Smoking, e-cigs and reduced risk products91a5a7bb-c4f0-4092... · John Schoonbee | Smoking, e-cig and RRPs | IMS 2017 • electronic nicotine-delivery system (ENDS) • Electronic

Dr John Schoonbee, IMS November 2017

Smoking, e-cigs and reduced risk products

John Schoonbee | Smoking, e-cig and RRPs | IMS 2017 2

John Schoonbee | Smoking, e-cig and RRPs | IMS 2017

The storyline

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smoking is bad

yet many folks still smoke

because quitting is very hard

is it better, if one cannot quit, to use something less harmful?

what are the options? (and what does it mean for us?)


Smoker/non smoker mortality ratios

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On average about 170% mortality compared to non smokers


Males >15yr smoking prevalence (WHO)

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US cigarette smoking

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http://www.gallup.com/poll/109048/us-smoking-rate-still-coming-down.aspx


Percentage of smokers by age and sex, 2014

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Source: Opinions and Lifestyle Survey - Office for National Statistics



Stopping has benefits, even later in life

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How does quitting (/switching) improve health?

• Stopping gains 4 -10 yrs of life (age dependent)

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N Engl J Med 2013;368:341-50


• Options include

– cold turkey

– gum, patches

– medication

– (switching)

How easy is it to quit? Two thirds want to quit, only 1 in 20 manage

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2376894/pdf/0980317.pdf

http://www.dailymail.co.uk/news/article-2060414/Want-quit-smoking-Study-finds-6-cent-try-succeed---graduates-likely-kick-habit.html


Electronic Cigarettes

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• electronic nicotine-delivery system (ENDS)

• Electronic cigarettes, also known as e-cigarettes, are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn chemicals, including nicotine, into an aerosol (using an atomizer) that is inhaled by the user

• no smoke, no tobacco

• creates a vapour…hence the term vaping

Introduction

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Different flavours of e cigarettes

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E Cigarettes : An evidence update : Public Health England


E-Cigarettes : current adult cigarette smokers in Great Britain (2010-2015)

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ASH Fact Sheet on the use of electronic cigarettes among adults in Great Britain May 2015


• Study comparing 2010 to 2013

• Ever use : 1.8% to 13.0%

• Current use : 0.3% to 6.8%

• 2013 Current use:

18-24 14.2%

25-44 8.6%

45-64 5.5%

65+ 1.2%

daily smokers 30.3%

non daily smokers 34.1%

former smokers 5.4%

never smokers 1.4%

Prevalence of e-cigarette usage (US)

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Nicotine Tob Res (2014) doi: 10.1093/ntr/ntu213


• Regulations differ in various markets

nicotine and non nicotine containing may be different

• Only e-cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Centerfor Drug Evaluation and Research (CDER). Currently, the FDA Center for Tobacco Products (CTP) regulates

cigarettes,

cigarette tobacco,

roll-your-own tobacco, and

smokeless tobacco

• Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.

E-cigarette Regulation

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E-cigarette Regulation

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• e-cigarettes are about 95% safer than combustibles

• The concentration of nicotine in nicotine containing devices is however not standardised and the dose delivered is inconsistent

“the constituents of cigarette smoke that harm health – including carcinogens – are either absent in e-cigarette vapour or, if present, they are mostly at levels much below 5% of smoking doses (mostly

below 1% and far below safety limits for occupational exposure)”

E-cigarettes - are they harmful?

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BMJ 2015;351:h4634


• Recent reports raised a possibility that under certain conditions, EC may release high levels of aldehydes

(released in tobacco smoke and contribute to its toxicity)

• Aldehydes are also released with thermal degradation of propylene glycol and glycerol in e-liquids.

• Previous studies detected the presence of aldehydes, especially formaldehyde, in the vapour from some EC,

but at levels much lower than in cigarette smoke.

• Across brands, EC released 1/50th of the level of formaldehyde released by cigarettes. The highest level

detected was six times lower than the level in cigarette smoke.

• Normal vaping generated negligible aldehyde levels. (McRobbie, H., et al., Effects of the use of electronic cigarettes with and

without concurrent smoking on acrolein delivery. 2014)

Is it safe? What about the aldehydes?

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Farsalinos, K. E Cig aerosol contains 6 x LESS formaldehyde than tobacco cigarette smoke. 2014 , Farsalinos, C., E-cigarette aerosols generates high levels of formaldehyde only in 'dry puff' conditions. Addiction


• CDC findings (2013 vs 2014) indicated that past 30-day use of EC increased among middle and

high school students

• High school students use increased from 4.5% to 13.4% between 2013 and 2014.

• Middle school students, current EC use increased from 1.1% in 2013 to 3.9% in 2014.

• However, cigarette smoking had continued to decline during this period (high school students:

15.8% to 9.2%; middle school students: 4.7 % to 2.5%) such that smoking was at a 22-year low in

the US.

• These findings strongly suggest that EC use is not encouraging uptake of cigarette smoking.

E-cigarettes - Gateway to tobacco?

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Arrazola, R.A., et al., 2011-2014. MMWR Morb Mortal Wkly Rep, 2015. 64: p. 381-5. Dutra, L.M. and S.A. Glantz, JAMA pediatrics, 2014. 168(7): p. 610-617. Centre for Disease Control and Prevention. E cig use….2015


E-cigs haven’t been shown to be effectiveThere haven’t been any scientific studies that prove e-cigs actually help people to quit smoking. There is also concern that using e-cigs may lead kids to start smoking regular cigarettes.The bottom line is that we just don’t know enough about e-cigs, so we don’t recommend that you use them.

smokefree.gov

22John Schoonbee | Smoking, e-cig and RRPs | IMS 2017


“Switching from smoking to vaping avoids most of the risks of smoking and smokers should be encouraged to do so.

E-cigarettes currently are much more popular than other treatments and hence have much wider reach and potential for a major public health impact.”

John Schoonbee | Fitter with E Cigarettes? | ARMS, November 2015

Public Health England’s position on e-cigarettesBMJ 2015;351:h4863

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E-cigarettes – do they help smokers quit or decrease use of tobacco cigarettes?

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Caponnetto P, et al. (2013) EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as

Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study.

PLoS ONE 8(6): e66317. doi:10.1371


E-cigarettes - do they help smokers quit or decrease use of tobacco cigarettes?

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Caponnetto P, et al. (2013) EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as

Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study.

PLoS ONE 8(6): e66317. doi:10.1371


• Representative samples of adults in 2 US metropolitan areas were surveyed in 2011/2012 about their use of novel tobacco products. In 2014, follow-up interviews were conducted with 695 of the 1,374 baseline cigarette smokers who had agreed to be re-contacted (retention rate: 51%).

• The follow-up interview assessed their smoking status and history of electronic cigarette usage. Respondents were categorized as intensive users (used e-cigarettes daily for at least 1 month), intermittent users (used regularly, but not daily for more than 1 month), and non-users/triers (used e-cigarettes at most once or twice).

• Logistic regression controlling for demographics and tobacco dependence indicated that intensive users of e-cigarettes were 6 times more likely than non-users/triers to report that they quit smoking (OR: 6.07, 95% CI = 1.11, 33.2).

E-cigarettes - Intensive e-cigarette users more likely to quit smoking

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Nicotine Tob Res. 2015 Feb;17(2):127-33


Reduced Risk Tobacco Products

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Reduced Risk Tobacco Products

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RRP Background

• Philip Morris International CEO has stated : “no more combustible cigarettes by 2050”

• PMI has invested 3bn USD in developing a new reduced risk product (RRP) – no combustion, only heating of tobacco to 300°𝐶 – “heat not burn”

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• The data shows risk reduction of >90% (compared to traditional cigarettes)

• They have launched in multiple markets – Japan, Europe and UK - in Japan alone they have >10% of the smokers on RRPs

• Single digit % of smokers manage to give up, PMI have managed over 70% conversion in Japan (first market)

• This is the first of 4 different platforms they are developing, all reduced risk products. The second is in live city testing.


Reduction in metabolites, carcinogens equivalent to abstinence when smokers switch to RRP

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CC – combustible cigTHS – RRPSA - abstinence

John Schoonbee | Smoking, e-cig and RRPs | IMS 2017 31 |


Underwriting

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• How to test if someone still inhales nicotine?

• How sustainable is the switch?

• How absolute is the switch?

• Do we really know long term outcomes?

• Nicotine = ?lifelong addiction

• How much lower is the risk?

What we have think about, assuming we believe an e-cig (only) user or RRP (only) user has a lower risk than traditional cigarette smoker

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?



Legal notice

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Smoking, e-cigs and reduced risk products91a5a7bb-c4f0-4092... · John Schoonbee | Smoking, e-cig and RRPs | IMS 2017 • electronic nicotine-delivery system (ENDS) • Electronic