The Center for the Assessment of Tobacco Regulations (CAsToR) aims to provide evidence-based and expert-informed modeling of the behavioral and public health impacts of tobacco regulations. Funded through the TCORS 2.0 program, this multi-institutional Center includes experts in the field of tobacco regulatory science and modeling from the University of Michigan, Georgetown University, Yale University, University California San Francisco, and University of Minnesota.
Under the Family Smoking Prevention and Tobacco Control Act, the FDA must show that any new rule to regulate the marketing and sale of tobacco products or to regulate the characteristics of tobacco products is appropriate for the protection of the public health. The Act requires the FDA to show the impact on the population as a whole, including users and nonusers of the tobacco products, and to take into account initiation, cessation and toxicity. With the recent deeming regulations extending the jurisdiction of the Center for Tobacco Products (CTP) to e-cigarettes and cigars, public health analyses of regulations will need to account for the complexities of effects over a broad range of products. For the FDA to determine whether regulatory action is appropriate for the protection of public health, reliable, research-based projections of behavioral and public health impacts is thus required. Detailed and reliable simulation modeling of tobacco use and related health outcomes is a tool that can assist the FDA to make such projections of regulatory impacts.
To provide a comprehensive approach for showing the population impacts of FDA regulations, we will form the Center for the Assessment of the Public Health Impact of Tobacco Regulations. Our integrative theme is to provide the CTP external modeling capabilities to evaluate the potential health and behavioral impacts of individual and combined regulations, as well as to provide modeling capabilities on a rapid response basis. The primary scientific domains of the Center are Impact Analysis and Health Effects. Our Center has six aims:
- Aim 1: Analyze longitudinal and cross-sectional polytobacco use data to estimate rates of tobacco use prevalence, initiation, cessation, and switching that will parameterize four tobacco simulation models.
- Aim 2: Expand existing models so that they can project a broader range of health impacts, including cardiovascular and respiratory diseases.
- Aim 3: Develop evidence-based estimates of the major behavioral impacts from selected FDA tobacco regulatory actions.
- Aim 4: Develop the capacity to provide increasingly reliable, research-based projections of future use patterns and health outcomes for current and new products.
- Aim 5: Develop the administrative infrastructure and substantive capacity to provide increasingly comprehensive evidence-based projections of behavioral and public health impacts from current and potential new FDA tobacco regulatory actions, both generally and on a rapid response basis.
- Aim 6: Educate existing and next generation tobacco control researchers about tobacco control policy modeling and how to make their research more relevant to policy-focused efforts.
To achieve our aims, we will complete three projects based on detailed analysis of current and historical tobacco use patterns in the US using four established tobacco simulation models. In Project 1, we will conduct comparative modeling of the impact of FDA regulatory actions on cigarette and e-cigarette use and long-term health outcomes (scientific domains: Impact Analysis, Health Effects, Behavior). In Project 2, we will project the impact of regulating nicotine in combusted tobacco products on tobacco use and tobacco-related mortality and health outcomes (scientific domains: Impact Analysis, Health Effects, Addiction). In Project 3, we will model the impact of FDA regulatory actions on polytobacco use and associated health disparities (scientific domains: Impact Analysis, Health Effects, Behavior). Potential policies that will be considered include toxicity-related policies (e.g., health claims by manufacturers, health warnings, regulation of toxic content), addiction-related policies (e.g., nicotine reduction), and product appeal-oriented policies (e.g., flavorings, marketing).
We also propose four cores that will help us achieve our aims. The Administrative Core (AC) will monitor and coordinate the projects and cores. The Career Enhancement Core (CEC) will provide training to junior investigators on the capabilities and limitations of tobacco simulation modeling. The Data Analysis and Dissemination (DAD) Core will analyze data from the Population Assessment of Tobacco and Health (PATH) and Monitoring the Future (MTF) surveys and other nationally representative surveys to provide estimates of initial levels of product use, and of initiation, cessation and switching transitions, and will develop infrastructure for model and results dissemination. The Research Assessment and Input Development (RAID) Core will generate estimates for key policy and health effects modeling parameters via systematic reviews, metaanalyses, and expert panels. Through these integrated projects and cores, our Center will develop the data and modeling infrastructure to provide comprehensive analyses of the public health impact of new and existing FDA tobacco regulations.
- Rafael Meza, PhDUniversity of Michigan
- Rafael Meza, PhD
- University of Michigan: Associate Professor, Epidemiology; Associate Professor of Global Public Health; Co-Leader, Cancer Epidemiology and Prevention Program, UM Rogel Cancer Center
- Position: CAsToR Principal Investigator
- Profile: sph.umich.edu
- Dr. Rafael Meza is PI for CAsToR at the University of Michigan and co-Lead of Projects 1 - 2, as well as the Data Analysis and Dissemination Core. He is an Associate Professor of Epidemiology at the University of Michigan, as well as Co-Lead the Cancer Epidemiology and Prevention Program at the UM Rogel Cancer Center. His research utilizes mathematical modeling to assess risk of and develop screening tools for cancer. Dr. Meza has extensive experience in tobacco simulation modeling and has developed models as Coordinating PI for the Cancer Intervention and Surveillance Modeling Network (CISNET) lung group.
- David Levy, PhDGeorgetown University
- David Levy, PhD
- Georgetown University: Professor, Georgetown University Medical Center
- Position: CAsToR Principal Investigator
- Profile: globalhealth.georgetown.edu
- Dr. David Levy is PI for CAsToR at Georgetown University and co-Lead of Projects 1 - 3, and the Research Assessment and Input Development Core. He received his PhD in Economics from UCLA (USA), and is currently a Professor of Oncology at Georgetown University. He has published over 250 articles, in renowned journals such as the American Economic Review, BMJ, AJPH, JAMA, The Lancet, Tobacco Control, and PLOS Medicine. He has been principal investigator of grants from the CDC, WHO, the National Cancer Institute, and Bloomberg/Gates Foundation. Dr. Levy currently oversees the design and development of the SimSmoke tobacco policy simulation model, for which he has developed models for over 40 countries covering 85% of the world’s population, and has recently developed models of smokeless tobacco and e-cigarette use. In addition to being a principal investigator on the TCORS grant, he is currently a principal investor on a National Cancer Institute grant with the InternationalTobaccoControl Policy Evaluation Project (theITCProject) in which he has developed models of e-cigarette use for Canada, England and France; and is a principal investigator on the National Cancer Institute CISNET Lung Group. He has recently published articles providing a public health framework for evaluating e-cigarettes and showing the potential benefits of e-cigarettes, as well as papers on the cigarette and e-cigarette markets.