Tobacco Harm Reduction the Public Health Benefits

TMA Centenary Meeting8.30am Tuesday 19th May 2015

Clive BatesCounterfactual

www.clivebates.com

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

Harm reduction categories – risk continuum?

Cigarettes Smokeless E-cigs NRT0

20

40

60

80

100

120

Crud

e es

timat

e of

risk

– C

igs

= 10

0

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 risksProfessor Robert WestProfessor Ann McNeillProfessor Peter HajekDr Jamie BrownMs Deborah Arnott

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”

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

10 years of life

Doll R et al. BMJ 2004;328:1519

The Big Picture

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.

19801982

19841986

19881990

19921994

19961998

20002002

20042006

20082010

2012 -

1,000

2,000

3,000

4,000

5,000

6,000

7,000

Global cigarette consumption 1980-2012

Billi

on p

iece

s

Developing countries

Developed countries

The Lancet – March 2015

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

19801983

19861989

19921995

19982001

20042007

20102013

20162019

20222025

20282031

20342037

2040 -

1,000

2,000

3,000

4,000

5,000

6,000

7,000

Global cigarette consumption per year - phase out by 2040

Billi

on p

iece

s

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.

19801982

19841986

19881990

19921994

19961998

20002002

20042006

20082010

20122014

20162018

20202022

20242026

20282030

-

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

f(x) = − 1.0885895413884 x² + 90.2145845141575 x + 2525.92595307918R² = 0.996217080527582

f(x) = − 0.373689285098205 x² − 3.79556698045781 x + 2363.00806451613R² = 0.984255731677563

f(x) = − 1.46227882648661 x² + 86.4190175336997 x + 4888.93401759531R² = 0.993220971257086

Global cigarette consumption and trends – parabolic trend

Billi

on p

iece

s

Global

Developed countries

Developing countries

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.

20102011

20122013

20142015

20162017

20182019

20202021

20222023

20242025

20262027

20282029

2030 -

1,000

2,000

3,000

4,000

5,000

6,000

7,000

Global cigarette consumption 2010-2030 - on trend

Billi

on p

iece

s

Global cigarette consumption

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.

20102011

20122013

20142015

20162017

20182019

20202021

20222023

20242025

20262027

20282029

2030 -

1,000

2,000

3,000

4,000

5,000

6,000

7,000

New non-combustible nicotine with high initial but declining growth

Billi

on p

iece

s

Low risk nicotineconsumption

Global cigarette consumption

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.

20102011

20122013

20142015

20162017

20182019

20202021

20222023

20242025

20262027

20282029

2030 -

1,000

2,000

3,000

4,000

5,000

6,000

7,000

New non-combustible nicotine with high initial but declining growth

Billi

on p

iece

s

This boundary is harder to move.

This boundary is easier to move.

Anatomy of a moral panic 1

CANCER

…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 RELEASEJuly 22, 2009

…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 RELEASEJuly 22, 2009

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.

Anatomy of a moral panic 2

POISON

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.

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.

2011 2012 2013 2014 -

1,000

2,000

3,000

4,000

5,000

271 460

1,543

3,957

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

But e-cigs and liquids are a tiny fraction of reports

E-cigs &

liquids 2

013

E-cigs a

nd liquids 2

014

Analgesics

Cosmetics

Cleaning substa

nces

Sedatives

Antidepressants

Foreign bodies

Cardiovascu

lar dru

gs

Antihistamines

Topical p

reps

Pesticid

es

Alcohols

-

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)

Peak poison = Peak publicity

New York TimesPoison CentersCDC

23 March. New York Times: Selling poison by the barrel25 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

Anatomy of a moral panic 3

CHILDREN

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

Bold claim: use doubles to 1.78m

2011 2012 2011 2012Middle School (age 11-14) High School (age 14-18)

0

2

4

6

8

10

12

14

16

18

E-cigarette 'ever use' doubles in US adolescents

Ever used e-cigs

CDC National Youth Tobacco Survey 2012 (US data: Septemeber 2013)

Perc

ent e

ver u

sed

But most were not ‘current users’ (last 30 days)

2011 2012 2011 2012Middle School (age 11-14) High School (age 14-18)

0

2

4

6

8

10

12

14

16

18

E-cigarette 'current user' prevalence in US adolescents

E-cigarette users

CDC National Youth Tobacco Survey 2012 (US data: Septemeber 2013)

Perc

enta

ge u

sing

in la

st 3

0 da

ys

Separated publication of the e-cig and smoking data 2013

10 weeks

But most were not ‘current users’ (last 30 days)

2011 2012 2011 2012Middle School (age 11-14) High School (age 14-18)

0

2

4

6

8

10

12

14

16

18

E-cigarette 'current user' prevalence in US adolescents

E-cigarette users

CDC National Youth Tobacco Survey 2012 (US data: Septemeber 2013)

Perc

enta

ge u

sing

in la

st 3

0 da

ys

…and most of them were smokers

2011 2012 2011 2012Middle School (age 11-14) High School (age 14-18)

0

2

4

6

8

10

12

14

16

18

E-cigarette ‘current user’ prevalence in US adolescents

E-cigarettes onlyBoth

CDC National Youth Tobacco Survey 2012 (US data: November 2013)

Perc

enta

ge u

sing

in la

st 3

0 da

ys

…and don’t mention the smoking

2011 2012 2011 2012Middle School (age 11-14) High School (age 14-18)

0

2

4

6

8

10

12

14

16

18

4.02.8

14.6

11.8

0.30.7

1.2

2.2

0.30.4

0.3

0.6

Cigarette and e-cigarette use among US school students 2011-12

E-cigarettes onlyBothCigarettes

Perc

enta

ge u

sing

in th

e la

st 3

0 da

ys

Sources: Raw data from CDC National Youth Tobacco Surveys 2012-13. Analysis and graphic by Brad Rodu

E-cigarette growth coincides with decline in smoking

2011 2012 2013 2011 2012 2013Middle-School Students High-School Students

0

2

4

6

8

10

12

14

16

18

4 2.8 2.4

14.6

11.8

9.70.3 0.70.5

1.2

2.2

3

0.30.4 0.6

0.3

0.6

1.3

Cigarette and e-cigarette use among US school students 2011-13

E-cigarettes onlyBothCigarettes

Perc

enta

ge u

sing

in th

e la

st 3

0 da

ys

Sources: Raw data from CDC National Youth Tobacco Surveys 2012-13. Analysis and graphic by Brad Rodu

Anatomy of a moral panic 4

HIDDEN FORMALDEHYDE

Launching a panic

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

“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.

About as clever as…

Anatomy of a moral panic 5

KIDDIE FLAVOURS

Flavours

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

Panic attack!!

Changing perceptions – for the worse

Pulmonary inflammation

Lipoid pneumonia

Third hand nicotine

Ultrafine particles

Blindness

Anti-freeze

PoisoningsGateway

10x Formaldehyde!

WE JUST DON’T

KNOW!!!

Failure: risk perception United States

2010 20130%

20%

40%

60%

80%

100%

85%

65%

Believe e-cigs safer than cig-arettes?

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.

Failure: risk perception England

E-cigarette user

Non user Total0

20

40

60

80

100

61

4044

Proportion of smokers be-lieving e-cigarettes less harmful than cigarettes

Perc

ent

Smoking Toolkit Survey (England) 30 April 2015November 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

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

A LOT M

ORE harmful

MORE harm

ful

JUST AS harm

ful

LESS harm

ful

A LOT LE

SS harmful

Completely harmless

Don’t know

0%

5%

10%

15%

20%

25%

30%

35%

40%

1% 1%

14%

35%

17%

2%

30%

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

A LOT M

ORE harmful

MORE harm

ful

JUST AS harm

ful

LESS harm

ful

A LOT LE

SS harmful

Completely harmless

Don’t know

0%

5%

10%

15%

20%

25%

30%

35%

40%

1% 1%

14%

35%

17%

2%

30%

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

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

2015-10

5

10

15

20

25

Prevalence of electronic cigarette use: smokers and recent ex-smokers (England)

Perc

enta

ge o

f sm

oker

s and

rece

nt e

x-sm

oker

s

Any

Daily

Source: Smoking Toolkit Study, April 2015

N=16529 adults who smoke or who stopped in the past year; increase p<0.001

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