This summer, at the annual conference of the American Society of Clinical Oncology (ASCO 2024) held in Chicago, for the first time, one of the topics of discussion was the international experience of using alternative nicotine-containing products in order to reduce harm and then completely give up smoking. However, the potential of electronic nicotine delivery systems (ESDS) is being studied and discussed not only by oncologists, but also by scientists and doctors of various specialties. Unfortunately, the accumulated experience of the medical and scientific community in this area was not reflected in the clinical recommendations of the World Health Organization (WHO) on tobacco cessation published in July. WHO continues to adhere to the approach, the effect of which Russian President Vladimir Putin recently compared with the effect of the "prohibition law", once adopted in the USSR.
According to WHO estimates, there are now 1.25 billion smokers in the world. At the same time, more than 60% of them (that is, more than 750 million people) We would like to get rid of this bad habit.
The WHO Global Action Plan for the Prevention and Control of Chronic Noncommunicable Diseases for 2013-2020 set a target to reduce the prevalence of tobacco use among adults by 30% by 2025 compared to 2010. Since then, WHO has released five reports on global trends in tobacco consumption. The 2021 report noted that only 60 countries — that is, only one third of the countries that have signed the WHO Framework Convention on Tobacco Control (WHO FCTC) — are on track to achieve this goal. The 2024 report indicates that there are no longer 60 such countries, but 56. At the same time, tobacco consumption is growing in six countries of the world, and in nine it does not change.
The authors of the WHO report note that such a situation is completely unacceptable, and one cannot disagree with this. The only question is which approaches in healthcare and regulation will make it possible to correct this situation.
Russia is among the countries where the number of tobacco users has decreased in recent years, but at the same time, according to WHO estimates, the goal of reducing the prevalence of smoking by 30% by 2025 compared to 2010 will not be achieved. At the same time, since 2023, according to WHO, Russia has been included in the list of countries with policies that "most protect the population from tobacco exposure."
In 2013, the Federal Law "On the Protection of Citizens' Health from Exposure to Ambient Tobacco Smoke and the Consequences of Tobacco Consumption" came into force in Russia. Smoking in public places, the open display of cigarette packs in shop windows, advertising of any tobacco and nicotine-containing products were banned, and labels about the dangers of smoking and frightening pictures appeared on tobacco packages.
According to VTsIOM, thanks to the anti—smoking law, the share of Russians who smoke has actually decreased in ten years - from 41% in 2013 to 30% in 2023. At the same time, the strongest decline was recorded only in the first years of the law, whereas from 2016 to 2022 the percentage of smokers even increased — from 31% to 33%. The proportion of heavy smokers who smoke a pack of cigarettes or more every day currently stands at 17% of the adult population. Among men, heavy smokers account for almost a third (31%). At the same time, only 3% of smokers are ready to quit in case of an increase in the cost of tobacco products.
Cochrane reviews are internationally recognized as the highest standard in evidence-based healthcare. Thus, the 2016 review included 77 studies on the impact of legislative prohibitions on reducing the prevalence of tobacco smoking. Researchers were able to find evidence of a decrease in the prevalence of cardiovascular diseases and mortality, but the impact of bans on the number of respiratory diseases, on the health of newborns and on reducing the number of smokers and cigarette use was not so obvious. Moreover, "some studies have not revealed any reduction at all." Another Cochrane review showed a lack of convincing evidence that media campaigns contribute to reducing the number of smokers.
All of the above indicates that the anti-smoking measures currently being implemented have indeed brought results, but they no longer contribute to further reducing the prevalence of tobacco smoking in Russia. In order to more effectively influence the formed core of heavy smokers who are not motivated to give up, other, more flexible approaches are needed.
An alternative to the prohibitive approach is risk—based regulation, an approach based on a harm reduction strategy and modification of the risks associated with smoking. The main point of the harm reduction concept is that even if some risk cannot be completely eliminated, it can be reduced, or, in other words, modified.
The risk-based approach in healthcare is supported by the U.S. Food and Drug Administration (FDA). Here's how the FDA formulates its position: "There are no safe tobacco products. However, the level of risk associated with different tobacco products is in a certain range, which is sometimes called the "risk spectrum". Tobacco products related to the combustion process (smoking), such as cigarettes, are the most harmful type of tobacco products. Gorenje Certified products that are not associated with the combustion process, such as electronic cigarettes and other smokeless tobacco products, carry a lower health risk than cigarettes and other gorenje tobacco products."
The Cochrane review, published in January 2024, provides evidence that electronic nicotine-containing products contribute more to the gradual cessation of smoking than nicotine replacement therapy, which is considered as the main support tool for quitting smoking.
Meanwhile, the potential of electronic nicotine delivery systems is currently recognized by leading American cardiologists. Thus, in July 2023, the use of ESDN was included in the clinical recommendations of the American Heart Association and the American College of Cardiology (AHA/ACC) for the treatment of coronary heart disease as a harm reduction tool for non-motivated smokers.
Moreover, this summer, the risk-based approach and the potential of ESDN in reducing harm to human health were actively discussed by oncologists at ASCO 2024. The discussion on this topic can be considered a serious breakthrough in the prevention of cancer related to smoking.
In her speech at ASCO 2024, Anne McNeill, Professor at King's College London, pointed to the important role of electronic smokeless products in the British national smoking prevention strategy. In her speech, she described the difference between the two types of risks associated with tobacco use as follows: "Relative risk implies the difference between the harm to which consumers of electronic products are exposed compared with smokers of traditional cigarettes. Absolute risk is the difference between the harm caused to smokers and consumers of alternative products, compared to the non—smoking population. It was found out that there are no absolutely safe alternatives to smoking. However, it follows from the available data that electronic products in the short and medium term account for a much lower proportion of risks compared to classical tobacco smoking. Long-term data is continuously being collected, but it is important to understand that alternative electronic nicotine-containing products have appeared on the market relatively recently, so long-term data collection requires time, which is very precious to save the lives and health of smokers here and now."
It makes sense to pay special attention to the British tobacco control strategy. At the moment, the UK is among the very minority of countries that will be able to achieve the goal of reducing the proportion of smokers by 30% by 2025 compared to 2010. By 2030, the country wants to reduce the number of smokers to below 5% of the population. It is this threshold that the WHO considers sufficient to recognize the state as "smoke-free". What actions of the authorities contributed to such achievements?
At the end of 2021, the British Medicines and Healthcare Products Regulatory Authority (MHRA) amended the licensing guidelines for electronic nicotine-containing products, equating them to medicines.
In April 2023, the British Ministry of Health announced the launch of a program that has no global analogues, under which smokers will be able to receive 1 million electronic smokeless nicotine-containing devices for free, which should contribute to the abandonment of traditional cigarettes.
British doctors are officially allowed to recommend electronic products as a means of therapy for heavy smokers with low motivation to give up. Recommendations regarding electronic products as an alternative means of quitting smoking cigarettes are contained, for example, in the official guidelines of the Royal College of General Practitioners.
Public Health England reports over the years indicate that the levels of harmful substances released in smokeless products are reduced by 90-95% compared to conventional cigarettes, and their use by smokers is more effective in terms of quitting a bad habit. The Ministries of Health of New Zealand and Canada also urge smokers who do not give up smoking cigarettes to switch to electronic nicotine-containing products.
In the Philippines, a law came into force in July 2022, according to which tobacco products are divided according to the degree of health risk. Simultaneously with the ban on the sale of nicotine-containing products to minors, risk-proportional regulation is introduced for different types of nicotine-containing products. According to local doctors, the law encourages adult smokers to switch from cigarettes to less harmful tobacco products, which significantly reduces morbidity and mortality in the country.
The World Health Organization opposes the use of nicotine in any form other than nicotine replacement therapy prescribed by a doctor. Many scientists, based on new scientific data, express doubts about the correctness of the WHO position. Even former employees of this international organization come out with justified criticism. So, in 2022, the authoritative medical journal Lancet published an article by Robert Biglehol (Director of the WHO Department of Chronic Diseases and Health Promotion from 2004 to 2007) and Ruth Bonita (Director of Surveillance in the WHO cluster of noncommunicable diseases from 1999 to 2005) criticizing the current WHO Framework Convention on Tobacco Control (FCTC).
The authors of the article claim that "neither WHO nor the FCTC rely on the latest data on the role of innovative nicotine delivery devices in helping to transition from cigarettes to much less harmful products," and "WHO and FCTC policies lack a strategy to reduce the harmful effects of tobacco combustion products on smoker's health." Gorenje According to Biglehol and Bonita, alternative methods of nicotine delivery that exclude tobacco burning are not only less harmful to the consumer, but also in the long term can "shake the market of cigarette manufacturers." Gorenje However, WHO and the FCTC do not take into account these scientifically based technological achievements of the XXI century, and the rejection of the potential of the harm reduction concept actually, according to the authors of the article, "puts the most harmful products — cigarettes in a privileged position."
One of the most popular arguments of supporters of a strict prohibitive approach is the claim that electronic products can be dangerous because they attract young people and teach them to smoke tobacco. However, Kenneth E. Warner, professor at the University of Michigan School of Public Health, speaking at ASCO 2024, noted: "We have two goals. The first is to discourage the use of e—cigarettes by young people, and the second is to encourage adults who would otherwise continue to smoke cigarettes to choose e—cigarettes as a product with less harm."
Of course, when implementing a risk-based strategy in healthcare and regulation, it is necessary to show zero tolerance to the consumption of any tobacco and nicotine-containing products by minors. The younger generation should be completely protected from tobacco products and the harmful effects of tobacco smoke.
As for adult smokers, it is necessary to initiate long-term studies in order to understand and make final conclusions about the degree of harm of ESDN compared to conventional cigarettes. However, it is already clear that certified ESDS at least cannot be more harmful, and a number of short- and medium-term scientific data already show that they are less harmful compared to traditional smoking. It will take time, new research, and processing of large amounts of statistical data to reach a final verdict. And a more flexible approach to regulating different types of nicotine-containing products, depending on the degree of their harm, could show more impressive results in the fight against smoking than now.
President of the Russian Federation Vladimir Putin, speaking on September 2, 2024, on the Day of Knowledge, at an open lesson in Kyzyl (Republic of Tyva), also touched upon the problem of total bans and tobacco smoking among minors in Russia. The president compared the attempt to combat the spread of electronic products through total bans and tax increases to the campaign against drunkenness in the USSR — the so-called prohibition. As part of the adoption of this law, all vineyards in the country were cut down, which led to an increase in moonshine and a sharp increase in the number of deaths. A similar situation may arise in the tobacco market, the president says: "Somewhere it is necessary to ban, but there is always a line where these prohibitions no longer apply. Tobacco products will appear — and are already appearing in large numbers — entering the market "rough" or "in earnest" from taxes, produced outside the framework of the current law."
Vladimir Putin called for a comprehensive approach to solving the problem of tobacco smoking, including minors. "... First of all, it is necessary to explain the real situation, what bad habits lead to," he says. "It is important that healthy lifestyle and sports become fashionable, so that it is cool."
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