UNC partners with FDA, NIH to create Tobacco Centers of Regulatory Science

Research from new programs to inform potential tobacco regulatory activities

UNC partners with FDA, NIH to create Tobacco Centers of Regulatory Science click to enlarge Robert Tarran, Ph.D.
UNC partners with FDA, NIH to create Tobacco Centers of Regulatory Science click to enlarge Kurt Ribisl, Ph.D.

Thursday, Sept. 19, 2013
Media Inquiries:
UNC Lineberger Comprehensive Cancer Center — William Davis, 919-966-5906, william_davis@med.unc.edu
UNC Gillings School of Global Public Health – David Pesci, 919-962-2600, dpesci@unc.edu
UNC School of Medicine — Tom Hughes, 919-966-6047, tahughes@unch.unc.edu
FDA — Jenny Haliski, 301-796-0776, jennifer.haliski@fda.hhs.gov
NIH — Jody Engel, 301-402-9846, engeljo@mail.nih.gov
Consumer Inquiries: 888-INFO-FDA

The University of North Carolina at Chapel Hill received two separate grants from the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) today as part of an on-going interagency partnership. UNC will house two of 14 Tobacco Centers of Regulatory Science (TCORS), which are receiving a total of up to $53 million for tobacco-related research in fiscal year 2013.

The UNC Center for Regulatory Research on Tobacco Communication (CRRTC) will be based at the UNC Lineberger Comprehensive Cancer Center. This center will house projects headed by Adam Goldstein, MD, MPH, director of UNC Tobacco Intervention Programs; Noel Brewer, PhD, associate professor of health behavior at UNC’s Gillings School of Global Public Health; and Erin Sutfin, PhD, assistant professor of social sciences and health policy at Wake Forest School of Medicine, and include faculty members from the UNC School of Journalism and Mass Communication.

The 46 faculty, staff and students at the CRRTC will work on three major studies into reinforcing communication with the public about the dangers of alternative tobacco products such as electronic cigarettes, hookahs and smokeless tobacco; the harmful effects of chemicals found naturally in tobacco and cigarette smoke; increasing the credibility of risk communications and health risks to audiences from diverse ethnic and LGBT communities; and how to optimally communicate FDA authority over tobacco products.

“The goal is to inform and shape how the FDA regulates tobacco products by doing high impact research that will ultimately help reduce tobacco use,” said Kurt Ribisl, PhD, program leader of Cancer Prevention and Control Program at the UNC Lineberger, professor of health behavior at UNC’s Gillings School of Global Public Health, who will serve as center director.

The UNC Center for Tobacco Regulatory Science and Lung Health will be based in the School of Medicine and will be directed by Robert Tarran, PhD, associate professor of Cell Biology and Physiology. Other projects will be headed by Claire Doerschuk, MD, professor of Medicine and Pathology and director of the UNC Center for Airways Disease; Ilona Jaspers, PhD, associate professor of Microbiology and Immunology and Director  of the Curriculum in Toxicology; and Mehmet Kesimer, PhD, associate professor of Pathology and Medicine. The work of this center is aimed at better understanding which components of tobacco and which new and emerging tobacco products have an adverse effect on lung hydration and innate immune defense.

The 48 faculty, staff and students who comprise CTRSLH will work on four separate projects to comprehensively understand how new and emerging tobacco products such as little cigars and hookah can be harmful to lung health, including the development of chronic bronchitis, impaired innate immunity, tobacco induced lung inflammation and mucus overproduction.

"Tobacco-induced lung dehydration produces disease in more than 12 million Americans with chronic obstructive pulmonary disease (COPD) and more than 64 million people worldwide," Tarran said. "Data obtained in this project will be vital for directing new legislation aimed at limiting the development of harmful new and emerging tobacco products."

Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease. A new, first-of-its-kind regulatory science tobacco program, TCORS is designed to generate research to inform the regulation of tobacco products to protect public health. Using designated funds from FDA, TCORS will be coordinated by NIH’s Office of Disease Prevention, directed by David M. Murray, Ph.D., and administered by three NIH institutes — the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung and Blood Institute.

“For the first time, under the Family Smoking Prevention and Tobacco Control Act, the federal government, through the FDA Center for Tobacco Products (CTP), is able to bring science-based regulation to the manufacturing, marketing and distribution of tobacco products,” said FDA Commissioner Margaret A. Hamburg, M.D.  “The FDA is committed to a science-based approach that addresses the complex public health issues raised by tobacco product regulation.”  The agency is establishing science and research programs designed to increase understanding of the risks associated with tobacco use.

The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identified a targeted research goal. Taken together, the TCORS sites will increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.

“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, M.D., Ph.D.  “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.”

Comprised of scientists with expertise in fields including epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications, and marketing, the TCORS program is the centerpiece of the FDA/NIH collaboration to foster research relevant to tobacco regulatory science. New research from TCORS will help inform and assess the impact of FDA’s prior, ongoing and potential future tobacco regulatory activities implemented by CTP under the direction of Mitch Zeller, J.D.  In addition, the TCORS investigators will have the flexibility and capacity to begin new research to address issues raised in today’s rapidly evolving tobacco marketplace.

The TCORS awards represent a significant investment in federal tobacco regulatory science, including $53 million in the first year and a potential total of more than $273 million over the next five years. TCORS funding may not exceed $4 million in total costs per year per center, and an investigator could request a project period of up to five years.

Designed to generate vital research in seven core areas, as well as ensure innovation in the field, the research supported by this 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.

 

TCORS proposals were selected for funding based on their scientific and technical merit as determined by NIH scientific peer review, availability of funds, and relevance of the proposed projects to program priorities.

The other 12 TCORS have been awarded to:

  • Aruni Bhatnagar, Ph.D., and Rose M. Robertson, M.D., American Heart Association, Dallas
  • Pamela I. Clark, Ph.D., University of Maryland, College Park
  • Thomas E. Eissenberg. Ph.D., Virginia Commonwealth University, Richmond
  • Michael P. Eriksen, Ph.D., Georgia State University, Atlanta
  • Stanton A. Glantz, Ph.D., University of California-San Francisco
  • Stephen T. Higgins, Ph.D., University of Vermont and State Agriculture College, Burlington
  • Robert C. Hornik, Ph.D., and Caryn Lerman Ph.D., University of Pennsylvania, Philadelphia
  • Suchitra Krishnan-Sarin, Ph.D., and Stephanie S. O’Malley, Ph.D., Yale University, New Haven
  • Joshua E. Muscat, Ph.D., and Jonathan Foulds, Ph.D., Penn State University Hershey Medical Center, Hershey
  • Mary Ann Pentz, Ph.D., and Jonathan Samet, M.D., University of Southern California, Los Angeles
  • Cheryl L. Perry, Ph.D., University of Texas Health Sciences Center, Houston
  • Peter G. Shields, M.D., and Mary Ellen Wewers, Ph.D. The Ohio State University, Columbus


For more information:

FDA: Center for Tobacco Products
www.fda.gov/TobaccoProducts

Tobacco Centers of Regulatory Science (TCORS):
http://prevention.nih.gov/tobacco/tcors.aspx

NIH: Office of Disease Prevention
http://prevention.nih.gov/default.aspx

NIH: Tobacco Regulatory Science Program
http://prevention.nih.gov/tobacco/default.aspx

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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