New research center

The University of Michigan School of Public Health will house a new, multi-institutional center focusing on modeling and predicting the impact of tobacco regulation, funded with an $18 million federal grant from the National Institutes of Health and the Food and Drug Administration.

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, the centerpiece of an ongoing partnership formed in 2013 to generate critical research that informs the regulation of tobacco products.

The center will provide evidence-based and expert-informed modeling 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, said Rafael Meza, associate professor of epidemiology at the U-M School of Public Health and co-principal investigator for the center.

“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,” said Meza, who is also 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 the Yale University School of Public Health, in addition to researchers from across U-M, including 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 take into account 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,” said 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 non-addictive 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,” Meza said.

The center will tackle three major projects based on detailed analysis of historical tobacco-use patterns in the U.S., including:

• Evaluating 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.
• Analyzing the possible consequences of regulating the amount of nicotine in smoked tobacco products.
• Modeling tobacco-related health disparities and investigating how potential policy options may impact those disparities.

The center will bring together panels of experts in tobacco policy and regulation to generate estimates for key policies and health effects that the projects will model. Hosted at Georgetown, the expert panels will also be available as a resource to the FDA.

Researchers at the center will analyze data from the Population Assessment of Tobacco and Health and Monitoring the Future surveys and other nationally representative surveys to provide estimates of initial levels of tobacco-use trends and will develop an infrastructure for model and results dissemination.

Meza said the center will also promote the development of a new generation of tobacco regulatory scientists by supporting students, postdoctoral researchers and junior faculty with an interest in tobacco regulation.

“This is the part I’m most excited about,” he said. “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.”

In addition to Meza and Levy, the center’s lead investigators and steering committee members include Theodore Holford, the Susan Dwight Bliss professor of biostatistics and professor of statistics and data science at Yale; and several faculty members from the U-M School of Public Health, including David Mendez, associate professor of health management and policy; Nancy Fleisher, assistant professor of epidemiology; Ritesh Mistry, associate professor of health behavior and health education; and Kenneth Warner, the Avedis Donabedian Distinguished University Professor Emeritus of Public Health.