The overall goal of this proposal is to facilitate Micah Berman's development into an established, independent cancer control investigator who focuses on the intersection of tobacco regulatory science and public health law. Prof. Berman is an attorney with considerable experience in tobacco policy and law; he has advised the U.S. Food and Drug Administration (FDA) on tobacco regulation, provided policy support to state and local tobacco control programs, and taught public health law. The proposed training plan will enable him to obtain training in public health sciences (including biology, epidemiology, health behavior, and environmental health sciences), risk sciences (including toxicology and risk assessment), and statistical analysis. Coursework will be split between in-person classes at Ohio State University (OSU) and online courses from the Risk Sciences and Public Policy Program at Johns Hopkins University. As a member of OSU's Comprehensive Cancer Center and with a joint faculty appointment in law and public health, Prof. Berman has an exceptionally supportive environment in which to undertake the planned training and research. Combined with his legal background, the training and research plan will enable him to engage in innovative transdisciplinary research that considers both the scientific and legal aspects of tobacco regulation. The proposed research will advance the science of tobacco regulation, thereby helping to reduce the incidence of tobacco-related cancer. Tobacco use is the leading preventable cause of cancer death in the U.S., responsible for approximately one in three cancer deaths. In 2009, Congress granted the FDA the authority to regulate tobacco products, including the ability to conduct pre-market review of new products, evaluate health-related claims made by manufacturers, and set standards relating to a product's composition or characteristics. These new regulatory tools represent a tremendous opportunity to reduce tobacco-related death and disease. In implementing this new authority, the FDA must be able to synthesize information from a wide range of scientific disciplines-from toxicology to epidemiology-and make informed predictions about the likely effects of regulatory judgments. Thus, new methods are needed for conducting weight-of-scientific-evidence (WOSE) reviews and risk assessments in the context of tobacco regulation. Additionally, because tobacco regulations are likely to be challenged in court, any framework for tobacco product assessment must incorporate the standards that courts will use when reviewing the adequacy of the scientific evidence. The overall objective of this proposed research plan is to develop a comprehensive framework for the assessment of tobacco products that fuses scientific and legal considerations and includes novel risk assessment methodologies. This research builds upon the work of the NCI-funded Tobacco Product Assessment Consortium (TobPRAC), which was led by Dr. Peter Shields, the primary mentor for this project.
Specific Aim 1 will develop methods for WOSE reviews and risk assessments in the tobacco context, building upon best practices in other regulatory areas.
Specific Aim 2 will apply the scientific framework developed by TobPRAC (incorporating the risk analysis methodologies developed in Aim 1) to two test cases, in order to validate the TobPRAC framework and identify remaining research gaps. The two test cases are: (1) the historical example of low tar cigarettes, which were promoted as reduced-risk products but in fact increased the risk of lung cancer; and (2) a potential regulation of nicotine content in cigarettes designed to reduce addictiveness.
Specific Aim 3 will connect the TobPRAC framework to the evidentiary standards applied by the courts. In all, this research project seeks to develop a comprehensive framework for tobacco product assessment that will inform the FDA's tobacco regulatory efforts and also be transferrable to other regulatory contexts. The mentoring team is led by Dr. Shields, Deputy Director of the OSU Comprehensive Cancer Center, and Dr. Mary Ellen Wewers, Professor of Health Behavior and Health Promotion at the OSU College of Public Health. Dr. Shields and Dr. Wewers are co-PIs of OSU's NCI P50 Tobacco Center of Regulator Science. The mentoring team also includes Dr. David Ashley, Director of the Office of Science at the FDA Center for Tobacco Products; Dr. Mary Fox, Acting Director of Johns Hopkins University's Risk Sciences and Public Policy Institute; Dr. George Gray, Director of the Center for Risk Science and Public Health at George Washington University; and Dr. David Levy, the leading expert in statistical modeling of tobacco policies. The scientific/legal framework resulting from this project will be used to develop an R01 application that will apply the framework developed in this project to additional case studies, including the regulation of electronic cigarettes and other new/emerging tobacco products. This proposal has direct relevance to the mission of the National Cancer Institute in that it will help further the development of new and legally sound approaches to preventing cancer caused by tobacco use or exposure.
Tobacco use is responsible for the vast majority of cases of lung cancer, which is the leading cause of cancer- related deaths, in addition to causing numerous other cancers and diseases. Approximately 480,000 Americans die from a tobacco-related disease every year. This proposal will improve the process for analyzing potential regulations of tobacco products, thereby helping to reduce tobacco-related harms.
