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Vaping and tobacco harm reduction
10 February 2021
Clive Bates
Counterfactual
www.clivebates.com
Webinar
1
Well research toll of harm from smoking…
Smoking prematurely
kills around 96,000
annually in the UK
…more than obesity,
alcohol, road
accidents, drug
misuse and HIV
combined
2
Median smoker loses 10 years between 73-83…
3
Levelling up – deprived areas
NHS CCG - Adult smoking prevalence %
1 Corby 27.5
2 Blackpool 23.4
3 Great Yarmouth and Waveney 22.5
4 Hull 22.2
5 North East Lincolnshire 22.2
6 Thanet 21.0
7 Nottingham City 20.9
8 West Lancashire 19.2
9 Doncaster 19.1
10 Salford 19.1
11 Durham Dales, Easington and Sedgefield 19.0
12 Mansfield and Ashfield 18.9
13 Barnsley 18.3
14 Bradford City 18.3
15 Stoke on Trent 18.3
16 Barking and Dagenham 18.1
17 Manchester 18.0
18 Bradford Districts 17.9
19 Oldham 17.9
20 North Lincolnshire 17.8
England 13.9
4
Levelling up – Employment gradient
0%
10%
20%
30%
40%
Unemployed Employed
Smoking - Employment status
ONS, Adult Smoking habits in the UK: 2019. July 2020 5
Levelling up – Socioeconomic gradient
0%
10%
20%
30%
40%
Manual Managerial
Smoking - Socioeconomic status
ONS, Adult Smoking habits in the UK: 2019. July 2020 6
Levelling up – Education gradient
0%
10%
20%
30%
40%
No qualifications Degree
Smoking - Eduction status
ONS, Adult Smoking habits in the UK: 2019. July 2020 7
Levelling up – Mental health gradient
0%
10%
20%
30%
40%
Serious mental illness Adults 2014
Smoking - Mental health status
ONS, Adult Smoking habits in the UK: 2019. July 2020 8
Very high prevalence in some sub-populations
40%
depression
62%
psychosis
88%
substance
use
disorder
57-82%
Homeless
80%
Prisons
• Dawkins L, Ford A, Bauld L, Balaban S, Tyler A, Cox S. A cross sectional survey of smoking
characteristics and quitting behaviour from a sample of homeless adults in Great Britain.
Addict Behav. 2019;
• Public Health England Reducing Reducing Smoking in Prisons, 2015
• Cookson C, Strang J, Ratschen E, Sutherland G, Finch E, McNeill A. Smoking and its
treatment in addiction services: Clients’ and staff behaviour and attitudes. BMC
Health Serv Res. 2014 Jul 14;14(1):1–8.
• Royal College of Physicians, Royal College of Psychiatrists Smoking and mental
health London (2013)
• L Szatkowski, A McNeill Diverging trends in smoking behaviours according to
mental health status Nicotine Tob Res, 3 (2015), pp. 356-360
With thanks to Sharon Cox & Debbie Robson 9
Levelling up - eye-watering cost of being a smoker
79% tax
Pack a day =
£3,760 per year
10
“People smoke for
the nicotine but
die from the tar”
(1976)
Russell MJ. Low-tar medium nicotine cigarettes:
a new approach to safer smoking. BMJ
1976;1:1430–3
Professor Michael Russell 1932-2009
The central insight in smoking and health
11
Smokeless tobacco
Tobacco based
Pure nicotine based
Heated
aerosol
Unheated
Reduced-risk consumer nicotine market
Vaping products Heated tobacco products
“Heat-not-burn”
Items are not shown to scale
Oral nicotine products
12
“A diverse class of alternative nicotine
delivery systems (ANDS) has recently
been developed that do not combust
tobacco and are substantially less
harmful than cigarettes”.
“ANDS have the potential to disrupt
the 120-year dominance of the
cigarette and challenge the field on
how the tobacco pandemic could be
reversed if nicotine is decoupled from
lethal inhaled smoke”.
US Annual Review of Public Health
13
Snus: proof of concept
14
European Union smoking prevalence 2017
15
European Union smoking prevalence 2017 - Sweden
Sweden
16
Smoking Disease
17
The public health mechanism
18
Smoking and vaping 2019 – Great Britain (ONS)
ONS, E-cigarette use in Great Britain in 2019, July 2020
~3m vapers
~8m smokers
19
Smoking and vaping – “making smoking products obsolete”
ONS, E-cigarette use in Great Britain in 2019, July 2020
5% prevalence
Two-thirds cut
20
Last 10 years – about a one-third cut in smoking
0
5
10
15
20
25
30
%
cigarette
smokers
(3
month
moving
average)
Smoking prevalence trend - last ten years - England
~One-third cut
21
Much
lower
Much
lower
Much
lower
Much
lower
Much
lower
Much
lower
The strongest evidence for reduced harm is reduced exposure
22
Royal College of Physicians – on relative risk
"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".
23
Risk perceptions are far out of line with expert judgement and getting worse
ASH / YouGov surveys 2013-2020 24
“EVALI” E-cigarette and Vaping Product Associated Lung Injury
25
“EVALI” E-cigarette and Vaping Product Associated Lung Injury
26
“EVALI” looks exactly like localised supply chain contamination
27
Randomised controlled trial – e-cigs versus NRT
886 smokers
1 year quit status
18% E-cigarette
9.9% NRT
Hajek et al., 2019. A randomized trial of e-cigarettes versus nicotine
replacement therapy . New England Journal of Medicine. 28
Cochrane review – October 2020
More people probably stop
smoking for at least six months
using nicotine e-cigarettes than
using nicotine replacement
therapy (3 studies; 1498 people),
or nicotine-free e-cigarettes (3
studies; 802 people).
Nicotine e-cigarettes may help
more people to stop smoking
than no support or behavioural
support only (4 studies; 2312
people).
29
The public health mechanism is not “smoking cessation medication”
Harm reduction = Reduced risk x Number who switch
Product toxicity &
other risks
Proportion who succeed
Who tries and how
many
Harm reduction equation (crude)
Appeal and
user choice
30
The public health mechanism: “value propositions” – the 7 Ps
Value
Price
Promotion
Place
Product
Positioning
People
Packaging
31
The public health mechanism: rival “value propositions”
Tobacco control
Smoking
Price
Promotion
Place
Product
Positioning
People
Packaging
Degrade the value
Tobacco harm reduction
Vaping
Price
Promotion
Place
Product
Positioning
People
Packaging
Enhance the value to smokers
32
2. The public health mechanism: rival “value propositions”
Tobacco control
Smoking
Price
Promotion
Place
Product
Positioning
People
Packaging
Degrade the value
Tobacco control
Vaping
Price
Promotion
Place
Product
Positioning
People
Packaging
Degrade the value to everyone
33
Evidence for beneficial population effect ‘triangulates’
• Also, user testimony
• And… it is what you would expect!!
34
Royal College of Physicians – unintended consequences
35
…if a risk-averse, precautionary approach
makes e-cigarettes:
• less easily accessible
• less palatable or acceptable
• more expensive
• less consumer friendly
• pharmacologically less effective
• inhibits innovation …
…then it causes harm by perpetuating
smoking.
Royal College of Physicians – unintended consequences
36
3. Perverse consequences: warnings
This product contains
nicotine which is a highly
addictive substance. It is not
recommended for use by
non-smokers
37
3. Perverse consequences: warnings
0% 2% 4% 6% 8% 10% 12% 14% 16% 18%
I do not want to substitute one addiction for another
I am not addicted to smoking and don't need help to quit
I do not know enough about them
I do not want to quit smoking
I do not think they would help me to quit or cut down
I am concerned they are not safe enough
Haven't got around to it yet
They cost too much
Other
I would be embarrassed to use them in public
I do not like the way they look
There are too many products to choose from
I’m using other things to help me quit smoking
They are too difficult to get hold of
Main reason for not trying an e-cigarette among smokers (2019)
38
3. Perverse consequences: warnings
0% 2% 4% 6% 8% 10% 12% 14% 16% 18%
I do not want to substitute one addiction for another
I am not addicted to smoking and don't need help to quit
I do not know enough about them
I do not want to quit smoking
I do not think they would help me to quit or cut down
I am concerned they are not safe enough
Haven't got around to it yet
They cost too much
Other
I would be embarrassed to use them in public
I do not like the way they look
There are too many products to choose from
I’m using other things to help me quit smoking
They are too difficult to get hold of
Main reason for not trying an e-cigarette among smokers (2019)
39
Perverse consequences: warnings
“[Our findings] suggest that the
TPD nicotine addiction e-cigarette
health warning may reduce
smokers' willingness to use, and
likelihood of purchasing an e-
cigarette.”
40
This product is likely to
be at least 95% safer
than smoking cigarettes
No product is completely
safe, but use of this
product is much less
harmful than smoking
Perverse consequences: better warnings
41
E-cigarettes were the most
commonly cited tobacco
product currently used by
27.5% of high school
students (4.1 million)
The US “youth vaping epidemic”
42
Drill down into the 2019 NYTS headline
27.5%
Percentage of high school students who used e-cigarettes in past 30 days
HEADLINE
more than one
in five high
school
students is
vaping
43
We can distinguish between frequent and infrequent use
Frequent use
≥20 days per
month
Infrequent use
≤ 19 days per
month
9.4%
18.1%
Most teen
vapers (66%)
are not
frequent users
Percentage of high school students who used e-cigarettes in past 30 days
44
We can distinguish between prior tobacco users and never-users
8.8% 18.7%
Most teen
vapers (68%)
are prior
tobacco users
Percentage of high school students who used e-cigarettes in past 30 days
Prior tobacco use
Never used tobacco
45
We can segment by both frequency and prior tobacco use
Prior tobacco use
Never used tobacco
Frequent use
≥20 days per
month
Infrequent use
≤ 19 days per
month
1.4% 8.0%
10.7%
7.4%
Percentage of high school students who used e-cigarettes in past 30 days
46
We can segment by both frequency and prior tobacco use
Prior tobacco use
Never used tobacco
Frequent use
≥20 days per
month
Infrequent use
≤ 19 days per
month
1.4% 8.0%
10.7%
7.4%
Few teen
vapers (5%) are
both tobacco
naïve and
frequent users
Percentage of high school students who used e-cigarettes in past 30 days
47
We can identify a significant group who may benefit
Frequent use
≥20 days per
month
Infrequent use
≤ 19 days per
month
1.4% 8.0%
10.7%
7.4%
Most of the
teen frequent
vapers (85%)
are prior
tobacco users
– vaping may
be helping
them
Percentage of high school students who used e-cigarettes in past 30 days
Prior tobacco use
Never used tobacco
48
49
Perverse consequences: flavour bans
Tobacco
Fruit
Dessert
or pastry
Choc,
sweets
Russell et al. vaping
flavour preferences
Russell C, McKeganey N, Dickson T, Nides M. Changing patterns of first e-cigarette flavor used
and current flavors used by 20,836 adult frequent e-cigarette users in the USA. Harm Reduct J.
BioMed Central; 2018 Jun 28;15(1):33
50
Possible consequences – a flavour ban
• The intended outcome - abstinence from nicotine and not adopting any other risk behaviour
• Using tobacco flavoured vape products instead of other flavoured products
• Accessing flavoured vapes via an illicit supply chain (a black market)
• Buying from foreign suppliers in person or via the internet and importing for personal use
• Buying from foreign suppliers to resell to others through informal networks
• Making and mixing their own flavours at home or buying or selling home-mixed flavours
• Using vapes that are made to look tobacco flavoured but have other flavours
• Using flavour agents for food, drink or aromatherapy for adding to unflavoured nicotine liquids
• Using flavours made for vaping but ostensibly marketed for another purpose
• Switching to cannabinoid (THC or CBD) vapes
• Relapsing back from vaping to smoking – both teenagers and adults
• Not switching from smoking to vaping and continuing to smoke
• Initiating smoking instead of initiating vaping
• Continuing to smoke or to start smoking as an adolescent because parents or adult role models smoke instead of vaping
• Using other tobacco or nicotine products – hand-rolling tobacco, smokeless tobacco, heated tobacco, or new nicotine pouches
• Adopting another risk behaviour that may be worse
51
CDC, Tobacco Product Use and Associated Factors Among Middle and
High School Students — United States, 2019, Table 6 (simplified)
Reasons for e-cigarette use among middle and high
school students who reported using e-cigarettes and
other tobacco products during the past 30 days
Reason given for vaping
Use e-cigarettes
only
Use e-
cigarettes and
other tobacco
products
I was curious about them 56.1% 38.4 %
Friend or family member used them 23.9% 22.2%
They are available in flavors, such as
mint, candy, fruit, or chocolate
22.3% 26.6 %
I can use them to do tricks 22.0% 29.0%
They are less harmful than other
forms of tobacco, such as cigarettes
17.2% 19.1%
Adolescents are curious
52
Heated tobacco products
53
Heated tobacco product (iQOS) versus smoking abstinence – exposure biomarkers
…a measurable and substantial
reduction in morbidity or
mortality among individual
tobacco users is reasonably likely
in subsequent studies, and
issuance of an order is expected
to benefit the health of the
population as a whole taking into
account both users of tobacco
products and persons who do not
currently use tobacco products.
FDA modified risk order
54
Risk-Proportionate Regulation
Measure Cigarettes, hand-rolling tobacco and other
combustibles
Vaping, heated tobacco smokeless and oral
nicotine
Taxation Relatively high taxes Low or zero tax (sales tax only)
Illicit trade Track and trace (FCTC protocol) Complaint-driven
Advertising Prohibit other than within trade Control themes and placement
Warnings Graphic warnings depicting disease Messages encouraging switching
Public places Legally mandated controls Up to the discretion of the owner
Plain packaging Yes No
Ingredients Control reward-enhancing additives Blacklist material health hazards
Flavours Prohibit Allow, subject to health hazards
Flavour descriptors Not applicable if flavours banned Control appeal to youth/trademarks
Age restrictions No sales to under-21s No sales to under-18s
Internet sales Banned Permitted with age controls
Product standards Control risks and reduce appeal Control risks
55
Summary
1. Smoking remains a major burden
2. Now low risk alternatives
3. Good evidence for reduced harm
4. Good evidence for population benefits
5. Long term nicotine market
6. Risk proportionate regulation
7. New front in the war on drugs
Thank you!
Clive Bates
Counterfactual
clivedbates@gmail.com
www.clivebates.com
@clive_bates
56

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Vaping and Tobacco Harm Reduction

  • 1. Vaping and tobacco harm reduction 10 February 2021 Clive Bates Counterfactual www.clivebates.com Webinar 1
  • 2. Well research toll of harm from smoking… Smoking prematurely kills around 96,000 annually in the UK …more than obesity, alcohol, road accidents, drug misuse and HIV combined 2
  • 3. Median smoker loses 10 years between 73-83… 3
  • 4. Levelling up – deprived areas NHS CCG - Adult smoking prevalence % 1 Corby 27.5 2 Blackpool 23.4 3 Great Yarmouth and Waveney 22.5 4 Hull 22.2 5 North East Lincolnshire 22.2 6 Thanet 21.0 7 Nottingham City 20.9 8 West Lancashire 19.2 9 Doncaster 19.1 10 Salford 19.1 11 Durham Dales, Easington and Sedgefield 19.0 12 Mansfield and Ashfield 18.9 13 Barnsley 18.3 14 Bradford City 18.3 15 Stoke on Trent 18.3 16 Barking and Dagenham 18.1 17 Manchester 18.0 18 Bradford Districts 17.9 19 Oldham 17.9 20 North Lincolnshire 17.8 England 13.9 4
  • 5. Levelling up – Employment gradient 0% 10% 20% 30% 40% Unemployed Employed Smoking - Employment status ONS, Adult Smoking habits in the UK: 2019. July 2020 5
  • 6. Levelling up – Socioeconomic gradient 0% 10% 20% 30% 40% Manual Managerial Smoking - Socioeconomic status ONS, Adult Smoking habits in the UK: 2019. July 2020 6
  • 7. Levelling up – Education gradient 0% 10% 20% 30% 40% No qualifications Degree Smoking - Eduction status ONS, Adult Smoking habits in the UK: 2019. July 2020 7
  • 8. Levelling up – Mental health gradient 0% 10% 20% 30% 40% Serious mental illness Adults 2014 Smoking - Mental health status ONS, Adult Smoking habits in the UK: 2019. July 2020 8
  • 9. Very high prevalence in some sub-populations 40% depression 62% psychosis 88% substance use disorder 57-82% Homeless 80% Prisons • Dawkins L, Ford A, Bauld L, Balaban S, Tyler A, Cox S. A cross sectional survey of smoking characteristics and quitting behaviour from a sample of homeless adults in Great Britain. Addict Behav. 2019; • Public Health England Reducing Reducing Smoking in Prisons, 2015 • Cookson C, Strang J, Ratschen E, Sutherland G, Finch E, McNeill A. Smoking and its treatment in addiction services: Clients’ and staff behaviour and attitudes. BMC Health Serv Res. 2014 Jul 14;14(1):1–8. • Royal College of Physicians, Royal College of Psychiatrists Smoking and mental health London (2013) • L Szatkowski, A McNeill Diverging trends in smoking behaviours according to mental health status Nicotine Tob Res, 3 (2015), pp. 356-360 With thanks to Sharon Cox & Debbie Robson 9
  • 10. Levelling up - eye-watering cost of being a smoker 79% tax Pack a day = £3,760 per year 10
  • 11. “People smoke for the nicotine but die from the tar” (1976) Russell MJ. Low-tar medium nicotine cigarettes: a new approach to safer smoking. BMJ 1976;1:1430–3 Professor Michael Russell 1932-2009 The central insight in smoking and health 11
  • 12. Smokeless tobacco Tobacco based Pure nicotine based Heated aerosol Unheated Reduced-risk consumer nicotine market Vaping products Heated tobacco products “Heat-not-burn” Items are not shown to scale Oral nicotine products 12
  • 13. “A diverse class of alternative nicotine delivery systems (ANDS) has recently been developed that do not combust tobacco and are substantially less harmful than cigarettes”. “ANDS have the potential to disrupt the 120-year dominance of the cigarette and challenge the field on how the tobacco pandemic could be reversed if nicotine is decoupled from lethal inhaled smoke”. US Annual Review of Public Health 13
  • 14. Snus: proof of concept 14
  • 15. European Union smoking prevalence 2017 15
  • 16. European Union smoking prevalence 2017 - Sweden Sweden 16
  • 18. The public health mechanism 18
  • 19. Smoking and vaping 2019 – Great Britain (ONS) ONS, E-cigarette use in Great Britain in 2019, July 2020 ~3m vapers ~8m smokers 19
  • 20. Smoking and vaping – “making smoking products obsolete” ONS, E-cigarette use in Great Britain in 2019, July 2020 5% prevalence Two-thirds cut 20
  • 21. Last 10 years – about a one-third cut in smoking 0 5 10 15 20 25 30 % cigarette smokers (3 month moving average) Smoking prevalence trend - last ten years - England ~One-third cut 21
  • 23. Royal College of Physicians – on relative risk "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". 23
  • 24. Risk perceptions are far out of line with expert judgement and getting worse ASH / YouGov surveys 2013-2020 24
  • 25. “EVALI” E-cigarette and Vaping Product Associated Lung Injury 25
  • 26. “EVALI” E-cigarette and Vaping Product Associated Lung Injury 26
  • 27. “EVALI” looks exactly like localised supply chain contamination 27
  • 28. Randomised controlled trial – e-cigs versus NRT 886 smokers 1 year quit status 18% E-cigarette 9.9% NRT Hajek et al., 2019. A randomized trial of e-cigarettes versus nicotine replacement therapy . New England Journal of Medicine. 28
  • 29. Cochrane review – October 2020 More people probably stop smoking for at least six months using nicotine e-cigarettes than using nicotine replacement therapy (3 studies; 1498 people), or nicotine-free e-cigarettes (3 studies; 802 people). Nicotine e-cigarettes may help more people to stop smoking than no support or behavioural support only (4 studies; 2312 people). 29
  • 30. The public health mechanism is not “smoking cessation medication” Harm reduction = Reduced risk x Number who switch Product toxicity & other risks Proportion who succeed Who tries and how many Harm reduction equation (crude) Appeal and user choice 30
  • 31. The public health mechanism: “value propositions” – the 7 Ps Value Price Promotion Place Product Positioning People Packaging 31
  • 32. The public health mechanism: rival “value propositions” Tobacco control Smoking Price Promotion Place Product Positioning People Packaging Degrade the value Tobacco harm reduction Vaping Price Promotion Place Product Positioning People Packaging Enhance the value to smokers 32
  • 33. 2. The public health mechanism: rival “value propositions” Tobacco control Smoking Price Promotion Place Product Positioning People Packaging Degrade the value Tobacco control Vaping Price Promotion Place Product Positioning People Packaging Degrade the value to everyone 33
  • 34. Evidence for beneficial population effect ‘triangulates’ • Also, user testimony • And… it is what you would expect!! 34
  • 35. Royal College of Physicians – unintended consequences 35
  • 36. …if a risk-averse, precautionary approach makes e-cigarettes: • less easily accessible • less palatable or acceptable • more expensive • less consumer friendly • pharmacologically less effective • inhibits innovation … …then it causes harm by perpetuating smoking. Royal College of Physicians – unintended consequences 36
  • 37. 3. Perverse consequences: warnings This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers 37
  • 38. 3. Perverse consequences: warnings 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% I do not want to substitute one addiction for another I am not addicted to smoking and don't need help to quit I do not know enough about them I do not want to quit smoking I do not think they would help me to quit or cut down I am concerned they are not safe enough Haven't got around to it yet They cost too much Other I would be embarrassed to use them in public I do not like the way they look There are too many products to choose from I’m using other things to help me quit smoking They are too difficult to get hold of Main reason for not trying an e-cigarette among smokers (2019) 38
  • 39. 3. Perverse consequences: warnings 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% I do not want to substitute one addiction for another I am not addicted to smoking and don't need help to quit I do not know enough about them I do not want to quit smoking I do not think they would help me to quit or cut down I am concerned they are not safe enough Haven't got around to it yet They cost too much Other I would be embarrassed to use them in public I do not like the way they look There are too many products to choose from I’m using other things to help me quit smoking They are too difficult to get hold of Main reason for not trying an e-cigarette among smokers (2019) 39
  • 40. Perverse consequences: warnings “[Our findings] suggest that the TPD nicotine addiction e-cigarette health warning may reduce smokers' willingness to use, and likelihood of purchasing an e- cigarette.” 40
  • 41. This product is likely to be at least 95% safer than smoking cigarettes No product is completely safe, but use of this product is much less harmful than smoking Perverse consequences: better warnings 41
  • 42. E-cigarettes were the most commonly cited tobacco product currently used by 27.5% of high school students (4.1 million) The US “youth vaping epidemic” 42
  • 43. Drill down into the 2019 NYTS headline 27.5% Percentage of high school students who used e-cigarettes in past 30 days HEADLINE more than one in five high school students is vaping 43
  • 44. We can distinguish between frequent and infrequent use Frequent use ≥20 days per month Infrequent use ≤ 19 days per month 9.4% 18.1% Most teen vapers (66%) are not frequent users Percentage of high school students who used e-cigarettes in past 30 days 44
  • 45. We can distinguish between prior tobacco users and never-users 8.8% 18.7% Most teen vapers (68%) are prior tobacco users Percentage of high school students who used e-cigarettes in past 30 days Prior tobacco use Never used tobacco 45
  • 46. We can segment by both frequency and prior tobacco use Prior tobacco use Never used tobacco Frequent use ≥20 days per month Infrequent use ≤ 19 days per month 1.4% 8.0% 10.7% 7.4% Percentage of high school students who used e-cigarettes in past 30 days 46
  • 47. We can segment by both frequency and prior tobacco use Prior tobacco use Never used tobacco Frequent use ≥20 days per month Infrequent use ≤ 19 days per month 1.4% 8.0% 10.7% 7.4% Few teen vapers (5%) are both tobacco naïve and frequent users Percentage of high school students who used e-cigarettes in past 30 days 47
  • 48. We can identify a significant group who may benefit Frequent use ≥20 days per month Infrequent use ≤ 19 days per month 1.4% 8.0% 10.7% 7.4% Most of the teen frequent vapers (85%) are prior tobacco users – vaping may be helping them Percentage of high school students who used e-cigarettes in past 30 days Prior tobacco use Never used tobacco 48
  • 49. 49
  • 50. Perverse consequences: flavour bans Tobacco Fruit Dessert or pastry Choc, sweets Russell et al. vaping flavour preferences Russell C, McKeganey N, Dickson T, Nides M. Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA. Harm Reduct J. BioMed Central; 2018 Jun 28;15(1):33 50
  • 51. Possible consequences – a flavour ban • The intended outcome - abstinence from nicotine and not adopting any other risk behaviour • Using tobacco flavoured vape products instead of other flavoured products • Accessing flavoured vapes via an illicit supply chain (a black market) • Buying from foreign suppliers in person or via the internet and importing for personal use • Buying from foreign suppliers to resell to others through informal networks • Making and mixing their own flavours at home or buying or selling home-mixed flavours • Using vapes that are made to look tobacco flavoured but have other flavours • Using flavour agents for food, drink or aromatherapy for adding to unflavoured nicotine liquids • Using flavours made for vaping but ostensibly marketed for another purpose • Switching to cannabinoid (THC or CBD) vapes • Relapsing back from vaping to smoking – both teenagers and adults • Not switching from smoking to vaping and continuing to smoke • Initiating smoking instead of initiating vaping • Continuing to smoke or to start smoking as an adolescent because parents or adult role models smoke instead of vaping • Using other tobacco or nicotine products – hand-rolling tobacco, smokeless tobacco, heated tobacco, or new nicotine pouches • Adopting another risk behaviour that may be worse 51
  • 52. CDC, Tobacco Product Use and Associated Factors Among Middle and High School Students — United States, 2019, Table 6 (simplified) Reasons for e-cigarette use among middle and high school students who reported using e-cigarettes and other tobacco products during the past 30 days Reason given for vaping Use e-cigarettes only Use e- cigarettes and other tobacco products I was curious about them 56.1% 38.4 % Friend or family member used them 23.9% 22.2% They are available in flavors, such as mint, candy, fruit, or chocolate 22.3% 26.6 % I can use them to do tricks 22.0% 29.0% They are less harmful than other forms of tobacco, such as cigarettes 17.2% 19.1% Adolescents are curious 52
  • 54. Heated tobacco product (iQOS) versus smoking abstinence – exposure biomarkers …a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies, and issuance of an order is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. FDA modified risk order 54
  • 55. Risk-Proportionate Regulation Measure Cigarettes, hand-rolling tobacco and other combustibles Vaping, heated tobacco smokeless and oral nicotine Taxation Relatively high taxes Low or zero tax (sales tax only) Illicit trade Track and trace (FCTC protocol) Complaint-driven Advertising Prohibit other than within trade Control themes and placement Warnings Graphic warnings depicting disease Messages encouraging switching Public places Legally mandated controls Up to the discretion of the owner Plain packaging Yes No Ingredients Control reward-enhancing additives Blacklist material health hazards Flavours Prohibit Allow, subject to health hazards Flavour descriptors Not applicable if flavours banned Control appeal to youth/trademarks Age restrictions No sales to under-21s No sales to under-18s Internet sales Banned Permitted with age controls Product standards Control risks and reduce appeal Control risks 55
  • 56. Summary 1. Smoking remains a major burden 2. Now low risk alternatives 3. Good evidence for reduced harm 4. Good evidence for population benefits 5. Long term nicotine market 6. Risk proportionate regulation 7. New front in the war on drugs Thank you! Clive Bates Counterfactual clivedbates@gmail.com www.clivebates.com @clive_bates 56

Editor's Notes

  1. Vaping products Top row shows: 1st generation cig-a-likes 2nd generation ego or ‘pen’ type devices 3rd generation tanks / mods type Bottom row shows Large electronic hookah Small shisha pipes Electronic pipe … there are many other configurations Heated tobacco products – sometimes referred to as heat-not-burn to distinguish between combustible products Shows the iQOs, Ploom and Glo products Novel nicotine products - shows Nicoccino – a nicotine containing film Zonnic – a range of nicotine products – lozenges, gum etc Voke – a cold aerosol (approved but not marketed) Niorette – cross-over NRT Smokeless tobacco Snus Moist snuff Tobacco-based lozenge
  2. Don’t worry if you aren’t mathematical… this is just codifying common sense…. The simple idea is that a the impact of reduced risk alternative to cigarettes is the risk reduction per user multiplied by the number of users who switch. Both terms are important. The first term is really determined by toxic exposure arising from continued nicotine use – a product characteristic. For e-cigs and snus this is 95-99% - at least 20-fold improvement… The second term is why we don’t want to be too prescriptive and end up dissuading people from take the 95-99% reduction and carrying on with the greatest danger. That’s why alarm bells should ring when there are plans to restrict reduced risk only to the ‘cleanest and safest’ - or there are plans to ban things that might make these products attractive – like flavourings – or to have regulators control ingredients – or attempt to remove all residual toxins (some of which might be important for flavour) The consumer and mechanisms of market competition should be the primary driver of what makes these products attractive – not regulators who may insist they are safe at the expense of making them less attractive [The equation could be elaborated to have a second term… those that use the reduced risk products who would otherwise have stopped completely. Not shown here because the residual risk is so low – the reduced risk products are not that much difference to quitting completely].