Reynolds American
Embracing the Continuum of Risk FDLI Presentation April 24, 2013
Reducing Harm from Cigarette Smoking
Tobacco Control and RAI share common vision that focus should be on reducing harm from smoking
“Reducing the diseases and deaths associated with the use of cigarettes serves public health goals and is in the best interest of consumers, manufacturers and society.” (RAI Guiding Principles and Beliefs)
“[T]he goal of coordinated tobacco control efforts should centre on the dramatic reduction or elimination of combustible tobacco use.” (Zeller, 2013)
2
Current Tobacco Control Strategies
Current strategies focus on abstinence-only
decreasing smoking initiation increasing smoking cessation
reducing exposure to second-hand smoke
Strategies effective in reducing smoking prevalence, but declines have stalled; tobacco harm reduction intended to complement existing strategies
disease risk significantly influenced by tobacco product type, as well as frequency, duration and manner of use
risks associated with use of smokeless tobacco and nicotine products significantly less than smoking
3
Tobacco Use and Disease Risks Mortality Risk Compared to Never Tobacco Use (CPS-II) 22.4 *
lung cancer
2.0*† 9.7 *
respiratory disease
1.3 1.9 * 1.3 *
heart disease
27.5 *
oropharyngeal cancer
0.9 0
5 cigarettes
10
15
20
25
30
smokeless tobacco
Risks relative to reference population of never tobacco users (HR = 1.00); *statistical difference from never tobacco users; † not replicated in other studies
substantial reduction in mortality risks for smokeless tobacco use supported by same US data used to establish disease risks for smoking
4
Continuum of Risk
Relative Risk for Chronic Disease
Cigarettes For illustrative purposes only
Smokeless Tobacco
Product Category
Nicotine Products
Public health organizations recognizing pronounced continuum of risk, potential for harm reduction with product switching (e.g., LN-SLT)
Institute of Medicine (2001)
American Council on Science and Health (2006)
Royal College of Physicians (2002, 2007)
Scientific Committee on Emerging and Newly Identified Health Risks (2007)
Life Sciences Research Office (2008)
American Association of Public Health Physicians (2008)
World Health Organization (2008)
Strategic Dialogue on Tobacco Harm Reduction Group (2009)
[LN-SLT = low-nitrosamine smokeless tobacco, e.g., snus, dissolvable products]
5
New Approaches Necessary
“[W]hen a group of global thought leaders gathered in 2012 to consider the endgame, there was a convergence around the notion that we need new approaches to dramatically reduce consumption of conventional combusting cigarettes” (Zeller, 2013)
Embracing continuum of risk holds prospect of switching smokers to less hazardous forms of nicotine-containing products (includes smokeless products, as well as tobacco-derived nicotine products such as e-cigarettes)
6
Continuum of Risk Not Understood
Vast majority (~85%) of US tobacco users incorrectly perceive disease risks associated with smokeless tobacco use as similar or greater than cigarette smoking (e.g., O’Connor et al., 2007; Borland, et al., 2011)
Many (~30%) tobacco control professionals unaware that cigarettes more harmful than smokeless tobacco products (Biener, et al., 2013)
7
Continuum Not Effectively Communicated
Opportunities exist to improve communication; change to smokeless warning provides such an opportunity
“WARNING: This product is not a safe alternative to cigarettes.” (in place since 1985)
Comparative warning incomplete and misleading
conveys message that smokeless tobacco products and cigarettes equally unsafe
acts as disincentive for smokers to switch to lower-risk tobacco products
8
Addressing Misperceptions of Risk
FDA can address misperceptions of risk by revising warning through rulemaking (Section 205, FSP&TCA)
Issue raised by Citizen Petition (FDA-2011-N-0573; 28-Jul-2011)
Recommended FDA revise warning, as follows:
“WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”
Petition updated to reflect recent publications further supporting scientific consensus that smokeless tobacco presents less risk than cigarettes, and that vast majority remain misinformed
9
Conclusion
Agreement that new strategies necessary to reduce harm from smoking
Developing strategies based on science underlying continuum of risk provides opportunity to achieve goal of harm reduction
Challenge will be that CTP and Tobacco Control identify ways to effectively communicate continuum of risk to adult tobacco consumers, thus allowing informed decision making
10
Questions?
11
Reducing Harm from Cigarette Smoking
Tobacco Control and RAI share common vision that focus should be on reducing harm from smoking
“Reducing the diseases and deaths associated with the use of cigarettes serves public health goals and is in the best interest of consumers, manufacturers and society.” (RAI Guiding Principles and Beliefs)
“[T]he goal of coordinated tobacco control efforts should centre on the dramatic reduction or elimination of combustible tobacco use.” (Zeller, 2013)
2
Current Tobacco Control Strategies
Current strategies focus on abstinence-only
decreasing smoking initiation increasing smoking cessation
reducing exposure to second-hand smoke
Strategies effective in reducing smoking prevalence, but declines have stalled; tobacco harm reduction intended to complement existing strategies
disease risk significantly influenced by tobacco product type, as well as frequency, duration and manner of use
risks associated with use of smokeless tobacco and nicotine products significantly less than smoking
3
Tobacco Use and Disease Risks Mortality Risk Compared to Never Tobacco Use (CPS-II) 22.4 *
lung cancer
2.0*† 9.7 *
respiratory disease
1.3 1.9 * 1.3 *
heart disease
27.5 *
oropharyngeal cancer
0.9 0
5 cigarettes
10
15
20
25
30
smokeless tobacco
Risks relative to reference population of never tobacco users (HR = 1.00); *statistical difference from never tobacco users; † not replicated in other studies
substantial reduction in mortality risks for smokeless tobacco use supported by same US data used to establish disease risks for smoking
4
Continuum of Risk
Relative Risk for Chronic Disease
Cigarettes For illustrative purposes only
Smokeless Tobacco
Product Category
Nicotine Products
Public health organizations recognizing pronounced continuum of risk, potential for harm reduction with product switching (e.g., LN-SLT)
Institute of Medicine (2001)
American Council on Science and Health (2006)
Royal College of Physicians (2002, 2007)
Scientific Committee on Emerging and Newly Identified Health Risks (2007)
Life Sciences Research Office (2008)
American Association of Public Health Physicians (2008)
World Health Organization (2008)
Strategic Dialogue on Tobacco Harm Reduction Group (2009)
[LN-SLT = low-nitrosamine smokeless tobacco, e.g., snus, dissolvable products]
5
New Approaches Necessary
“[W]hen a group of global thought leaders gathered in 2012 to consider the endgame, there was a convergence around the notion that we need new approaches to dramatically reduce consumption of conventional combusting cigarettes” (Zeller, 2013)
Embracing continuum of risk holds prospect of switching smokers to less hazardous forms of nicotine-containing products (includes smokeless products, as well as tobacco-derived nicotine products such as e-cigarettes)
6
Continuum of Risk Not Understood
Vast majority (~85%) of US tobacco users incorrectly perceive disease risks associated with smokeless tobacco use as similar or greater than cigarette smoking (e.g., O’Connor et al., 2007; Borland, et al., 2011)
Many (~30%) tobacco control professionals unaware that cigarettes more harmful than smokeless tobacco products (Biener, et al., 2013)
7
Continuum Not Effectively Communicated
Opportunities exist to improve communication; change to smokeless warning provides such an opportunity
“WARNING: This product is not a safe alternative to cigarettes.” (in place since 1985)
Comparative warning incomplete and misleading
conveys message that smokeless tobacco products and cigarettes equally unsafe
acts as disincentive for smokers to switch to lower-risk tobacco products
8
Addressing Misperceptions of Risk
FDA can address misperceptions of risk by revising warning through rulemaking (Section 205, FSP&TCA)
Issue raised by Citizen Petition (FDA-2011-N-0573; 28-Jul-2011)
Recommended FDA revise warning, as follows:
“WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”
Petition updated to reflect recent publications further supporting scientific consensus that smokeless tobacco presents less risk than cigarettes, and that vast majority remain misinformed
9
Conclusion
Agreement that new strategies necessary to reduce harm from smoking
Developing strategies based on science underlying continuum of risk provides opportunity to achieve goal of harm reduction
Challenge will be that CTP and Tobacco Control identify ways to effectively communicate continuum of risk to adult tobacco consumers, thus allowing informed decision making
10
Questions?
11
