The University of Michigan in Ann Arbor today announced its School of Public Health will house a new, multi-institutional center focusing on modeling and predicting the impact of tobacco regulation, funded through an $18-million federal grant from the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).
The Center for the Assessment of the Public Health Impact of Tobacco Regulations will be part of the NIH and FDA’s Tobacco Centers of Regulatory Science, part of a partnership formed in 2013 to generate research that informs the regulation of tobacco products.
The center will provide projections of the behavioral and public health impacts of tobacco regulations to support the FDA in regulating the characteristics, marketing, and sale of tobacco products.
“There is a particular need for modeling in the current environment, in which people are using many different forms of tobacco – cigarettes, cigars, chewing tobacco, etc. – and increased availability and use of alternative nicotine delivery products, such as e-cigarettes,” says Rafael Meza, associate professor of epidemiology at the U-M School of Public Health, co-principal investigator for the center, and co-leader of the cancer epidemiology and prevention program at the U-M Rogel Cancer Center. “We can create models that predict the impact of different regulations, from reducing the amount of nicotine in cigarettes to making cigarette packaging less appealing, based on the best available evidence.”
Collaborating institutions include the Georgetown Lombardi Comprehensive Cancer Center and Yale University School of Public Health. Researchers from across U-M will also contribute, including some from the Rogel Cancer Center, Ford School of Public Policy, Institute for Social Research, and Institute for Healthcare Policy and Innovation.
Under the Family Smoking Prevention and Tobacco Control Act, the FDA must demonstrate that any new tobacco-related regulation is appropriate for the protection of public health. The act requires the FDA to show the impact on the population as a whole, including tobacco users and nonusers, and to consider smoking initiation and cessation as well as toxicity of tobacco products.
“Modeling the impacts of potential regulations will help inform the FDA in evaluating alternative policies and setting agency priorities,” says David Levy, co-principal investigator of the center and professor of oncology at the Georgetown Lombardi Comprehensive Cancer Center. “Our goal is to provide the FDA with the most comprehensive and detailed external modeling capabilities to evaluate policies and to provide these capabilities on a rapid-response basis.”
For example, Meza said the center could create models to predict the health and behavioral impacts if the FDA were to regulate the amount of nicotine in cigarettes to bring it down to a nonaddictive level.
“If someone is already addicted, are they going to switch to something else? Would this regulation incentivize a black market? Our center will look at the trade-offs and consequences of such regulations,” says Meza.
The center will examine three major issues based on the analysis of historical tobacco-use patterns in the U.S. One is examining the impact of tobacco regulations and policies on smoking and e-cigarette use and long-term health outcomes, including heart and lung disease and maternal and child health. Another is analyzing the possible consequences of regulating the amount of nicotine in smoked tobacco products, while a third is modeling tobacco-related health disparities and investigating how potential policy options may impact those disparities.
The center will coordinate panels of experts that will be hosted at Georgetown and available as resources to the FDA.
Researchers at the center will analyze data from nationally recognized surveys to provide estimates of initial levels of tobacco-use and develop an infrastructure for model and results dissemination.
The center will also support students, postdoctoral researchers, and junior faculty.
“This is the part I’m most excited about,” says Meza. “We will fund scholarships for students interested in tobacco regulation modeling and provide financial support for proposals from junior scientists related to and in support of the work the center is doing. It’s about ensuring that there is continued research and growth in this area into the future, educating the tobacco control community about the value and uses of modeling, and creating and supporting the new generation of tobacco modelers.”