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E-Cigarette Summit - Prof. Linda Bauld

Chair: Okay. We’re going to follow a very similar format for the second session wherein we have four speakers and if they finish within their allotted time we’ll have time for questions, otherwise we’ll save questions to the open session at the end of the morning. So our first speaker then, it gives me great pleasure to introduce Professor Linda Bauld who is Professor of Health Policy at the University of Stirling, and she’s also a Deputy Director of the UK Centre for Tobacco and Alcohol Studies.


Linda Bauld: Thank you very much, Ann. It’s very nice to be here. Unfortunately I didn’t hear all of this morning’s presentations so there may be a small amount of overlap possibly between what I say and what Robert’s said in particular, but look forward to the discussion afterwards.


What I’m going to try and do now really is set the scene for you in terms of the policy context about what’s happening with e-cigarettes in the UK and the EU. I know many of you, not all of you, will realise that in some ways we are in a different position in the UK from other countries on this issue, and I think it’s important that we all understand the place that e-cigarettes potentially have in tobacco harm reduction. And that’s what I’m going to talk about primarily. So the question I wanted to ask was where do e-cigarettes fit within the wider context of smoking and tobacco policies in the UK and the EU? So where are we now? What are smokers doing in relation to cessation and harm reduction? Just ask you all to reflect on the evidence about just cutting down smoking which I think is important for everyone to understand and has a place in thinking about where e-cigarettes might fit in the policy landscape. I’m going to talk about the NICE guidance development process on tobacco harm reduction, guidance that was published earlier this year, and then talk about the EU Tobacco Product Directive and where e-cigarettes may fit into that, and then just a final couple of concluding thoughts.


So some of you may have seen this slide from Robert, I’m not sure if he showed it, but as you know, in the UK we have every year, and this shows from 2007 to this year, this is Robert’s smoking toolkit study, anywhere between a third and 42% of smokers have made a quit attempt in a single year. However, when you look at whether people are trying to change their smoking behaviour but are not necessarily trying to stop you see a far higher proportion of smokers engaging in that.


So we know that if you ask smokers whether they are cutting down their smoking at any particular time, you’ll see that somewhere between 50 and 60% of smokers are trying to change their behaviour in some way or another. They’re cutting down. And then this slide also shows you the proportion from June 2011 to September ’13, they’ve been cutting down using e-cigarettes.


Now for me, and the research I primarily do is about smoking cessation and particularly smoking cessation services, for me the interesting question is, those 50 to 60% of smokers who are cutting down, how do we engage with them to make sure that if they want to reduce their smoking or they want to stop they do that effectively with the right support. And I think e-cigarettes as we’ve heard this morning may have an interesting role to play there. But all those smokers that are trying to cut down, if they’re doing it on their own or if they’re using products, what benefit does that have? Now many people who have smoked or who have smoked in the past, if you ask them about harm reduction or cutting down they genuinely believe there must be some benefit involved in that, and I’m just going to run through some of the main bits of evidence on that.


So we know that the benefits of smoking cessation are well established, we have good quality research and we also have effectiveness studies from a range of countries, but the benefits of reduction or indeed temporary abstinence are still very unclear, and it’s important for e-cigarette users as we know that many continue to smoke and use e-cigarettes as a harm-reduction tool, so there’s concurrent use. There are a number of systematic reviews of smoking reduction, this is just one example. This brought together the evidence from a number of different studies and essentially shows you whether there’s a reduced risk or an increased risk for all cause mortality or for mortality from different conditions when you’re cutting down alone. And what you’ll see really is that there’s a small benefit if you reduce your cigarette consumption in relation to tobacco related cancer, but there really isn’t particularly when you look at the hazard ratio for all causes.


We published a study earlier this year in the American Journal of Epidemiology that uses data from one of the mid-span studies we have in Scotland where we manage to recruit very high proportions of the local population in one community from Paisley in the west of Scotland into a study that looked at a whole range of factors, and then another study, the collaborative study that involved working men and women. These people were followed up from the 1970s when they were first recruited. They were then followed up three to five years later to look at whether there had been any changes in their health or their lifestyles, and then their death rates were tracked. And just over 80% of the sample is now deceased. So we’re able to look through the death records at what the outcomes were for these groups. What we found in relation to smoking is people were either assessed as smoking at a certain level at baseline and then whether they’d increased or reduced at follow-up and then tracked through time. And what you find in this sample is similar to other longitudinal studies, is that there were clear benefits in terms of mortality, reduced risk to mortality for the people who stopped smoking between time one and time two, but for the sample as a whole there wasn't any benefit for those who reduced smoking between time one and time two when we looked at death rates. In the collaborative study alone there was a small benefit for the people who were very heavy smokers at time one and who reduced their cigarette consumption significantly by time two, but overall you’re still not seeing any real benefit from reduction, and this is during a time period when nicotine replacement therapy wasn’t available. So why should we bother talking about smoking reduction at all, those of us in the room who do tobacco related research and who are in the tobacco control community, why bother? Well there are some very important reasons and one of, I suppose, the underpinning bits of evidence we look to in the NICE Tobacco Harm-Reduction guidance was from again a University College London study. And this essentially shows you the percentage of smokers who report a quit attempt in the previous 12 months.


The people who are not really doing anything in terms of trying to reduce their smoking, very few of them are making a quit attempt, but those who try and cut down, so SR on the slide is smoking reduction, those who try and cut down without nicotine replacement therapy, a slightly higher proportion of them report making a quit attempt, but when you get up to the side of the slide that looks at people who are trying to cut down with nicotine replacement therapy and those who are trying to cut down and engage in temporary abstinence with nicotine replacement therapy, those people are far more likely to report that they’ve tried to stop smoking. So there’s something happening with people who try to reduce and they use clean nicotine and a licensed nicotine product. They may be much more likely to be successful in stopping smoking in the long-term. So in terms of reduction that’s an important message for us to get across. And until recently we really didn’t have evidence of that kind.


So the guidance that was produced earlier this year was really the first guidance from NICE on this approach. Most of you will know that NICE, the National Institute for Health and Care Excellence has played a very important role in supporting the NHS and increasingly local government and others in delivering evidence-based tobacco control interventions, a lot of that’s been on smoking cessation, but it’s primarily been focused on saying to smokers, if you’re going to try and stop you need to set a quick date and you need to stop in one step. Now that is an approach that appeals to everybody and it isn’t necessarily an approach that’s going to work for everybody. So tobacco harm reduction offers an alternative perspective. And essentially what it says, and there’s no other country in the world that has produced guidance of this kind, it says that people have a number of choices. They can reduce the harm from tobacco by stopping smoking completely, and the guidance makes it very clear that that is still open one and the preferred option in terms of the evidence on health benefits not just for the smoker but people around them. They can cut down prior to stopping smoking, so a gradual reduction and then cessation. They can just smoke less, full stop, the types of evidence I just showed you, or they can abstain from smoking temporarily.


So those are the options, and the guidance talks in detail about each of those. The guidance does talk about what people can or should use if they engage in tobacco harm reduction. Essentially it says that this can involve substituting the nicotine in tobacco with nicotine from less have harmful nicotine-containing products, and you discussed some of the evidence on nicotine and health this morning. And this includes nicotine replacement therapy products that are licensed by the MHRA as pharmaceutical treatments for smoking. And as you know, electronic cigarettes are currently unregulated. So the guidance only recommends use of licensed products, recognising that when electronic cigarettes become licensed they can be recommended by NICE, by the NHS, by health professionals who are supporting smokers to change their behaviour if they choose to do so, they can be recommended as part of this. And nicotine containing products might be used either temporarily or indefinitely and as a partial or complete substitution for tobacco.


So the other really important thing the guidance says is we looked at the evidence on long-term licensed product use, nicotine containing products, and the studies we looked at really only looked at the period up to about five years after stopping smoking for example and continuing to use a product. But we can be confident that that type of use is relatively safe. And that’s an important message for smokers to understand because a lot of people believe that they need to stop using nicotine replacement therapy for example fairly quickly after stopping smoking and this guidance makes clear that that’s not necessarily the case. So what it says is, “There’s reason to believe that lifetime use of licensed nicotine containing products will be considerably less harmful than smoking.” And then it just points out that there’s little direct evidence on the effectiveness, safety, and quality of nicotine containing products that aren’t regulated by the MHRA, but it does say, “They are expected to be less harmful than tobacco.”


Now I do a lot of work with NHS stop smoking services as does Robert and others and their advisors, I think there are some in the room, all across the country whose clients are asking them, “I’m using an e-cigarette. Should I stop using it?” I think this guidance says to them, we don’t yet know about the quality and safety of all of these products but we know that using these types of products is going to be less harmful than continued smoking. So although we cannot recommend them to you, we accept that you’re continuing to use them.” So that’s the message that is being conveyed at the moment. But we do have a problem with a lot of this, and this is just one slide that shows you some of the barriers.


This is a slide, one of Ann’s in fact from the International Tobacco Control Survey that shows you, when UK smokers were asked, “Does nicotine cause most cancer?” just under half of them believe that it does. So there is a public misconception, probably not in this room because you’re informed about this issue, but in general about what nicotine is, what licensed nicotine products contain, and how the nicotine in these types of products is different from the nicotine in cigarette and the other harmful toxins that a cigarette contains. So misunderstanding of nicotine is out there in relation to health professionals and smokers that’s an issue we need to address. So that provides you with the UK guidance and policy context. As I say, the fact that we’re talking about harm reduction actively, we’re encouraging people to think about reducing harm, it’s quite different from where many other countries are in relation to smoking and tobacco control.


So what’s happening in Europe? Well, the EU Tobacco Products Directive, sorry I should say here, wrong title, was in place and was adopted in 2001. An important context for understanding the directive is it’s part of EU legislation that focuses on the internal market, it’s not public health legislation per se. The directive aims to approximate national regulation on the manufacture, presentation and sale of tobacco products and the TPD covers content, labelling, ingredients and descriptors, terms like light and mild. And it really provides a minimum; member states can introduce more stringent provisions if they wish. Now this directive was adopted in 2001; of course, since then the EU has become a signatory to the Framework Convention on Tobacco Control. So the original TPD has required revision for some time. And a process began in 2009 to revise the TPD and that is currently underway.


As many of you will know, there was a legislative proposal for the revision of the TPD that was produced earlier this year, the European Parliament voted to approve a mandate for negotiations to proceed on a revised TPD just recently, and these negotiations are now underway and it’s a trialog process, we can talk about this perhaps in the discussion, between Parliament, the Council, and the Commission. So that’s what’s underway at the moment. So why is the TPD relevant for electronic cigarettes? The TPD is a large document that has some very important provisions in it. For example on cigarette warning labels that we hope will pass because of the importance for smoking prevention and also for cessation. But it has a section on e-cigarettes, and the original legislative proposal that was relevant to e-cigarettes recommended that those containing nicotine above a very small amount be regulated as medicines. When the original vote on the proposal was taken in October this part of the proposal was rejected in the vote, most of you will know that, and at the moment there is a new tabled amendment that recommends summarising it, recommends general product safety regulation with a number of additions unless the products claim to treat or prevent disease.


The amendment also suggests things like the product should only be available to people over the age of 18. It also makes clear there should be advertising restrictions. It asks member states to make sure that manufacturers make clear what the content is of their products. It asks for clear labelling, it asks for instructions. There’s a variety of additions that ar in that amendment. And that is currently being discussed and debated. So what we need to see now and what’s happened in the next few weeks is that the European Parliament needs to ratify and agreement on a revised TPD including the provision on e-cigarettes by its last plenary in March 2014, and in this trialog process there are at least four separate meetings that are currently scheduled between now and the end of December.


I think all of us who are involved in this field are aware that we’re still unclear what the outcome will be. As I say, the TPD is hugely important, not just because of its e-cigarette content but also the other regulations in the TPD. But when it comes down to e-cigarettes the debate that’s happening at the moment is between the need to ensure that the products are effective and safe while also providing access. And the UK has certainly made very clear through the MHRA decision that you’re going to hear about from Jeremy Mean in a moment, through the tobacco harm-reduction guidance and through the statements of the UK government that in terms of our national context the position is still that we believe medicines regulation will provide efficacy and safety light-touch regulation and we hope will also provide good access to consumers for the products.


But there are some real concerns and issues that need to be dealt with both within the UK and the EU for that to proceed. So as I say, Jeremy will provide more detail on that. So I hope we can address some of this in the discussion and I hope that provided a useful context for the next few speakers that we’re going to hear, so thank you. (Applause)

Chair: Okay. Thanks very much, Linda. We’ve got time for one question if anybody has got a point of clarity that they need. Thank you.

Katherine: Hello. I’m Katherine Devlin from ECITA, the Electronic Cigarette Industry Trade Association. Is it not the case that medicines regulation for these products is actually what’s holding back the UK position to the point where NICE guidance is not able to recommend for healthcare professionals to recommend these products for smokers despite the obvious public health gains that could be achieved?

Linda Bauld: I think what you will hear from Jeremy is that the process that the MHRA has gone to in reaching its decision about regulation is it went through a series of steps in relation to looking at the evidence that was hugely valuable to inform not just the broader context but also the NICE deliberations. And what came out of that were some really important unanswered questions about safety and efficacy, and that’s why the decision was taken to recommend medicines regulation. So in terms of the NICE guidance my view on that is actually we needed the NICE guidance to come first to set the framework for that, and then our hope is that through the MHRA process, as I say, these products will be able to be recommended by a health professional in the future. And that’s where we are at the moment; we’re certainly not at the end of that process yet.

Chair: Okay. Thanks very much again, Linda, for an excellent talk. Okay, we’ll hear from Jeremy in a minute but before that we’ve got a presentation from Clive Bates who you’ve heard from speaking from the floor a couple of times this morning. He’s a former CEO of ASH, also an ex-civil servant, and is currently a public health commentator. Clive.

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