On 5th January, Ireland’s Health Information and Quality Authority published a draft Health Technology Assessment on smoking cessation interventions with a press release. The assessment was positive about e-cigarettes.
Dr Máirín Ryan said: “This HTA found a high level of uncertainty surrounding both the clinical and cost-effectiveness of e-cigarettes. While the long-term effects of using e-cigarettes have not yet been established, data from Healthy Ireland reveals that 29% of smokers currently use e-cigarettes as an aid to quitting smoking. HIQA’s analysis shows that increased uptake of e-cigarettes as an aid to quitting would increase the number of people who successfully quit compared with the existing situation in Ireland and would be cost-effective, provided that the currently available evidence on their effectiveness is confirmed by further studies.”
In Ireland, that is very positive!
The report is out for public consultation until the 3rd February 2017. The consultation page allows for a free-form response. You can put in whatever information you think will assist the review team. Here is my response, framed around five quotes from the Royal College of Physicians:
- On the relative risk of e-cigarettes and cigarettes
- On population effects
- On the impact on smoking cessation
- On unintended consequences of well-intentioned but excessive or over-cautious regulation
- On the recommendation of a tobacco harm reduction strategy
Key elements of Royal College of Physicians’ report on tobacco harm reduction
I would like to draw the attention of the review team to the London-based Royal College of Physician’s 2016 report, Nicotine without smoke: tobacco harm reduction, 28 April 20016, London [link]
Five quotes from the report provide an excellent basis for outlining the main issues relating to e-cigarettes, smoking cessation and tobacco harm reduction:
1. On the relative risk of e-cigarettes and cigarettes
“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.” (Section 5.5 page 87)
This carefully worded statement takes the practical approach of focussing on what scientists do know, rather than unknown or unknowable information that will only become available over many decades and only if the right studies are put in place. The judgement of relative risk is based on the completely different physics and chemistry of tobacco smoke and e-cigarette aerosol – some we do not have to wait 50 years for. The former is the product of complex chemical reactions in high-temperature combustion of dried tobacco leaf. The latter is the electrical heating at much lower temperature of an inert liquid bearing nicotine and flavourings – there is no combustion. Most of the important harmful toxins in tobacco smoke are products of combustion. For this reason, they are either not detectable in e-cigarette aerosol or present at very low levels.
The result is that the overall toxicity of the e-cigarette aerosol is very much lower than cigarette smoke. As one would expect from such an organisation, the Royal College of Physicians has expressed its statement with careful reflection of uncertainties in both directions, but with a steer to make it clear that 5% of the risk of smoking is a conservative estimate. At present, there is no credible evidence to suggest these products will cause any serious disease or premature death. However the claim is not that they are safe, just very much safer.
2. On population effects
“There are concerns that e-cigarettes will increase tobacco smoking by renormalising the act of smoking, acting as a gateway to smoking in young people, and being used for temporary, not permanent, abstinence from smoking. To date, there is no evidence that any of these processes is occurring to any significant degree in the UK. Rather, the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco, by confirmed smokers who are trying to reduce harm to themselves or others from smoking, or to quit smoking completely.” (Recommendations)
This summary address a number of claims made by tobacco control activists to the effect that the availability of a low-risk alternative to smoking would somehow increase smoking. It is worth recognising just how counter-intuitive these claims are, and as such should require a very credible evidence base before they are accepted as remotely plausible. The RCP draws the opposite, more intuitive, conclusion from the evidence, namely that: (1) people use safer products to reduce their risks; (2) that the promotion of vaping promotes vaping, not smoking; (3) any ‘gateways’ seem more likely to be ‘exits’ from the more harmful to less harmful products.
3. On the impact on smoking cessation
“E-cigarettes are marketed as consumer products and are proving much more popular than NRT as a substitute and competitor for tobacco cigarettes. E-cigarettes appear to be effective when used by smokers as an aid to quitting smoking.” (Recommendations)
The RCP makes the important observation that e-cigarettes are consumer products, and that their success in part derives from their appeal to those who would never even try to quit smoking via conventional methods or are unwilling or unable to quit. E-cigarettes are not medical aids to reduce craving and withdrawal during a quit attempt, but an alternative way of taking the recreational drug nicotine. It important, therefore, not to treat e-cigarettes as medicines, to misapply concepts like ‘efficacy’ or to rely on randomised controlled trials that are suited to singular interventions, such as administering a drug.
The ‘efficacy’ of e-cigarettes is not a property of the device and liquid, but the outcome of a complex ecology of behavioural influences, including properties of the product, but also peer support, marketing, beliefs about risk and scare stories in newspapers, local availability, the attitude to smoking/vaping in the social and work environment, and the policy framework – packaging, warnings, restrictions, diversity, marketing, taxation etc. Users tend to progress over time, acquire vaping skills and switch products to more complex configurations, lower nicotine liquids and more diverse flavours as they migrate away from tobacco. A period of dual use may be part of a transition that lasts longer than any RCT ever would, but ends in permanent smoking cessation. Because of their poor efficacy, conventional smoking cessation techniques also involve prolonged “dual use”, but this occurs serially with successive quit attempts and relapses back to smoking then the next quit attempt and so on until success or through an indefinite cycle of cessation and relapse.
4. On unintended consequences of well-intentioned but excessive or over-cautious regulation
“A risk-averse, precautionary approach to e-cigarette regulation can be proposed as a means of minimising the risk of avoidable harm, eg exposure to toxins in e-cigarette vapour, renormalisation, gateway progression to smoking, or other real or potential risks. However, if this approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking.Getting this balance right is difficult.” (Section 12.10 page 187)
The RCP draws out the most challenging question for regulators. By regulating or communicating with excessive caution, well-intentioned authorities can make the situation worse, cause avoidable harm to consumers and protect the cigarette trade. In forming the EU Tobacco Products Directive provisions on e-cigarettes (and the ban on snus), far too little attention was paid the risk that the measures proposed would have harmful unintended consequences. These could arise by reducing appeal, making the products harder to use, by hampering innovation, by raising prices, by denying the means to communicate and, above all, by creating regulatory barriers to entry that have the effect of protecting the incumbent cigarette trade against disruptive innovation. Ireland’s health community should take great care to avoid compounding these errors.
5. On the recommendation of a tobacco harm reduction strategy
“However, in the interests of public health it is important to promote the use of e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.” (Recommendations, original emphasis).
Taking all the available evidence into account, the organisation that first reported on Smoking and Health in 1962, endorses a tobacco harm reduction approach including the promotion of e-cigarettes.
Ireland’s 2025 tobacco policy aims
Ireland’s ambitious goal to be tobacco-free by 2025 has been translated into achieving a smoking prevalence rate of less than 5%. This goal is very ambitious. It will be exceedingly challenging if the only strategies to be deliberately deployed are complete cessation and reduced initiation. Current rates of decline in smoking are unlikely to come close to meeting this target. However, a third strategy is available, that is to encourage smokers to switch to smoke-free products – primarily e-cigarettes but also other nicotine products that does not involve combustion and smoke. Many smokers will find it easier to switch from smoking to vaping than to stop both smoking and nicotine use altogether. The switching strategy only involves giving up part of what is involved in smoking. Switching from smoking to vaping allows the user to continue using nicotine and to maintain several behavioural and sensory aspects of smoking, though with radically reduced risk and a contribution to the attainment of the 2025 smoking prevalence target.