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The Regulatory Agency for Medical Devices and Medicines (MHRA, for its acronym in English) has updated a guide so that companies that produce these devices can obtain a license to be prescribed within the national health system. As long as they meet the same safety, quality and efficacy requirements that apply to medicines.
To contextualize this decision, we must answer the following questions: what is the evidence on the effectiveness of electronic cigarettes? Does its inclusion as a medical device make sense?
According to data from the 2019 National Health SurveyIn Spain, almost 20% of the population over 15 years of age consume tobacco on a daily basis. The percentage rises to almost 25% between 25 and 64 years.
This practice is more common in men than in women (23% vs. 16%). 2% and 22% of the population over 15 years of age declare to smoke occasionally or to have quit, respectively.
Regarding the level of education, while there are more daily smokers among men with a low educational level, in the case of women it is more frequent among those with an intermediate level.
In relation to income, the distribution of daily smokers follows a social gradient: the higher the income level, the fewer daily smokers.
These inequalities are also observed in the impact of smoking on health. Tobacco-attributable mortality is higher among people with a lower educational level for the same level of consumption.
The association of smoking with multiple oncological, pulmonary and cardiovascular diseases is solid and has been established for decades.
Something more unknown to the general population may be the higher risk that former smokers also have of a worse quality of life, more cardiovascular events and higher mortality, compared to those who have never used tobacco.
The problem of smoking as a matter of public health is not limited exclusively to people who smoke at a given time, but increases as the non-smoker category is abandoned, and its impact remains over time once it is stopped. to smoke. In addition, it is an issue with important implications in terms of equity and social justice.
The approach to smoking proposed by the WHO in its strategy MPOWER It consists of public health measures (taxes, plain packaging, limitation of public spaces where you can smoke) and more individual measures within the health system, such as the use of nicotine replacement therapies (chewing gum, patches) and drugs such as bupropion and vaneliclin.
The British NHS announcement would mean that e-cigarettes, if they meet the same standards as other treatments, would begin to be offered to help people quit smoking.
But what evidence do we have of the effectiveness of these devices to stop smoking?
reviews systematics and meta-analyses available on clinical trials indicate that the evidence is, to say the least, controversial.
First, there is no strong evidence of its benefit for smoking cessation, and the quality of the studies is generally low.
Secondly, there are alternatives such as varelicline itself whose effect is superior or similar to that of electronic cigarettes.
Third, some observational studies (under real conditions) show the loss of effect of electronic cigarettes shown in some clinical trials carried out under ideal conditions.
Fourth, almost a third of the investigations into these devices are not transparent about their conflicts of interest. Those that are more favorable to electronic cigarettes more often present conflicts of interest with the industry that manufactures these products.
In summary, we have some devices whose efficacy in clinical trials has not been solidly demonstrated and whose potential beneficial effect is lost in studies carried out under real conditions. In addition, we have better alternatives compared to electronic cigarettes.
Proponents of e-cigarettes often argue that those who question their use are preventing many lives of smokers from being saved. However, we have already stated that the evidence for this is controversial.
In addition, the debate is not framed in the use of these products as part of the approach to smoking. If this were the case, and they met the requirements for any other treatment, there would be no problem in their use being conditioned on prior medical prescription. This is not the case, and the e-cigarette business depends on their continued sale to the general public.
That’s why proponents of these devices oppose any policy that limits their sale. The analysis must go beyond the health framework to understand electronic cigarettes in the current social context.
Under real-world conditions, evidence tells us that those who use e-cigarettes have a higher risk of tobacco use and relapse among former smokers.
Some research has found that the risk of using tobacco is greater among those who had lower susceptibility at the beginning. Therefore, the sale of these devices to the public entails a series of impacts in terms of public health that requires public policies.
Reports in the United States have highlighted that the practices carried out by electronic cigarette companies are similar to those carried out by the tobacco industry. They share the same promotional and advertising tactics to sell their products.
In some cases, the industry itself is the creator of some of the electronic cigarettes available on the market. In the case of heated tobacco products recently there was a conviction of Phillip Morris in Spain for surreptitious advertising.
There were also reports in the United States stating that heated tobacco poses less risk than conventional cigarettes. Behind this campaign was Phillip Morriswhich was attempting to pass off an FDA authorization (a standard procedure for marketing any tobacco-related product, which must be notified to the agency) as proof of the benefits of such products.
It is hard to imagine that the interests of the tobacco industry are aligned with the use of these products exclusively in the health field if, as we have seen, these can function as a gateway to tobacco consumption.
The use of these devices at a healthcare level is not what arouses debate within the field of public health, since not even their defenders advocate this route. What it is about is understanding the social impact that these products have today, and the economic interests behind them, since their consumption is available to both smokers and non-smokers.
For all this, the approach necessarily requires public health measures that regulate these products, such as tobacco, to limit their negative impacts at the population level.
Mario Fontan Vela. Doctoral student in Epidemiology and Public Health, University of Alcalá
Francisca Sureda Llull. Hired Professor of Epidemiology and Public Health, University of Alcalá
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