New research may help in regulation of tobacco products to protect public health

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 and the National Institutes of Health.

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.

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.

-Our results will 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 the world to develop better policies to curb the global tobacco epidemic.-

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 composed 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.-

The research supported by the new initiative will provide scientific evidence within the following seven FDA tobacco-related research interest areas:

• Diversity of tobacco products;
• Reducing addiction;
• Reducing toxicity and carcinogenicity;
• Adverse health consequences;
• Communications;
• Marketing of tobacco products;
• Economics and policies.

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 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.

-We-ve identified issues in the way 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 cost-benefit models that are more realistic than current models which will better support sensible regulation.-

At UCSF, the center-s individual project primary investigators are Wendy Max, PhD, professor of health economics at the UCSF School of Nursing and director of the UCSF Institute for Health & Aging; Bonnie L. Halpern-Felsher, PhD, professor in the department of pediatrics; Margaret Walsh, EdD, professor of preventive and restorative sciences; Carolyn S. Calfee, MD, associate professor of medicine and anesthesia; Peter Ganz, MD, UCSF professor of medicine and chief of cardiology at the UCSF-affiliated San Francisco General Hospital and Trauma Center; Janine Cataldo, RN, PhD, assistant professor at the School of Nursing; and Matthew L. Springer, PhD, associate professor medicine. Other leading participants are Karen Butter, MA, university librarian and assistant vice chancellor; and Peyton Jacob, PhD, research chemist in the department of psychiatry. Co-investigators are Neal Benowitz, MD, professor of medicine and bioengineering & therapeutic sciences and chief of the division of clinical pharmacology at SFGH; and Pamela M. Ling, MD, MPH, associate professor of medicine and associate director of the UCSF Center for Tobacco Control and Research and education.