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4
Reducing Tobacco Use: A Policy Framework

The committee was charged with developing a blueprint for reducing tobacco use in the United States. As shown in Part I, a continued gradual decline in the prevalence of tobacco use can probably be expected over the next 20 years as a result of the social, economic, and demographic forces already at work. However, reductions in tobacco use substantial enough to eliminate tobacco use as a public health problem are not likely to occur if the nation simply waits for past successes to continue. Ending the tobacco problem will require the persistence and nimbleness needed to counteract industry innovations in marketing and product design, as well as the larger cultural and economic forces that tend to promote and sustain tobacco use, especially among young people. The challenge is heightened by the fact that heavy tobacco users may increasingly be harder to reach effectively with the customary tools of tobacco control. Any slackening of the public health response not only will reduce forward progress but also may lead to backsliding. Chapters 5 to 7 offer a detailed blueprint for strong remedial actions to reduce tobacco use and aiming, eventually, to erase tobacco as a significant public health problem. This chapter aims to establish the normative context for the blueprint that follows.

PRODUCT SAFETY AND CONSUMER SOVEREIGNTY

At bottom, the tobacco problem is a product safety problem. In an economic and social system that values freedom of choice, consumers are generally permitted to select products and activities as they see fit. If they want to assume risks, they are permitted to do exactly that. Government



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Ending the Tobacco Problem: A Blueprint for the Nation 4 Reducing Tobacco Use: A Policy Framework The committee was charged with developing a blueprint for reducing tobacco use in the United States. As shown in Part I, a continued gradual decline in the prevalence of tobacco use can probably be expected over the next 20 years as a result of the social, economic, and demographic forces already at work. However, reductions in tobacco use substantial enough to eliminate tobacco use as a public health problem are not likely to occur if the nation simply waits for past successes to continue. Ending the tobacco problem will require the persistence and nimbleness needed to counteract industry innovations in marketing and product design, as well as the larger cultural and economic forces that tend to promote and sustain tobacco use, especially among young people. The challenge is heightened by the fact that heavy tobacco users may increasingly be harder to reach effectively with the customary tools of tobacco control. Any slackening of the public health response not only will reduce forward progress but also may lead to backsliding. Chapters 5 to 7 offer a detailed blueprint for strong remedial actions to reduce tobacco use and aiming, eventually, to erase tobacco as a significant public health problem. This chapter aims to establish the normative context for the blueprint that follows. PRODUCT SAFETY AND CONSUMER SOVEREIGNTY At bottom, the tobacco problem is a product safety problem. In an economic and social system that values freedom of choice, consumers are generally permitted to select products and activities as they see fit. If they want to assume risks, they are permitted to do exactly that. Government

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Ending the Tobacco Problem: A Blueprint for the Nation does not guarantee absolute safety, nor should it. Of course, some dangers are too high to be acceptable. So long as consumers are properly informed, however, the presumption has traditionally been in favor of consumer sovereignty and freedom of choice. Yet, even most libertarians will admit that the tobacco market has been characterized by severe market failures, including information asymmetry between producers and users, distorted consumer choice due to information deficits, and product pricing that has not reflected the full social costs of the product’s use (especially the effects on nonsmokers). They acknowledge the legitimacy of interventions aiming to prevent youth smoking, to disseminate accurate information and correct misinformation, and to assure that nonsmokers are protected from involuntary exposure to tobacco smoke if the market does not function properly. The residual issue concerns the legitimacy of interventions that burden smokers’ choices for the purpose of getting them to quit. The overarching task for the nation is to consider thoughtfully how consumer freedom can be respected while also taking into account the unique properties of tobacco and tobacco products. The committee’s major goal here is to set forth a framework for reducing tobacco use, and its associated morbidity and mortality, while being duly respectful of the interests of consumers and the companies that satisfy consumer needs. THE POLICY CONTEXT During the first six decades of the 20th century, tobacco use became deeply embedded in the economic and cultural life of the United States and in many parts of the world, sowing the seeds of a massive public health problem. The prevalence of smoking among adults in the United States was 42 percent in 1965. The tide turned in the 1960s as the adverse health effects became known, but the prevalence of smoking among adults was still 21 percent in 2005. Absent a major initiative, the prevalence of smoking among adults is likely to level off in 2025 at about 15 percent (see Chapter 3). Aggressive policy initiatives were impeded for four decades by the tobacco industry’s political and legal strategy of denying and obscuring the addictive properties of nicotine and the real health effects of tobacco use. All this also was reinforced by widespread popular acceptance of consumer freedom to smoke (characterized by its defenders, somewhat ironically, as the “right to be foolish”). In retrospect, it is surprising and puzzling that strong measures to discourage smoking were regarded as unduly paternalistic even by people who otherwise might have been expected to favor strong consumer protection measures. Laissez-faire more or less prevailed despite the seriousness of the problem. Until the late 1980s, the operating assumptions of tobacco policy in the United States were rooted in the society’s general preference for individual

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Ending the Tobacco Problem: A Blueprint for the Nation liberty and freedom of choice, especially in matters that affect individual health. Thus, although it has been widely understood for many years that smoking poses serious health risks, the prevailing assumption was that the weighing of the benefits and the health risks of consumer products, including tobacco products, is up to the consumer and that government efforts to force people to make healthy choices would amount to an unacceptable form of paternalism. The underlying intuition is that people are and ought to be free to make their own choices and are responsible for the consequences of their choices. This perspective was also reflected in the unbroken line of jury verdicts and judicial decisions refusing to hold tobacco companies liable for smoking-induced disease and death among informed consumers. The first major change in tobacco policy was consistent with the antipaternalism principle and with traditional economic theory. The nonsmokers’ rights movement, which took root in California in the late 1970s, called attention to the fact that some of the costs of smoking are borne by third parties and urged lawmakers to adopt bans on smoking in public buildings and workplaces. The antismoking movement received a major boost when the U.S. Environmental Protection Agency classified environmental tobacco smoke as a carcinogen in 1992 (EPA 1992). Although the tobacco industry disputed the nature and the extent of the risks associated with exposure to sidestream smoke and continues to do so, the evidence documented suggesting the considerable health dangers of environmental tobacco smoke has been definitively summarized by the Surgeon General (DHHS 2006), and the moral legitimacy of smoking restrictions in enclosed public places is now taken for granted. In the late 1990s, the weaknesses in the libertarian point of view began to seep into public understanding and to transform the policy debate about tobacco. This profound change in the political dynamic occurred as a result of three intertwined developments. The first important development was a profound change in public understanding as the addictive nature of nicotine became scientifically established (DHHS 1989). The simultaneous proliferation of nicotine replacement treatments (NRTs) and other cessation tools, along with evidence of their effectiveness, helped to reinforce public understanding of the grip of nicotine addiction and the need for stronger measures to help people quit. This development also began to erode the anti-paternalism objection against efforts to reduce consumption directly on the grounds that many people who have become hooked would like to quit. The second convergent development was a concerted focus on the problem of smoking initiation. It became clear that almost all adult smokers began smoking as teenagers and that prevention of the initiation of smoking needed to be a core aim of tobacco policy. (Although it is not the only

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Ending the Tobacco Problem: A Blueprint for the Nation aim, prevention of smoking initiation is essential if the nation is to achieve a long-term permanent reduction in prevalence.) Understanding of nicotine addiction as a “pediatric disease” (Kessler 1995) also strengthened the ethical case for aggressive efforts to reduce smoking initiation by teenagers, even if the measures also had spillover effects on adult smokers. Reports by the Surgeon General and the Institute of Medicine in 1994 established the scientific foundation for a youth-oriented policy initiative (eventually spearheaded by Food and Drug Administration [FDA] Commissioner David Kessler in 1995) and also galvanized public opinion against the tobacco industry for targeting young people (DHHS 1994; IOM 1994). Third, the state Medicaid lawsuits and other tobacco litigation led to revelations of industry deception and duplicity and confirmed the industry’s role in fostering and perpetuating tobacco use. These disclosures weakened the force of the antipaternalism principle as a constraint on tobacco policy and eroded the supposition that smokers have freely assumed the risks of smoking and are responsible for the often fatal consequences. Instead of being a champion of individual freedom and consumer sovereignty, the tobacco industry is now more often seen as a vector of disease and death, bringing public understanding into alignment with the premises of the public health community. In sum, over the past 15 years, the operating assumptions of tobacco policy in the United States and elsewhere in the world have changed dramatically in part because of the fundamental realization that tobacco use is grounded in addiction to nicotine and that nicotine addiction typically begins before smokers become adults. Most smokers actually start smoking and become addicted while they are adolescents; and most addicted adult smokers want to quit, try to quit, and would rather be nonsmokers. The deeper public understanding of tobacco addiction has, over a short time, transformed the ethical and political context of tobacco policy-making. A widespread popular consensus in favor of aggressive policy initiatives is now emerging, and this shift in popular sentiment has also been accompanied by support across most of the political spectrum (see material in Chapter 5 on the proliferation of state laws and local ordinances prohibiting indoor smoking and on increases in state tobacco excise taxes). THE ETHICAL CONTEXT The committee believes that this shift in popular sentiment rests on a solid ethical footing, and that the blueprint is securely grounded in either of two ethical frameworks. From a traditional public health perspective, the legitimacy and importance of reducing tobacco use is grounded in the enormous social costs attributable to tobacco-related disease: reducing tobacco use increases over-

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Ending the Tobacco Problem: A Blueprint for the Nation all population health. Implementing the blueprint would reduce tobacco use and the attendant social costs to a degree that exceeds the costs of the proposed interventions. Moreover, studies of cost-effectiveness show that the tobacco control interventions are less costly per year of life saved and per quality-adjusted life year than many other standard public health interventions (see, for example, Cromwell et al. 1997; Tengs et al. 2001; Warner 1997). Admittedly, these traditional public health calculations do not include the “savings” to society in health care costs or social security payments attributable to premature death, but the committee does not regard these “savings” as a social benefit. Once the question of “savings” due to premature mortality is set aside, the “public health” case for aggressive, cost-effective measures is generally acknowledged to be a powerful one. The main ethical objection raised to tobacco control policies has been raised by people who eschew the public health paradigm in favor of a non-consequentialist ethical paradigm grounded in an analysis of individual rights. In the context of tobacco use, the rights-based framework most often invoked is libertarian. The committee recognizes that strict adherents to this perspective may resist any regulation of consumer products, including tobacco, that is not designed to promote informed choice or to reduce external harms. However, product regulation is common in many domains, dating at least to the Pure Food and Drug Act of 1906, and certain characteristics of tobacco products might make tighter control acceptable even to those who tend to embrace a libertarian approach toward regulation of most consumer products. We outline those characteristics next. The first point to be noted is that, even within a libertarian framework, each of the subsidiary goals of tobacco policy has some justification: reducing exposure to ETS prevents harm to people other than the smokers themselves, preventing initiation of tobacco use by youth is arguably justified by the recognized shortcomings of adolescent judgment, and promoting cessation helps to restore the liberty of smokers who do succeed in quitting (rather than contracting their liberty). In this respect, it is important to recall that 90 percent of adult smokers eventually regret having become smokers, about 70 percent have tried to quit, and—at any given moment— 40 percent are either actively trying to quit or thinking about making a quit attempt within the next six months (see Chapter 2). The most ethically controversial policies aiming to reduce tobacco use are those aimed exclusively at reducing use by the minority of adult smokers who do not want to quit. This is the nub of the so-called paternalism problem. However, since every intervention aimed at current smokers serves the interests and the express wishes of the subset of smokers who do want to quit, interventions designed to protect the health of adult smokers do not necessarily rest on a paternalistic foundation. Instead, they entail both

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Ending the Tobacco Problem: A Blueprint for the Nation liberty-enhancing effects (achieved by assisting addicted smokers to quit) and liberty-restricting effects (insofar as they also “burden” the choices of smokers who do not want to quit or who object to the restrictions or costs imposed on them). Thus ethical analysis of tobacco control interventions within the libertarian paradigm requires a weighing of the liberty-reducing effects of particular intervention against the liberty-enhancing effects of these interventions for nonsmokers whose freedom to avoid ETS exposure is protected, for youths whose long-run autonomy is preserved, and for adult smokers whose ability to quit is enhanced (and who therefore regard the intervention as a benefit rather than a cost). Even within these boundaries, however, burdens on individual smokers that are intrusive or coercive do require heightened justification. The more restrictive the intervention (and, consequently, the greater the burden on smokers’ freedom) the stronger the case must be that the intervention protects youths or nonsmokers or helps smokers quit. That important principle is embraced by the committee in its evaluation of each of the tobacco control interventions considered in the following chapters. AN ASIDE ON THE PATERNALISM PROBLEM It can also be argued that paternalism in this context is a justified response to irremediable deficiencies in smokers’ capacity to successfully exercise self-interested decision-making about whether they should continue to smoke. Although the committee’s blueprint need not rest on this argument, many committee members do find elements of it convincing, and that is why we summarize it here. The argument runs as follows: (1) virtually all addicted adults begin smoking (and probably become addicted) while they are adolescents before they have developed the capacity to exercise mature judgment about whether or not to become a smoker; (2) the preferences expressed when people begin to smoke, which tend to ignore long-term health risks, are inconsistent with the health-oriented preferences they later come to have, and they soon regret the decision to have become a smoker; and (3) once smokers begin to be concerned about the health dangers of smoking, their judgment is often distorted by optimism bias (“the harms will happen to other people, not to me”), thereby weakening their motivation to quit. Adolescent Initiation As shown in Chapter 2, between 80–90 percent of smokers start smoking before they turn 18 years of age. When they begin to smoke, they typically lack a full and vivid appreciation of the consequences of smoking and the grip of addiction, even if they have a roughly accurate understanding of

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Ending the Tobacco Problem: A Blueprint for the Nation the statistical evidence. When young people begin to smoke, they typically fail to appreciate the serious possibility that they will continue smoking for many years (see Chapter 2). Inconsistent Preferences and Regret Many people neglect long-term risks to their health, simply because they tend to have a short-term perspective when they consider the risks and the benefits of a particular behavior. In the language of economists, they apply a high “discount rate” to future harms. This neglect of the long-term danger is especially serious for young people. Because the most serious health risks of smoking do not come to fruition for many years, young smokers often treat those risks as if they were trivial. Even adult smokers often fail to take adequate account of the associated risks, simply because those risks are not likely to materialize for decades. Smokers themselves will typically change their minds later on, reflecting a difference between their preferences when they start smoking and the preferences that they have later in life, when they want to quit. (Economists call this problem “inter-temporal inconsistency.”) In short, when people begin to smoke, at whatever age, they tend to give more weight to the pleasures of smoking and too little weight to the possible impact of smoking on their long-term well-being. Once people have become addicted, they give more weight to the health concerns and regret having become smokers. Most of them want to stop. Optimism Bias In some domains, people are unrealistically optimistic about risks, believing that they are immune from the dangers that others who are similarly situated face. For smokers, the problem of unrealistic optimism takes three distinct forms. First, many smokers, even those who have an adequate sense of the statistical realities, falsely believe that they are unlikely to face the risks that most smokers face. Second, many smokers, both young and old, are unrealistically optimistic about their future health and their longevity if they quit at some later point. Third, many smokers believe, falsely, that they will quit in the near future. Taken together, these forms of unrealistic optimism can be deadly. More than four decades after the Surgeon General’s initial report (HEW 1964) on the health risks of smoking, policymakers have not addressed these three problems with anything like the seriousness that they deserve. To be sure, the problem of addiction plays a large role in current thinking; and both states and localities, along with the private sector, have adopted commendable steps to protect and to inform young people. However, the whole notion of consumer sovereignty—of unambivalent respect for private

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Ending the Tobacco Problem: A Blueprint for the Nation choices—runs into serious difficulty when the underlying product creates serious long-term individual and societal harms, has addictive properties, and is usually chosen by young people who fail to appreciate the associated risks. TOBACCO PRODUCTS ARE INHERENTLY DANGEROUS As they are now designed, tobacco cigarettes are inherently dangerous products that would not be allowed to enter the marketplace if their effects were known and if they were being introduced for the first time. For example, the nicotine in tobacco products would meet the criteria for classification of a Schedule 1 drug under the Controlled Substances Act, tobacco smoke could be classified as a “toxic substance” posing an “unreasonable risk” under the Toxic Substances Control Act, and tobacco cigarettes (and perhaps other tobacco products) could be characterized as “unreasonably dangerous product[s]” under the Consumer Product Safety Act, if tobacco products were not exempted from regulation by the specific exclusionary language in each of these statutes. If tobacco products were within FDA jurisdiction under the Federal Food, Drug, and Cosmetics Act, pre-market approval from the FDA would be required, and it could safely be predicted that such approval would not be forthcoming in light of the addictive properties of nicotine and the multitude of dangerous constituents in tobacco smoke. However, tobacco products were introduced into the marketplace not only before their adverse effects were understood but also before any modern consumer protection or environmental health legislation had been enacted. The early efforts to suppress the sale of cigarettes, largely on moral and hygienic grounds, occurred at the state level, but most of the early bans had been repealed by 1925. The advent of mass production capabilities in the late 19th century, waning opposition from temperance groups during the first third of the 20th century, and the explosion of smoking during and after World War II catapulted the cigarette to the status of one of the most successfully marketed consumer products in the nation’s history. Given such a deep entrenchment in the cultural, social, and commercial life of the country, it is hardly surprising that the burden of demonstrating the need for any substantial regulatory restriction has rested on the proponents of regulation. As indicated in Chapter 3, however, this burden has now been convincingly met. The harmfulness of cigarettes is no longer disputed, even by the manufacturers; and the rhetoric of personal freedom has been softened by a general recognition of the powerful grip of nicotine addiction, the purposeful manipulation of that addictive potential by the manufacturers, and the hazardous effects of secondhand smoke on nonsmokers. Hence the burden has been shifting to the tobacco companies to explain why they

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Ending the Tobacco Problem: A Blueprint for the Nation should be permitted to continue to promote and market this admittedly dangerous product. The central point is that cigarettes and other tobacco products are not ordinary consumer products. For no other lawful consumer product can it be said that the acknowledged aim of national policy is to suppress consumption. For alcohol, the generally accepted aim of national policy is to suppress underage drinking and excessive or otherwise irresponsible use by adults; reducing adult consumption per se is not the nation’s goal. Indeed, in many respects, state and federal governments aim to facilitate alcohol consumption, such as by liberalizing access (IOM/NRC 2004). Similarly, although firearms are indisputably dangerous products, and their unlawful sale, possession, and use is suppressed, their lawful use is widely regarded as a valued constitutional right, and many aspects of recent changes in state law have been designed to facilitate access to weapons by lawful purchasers and owners. In terms of its goal, tobacco policy has more in common with the nation’s policy toward marijuana and other illegal drugs than it does with policies pertaining to alcohol or firearms. It has become commonplace for critics of aggressive tobacco control measures to invoke the classic slippery slope argument, claiming that restrictions on tobacco will lead down the slope to measures taking away food and drinks that people like on the ground that they are not healthy enough. After all, it is said, if the “nanny state” is empowered to suppress tobacco use, it will go after the Big Mac­® next. This argument underappreciates the extent to which tobacco products are unlike ordinary consumer products. Tobacco is a highly addictive, carcinogenic, and deadly product. Foods rich in fats or carbohydrates may lead to overweight and increase disease risks if consumed in excess, but they are not addictive or inherently dangerous. It therefore bears repeating that tobacco is the only lawful consumer product for which the nation’s unequivocal aim is to suppress consumption altogether—rather than promoting informed, healthy choices and moderation. That being the case, governments at all levels must play a central role in the effort to overcome and reverse the forces that create and sustain tobacco use. Governments have both the authority and the obligation to establish and sustain conditions under which people can be healthy while respecting the constitutional liberties and other important values (IOM 1988, 2003). People trust and expect the government to protect children from hazards such as poisons, lead, and tobacco; to prevent the tobacco industry from misleading people and drawing them into or sustaining an addictive behavior that they will regret; to counteract industry efforts to stimulate and sustain demand for its dangerous products; and to help people quit if they want to do so.

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Ending the Tobacco Problem: A Blueprint for the Nation BLUEPRINT OUTLINE The committee’s blueprint for reducing tobacco use in the United States reflects a two-pronged strategy. The first prong envisions strengthening traditional tobacco control measures; the second envisions changing the regulatory landscape to permit new policy innovations. Chapter 5 reviews the current legal structure and framework of tobacco policy and focuses on intensifying and strengthening the tools of tobacco control known to be effective. The emphasis in that chapter is largely, although not exclusively, on state and local initiatives. This is because almost all of the energy and innovation in tobacco control are currently generated at the state and local levels and are undergirded by public health partnerships and supported by community-based advocacy efforts. Policy changes are typically enacted and implemented through state laws and local ordinances, although the federal government plays a secondary role—often supporting state and local efforts, but sometimes impeding them. Chapter 6 envisions a much more substantial federal presence characterized by a fundamentally transformed legal structure under which a federal regulatory agency, most likely the FDA, is given plenary regulatory authority while the states are liberated to take aggressive actions now forbidden by federal law. Federal power would be exercised to bolster and support state efforts in the traditional domains of tobacco control while the agency takes bold steps in under-regulated areas, including the use of more effective health warnings and constraints on industry advertising and promotional activity, with particular attention given to claims regarding so-called reduced-risk products. The federal government would also play a more substantial role in funding and coordinating state tobacco control activities. Chapter 7 presents opportunities for policy innovations that can open new frontiers of tobacco control. One such possibility is gradually reducing the nicotine content of cigarettes. Implementation of a nicotine-reduction strategy or any other bold initiative aiming to end the tobacco problem will require sophisticated policy research, and the committee urges the federal government to create a robust capacity for tobacco policy research and development. REFERENCES Cromwell J, Bartosch WJ, Fiore MC, Hasselblad V, Baker T. 1997. Cost-effectiveness of the clinical practice recommendations in the AHCPR guideline for smoking cessation. Journal of the American Medical Association 278(21). DHHS (U.S. Department of Health and Human Services). 1989. Reducing the Health Consequences of Smoking: 25 Years of Progress (A Report of the Surgeon General). Rockville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.

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Ending the Tobacco Problem: A Blueprint for the Nation DHHS. 1994. Preventing Tobacco Use Among Young People (A Report of the Surgeon General). Rockville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Center for Health Promotion and Education, Office on Smoking and Health. DHHS. 2006. The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Coordinating Center for Health Promotion, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. EPA (Environmental Protection Agency). 1992. Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. Washington, DC: Office of Health and Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency. HEW (Department of Health, Education, and Welfare). 1964. Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service. Washington, DC: U.S. Department of Health, Education, and Welfare; Public Health Service. IOM (Institute of Medicine). 1988. The Future of Public Health. Washington, DC: National Academy Press. IOM. 1994. Growing Up Tobacco Free: Preventing Nicotine Addiction in Children and Youth. Washington, DC: National Academy Press. IOM. 2003. The Future of the Public’s Health in the 21st Century. Washington, DC: The National Academies Press. IOM/NRC (National Research Council). 2004. Reducing Underage Drinking: A Collective Responsibility. Washington, DC: The National Academies Press. Kessler D. 1995. Nicotine addiction in young people. New England Journal of Medicine 333:186-189. Tengs TO, Osgood ND, Chen LL. 2001. The cost-effectiveness of intensive national school-based anti-tobacco education: Results from the Tobacco Policy Model. Preventive Medicine 33(6):558-570. Warner KE. 1997. Cost effectiveness of smoking-cessation therapies. PharmacoEconomics 11:538-549.

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