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E-Cigarette Summit - Q&A Session 1 Prof. West, Prof. Etter, Dr. Dawkins, Dr Farsalinos, Clive Bates

Chair: What I’d like to do now is invite the speakers back up here to the front, please. So Robert, Lynne, Jacques, Konstantinos, if you want to sit here at the front. So now is an opportunity to ask any questions about what you’ve heard during the course of this session. Again, just as a reminder please, name and where you’re from, and if you want to direct your question at a particular panellist then please do say so. Thank you.

Robin Ward: Robin Ward from Alchem International. The question I have is there’s been a lot of talk about the variability in the various devices that have been used and the potential problems of various flavourings. What I’m not hearing is that there seems to be any consideration that there are lots of different qualities of nicotine on the market. In particular there was a US FDA study which showed that nicotines from various sources had great variability in the levels of potential carcinogens. Has the panel any comment on this?

Konstantinos: Yes, I have a comment on that. This is not the case, what happened with the FDA. It was not a matter of nicotine quality. First of all you must know that pharmaceutical grade nicotine is 99% nicotine, which means that there is 1% of impurities. These impurities concern tobacco or whole tobacco alkaloids at very low levels and some heavy metals, maybe waters, but they are present. Now, the FDA did the study in 2009, I suppose this is what you are referring to, yes? On products that are currently not in the market. They said that they found toxic chemicals. They never reported at which levels and after that came the study from Cahn and Siegel who showed that the levels are at the same amount compared to nicotine replacement therapies. The FDA has not yet commented on their study that for example they discussed about diethylene glycol. It was present. It was an impurity from propylene glycol, probably bad quality propylene glycol. In one of the 16 samples they tested, the levels were not toxic and would not cause any problem to anyone if you used that liquid. The FDA study found toxic substances. Yes, we know that formaldehyde is toxic, acralane(?) is toxic. Everything can be toxic depending on the quantity. That’s why in such a discussion we have to enter into the equation what’s happening with a tobacco cigarette. So nitrosamines are toxic. Even the levels present in electronic cigarette but the levels present in an electronic cigarette are 1000 times less than in tobacco. So we have to say that. It’s not just talking about electronic cigarette as if we are comparing it with atmospheric air or with oxygen, we have to enter into the discussion what is going on with a tobacco cigarette and then the user can understand the impact from using one or the other, because it’s a question between the two. We never say that electronic cigarettes should be used by the non-smoker. We’ll never say that it is a new habit for the whole society to adopt. I mean we must be clear on that. It’s only for the smoker.

Chair: Thank you. Would anybody else like to contribute from the floor? No? Okay, thank you.

Robin Ward: If I could just come back on that slightly. The USP and the EP were developed for controlled dosage forms of which electronic cigarette is not. So I have a little bit of a vested interest in this area, but for me I think we should be looking above USP and EP for electronic cigarettes.

Chair: Good point. Thank you. I saw this person next.

Tony Price: Tony Price. Volcano E-cigarettes Europe. I understand anecdotally that nicotine can have a medically beneficial effect, especially perhaps for intestinal problems, so I guess a question for Jacques. Is there actually any evidence of the beneficial effects of nicotine?

Jacques: Yes, there are studies, and particularly, I mean Nicotine receptors are all over the body and they are all over the brain and they interact with all the neurotransmitter systems. So you can imagine that nicotine can help in many aspects. And I have been very much arguing for that for many years. I participated in a small pilot study for example in Parkinson’s disease, and we found out that actually smoking protects in some way of Parkinson’s disease. Parkinson’s disease is more a non-smoker disease than a smoker disease, because of the nicotine effect. So we used nicotine patch in six non-smoking Parkinsonians. We used up to five patches a day. You need to have higher dose, and then you get a clinical effect, and it’s reversed when you stop. So yes, there is clearly ways to use nicotine. It’s true also for schizophrenia. I mean there are plenty of potential uses of probably e-cigarettes also to treat brain disease.

Chair: Thank you. And Robert, you wanted to just answer that.

Robert West: Yeah. If I could just make a comment on any supposed mental health benefits of nicotine. There are claims that nicotine helps to reduce stress and a lot of smokers think that it does. There’s also claims that nicotine can help with concentration and there were some studies many years ago suggesting that it does. The evidence in humans from my reading of it is that nicotine doesn’t have a positive effect on these things but rather potentially creates a problem that it then solves, in the sense that long-term nicotine use creates nicotine withdrawal symptoms when you don’t smoke and then you smoke and you relieve those symptoms. And if you look at what happens when people stop smoking you find generally speaking that their quality of life improves, that their levels of happiness, life satisfaction improve, and their mental health looks as though it improves as well. So I think probably if there is an issue about long-term use of nicotine it may well be more to do with the mental health side of things than physical health. Chair: Jacques, do you just want to come back on that?

Jacques: Yeah. Just precision, because what are you talking, you’re talking about people stopping smoking. Here we are talking about pure nicotine, and there might be effects from the rest of the products in the tobacco smoke and not pure nicotine.

Chair: Lynne, did you want to answer?

Lynne: Yeah. I mean I echo Robert’s points. I think the evidence is quite mixed with regard to cognition and a lot of the evidence does suggest that smokers by smoking are just reversing a cognitive detriment that they have because they’re in nicotine abstinence. Nicotine is a stimulant, and as Jacques said, it has receptors throughout the body, so there is some evidence that the alerting effects might be beneficial for sustained attention, but generally most of the evidence is pointing to reversal of withdrawal deficits in long-term smokers.

Jacques: We never agreed on that.

Lynne: In relation to mental health there have been some longitudinal studies looking at depression in smokers showing that smokers who start smoking, people who start in adolescence; there are a couple of longitudinal studies in adolescence suggesting that quitting smoking is associated with a reduction in depression.

Chair: And I think there’s also some work showing nicotine reverses the gating effect in people with schizophrenia. So complex and obviously we need to look separating nicotine from smoking. Okay, I have some more people with hands up in the audience, so let’s try and capture a few more comments.

Clive Bates: Clive Bates again. If you had to synthesise your presentations and your whole understanding to give advice to a policy-maker like the Secretary of State for Health or Director General of the World Health Organisation, and they came at you and asked you, “Are e-cigarettes safe? How should I think about the risks? What are they like compared to cigarettes?” what would you say?

Chair: That’s a very good question. Who wants to start? Very short, please. So ecigarettes, are they safe?

Lynne: I’ll kick off with that one then. Based on the current evidence that we have, ecigarettes, the relevant comparison has got to be tobacco smoking of course, and far, far safer than tobacco smoking. So I think we need some light touch regulation clearly, but we have to be very cautious of over-regulation because we don’t want to spoil this great opportunity we have where we’re seeing this unprecedented growth and evolving technology that I don't really think has been seen before, and we’ve got to be really careful not to stunt that. We have a great opportunity here to offer smokers a viable, safer alternative.

Chair: Thank you very much, Lynne. Can I just caution, can we not discuss the regulatory aspects because we’re going to come on to discuss those afterwards?

Lynne: Okay.

Chair: For the rest of the panel. Who’s next? Jacques?

Jacques: Well, I would say the same. I would say that the comparator is tobacco smoking. Tobacco smoking is so harmful there’s no way to over-regulate or to put a barrier on e-cigarette use, and also because we have to remember, this for us, I mean we’ve been in the field for very long, this for us is a revolution, and the revolution is coming from the base, not from the scientists.

Chair: Okay. Next.

Konstantinos: I’m not going to comment how to regulate, but I must say that we must have some regulation as soon as possible because currently the e-cigarette companies are all hiding behind the lack of regulation and are not performing any tests on their products, and this is a big problem. This lack of regulation causes the e-cigarette companies to not care about that because they are not obliged to do anything. There must be some light regulation. I think we will discuss in the afternoon about what that should be, but there must be as soon as possible in my opinion.

Chair: Okay. Robert.

Robert West: Well, cigarettes are killing 5.4 million people a year in the world and approximately 100,000 people in this country, and that’s the problem, and I don't think there’s anyone in this room whatever their position might be on the issue of e-cigarettes who would argue that if all of those smokers switched today to an electronic cigarette you would save literally millions of lives. So that’s the goal. The big question, and probably why we’re here, is whether that goal can be realised and how best to do it, and what kind of commercial environment, what kind of cultural environment and regulatory environment we want to put in place to make sure that that’s achieved. I think that can be achieved but that is a hope and a promise, not a reality yet.

Chair: Okay. So in answer to the question I think considerable consistency there across the panel in terms of relative safety compared with cigarettes. Thank you.

Claus: Hi again. Claus Hecking from Capital Magazine, Germany. I’m a business journalist and not a scientist and this is why maybe I have a stupid question to ask you. I have met some e-cigarette manufacturers who told me that their products are less addicted than normal tobacco products even if you inhale the same level of nicotine. They say it has to do with a PH level, you mentioned, and some even say that their products cannot cause any addition to nicotine if you have been a non-smoker before. Is that true, or could that be true, or is it just bullshit? Thanks. (Laughter)

Chair: Okay. So good question.

Konstantinos: This is a typical example of a scientist trying to be a scientist. I mean I would say not to take this thing seriously, because first of all we don’t know how addictive they are. Now, there is a possibility that they may not be as addictive as cigarettes, but who can say that they are not addictive at all? That’s a statement not supported by any kind of evidence. So we must be very, very cautious on that. Of course, when smokers are involved, smokers are already addicted to nicotine so nothing new will happen, but saying that this product is not addictive at all is I think a very risky thing to say.

Jacques: I fully agree with this. I mean it’s certain as I pointed out that it’s not only nicotine that causes tobacco dependence, but pure nicotine, I’m convinced can create dependence, less strong but it can.

Lynne: Yeah. I agree. I mean nicotine is addictive, without doubt. I don't know whether this “is it as addictive?” is really a relevant question to ask, as Konstantinos pointed out. These are smokers anyway, smokers are already addicted to nicotine, and it raises this interesting question that I’ve toyed with is whether nicotine addiction, if it’s delivered in a pure form, is that an issue anyway?

Chair: Robert, do you want to add anything?

Robert Ward: No.

Chair: Okay. So again, fairly consistent in terms of that we need to think about addition.

Klaus: Sorry, just a quick follow-up, it wasn’t such an absurd question because it was when I asked the people, you know, “Are you interested in getting new consumers?” and so on, you know, “People who haven’t smoked before. Is it dangerous for them to start?” And then they said, “Well, our products, they are not addictive. They cannot cause any addition.” This is why I was asking. Because it’s not like you guys, you guys say, “Well, these are only products for smokers,” but I think in this commercial world, of course, these e-cigarette manufacturers are interested in getting new customers as well.

Chair: Absolutely.

Jacques: Well, then the question is, are we concerned to create an addiction that hopefully has no consequences? Can people use pure nicotine without consequences?

Chair: Okay. So it wasn’t a stupid question, a very relevant one, and I think there are some issues there to be addressed. At the back. Thank you.

Wendy: Hello, my name’s Wendy Preston. I’m a senior lecturer at Coventry University for smoking cessation and I’m also affiliated to the Association of Respiratory Nurses. My question is for Robert West. What are your thoughts on having robust random control trials comparing e-cigarettes with behavioural support versus nicotine replacement therapy with behavioural support so that we’re comparing apples and apples rather than apples and pears?

Robert West: Well, I think that’s a very interesting question. I think that we can do that and I think those trials will be done, but the problem that I alluded to earlier is that when you do any RCT you've got to define your intervention and you can do it on one brand of e-cigarettes and someone can say, “Well what about another brand?” You can do pragmatic randomised control trials in which you, for example, allow people to choose from among the most popular brands, so you’re not testing a particular brand but what you are testing is a range of brands. But then you also have the problem that we face in behavioural research which is that you have to get people to consent to be randomised. That means that the people who are going to take part in the trial are not necessarily representative of the population. And when you think that a trial like that costs several million pounds to do and would take three or so years to report, you can see the difficulties. So probably at least in the meantime I favour another approach which is to look at what people are doing and to try to control statistically for any biases that might occur as a result of some people selecting into one form of treatment or another. So for example, we already do that with nicotine replacement therapies and other medications, and you can show in population level studies that when people use behavioural support, for example the stop smoking services, once you've controlled for the fact that they tend to be more dependent than people who just try and stop by themselves, the success rates are about three or four times higher, which is what you expect and what we’ve found from the randomised trials. So I think there are methodologies that we can use. They’re not as robust as randomised trials but they do give us, I think, answers of a sort that can be used by policy makers and we will do those studies.

Wendy: Thank you.

Chair: Thank you. Okay. We’ve got time for one or two more before the break. So over here.

Chris Choi: Yeah, hi. It’s Chris Choi from ITV. I was really fascinated by this idea that it’s not just what you’re smoking but the way that you’re smoking. I think Lynne touched on it a lot and Konstantinos, and particularly this idea that there could be an overheating effect, which I think you mentioned could create or elevate toxic levels. Could you just talk a little bit more about the effect of the variation on smoking styles and particularly overheating, what the impact of that can be?

Konstantinos: Yeah. We know that for example in cigarette smoking every smoker smokes the cigarette differently. In the case of the e-cigarette it’s not only that every vapour vapes differently but every vapour vapes differently according to the device he is using. So the same vapour will use one device on the specific path duration or interpath interval, another device on a different way. Why? Because there are so many devices with different design characteristics, different amount of resupply of liquid to the wick during the evaporation process, and the user can understand the difference in the taste and believe me the overheating is immediately understood by the vapour because it has a very harsh, a very toxic taste, and he doesn’t like it, he cannot stand that. So he knows immediately that he is either out of liquid in the atomiser or that he has overused the device and the atomiser cannot handle the patterns of use. So he knows he has to reduce path duration or increase the interpath interval. This is something that we cannot detect in the laboratory, there is no objective way to detect it in the laboratory, so if I take a device and I puff it for four seconds it may be overheated, I will not be able to understand that in the laboratory, but a user will immediately understand it and will not use it in this way. And that’s the risk and the trap you can fall in when you are doing laboratory studies and you are taking different devices, you are using all of them in the same way. The only way to bypass that is to ask experienced vapours to test the devices that you will use in the laboratory. It’s the only way to do it.

Chair: Okay. Thank you very much, Konstantinos. We have one more question and then we’ll break.

Melody: Hi, I’m Melody Tilton, I’m with the Non-Smokers Rights Association in Canada. You've all commented that the health risks need to be compared with those of cigarette smoking but I’d like to hear your comments on the risks to non-smokers using these products. Thank you.

Chair: Okay. So just very short again. What’s your views on the risk of e-cigarette to non-smokers?

Konstantinos: The risk is probably low but existent and I find no reason for a non-smoker to use electronic cigarette. The human is made to inhale clean air. I mean clean, not even the air in the atmosphere in big cities. So even if the risk is, however small it may be, there is no reason to adopt a new habit which may have a very small risk. That’s my opinion.

Jacques: I would just add something. Every adolescent tries something new. Many adolescents try smoking. I would prefer them trying e-cigarettes than regular cigarettes.

Chair: Thank you.

Lynne: Just to make the point that, yeah, ideally we do want everyone to inhale pure air, people will take a variety of legal, illegal drugs, legal highs, nicotine. People will engage in these risky type decisions, so yes, it is important for us to know what the risks are. But I echo Jacques’ point that people are going to experiment with cigarette smoking so the risks are low but we need more research. I’m always going to advocate more research, aren’t I, to really qualify those risks.

Chair: Okay. So for those of you for whom caffeine is one of your recreational drugs we now have a coffee break. Please make sure you’re back in by half past eleven and can I thank once again the speakers and panellists from this morning. (Applause)