E-cigarettes: utilisation, législation, recommandations · Goniewicz (2013), Drug and Alcohol...
Transcript of E-cigarettes: utilisation, législation, recommandations · Goniewicz (2013), Drug and Alcohol...
Jean-François ETTER, PhDAssociate ProfessorFaculty of Medicine University of Geneva, Switzerland
RESPADD Paris, 15 Mai 2014
E-cigarettes: utilisation, législation, recommandations
Conflicts of interests
Tobacco industry: - never received any funding, no COI
Pharmaceutical industry- no funding in past 8 years, no COI
E-cigarette industry- plane ticket + hotel (London + China)
Attributable deaths by risk factor, USA
WHO – 1 billion deaths in 21st century
Cancer mortality, USA, 1930-2000
E-cig + nicotine vaporizers: Potential to obsolete cigarettes
Nicotine + tobacco vaporizers: no combustion of tobacco
Without tobacco:
1. E-cigarettes
2. VOKE (BAT: British American Tobacco): nicotine vaporizer (technology of asthma vaporizers)
3. Nicotine pyruvate (PMI: Philip Morris, Jed Rose)
With tobacco:
1. Heated tobacco products (PMI, BAT): - electric heating- charcoal heating
2. Hot air over leaves (Ploom: Japan Tobacco)
Why now?Battery development
3 types: cigalikes, vaporizers, mods
Cigalikes
Vaporizers
Mods
E-cig global sales, $ million
190 350700
1200240 160
150
100
480770
950
1200
0
500
1000
1500
2000
2500
2010 2011 2012 2013USA China International
(source: Philip Morris)
England Toolkit study:Aids used in most recent quit attempt
13
05
101520253035404550
Perc
ento
f sm
oker
s try
ing
to s
top
E-cigsNRT OTCNRT RxChampixBeh'l supp
N=4,164 adults who smoke and tried to stop or who stopped in the past year
E-cig use in Switzerland, 2013
6,7
28,5
1,1
5,5
0,1 0,40
5
10
15
20
25
30
All Daily smokers
%
Ever use In past 30 days Daily use
Source: Monitorage suisse des addictions (OFSP)
Safety, toxicity of e-cigs
Impurities + toxicants found in e-liquids + vapors:- in concentration much lower than in tobacco smoke- often below the levels known to be toxic- heterogeneity, many manufacturers
Passive exposure to second-hand vapor- only partially documented- unlikely to be harmful, but unpleasant- use etiquette, common sense
Diacetyl as ingredient not contaminant (buttery flavor): popcorn lung disease Nicotine
- not harmful at doses used by vapers or users of nicotine patch, gum PG, VG
- appear to be safe when inhaled- but: effects on users with respiratory diseases ?
Flavors: intended for food, not inhalation Long term effects not known (150 puffs per day over several years)
Adverse effects
No serious adverse event was reported in e-cig clinical studies (after 12 months), in particular no clinically significant effect on cardiovascular or respiratory systems
Most frequent symptoms:- irritation, dryness of mouth, throat
Adverse events were reported to FDA and MHRA (UK)- causality ?
One case of lipoid pneumonia reported in the literature Nicotine poisoning
- press release (Israel): 2y old girl dies after drinking e-liquid bottle- failed suicide attempt, women drinks 1500 mg nicotine in e-liquids,
fully recovers
Smoking status of vapers
Across 8 surveys in representative samples of the general population, the proportion of EC users was 2 to 8 times higher in current smokers than in former smokers
Most users = dual users (e-cig + cig)
Sources:Choi. Am J Public Health. 2013Dockrell Nic Tob Res 2013Douptcheva. J Epidemio Comm H 2013Goniewicz. Pediatrics. 2012King. Nicotine Tob Res. 2013McMillen. J Environ Public H 2012Pearson Am J Public Health 2012Regan Tob Control 2011Sutfin Drug Alc Depend 2013
Experimentation and use by never smokers
From 12 surveys in representative samples of the general population UK, USA, Australia, New Zealand, Canada, Poland, Switzerland, Czech Ever use in never smokers :
- range : 0.1% to 3.8%- median : 0.5%
Use in past 30 days, in never smokers :- range : 0% to 2.2%- median : 0.3%
Sources:Camenga Addict Behav 2013Cho. J Adol Health. 2011Choi. Am J Public Health. 2013Corey MMWR 2013Dockrell Nic Tob Res 2013Douptcheva J Epidemio Comm H 2013Goniewicz. Pediatrics. 2012King. Nicotine Tob Res. 2013McMillen. J Environ Public H 2012Pearson Am J Public Health 2012Regan Tob Control 2011Sutfin Drug Alc Depend 2013
Daily use by never smokers
Sources:Douptcheva. J Epidemiol Comm Health. 2013ASH-UK. 2013
Was assessed in 2 surveys in representative samples of the general population
UK, Switzerland
To date, no daily use in never smokers has been reported
Perceived effects on smoking reduction, cessation
In 8 studies in convenience samples of vapers
42-99% of ex-smokers said e-cigs helped them quit smoking
60-86% of smokers said e-cigs helped them reduce cig./day
Sources:ETTER (2010), BMC Public Health, 10, 231.SIEGEL (2011), American Journal of Preventive Medicine, 40, 472-5.ETTER (2011), Addiction, 106, 2017-28.FOULDS (2011) International Journal of Clinical Practice, 65, 1037-42.GONIEWICZ (2013), Drug and Alcohol Review, 32, 133-140.DAWKINS. (2013) Addiction.KRALIKOVA (2013), Chest.FARSALINOS (2013), International Journal of Environmental Research and Public Health, 10, 2500-14.
Effects on smoking cessation: 2 randomized, controlled trials
Italy, New Zealand Modest quit rates, comparable to nicotine patch Used obsolete models that delivered little nicotine Both studies present methodological limitations (even though one
study was published in The Lancet)
Sources:Bullen The Lancet 2013Caponnetto PLOS One 2013
Addiction
Definition: Compulsive use in spite of adverse consequences for the user’s
health, family and social life
The « adverse consequences » element is lacking for e-cigs
Addictiveness of e-cigs
Surveys of vapers:- Vapers are former and current smoker- 97% to 100% of vapers use nicotine-contining e-cigarettes
Thus, e-cigs are nicotine-delivery devices
Addictiveness depends on the speed of delivery to the blood Nicotine is highly addictive when smoked Some users are addicted to the nicotine gum Nicotine patches are not addictive
Speed of delivery for e-cigs: quicker than for nicotine inhaler, but slower than for cigarettes (Bullen, Farsalinos)
Speed of nicotine delivery to the blood:1st generation e-cig, 2nd generation e-cig, tobacco cigarettesSource: Farsalinos et al Sci Rep. 2014; 4: 4133
Are e-cigarettes addictive ?
This is not yet well documented, but it is possible
Some former smokers who were already addicted to nicotine probably use e-cigarettes compulsively
Surveys suggest that addiction to e-cigarettes is weaker thanaddiction to tobacco (but this need confirmation)
Compulsive use of e-cigarettes can be treated- with nicotine patches, which are not addictive- with varenicline- and counseling by a clinician
Is it a public health problem ?
Adverse consequences of long-term vaping are not yet documented
But long-term vaping is much safer than smoking
E-cigs help people quit smoking and avoid relapse
Compulsive use of e-cigarettes can be treated, probably more easily thanaddiction to tobacco
Comparison with nicotine gums: 1% of smokers who quit smoking with nicotine gums remain addicted to
these gums, but… - this is not a public health problem- nicotine gums are sold without a medical prescription- FDA 2013: long-term use of nicotine products not harmful
Summary of evidence
1. E-cigarettes are used by current and former smokers, as a cheaper and safer alternative to tobacco
2. Regular or daily use in non-smokers has not been documented so far
3. E-cigs most certainly help smokers quit or reduce smoking
4. E-cigs are less addictive and less toxic than cigarettes, long-term effects not known
Sources:1)Cho. J Adol Health. 2011 Choi. Am J Public Health. 2013Corey MMWR 2013 Dockrell Nic Tob Res 2013Douptcheva J Epidemio Comm H 2013 Goniewicz. Pediatrics. 2012King. Nicotine Tob Res. 2013 McMillen. J Environ Public H 2012Pearson Am J Public Health 2012 Regan Tob Control 2011Sutfin Drug Alc Depend 20132) Douptcheva et al. J Epidemiol Comm Health. 2013; Zhu et al. PLOS One. Oct 2013; ASH-UK. 20133) Etter (2010), BMC Public Health, 10, 231. Siegel (2011), American Journal of Preventive Medicine, 40, 472-5.Etter (2011), Addiction, 106, 2017-28. Foulds (2011) International Journal of Clinical Practice, 65, 1037-42.Goniewicz (2013), Drug and Alcohol Review, 32, 133-140. Dawkins. (2013) Addiction.Kralikova (2013), Chest. Farsalinos (2013), Int J Environ Res and Public Health, 10, 2500-14.4) On addictiveness of e-cigs: Foulds Int J Clin Pract 2011, Goniewicz Drug Alc Rev 2013, Dawkins Addiction 2013, Farsalinos IJERPH 2013
Should clinicians recommend e-cigarettes for smoking cessation?
Not regulated as a medication, no therapeutic intention
For all smokers : - Say that combustion is the most toxic method of inhaling nicotine, all other methods are safer- Inform about e-cig safety, efficacy- Inform about the nature of nicotine
For non-users of e-cigs :- Recommend approved medications / methods first
For current e-cig users :- Focus on smoking cessation, not e-cig cessation. Help them if they say e-cig helps them, don’t be a barrier on their road to quitting- Recommend to test several products, flavors, nicotine strengths before they find the one that most suits them.- Cigalikes are not very effective, prefer tank systems
In many countries: nicotine allowed only in smoked tobacco or in medications
Currently in many countries, nicotine is available either in :- smoked tobacco (smokeless banned in many countries)- medications (patch, gum, etc.)
For public health, this approach is largely a failure
The most deadly product is cheap + available everywhere
Nicotine replacement therapy- not very appealing- not very effective in the long term (increases smoking cessation
rates by a few percentage points only)
The success of e-cigs challenges this approach
The regulation of nicotine needs to be rethinked, but how ?
Regulation: European Union (EU)
Tobacco Products Directive: article 20 EU Parliament voted February 26, 2014: Opacity, no consultation, many pages of text, behind closed doors. Applies to “cross-border distance sales of e-cigarettes” Disclose list of ingredients + emissions Products should be notified:
- Toxicological data, document effects on health, addictiveness Restrictions on advertising and sponsorship Rejects proposal to regulate e-cigs as medicines Nicotine liquids: containers maxi 10 ml, tanks maxi 2 ml Maxi 20 mg/ml nicotine Only ingredients that do not pose any risks to health E-cigs must deliver nicotine at consistent level Surveillance system for adverse effects
EU Directive
Leaflet: warnings, addictiveness, toxicity'This product contains nicotine which is a highly addictive substance.'
Advertisement is prohibited “any form of public or private contribution to radio programmes with
the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited”
Where, …, the placing on the market of specific electronic cigarettes or refill containers, …has been prohibited on duly justified grounds in at least three Member States, the Commission shall be empowered… to extend such a prohibition to all Member States
USA « deeming regulation »
Currently : - FDA cannot regulate e-cigs as drugs : court decision Sottera 2010- FDA regulates all non-medicinal nicotine as tobacco : FSPTCA 2009 - E-cigs are currently largely unregulated at federal level- State and local regulations (bans in public places, sales to <18 yr)
FDA (M. Zeller): regulation of nicotine products should be based on a continuum of risk
FDA «deeming regulation» (i.e. for products deemed tobacco) : - consultation procedure began in April, outcome unknown:- register products with FDA, marketed only after FDA review- no claims of reduced risk (unless FDA confirms that scientific
evidence supports that claim)- no sales to youth- health warnings
Harm reduction equation
Harm reduction = Reduced risk x Number who switch
Product toxicity & other risks
Product attractiveness
Consumer preference
0
More regulationLower risk
regulated e-cig “unregulated” e-cig
10 100
cigarettee-cigarettes
0 100
Focus on the right relative risk (Clive Bates)
Perspectives
One of the most important public health debates in recent decades:
To redefine the place of nicotine in society and in the law, and make room for new nicotine products
50 by 25 Decrease the tobacco cigarette market by 50% in 2025
(Clive Bates)
Conclusions
A major innovation that has the potential to save many lives
Safety ?
Efficacy ?
Effective addictive
How to regulate nicotine vaporizers?
Window of opportunity: 2014 (EU Directive, FDA, CH)
Balance public health impact vs risks
Research is urgent: supported by whom?
Training (gap between opinions of vapers vs. NHS staff)
Education of the public, clinicians, journalists, policy makers, legislators
Precautionary principle
The European Commission published useful guidance on the precautionary principle in 2000. It sets out six guidelines. Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:
1) proportional to the chosen level of protection,
2) non-discriminatory in their application
3) consistent with similar measures already taken,
4) based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis),
5) subject to review, in the light of new scientific data, and
6) capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment.