Regulatory Science

Enhancing the Economic Impact Analysis Used in FDA’s Rules for Tobacco Products

Justin White, PhD

We use a randomized field experiment to measure the costs to smokers of decision errors identified in the behavioral economics literature, and incorporate the behavioral costs into improved estimates of the economic impact of tobacco control policies. 

Analysis of Tobacco Industry Documents

Stanton Glantz, PhD

The tobacco industry is like an intelligent and aggressive ever-evolving pathogen that accounts for one-third of all cancer and nearly two-thirds of heart disease among people under 55.  To reduce this burden of disease requires understanding how the tobacco industry maintains a social and policy environment favorable to smoking. To understand a pathogen, one might study its genetic code.

Cardiovascular Assessment of the Effects of Tobacco and Nicotine-Delivery Products

Peter Ganz
Cigarette smoking continues to be a major cause of cardiovascular disease (CVD). In contrast, the cardiovascular risks of other tobacco products in common use (smokeless tobacco) and new tobacco products (e-cigarettes) are not adequately understood. The FDA will need information about the cardiovascular safety of these products to inform their regulatory decisions.

Cardiovascular Health Effects of Emerging Heat-Not-Burn Tobacco Products (2.0)

Matthew Springer, PhD

Heat-not-burn (HNB) products, which heat a mixture of tobacco and other compounds to temperatures below those at which combustion occurs, deliver an inhalable aerosol containing nicotine and other chemicals. Although previous attempts by the tobacco industry to introduce such products have been largely unsuccessful, Philip Morris International’s iQOS is successfully being test marketed in several countries. In addition, Philip Morris Products S.A. has submitted modified risk tobacco product applications to the FDA to permit marketing iQOS in the United States.

Clinical Pharmacology of Electronic Cigarettes

Gideon St Helen, PhD

We are investigating the addictive potential of e-cigarettes through assessment of nicotine pharmacokinetic parameters in clinical studies as well as e-cigarette features that affect nicotine delivery and toxic compound formation

Core A: Administrative Core

Stanton Glantz, PhD
The Administrative Core is the central unit that will oversee all aspects of the TCORS, including the five full scientific Research Projects, two initial Developmental Projects, two other Cores, the Research Training and Education Component, and the solicitation and selection of future Developmental Projects.

Core A: Administrative Core (2.0)

Stanton Glantz, PhD

The Administration Core will have primary responsibility for overall scientific and financial management of the TCORS. The integrated health effects, behavior, and impact analysis will provide actionable information for regulation of and public communications about current and emerging tobacco products. The TCORS’ five projects will be complemented by four cores (including this one), which include Rapid Response Projects and career enhancement activities.  The Administration Core will meet its responsibility by implementing five specific aims:

Core B: Career Enhancement Core (2.0)

Pamela Ling, MD

The Career Enhancement Core will continue and expand our current efforts to build the community of investigators with the knowledge, skills and experience to conduct high-quality cutting-edge tobacco regulatory science.

Core B: Informatics and Analytic Core

Kevin Delucchi, PhD
The Informatics and Analytic Core provides ongoing support for key central activities: data management, statistical analysis, collaboration, data sharing and informatics.

Core C: Biomarker Core

Neal Benowitz, MD
This Core serves two functions: (1) to provide a service to TCORS investigators by carrying out the analysis of biofluid samples for their studies and (2) to develop new biomarkers of exposure that can be applied to the studies carried out by TCORS investigators, as well as to advance the field.

Core C: Statistics and Informatics Core (2.0)

Kevin Delucchi, PhD, Stuart Gansky, MS, DrPH

The Statistics and Informatics Core of this UCSF TCORS Center will provide full and ongoing support for all statistical analysis and data management activities of the Center.

Core D: Biomarker Core (2.0)

Neal Benowitz, MD

Exposure assessment is necessary for evaluating the health effects of tobacco use.

Current and Emerging Tobacco Products in a Rural Context: Influences of Product Characteristics on Perceptions, Behaviors, and Biologic Exposures (2.0)

Benjamin Chaffee, DDS, MPH, PhD

Cigarette smoking among U.S. adolescents has declined, but similar declines have not occurred in youth smokeless tobacco (ST) use. There is also a growing trend among adolescents and young adults of poly-use of multiple tobacco products in combination. In recent decades, ST use has shifted from an older to a younger demographic, coincident with increasing industry marketing and expanding diversity in ST product characteristics. These new ST products include different types, brands, flavors, and varying levels of bioavailable nicotine and cancer-causing nitrosamines.

Development of a Low-Level Continuous Smoke Exposure System

Matthew Springer, PhD

This project will lay the groundwork for important studies with relevance to FDA tobacco product regulation, including the FDA’s regulatory responsibility to consider effects of exposure to tobacco products on bystanders. We will do so by improving an existing cigarette smoke exposure system to produce sidestream smoke at stable levels approximating real-world secondhand smoke exposures. Most commercially available cigarette smoking systems generate relatively constant levels but are not designed to deliver smoke through the low range of levels typical of many every-day situations.

E-cigarettes

Stanton Glantz, PhD

Dr. Glantz conducts research on a wide range of issues related to e-cigarettes, particularly how e-cigarette use affects cigarette smoking behavior among adults and youth as well as health effects.

Impact of Changing Tobacco Product Use on Healthcare Costs for General and Vulnerable Populations (2.0)

Wendy Max, PhD, Hai-Yen Sung, PhD, Tingting Yao, PhD

Healthcare costs play a central role in FDA regulatory impact analysis. Many factors contribute to tobacco- attributable healthcare costs, including changing tobacco product use patterns, sociodemographic characteristics, health status, and socioeconomic status (SES). The central goal of this project is to develop economic models that analyze the impact of new patterns of tobacco product use on healthcare costs for different populations including those that are particularly vulnerable.

Impact of Cigarette Smoke Exposure on Acute Lung Injury

Carolyn Calfee, MD, MAS

We are studying the effects of both active smoking and secondhand smoke exposure on susceptibility to acute lung injury, a major cause of respiratory failure among critically ill patients.

Impact of Different E-Cigarette Characteristics on Acute Lung Injury (2.0)

Carolyn Calfee, MD, MAS, Michael Matthay, MD, Jeffrey Gotts, MD, PhD, Farzad Moazed, MD

Over the past decade, use of electronic cigarettes (e-cigarettes) has been rapidly growing. Because e-cigarettes are relatively new to the market, there is little biologic data on their health effects, particularly how these health effects are affected by specific product characteristics.

In-vivo Measurements of the Antioxidant Glutathione at 7T and 3T Magnetic Field Strengths

Dieter Meyerhoff, PhD
In the general public and most research communities, the primary health consequences of smoking are perceived to be cancer, cardiovascular disease, chronic pulmonary disease as well as acute pulmonary consequences of smoke exposure in the young and critically ill patients. However, comparatively little research has focused on the detrimental effects of chronic tobacco smoking on the human brain and on cognitive functioning. The FDA needs information about the newly emerging cerebral (and cognitive) consequences of tobacco use to properly assume their regulatory responsibilities.

Marketing, FDA Communication, Tobacco Perceptions and use in Addition Treatment

Joe Guydish, PhD

Persons in addictions treatment are highly likely to smoke, they have high exposure to tobacco marketing and are likely to try, use, and adopt some emerging and potentially modified risk tobacco products. This study will recruit a national stratified random sample of 25 addiction treatment programs, where patients will be recruited into three annual cross-sectional interview waves (N=1,000 per wave) and will be interviewed concerning use of traditional and emerging tobacco products, exposure to FDA communication and tobacco marketing, risk perception related to a range of tobacco products,

Older Adult Risk Perceptions of Conventional and Emerging Tobacco Products

Janine Cataldo, RN, PhD, FAAN

The absolute negative health burden from smoking is greatest for adults over age 50. Older adults are growing in number and are the least likely to quit of any age group, because they underestimate both the risks for smoking and the benefits of cessation. While quitting smoking by age 50 halves the risk of lung cancer, and almost immediately decreases cardiovascular risk, older adults are often unaware of these benefits.

Pharmacologic Basis of Racial Difference in Nicotine Dependence

Neal Benowitz, MD, Gideon St Helen, PhD

AA and EA smokers undergo detailed monitoring of smoking behavior, receive known doses of nicotine to establish nicotine metabolic rate, undergo DNA testing, and have their responses to not smoking for several hours studied. Exposure to carcinogens and other tobacco smoke toxins is also measured.  It is hypothesized that there are racial differences in metabolism that may explain different patterns of smoking, and that this in turn influences the reasons why smokers continue to self-administer nicotine (i.e., continue to smoke).

Quantification and Biomarkers of Short-Term Pulmonary Effects of Tobacco Smoke Exposure: Infection-Related Acute Lung Injury

Jeffrey Gotts, MD, PhD, Carolyn Calfee, MD, MAS

The health consequences of smoking are primarily perceived to be cancer, cardiovascular disease, and chronic pulmonary disease, but acute pulmonary consequences of exposure to cigarette smoke are likely to be as or more important.  However, there has been little research on smoking and acute lung injury a common cause of acute respiratory failure in critically ill patients.

Risk And Benefit Perceptions in the Use of Conventional and Emerging Tobacco Products Among Older Smokers

Janine Cataldo, RN, PhD, FAAN
The absolute negative health burden from smoking is greatest for adults over age 55. Older adults (>45) are growing in number and are the least likely to quit of any age group, perhaps because they underestimate both the risks for smoking and the benefits of cessation.Older age is positively correlated with rationalizing beliefs about quitting smoking: older smokers exhibit greater unrealistic optimism about their risks for tobacco-related diseases and death than their younger counterparts.

Short-Term Cardiovascular Effects of E-Cigarettes: Influence of Device Power and E-Liquid pH and How E-Cigarettes Compare with Heat-Not-Burn Products (2.0)

Gideon St Helen, PhD, Neal Benowitz, MD

Components and parts of electronic cigarettes (e-cigarettes), such as batteries and e-liquids, are within the Food and Drug Administration’s regulatory authority. There are, however, significant gaps in understanding of how specific aspects of these components and parts influence the overall health effects of e-cigarettes, including short-term cardiovascular effects.

The Impact of Changing Tobacco Product Use on Tobacco-Related Disease and Healthcare Costs

Wendy Max, PhD

An important component of any FDA regulation of tobacco products is an economic analysis of the regulation. Models of the health-related economic costs of cigarette smoking have evolved and improved over the years, and current models take into account the complex relationship between smoking, health, and healthcare expenditures. However, there is a lack of research on healthcare costs attributable to the use of tobacco products other than cigarettes. It is important to have this information given the increased rates at which non-cigarette products are being used.

Tobacco Biomarker Core

Neal Benowitz, MD, Gideon St Helen, PhD

This Core serves two functions: (1) to provide a service to TCORS investigators by carrying out the analysis of biofluid samples for their studies and (2) to develop new biomarkers of exposure that can be applied to the studies carried out by TCORS investigators, as well as to advance the field.

Tobacco Center of Regulatory Science: Improved Models to Inform Tobacco Product Regulation

Stanton Glantz, PhD
The UCSF Center for Tobacco Control Research and Education is home to one of 14 Tobacco Centers of Regulatory Science (TCORS) funded as part of a first-of-its-kind tobacco science regulatory program by the U.S. Food and Drug Administration and the National Institutes of Health.  CTCRE Director Professor Stanton Glantz is Principal Investigator for this 4 year $20 million project.

Tobacco Use Among Rural High School Males and Associated Nicotine and Carcinogen Exposure

Neal Benowitz, MD, Stuart Gansky, MS, DrPH

Unlike smoking,conventional smokeless tobacco (ST) (moist snuff, known as dip and chewing tobacco) among US high school students is much higher among males (13%) than females (2%) and is especially high in rural areas.  In 2005, ST manufacturers spent over $250 million on marketing, including “new” ST products such as dissolvable films, compressed tobacco (e.g.

Understanding Smokeless Tobacco Marketing

Pamela Ling, MD

Combine research from previously secret tobacco industry documents and content analysis of smokeless tobacco advertising to develop and test new counter-advertising messages to decrease smokeless uptake by new users or quitters.