the Authors David Young is the Inaugural Sally Birch Fellow in Cancer Control and Senior Social Scientist, Tobacco Control Unit, The Cancer Council Victoria. David has experience in

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academic, private, public, and NGO settings, carrying out strategic planning and research. His current work focuses on research-practice translation and innovation in cancer control. To this end he has been employing, and integrating, Systems Thinking and Actor-Network Theory. He has also been working on, and publishing about, the prevalence and attributes of RYO tobacco smokers and smokers’ attitudes to increased tobacco regulation. His recent articles appear in American Journal of Public Health, Journal of Translational Behavioural Medicine, Nicotine and Tobacco Research, and Tobacco Control. Ron Borland is the Nigel Gray Distinguished Fellow in Cancer Control, Tobacco Control Unit, The Cancer Council Victoria. Ron has worked for over 25 years at the Cancer Council. He has published over 250 peer-reviewed papers, mostly related to aspects of tobacco control. He is one of the Principal Investigators of the International Tobacco Control Policy Evaluation Project: an international collaboration currently active in over 20 countries. His work is designed to understand the impact on smokers of tobacco control policies, to help design better systems for regulating tobacco, and to research mass-disseminable strategies for helping smokers quit. Recent papers appear in Addiction, American Journal of Public Health, Family Practice, and Tobacco Control. Ken Coghill is an Associate Professor in the Department of Management, Monash University. His areas of expertise and interest are governance, parliamentary studies, and capacity building for elected officials. Recent articles appear in American Journal of Public Health, Governance-An International Journal of Policy and Administration, and Journal of Legislative Studies.

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