E-Cigarettes: Implications for Health Promotion in the Asian Pacific Region

Introduction

The rapid growth of electronic cigarette (e-cigarette; vaping) use globally is heralded by some, including the United Kingdom’s (UK) Royal College of Physicians as well as multinational tobacco companies (“Big Tobacco”), as a potentially important public health measure that could ultimately replace tobacco cigarettes.^1-3 However, other authoritative groups, including the Office of the Surgeon General of the United States (US), the World Health Organization, and most Australian medical and public health organizations recommend a cautionary approach until there is clear evidence that they will not become the “new tobacco” bringing with it a possible myriad of other problems.^4-6 This reticence is understandable considering negative perceptions that are associated with Big Tobacco being a major manufacturer and promoter of the product. ⁷

In mid-2015 we concluded, “From the limited evidence available to date on ECs [e-cigarettes], it is apparent that a cautious approach is warranted with a case that supports strict regulation until rigorous research is conducted.” ⁸ Despite extensive new international publications over the past 30 months, our conclusions and recommendations remain largely unchanged for Australia, which has a very low smoking rate (12% of adults; and only 2% of 12-17 year olds). ⁹ For countries with a high smoking rate, for example, several countries of the Asian Pacific region with smoking rates by male adults well in excess of 40%, and Indonesia at 76%, ¹⁰ a similar cautious approach is justified.

This commentary reviews evidence that supports a cautious approach to e-cigarette availability in Australia and the Asian Pacific region.

Support and Concerns for E-Cigarettes

The international debate continues in the public media and scientific literature as to whether e-cigarettes should be readily available to the general public. For example, the recent Royal College of Physicians report Nicotine without Smoke ¹ created substantial conversation among the scientific community and was quickly picked up and cited by the e-cigarette and vaping industry. There were numerous critical reviews of the report and of particular note was the concern relating to the claim of e-cigarettes being 95% less harmful than regular cigarettes, even though there is no scientific data to support this position. Eminent toxicologist Robert Combes and colleague explained that this finding was simply based on a multi-criteria decision analysis study, whereby a group of so-called experts considered the harm of a wide range of tobacco products. ¹¹ The products were ranked on a scale where cigarette smoking was ranked at 100% and e-cigarettes at 4%.^11,12 This ranking was then uncritically cited by Public Health England (a UK executive agency sponsored by the Department of Health) ¹³ even though these data were not evidence based. Combes and Balls ¹¹ go on to state, “If e-cigarettes are really ‘safer,’ then their use should be recommended, but only after an intelligent analysis of their risk to human health, based on integrated in silico, in vitro, and clinical studies for both scientific and logistical reasons.” Unfortunately, this figure of 95% has been restated and used to support arguments in favor of e-cigarettes.

Potential E-Cigarette Benefits

However, it must also be acknowledged that e-cigarettes may have real benefits. For example, Levy et al ¹⁴ conducted a hypothetical modelling study in the US, where replacing cigarette use with e-cigarettes in their most pessimistic scenario yielded 1.6 million fewer premature deaths and 20.8 million fewer years of life lost over a 10-year period. However, their scenario also acknowledged that it may eventuate that e-cigarettes are actually more harmful than current evidence suggests; there is potential for an increase in initiation into regular e-cigarette use by people including youth who would not otherwise use a nicotine delivery product, resulting in unacceptably high levels of e-cigarette use through normalization of vaping. ¹⁴ This assertion by Levy et al, ¹⁴ which was made in a US context, is contested by Bauld et al, ¹⁵ who presented UK youth (11-16 year olds) data indicating that regular smoking was 1% to 4%, regular e-cigarette use was 1% to 3%, and ever use 7% to 18%. Their contention was that while prevalence of ever use of e-cigarettes rose from 7% in 2016 to 11% in 2017, the prevalence of regular use did not change.

Do No Harm

Fundamental to public health practice is the requirement to do no harm. In their book Law and the Technologies of the Twenty-First Century, the authors explore the legal frameworks and principles through which risk from new technologies can be mitigated. ¹⁶ The use of e-cigarettes or vaping is an example of new technology with an impact on health. Central to the risk-mitigation process is the precautionary principle, which is a principle of decision making that requires decision makers in cases where there are threats of environmental or health harm not to use “lack of full scientific certainty” as a reason for not taking measures to prevent such harm. ¹⁷

The trigger to invoke a precautionary principle is based on the desire to protect a population from a level of risk, and the acknowledgement that there may be a gap in the evaluation of the level of risk due to insufficient data. This insufficiency may include absence of cause and effect relationship (which for smoking took a long time to demonstrate), quantifiable dose-response relationship, and evidence of the emergence of adverse effects following exposure. Further, in the case of substances that are a priori hazardous or which are potentially hazardous to a certain level of absorption (such as nicotine and vegetable glycerin that are both present in some e-cigarettes), there should be a reversed burden of proof by requiring that the substances be deemed hazardous until ultimately proven otherwise. Until this is done the legislator is not legally entitled to authorize use of the substance unless exceptionally for test purposes. The decision to act is a political decision with decision makers having to determine the level of risk that is acceptable to the society on which the risk will be imposed. In the case of e-cigarettes there is continuing emerging evidence indicating potential harms,^18-20 and as such the precautionary principle should be followed.

Some reputable public health advocates and medical organizations have been criticized because they support a very cautious approach to the use of e-cigarettes rather than the more liberal approach.^1,21,22 The Royal College of Physicians ¹ review purports that e-cigarettes are used almost exclusively as safer alternatives to cigarette smoking. However, other international authorities are concerned about the potential for their unrestricted use to renormalize smoking and to act as a gateway to smoking by youth.^4-6,21,23 There is also concern that the harm reduction/harm minimization arguments of the e-cigarette proponents are severely flawed and inappropriately applied.^3,6,24

E-Cigarettes and Cigarette Consumption

Barrington-Trimis et al ²⁵ identified 3 studies where there were associations between e-cigarette use and subsequent cigarette smoking by adolescents. In one study, they found that adolescents who used e-cigarettes had more than 6 times the odds of initiating cigarette smoking compared with non–e-cigarette users. These findings suggest that e-cigarette use may increase the risk of smoking during the transition to adulthood. A systematic review and meta-analysis of 9 longitudinal studies of over 17 000 young people found that e-cigarette users had at least a 3-fold risk of becoming cigarette smokers after adjustments were made to factors that predict cigarette smoking. ²³ The authors concluded that “Strong e-cigarette regulation could potentially curb use among youth and possibly limit the future population-level burden of cigarette smoking.” ²³ A Canadian study that tracked teenagers over 12 months found that users of e-cigarettes were almost twice as likely to become regular cigarette smokers, with a study by Chatterjee et al ²⁶ making a similar conclusion in their review of longitudinal studies. This adds weight to the concern that vaping is a gateway to smoking by “renormalizing” it. ²⁷

A recent Italian national study indicated that smokers who used e-cigarettes as an aid to quit smoking had similar abstinence rates (8%) as those using no aid (9%), compared with significantly higher abstinence by those using official quitting methods (15%). Use of e-cigarettes may have been a key motivator for a number of the 8% to quit; ²⁸ however, this cannot be proven from such a cross-sectional study alone. This concurs with other recent reviews that concluded that the evidence to date in support of the effectiveness of e-cigarettes in helping smokers quit was inconclusive.^4,5

Chemical Composition

Studies indicate that e-cigarette vapor is not as harmless as often claimed, though less harmful than tobacco smoke.^4,6,8,29 Chemicals and toxins emitted by e-cigarettes have potential to cause adverse health effects. As well as formaldehyde, other carcinogenic compounds can be formed when solvents such as propylene glycol, glycerol, and ethylene glycerol are vapourized.^4,30 Combes and Balls ¹¹ highlight that 9 chemicals found in e-cigarette fluid as listed by the Environmental Protection Authority of the US State of California are of concern in regard to human safety. These include acetaldehyde, cadmium, isoprene, lead, nickel, nicotine N-nitrosonornicotine, and toluene. There is also potential for the heating element and associated components (eg, adhesives and solders) to shed particles on heating. This all requires investigation. However, Combes and Balls ¹¹ emphasize that the way that e-cigarettes are used makes risk assessment of chemical exposure more challenging because of the way the delivery device is used, how often it is used, the differences in e-cigarette design, and the composition of the e-juice (mixture used in vapor devices).

Availability and Promotion

Evidence from the UK and Germany concludes that the ready availability of e-cigarettes in community outlets accompanied by promotions makes these products attractive to children. ³¹ Most European Union member states have advertising bans on e-cigarettes but promotion of the product still occurs there and in many other countries.^3,6 A total of 40% of respondents aged ≥15 years in 28 European Union member states reported having been exposed to e-cigarette advertising or promotion in the previous 12 months. ³¹ In the US, marketing of e-cigarettes is carried out by using techniques similar to those used for tobacco cigarettes, with high levels of exposure to youth and young adults. ⁶

Tobacco companies are increasing their advocacy for e-cigarettes as they claim they plan to eventually replace their tobacco products with the much safer e-cigarette alternative.^2,3 Tobacco control experts, however, are concerned about the dubious tactics of the tobacco industry. They claim that promotional activities to date lure nonsmokers, especially young people to the new product, rather than just encouraging current smokers to switch to e-cigarettes as a quit aid. ⁶ Daube et al ⁷ are very clear that Phillip Morris and associated global tobacco companies cannot be trusted as they continue to pour millions of dollars into undermining the global “tobacco control” movement. It is very unlikely they are serious about a “tobacco-free world.” Evidence from leaked documents offers no indication that the tobacco industry has become less cynical and dishonest over time. Their hypocrisy is epitomized in Phillip Morris’s youth-oriented marketing of their “Be Marlboro” cigarette campaign targeting low- and middle-income countries. ⁷

A critical question is posed for the future. If the target of e-cigarette sales is current tobacco smokers, who will be the target once the numbers of smokers continues to fall to very low levels? Can we trust that the e-cigarette manufacturers will not make their main target young people as the tobacco industry did so successfully over many decades? Now that Big Tobacco is a major player, such a scenario is very likely considering their unethical marketing record. Indeed, there is evidence this is already happening worldwide.^6,7

What Is the Sensible Way Forward for Australia and the Asian Pacific Region?

Despite considerable progress in research on e-cigarettes with many studies funded by eminent funding bodies like the Australian National Health and Medical Research Council and the US National Institutes of Health, it is likely that we are still at least a couple of years away from reasonably conclusive findings. Limitations of research to date and conflicting and inconclusive results support continuation of a relatively cautious approach to policy regulating e-cigarette use globally.

In light of the growing incidence of lung cancer in low- and middle-income countries, a Lancet Editorial also supports this stance by concluding, “The fact remains that most lung cancers are highly preventable, and could almost all be avoided through tobacco control.” ³² The editorial acknowledges that appropriate policies in relation to the escalating use of e-cigarettes must be a key element in global tobacco control. They call for regulation of e-cigarettes that will protect youth and other vulnerable people from the potential gateway effect on smoking and minimize potential renormalization of smoking. On the other hand, they concede that e-cigarettes should be accessible to addicted smokers as part of a quit strategy. ³²

Proponents in Australia also argue that it would be desirable if there was better availability of e-cigarettes than currently is the case for addicted smokers trying to quit. ³³ This appears a challenge, as it seems that only a small proportion of e-cigarette users currently obtain their supplies via medical prescription from a pharmacy, the only legal avenue in Australia. Evidence at the recent Australian Parliamentary Inquiry suggests that there is a thriving “black market” of e-cigarette products including liquid nicotine that are readily available. ³ A range of retail stores and markets as well as online sources sell the products with a concomitant range of health and safety standards. Hence, to better control the “illegal” trade in e-cigarettes consideration may be given to extending availability to other special outlets besides pharmacists such as selected outlets that sell cigarettes, but still under medical prescription. Such a regulated scheme where the Therapeutic Goods Administration approves licensing of their sales may ensure better health and safety quality control over the products. It is assumed that similar restricted availability of e-cigarettes would be possible in other countries of the Asian Pacific region but considering the unique circumstances of each country. ⁵

Surveys indicate that a majority of people support significant restrictions on e-cigarette use. An Australian Institute of Health and Welfare ⁹ report indicates strong public support in Australia for restrictions on the use of e-cigarettes in public places (66%) and on advertising of them, plus a ban on their sales to under 18 year olds (75%). Similarly, an European Union–wide survey on the use of e-cigarettes in public places found that 79% of never smokers, 63% of former smokers, and 46% of current smokers supported a ban. ³⁴ A systematic review found that there was no clear evidence that restrictions on e-cigarette use in public places would deter smokers switching to e-cigarettes for harm reduction purposes. ³⁵

Conclusions

From the inconclusive evidence we have to date on e-cigarettes, it is apparent that a cautious approach is warranted with a case that supports strict regulation until rigorous research results are published. More randomized controlled trials are needed to compare e-cigarettes with other nicotine-replacement therapies, and research studies should be designed to assess long-term health outcomes of e-cigarette use. The same rigor that is applied to new therapeutic products should to be applied to e-cigarettes. ⁸ Above all we must support the precautionary principle, which is a principle of decision making that requires decision makers in cases where there are threats of environmental or health harm not to use “lack of full scientific certainty” as a reason for not taking measures to prevent such harm. ¹⁷ The trigger to invoke a precautionary principle is based on the desire to protect a population from a level of risk, and the acknowledgement that there may be a gap in the evaluation of the level of risk due to insufficient data on the health impact of e-cigarettes.