the WHO report on the global tobacco epidemic 2021

 

This is an amazing success in the face of continuing aggressive opposition by the multinational tobacco companies.

 

The major new item in the report is the extensive discussion of new tobacco products and how the tobacco companies are using these products to fight effective tobacco control. As WHO Director General Dr Tedros Adhanom Ghebreyesus writes, ““We must remain vigilant to the challenges posed by new products such as electronic nicotine delivery systems and heated tobacco products.”

 

The report contains a detailed summary of e-cigarettes, heated tobacco products and other new products (collectively called electronic nicotine delivery systems, ENDS). For example, the report says:

 

There is growing evidence of harmful effects of ENDS

 

 

Tobacco and related industries market and promote ENDS as “safer” alternatives to conventional cigarettes and many users perceive them to be significantly “less harmful” than tobacco products, especially cigarettes

(42). However, even though many of the long-term health effects of ENDS use are still unknown, there is growing

evidence to demonstrate that these products are not harmless (43). For example, recent studies suggest that

ENDS have negative acute effects on cardiovascular health, including heart rate and blood pressure (44–46), and that daily ENDS use has been shown to be associated with increased risk of myocardial infarction. In addition, studies on the impact of ENDS use on respiratory health show measurable adverse effects on organ and cellular health in humans, in animals, and in vitro, and is likely to be associated with asthma and chronic obstructive pulmonary disease (47, 48).

 

The health impacts on users of these products are also likely to depend on the many factors associated with the range of ENDS design and how they are used, as well as on other products that the user is consuming at the same time, and the quantity or pattern of that consumption. For

example, ENDS are often used as complements to cigarette smoking and not as substitutes, especially in the smoke-free environments where ENDS use is not banned. This means many ENDS users use both ENDS and conventional cigarettes (dual use) (49) – a pattern of use that may in fact have more deleterious effects on users’ health than the use of ENDS or conventional cigarettes alone. In the United States, almost 70% of adult ENDS users also currently smoke cigarettes (50). Dual use of ENDS and cigarettes may also sustain nicotine dependence. Some studies suggest that dual use is associated with increased risk of respiratory and cardiovascular conditions relative to single product use

(51–53). [emphasis added] (page 36)

 

When discussing the literature on e-cigarettes and cessation, the report makes the point that the FCTC defines cessation as stopping all tobacco products, not just switching from cigarettes to another tobacco product.

 

Cessation is defined in the Guidelines for implementation of Article 14 of the WHO FCTC as “the process of stopping the use of any tobacco product…” and it is, therefore, implausible to claim this may be done by switching to another tobacco product. (page 28)

 

It also has an excellent discussion of problems with fact that the randomized controlled trials that form the basis for most analyses of e-cigarettes for smoking cessation as exemplified by the Cochrane reviews of this question have serious limitations

 

To date, evidence on the use of ENDS as a cessation aid is inconclusive. A recent Cochrane Review suggests that e-cigarettes can help smokers quit (83). This review compared ENDS to behavioural support and other nicotine replacement therapy (NRT) and pooling the results of four studies found a small but significant increase in quitting rates among ENDS users. The results suggested that out of 100 people using NRTs, six of them are likely to quit successfully, while 10 out of 100 people using e-cigarettes to quit are likely to be successful.

 

There are a number of caveats to this conclusion. Firstly, the authors note that the certainty of these findings is low (for the comparison to behavioural support) to moderate (for the comparison to NRTs). Secondly, the studies included used a single product type in a therapeutic environment, and this is not considered comparable to the current real-world context of e-cigarette use. Thirdly, and perhaps most significantly, there is the question of defining cessation. Cessation may be seen to be the quitting of smoked tobacco products, the quitting of any tobacco product or the quitting of any nicotine product. In the Cochrane Review, cessation was considered successful

if people quit smoking any tobacco product. In other words, a person could move from conventional cigarettes to ongoing use of ENDS and be considered to have successfully “quit”. This leaves open the question about the duration for which a person would be expected to continue using ENDS as a cessation device, especially since longer-term use may entail increased exposure to the potential health risks associated with ENDS. NRTs are designed such that nicotine content is progressively reduced throughout the treatment so as to reduce dependence on nicotine. (page 39)

 

…

 

Given the diverse nature of ENDS, more evidence is needed to inform a conclusive statement on the potential of any specific ENDS product as a cessation tool. At this time, there are still a number of unknown factors which mean that ENDS cannot be recommended as cessation aids at the population level. Currently available cessation treatments such as NRTs (gums and patches), and pharmacotherapies (Bupropion and Varenicline), must be approved by each country’s regulatory authority before they can be marketed and made available in that country and comply with regulatory requirements (87). ENDS are not currently subject to this regulatory approach in most countries where they are sold, and consequently do not benefit from the same quality assurance and oversight guaranteed for other cessation treatments. (page 39)

 

There are four direct implications of these points:

 

Randomized controlled trials, which are designed to assess specific medicines delivered to specific patients who have specific clinical implications.

Approval of e-cigarettes under these conditions by a medicines authority should come with these specifics attached.

Approval should use the WHO FCTC definition of “cessation.”

Approval should assess risks as well as benefits, as is done with other potential therapeutics.

On October 2021 Australia is moving to bring e-cigarettes for cessation under its therapeutic policies:

 

On 1 October 2021 Australia will become the first country in the world to ban the purchase or import of ENDS by consumers unless they have a valid doctor’s prescription to do so. The main reason a doctor may provide a prescription is to help the user quit.

 

As there are currently no approved nicotine e-cigarettes

on the Australian Register of Therapeutic Goods (ARTG),

doctors themselves may need to apply to the Therapeutic Goods Administration (a regulatory agency of the Australian Government) for access to the unapproved product before they issue a prescription. (page 39)

 

(The population level observational studies that are most relevant to e-cigarettes as unsupervised consumer products do not show cessation benefits even using the weak definition that allows people to continue using e-cigarettes.)

 

The WHO also has extensive discussions of use by youth, the gateway effect (i.e., attracting low risk youth who then go on to add cigarettes) and specific activities by the tobacco industry to promote these products and use them to slow down tobacco regulation.

 

How ENDS challenge tobacco control and effective public health implementation (page 41)

 

Legislation and regulatory mechanisms struggle to keep pace with changing product characteristics Because ENDS often do not have the same characteristics as conventional products and are constantly evolving, they may not be covered under existing laws and can fall between regulatory cracks. In particular, open-system (modifiable) ENDS are difficult to regulate (92) and regulations are often not able to keep pace with changing product characteristics.

ENDS use among children and adolescents may act as a gateway to tobacco use ENDS are aggressively marketed towards children and adolescents, including through the use of flavouring and promotional strategies (93, 94) and their use could lead young people to take up more harmful forms of nicotine or tobacco consumption. The advent of high-concentration nicotine solutions and nicotine salts may increase a new user’s dependence on nicotine and increase their likelihood of moving on to conventional tobacco cigarettes (95, 96).

ENDS subvert tobacco control laws and thereby undermine tobacco control achievements Many ENDS users cite the ability to get around smoke-free restrictions as a major motivation for using these products (97). If ENDS are not banned in smoke-free spaces, people will not only be exposed to second-hand emissions but existing bans on tobacco products such as HTPs (which can be difficult to differentiate from ENDS) may be more difficult to implement, thus undermining the measures in place to protect by-standers.

ENDS are renormalizing smoking in society ENDS use mimics the behaviour of smoking by the hand to mouth movement, with the aerosol generated bearing close resemblance to tobacco smoke. Where regulations do not exist to restrict it, the use of ENDS in public spaces may make people more comfortable around those using them and may increase acceptance of smoking (98, 99).

ENDS may entice former smokers to take up ENDS ENDS may remind people of smoking and result in former smokers taking up ENDS or relapsing to use tobacco products again (100).

ENDS may discourage smokers from fully quitting by prolonging dual use or continuing their use of nicotine products It is still unclear if ENDS use is likely to eventually lead to cessation. Switching from tobacco to ENDS or dual use may prolong the use of tobacco products beyond what would have been the case had users been relying on NRTs or other evidence-based interventions to quit (86, 101, 102).

The report also has an excellent discussion of COVID-19 and tobacco use, how the industry has attempted to use COVID-19 to its political advantage, and how countries have responded under the FCTC.

 

Among the report’s conclusions is:

 

The focus of this report, addressing new and emerging products, charts a new threat to tobacco control. ENDS are increasingly available in many countries along with other novel products like heated tobacco products and nicotine pouches. As they emerge and rapidly evolve, these products can be difficult to characterize and therefore bring with them many regulatory challenges. At the same time, the tobacco and related industries behind these newer products pedal misinformation campaigns, marketing them as “clean”, “smoke-free” or “safer”, and claim they are effective cessation aids. By doing so, these industries attempt to appear part of the solution to the tobacco epidemic, as opposed to instigators and perpetrators of the epidemic. These industries also target children and adolescents by using marketing strategies and thousands of flavours that make ENDS and other nicotine and tobacco products appealing. When children use ENDS, or even try them, they are more than twice as likely to use conventional cigarettes. The tobacco industry gains new customers.

 

The evidence from this report indicates that 32 countries currently ban the sale of ENDS, taking a strong stance on preventing the potential harms they pose to their populations. A further 79 countries have adopted bans on use in public indoor areas, advertising, promotion or sponsorship bans or graphic health warnings for ENDS; however, 39 of these are only partially adopted. This leaves a total 84 countries with no legislation addressing ENDS in any of these domains.