The Food and Drug Law Institute
October 21, 2015
Michael P. Eriksen, ScD
Dean, School of Public Health
Georgia State University
Phone: (404) 413-1480
Email: meriksen@gsu.edu
Web: http://publichealth.gsu.edu
Twitter: @MPEriksen

Funding Sources
• NIDA TCORS (P50DA036128)
• Pfizer, Inc. (Diffusion of Tobacco Control Fundamentals in Large
Chinese Cities)
Disclaimer
Research reported in this presentation was supported by NIDA and FDA
Center for Tobacco Products (CTP). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.
Acknowledgements
Kyle Gregory, JD, MSHA; Cathy Kemp, MHA; Rachel Lawley, MPH, MBA; Ban
Majeed, PhD; Pratibha Nayak, PhD; Amy Nyman, MA; Terry Pechacek, PhD;
Pam Redmon, MPH; Scott Weaver, PhD; Carrie Whitney, MPH

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

Annual deaths attributable to cigarette smoking in the U.S. 2005 –2009

The majority of harm from tobacco occurs as a result of smoke – a product of combustion

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

Existing tobacco control strategies won’t result in single-digit smoking prevalence. We need to disrupt the status quo.
Unpublished Data: Mendez and Warner, University of Michigan School of Public Health

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

Decision making process for current smokers – adolescent decision
• Most current adult smokers started as adolescents and were addicted and wanted to quit before high school graduation.
• Adolescent minds:
– Do not understand the addictive nature of cigarettes.
– Do not appreciate the cumulative risk of cigarettes.
– Underestimate future risks relative to immediate benefits.
• Adolescent smoking is clearly stimulated by tobacco industry due to the need for replacement smokers and competition for first brand.

Young smokers are quickly addicted and regret starting to smoke
• The most susceptible youth can begin showing signs of addiction within a day or two of first inhaling a cigarette (DiFranza and colleagues, Pediatrics, 2007).
• Almost one-half of high school smokers in 2013 had tried to quit unsuccessfully in the last 12 months (YRBSS, 2013).
• 86% of young adults (18-24 year-old) regret having started to smoke (Fong et al., NTR, 2004).
• 73.2% of 18-24 year olds tried to quit smoking in the past year
(CDC, 2015).

Tobacco use among teens and young adults remains shockingly high
• In 2014, nearly 2.2 million youth and young adults started smoking, 90,000 more than in 2013 (NSDUH, 2014).
• Additionally, more than 2.5 million started smoking cigars
(NSDUH, 2014).
• For every person who dies due to smoking—more than 1,200 each day —at least two youth or young adults become regular smokers (2012 SGR Consumer Summary).
• Nearly 90% of replacement smokers try their first cigarette by age 18 (2012 SGR Consumer Summary).

RJR reactions to the marketing success of Marlboro brand among youth
• “…if our Company is to survive and prosper, over the long term, we must get our share of the youth market.”
RJR Scientist Claude E. Teague, Jr., 1973
• Cigarettes for beginning smokers should be “low in irritation and possibly contain flavors to make it easier for those who never smoked before to acquire the taste for it more quickly.”
RJR Meeting Summary, 1974
2012 Surgeon General Report, Chapter 5, “Designing Cigarettes for the Youth Market” pp 535-541

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

Paul Slovic Health, Risk & Society, 14(5), 2012, using unpublished data from
Weinstein & Slovic, 2001

If I had it to do over again, I would not have started smoking cigarettes. How much do you agree or disagree with this statement? (Current Smokers, n=1284)
Unpublished Data: 2015 Tobacco Products and Risk Perceptions
Survey; Georgia State University, School of Public Health,
Tobacco Center of Regulatory Science (TCORS)

No Regret Don't Know Do Regret
M A L E F E M A L E 1 8 - 3 4 3 5 - 5 4 5 5 +
Unpublished Data: 2014 Tobacco Products and Risk Perceptions Survey; Georgia State University, School of Public
Health, Tobacco Center of Regulatory Science (TCORS)

Understanding the risks of smoking

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

Can these products advance public health?
Sources: MarkTen ® from Markten.com; VUSE ® from Vusewapor.com; Blu ® from blucigs.com; Orbs from evolvement.org; Hookah from hookashisha.org; all other images from Wkimedia Commons

• Thus far, the U.S. Preventive Services Task Force (USPSTF) has made the strongest stance about electronic nicotine delivery systems (ENDS).
• In September 2015, the USPSTF “found the evidence on ENDS use as a smoking cessation tool in adults or adolescents to be insufficient.”
• The USPSTF was only able to identify two randomized controlled trials that evaluated the effect of e-cigarettes on smoking abstinence in adults. These two studies found mixed results.

American Lung Association
– “Until and unless the FDA approves a specific electronic nicotine delivery system or e-cigarette as safe and effective for use as a tobacco cessation aid, the Lung Association does not support using them for cessation, nor does it support any direct or implied claims that e-cigarettes help smokers quit .”
American Heart Association
– “There is not yet enough evidence for clinicians to counsel their patients who are using combustible tobacco products to use ecigarettes as a primary cessation aid. The efficacy of e-cigarettes as a primary smoking cessation aid has not been established as being better than other cessation modalities .”
American Medical Association
– Supports regulations that … “prohibit claims that electronic cigarettes are effective tobacco cessation tools .”
Note: Underlining added for emphasis

• Public Health England published a report in August 2015 stating that “The current best estimate is that e-cigarette use is around
95% less harmful to health than smoking.”
• Vape shops quickly capitalized on this finding, using the statistic in the front window of e-cigarette shops.
• Some criticize that the report is based on expert opinion (multi-criteria decision analysis) rather than empirical evidence.

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

The e-cigarette quandary : helping smokers quit while enticing new addicts. The e-cigarette dilemma:
“E-cigarettes pose a public policy conundrum . They are a gateway drug — but it’s not, or hasn’t been, entirely clear in which direction most traffic through that gateway flows.”
Ruth Marcus, September 5, 2014

60
50
40
30
20
10
0
30,4
33,8
11,1
28,3
1,8
2,8
56,7
35,1
Less
Harmful
About the
Same
More
Harmful
2012 2014
I Don't
Know
“The promotion of electronic cigarettes and other innovative tobacco products is much more likely to be beneficial in an environment where the appeal, accessibility, promotion, and use of cigarettes are being rapidly reduced.
”
Unpublished Data: 2012 HealthStyle survey and 2014 Tobacco Products and Risk Perceptions Survey; Georgia State
University, School of Public Health, Tobacco Center of Regulatory Science (TCORS)

Cigarette word cloud
Word cloud created by asking more than 5,000 respondents for the first thought/image that comes to mind when hearing the word “cigarette.”

E-cigarette word cloud
Word cloud created by asking more than 5,000 respondents for the first thought/image that comes to mind when hearing the word “e-cigarette.”

There are extremes…

E-Cigarettes are the source of a new sport, called Cloud
Chasing, where participants try to blow the most vapor.
Photo Credit:
David Becker/Reuters

Global bans on e-cigarettes

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

The Georgia State University TCORS
Decision Research – Eugene, OR
University of Illinois at Chicago
Research Triangle Institute – Durham, NC
Georgia State University – Atlanta, GA

The Science of Decision Making –
Connecting People and Policy
Enhancing the Economic Impact Analysis used in
FDA’s Rules for Tobacco Products (University of
Illinois at Chicago)
Testing Tobacco Ad Restrictions and Counter
Ads in a 3D Virtual Retail Store (RTI International)
Conducting Consumer Behavior, Risk Perception and Media Research on Novel Tobacco Products
(Georgia State University)

Research: Behavioral Economics
• University of Illinois, Chicago
• PI: Frank J. Chaloupka, PhD
• One of the few TCORS to include a behavioral economics experiment
• Examining the effects of social, mental, and emotional factors on the purchasing decisions of tobacco users
• Focus on “consumer preference”
• Analysis of economic impact of FDA rule-making

• RTI International
• PI: Matthew Farrelly, PhD
• The only TCORS with a virtual reality, point-of-sale research project — iShoppe
• Using virtual immersion methodology to examine the point-of-sale environment and how it can be changed to influence consumer behavior

• Based on the work of Paul Slovic and others, we know that risk decisions are more likely to be based on affect than on rational or reasoned thought processes (Affect Heuristic).
• While smokers “know” that smoking is harmful, they often lack a deeper understanding of risk (e.g., the misery of certain diseases) or the likelihood that it will really happen to them.
• An individual’s worldview (e.g., individualism vs. egalitarianism) may influence their assessment of risk/benefit ratios (Kahan & nanotechnology).
• Challenge is to develop affective messages that correspond to differing worldviews so that smokers feel the misery and understand the likelihood of harm from combustibles, and the likely benefit from ENDS.

How often do you worry about getting lung cancer?
(Current Smokers, n=1284)
Unpublished Data: 2015 Tobacco Products and
Risk Perceptions Survey; Georgia State
University, School of Public Health, Tobacco
Center of Regulatory Science (TCORS)

5
4,5
4
3,5
3
2,5
2
1,5
1
E-Cig Less
Harmful E-Cig Help Me
Quit
E-Cig Reduce
Cigarette
Consumption
All Smokers Switchers
E-Cig Less
Harmful to
Others
Switchers: Former smokers who currently use ENDS exclusively
Unpublished Data: 2014 Tobacco Products and Risk Perceptions Survey; Georgia State University,
School of Public Health, Tobacco Center of Regulatory Science (TCORS)

90
80
70
60
50
40
30
20
10
0
E-Cig Rejecters
(n=337)
E-Cig Dual Users
(n=248)
Quit All Products
(n=103)
Switchers (n=43)
E-cigarettes are more enjoyable About the same E-cigarettes are less enjoyable
Unpublished data 2014 GSU Tobacco Products and Risk Perceptions Survey

HOW MUCH DO YOU TRUST WHAT EACH OF THE FOLLOWING
SAY ABOUT THE HEALTH EFFECTS OF ELECTRONIC VAPOR
PRODUCTS?
(-2 = STRONGLY DISTRUST, +2 = STRONGLY TRUST)
Unpublished Data: 2015 Tobacco Products and Risk
Perceptions Survey; Georgia State University,
School of Public Health, Tobacco Center of
Regulatory Science (TCORS)

Everyone knows that smoking is bad for you, so how did we get in this mess and how do we get out of it?
• The current level of harm and why it is so bad
• Existing tobacco control strategies are too incremental
• The initial decision to smoke was an adolescent decision
• Current smokers are plagued with regret, guilt, and are looking for a way out
• Electronic nicotine delivery systems (ENDS) are perceived as being less harmful and are considered to be a new cessation option
• Given uncertainty, how do we provide smokers and policy makers with the best information that leads to informed decision making, resulting in a clear public health benefit?
• The importance of understanding risk perceptions as a foundation for communications
• Common Ground: The need to focus on ending combustion

As the popularity of ENDS increases, more smokers are thinking about quitting:
•
Capitalize on this unprecedented interest in quitting and communicate the best information available to guide informed decision making.
•
Communicate that there are proven and effective methods to stop smoking (e.g.,
NRT, counseling, Chantix). If these methods haven’t worked for a particular smoker, may want to recommend ENDS (off label).
• Emphasize that there is little evidence about the efficacy or unintended consequences of ENDS. But, while there may be unknown harms from ENDS, it is almost certainly less harmful than continued smoking.
• Advise smokers to avoid dual use and that ENDS should only be used for a finite period of time, rather than as a permanent replacement product for smoking.
•
Strike the proper balance between possible individual benefit (smokers quitting), against possible population harm (kids starting & ongoing dual use).
•
Use the public discourse on ENDS to completely quit smoking and advance other tobacco control policies.

www.publichealth.gsu.edu