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E-Cigarette Summit - Prof. Antoine Flahault

Chair: Okay, so for this session we’ve got one speaker and then we’ll have the expert panel to take more questions and answers from the floor. So it gives me great pleasure to introduce our first speaker then this afternoon, who is Professor Antoine Flahault, Professor of Public Health, from the Descartes School of Medicine in France, and the title of his talk is ‘E-Cigarettes a disruptive public health phenomenon’ and he’s going to talk about ethics, risk and the precautionary principle. Thank you very much.


Prof. Flahault: Thank you, Professor McNeill, and I would like to thank the organiser for having invited me today to talk after the lunch and the networking which is not an easy task. I don’t know if you can read my conflict of interest. It’s seems almost unreadable so clear the font is but at least it is transparent! So yes, I have only indirect potential sources of conflicts as I received consultancy fees from Sanofi for institutional research grant and a member of my family works also for the French Association of Pharma Manufacturers


I will talk about ethics, risk and the precautionary principle. There are many definitions of the precautionary principle. We can say that the general spirit of PP is to take “caution in advance”, to take “caution in the context of uncertainty”, to keep “informed prudence”. We may rely on Principle 15 of the Rio Declaration. It said, ‘In order to protect the environment, the precautionary approach shall be widely applied by states according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.’ It is well accepted since the Rio Declaration that it extends now beyond the environmental degradation and environmental aspect and particularly the health aspect, so we will try to explore this principle as it is written in this Rio Declaration.


First about the threats of serious or irreversible damage, I think we have talked a lot about that. I would like to take some wording from WHO itself. ‘Tobacco kills up to half of its users. Tobacco kills nearly 6 million people each year and for more than 5 million of those deaths, they are the results of direct tobacco use, and 600, 000 are the results of non-smokers being exposed to second-hand smoke’ I apologise for showing again these figures. Most of you know them very well, but those are threats of serious and irreversible damage of what tobacco can do, smoking tobacco particularly. ‘Unless urgent action is taken,’ says WHO, ‘the annual death toll could rise to more than 8 million by 2030, and as it has been said,’ WHO also foresees 1 billion of deaths expected in this current century.’ What is more important that has not been addressed today and is probably difficult to address with electronic cigarettes is that nearly 80% of the world’s 1 billion smokers today live in low and middle income countries. In countries like India, for instance, probably electronic cigarettes is not really affordable and it may become an issue for them, since they use all forms of oral tobacco which are not as safe as the Swedish snus. We will not talk about that today although it is a huge associated issue, since consumption of tobacco products is increasing globally, except in some high income and upper middle income countries.


This other which is actually derived from WHO figures mentions that smoking is responsible for 90% of lung cancer, 75% of chronic bronchitis and emphysema and 25% of cases of ischemic heart disease. I will not discuss these figures but we can take them for granted. "Every cigarette takes seven minutes off your life" is also a WHO statement, which lists some of the main toxins which are inside the classic existing cigarettes.


What I wanted to say also is that the leading causes of death which are again reported by WHO are for most of them related to some extent to to smoking tobacco consumption: ischemic heart disease,  stroke, lower respiratory infection, chronic obstructive pulmonary disease, tracheal bronchus and lung cancer. So among the top leading causes of death, you have this threat which is currently ongoing.


What about the lack of full scientific certainty? I will give here the floor to the International Union against Tuberculosis and Lung Disease which are not really in favour of the electronic cigarettes. What do they say? We can listen to them. It’s the International Union against Tuberculosis and Lung Disease. They say that the "safety of electronic cigarettes or electronic nicotine delivery systems has not been scientifically demonstrated". Okay, that’s probably true. It has not been demonstrated, and what does that mean to demonstrate the safety of electronic cigarettes? We may come back to this issue but we have discussed that this morning all the way.  "Adverse effects of third parties exposed to second-hand exposure cannot be excluded because the use of electronic cigarettes leads to emission of fine or ultrafine inhalable liquid particles, nicotine and cancer-causing substance into indoor air". Okay, it’s not completely excluded. We don’t know to what extent. "The benefits of electronic cigarettes have not been scientifically proven. To date very few studies have assessed electronic cigarettes as to how addiction cessation aid with conflicting findings". You can have your own opinion on that. What is probably true, it has not been scientifically proven, that e-cigarettes are completely beneficial and I’m not sure that for the bicycle, or the vegetables, or fruits it has been proven true, although these are largely recommended for health purpose from regulatory agencies and scientific societies worldwide.


Some uncertainties are sometimes presented as messages that are clearly wrong, even by noble organisations such as WHO. When they say, for instance: “ if they chew tobacco there is cancer of the lip, tongue and mouth", it’s not completely wrong. It occurs that in India if we take this example, where most of the tobacco consumers use oral forms of tobacco, they are really prone to increased risk in cancer of the lip, tongue and mouth. To deduce from this example that it is generalizable to all forms of the oral consumption of tobacco, is questionable. What is oral consumption of tobacco? In India, it’s probably  not pure, oral tobacco products, because with Swedish snus, tied to a  lower level of nitrosamines, that has been said this morning, we don’t see any evidence of an increase in risk in cancer of the lip, tongue and mouth, and that is certain today.


I want to come back to this Swedish example because I think it is one of the most convincing elements which really push us to be in favour of the electronic cigarettes, and of high quality smokeless use of tobacco products, or tobacco-derived products, like nicotine. Swedish males have a cultural use of snus. They don’t use snus because of public health incentives. I am a public health professor. I am a medical doctor, but there is absolutely no link between public health action and the promotion of snus in Sweden, although we may regret it. It’s really a cultural habit, exactly like the bike in the Netherlands. Please let's look at figures and facts. There are 13% of smokers in Sweden, which is below the target of the WHO. WHO say that prevalence of smoking in population should be below 20%. Of course we should target below 5%, as ambitious New Zealanders said today, but WHO with a less ambitious goal regarding tobacco say we should be below 20%, and Sweden is. But there many more users of tobacco in Sweden. 19% of the male population use this so-called snus. Females don’t use so much snus, again by culture. And what are the corresponding figures in Sweden regarding the main targets of tobacco, which list among the top killing diseases? First lung cancer, you can see that the rate is 37 per 100,000 males. That is the mortality rate, which is the lowest in Europe, almost half the rate of Germany and France. For oral cancer, it is lower again, maybe five times below the average in Europe. So what has been achieved in Sweden, which is not often claimed, is that due to their policies which promote snus in addition, of course, to all evidence based measures for tobacco control, Sweden has succeeded to achieve figures that none of any other European countries has achieved today. And, of course, none in the world too.


Is oral tobacco in Sweden a gateway for smoking tobacco? Please let's look at the figures again! Sweden is the country where the number of smokers is the lowest in all the OECD countries, so it has not become a gateway for smoking tobacco. We know after decades of experience, that the use of oral forms of tobacco was absolutely not a gateway for smoking tobacco - just the opposite.


“That should not postpone taking cost-effective measures”, said the Rio Declaration.So would that be a cost-effective measure to have the same rates as the Swedish people have achieved? There were, in 2002, 172,000 lung cancer deaths among men in the European Union. If all EU countries had the lung cancer mortality rate of men in Sweden, there would have been more than half of these deaths avoided. So it is really something which could be cost effective to have just what our neighbour is doing, and doing well.


  So if we come back to what I called the “spirit” of the precautionary principle, i.e. “inform prudence”. What does that mean? We can come back to what I tried to show you from various authors or societies, not all of them were in favour of electronic cigarettes, they were saying that maybe electronic cigarettes could be harmful. How harmful are electronic cigarettes? We don’t know. But what we know is that cigarettes kill half of their users. What about the second handvapor? Unknown. That’s true. But what we know is that the second hand smoke does kill  600,000 per year. Will e-cigs lead to smoking cessation? That’s not been proven. Will they really lead to smoking cessation? However I invite you to see the figures of sales, the cigarette sales are declining, each time the market of electronic cigarettes does increase. So probably there is something in this switch which regards the smoking cessation, don’t you think so? But what we can see that has been so well demonstrated by Clive Bates this morning, there is a plateau in smoking prevalence, everywhere, in every country. Even in the most dynamic countries, aggressive countries, against tobacco and promoting tobacco control, they have reached a plateau. And I have heard New Zealander experts saying, ‘We have reached a plateau and we will probably need the electronic cigarettes if we want to achieve our figures of less than 5% of smokers by 2025.’ Will these electronic cigarettes reinforce the tobacco and smoking habits, the so-called gateway to smoking tobacco? Preliminary stats show a decrease in cigarette sales when electronic cigarettes increase their share. So I agree of course with all of you that more science is needed and will come in the near future. But today, the prudence is really in favour of electronic cigarettes.


So in conclusion, we have to talk about ethics, I am not an expert about ethics. But, when we see, when we observe, when WHO records 6 million deaths per year due to smoking tobacco, isn’t it a failure to assist persons in danger here? Is it really ethical not to take urgent actions, a statement made by WHO itself? Regarding the risks, the cigarette is such a well-known major killer facing any competitors, that any competitors and, practically, electronic cigarettes, will obviously reduce the risk, although at an unknown level. Some of you said 90%? Maybe 95? Maybe 99? We don’t yet know but the risks are tremendously lower. So the precautionary principle is very clear in such a situation.

There are known and certain threats of serious and irreversible damage with smoking tobacco. And the lack of full scientific certainty on electronic cigarettes shall not be used as a reason for postponing recommending the use of electronic cigarettes, in addition to other tobacco control measures to prevent further smoking tobacco devastation.

What I want to add also is that I do believe that asking for level of certainty and level of evidence for risk reduction and for safety of these products in the same demand as for drug products, will push this young industry in the arms of the big players, that’s what we have to absolutely keep in mind. So I thank you for your attention. [Applause]

Chair: Thank you very much, Antoine, that was a wonderful presentation. And good to remember the Swedish example I think here this afternoon as well as appropriate use of the precautionary principle. Okay, we’ve got a few minutes for questions. Anyone like to ask Antoine questions from the floor? All very clear. Yes, a question from you.

Speaker: We keep hearing and often been told over the last few years that e-cigarettes are 99%, maybe 99.9%, 95% safe. What is actually the plausible way by which someone would die by using an e-cigarette? And why do we say 99%? Why do we not assume 100%?

Prof. Flahault: It’s a good question. Because we don’t know for sure. I often use the comparison with condoms for prevention of AIDS. Of course, nobody dared at that era when AIDS did emerge to push the arguments of risk of use of condoms, to ban it or to at least be reluctant for its use. You remember,those who were reluctant vis-à-vis condom use were so mostly for moralistic reasons, coming from some churches, and some conservative movements. They said “Don’t use condoms for risk reduction. Abstinence is a better way. And condoms could be a gateway for more sex . So there are some similarities with e-cigs. But there was some risks with condom use risk at that time, we could have known at that time, because of the latex allergy. There was some risk with the use of condoms which was really a very, very small risk in comparison with the huge risk of getting AIDS, due to HIV infection. So I would say that nobody can say today there is zero risk, it’s so difficult to say there is zero risk for anything. Of course,, you may report devices which explode in some houses. You may have some allergy due to some flavours. It will happen most probably. So to promote a risk reduction strategy which does not exclude completely a limited number of hardly avoidable risks, which we have to keep under vigilance of course, is probably a safer attitude and a more reasonable attitude rather than claiming a zero risk today.

Chair: Thank you very much. A very sensible answer. Okay. Well if that’s this session thank you once again.

Prof. Flahault: Thank you.