Lessons from the history of tobacco harm reduction: The National Cancer Institute's Smoking and Health Program and the "less hazardous cigarette".

Scientists and public health practitioners are sharply divided today over the risks and benefits of tobacco harm-reduction strategies. At the same time, a range of novel tobacco products is being marketed with claims of reduced exposure or risk. Current scientific efforts to study tobacco products and harm reduction should be informed by past experience. During the 1960s and 1970s, there was substantial support within government and academia, as well as among voluntary health organizations, for efforts to modify tobacco products to reduce harm. This paper analyzes the former National Cancer Institute (NCI) Smoking and Health Program, which, between 1968 and 1980, pursued the development of "less hazardous" cigarettes as its primary goal. During this period, the program spent over dollar 50 million on contract research, of which 74% went toward biological and chemical analysis of modified cigarettes, 9.6% to epidemiological studies of risk factors, and only 1.4% to studies evaluating smoking cessation or prevention programs. NCI officials predicted during the mid-1970s that new "low-tar" cigarette brands would substantially reduce smoking-related mortality, but by 1978 the research agenda began to change in response to a reorganization of NCI research activities, modification of government antismoking efforts, and an emerging understanding of nicotine addiction that challenged key scientific assumptions. In retrospect, the program suffered from significant weaknesses that severely limited the likelihood that it would generate knowledge beneficial to public health, including a research agenda that failed to include surveillance and behavioral research, tobacco industry influence of the research agenda, and a lack of access to information about the characteristics of products on the market. There exists today a need for a public health-oriented research agenda on tobacco products and harm reduction, but current efforts should include input from a diverse range of disciplines, collect data on users' behavior, and limit the involvement of industry scientists.     

Literature review and summary of perceptions, attitudes, beliefs, and marketing of potentially reduced exposure products: communication implications.

Potentially reduced exposure products (PREPs) have continued to enter the market during the 1990s and first part of the 21st century. Attempts by the tobacco industry to develop and market products with implied reductions in adverse health effects (i.e., harm reduction) are not new. Over the last half of the 20th century, the tobacco industry developed and marketed several products that purported to reduce the health risks associated with smoking cigarettes. Among these were filtered cigarettes in the 1950s and light and ultra-light cigarettes in the 1970s and 1980s. This review summarizes published and unpublished research that is directly relevant to the marketing, advertising, and communication about PREPs. The marketing strategies for these new products do not appear to differ from those used by the tobacco industry for light and ultra-light cigarettes. Although smokers report not using the new products in large numbers because of dissatisfaction with taste, they are interested in using products with reduced risk. Despite the absence of explicit health claims by the industry for PREPs, many smokers believe that these products are safer based on the advertising claims of reduced exposure and a belief that claims are approved by the government. No data are available to indicate that PREPs are useful for prevention or cessation of smoking, nor does specific research exist to suggest what health communication messages will provide smokers with accurate information about these products.     

Rauchlose Tabakprodukte und die Folgen ihres Gebrauchs für die Gesundheit

Smokeless tobacco products include chewing tobacco, oral tobacco and snuff for inhalation. These products are consumed without burning the tobacco. Smokeless tobacco products contain tobacco specific nitrosamines and several other carcinogenic substances and additives. Epidemiologic studies from North America, Europe, Asia and Africa provide sufficient evidence that smokeless tobacco causes oral cancer and cancer of the pancreas. The evidence for an association of smokeless tobacco with cardiovascular disease and diabetes is limited. Furthermore, there is some evidence for adverse pregnancy outcomes in pregnant women who use smokeless tobacco. The health consequences of smokeless tobacco products are discussed critically against the background of the international debate about a proposed strategy of harm reduction, which involves offering smokeless tobacco as a smoking cessation aid.     

Whither tobacco product regulation?

Despite decades of industry innovation and regulatory efforts, the harmfulness of conventional cigarettes has not changed. There are several pitfalls in this area, including the long time lag before health impacts of product regulatory changes become apparent, the danger of consumers deriving false reassurance of lesser harm in the interim period, the lack of relevant expertise and the lack of an internationally agreed and evidence-based strategic approach. Articles 9 and 10 of the Framework Convention on Tobacco Control provide the potential for such a global strategy, and knowledge and research has increased significantly over recent years. However, there are huge opportunity costs in implementing product disclosure and regulatory strategies: most national regulators have very limited human and financial resources, which should be focused on other evidence-based tobacco control interventions. We believe therefore that it is now time to abandon the notion of safe or safer cigarettes while moving consumers towards cleaner nicotine products as soon as possible. In parallel to this, we recommend a number of other strategies be implemented including: reducing the appeal of all tobacco products, forbidding new tobacco products or brand variants being marketed without evidence of reduced harm, appeal or addictiveness, and developing a tobacco industry resourced, but industry independent, Framework Convention on Tobacco Control global repository to assist national regulators in understanding and regulating the products on their markets.     

A research agenda for assessing the potential contribution of genomic medicine to tobacco control

This paper identifies research priorities in evaluating the ways in which "genomic medicine"--the use of genetic information to prevent and treat disease--may reduce tobacco-related harm by: (1) assisting more smokers to quit; (2) preventing non-smokers from beginning to smoke tobacco; and (3) reducing the harm caused by tobacco smoking. The method proposed to achieve the first aim is "pharmacogenetics", the use of genetic information to optimise the selection of smoking-cessation programmes by screening smokers for polymorphisms that predict responses to different methods of smoking cessation. This method competes with the development of more effective forms of smoking cessation that involve vaccinating smokers against the effects of nicotine and using new pharmaceuticals (such as cannabinoid antagonists and nicotine agonists). The second and third aims are more speculative. They include: screening the population for genetic susceptibility to nicotine dependence and intervening (eg, by vaccinating children and adolescents against the effects of nicotine) to prevent smoking uptake, and screening the population for genetic susceptibility to tobacco-related diseases. A framework is described for future research on these policy options. This includes: epidemiological modelling and economic evaluation to specify the conditions under which these strategies are cost-effective; and social psychological research into the effect of providing genetic information on smokers' preparedness to quit, and the general views of the public on tobacco smoking.     

Tobacco commerce on the internet: a threat to comprehensive tobacco control

Although internet use continues to increase and e-commerce sales are expected to exceed US$1 trillion by the end of 2001, there have been few assessments in the literature regarding the implications of this medium for tobacco control efforts. This commentary explores the challenges that the internet may pose to the key components of a comprehensive tobacco control strategy, and pinpoints potential approaches for addressing these challenges. Four key challenges that the internet presents for tobacco control are identified: unrestricted sales to minors; cheaper cigarettes through tax avoidance and smuggling; unfettered advertising, marketing and promotion; and continued normalisation of the tobacco industry and its products. Potential strategies for addressing these challenges include international tobacco control agreements, national and state regulation, and legal remedies.     

Global assessment of deforestation related to tobacco farming

OBJECTIVES: To assess the global amount of forest and woodland consumed annually for curing tobacco between 1990 and 1995; to estimate tobacco's share in total deforestation; to rank tobacco-growing countries by the degree of impact of tobacco deforestation; and to indicate environmental criticality emerging from tobacco's impact on forest resources. DESIGN: Production of country-specific estimates of forests/woodlands needed and depleted on the basis of growing stock/increment of woody biomass involved and wood consumption of tobacco. Comparison of results with secondary statistics on forest cover, deforestation, and population development. RESULTS: An estimated 200,000 ha of forests/woodlands are removed by tobacco farming each year. Deforestation mainly occurs in the developing world, amounting to 1.7% of global net losses of forest cover or 4.6% of total national deforestation. Environmental criticality exists or is emerging in 35 countries with an estimated serious, high, and medium degree of tobacco-related deforestation, mainly in southern Africa, middle east, south, and east Asia, South America, and the Caribbean. CONCLUSION: The hypothesis that deforestation from tobacco production does not have a significant negative effect has to be challenged. For empirical validation, the globally significant pattern of estimated tobacco-related environmental damage ought to be included in international research agendas on global environmental change, to become an integral and rational part of tobacco control policy.     

Couple dynamics during women's tobacco reduction in pregnancy and postpartum.

Smoking cessation during pregnancy is often temporary; many women relapse postpartum. To develop strategies for supporting successful long-term smoking cessation, we conducted a qualitative study to explore the influence of couple interactions on women's tobacco reduction within the context of pregnancy and the postpartum period. A total of 28 women who quit or reduced smoking for pregnancy and their partners were interviewed following delivery and at 3-6 months postpartum. Open-ended, individual interviews elicited the challenges posed by the women's tobacco reduction and how their partners influenced their cessation efforts. The use of constant comparative analytic strategies focusing on women's processes, experiences, and responses revealed that unquestioned expectations for pregnant women's cessation created the social context of compelled tobacco reduction. Women's engagement in tobacco reduction in this context fundamentally altered couples' previously established tobacco-related routines. The intensity of these changes varied depending on the couples' established interaction patterns with respect to tobacco (i.e., disengaged, conflictual, or accommodating) and was a source of conflict for some couples. The findings offer novel ways to understand smoking cessation during pregnancy that provide new directions for research and for tailoring smoking cessation interventions.     

Clinical laboratory evaluation of potential reduced exposure products for smokers.

Smoking-related cancer and other disease account for more than 400,000 U.S. deaths annually. Smoking cessation reduces smoking-related disease rates, but relapse rates are high. Thus, interest in reducing the harm of continued smoking is growing. Potential reduced exposure products (PREPs) are marketed to reduce smokers' exposure to smoke toxicants such as carbon monoxide (CO) and carcinogens and may be harm reduction tools. New PREPs are proliferating, but past experience with "low-yield" cigarettes that failed to reduce smokers' toxicant exposure suggests that comprehensive evaluation is necessary to predict if these new products are likely to alter the harm caused by smoking. The purpose of the study was to develop clinical laboratory methods for PREP evaluation. Smokers (N = 35) completed four, 5-day conditions that differed by product used: Advance, Eclipse, own brand cigarettes, or no cigarettes. Carcinogen (as assessed by one nitrosamine and one polycyclic aromatic hydrocarbon biomarker) and nicotine exposure were assessed via thrice-weekly urine sampling. Withdrawal symptoms were measured daily, and smoking behavior was assessed on the first and last day of each condition. Relative to own brand, Advance reduced exposure to the nitrosamine NNK and CO, and Eclipse reduced exposure to nicotine and the nitrosamine NNK, increased exposure to CO, and resulted in larger, longer, and more frequent puffs. No smoking reduced exposure to the nitrosamine NNK, CO, and nicotine, whereas withdrawal was elevated (all p values <.05). Clinical laboratory evaluation of PREPs for smokers is valuable for measuring users' smoke toxicant exposure, withdrawal, and smoking behavior and should be incorporated into a comprehensive PREP evaluation strategy.     

What should be the elements of any settlement with the tobacco industry?

Litigation and regulatory assaults on the tobacco companies may create a willingness among tobacco manufacturers to bargain resources and acceptance of public policy changes for limitations of liability, as has been seen by the recent settlement with the Liggett Group. Two elements absolutely critical to any plan are the elimination of tobacco advertising and promotion and the removal of addiction as a reason for tobacco use. Minimal components of any settlement should include: (a) acceptance by the tobacco manufacturers of the causal relationship between tobacco use and disease, and the addictive nature of nicotine; (b) a total ban on tobacco advertising and promotion; (c) FDA jurisdiction over tobacco products and their nicotine content, with the intent of removing nicotine as soon as acceptable nicotine substitution products are available; (d) reimbursement to the states for Medicaid and other state expenditures attributable to smoking, to the maximum extent feasible; (e) funding for local, state, and federal programmes and research in tobacco control; (f) acceptance of legislation and regulations protecting the right of non-smokers to breathe air free of tobacco smoke; (g) funding for a large, national, media-led, anti- tobacco campaign; and (h) cessation assistance for addicted smokers. If negotiations toward a settlement proceed, it is essential that the public health community participate in defining the elements of any agreement to ensure that whatever agreement develops is focused on reducing tobacco-related disease rather than continuing the profitability of American tobacco companies. That participation requires articulation of the core elements essential to an acceptable agreement. If resolution of the public health issues surrounding continued sale of tobacco products can be reached in the United States, it may provide a model for similar resolution in other countries.


     

European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health

Rationale: This statement is an updated version of one released by the same authors in February 2003. The statement was produced to follow up the Royal College of Physicians (RCP) Tobacco Advisory Group report "Protecting smokers, saving lives: the case for a tobacco and nicotine regulatory authority",¹ which argued for an evidence based regulatory approach to smokeless tobacco and harm reduction and posed a series of questions that regulators must address in relation to smokeless tobacco.

The purpose of this statement is to provide arguments of fact and principle to follow the RCP's report and to outline the public health case for changing existing European Union (EU) regulation in this area. A review of regulation in relation to harm reduction and regulation of tobacco products other than cigarettes is required in Article 11 of EU directive 2001/37/EC,² and this is a contribution towards forming a consensus in the European public health community about what policy the EU should adopt in the light of this review, or following ongoing legal action that may potentially strike out the existing regulation altogether.

Public health case: We believe that the partial ban applied to some forms of smokeless tobacco in the EU should be replaced by regulation of the toxicity of all smokeless tobacco. We hold this view for public health reasons: smokeless tobacco is substantially less harmful than smoking and evidence from Sweden suggests it is used as a substitute for smoking and for smoking cessation. To the extent there is a "gateway" it appears not to lead to smoking, but away from it and is an important reason why Sweden has the lowest rates of tobacco related disease in Europe. We think it is wrong to deny other Europeans this option for risk reduction and that the current ban violates rights of smokers to control their own risks. For smokers that are addicted to nicotine and cannot or will not stop, it is important that they can take advantage of much less hazardous forms of nicotine and tobacco—the alternative being to "quit or die"... and many die. While nicotine replacement therapies (NRT) may have a role in harm reduction, tobacco based harm reduction options may reach more smokers and in a different, market based, way. Chewing tobacco is not banned or regulated in the EU but is often highly toxic, and our proposal could remove more products from the market than it permitted.

Regulatory options: We believe that the EU policy on smokeless tobacco should adapt to new scientific knowledge and that the European Commission should bring forward proposals to amend or replace Article 8 of directive 2001/37/EC with a new regulatory framework. Canada has developed testing regimens for tobacco constituents and these could be readily adapted to the European situation. A review of EU policy in this area is required no later than December 2004, and we believe the Commission should expedite the part of its review that deals with harm reduction and regulation of tobacco products other than cigarettes so as to reconsider its policy on smokeless tobacco. We held this view before Swedish Match brought its legal proceedings to challenge EU legislation and we will continue to hold these views if its action fails.

     

形势与未来:烟草科技发展展望

综述中国烟草过去几十年、特别是近十年重要科研突破,总结中式卷烟产品在关键技术领域取得的重要创新成果,分析了我国烟草科技发展的现状与形势,在此基础上,遵循科技发展一般规律,围绕卷烟产品这一核心和中式卷烟产品开发基本原则,研判提炼各领域技术创新的共同要素特征,提出并阐释了"烟叶生产精准化,卷烟加工智能化,产品设计数字化,降焦减害持续化"的"烟草科技四化"发展趋势。结合中国烟草发展实际,得出今后相当长时间内中式卷烟仍将是我国烟草消费主流形态的判断,而实现"烟草科技四化"是支撑中式卷烟品牌稳定发展的必然选择,是进一步巩固卷烟民族品牌的认同度和市场竞争力的有力保障。      

Regulatory strategies to reduce tobacco addiction in youth

Preventing tobacco addiction and achieving cessation in established users are the cornerstones of efforts to reduce tobacco use and disease. It has been increasingly recognised that reducing tobacco toxin exposure has theoretical potential to reduce disease in continuing tobacco users. This has been controversial because such approaches also carry the potential to undermine prevention and cessation. As complicated as harm reduction issues are for adults, they are still more complicated for youth. Harm reduction is not a singular approach, but rather a concept that encompasses an extremely diverse array of potential approaches. These carry equally diverse potential risks and benefits. The regulatory framework (for example, whether or not the Food and Drug Administration regulates the approach) is also predicted to be a major factor in determining the consequences of harm reduction approaches. This paper examines the various issues and potential approaches concerning the application of harm reduction to youth. We conclude that although some carry great risk, others may actually support broader tobacco control efforts to prevent tobacco use and foster cessation in youth and adults.     

Adolescent tobacco-related associative memory: A cross-sectional and contextual analysis.

Tobacco use is prevalent in adolescents, and understanding factors that contribute to its uptake and early development remains a critical public health priority. Implicit drug-related memory associations (DMAs) are predictive of drug use in older samples, but such models have little application to adolescent tobacco use. Moreover, extant research on memory associations yields little information on contextual factors that may be instrumental in the development of DMAs. The present study examined (a) the degree to which tobacco-related memory associations (TMAs) were associated with concurrent tobacco use and (b) the extent to which TMAs mediated the association of peer and self-use. A sample of 210 Australian high school students was recruited. Participants completed TMA tasks and behavioral checklists designed to obscure the tobacco-related focus of the study. Results showed that TMAs were associated with peer use, and TMAs predicted self-use. We found no evidence that TMAs mediated the association of peer and self-use. Future research might examine the emotive valence of implicit nodes and drinking behavior. The results have implications for testing the efficacy of consciousness-raising interventions for adolescents at risk of tobacco experimentation or regular use.     

A nicotine delivery device without the nicotine? Tobacco industry development of low nicotine cigarettes

Background: Defining harm reduction and regulating potentially reduced exposure products (PREPs), including low nicotine products, are key issues in tobacco control policy. The US Congress has been considering legislation authorising the Food and Drug Administration (FDA) to regulate tobacco products.     

Rauchlose Tabakprodukte und die Folgen ihres Gebrauchs für die Gesundheit

Smokeless tobacco products include chewing tobacco, oral tobacco and snuff for inhalation. These products are consumed without burning the tobacco. Smokeless tobacco products contain tobacco specific nitrosamines and several other carcinogenic substances and additives. Epidemiologic studies from North America, Europe, Asia and Africa provide sufficient evidence that smokeless tobacco causes oral cancer and cancer of the pancreas. The evidence for an association of smokeless tobacco with cardiovascular disease and diabetes is limited. Furthermore, there is some evidence for adverse pregnancy outcomes in pregnant women who use smokeless tobacco. The health consequences of smokeless tobacco products are discussed critically against the background of the international debate about a proposed strategy of harm reduction, which involves offering smokeless tobacco as a smoking cessation aid.

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Zusammenfassung: Rauchlose Tabakprodukte sind Schnupftabak, Kautabak und Lutschtabak. Diese werden konsumiert, ohne dass der Tabak verbrannt wird. Rauchlose Tabakprodukte enthalten tabakspezifische Nitrosamine und zahlreiche weitere karzinogene Substanzen sowie Zusatzstoffe. Epidemiologische Studien aus Nordamerika, Europa, Asien und Afrika zeigen hinreichende Evidenz, dass rauchloser Tabak Mundh?hlenkrebs und Bauchspeicheldrüsenkrebs verursacht. Eine bislang unklare Evidenzlage besteht für den Zusammenhang rauchlosen Tabaks mit kardiovaskul?ren Erkrankungen und Diabetes. Weiterhin gibtes Hinweise auf Schwangerschaftskomplikationen beim Konsum rauchloser Tabakprodukte bei schwangeren Frauen. Die Gesundheitsfolgen rauchloser Tabakprodukte werden schlie?lich kritisch vor dem Hintergrund der internationalen Debatte um eine Strategie der „harm reduction“ diskutiert, derzufolge rauchloser Tabak als weniger gesundheitssch?dliche Alternative zu Rauchwaren angeboten werden sollte.

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Eingegangen: 2. Juli 2007; Angenommen: 4. Juli 2007     

Surveillance of tobacco industry retail marketing activities of reduced harm products.

With the introduction of potential reduced exposure products (PREPs) and the interest in studying tobacco harm reduction, sound research and surveillance are needed to examine and understand the distribution and availability of PREPs in communities, as well as the tobacco industry's marketing practices surrounding these products. We examined the availability and marketing of PREPs in a national sample of tobacco retail stores. We also compared the price of PREPs to those of premium brand cigarettes and examined the distribution of PREPs in comparison with premium brand cigarettes by store type, urbanization, region, and race/ethnicity. We found that PREPs are not widely available, are priced similarly to leading cigarette brands, and have few promotional offers. We also found some significant differences in the distribution of PREPs and cigarettes, as well as in the distribution of Ariva and Omni, by store type and community demographics. The fact that this study used data collected nationally emphasizes the importance of these findings and helps shed some light on the tobacco industry's PREP marketing strategies. This study's national sample provides a unique perspective that needs to be replicated if and when other PREPs are widely marketed.     

Tobacco-related research funding at the National Cancer Institute: Portfolio analysis, fiscal year 2003.

A variety of methods is used to classify research conducted or funded by the National Institutes of Health (NIH). We undertook this analysis to delineate research funded by the National Cancer Institute (NCI) that specifically addresses a tobacco-related research question. Intramural projects, extramural grants, and contracts were coded according to eight categories based on information in the abstracts. One category, "research area," classified projects by the primary study outcome. A total of 318 projects met our inclusion criterion of addressing a tobacco-related research question. As a result, our estimate of about US$107 million in tobacco research during the 2003 fiscal year is different from what is officially reported by NCI. The greatest proportion of tobacco research dollars was devoted to policy research (20%, n = 47) and research on the determinants of tobacco use (19%, n = 36). The greatest number of studies focused on investigating the consequences of tobacco use (32%, n = 105). A substantial number of projects addressed a tobacco-related question specifically about women (n = 45) or a racial/ethnic group (n = 99) and used cigarettes as the primary tobacco product (n = 277). These findings elucidate key areas for future tobacco control research and may help to determine future funding priorities at NCI and in the research community at large. Although tobacco causes nearly 30% of all cancer deaths, NCI spent 2.3% of its total fiscal year 2003 budget on tobacco-related research funding.