Tobacco Center of Regulatory Science (TCORS)

Improved Models to Inform Tobacco Product Regulation 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. The overarching theme of this Tobacco Center of Regulatory Science is the development of improved models to inform tobacco product regulatory strategies that integrate

  1. economic impacts of tobacco use on health costs
  2. risk perceptions, perceived acceptability, consumer responses to pro-tobacco marketing and anti-tobacco messages and other social determinants of tobacco use
  3. rapid changes in risk due to tobacco use and secondhand smoke exposure as manifest in cardiovascular and pulmonary dysfunction

This TCORS includes five full projects (one on economic models, two on behavioral models, and two on cardiovascular and pulmonary disease models), two developmental projects (one on behavioral models and one on cardiovascular and pulmonary disease models), three Cores (Administrative, Informatics and Analytics, and Biomarker), a postdoctoral training program and a process for selecting future developmental projects. The results will inform FDA regulation of the manufacture, distribution and marketing of tobacco products by providing an improved scientific framework in which to evaluate the likely effects of specific regulatory strategies by developing

  1. improved economic models for analysis of proposed regulations that account for short-term as well as long-term effects of tobacco use
  2. better understanding of behavioral and social determinants of tobacco use (including perception of risk and decision making processes) to inform the economic models, regulation of marketing, and public education about risks of tobacco products
  3. functional biomarkers of acute cardiopulmonary responses to tobacco use and secondhand smoke that may predict future disease and also support development of improved economic models. In particular, these improved economic models will integrate the rapid changes in risk due to reductions in cardiovascular and pulmonary diseases which would be expected to result from FDA regulatory decisions
  • Since their introduction a decade ago, e-cigarettes (e-cigs), which use a heated coil to aerosolize nicotine-containing e-liquids, have been aggressively promoted by tobacco companies as safe alternatives to cigarettes. The use of these devices has increased at an alarming rate across all segments of society and especially among adolescents, with 13% of US high school students reporting recent use in 2014.

  • The goal of this study was to examine the associations between the rate of nicotine metabolism and cigarette consumption, addiction and withdrawal symptoms.

  • 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

  • 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 companies have developed and implemented advertising and marketing efforts to reduce perceptions of harm associated with tobacco use, increase perceptions that tobacco is socially acceptable, and encourage and sustain use of tobacco. Many marketing strategies have particularly focused on adolescents and young adults.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • The Informatics and Analytic Core provides ongoing support for key central activities: data management, statistical analysis, collaboration, data sharing and informatics. The specific aims are:

  • 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.