Who's still smoking? Disparities in adult cigarette smoking prevalence in the United States.

The continuing high prevalence of cigarette smoking among specific subpopulations, many of them vulnerable, is one of the most pressing challenges facing the tobacco control community. These populations include individuals in lower education and/or socioeconomic groups; from certain racial/ethnic groups; in the lesbian, gay, bisexual, and transgender community; with mental illness; and in the military, particularly among those in the lowest pay grades. Although traditional tobacco control measures are having positive health effects for most groups, the effects are not sufficient for others. More attention to and support for promising novel interventions, in addition to new attempts at reaching these populations through conventional interventions that have proven to be effective, are crucial going forward to find new ways to address these disparities. CA Cancer J Clin 2018;68:106-115. © 2018 American Cancer Society.

A blueprint for the primary prevention of cancer: Targeting established, modifiable risk factors.

In the United States, it is estimated that more than 1.7 million people will be diagnosed with cancer, and more than 600,000 will die of the disease in 2018. The financial costs associated with cancer risk factors and cancer care are enormous. To substantially reduce both the number of individuals diagnosed with and dying from cancer and the costs associated with cancer each year in the United States, government and industry and the public health, medical, and scientific communities must work together to develop, invest in, and implement comprehensive cancer control goals and strategies at the national level and expand ongoing initiatives at the state and local levels. This report is the second in a series of articles in this journal that, together, describe trends in cancer rates and the scientific evidence on cancer prevention, early detection, treatment, and survivorship to inform the identification of priorities for a comprehensive cancer control plan. Herein, we focus on existing evidence about established, modifiable risk factors for cancer, including prevalence estimates and the cancer burden due to each risk factor in the United States, and established primary prevention recommendations and interventions to reduce exposure to each risk factor.

Key issues surrounding the health impacts of electronic nicotine delivery systems (ENDS) and other sources of nicotine.

Answer questions and earn CME/CNE Over the last decade, the use of electronic nicotine delivery systems (ENDS), including the electronic cigarette or e-cigarette, has grown rapidly. More youth now use ENDS than any tobacco product. This extensive research review shows that there are scientifically sound, sometimes competing arguments about ENDS that are not immediately and/or completely resolvable. However, the preponderance of the scientific evidence to date suggests that current-generation ENDS products are demonstrably less harmful than combustible tobacco products such as conventional cigarettes in several key ways, including by generating far lower levels of carcinogens and other toxic compounds than combustible products or those that contain tobacco. To place ENDS in context, the authors begin by reviewing the trends in use of major nicotine-containing products. Because nicotine is the common core-and highly addictive-constituent across all tobacco products, its toxicology is examined. With its long history as the only nicotine product widely accepted as being relatively safe, nicotine-replacement therapy (NRT) is also examined. A section is also included that examines snus, the most debated potential harm-reduction product before ENDS. Between discussions of NRT and snus, ENDS are extensively examined: what they are, knowledge about their level of "harm," their relationship to smoking cessation, the so-called gateway effect, and dual use/poly-use. CA Cancer J Clin 2017;67:449-471. © 2017 American Cancer Society.

Do Tobacco Companies Have an Incentive to Promote "Harm Reduction" Products?: The Role of Competition.

INTRODUCTION: Some cigarette companies have started to talk about replacing cigarettes with less harmful alternatives, which might include nicotine vaping products (NVPs), heated tobacco products (HTPs), and oral nicotine delivery products. We consider market competition as a primary driver of whether cigarette companies follow through on their stated intentions. AIMS AND METHODS: We focus on the behavior of cigarette companies in the United States. We compare competition in the pre- and post-2012 time periods, analyze the impact of the growth in NVPs on smoking prevalence and cigarette company profits, and examine the potential future role of competition. RESULTS: Since 2006, consumers have broadened their use of non-combustible nicotine delivery products (NCNDPs) to include, inter alia, NVPs, HTPs, and oral nicotine pouches. U.S. cigarette companies have acquired major stakes in each of these product categories which corresponds to a period of rapidly declining adult smoking prevalence, especially among younger adults (ages 18-24 years). The shifting dynamics of the nicotine product marketplace are also reflected in cigarette company stock prices. While cigarette companies are likely to promote HTPs and nicotine delivery products over NVPs, their incentives will be directly related to competition from independent firms, which in turn will depend on government regulation. CONCLUSIONS: Although cigarette companies will back alternatives to combusted tobacco when threatened by competition, the prospects for their lasting conversion to NCNDPs will depend on the extent of such competition, which will be influenced by government regulation of tobacco products. IMPLICATIONS: Regulations that limit competition from independent firms while also protecting cigarette company profits risk slowing or even reversing recent declines in smoking, especially among youth and young adults. Regulations that reduce the appeal and addictiveness of combusted tobacco products, such as higher cigarette taxes or a reduced nicotine standard, will encourage smokers to quit and/or switch to less harmful non-combusted forms of tobacco. The regulation of non-combustible nicotine delivery products and cigarettes should be proportionate to their relative risks, so that smokers have incentives to switch from combustibles to safer alternatives, and cigarette companies have incentives to promote safer products.

Applying the Population Health Standard to the Regulation of Electronic Nicotine Delivery Systems.

Regulatory authorities have devoted increasing attention and resources to a range of issues surrounding the regulation of novel nicotine and tobacco products. This review highlights the inherent complexity of evaluating prospective policies that pertain to products that heat solutions containing nicotine, but not tobacco leaf, sometimes referred to as electronic nicotine delivery systems (ENDS). The US Food and Drug Administration (FDA) is compelled to incorporate a set of public health criteria in their decision making, collectively referred to as the Population Health Standard. Adherence to this standard is necessary to estimate the impact of prospective ENDS policy decisions on net population harm associated with nontherapeutic nicotine products. For policies that are expected to decrease or increase ENDS use, application of the Population Health Standard requires a comprehensive assessment of the status quo impact of ENDS use on population health. Accordingly, this review first assesses the state of the evidence on the direct harms of ENDS and the indirect effects of ENDS use on smoking, particularly rates of initiation and cessation. After that, the example of flavor restrictions is used to demonstrate the further considerations that are involved in applying the Population Health Standard to a prospective ENDS policy. Implications: This narrative review aims to inform regulatory considerations about ENDS through the prism of the Population Health Standard. More specifically, this review (1) describes and explains the importance of this approach; (2) provides guidance on evaluating the state of the evidence linking ENDS to the net population harm associated with nontherapeutic nicotine products; and (3) illustrates how this framework can inform policymaking using the example of flavor restrictions.

An Expert Elicitation on the Effects of a Ban on Menthol Cigarettes and Cigars in the United States.

INTRODUCTION: The US Food and Drug Administration announced its intention to ban menthol in cigarettes. However, information is needed on how a federal ban would affect population health. AIMS AND METHODS: We conducted an expert elicitation to gauge the impact of a menthol cigarette and cigar ban in the United States. We developed and pilot tested a questionnaire that focused on tobacco use transitions of current smokers (age 18-24 menthol, age 35-54 menthol, and age 35-54 nonmenthol) and potential menthol smokers (age 12-24). Using a structured expert elicitation, we estimated mean net transitions under a ban from cigarette use to combustible tobacco product, smokeless tobacco, novel nicotine delivery product (NNDPs, such as e-cigarettes) use, or no tobacco use. RESULTS: Eleven experts provided responses. Of those ages 12-24 who would have initiated menthol cigarette use in the absence of a ban, the experts estimated that 41% would still initiate combustible products under a ban, while 18% would initiate with NNDPs and 39% would not initiate regular tobacco use. Combustible use by menthol smokers ages 35-54 was expected to decline by 20% postban relative to preban rates, half switching to NNDPs and half quitting all tobacco use. Menthol smokers ages 18-24 were expected to reduce combustible use by 30%, with 16% switching to NNDPs. Greater reductions in combustible use were estimated for African Americans across the three age groups. Negligible impacts were expected for current adult nonmenthol smokers. CONCLUSIONS: According to expert opinion, a menthol ban is expected to substantially reduce smoking initiation and combustible tobacco product use among current menthol smokers. IMPLICATIONS: The US Food and Drug Administration recently announced its intention to ban menthol in cigarettes, but information on the potential impact on smoking and other nicotine product use is limited. We conducted an expert elicitation to gauge the impact of a menthol cigarette and cigar ban in the United States. A panel of experts estimated that menthol smokers ages 35-54 would reduce combustible tobacco use by 20%, with half switching to e-cigarettes and half quitting all nicotine use. Larger reductions were expected at younger ages, and menthol smoking initiation was reduced by 59% with 18% instead using e-cigarettes. African Americans were expected to have greater reductions in combustible tobacco use than the rest of the population.

An Analysis of the Altria-Juul Labs Deal: Antitrust and Population Health Implications.

On December 19, 2018, Altria announced an offer of $12.8 billion for Juul Labs, combining the largest U.S. cigarette manufacturer with the largest U.S. e-cigarette company. This deal is currently being challenged by the Federal Trade Commission (FTC). We consider the antitrust implications. We also consider population health implications, which we argue are essential to a comprehensive analysis of the impact on consumers. Although the FTC antitrust investigation has focused on closed vaping systems, we argue that the relevant market is the broader nicotine delivery product market, which includes all vaping products along with tobacco products. With Altria having a large market share in the key nicotine delivery product submarkets and with important entry barriers, the merger potentially places Altria in a dominant position in the relevant market. In particular, competition in the vaping submarket is reduced, thereby likely to reduce the availability of less harmful alternatives to cigarettes.

A Proposed Policy Agenda For Electronic Cigarettes In The US: Product, Price, Place, And Promotion.

Growth in the market for electronic cigarettes (e-cigarettes) raises complex questions about the devices' public health implications and, hence, challenging policy issues. We propose a policy agenda addressing concerns about preventing youth uptake of e-cigarettes and the desire to realize the potential of e-cigarettes to increase adult cigarette smoking cessation. We organize interventions according to the "four Ps" of marketing: product, price, place, and promotion. Policies include decreasing the addictiveness of combusted tobacco products while ensuring the availability of consumer-acceptable reduced-risk nicotine products, imposing large taxes on combustible products and smaller taxes on e-cigarettes, limiting the sale of all tobacco and (nonmedicinal) nicotine products to adult-only retailers, and developing communications that accurately portray e-cigarettes' risks to youth and benefits for inveterate adult smokers. All members of the public health community should unite to pursue a shared commitment to the principle that both youth and adults deserve a future free of tobacco-related disease.

Health Effects of Electronic Cigarettes: An Umbrella Review and Methodological Considerations.

E-cigarettes are often marketed as a safer alternative to combustible cigarettes. However, their health effects, especially those associated with long-term use, remain largely uncertain. We conducted an umbrella review of the cardiopulmonary and carcinogenic risks of e-cigarette use, distinguishing between short-term and long-term health effects. The search for systematic reviews was conducted across four electronic databases through 25 January 2022. Methodological quality was assessed using the AMSTAR-2 quality appraisal tool. Seventeen systematic reviews, including five meta-analyses, were included in our umbrella review. There was a clear underreporting of e-cigarette devices and e-liquid types, e-cigarette and cigarette exposure, and the health and smoking status of study participants. Overall, the findings suggest that short-term use of e-cigarettes may be associated with acute cardiopulmonary risks, although to a lesser extent than cigarette use. Long-term e-cigarette use may have pulmonary/respiratory benefits in those who switch from chronic cigarette smoking, particularly in individuals with asthma and chronic obstructive pulmonary disease (COPD). Evidence on intermediate and long-term carcinogenic effects is lacking. This umbrella review underscores the urgent need for systematic reviews with better adherence to established reporting guidelines, consistent definitions of duration of e-cigarette use, a focus on newer devices, and accounting for the impacts of former or current smoking.

The Use of Expert Elicitation among Computational Modeling Studies in Health Research: A Systematic Review.

BACKGROUND: Expert elicitation (EE) has been used across disciplines to estimate input parameters for computational modeling research when information is sparse or conflictual. OBJECTIVES: We conducted a systematic review to compare EE methods used to generate model input parameters in health research. DATA SOURCES: PubMed and Web of Science. STUDY ELIGIBILITY: Modeling studies that reported the use of EE as the source for model input probabilities were included if they were published in English before June 2021 and reported health outcomes. DATA ABSTRACTION AND SYNTHESIS: Studies were classified as "formal" EE methods if they explicitly reported details of their elicitation process. Those that stated use of expert opinion but provided limited information were classified as "indeterminate" methods. In both groups, we abstracted citation details, study design, modeling methodology, a description of elicited parameters, and elicitation methods. Comparisons were made between elicitation methods. STUDY APPRAISAL: Studies that conducted a formal EE were appraised on the reporting quality of the EE. Quality appraisal was not conducted for studies of indeterminate methods. RESULTS: The search identified 1520 articles, of which 152 were included. Of the included studies, 40 were classified as formal EE and 112 as indeterminate methods. Most studies were cost-effectiveness analyses (77.6%). Forty-seven indeterminate method studies provided no information on methods for generating estimates. Among formal EEs, the average reporting quality score was 9 out of 16. LIMITATIONS: Elicitations on nonhealth topics and those reported in the gray literature were not included. CONCLUSIONS: We found poor reporting of EE methods used in modeling studies, making it difficult to discern meaningful differences in approaches. Improved quality standards for EEs would improve the validity and replicability of computational models. HIGHLIGHTS: We find extensive use of expert elicitation for the development of model input parameters, but most studies do not provide adequate details of their elicitation methods.Lack of reporting hinders greater discussion of the merits and challenges of using expert elicitation for model input parameter development.There is a need to establish expert elicitation best practices and reporting guidelines.

Trends in E-Cigarette Use by Age Group and Combustible Cigarette Smoking Histories, U.S. Adults, 2014-2018.

INTRODUCTION: The trends in e-cigarette prevalence and population count of users according to cigarette smoking histories are unknown. These data are needed to inform public health actions against a rapidly changing U.S. e-cigarette market. METHODS: Data collected between 2014 and 2018 (analyzed in 2020) from cross-sectional, nationally representative National Health Interview Surveys were used to estimate current e-cigarette prevalence, adjusted prevalence differences (percentage points), and population counts of users. Analyses were stratified by age group (younger, 18-29 years, n=25,445; middle age, 30-49 years, n=47,745; older, ≥50 years, n=79,517) and cigarette smoking histories (current smokers, recent quitters [quit <1 year ago], near-term quitters [quit 1-8 years ago], long-term quitters [quit >8 years ago], never smokers). RESULTS: Among younger adults, e-cigarette use increased in all groups of smokers, with notable increases between 2014 and 2018 among never smokers (1.3%-3.3%, adjusted prevalence difference=2%, p<0.001) and near-term quitters (9.1%-19.2%, adjusted prevalence difference=8.8%, p=0.024). Conversely, the only substantial increase in e-cigarette use between 2014 and 2018 among middle-aged (5.8%-14.4%, adjusted prevalence difference=8.2%, p<0.001) and older (6.3%-9.5%, adjusted prevalence difference=3.3%, p=0.045) adults was among near-term quitters. The largest absolute population increase in e-cigarette users between 2014 and 2018 was among younger-adult never smokers (0.49-1.35 million), followed by near-term quitters among middle-aged (0.36-0.95 million), younger (0.23-0.57 million), and older (0.35-0.50 million) adults. CONCLUSIONS: The continuous increase among younger-adult never smokers suggests a rise in primary nicotine initiation with e-cigarettes. The concomitant increase among near-term quitters of all age groups suggests continuing e-cigarette use among smokers who may have switched from cigarettes previously.

An Analysis of the FTC's Attempt to Stop the Altria-Juul Labs Deal.

On 20 December 2018, Altria, the largest US cigarette company, announced an offer for a 35% share of the large and rapidly growing vaping product company, Juul Labs. On 2 April, 2020, the Federal Trade Commission issued a complaint that the deal was anticompetitive and should be voided. This paper analyzes the deal. We find that the deal gives Altria market power in the e-cigarette market through its support of Juul in retail stores and through the agreement not to otherwise compete in the e-cigarette market. The deal also has implications for its marketing of heated tobacco product IQOS and generally may provide Altria greater control of the broader nicotine delivery product market.

The Tobacco Deposition and Trial Testimony Archive (DATTA) project: origins, aims, and methods.

Research on previously secret tobacco industry documents has grown substantially during the past decade, since these documents first became available as the result of private and governmental litigation and investigations by the US Congress and the US Food and Drug Administration. Complementary research on tobacco litigation testimony is now being conducted through the Tobacco Deposition and Trial Testimony Archive (DATTA) project. We obtained transcripts of depositions and trial testimony, deposition and trial exhibits, expert reports, and other litigation documents from law firms, court reporter firms, individual lawyers and witnesses, tobacco company websites, and other sources. As of 3 March 2006, the publicly available collection of DATTA (http://tobaccodocuments.org/datta) contained 4850 transcripts of depositions and trial testimony, including a total of about 820,000 transcript pages. Transcripts covered testimony from 1957 to 2005 (85% were for testimony from 1990 to 2005) given by more than 1500 witnesses in a total of 232 lawsuits. Twelve research teams were established to study the transcripts, with each team covering a particular topic (for example, the health consequences of tobacco use, addiction and pharmacology, tobacco advertising and promotion, tobacco-product design and manufacture, economic impact of tobacco use, youth initiation of tobacco use, and public understanding of the risks of tobacco use and exposure to second-hand smoke). The teams used qualitative research methods to analyse the documents, and their initial findings are published throughout this journal supplement.

Consumer acceptable risk: how cigarette companies have responded to accusations that their products are defective.

OBJECTIVE: To describe arguments used by cigarette companies to defend themselves against charges that their cigarettes were defective and that they could and should have done more to make cigarettes less hazardous. METHODS: The data for this paper come from the opening statements made by defendants in four court cases: two class action lawsuits (Engle 1999, and Blankenship 2001) and two individual cases (Boeken 2001, and Schwarz 2002). The transcripts of opening statements were reviewed and statements about product defect claims, product testing, and safe cigarette research were excerpted and coded. RESULTS: Responses by cigarette companies to charges that their products were defective has been presented consistently across different cases and by different companies. Essentially the arguments made by cigarette companies boil down to three claims: (1) smoking is risky, but nothing the companies have done has made cigarettes more dangerous than might otherwise be the case; (2) nothing the companies have done or said has kept someone from stopping smoking; and (3) the companies have spent lots of money to make the safest cigarette acceptable to the smoker. CONCLUSIONS: Cigarette companies have argued that their products are inherently dangerous but not defective, and that they have worked hard to make their products safer by lowering the tar and nicotine content of cigarettes as recommended by members of the public health community. As a counter argument, plaintiff attorneys should focus on how cigarette design changes have actually made smoking more acceptable to smokers, thereby discouraging smoking cessation.

Epidemiology of the third wave of tobacco litigation in the United States, 1994-2005.

OBJECTIVE: To describe the epidemiology of litigation against the tobacco industry in the United States during the years 1994-2005 (described as the "third wave" of tobacco litigation). "Epidemiology" refers to the study of the distribution and determinants of disease in populations. We apply the term "epidemiology" to the litigation context for purposes of characterising qualitatively and, to the extent possible, quantitatively the variety of cases litigated against tobacco manufacturers and allied tobacco interests during the third wave and their impact on the tobacco industry. METHODS: The data for this paper come from legal cases identified in the Tobacco Deposition and Trial Testimony Archive (DATTA) collection (http://tobaccodocuments.org/datta), transcripts of testimony and related documents found in DATTA, government-mandated reports filed by tobacco manufacturers with the US Securities and Exchange Commission, investment company reports, reports and analyses published by the news media, a variety of informational documents produced by the Tobacco Control Resource Center at the Northeastern University School of Law, and legal settlement documents provided by the National Association of Attorneys General. RESULTS: The US tobacco industry faced a far greater number of lawsuits, and a greater variety of types of lawsuit, between 1994 and 2005 than it had in previous years. Plaintiffs won 31 (41%) of the 75 cases that were tried to verdict during the years 1995-2005. Seven plaintiffs have been paid awards totalling US$115 million, including interest, following the exhaustion of appeals. Based on an evaluation of litigation brought against US industry leader Philip Morris, the total number of cases pending peaked in 2000, dropping off modestly since then. For example, 36 class actions were pending in 2000, while 33 were pending in 2005. In the same time period, individual actions fell from a total of 3385 to 2863. While the playing field has been levelled to some degree in the tobacco litigation arena with respect to the resources brought to bear by plaintiffs and defendants, tobacco industry defendants continue to employ far greater financial and human resources than their adversaries. CONCLUSIONS: The third wave of tobacco litigation has represented a sea change in efforts to hold the tobacco industry in the United States accountable in American courtrooms. While tobacco manufacturers continue to do their utmost to make these cases difficult to pursue, many of the cases that have gone to trial have met with success in recent years, which suggests that plaintiffs' lawyers are now better equipped to persuade juries of the defendants' culpability.

Tobacco manufacturers' defence against plaintiffs' claims of cancer causation: throwing mud at the wall and hoping some of it will stick.

BACKGROUND: In the late 1990s and the early part of this decade, the major US cigarette manufacturers admitted, to varying degrees, that smoking causes cancer and other diseases. OBJECTIVE: To examine how tobacco manufacturers have defended themselves against charges that their products caused cancer in plaintiffs in 34 personal injury lawsuits, all but one of which were litigated between the years 1986 and 2003. METHODS: Defence opening and closing statements, trial testimony, and depositions for these cases were obtained from the Tobacco Deposition and Trial Testimony Archive (http://tobaccodocuments.org/datta/). All available defence-related transcripts from these cases were reviewed and a content analysis was conducted to identify common themes in the defendants' arguments. RESULTS: After review of the transcripts, defendants' arguments were grouped into seven categories: (1) there is no scientific proof that cigarette smoking causes lung cancer; (2) the plaintiff did not have lung cancer as claimed; (3) the plaintiff had a type of lung cancer not associated with cigarette smoking; (4) the plaintiff had cancer that may have been associated with cigarette smoking or smokeless tobacco use, but tobacco products were not to blame in this particular case; (5) the plaintiff had cancer that may have been associated with cigarette smoking, but the defendant's cigarette brands were not to blame; (6) the defendant's cigarettes (or smokeless tobacco) may have played a role in the plaintiff's illness/death, but other risk factors were present that negate or mitigate the defendant's responsibility; and (7) the defendant's cigarettes may have been a factor in the plaintiff's illness/death, but the plaintiff knew of the health risks and exercised free will in choosing to smoke and declining to quit. Use of the argument that smoking is not a proven cause of lung cancer declined in frequency during and after the period when tobacco companies began to publicly admit that smoking causes disease. Corresponding increases occurred over time in the use of other arguments (namely, presence of other risk factors and "free will"). CONCLUSIONS: Despite the vast body of literature showing that cigarette smoking causes cancer, and despite tobacco companies' recent admissions that smoking causes cancer, defendants used numerous arguments in these cases to deny that their products had caused cancer in plaintiffs. The cigarette companies, through their public admissions and courtroom arguments, seem to be saying, "Yes, smoking causes lung cancer, but not in people who sue us".