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Smoking and Tobacco

Center for the Assessment of the Public Health Impact of Tobacco Regulations (TCORS 2.0)

The tobacco market has become increasingly complex over the past decade, with new products recently introduced and others on the horizon. The increasing diversity of products will change the way people use tobacco and other nicotine-containing substances, including new combinations of polytobacco users. Little is known about how the evolving tobacco marketplace will shape the patterns of individual- and poly-tobacco use, their subsequent long-term health effects, and potential disparities by socioeconomic status (SES) and race/ethnicity. Because many products, including e-cigarettes, have only recently entered the market, long-term health outcome studies have not yet been conducted. Instead of waiting decades for such data, simulation modeling can predict future health outcomes and provide insights into how different policies and regulations may affect disparities in the consumption of polytobacco use and downstream health outcomes.

The Center for the Assessment of the Public Health Impact of Tobacco Regulations will provide evidence-based and expert-informed modeling of the behavioral and public health impacts of FDA tobacco rules or other regulatory actions, focusing on Impact Analysis and Health Effects as Scientific Domains. The Center will have projects based on the detailed analyses of current and historical tobacco use patterns in the US using four established tobacco simulation models, with different approaches to provide a range of diverse insights.

TCORS 2.0, Project 1: Comparative Modeling of the Impact of E-cigarettes use on Smoking and Long-Term Health Outcomes

Under the Family Smoking Prevention and Tobacco Control Act, the FDA is required to show that any new rule to regulate the marketing, sale, or content of tobacco products is “appropriate for the protection of the public health.” To provide the FDA with a framework to assess the potential health impacts of tobacco regulations, Project 1 will harmonize and extend four established tobacco control simulation models to examine the impact of different possible FDA regulatory actions on future trends in cigarette and e-cigarette use, and associated health outcomes.

The project will focus on impact analysis and health effects, with a secondary emphasis on behavior. We will use several statistical approaches to distinguish experimentation from long-term tobacco product use to develop initial prevalence rates for the models; a range of plausible future status quo transitions by age and gender for initiation and cessation for cigarettes and e-cigarettes; and a range of plausible switching rates between cigarettes and e-cigarettes. Through literature reviews and expert elicitation panels, we will develop relative risk estimates for specific health outcomes, and extend the models from all-cause mortality to project tobacco-related mortality due to cardiovascular and chronic obstructive pulmonary disease, and adverse maternal and child health outcomes. We will also extend the models to consider the impact of specific policies related to cigarette and e-cigarette use, such as the provision of information about health effects, using literature reviews and expert panels to develop policy effect estimates.

Upon incorporating the common initial prevalence and transition rates for cigarette and e-cigarette use, the extensions regarding health outcomes, and the policy parameters, we will use the four models with their different structures to examine the impact of current and projected future e-cigarette use on overall harms. We will also project how specific potential FDA regulations individually and in combination will likely impact cigarette and e-cigarette use rates and associated health outcomes over a 50-year period in the future. Comparative analyses of the four models’ predictions will be conducted to further refine the likely best-case, worst-case, and most likely projected scenarios to better assess regulatory impacts. In addition, the models will have the capacity and flexibility to rapidly use new data from national surveillance cohorts and incorporate new regulatory policy options. Our models will also be flexible to further consider substitution into and away from other alternative nicotine delivery products, including cigars, smokeless tobacco, and heat-not-burn products.

Yale Co-Lead, Project 1:

TCORS 2.0, Project 3: Modeling the Impact of Tobacco Control Policies on Polytobacco Use and Associated Health Disparities

The purpose of this project is to estimate tobacco-related health disparities associated with polytobacco use and to investigate the impact of specific tobacco control policy options on these disparities by: (1) determining disparities in polytobacco use and monitoring changes in patterns over time; (2) estimating the impact of tobacco control policies on disparities in patterns of tobacco and nicotine product use; (3) determining downstream tobacco-related health disparities in health outcomes associated with individual- and poly-tobacco use; and (4) modeling the impact of potential policies on tobacco-related health disparities associated with individual- and polytobacco use. The results will provide evidence-based and expert-informed estimates of polytobacco use, potential policy impacts, and health outcomes by socio-economic status (SES) and race/ethnicity to inform our modeling, which will directly address disparities in long-term health consequences and policy impacts. This project will focus on impact analysis and health effects, with a secondary emphasis on behavior. Knowledge gained from this study will guide policy-makers’ decisions regarding which potential policies may be most effective in reducing downstream tobacco-related health disparities due to polytobacco use over time.

Yale Co-Investigator, Project 3:

TCORS 2.0, Data Analysis and Dissemination Core (DAD)

The Data Analysis and Dissemination (DAD) Core is designed to provide data processing and analysis services to three Center Projects, Rapid Response Proposals (RRPs), and Career Enhancement Pilot Projects, as well as to the TCORS Consortium and the FDA Center for Tobacco Products (CTP). The Core will ensure that there are uniformly high standards of data collection and analyses, as well as consistent measures of tobacco use across research projects. The Core will also provide the infrastructure for disseminating the resulting tobacco use parameters (product-specific prevalence, initiation and cessation rates, intensity of use by age, gender, year, and birth cohort), mortality rates by tobacco use status, and modeling results.

Yale Co-Lead, Data Core:


Comparative Modeling of Lung Cancer Prevention, Early Detection and Treatment Interventions (CISNET 2)

Lung cancer remains the leading cause of cancer-related mortality in the US and globally accounting for 1.8 million deaths annually. The collaborative investigators of the Cancer Intervention and Surveillance Modeling Network (CISNET) Lung Working Group (LWG) have contributed to the development of US national strategies for reducing the lung cancer burden by quantifying the impact of tobacco control on smoking, lung cancer, and overall mortality, and by evaluating the population benefits and harms of lung cancer screening in the US. Our current work will extend existing CISNET LWG models to assess the impacts of future tobacco control interventions in the ever-changing tobacco market landscape, improvements in lung cancer screening and other emerging early detection strategies, innovations in lung cancer treatment, and their synergistic interactions, on lung cancer rates and overall mortality in the US and globally.

Principal Investigator (Yale Subaward):