4. Nicotine rewards and reinforcement
• Nicotine induces pleasure and reduces stress and anxiety.
Smokers use it to modulate levels of arousal and to control
mood.
• Smoking improves concentration, reaction time, and
performance of certain tasks.
• Relief from withdrawal symptoms is probably the primary
reason for this enhanced performance and heightened mood.
• In addition, conditioning has an important role in the
development of tobacco addiction.
Source: Neal Benowitz, N Engl J Med. 2010 June 17; 362(24): 2295–2303.
5. Nicotine rewards and reinforcement
• Nicotine induces pleasure and reduces stress and anxiety.
Smokers use it to modulate levels of arousal and to control
mood.
• Smoking improves concentration, reaction time, and
performance of certain tasks.
• Relief from withdrawal symptoms is probably the primary
reason for this enhanced performance and heightened mood.
• In addition, conditioning has an important role in the
development of tobacco addiction.
Source: Neal Benowitz, N Engl J Med. 2010 June 17; 362(24): 2295–2303.
6. Value proposition: a smokers’ cost-benefit analysis
Benefit: nicotine effects, ritual, brand-related
1. Keep smoking
Cost: illness, money, social disapproval, addiction
“Quit
or die”
Benefit: avoid smoking harm
2. Quit smoking
Cost: withdrawal symptoms, 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
7. 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
8. Why now? … battery development
Source: ICCNExergy
12. The Endgame?
Billion adults > 15 years
Projected global adult population growth
9.0
8.0
Adult
population
7.0
6.0
5.0
4.0
3.0
Smoker
population at
constant
prevalence
2.0
1.0
0.0
2010
2015
2020
2025
2030
2035
Smokers: WHO Tobacco Atlas 2006. Population: UN
2040
2045
2050
13. The endgame?
Billion adults > 15 years
Scenarios for future smoker population
2.5
Constant
prevalence
(28%)
2.0
1.5
Global smoking
prevalence
declines to 15%
1.0
0.5
0.0
2010
2015
2020
2025
2030
Scenario – 15% global prevalence by 2050
2035
2040
2045
2050
14. If all goes well
Billion adults > 15 years
Scenarios for future smoker population
2.5
Constant
prevalence
(28%)
2.0
Contested by tobacco control
1.5
Global smoking
prevalence
declines to 15%
1.0
HARM
0.5
0.0
2010
2015
2020
2025
2030
2035
2040
2045
2050
15. The endgame – a nicotine product contest?
Billion adults > 15 years
Scenarios for future nicotine markets
2.5
Constant
prevalence
(28%)
2.0
Contested by tobacco control
1.5
Global nicotine
prevalence
declines to 15%
1.0
Contested by nicotine products
0.5
0.0
2010
2015
2020
2025
2030
2035
2040
2045
2050
16. How far could low-risk nicotine products go?
Billion adults > 15 years
Scenarios for future nicotine markets
2.5
Constant
prevalence
(28%)
2.0
Contested by tobacco control
1.5
Global nicotine
prevalence
declines to 15%
1.0
Contested by low risk nicotine products
Global smoking
prevalence
declines to 5%
0.5
Cigarettes and other combustible tobacco
0.0
2010
2015
2020
2025
2030
2035
2040
2045
2050
17. How far could low-risk nicotine products go?
Billion adults > 15 years
Scenarios for future nicotine markets
2.5
2.0
1.5
This boundary matters most for public health
1.0
0.5
0.0
2010
2015
2020
2025
2030
2035
2040
2045
2050
18. How far could low-risk nicotine products go?
Billion adults > 15 years
‘Modified Herzog scenario’ for future nicotine markets
2.5
Constant
prevalence
(28%)
2.0
1.5
Global nicotine
prevalence
declines to 15%
1.0
Global smoking
prevalence
declines to 5%
0.5
0.0
2010
2015
2020
2025
2030
2035
2040
2045
Disclaimer: this is a Counterfactual scenario not a Wells Fargo Securities or Bonnie Herzog scenario
2050
20. A regulator’s instinct
Strategies should be pursued that encourage
the use of the cleanest and safest form of
nicotine delivery
Mitch Zeller
(now) Director of the Center for Tobacco Products
FDA
Source: Zeller M. Reflections on the endgame for tobacco: Tob Control. 2013 May; 22(Suppl 1): i40–i41.
21. Harm reduction equation
Harm reduction = Reduced risk x Number who switch
Product toxicity &
other risks
Product appeal
Consumer preference
23. Focus on the right relative risk - illustration
More regulation
Lower risk
regulated e-cig
0
10
0
e-cigarettes
“unregulated” e-cig
100
100
cigarette
24. Five talking points
1. The value proposition
2. The prize
3. Harm reduction equation
4. Much safer, many dead
25. Harm reduction equation
Harm reduction = Reduced risk x Number who switch
Product toxicity &
other risks
Product attractiveness
Consumer preference
26. Analysts
We remain very bullish on the vast potential of e-cigs given the
rapid pace of innovation. [We believe] that the benefits of e-cigs
are becoming increasingly apparent to consumers, helping to
drive trial and repeat purchases aided by stepped-up advertising
and a lot of internet “buzz”
Bonnie Herzog, Wells Fargo Securities
27. Regulation – the dead hand
Fewer, duller
innovations
Boring branding
& marketing
Slower
innovation pace
Less
personalisation
Greatly reduced
variety & niche
products
Increased cost
Trusted brands
& firms
destroyed
Reduced
appeal
Black
market, DIY
response
28. Harm reduction equation
Harm reduction = Reduced risk x Number who switch
Trade offs
Conclusion 1. The perfectly risk free product that no-one
wants is useless for public health
Conclusion 2. A diverse range of products with substantially
reduced risk lets each smoker decide which product is best
29. Much safer, many dead: regulatory triple negative
Tough on e-cigarettes
Tough on harm reduction
Easy on harm
30. Five talking points
1. The value proposition
2. The prize
3. Harm reduction equation
4. Much safer, many dead
5. The desperate search …for a problem
31. FDA Pre-Market Tobacco Application
FDA seeks evidence on population effects:
• +/- quitters
– The increased or decreased likelihood that existing users of tobacco
products will stop using such products; and
• +/- starters
– The increased or decreased likelihood that those who do not use
tobacco products will start using such products.
32. Harm reduction equation with population effects
Harm reduction = Reduced risk x Number who switch
- Extra smokers + Extra quitters
Gateway to smoking
Dual use
Reduced quitting
Normalising smoking
Gateway exits
Complete cessation
Extra quitting
Normalising non-smoking
33. Gateway effects
For there to be net harm caused by e-cigs…
Smoking followed e-cig use
E-cig use caused the smoking
Smoker does not revert to e-cigs or quit later
… and e-cigs not displacing smoking elsewhere
34. 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
35. Probing the CDC survey
• High school use doubled?
– Ever use from 4.7 to 10.0%
– Current use (last 30 days) from 1.5% to 2.8%
• High school cigarette smoking?
– Decreased from15.8% to 14.0%
• E-cigs use in adults?
– About doubled
• What would have happened had there been no e-cigs?
–
–
–
–
–
Can’t say, but…
80.5% of e-cig current-users are current smokers
Zero evidence for a ‘gateway’ effect
Zero evidence of ‘marketing to youth’
Data consistent with experimentation and e-cigs displacing smoking
36. Five talking points
1. The value proposition
2. The prize
3. Harm reduction equation
4. Much safer, many dead
5. The desperate search …for a problem
37. Conclusion
• Be positive about the (vast) potential at individual and
population level
• Put the (minor and mostly implausible) risks in perspective
• Regulate as though the 1 billion matter most
Smoking and nicotine use are forms of legal recreational drug use – along with alcohol and caffeine. We care as much as we do about smoking because of the harm caused by the drug delivery system – primarily tobacco smoke. Key point is that people smoke for the nicotine and dies from the tar. Nicotine is not totally safe but it is probably comparable with caffeine
Wesomtimesforgetthat people smoke for a reason, and whetheritis the functionaleffect of the drug or ‘addiction’ and relief fromwithdrawal or a bit of each, ithardlymatter if yousmoke– if you are a smokerthesethingsmatter to you.N Engl J Med. 2010 June 17; 362(24): 2295–2303.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928221/
Wesomtimesforgetthat people smoke for a reason, and whetheritis the functionaleffect of the drug or ‘addiction’ and relief fromwithdrawal or a bit of each, ithardlymatter if yousmoke– if you are a smokerthesethingsmatter to you.Neal Benowitzdescribes the nicotine reward and reinforcement system – thisis an extractfromhispaperN Engl J Med. 2010 June 17; 362(24): 2295–2303.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928221/
This looks at the choices faced by smokers – the first two represent the ‘quit or die’ proposition.The third is a new value proposition in which smokers can switch and get almost all of the benefits (and some new ones like personalisation) and almost none of the costs. This value proposition will get stronger with advancing innovation, as recreational experience matches that of smoking. But it does need regulators to enable this.
These are the kind of results everyone in public health should be coming to work for.Obviously this is only an anecdote, but there are thousands like this on forums and other social media.
The key breakthrough was probably battery technology – enough power and energy to heat vapour on demand and for long enough. Note batteries are quite a slow moving technology compared to other electrical / electronics.
WHO has a headline that one billion will die from smoking on current trends in the 21st Century
This is one view of how WHO saw the evolution of tobacco use in 2006… it thought tobacco control measure could pull the number of smokers down from 2.2 to 1.5 billion (remember there is a a lot of growth in the adult population over this period (about 2.6 billion extra over 15s accornding to UN figures.
One of the biggest drivers of the future for tobacco is population growth. This shows the adult population growing by over 2.6 billion by 2050. Smoking rates have been historically slow to change because it is cultural embedded – new smokers join because of the existing smokers setting the pattern in society (‘normalising’ smoking), so it is hard to get rapid changes as the ‘flow’ of new smokers is going to be proportional to the ‘stock’ of smokersHow much people smoke will depend on many things – population, growth of income, policy interventions, alternatives etc. At global level there are pressure upwards and downwards: will policy measures and better information prevail, or will Chinese women begin to smoke like Chinese men? The bottom line shows what happens if smoking sticks at 28% prevalence – rising from about 1.5 billion in 2010 to 2.2 billion in 2050. This is based on data from 2003 and projections made in the WHO Tobacco Atlas 2006 version
We can’t make predictions really – but we can think about how these numbers might vary. The chart shows the constant prevalence line from the previous chart (rescaled0. For this scenario we assume this is the worst case… in fact it could rise – this would set world smoking prevalence at the current EU level. The lower line look at what happens if smoking prevalence globally falls to 15% - more or less the best claimed smoking prevalence in the world and what WHO showed on its 2006 chart
Without taking too many liberties, we can redraw these as public health challenges… maybe this is what could be achieved using the traditional techniques of tobacco control (maybe)… this would be challenging requiring sustained 1.3% per annum decline in smoking prevalence (note not 1.3 percentage points).We characterise the top area as the contribution of tobacco control – getting prevalence to 15% world wide – no mean feat..!Below that is residual smoking – and this can be loosely characterised as aggregate ‘harm’ (in fact it is a little more complicated because harm depends on lifetime consumption for each individual).
We can also this of this as a market place – the bottom segment is the market for people who would carry on smoking – but in future this will be contested by new nicotine products far more strongly…These include smokeless tobacco, e-cigarettes and new nicotine products, and novel tobacco products – including ‘heat not burn’ tobacco products
Given that we don’t ask users of these products to quit using nicotine, the primary motivation for smoking, and these products like e-cigarettes have been growing very rapidly achieving widespread consumer acceptance, with numerous advantages to the user (health, wellbeing, cost, anti-social impacts) we might expect them to have a considerable impact. There is proof of concept: in Sweden for example about half of males tobacco use is through snus and it has less than half the smoking prevalence of the EU (13% compared to 28%). In some areas of Sweden smoking has fallen to very low levels. The green wedge is a scenario and ‘made up by me’… It is not a forecast… but I think it is a more likely and promising for an ‘end game’ for smoking than most of the other ideas.
Some people may object that there is no need for the green wedge, this can all be done with yellow. Maybe, but probably not. People do like nicotine – it is a long-standing, widely-used, legal recreational drug that has benefits to the user (mood stabilisation, stress relief, and may ease some psychiatric conditions) and does very little harm to the user. In any case, the health difference between being in the green wedge and the gold wedge isn’t that much and not something we should care that about from a public health perspective. Some people do care about the upper boundary – but it’s usually because they have an ideological concern about people taking any sort of drug – though they will often be indifferent to their own caffeine and alcohol use.
In this scenario, e-cigs overtake smoking in 2035Wells Fargo has a scenario for the US of this happening in 2023. So I’m allowing 12 extra year for this to be reached globally
We’ll start with this quote… it seems pretty reasonable … and it is by the new head of tobacco at the FDA – in fact writing in the Tobacco Control ‘end-game’ supplement mentioned earlier before he got the big job (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3632976/)Just one alarm bell on this – the ‘cleanest and safest form’… really? What if no-one wants to use it? Is something 99% less dangerous than smoking okay, but something 97% unacceptable? What we need is high ‘participation’ – a large number switching to products much less dangerous than cigs without being too pedantic about comparison between 99% and 97% less.
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].
This si my own conceptualisation of the risks – it my be a few points different in reality but there are two characteristics:A very low risk elative to cigarettesA residual risk that is not very large and probably within the normal range of things we accept without huge regulatory oversight (eg. Bacon, BBQs, cheese, coffee etc)
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].
So my point is – that there are trade offs between reduced risk and number who switch… ie between ‘cleanest and safest’ and ‘attractiveness as an alternative to smoking’ … and that leads to the conclusions on the chart
It’s a simple idea, but If the regulator is tough on the competitor to cigarettes then he s being easy on the incumbent, easy on harm and hard on health
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].
From CDC press release 5 September 2013: “E-cigarette use more than doubles among U.S. middle and high school students from 2011-2012”http://www.cdc.gov/media/releases/2013/p0905-ecigarette-use.html
Sources for data:Notes from the field: Electronic Cigarette Use Among Middle and High School Students — United States, 2011–2012 (6 September 2013)http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a6.htm Tobacco Product Use Among Middle and High School Students — United States, 2011 and 2012 – 15 November 2013http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6245a2.htm?s_cid=mm6245a2_w#tabWhat does use mean? It can mean ‘ever use’, ‘use in last 30 days’ or ‘daily use’ – these very different meanings. Among high school students, ever e-cigarette use increased from 4.7% to 10.0% during 2011–2012; current e-cigarette use increased from 1.5% to 2.8% - for every one that has tried it two no long use them. It experimentation.For high school kids in the CDC survey ‘current use’ (in last 30 days) of electronic cigarettes increased from 1.5% to 2.8% from 2011 to 2012. However, current smoking during the same period declined from 15.8% to 14.0% and current tobacco use fell from 24.3% to 23.3%E-cig sales roughly doubled…This survey can’t tell us anything about gateways, transition to smoking, whether advertising is to blame. Moreover, in 2012, an estimated 160,000 students who reported ever using e-cigarettes had never used conventional cigarettes. In 2012, among high school ever e-cigarette users, 7.2% reported never smoking conventional cigarettes; among high school current e-cigarette users, 80.5% reported current conventional cigarette smoking.About all you say is that it shows some interest and experimentation, and it is consistent with smokers giving it a try – it might therefore be beneficial.