UC San Francisco will receive a five-year, $20 million grant as part of a first-of-its-kind tobacco science regulatory program by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
The overall aim is to conduct programs of multidisciplinary research that will inform the FDA’s regulation of the manufacture, distribution and marketing of tobacco products to protect public health.
Stanton A. Glantz, PhD
UCSF is one of 14 institutions nationally to be awarded the new Tobacco Centers of Regulatory Science (TCORS) grants.
The UCSF principal investigator is Stanton A. Glantz, PhD, director of the UCSF Center for Tobacco Control Research and Education.
“We have identified serious problems in the way that the FDA has done cost-benefit analysis of major tobacco regulations, most notably warning labels on cigarette packages,” Glantz said. “In particular, the FDA underestimated the immediate benefits of smoking prevention and cessation, and based its behavioral assumptions on outmoded ideas.
“By combining cutting-edge economic research with modern behavior studies, and studies of the immediate effects of smoke exposure on the cardiovascular and pulmonary systems, we hope to help the FDA develop more realistic cost-benefit models that will better support sensible regulation.”
Science-Based Approach to Tobacco Regulation
Altogether, the 14 new centers will receive $53 million in federal funding for tobacco-related research in fiscal year 2013, and potentially $273 million over the next five years.
“For the first time … the federal government … is able to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products,” said FDA Commissioner Margaret A. Hamburg, MD, in a statement. “The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation.”
Representing a significant investment in federal tobacco regulatory science, the new centers will be comprised of scientists with expertise in fields including epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications and marketing. The UCSF TCORS spans all these areas.
Despite decades of work to reduce tobacco use in the U.S., it continues to be the leading cause of preventable death and disease.
“While we’ve made tremendous strides in reducing the use of tobacco products in the U.S., smoking still accounts for one in five deaths each year, which is far too many,” said NIH Director Francis S. Collins, MD, PhD, in a statement. “FDA/NIH partnerships like the Tobacco Centers of Regulatory Science keep us focused on reducing the burden and devastation of preventable disease caused by tobacco use.”
Research Focus of UCSF
Proposals selected for funding were based on scientific and technical merit as determined by NIH scientific peer review, availability of funds and relevance to program priorities.
Using designated funds from the FDA, the TCORS will be coordinated by NIH’s Office of Disease Prevention and administered by three NIH institutes – the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung and Blood Institute.
The UCSF Center for Tobacco Control Research and Education serves as a focal point for a broad range of research, education, and public service activities for 46 faculty from all four schools at UCSF, as well as colleagues at UC Berkeley and UC Merced.
Scientific achievements over the past decade include:
2002: Creating the Legacy Tobacco Documents Library to house and maintain tobacco industry internal corporate documents produced during litigation between 46 states and the seven major tobacco industry organizations. Today, the library has more than 80 million pages.
2007: Finding that reduced nicotine cigarettes promote lower nicotine intake without increasing the intake of inhaled carcinogens. This suggests that a national policy to gradually reduce cigarette nicotine content could reduce nicotine addiction in youth, without increasing carcinogen intake in current smokers.
2007: Showing that smoking in the movies causes youth cigarette experimentation, a study that supports a global campaign to reduce depiction of smoking in movies.
2009: Conducting two large, controlled clinical trials for treatment of chronic smokers, that resulted in long-term abstinence rates of approximately 50 percent - markedly exceeding the usual rates of 20 percent to 35 percent.
2009: Determining risk factors for smoking in youth in Latin America, the region in the world with the highest smoking rates, identifying mixed-race and indigenous youth as those at highest risk.
2011: Documenting the impact of tobacco use on economic burden and poverty in developing countries, especially China and India.
2012: Revealing how the tobacco industry has used cross-promotions and political alliances with alcohol to promote smoking and prevent anti-tobacco policies.
UCSF also is committing $750,000 in institutional support over five years to the project.
“Creation of such a center is a logical extension that builds on the UCSF Center for Tobacco Control Research and Education’s strong history of collaborative transdisciplinary research and public service,” said Jeffrey A. Bluestone, PhD, UCSF executive vice chancellor and provost, in a letter of support filed with the grant application. “UCSF is proud of its leadership in tobacco control research and is excited to contribute to developing the scientific base for regulation of cigarettes and other tobacco products.”
The new UCSF center will feature the development of research and programs spanning all seven designated interest areas. It has five aims:
1. Develop the science base to inform the regulation of tobacco products and the marketing of these products;
2. Develop empirically-based models of tobacco use behavior that integrate the effects of pro-tobacco marketing and anti-tobacco messages on perceptions of the risks and benefits of tobacco use, and how these perceptions affect decisions to start, continue, stop, relapse, switch tobacco products;
3. Evaluate the rapid changes in health risks due to tobacco use and secondhand smoke exposure as shown through cardiovascular and pulmonary disease to support the development of mechanistically-based biomarkers;
4. Implement an education and training program for postdoctoral fellows, and collaborate with other TCORS;
5. Attract new faculty investigators to develop research that will support tobacco regulatory science, and implement a developmental pilot program that will allow TCORS investigators and fellows to pursue new opportunities that arise from their projects.
The UCSF TCORS also has two developmental projects – one on risk perceptions of smoking by older Americans, and another to develop better animal models of the cardiovascular effects of secondhand smoke and exposure to other tobacco products, said Glantz. It also expands UCSF’s postdoctoral training program in tobacco control.
“Our results will not just provide information that the FDA can use to improve its regulatory decision making,” Glantz said. “They will also help the public and public health authorities around the country and to world to develop better policies to curb the global tobacco epidemic.”
At UCSF, the center’s individual project primary investigators include Wendy Max, PhD, professor of health economics at the UCSF School of Nursing and director of the UCSF Institute for Health & Aging; Bonnie Halpern-Felsher, PhD, professor in the department of pediatrics; Margaret Walsh, EdD, professor at the UCSF School of Dentistry in the department of preventive and restorative dental sciences; Carolyn Calfee, MD, associate professor of medicine and anesthesia; and Peter Ganz, MD, UCSF professor of medicine and chief of cardiology at the UCSF-affiliated San Francisco General Hospital and Trauma Center. Other leading participants include Janine Cataldo, PhD, RN, assistant professor at the School of Nursing, and Matt Springer, PhD, associate professor medicine.
UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy, a graduate division with nationally renowned programs in basic biomedical, translational and population sciences, as well as a preeminent biomedical research enterprise and two top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children’s Hospital.
UCSF TCORS Projects
Health Care Costs of Different Tobacco Products: Wendy Max, PhD, Hai-Yen Sung, PhD, and James Lightwood, PhD, will develop economic models to estimate health care costs resulting from the use of different tobacco products.
They will also study menthol and non-menthol cigarettes, moist snuff, chewing tobacco and combinations of these products, as well as exposure to secondhand smoke.
Additionally, they will develop econometric models that use national survey data and incorporate findings from the other TCORS studies. These models will be used to evaluate the impact of potential FDA regulations on health care costs.
Risk and Benefit Perceptions Among Older Smokers: Janine Cataldo, PhD, RN, will study risk and benefits perceptions of both conventional and emerging tobacco products among older smokers. She will analyze the extent to which these perceptions are related to exposure of older smokers to advertising, especially new ads that promote new products as a way to respond to smokefree environments. Cataldo will also study the perception of older smokers on the credibility of FDA-generated tobacco information.
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