Tobacco Harm Reduction - the public health case

1. Tobacco Harm Reduction
the Public Health Benefits
TMA Centenary Meeting
8.30am Tuesday 19th May 2015
Clive Bates
Counterfactual
www.clivebates.com

3. Multi-criteria estimate of nicotine product harms….
Nutt DJ et al Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach – European Addiction Research March 2014

4. Harm reduction categories – risk continuum?
0
20
40
60
80
100
120
Cigarettes Smokeless E-cigs NRT
Crudeestimateofrisk–Cigs=100
From analysis of the constituents of
e-cigarette vapour, e-cigarette use
from popular brands can be
expected to be at least 20 times safer
(and probably considerably more so)
than smoking tobacco cigarettes in
terms of long-term health risks
Professor Robert West
Professor Ann McNeill
Professor Peter Hajek
Dr Jamie Brown
Ms Deborah Arnott

5. Value proposition: a smokers’ cost-benefit analysis
1. Keep smoking
Benefit: nicotine, sensory, taste, ritual, brand-
related
Cost: illness, money, stigma, addiction
2. Quit smoking
Benefit: avoid smoking harm, take control, cash
savings
Cost: withdrawal, craving, sustained willpower, lost
smoking benefits
3. Switch to e-cigs
Benefit: most smoking benefits*, no/minor
smoking harms, personalisation, buzz, cash saving
Cost: addiction?
* Full benefits – subject to continued innovation
“Quit
or die”

6. I smoked for 45 years and tried every NRT
product available, none of them worked. I
continued to smoke even though my health was
getting worse, resulting in emphysema and
using oxygen daily.
September 2011 I discovered e-cigarettes and
they worked. It was like someone handed me a
miracle. In less than a week I stopped using
regular cigarettes. I haven’t had a tobacco
cigarette since.
Unsolicited comment left on www.clivebates.com

7. 10 years of life
Doll R et al. BMJ 2004;328:1519

8. The Big Picture

9. Global cigarette consumption - still rising
Data source: Ng M, Freeman MK, Fleming TD, et al. Smoking prevalence and cigarette consumption in 187 countries, 1980-2012. JAMA
2014; 311: 183–92.
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
1980 1985 1990 1995 2000 2005 2010
Billionpieces
Global cigarette consumption 1980-2012
Developing countries
Developed countries

10. The Lancet – March 2015

11. 2040 ‘endgame’
Data source 1980-2012: Ng M, Freeman MK, Fleming TD, et al. Smoking prevalence and cigarette consumption in 187 countries, 1980-2012.
JAMA 2014; 311: 183–92. Curve forced to zero with linearly increasing rate of decline from 2012
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
1980 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030 2035 2040
Billionpieces
Global cigarette consumption per year - phase out by 2040

12. Global cigarette consumption – trend to 2030
Data source: Ng M, Freeman MK, Fleming TD, et al. Smoking prevalence and cigarette consumption in 187 countries, 1980-2012. JAMA
2014; 311: 183–92.
y = -1.0886x2 + 90.215x + 2525.9
R² = 0.9962
y = -0.3737x2 - 3.7956x + 2363
R² = 0.9843
y = -1.4623x2 + 86.419x + 4888.9
R² = 0.9932
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
1980 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030
Billionpieces
Global cigarette consumption and trends – parabolic trend
Global
Developed countries
Developing countries

13. Cigarette global consumption trend projection to 2030
Consumption 2010-2030 on parabolic trend projection from 1908-2012 data from Ng M, Freeman MK, Fleming TD, et al. Smoking
prevalence and cigarette consumption in 187 countries, 1980-2012. JAMA 2014; 311: 183–92.
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
2010 2015 2020 2025 2030
Billionpieces
Global cigarette consumption 2010-2030 - on trend
Global cigarette
consumption

14. Hypothetical introduction of new nicotine products
Consumption 2010-2030 on parabolic trend projection from 1908-2012 data from Ng M, Freeman MK, Fleming TD, et al. Smoking
prevalence and cigarette consumption in 187 countries, 1980-2012. JAMA 2014; 311: 183–92.
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
2010 2015 2020 2025 2030
Billionpieces
New non-combustible nicotine with high initial but declining growth
Low risk nicotine
consumption
Global cigarette
consumption

15. Hypothetical introduction of new nicotine products
Consumption 2010-2030 on parabolic trend projection from 1908-2012 data from Ng M, Freeman MK, Fleming TD, et al. Smoking
prevalence and cigarette consumption in 187 countries, 1980-2012. JAMA 2014; 311: 183–92.
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
2010 2015 2020 2025 2030
Billionpieces
New non-combustible nicotine with high initial but declining growth
This boundary is
harder to move.
This boundary is
easier to move.

17. Anatomy of a moral panic 1
CANCER

18. …the FDA analyses detected carcinogens, including
nitrosamines. These tests indicate that these products
contained detectable levels of known carcinogens and toxic
chemicals to which users could potentially be exposed
FDA NEWS RELEASE
July 22, 2009

19. …the FDA analyses detected carcinogens, including
nitrosamines. These tests indicate that these products
contained detectable levels of known carcinogens and toxic
chemicals to which users could potentially be exposed
FDA NEWS RELEASE
July 22, 2009

20. The dose makes the poison
Total
nitrosamines
(ng)
Daily
exposure
(ng)
Ratio to
e-cigarettes
E-cigarette per ml 13 52 1.00
Nicotine gum per piece 2 48 0.92
Winston per stick 3,365 50,475 971
Newport 3,885 50,775 976
Marlboro 6,260 93,900 1,806
Camel 5,191 77,865 1,497
Levels of nitrosamines found in electronic and tobacco cigarettes
Source: Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette
substitutes: a systematic review. Ther Adv drug Saf 2014;5:67–86 0 Table 3.

21. Anatomy of a moral panic 2
POISON

22. What’s your poison?
In 2013, AAPCC found 1,414 reported exposures to either
e-cigarette devices or liquid nicotine; through March 24,
2014, there have been 651 reported exposures.

23. Reports of nicotine exposure rising rapidly!!
The term "exposure" means someone has had contact with the
substance in some way; for example, ingested, inhaled, absorbed by the
skin or eyes, etc. Not all exposures are poisonings or overdoses.
271
460
1,543
3,957
-
1,000
2,000
3,000
4,000
5,000
2011 2012 2013 2014
E-cigarette Device and Liquid Nicotine Reported
Exposures to US Poison Centers
Source: American Association of Poison Control Centres AAPCC - 2015
“Poisoning incidents …
jumped by 156% from
2013 to 2014 and have
increased more than 14
fold since 2011”
Matthew Myers CTFK

24. But e-cigs and liquids are a tiny fraction of reports
-
50,000
100,000
150,000
200,000
250,000
300,000
350,000
Exposure reports (US 2013)
Total = 2,596,915
2013 Annual Report of the American Association of Poison Control Centers ’ National Poison Data System (Table 17A)

25. Peak poison = Peak publicity
New York Times
Poison Centers
CDC
23 March. New York Times: Selling poison by the barrel
25 March. AAPCC: AAPCC and Poison Centers Issue Warning About Electronic Cigarette Devices and Liquid Nicotine
3 April. CDC: New CDC study finds dramatic increase in e-cigarette-related calls to poison centers
E-cig poison calls peak
in April 2014 and then
decline

26. Anatomy of a moral panic 3
CHILDREN

27. CDC announcement 6 September 2013
“E-cigarette use more than doubles among U.S. middle and high school students from
2011-2012”
CDC Press release
"The increased use of e-cigarettes by teens is deeply troubling. Nicotine is a highly
addictive drug. Many teens who start with e-cigarettes may be condemned to
struggling with a lifelong addiction to nicotine and conventional cigarettes.”
Tom Frieden, CDC Director
“These data show a dramatic rise in usage of e-cigarettes by youth, and this is cause
for great concern as we don’t yet understand the long-term effects of these novel
tobacco products.”
Mitch Zeller, Director of FDA Center for Tobacco Products
CDC Press release 5 September 2013

28. Bold claim: use doubles to 1.78m
0
2
4
6
8
10
12
14
16
18
2011 2012 2011 2012
Middle School (age 11-14) High School (age 14-18)
Percenteverused
CDC National Youth Tobacco Survey 2012 (US data: Septemeber 2013)
E-cigarette 'ever use' doubles in US adolescents
Ever used e-cigs

29. But most were not ‘current users’ (last 30 days)
0
2
4
6
8
10
12
14
16
18
2011 2012 2011 2012
Middle School (age 11-14) High School (age 14-18)
Percentageusinginlast30days
CDC National Youth Tobacco Survey 2012 (US data: Septemeber 2013)
E-cigarette 'current user' prevalence in US adolescents
E-cigarette users

30. Separated publication of the e-cig and smoking data 2013
10 weeks

31. But most were not ‘current users’ (last 30 days)
0
2
4
6
8
10
12
14
16
18
2011 2012 2011 2012
Middle School (age 11-14) High School (age 14-18)
Percentageusinginlast30days
CDC National Youth Tobacco Survey 2012 (US data: Septemeber 2013)
E-cigarette 'current user' prevalence in US adolescents
E-cigarette users

32. …and most of them were smokers
0
2
4
6
8
10
12
14
16
18
2011 2012 2011 2012
Middle School (age 11-14) High School (age 14-18)
Percentageusinginlast30days
CDC National Youth Tobacco Survey 2012 (US data: November 2013)
E-cigarette ‘current user’ prevalence in US adolescents
E-cigarettes only
Both

33. …and don’t mention the smoking
4.0
2.8
14.6
11.8
0.3
0.7
1.2
2.2
0.3
0.4
0.3
0.6
0
2
4
6
8
10
12
14
16
18
2011 2012 2011 2012
Middle School (age 11-14) High School (age 14-18)
Percentageusinginthelast30days
Cigarette and e-cigarette use among US school students 2011-12
E-cigarettes only
Both
Cigarettes
Sources: Raw data from CDC National Youth Tobacco Surveys 2012-13. Analysis and graphic by Brad Rodu

34. E-cigarette growth coincides with decline in smoking
4.0
2.8 2.4
14.6
11.8
9.7
0.3
0.7
0.5
1.2
2.2
3.0
0.3
0.4 0.6
0.3
0.6
1.3
0
2
4
6
8
10
12
14
16
18
2011 2012 2013 2011 2012 2013
Middle-School Students High-School Students
Percentageusinginthelast30days
Cigarette and e-cigarette use among US school students 2011-13
E-cigarettes only
Both
Cigarettes
Sources: Raw data from CDC National Youth Tobacco Surveys 2012-13. Analysis and graphic by Brad Rodu

35. Anatomy of a moral panic 4
HIDDEN
FORMALDEHYDE

36. Launching a panic

37. Media storm 22 January 2015
• Reuters: Ramping up e-cigarette voltage produces more formaldehyde -study
• LA Times E-cigarettes can produce more formaldehyde than regular cigarettes, study says
• NPR: E-Cigarettes Can Churn Out High Levels Of Formaldehyde
• NBC news: Before You Vape: High levels of Formaldehyde Hidden in E-Cigs
• CBS News: E-cigarette vapor filled with cancer-causing chemicals, researchers say
• Wall Street Journal: Study Links E-Cigarettes to Formaldehyde, Cancer Risk
• South China Morning Post: E-cigarettes 'expose smokers to more formaldehyde than regular tobacco'
• Mail Online: Some e-cigarettes may release more of a cancer-causing chemical than regular tobacco,
study suggests
• Consumer Health Day: High Levels of Cancer-Linked Chemical in E-Cigarette Vapor, Study Finds
• Buzzfeed: Study Finds E-Cigs Produce More Formaldehyde Than Regular Cigarettes
• News Everyday: Vaping worse than smoking, formaldehyde study
• Huffington Post (UK): Is Vaping Safe? Cancer-Causing Substance 'Formaldehyde' Hidden In E-Cigarettes

38. “Hidden Formaldehyde”
“This risk is 5 times as high
or even 15 times as high as
the risk associated with
long-term smoking.”
Full quote: If we assume that inhaling formaldehyde-releasing agents carries the same risk per unit of formaldehyde as the risk associated with inhaling gaseous formaldehyde, then long-
term vaping is associated with an incremental lifetime cancer risk of 4.2×10−3. This risk is 5 times as high (as compared with the risk based on the calculation of Miyake and Shibamoto
shown in Figure 1), or even 15 times as high (as compared with the risk based on the calculation of Counts et al. shown in Figure 1) as the risk associated with long-term smoking.

39. About as clever as…

40. Anatomy of a moral panic 5
KIDDIE FLAVOURS

41. Flavours

42. Did anyone ask the kids?
Shiffman S, Sembower MA, Pillitteri JL, Gerlach KK, Gitchell JG. The impact of flavor descriptors on nonsmoking teens’ and
adult smokers' interest in electronic cigarettes. Nicotine Tob Res 2015
Participants indicated their interest (0-10 scale) in e-cigarettes paired with various flavor descriptors

43. Panic attack!!

44. Changing perceptions – for the worse
Pulmonary
inflammation
Lipoid
pneumonia
Third hand
nicotine
Ultrafine
particles
Blindness
Anti-freeze
Poisonings
Gateway
10x
Formaldehyde!

45. WE JUST
DON’T
KNOW!!!

46. Failure: risk perception United States
85%
65%
0%
20%
40%
60%
80%
100%
2010 2013
Believe e-cigs safer than
cigarettes?
US adult smokers
Tan ASL, Bigman CA. E-cigarette awareness and perceived harmfulness: prevalence and associations with smoking-cessation
outcomes. Am J Prev Med 2014; 47: 141–9.

47. Failure: risk perception England
61
40
44
0
20
40
60
80
100
E-cigarette
user
Non user Total
Percent
Proportion of smokers
believing e-cigarettes less
harmful than cigarettes
Smoking Toolkit Survey (England) 30 April 2015
November 2014 survey N=1584 current smokers
Only about 45% of smokers
in England now believe e-
cigarettes are less harmful.
When we measured at the
end of 2012, albeit in a
different survey, the figure
was more like 70%
… and it’s getting worse
Dr Jamie Brown,
Principal investigator

48. Worsening trend among young British smokers
Perceived e-cig risk in
young British smokers
Trends in electronic cigarette use in young people in
Great Britain over 2013-2014 Arnott, Britton,
Cheeseman, Dockrell, Eastwood, Jarvis, & McNeill ASH,
CR-UK, PHE 2014

49. 49
1% 1%
14%
35%
17%
2%
30%
0%
5%
10%
15%
20%
25%
30%
35%
40%
A LOT MORE
harmful
MORE
harmful
JUST AS
harmful
LESS
harmful
A LOT LESS
harmful
Completely
harmless
Don’t know
Do you think electronic cigarettes are more, less or as
harmful as regular cigarettes?
Total sample size was 12269 adults. Fieldwork was undertaken by YouGov between 5th to 14th March 2014 . The
survey was carried out online. The figures have been weighted and are representative of all GB adults (aged 18+).
Data from

50. 50
1% 1%
14%
35%
17%
2%
30%
0%
5%
10%
15%
20%
25%
30%
35%
40%
A LOT MORE
harmful
MORE
harmful
JUST AS
harmful
LESS
harmful
A LOT LESS
harmful
Completely
harmless
Don’t know
Do you think electronic cigarettes are more, less or as
harmful as regular cigarettes?
Total sample size was 12269 adults. Fieldwork was undertaken by YouGov between 5th to 14th March 2014 . The
survey was carried out online. The figures have been weighted and are representative of all GB adults (aged 18+).
Data from

51. 51
0
5
10
15
20
25
Percentageofsmokersandrecentex-smokers
Prevalence of electronic cigarette use: smokers
and recent ex-smokers (England)
Any
Daily
Source: Smoking Toolkit Study, April 2015
N=16529 adults who smoke or who stopped in the past year; increase p<0.001

52. Huge public health potential by 2040… if….
• 25 years innovation
• Regulation & policy that enhances value proposition
• True and fair presentation of risk and science
• Pressure on smoking
• New accountability in public health
• From moral panic to moral imperative