To Vape or Not to Vape? - E-cigarettes, Evidence and Ideology
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05-Nov-18
To Vape or Not to Vape?
E-cigarettes, Evidence and Ideology
Professor Chris Bullen
APSAD November 2018
Personal Statement
• I have received no funding from, nor do I have any affiliation
with the tobacco and e-cigarette industries
• I have focused my research and advocacy over the past 15
years on supporting people to quit smoking, reducing
smoking inequities and promoting global tobacco control
1
05-Nov-18
Angela’s story
• 58 year office worker with depression and history
of epilepsy
• Short of breath on walking up stairs
• Smoked 25-30 cigarettes per day since age 15
• >$200 per week
• Tried to quit many times using all the standard
methods but always relapsed when under stress
“Smokes are my friend but I know they are killing
me. What about e-cigarettes?”
2
05-Nov-18
Stark Ethnic Differences in Smoking NZ, 2015/16
3
05-Nov-18
Smoking prevalence in people with Alcohol & Other Drug
Dependence, & Mental Illness, NZ, 2016
80%
70%
68%
60%
50%
47%
40%
30%
20%
15%
10%
2025 5%
0%
General population AOD MH
Source: NZ MoH
Hon Lik, 2003
Dr Murray Laugesen
4
05-Nov-18
What are e-cigarettes?
“Devices whose function is to vaporise and deliver to
the lungs of the user a chemical mixture typically
composed of nicotine, propylene glycol and other
chemicals.”
- World Health Organisation
Source; https://holysmokesmiami.com/e-cigarettes-frequently-asked-questions/
5
05-Nov-18
Sources: https://www.vapo.co.nz/pages/how-electronic-cigarettes-work’; Kruseman et al, 2018
Uptake
E-cig sales (£ bn) 2010-2020 estimated (Source: KEY Report 2018)
6
05-Nov-18
Unprecedented interest from smokers
• A cigarette substitute
• Health concerns with
smoking
• More acceptable and
satisfying than NRT inhaler
• Convenience
• Affordability
• Social support
• ‘Viral’ movement
• Regulatory vacuum
Source: Barbeau et al, 2013; Steinberg et al, 2014
Global e-cigarette policies (to October 2016)
Adapted from Kennedy et al, 2017
Regulatory
Country Product classification Regulatory domain
approach
Existing law; Advertising/promotion,
Australia Poison, consumer good
statement importation, sale
New Medicinal, tobacco, consumer Advertising/promotion,
Existing law
Zealand good distribution, importation, sale
UK Existing law; new E-cigarette, medicinal, consumer Advertising/promotion/
law; statement good sponsorship, child safety, health
warning labelling,
ingredients/flavours, minimum
age, nicotine volume/
concentration, reporting/
notification, safety and hygiene,
tax
USA New law Tobacco product Advertising/promotion, child-
safety, health warning labelling,
minimum age, reporting/
notification
7
05-Nov-18
E-cigarette Surveys in NZ
2011 2012 2014
Smoking monitor 7% - -
(N=480, ≥ 18 yrs, current ever
smokers recent quitters) purchased
Youth Insight Survey - 7% 20%
(N~3,000, 14-15 yrs) Ever tried Ever tried
Health & Lifestyles - - 13%
(N=2594, >15 yrs) Ever used
- - 0.8%
Current user*
* Current users defined as “used at least once a day, week or month”
Source: Merry and Bullen, NZMJ 2018
Divergent Perspectives on E-cigarettes
“Disruptive technology” that will end smoking
“Huge gains for public health if all smokers
adopt e-cigarette use”
OR
“A distraction from the tobacco end game”
“A major threat to tobacco control – they will
discourage quitting, renormalise smoking, recruit
new cigarette smokers and strengthen the arm of
Big Tobacco”
8
05-Nov-18
Why might this be?
• Public health advocates from the trenches of the ‘Tobacco
wars”, out of touch with the ‘messy reality’ of quitting and
lacking empathy for smokers trying to quit
• Lack of understanding of nicotine
• Blurring the distinction between combusted tobacco and other
forms of nicotine delivery
What informs such divergent perspectives?
9
05-Nov-18
Aren’t E-cigarettes a
Tobacco Industry ploy?
• E-cigarettes were developed outside the tobacco
industry and pharmaceutical industry
• Tobacco companies own several large e-cigarette
brands and and may use this position to have
influence on the e-cigarette market
• Most products popular in NZ and Australia are
not tobacco industry-sourced products
Goals for Tobacco Control
• Shut down Big Tobacco?
• Ban production and sale of all tobacco products?
• Ban recreational nicotine?
• Ban smoking tobacco?
• Meet a target?
• Reduce smoking-related harms and inequities?
1005-Nov-18
Tobacco Harm Reduction
FCTC Article 1.(d)
“tobacco control” means a range of supply, demand and
harm reduction strategies that aim to improve the health of a
population by eliminating or reducing their consumption of
tobacco products and exposure to tobacco smoke.
- WHO, FCTC, 2003
Evidence: A brief overview
• Evidence-base is still evolving
• Individual health
– Do e-cigarettes help people quit smoking?
– Are they safe?
• Public health
– Is there evidence of increase in quitting and a fall in smoking
prevalence?
– Is there a gateway-to-smoking effect?
– Is ‘second hand’ exposure harmful?
– Are e-cigarettes another Tobacco Industry tactic?
– Is there an effect on inequalities?
1105-Nov-18
Do e-cigarettes help people quit smoking?
• On-line user survey (N=3587) in 2010
• 96% of respondents said e-cigarettes helped them
quit
• 92% said they helped them reduce the number of
cigarettes they smoked
Source: Etter and Bullen, 2011
E-cigarettes reduce urge to smoke and
deliver nicotine
Change in desire to smoke from baseline
over the first hour after each product use: pK characteristics of E-cigarette vs
E-cigarette vs nicotine inhalator vs nicotine inhalator vs cigarette
cigarette
Product Mean tmax (min) Mean Cmax
(95% CI) (mg/mL) (95% CI)
Usual cigarette 14.3 (8.8 - 19.9) 13.4 (6.5 - 20.3)
(N=9)
16 mg E cig (N=8) 19.6 (4.9 - 34.20 1.3 (0.0-2.6)
Nicorette 32.0 (18.7 - 45.3) 2.1 (1.0-3.1)
inhalator(N=10)
Source: Bullen et al, Tob Control 2010
1205-Nov-18
Preferences
10
On average, participants rated e-cigs 83% as
9 highly as their own cigarettes (p < 0.001)
8
Preference Rating
7
6
5
4
3
2
1
0
own-cig e-cig
Source: Grace et al, 2014
The ASCEND trial
852 citations
Bullen et al, Lancet 2013
1305-Nov-18
E-cigarettes as effective as nicotine patches
Hartmann-Boyce J, McRobbie H, Bullen C, et al. Cochrane Database of Systematic Reviews 2016
Nicotine vs Non-Nicotine e-cigarettes
Hartmann-Boyce J, McRobbie H, Bullen C, et al. Cochrane Database of Systematic Reviews 2016
1405-Nov-18
Caveats
• The quality of the evidence overall was categorized
by the Cochrane methodology as low because it
was based on only 2 trials
• RCTs used in the trials are now-obsolete products
that delivered small amounts of nicotine.
Registered trials with a primary cessation endpoint
Gartner (Australia) Hajek (UK, Spain, Czech Walker et al (NZ)
Rep)
Study Pop Varying motivation to quit Motivated to quit Motivated to quit
Product Vype (BAT) Gamucci Kanga 2nd gen
2.4% nicotine Two tobacco flavours
18mg nicotine
Sample size N=1600 N=220 N=1809
Arms • NRT choice for short • Standard care plus e-cig • E-cig with nicotine
term use • Standard care (NRT plus • E-cig without nicotine plus
• NRT choice for short behavioural support) 21mg nicotine patch
and/or long term use • 21 mg Patch alone
• Choice of NRT and • Behavioural support for all
‘cigarette like’ nicotine 3 arms for 6 weeks post
products for short quit
and/or long term use
Intervention 9 weeks 4 weeks 14 weeks
period
Follow-up 12 months 6 months 6 months
Power 80% N/A 80%
Primary outcome Self-reported 12 month Verified 4 week continuous Continuous abstinence
continuous abstinence abstinence (Russell Standard)
1505-Nov-18
UK ‘real-world’ effectiveness
25%
Self-reported abstinence
20.0%
20%
15.4%
15% adj OR 1.61 (95% CI 1.19-2.18)
10.1%
10%
adj OR 1.63
(95% CI
5% 1.17-2.27)
0%
E-cigarette OTC NRT No aid
5863 adults who had smoked within the previous 12 months and made at least 1 quit attempt during that period
with either an E-cig only (n=464), OTC NRT only (n=1922) or no aid in their most recent quit attempt (n=3477)
Source: Brown et al., 2014
Daily use of e-cigarettes is important
Using data from wave 1 and wave 2 of the US Population Assessment of Tobacco and
Health (PATH) Study, daily e-cigarette users were more likely to have reduced
their cigarette use and quit smoking cigarettes compared with non-users.
Source: Berry et al., 2017
1605-Nov-18
Support used in quit attempts,
England 2009-2018
Source: Smoking in England http://www.smokinginengland.info/latest-statistics/
Summary
• E-cigarettes are at least as good as nicotine patches at helping
smokers quit
• Nicotine delivery is important to effectiveness
• Daily use increases effectiveness
• Support from others (vendors and online community) may
enhance effect
• Time course to completely quit cigarettes may be longer than
‘usual treatment’ with a long period of ‘dual use’
• Role as a ‘rescue’ treatment for cravings
• Many smokers like using them.
1705-Nov-18
Are e-cigarettes safe?
• Few adverse events reported in trials - mouth and throat
irritation, dissipating over time
• Longest randomised follow up: 18 months
• Effects of long-term frequent use unknown
• Increasing number of studies on toxicology of vapour and a
few on biomarkers
• Many studies suffer from major methodological problems -
unrealistic exposures, lack of comparator, extrapolation
from in vitro findings to health claims…
• Most find marked differences in comparative risks
i.e. e-cigarette use is safer than smoking
Lower exposure to toxicants than smoking
Source: Chen, Bullen & Dirks, 2017
1805-Nov-18
Royal College of Physicians Report , 2016
“Although it is not possible to precisely quantify the
long-term health risks associated with e-cigarettes,
the available data suggest that they are unlikely to
exceed 5% of those associated with smoked
tobacco products, and may well be substantially
lower than this figure.” -
As yet unknown health effects?
NEWSHEALTHStudy finds e-cigarettes can cause lung
damage
Medical experts say the study should have preceded e-
cigs' launch years ago.
1905-Nov-18
The precautionary principle?
• Sounds responsible…
• But “if it [precautionary approach] also makes
e-cigarettes less easily accessible, less palatable or
acceptable, more expensive, less consumer friendly or
pharmacologically less effective, or inhibits innovation
and development of new and improved products, then it
causes harm, by perpetuating smoking.”
(RCP, 2016)
What about population health?
• Population cessation rates and
smoking prevalence
• “Gateway” to or from smoking?
• Second hand exposure
• Tobacco Industry
• Inequalities
2005-Nov-18
Quit attempt rate and annual cessation rate
from 2001-02 to 2014-15, USA
CPS-TUS
(Current Population
Survey-Tobacco Use
Supplement)
Source: Zhu et al., BMJ 2017
©2017 by British Medical Journal Publishing Group
Cigarette smoking prevalence reductions UK, US and
Australia 2010-2016
2105-Nov-18
Gateway to - or from - smoking?
– Measure of
exposure to e-
cigarettes
inadequate
– In both US and
UK, increase in
access to e-
cigarettes has
been accompanied
by unprecedented
declines in youth
smoking.
Source: Levy et al.,2016
30 Day Prevalence of Daily Use of Cigarettes,
by School Grade, USA 1976-2015
Source: Johnston et al., 2016
2205-Nov-18
Total particle number, PM10 and Black Carbon (BC) concentrations
measured in a test room during cigarette and e-cigarette use
experiments
Source: Avino et al., 2018
Population Health Benefits
“Based on current use patterns and conservative
assumptions…project a reduction of
• 21% in smoking-attributable deaths
• 20% in life years lost as a result of e-cigarette
use by the 1997 US birth cohort compared to a
scenario without.”
Source: Abrams et al., 2016
2305-Nov-18
E-cigarette and NRT use by social gradient,
2017, England
50
45
Percent using the product
40
35
30
25 E-cig user
20 NRT user
15
10
5
0
AB C1 C2 D E
N=3,684 adults who smoke or who stopped in the past year and were surveyed in 2017
Source: Smoking in England http://www.smokinginengland.info/latest-statistics/
Preference ratings, by ethnicity
9
Ethnicity x Cig Interaction, p < .01
8
7 *
Preference Rating
6
5
NZ Euro
4
Maori/PI
3
2
1
0
own-cig e-cig
Source: Grace et al, 2014
2405-Nov-18
US Surgeon General and RCP Reports
“Death is overwhelmingly caused by cigarettes and other
combustibles... Promotion of e-cigarettes and other
innovative products is... likely to be beneficial where the
appeal, accessibility and use of cigarettes are rapidly
reduced.”
- US Surgeon General’s Report, 2014
“In the interests of public health it is important to
promote the use of e-cigarettes…. as widely as possible
as a substitute for smoking.”
- UK Royal College of Physicians, 2016
NASEM Report 2018
“Although e-cigarettes are not without risk,
compared to combustible tobacco cigarettes
they contain fewer toxicants; can deliver
nicotine in a similar manner; show
significantly less biological activity in
most, but not all, in vitro, animal, and
human systems; and might be useful as a
cessation aid in smokers who use e-
cigarettes exclusively.”
Source: http://nationalacademies.org/hmd/Reports/2018/public-
health-consequences-of-e-cigarettes.aspx
2505-Nov-18
Maximise benefits, mitigate risks
MAXIMISE BENEFITS MINIMISE RISKS
– Smokers should be able to access and – A risk-proportionate regulatory
afford quality reduced-harm nicotine environment (i.e. make more harmful
products tobacco smoking relatively less
– Responsible promotion to adult smokers, affordable, less accessible and
communicating the relative risks and the palatable)
truth about nicotine. – Promote vaping etiquette
– Work with vape store retailers to offer high – Prohibit marketing and sales to
quality quit support . minors
– Educate health care providers and smoking – Monitoring and research on
cessation providers about e-cigarettes and products, use patterns and adverse
supporting vapers to quit smoking. events
– Particular opportunities for some population
groups currently poorly served by current
treatments
Reaching unreached population groups
E-cigarettes
need to be
affordable,
accessible and
appealing to
smokers not
using current
services
2605-Nov-18
Vape stores: An opportunity to reach
smokers
Source: KEY report 2016
Increasing price of tobacco increases
demand for e-cigarettes
E-Cigarettes RYO: e-cig
FM: e-cig
• Demand for e-cigarettes
11
increased with price of
10
tobacco cigarettes
E-Cigarettes per Day
9
8
• No difference by
gender, ethnicity, FM
7
vs RYO
6
5
4
35c 70c 1.4
Price per Regular Tobacco Cigarette
Source: Grace et al., 2014
2705-Nov-18
Disrupting e-cigarette market
“More research is needed”
• Communications and promotion - communicate
proportionate risk, complete substitution, daily use, use in
relapse prevention and what works best to enhance
switching.
• Health effects - biomarkers, respiratory and cardiovascular
endpoints.
• Impact - policies, regulations, media coverage, interventions,
equity and vulnerable populations.
• Products and product use in a range of population groups.
New products entering market.
2805-Nov-18
Conclusions
• E-cigarettes are a popular consumer product that may help
people cut down and quit smoking
• They appear to be far safer than smoking; we should do
more to encourage smokers to switch to them completely.
• With the right regulatory levers and settings and a shift in
societal and health sector understanding, we can maximise
the opportunities and mitigate risks e-cigarettes present.
• Base our views and build policies on the highest quality
available evidence, AND counteract poor quality research
and media inaccuracies - but be ready to change our views
as new evidence emerges
Source: https://www.health.govt.nz/our-work/preventative-health-wellness/tobacco-control/vaping-smokeless-including-heated-tobacco
2905-Nov-18
Angela and e-cigarettes?
• Commenced e-cigarettes last year
• Was able to quit smoking almost immediately
• Apart from one lapse when she ran out of e-liquid, has been
abstinent from smoking since
• Feels much better - improved exercise tolerance, more energy
and self-confidence
• Has quit using her e-cigarette too, except as a ’rescue’ if she
experiences cravings to smoke
• Saved thousands of dollars - paying off debts and eating better
“It’s the best thing I’ve ever done for my health – and finances”
Professor Christopher Bullen
National Institute for Health Innovation (NIHI),
School of Population Health,
The University of Auckland,
Auckland, New Zealand.
www.nihi.auckland.ac.nz
c.bullen@Auckland.ac.nz
@DrChrisBullen
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