Electronic Electronic cigarettes: cigarettes:

how should public how should public health respond? health respond?

Linda BauldLinda Bauld

With thanks to Maciej L. Goniewicz, John Britton, Robert West& Martin Dockrell

Background Background

In order to consider how and where e-In order to consider how and where e-cigarettes feature in the current public cigarettes feature in the current public health landscape, it’s important to take health landscape, it’s important to take into account recent developments in into account recent developments in tobacco harm reductiontobacco harm reduction

Harm reduction measures are aimed at Harm reduction measures are aimed at those smokers who, for whatever those smokers who, for whatever reason, are not able or willing to reason, are not able or willing to stop stop using tobacco using tobacco or or stop using nicotine.stop using nicotine.

BackgroundBackground

NICE & Licensed Nicotine Products

The harm reduction approaches in the NICE guidance The harm reduction approaches in the NICE guidance can involve substituting the nicotine in tobacco with can involve substituting the nicotine in tobacco with nicotine from less harmful, nicotine-containing nicotine from less harmful, nicotine-containing products. products.

These include NRT products that are licensed by the These include NRT products that are licensed by the MHRA as pharmaceutical treatments for smoking. MHRA as pharmaceutical treatments for smoking.

There are also unregulated products such as There are also unregulated products such as electronic cigarettes. The guidance only recommends electronic cigarettes. The guidance only recommends use of licensed products recognising that when use of licensed products recognising that when electronic cigarettes become licensed, they can be electronic cigarettes become licensed, they can be recommended for use.recommended for use.

Nicotine-containing products might be used either Nicotine-containing products might be used either temporarily or indefinitely and as a partial or temporarily or indefinitely and as a partial or complete substitute for tobaccocomplete substitute for tobacco

NICE & Nicotine-containing NICE & Nicotine-containing productsproducts

The guidance states that:The guidance states that:There is reason to believe that lifetime use There is reason to believe that lifetime use of licensed nicotine-containing products will of licensed nicotine-containing products will be considerably less harmful than smokingbe considerably less harmful than smokingThere is little direct evidence on the There is little direct evidence on the effectiveness, quality and safety of nicotine-effectiveness, quality and safety of nicotine-containing products that are not regulated containing products that are not regulated by the MHRA. However, they are expected to by the MHRA. However, they are expected to be less harmful than tobacco.be less harmful than tobacco.

Hon Lik: inventor of the Ruyan Hon Lik: inventor of the Ruyan (“(“resembling smoking” resembling smoking” ) )

e-cigarette, marketed 2004e-cigarette, marketed 2004

Anatomy of Anatomy of an an e-e-cigarettecigarette

Development of Development of devicesdevices

Growth in useGrowth in use There are now an estimated 2.1 million users in the UKThere are now an estimated 2.1 million users in the UK In the Republic of Ireland in 2012 the Eurobarometer In the Republic of Ireland in 2012 the Eurobarometer

survey found that 3% of the Irish population had ever survey found that 3% of the Irish population had ever tried e-cigarettes and 1% used them regularlytried e-cigarettes and 1% used them regularly

In the UK by 2014 ever use rose by a factor of 1.9 and In the UK by 2014 ever use rose by a factor of 1.9 and current use by 1.7. If a similar rise happened in current use by 1.7. If a similar rise happened in Ireland, we can assume 1.7% of the population Ireland, we can assume 1.7% of the population regularly use ecigs and 5.6% have ever tried themregularly use ecigs and 5.6% have ever tried them

Amongst smokers in Ireland, we can estimate that Amongst smokers in Ireland, we can estimate that around 1/3 (34%) have tried them but the figure may around 1/3 (34%) have tried them but the figure may now be higher. now be higher.

Source: Eurobarometer and personal correspondence with Fenton Howell

Stop smoking aids Stop smoking aids (England)(England)

Source: West et al (2014) www.smokinginengland.info/lateststatistics

20% use NRT from store

25% use e-cig

40% use nothing

•nicotine

•propylen glycol

•glycerin

•water

•flavourings

What is in a cartridge ?

• The Food and Drug Administration (FDA) has classified PG as an additive that is “generally recognized as safe” for use in food.

• It is used to absorb extra water and maintain moisture in certainmedicines, cosmetics, or foodproducts. • PG is also used to createartificial smoke or fog used in theatrical productions.

• PG is practically odorlessand tasteless.

PropylenPropylenee Glycol Glycol

Current e-cigarette use Current e-cigarette use among adults in among adults in England 2014England 2014

13

ASH/YouGov March April 2014, Sample in England 10,112

Nicotine use by never Nicotine use by never smokers and long-term smokers and long-term

ex-smokersex-smokers

Source: West et al, 2014 N=5,272 from Nov 2013

E-cigarette use by never smokers is negligible

Use by children? Use by children?

Survey of children in GB Survey of children in GB 20132013

95%

90%

4%

8%

1%

1%

0%

1%

0% 25% 50% 75% 100%

11 to 1

5 (

N=

804)16 to 1

8 (

N=

624)

I use them often(more than once aweek)

I use them sometimes(more than once amonth)

I have tried them onceor twice

I have never usedthem

99%92%

82%74%

59%

39%

8%

7% 18%37%

48%

6%4%

7%4%5%

0%

25%

50%

75%

100%

Neversmoked

Tried smokingonce

Used tosmoke

Smoke <1 aweek

Smoke 1-6 aweek

Smoke 6+ aweek

Don't know/Wouldn't say

I use them often(more than once aweek)

I use themsometimes (morethan once a month)

I have tried themonce or twice

I have never usedthem

Source: ASH, 2014

Frequency of e-cigaretteuse amongst 11-18 year oldswho had ever heard ofe-cigs

E-cigarette use by smokingstatus, 11-18 year olds

E-cigarette/smoking by children: USA E-cigarette/smoking by children: USA

Source: US CDC data from National Youth Tobacco Survey 2011 and 2012. Graph from Bates & Rodu

E-cigarette marketingE-cigarette marketing

E-cigarette marketingE-cigarette marketing

Do e-cigarettes deliver nicotine?

E-cigarettes generate vapor that contains nicotine, but e-cigarettes brands and models differ in efficacy and consistency of nicotine vaporization.

In e-cigarettes that vaporize nicotine effectively, the amount inhaled from 15 puffs is lower than smoking a conventional cigarette.

Toxicants in e-Toxicants in e-cigarettes?cigarettes?

Other than nicotine, Other than nicotine, what else do e-what else do e-cigarettes deliver?cigarettes deliver?

A number of studies A number of studies have looked at this, with have looked at this, with at least 8 toxic at least 8 toxic compounds identifiedcompounds identified

However all of these However all of these were at significantly were at significantly lower levels than in lower levels than in conventional cigarettesconventional cigarettes

•Small study conducted by Goniewcz and colleagues involving 20 tobacco cigarette smokers

•Subjects were provided with electronic cigarettes with cartridges containing nicotine

•Subjects were asked to substitute their regular cigarettes with e-cigarettes for 2 weeks

•Researchers measured nicotine and selected carcinogens in their bodies

Exposure to toxicants Exposure to toxicants after switchingafter switching

Nicotine & Tobacco-Nicotine & Tobacco-specific Nitrosamines specific Nitrosamines

What about the vapour? What about the vapour? Should we be concerned about e-cigarette Should we be concerned about e-cigarette

vapour in enclosed public places? vapour in enclosed public places? Lab studies suggest that the vapour Lab studies suggest that the vapour

contains nicotine and some toxic metals contains nicotine and some toxic metals such as cadium, nickel and lead, but levels such as cadium, nickel and lead, but levels are much lower than in second hand smokeare much lower than in second hand smoke

No current evidence of health harms from No current evidence of health harms from occasional exposure occasional exposure

However the effects of regular exposure However the effects of regular exposure over many years is unknown. over many years is unknown.

Cessation: RCTs of E-Cessation: RCTs of E-cigarettescigarettes

• ‘‘Categoria’ 7.2mg nicotine EC vs. Categoria’ 7.2mg nicotine EC vs. 4.8mg nicotine EC vs. no nicotine 4.8mg nicotine EC vs. no nicotine ECEC 300 smokers (unwilling to quit)300 smokers (unwilling to quit) 1 year abstinence rates: 13%, 9% and 1 year abstinence rates: 13%, 9% and

4%4%(Caponnetto et al. 2013)(Caponnetto et al. 2013)

• ‘‘Elusion’ 16mg nicotine EC vs. Elusion’ 16mg nicotine EC vs. nicotine patch vs. no nicotine EC nicotine patch vs. no nicotine EC 657 participants657 participants 6 month abstinence rates: 7.3%, 5.8% 6 month abstinence rates: 7.3%, 5.8%

and 4.1%and 4.1%(Bullen et al. 2013)(Bullen et al. 2013)

Effectiveness in EnglandEffectiveness in England

Source: West et al (2014) www.smokinginengland.info/lateststatistics

E-cigarette users were more likely not to be smoking than those using NRT bought from a store and those using nothing

**

** Significantly different from both other groups

After adjusting for After adjusting for differences between differences between

groups groups

Source: West et al (2014) www.smokinginengland.info/lateststatistics

The odds of e-cigarette users still being abstinent were 61% greater than those using nothing and 63% greater than those using NRT

Success rates of different Success rates of different methods of quittingmethods of quitting

LowestLowest Nothing or NRT bought from a Nothing or NRT bought from a

store store HigherHigher

Prescription NRT/medicine or Prescription NRT/medicine or e-cigarette from a store (about e-cigarette from a store (about 50% better)50% better)

HighestHighest Specialist support from NHS Specialist support from NHS

Stop-Smoking Service (about Stop-Smoking Service (about 200% better)200% better)

There has been an increase in the rate of quitting smoking

More smokers are More smokers are quittingquitting

•Source: West et al, 2014 ENGLAND ONLY Base: All adults

Cigarette consumption has decreased as has overall nicotine use

Fewer people are using Fewer people are using nicotinenicotine

•Source: West et al, 2014 ENGLAND ONLY Base: All adults

Cigarette smoking Cigarette smoking prevalenceprevalence

Source: West et al, 2014 ENGLAND ONLY Base: All adults

Prevalence is declining faster than in previous years since 2008

A licensed product? A licensed product? NicoventuresNicoventuresVoke Voke inhaled inhaled

nicotinenicotine

RegulationRegulation

Medicine’s Medicine’s

“walled garden”?“walled garden”? • ““Safe” and Safe” and

“effective”“effective”• Therapeutic doseTherapeutic dose• AdvertisingAdvertising• VAT 5%VAT 5%

EU’s “Nicotine EU’s “Nicotine Jungle”?Jungle”?

• Health warning on Health warning on packpack

• Concentration capConcentration cap• No health claimsNo health claims• Ad banAd ban• 20% VAT20% VAT• Declaration of Declaration of

additivesadditives

Points for Points for discussiondiscussion

• In the struggle to reduce preventable mortality, In the struggle to reduce preventable mortality, how do we balance the risks?how do we balance the risks?

• What are the ongoing evidence needs and how What are the ongoing evidence needs and how do we address them?do we address them?

• Do we need to test diverse responses or do we Do we need to test diverse responses or do we need a “one size fits all” international response need a “one size fits all” international response now?now?

• How do we manage tobacco industry How do we manage tobacco industry involvement and what scope is there to use the involvement and what scope is there to use the Framework Convention on Tobacco Control?Framework Convention on Tobacco Control?

Thank youThank you

Linda.Bauld@stir.ac.ukLinda.Bauld@stir.ac.uk