Dual Use: If Electronic Cigarettes are so good, why are there so few exclusive users?. Jonathan Foulds, PhD

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Dual Use: If Electronic Cigarettes are so good, why are there so few exclusive users?. Jonathan Foulds, PhD jfoulds@psu.edu Penn State College of Medicine, Department of Public Health Science May 8, 2017

Acknowledgments/funding support JF is primarily funded by the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration (under Award Numbers P50-DA- 036107, P50-DA-036105). Additional support was provided by the Penn State Hershey Cancer Institute, the Penn State Social Science Research Institute, and the Penn State Clinical Translational Science Institute (NIH/NCRR Grant Number UL1RR033184). The content of this presentation is solely the responsibility of the author and does not necessarily represent the views of the NIH, FDA, or any other funding agency. JF has done paid consulting for pharmaceutical companies involved in developing and marketing smoking cessation products (e.g. Pfizer, GSK) and has received a grant and study product from Pfizer. JF has not done paid work of any sort for tobacco or e-cig manufacturers.

If people have difficulty overcoming both nicotine dependence and long-term habit change, then surely the solution is to help them avoid most of the health risks with only a minimal alteration in their nicotineseeking habits. This implies a nicotine replacement device which looks like a cigarette and delivers cigarette-like boli of nicotine, but does not deliver the tar and carbon monoxide which cause the vast majority of smoking-related disease... the development and promotion of such a product (and its eventual replacement of tobacco) could have massive beneficial public health implications lasting into the 21st century. (Foulds, 1994) Foulds J. Nicotine replacement therapy does work: time to stop sitting on the fence. A reply. Addiction 1994; 89:438 9.

There is a fine line between being visionary and being wrong. Unfortunately you have to be a visionary to see it. Dr Sheldon Cooper The Big Bang Theory

2011-2 2011-3 2011-4 2012-1 2012-2 2012-3 2012-4 2013-1 2013-2 2013-3 2013-4 2014-1 2014-2 2014-3 2014-4 2015-1 2015-2 2015-3 2015-4 2016-1 2016-2 2016-3 2016-4 2017-1 Percent of smokers and recent exsmokers Prevalence of electronic cigarette use: smokers and recent ex-smokers (Eng) 50 45 40 35 30 25 20 15 10 5 0 Use of e-cigarettes in smokers and recent ex-smokers is growing slowly Any Daily N=24611 adults who smoke or who stopped in the past year; increase p<0.001 Smokers Toolkit study, http://www.smokinginengland.info/latest-statistics/ 5

Percent Proportion of e-cigarette and NRT users who are smokers, Eng 100 90 80 70 60 50 40 30 20 10 0 The majority of both e-cigarette and NRT users are dual users (also smoke) E-cigs NRT N=3601 e-cigarette users and N=1831 NRT users of adults 6

Percent Proportion of daily e-cigarette and NRT users who are smokers (Eng) 100 90 80 70 60 50 40 30 20 10 0 A smaller proportion of both e-cigarette and NRT daily users are dual users (also smoke) E-cigs NRT N=2037 e-cigarette users and N=744 NRT users of adults 7

E-cigs not as sticky as cigarettes In USA, in the PATH wave 1 (2014) data-set (Kasza et al, 2017), almost a quarter (23.8%) of adults who have ever tried a cigarette are currently daily cigarette smokers, but less than 7% (6.8%) of ever e-cig users are daily e-cig users. In USA, in the PATH wave 1 (2014) data-set (Kasza et al, 2017), of those (4431) who have used an e-cig in the past 30 days, only 12.7% have NOT used another tobacco product in the past 30 days. i.e. 87% of current e-cig users are dual users with another tobacco product, mainly cigarettes. Compare that to past month cigarette smokers (at least one cigarette, n=14,219). 51.5% have not used another tobacco product in the past 30 days. (i.e. 48.5% are dual users)

E-cigs not as sticky as cigarettes So it seems as though e-cigs are not as sticky as cigarettes. People who try e-cigs are less likely to keep using them and certainly less likely to keep using them exclusively, as compared with cigarettes. This is a problem as it means we continue to have many more smokers than e-cig users and the positive effect of cannibalizing the cigarette market is less than we might hope for.

Penn State Nicotine Dependence Questions (% yes) Electronic Cigarette Use (n=3609) Traditional Cigarette Use (n=3609) 89.4 92.7 85.7 91.7 90.4 64.5 28.8 35.4 25.6 26.4 41.2 11.72 10.5 6.8 Do you smoke cigarettes/use e- cigarettes now because it is really hard to quit? Do you ever have strong cravings to smoke a cigarette/use e- cigarette? Do you experience strong, very strong, or extremely strong urges to smoke? Is it hard to keep from smoking a cigarette/use e-cigarette in places where you are not supposed to? When you haven't smoked cigarettes/used e-cigarettes, do you feel more irritable because you couldn t smoke/use e-cigarette? When you haven't smoked cigarettes/used e-cigarettes, did you feel more nervous, restless or anxious because you couldn t smoke/use e-cigarette? Do you sometimes awaken at night to have a cigarette/use e- cigarette?

Percentage Yes 100 90 Indicators of Dependence Among Exclusive Daily E-cig Users (n=156) and Exclusive Daily Cigarette Smokers (n=3430) in the PATH Wave 1 Survey* 86.9 88.5 94.0 80 70 72.8 71.5 77.2 60 50 40 30 28.6 24.0 20 15.1 10 5.6 0 Difficulty not using where prohibited Use within 5 minutes of waking E-cig users Have strong craving Really need to use Consider yourself addicted Cigarette smokers *All e-cig and cigarette differences p<0.0001 after adjusting for covariates. Liu, Wasserman, Kong, Foulds. Preventive Medicine 2017.

There is no such thing as an e-cig. There are many different e-cigs Examples of electronic cigarette devices currently available on the market (Farsalinos and Polosa, 2014)

There are hundreds of different types of electronic cigarettes. They vary by size, battery power, atomizer resistance, number of coils, liquid nicotine strength, liquid flavor, liquid type (PPG/VG) etc etc. Two broad categories are (a) First Generation/cigalikes (bottom) and Second Generation/Advanced (top)

Mean blood nicotine (ng/ml) Blood Nicotine Levels in Cigarette and E-cigarette Users Mean time puffing cigarettes, 5.2m First generation e-cigs deliver very little nicotine. 30 e-cig puffs ending here Advanced e-cigs deliver a higher blood nicotine concentration typically less than a cigarette Some advanced e-cigs can deliver nicotine as rapidly as cigarettes.

Nicotine absorption from a cigarette and different e-cigs in experienced dual users (Hajek et al, 2017)

Plasma nicotine concentration versus time as a function of electronic cigarette (ECIG) nicotine concentration. Carolina P Ramôa et al. Tob Control 2016;25:e6-e9 2016 by BMJ Publishing Group Ltd

The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. Participant transition from first to current device. Jessica M. Yingst et al. Nicotine Tob Res 2015;17:1242-1246

Fig. 2. Overall weighted scores for each of the products. Cigarettes, with an overall harm score of 99.6, are judged to be most harmful, and followed by small cigars at 67. The heights of the colored portions indicate the part scores on each of the criteria. Product-related mortality, the upper dark red sections, are substantial contributors to those two products, and they also contribute moderately to cigars, pipes, water pipes, and smokeless unrefined. The numbers in the legend show the normalized weights on the criteria. Higher weights mean larger differences that matter between most and least harmful products on each criterion. Nutt DJ, Phillips LD, Balfour D, Curran HV, Dockrell M, Foulds J, Fagerstrom K, Letlape K, Milton A, Polosa R, Ramsey J, Sweanor D. Estimating the harms of nicotine-containing products using the MCDA approach. European Addiction Research. 2014 April; 20:218-225 link: http://www.karger.com/article/fulltext/360220

Percent Proportion of smokers believing e- cigarettes less harmful than cigarettes 80 70 60 50 40 30 E-cigarette user Non-user Total 20 10 0 A declining minority of current smokers believe e- cigarettes are less harmful than cigarettes 2014-4 2015-1 2015-2 2015-3 2015-4 2016-1 2016-2 2016-3 2016-4 2017-1 N=9117 current smokers (in England) 19

As of 2015, 40% of US adults believe e-cigarettes are about the same harmfulness ( 36%) or more harmful (4%) than cigarettes. 31% correctly believe e-cigs are less harmful than cigarettes and 30% don t know. The proportion who incorrectly believe e-cigs are about as or more harmful than cigarettes has increased substantially since 2012 when it was only 13%. (Majeed et al, 2017) If smokers believe e-cigs are about as harmful, why switch?

Some say we are already having success with the current policies and smokers are already switching to e-cigs, so lets just keep doing what we are doing. Yes, youth and adult cigarette use continues to fall but progress remains very slow. Prevalence of daily product use among young adults (age 18-24) in PATH (2013-14) was: Cigarettes 14.7%, E-cigs: 1.3%, Smokeless: 2.1% Most e-cig use is relatively transient and involves dual rather than exclusive use We need strategies to improve on this

Conclusions-1 To date, the rate at which smokers completely switch to e-cigs has been mildly encouraging but generally disappointing. This is partly because most smokers start with e-cigs with very poor nicotine delivery. This is gradually changing for the better (better nicotine delivery). Another problem is doubt that e-cigs are really less harmful to health than smoking. This is changing for the worse (public more likely to believe e-cigarettes are about as harmful as cigarettes).

Conclusions -2 It is important we don t regulate in a way that limits e- cig nicotine delivery. It is important that we don t ban flavors that e-cig users like (unless they are shown to have adverse health effects), and it is important that we fully inform the public about our best estimate of the relative health effects of cigarettes and e-cigs. FDA-mandated reductions of permissible nicotine content in combustible products (e.g. cigarettes) will likely encourage smokers to quit and speed up transition to less harmful nicotine products, like e-cigs.