May 20th, 2014

People using e-cigarettes to quit smoking 60 percent more likely to succeed than those using NRT sold over the counter

AddictionThe survey of e-cigarette use published today is great news for those of us who long suspected that e-cigarettes are effective in helping people stop smoking.  So now we have a population study (i.e. a survey of real users’ experience, not a trial) that shows very positive results for e-cigarettes, but also showing NRT users have no better success rates than those quitting cold turkey, at least without behavioural support.  This is part of a pattern of positive results from UK survey data… Update 21 May. May I suggest reading this posting in conjunction with Carl Phillips’ excellent EP-ology blog: Understanding the West el al. paper on e-cigarettes an smoking cessation.  This explores the important dimension of self-selection in this survey and the fact that people are different:  i.e. those who chose a particular method may be more likely to succeed by their chosen method. As a result, I’ve changed the title to this blog, in a way that I hope explains the main point. Before: E-cigarettes 60 percent more likely to help smokers quit than NRT sold over the counter After: People using e-cigarettes to quit smoking 60 percent more likely to succeed than those using NRT sold over the counter End of update. From the article press release:
People attempting to quit smoking without professional help are approximately 60% more likely to report succeeding if they use e-cigarettes than if they use willpower alone or over-the-counter nicotine replacement therapies such as patches or gum, reveals new research published in Addiction. Brown, Beard, Kotz, Michie & West, ‘Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study’, Addiction, May 2014.
This paper follows excellent survey data from ASH-UK which shows:
  • An estimated 2.1 million adults in Great Britain currently use electronic cigarettes [about 20% of the total].
  • About one third of users are ex-smokers and two-thirds are current smokers.
  • The main reason given by current smokers for using the products is to reduce the amount they smoke while ex-smokers report using electronic cigarettes to help them stop smoking.
And this on top of data from the Smoking Cessation Toolkit Survey [PowerPoint download], which concluded:
Evidence conflicts with the view that electronic cigarettes are undermining tobacco control or ‘renormalizing’ smoking, and they may be contributing to a reduction in smoking prevalence through increased success at quitting smoking.
But all this splendidly positive news begs some questions:

1. Should NRT continue to be licensed for sale over the counter as a smoking cessation medicine without behavioural support?

2. How should the NICE guidance on tobacco harm reduction be amended? It appears to recommend products that do not work that well or maybe for a subset of users, but advises against products that do?

3. Isn’t the MHRA supposed to validate ‘efficacy’?  So what happened?

4. E-cigarettes seem to be working well ‘out in the wild’ but with some notable exceptions they attract considerable vocal opposition from the health lobby (Chief Medical Officer and various crumbling pillars of public health and medical establishment).  Will this lobby now recognise that their puritanical but evidence free campaigns against these products are campaigns against effective smoking cessation / harm reduction and therefore that they are probably harming people?

5. Much of the public health lobby persists in wanting e-cigarettes regulated as medicines.  Given they seem to be working well at the moment, what problem do they think this will solve? Have they considered what problems medicine regulation might induce into this working market?  For example, creating a banal, unexciting, ineffective product category that doesn’t meet smokers’ need but is safe to use but dangerous because it is liable to end up in more smoking?

6. Should we rely more on surveys and ‘real world’ population data and stop elevating randomised controlled clinical trials as an all-purpose ‘gold standard’ in this field.  The reality is that controlled trials measure one thing while artificially holding as much else as possible at as a constant.  That is not how this work in reality – people make choices about what products to use and self selection is an important feature of smoking cessation that is purposefully eliminated in RCTs.  so does the Cochrane Review approach this subject appropriately?

7. What should stop smoking services now say to smokers?  Will the thoughts of Louise Ross, the enterprising service manager who has embraced e-cigarettes, be combed over for clues?  Should pharmacies now ignore the advice of Chief Pharmaceutical Officers (of course they should, it was terrible advice to start with).

8. Does this reveal the EU Tobacco Products Directive 2014/40/EC to be already obsolete, on the very day it enters into force? I hope a survey this large will tell us what strength of e-cigarette liquids were in use.  Is there anything here that suggests that a ban on e-cigarette advertising is justified – in fact banning e-cigarette advertising would be simply protecting cigarettes and NRT that is ineffective in most real world settings.

9. Will the WHO and FCTC Secretariat stop being so negative now?

10. What does it mean for those countries like Australia and Canada that have tried to ban e-cigarettes by classifying them as medicines and have denied their smokers the opportunity to use these products (thankfully with near complete failure) and denied themselves the opportunity to survey their use in the way this study has been done.  they are making policy in a state of ignorance.

Please let me know in the comments if you think it raises new implications or I’m missing the point in raising the questions above?  Discuss!

60 comments to People using e-cigarettes to quit smoking 60 percent more likely to succeed than those using NRT sold over the counter

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  • This is kind of a crappy comparison in my view.

    If you allowed NRT makers to sell any product they wanted to, in any flavor, in any packaging, etc etc, NRT would be a lot more effective, too. The products would be better, used more and thus used more effectively.

    Now, that’s not all bad mind you (to restrict/control new product introduction). It *will* be demonstrated, for example, that a lot of the flavor systems in e juice are pretty toxic, and they are unwittingly sold for inhalation use (that really should not be the case).

    What you really see here is unfettered launch of new products verus a highly controlled industry. I think the situation ends up pretty much like you would expect — the unregulated products are better received by consumers, but carry some dangers associated with that very lack of regulation.

    • Clive Bates

      It’s a comparison of the world as it is. The world may be ‘crappy’ but you can’t fault the survey for that. As you’ve framed it, it makes my case against medicines regulation quite well. You get a highly controlled industry – with low appeal and poor innovation, and more smoking.

      What you are addressing here is at the heart of the regulatory challenge: you can apply heavy duty regulation to assure the highest protection to users (medicines) but end up with banal unappealing products – which smokers are less likely to choose. Unless your unsupported theories about the toxicity of inhaled flavours emerge as a material risk, then you need to account for the damage caused by poor uptake. The consequence of that may be far greater total harm, as it involves avoidable harm to people continue to smoke instead of using the safer but dull products. So a ‘tough’ regulator can do a great deal of net harm – and that is the risk with the FDA, the EU, the FCTC and UK’s MHRA and all the regulatory obsessives now piling in. There is a danger that they forget that the customer is a smoker.

      This is a theme developed in my last posting: Regulation of e-cigarettes: general ideas

  • the author of the study, Professor West, elaborates and answers some of the points raised in comments here – http://youtu.be/VUvm1E91cSI – I do apologise for the shameless plug, but I think it’s important.

  • It must be guarded against the report being ‘hijacked’ and used to promote Electronic Cigarettes be licensed as a medicine, purely so that NHS Stop Smoking Services can advise on their use as a NRT.

    The report found NHS Stop Smoking Services are still the most effective quitting method. I think a more interesting conclusion to draw is: If e-cigarette use is left as it is now, and NHS Stop Smoking Services are educated on the product options available so that they are able to advise on their use in an informed formal manner, by how much could the 60% figure be improved?

  • Louise Ross

    Adam, couldn’t paste a link but go to BBC Radio Leicester, J Lampon show about 40 mins in

  • Adam Williams

    Louise, is there a listen again link?

  • Louise Ross

    There should be a Like button! Some comments have really hit the nail on the head for me. Thanks for the kind words and the suggestions, it all makes me more determined to be courageous about innovation. I’m on BBC Radio Leicester tomorrow re the original story

  • Phil Day

    As a vaper l’d like to give you a big thank you for all your campaigning and, of course, to Louise Ross for her pioneering approach within the stop smoking service.

    Are either of you aware that Hampshire Stop Smoking has already changed it’s position on e-cigs? The manager there, Julia Robson, is very well informed and quite positive about the potential for harm reduction that e-cigs offer.

    Although l’m a vaper l do agree with others here – it’s the health benefits of not smoking that matter not how that’s achieved and anything that works should be available for use.

    A question for you Clive as l’ve never used snus. Where it is used why do you think it appears to be far more successful than oral NRT – and is that part of why it is banned in so many countries against all logic?

    • Clive Bates

      Phil – snus is used in Scandinavia but banned in the EU other than in Sweden since 1992 and, outrageously, the ban was reaffirmed in the 2014 Tobacco Products Directive. The best data comes from Sweden and Norway. Snus is also used in the United States. It is banned not because of NRT interests but because in the late 1980s and early 1990s, a moral panic was created around it in which all the same arguments we hear about e-cigs were trotted out: gateway effects; reduced quitting etc All proved to be wrong, and in fact these countries have now by far the lowest rates of smoking in Europe – with good health outcomes as a result. But that hasn’t stopped the activists still wanting a ban – which implies their underlying motivation is not much about health.

      I think it works because (1) it delivers a lot of nicotine; (2) it allows for nicotine use where smoking is banned; (2) it goes with the zeitgeist of tobacco use – packaged and sold as a consumer / lifestyle product, with flavours like bergamot and juniper – not a sterile medicine. Note that no public health bodies endorsed it; no public spending was consumed by it; no obsessive regulators intervened to micro-manage the risks of snus use. But it is fantastically successful at reducing diseases and death.

      • john

        Clive you raise a good point about the cost benefit angle, the costs of NRT in Australia is heavily subsidised by the health system- in contrast e-cigs are not subsidised. Uptake of ec-gigs therefore results in a reduced expenditure on public subsidies to NRT.

  • About 25% of my customer use strengths higher than 20mg to help them quit, especially when they first start using e-cigs.

    More than 85% of my customers use bottles larger than 10ml in size.

    The TPD needs massive adjustment to avoid reducing the effectiveness of e-cigs in helping people quit.

  • john

    Clive I think the better approach is : That on the whole if ‘it’ (NRT or e-cigs) helps you stop smoking it is a good idea.

    • Clive Bates

      Yes – I think this is a useful observation, and backed by the points made by Carl Phillips on his blog.

      The point is that for the people who quit with NRT, NRT may have been just the right thing. But another view is that people who are deterred from using e-cigs by the negative health establishment narrative and hence used NRT instead may just be part of the failure. If they had instead tried e-cigs they night have succeeded.

      • john

        Clive I agree, although in Australia , panic stories about e-cigs being ‘almost as bad as smoking’ have been relatively rare(there have been a few).

        Mind the Western Australian government is trying (again) to ban e-cig sales under regulations aimed at ‘chocolate cigarettes for children’. There are lots of legal constitutional reasons why this action by the WA government is unlikely to stand up, long term.

  • Kurtis Sunday

    Does the study cover ‘casual quitting’ – i.e. just trying vaping without any real serious intention to stop smoking tobacco cigarettes? Just wondering.

    Because that has been my experience and the experience of others I know. My own motivation was curiousity mainly – and I stopped smoking tobacco cigarettes within 2 days, not really trying. A friend had a similar experience.

  • This does not address your questions, but it does point out that your (and others’) headline is wrong: http://ep-ology.com/2014/05/20/understanding-the-new-west-et-al-paper-on-e-cigarettes-and-smoking-cessation/

  • spinster

    The news reports on this that I have read are saying NHS services are still the most successful. I have been trying to find out if the figures for this were collected during the same survey or whether they are the general published success figures from the NHS and whether they are directly comparable. I’m a bit suspicious of the NHS figures because as far as I know they count four weeks smoke free as success – even I can do that, I’ve done it lots of times! Please correct me if I’m wrong on this.

    If the figures are directly comparable it just goes to show what could be achieved by NHS support and ecigs together! Louise, I’ve been watching your project with interest, I think it’s a fantastic thing you’re doing. I work in mental health with lots of very disadvantaged people. The smokers among them have usually already tried lots of different ways to quit and have a lot of failed attempts behind them. It is very risky for them to shell out for something else when they don’t know if it will work for them.

    • Chris Price

      My personal view of the NHS SSS stats is that they are not just fraudulent, but criminally fraudulent. Every single figure given will be found to be a lie by omission, or a deliberate obfuscation, or simply an outright lie.

      Example: the success rate usually quoted is at 3 months, which is simply ridiculous. Sorry, it’s not ridiculous – it’s fraud.
      Example: the cost per quitter looks wonderfully low, until you realise that (a) it is for 3-month quitters, 80% of whom will relapse to smoking, and (b) half the cost is omitted (the drugs).
      Example: some ridiculous figure such as £300 per success is given, when the real cost is about £3,000 per successful quitter.

      The NHS SSS is a fine programme for employing staff and buying pharmacotherapies at the taxpayer’s expense. For getting smokers to quit – not so much. It’s rumoured to cost about £200 million a year, about 99% of which is flushed straight down the toilet. There couldn’t possibly be any less effective method for getting smokers to quit, possibly even including voodoo, hypnotism or homeopathy. Perhaps a combination of these could be tried instead, as it would certainly work better than the current system. It would also be cheaper.

  • Louise Ross

    Really helpful Roger, thanks. I suppose I’d thought the fancy ones were superior! Great Waitrose analogy

    • Paul Kendrick

      Hello Louise,
      Although the fancy ones (I’m assuming you mean 3rd generation devices) certainly can be superior they can also be quite mind boggling for beginners, with all the terminology and variation etc. Much better for a smoker considering switching to try out a 2nd generation device such as that described by Roger to see how they get on. They may well be perfectly happy with that (I switched almost overnight with something very similar) or they may need to tailor their equipment to suit them, longer lasting batteries for someone who works outdoors all day for example.

  • Louise Ross

    For some smokers, NRT works fine, as does Champix, but as stated above, support makes a huge difference. It’s about (among other things) helping people think they really can make a success of going smokefree, and self-belief can be hard to cultivate. A big part of this though is faith in the product too, and choice. That’s why I’ve been so committed to ecigs for stopping smoking – why turn your back on something that can visibly seen to be working, over and over again?
    What bothers me most right now is that the better-off can afford the cash up front for the best quality vapourisers. I’m plotting how my stop smoking service can get these into the hands of smokers who struggle to make ends meet and spend a disproportionate amount of their income on regular cigarettes. We should be able to break that cycle

    • Roger Hall

      Louise, well done btw on your sterling efforts in Leicester and your comment regarding best quality is a fair one. As a smoker of 35 years who I might add had absolutely no intention of giving up, until my sister (God bless her) presented me with a fairly basic battery and atty and I’ve not touched a tobacco cigarette since. I joined a vaping forum (surprised there aren’t NRT forums if NRT is that good!)and I appreciate that many of the enthusiasts that you meet will have probably spent a great deal on exclusive and expensive vaping gear, but I absolutely know for a fact that the cost isn’t an issue. My vaping budget/spend is in the region of £35 per month if I bought off the shelf e-liquid (I now mix my own)and knowledge is the key as with knowledge you understand that get the basics right and you can still vape effectively. In the same way that a fiat panda will get you from a to b, whereas a Ferrari looks better, costs more but fundamentally will still get you from a to b.

      Considering that a 20 a day smoker will spend upwards of £50 a week on tobacco cigarettes most effective starter kits bought from experienced and knowledgeable retailers will cost far less than a weeks tobacco cost. It may surprise you to know that my normal daily set up can actually be bought for less than £15 comprising a battery that should last all day (a spare can be bought for less than £5) a decent 2ml capacity steel/glass tank with a very long lasting attomiser that gives outstanding performance plus charger. Not everyone needs to shop at Waitrose to eat effectively and healthily and the same is true with vaping.

      • spinster

        Set up cost absolutely is an issue for lots of people. The cheapest kit + juice I recommend to new vapers that has a fair chance of working is £20 (2 x blister packs each containing a 650mah battery and 2 decent clearos, plus 10ml juice – you really need 2 batteries for any chance of success) Even £20 on something you don’t know will work for you is too much of a risk if that’s all you have for your nicotine needs. Lots of people I see are already choosing between eating and smoking and will skip meals in order to afford tobacco, they simply cannot afford to risk an extra £20 if they might end up having to buy fags as well (if vaping doesn’t work for them). That’s why schemes like Louise’s are so valuable – if they can replace a week or so’s smoking with vaping they can already afford their next lot of juice from their savings and in a few weeks can afford to get better kit if they want it. If it doesn’t work, they have lost nothing and haven’t had to skip any more meals … or take out unaffordable credit … or pick up dog ends …

    • Clive Bates

      Louise, but people getting behavioural support might well be different – more highly motivated perhaps, or with more to lose, as they have shown themselves willing make more effort to quit. The great eventual promise of e-cigs is that they may ultimately reach many more people than are prepared to go into an SSS programme.

  • neptune

    It would appear that NRT is virtually useless, unless it is used with counselling and support. To me, that suggests that it is the counselling that is achieving the result rather than the NRT. Most vapers got into vaping with little in the way of support. Imagine what could be achieved with vaping combined with counselling and support. Such support is available at good vape shops, but what about online buyers, market stalls and disposables from supermarkets and garages. More could be done in this direction.

  • In addition to the Toolkit and ASH UK’s research, one might also throw into the mix Dautzenberg’s study of Parisian youth and Ann McNeil’s presentation to the PHE gathering last week in which, in reference to declines in smoking across the spectrum of socio-economic status she stated she’d: “never seen anything like it in her career”.

    My view is that nicotine should never have been licensed as a medicine, and its medicinal status should now be removed from all products, save for those intended for prescription use only.

    In its place, a far more liberal regulatory framework should be created for harm-reduction nicotine products – whether low-risk tobacco or pure-nicotine. A recognition must now be made that NRT fails most smokers because it is intrinsically unpleasant and that it is unpleasant because it is medicinal.

    Unfortunately, the asymmetric application of the precautionary principal by Tobacco Control, and the entrenched medicinalisation of pure-nicotine products will prevent this from happening. But to my mind, it’s clear that this is what should be the course of action if we are to genuinely tackle the harms caused by smoking.

    For clarification: I use NRT products in addition to vaping – and I pay through the nose for a particular brand. I only do this because this brand is more pleasant to use than others, but it’s still unpleasant and took me quite some time to settle on. I’m quite confident that releasing these products from the medicinal paradigm, regulating them lightly and introducing some genuine competition into the market would result in quite transformative uptake by smokers.

    If Mr Glitchell wishes to argue that NRT products have some utility, even in the OTC form, I’m happy to agree. But this is a slightly absurd, damning-with-faint-praise argument when one accepts that its low uptake is principally due to its inherent unpleasantness.

    Finally: The assumptions in my little screed may be letting the pharmaceutical industry off the hook a touch. I’m assuming its products are unpleasant strictly because they are bound to be so by their medical status. It’s also completely plausible (and I’ve had this said to me by an authority on these matters), that in fact NRT is a neat little cash cow, requiring little in the way of innovation, and subject to little in the way of competition, and the pharmaceutical industry has made little efforts to spend money on innovating. But the point still stands – without competition, we will see next to no efforts made in actually making the products appeal to smokers.

  • Ros

    Hi.

    I think these are all very valid questions. They put into some order the thoughts that have been roaming and colliding in my head over the last 24 hours! My feeling is that these questions need to be directed towards the people who can effect change. It’s good to see them here on your blog but if they stay just here it’s a bit like preaching to the converted.

  • Anonymous

    @ james O’Leary – Denouncing OTC NRT off the back of one survey? Really? How about the anecdotal experiences of thousands of people who are, now, former smokers? How they found OTC NRT essentially useless and yet, once they encountered the electronic cigarette and were able to stop using lit tobacco within a matter of days? These people are not merely the inventions of harm reduction advocates. I myself went from a pack and a half habit per day to being tobacco free within the space of 24 hours. This is not a scientific problem. it’s a people problem. Listen to people. You will generally discover they have no ax to grind, they merely want to share their positive experiences. Did you ever see a huge social movement of nicotine gum chewers? I would venture that no, you did not. Do the math.

    • James O'Leary

      From Clive’s blog “…showing NRT is no better than quitting cold turkey, at least without behavioural support. This is part of a pattern of positive results from UK survey data”

      I would argue undermining proven forms of smoking cessation in this context is irresponsible. Of the two thirds of e-cig users that do not continue using them, it is a terrible outcome should they return to smoking tobacco because it is suggested, in spite of numerous studies and trials showing NRT effectiveness for some smokers, that they should not even bother with NRT.

      Clive has clarified his intention is not to denounce anything which is helpful

  • […] The survey of e-cigarette use published today is great news for those of us who long suspected that e-cigarettes are effective in helping people stop smoking. So now we have a population study (i….  […]

  • James O'Leary

    Point 5 – this includes Robert West, who is quoted in The Guardian as preferring medicinal regulation for products that could help to quit so that they can be recommended by the NHS.

    Denouncing OTC NRT of the back of one survey, when there are plenty of other full studies to the contrary, isn’t helping smokers to quit. Trying to cut off a set of proven products that work for some people (where e-cigs may not) is at best lazy and at worst dangerous. Having a pro-e-cig agenda is one thing but an anti-NRT is a quite different argument.

    Yes behavioural support works best and this is done through proven efficacious products underpinned by medicinal regulation. This would appear to support licensing for e-cigs rather than the opposite.

    • He went to pains to point out on the 5Live interview with Victoria that this is not what he is calling for.

      He said that ‘if’ “ecigarettes” were to be available on the NHS under prescription then they would have to go through a testing regime. This doesn’t apply to all vapourising devices and he supports the continued use by the general public.

      He said that what he is in favour of is that NHS quitting programmes accept that people may be vapers and work within that frame is leaving nicotine is the end goal of that individual with behavioural modification. :)

      He was effusive, as ever, in his support of personal vapourising devises.

      • James O'Leary

        Thanks, I didn’t hear the interview.

        I doubt if there was an agreed role for quitting, that vapourised devices would fall outside of medical licensing. This would ensure they are delivering what is claimed that they are delivering. If they are not for quitting (ie. recreational) one may argue they do not need to be scrutinised in the same way. Guess this comes back to the ‘where do you draw the line on regulation’ argument…

        The recent guidance from NCSCT suggests advisers talk to people about e-cigs and not turn them away which seems to be what Robert is referring to.

    • Clive Bates

      James – I haven’t really denounced anything, just asked questions. I think that licensing as a medicine just so it can be given away is a bit ridiculous frankly. The NHS should be capable of recommending products that aren’t medicines but are less unhealthy – like Diet Coke. It is consumers, rather than taxpayers, should be willing to pay. They are paying for the fags after all.

      I guess I am tired of all the double standards in this debate: if the result had been the other way round and NRT came out 60% better than e-cigs, what do you think the reaction would have been in the public health establishment? Also, I’m fed up with all those who wail about the lack of evidence for e-cigarettes, ask for evidence than can never be provided or simply haven’t been bothered to look at the evidence there is.

      • James O'Leary

        It’s a fair point Clive but healthcare professionals may point out that an established and proven regime is needed to give them the confidence that any recommendations they make are in the interests of public health. You’ll get plenty of people telling you that sweeteners in Diet Coke are worse than sugar, rightly or wrongly. Opinions in medicine may be commonplace but rigour via licensing unlocks the real public health benefit.

        If studies are showing some role for e-cigs in the stop smoking debate then I would hope the public health establishment rallies behind proper evidence gathering, including additional surveys that test ideas and full clinical studies. I agree it is a shame, and damaging for smokers, for each study to be jumped on and conclusions drawn when a lot of questions remain either way.

        • Chris Price

          James, the topic of e-cigarette clinical trials is an interesting one. I don’t know if ecigs are unique in this respect, but clinical trials and ecigs don’t mix: the results will never relate to any real-world result.

          This is a complex issue and deserves a whole article on it, but in general, whatever success rate or similar measure is reported in a clinical trial of ecigs, you can multiply that percentage by at least three to get the real-world effect; with something like NRTs you divide the clinical trial result by three to get the actual result in the wild. Ecigs and clinical trials are natural antagonists: they don’t work together and as far as I can see they never will.

          To explain the basic reason why: imagine setting up a clinical trial of a new consumer product, a drink called tea. Your trial subjects are given a loose green tea of a brand that doesn’t taste particularly nice to most of them. They can only use this material and no other. In addition you keep them (somehow) isolated from experts who can advise on how to prepare the tea. Then a year later you measure how many people are still drinking tea, and find you have a success rate of about 1% – which leads you to believe that tea isn’t very much use at all for anything and especially for converting people from drinking coffee.

          As your researchers are (a) bound by strict rules that prohibit any deviation from the set protocol (i.e. any product variation, or mentoring) and (b) know nothing about tea in any case, they cannot possibly measure how good tea is (for any purpose at all). They wouldn’t know that since they have provided loose tea, but 96% of tea is consumed in teabags; and that there are 100 more tea variants easily available that almost all their subjects would have preferred; and that a tea expert would be able to mentor the trial subjects and advise on factors they have no knowledge of, such as teapots, teabags, milk and sugar; and therefore that they have automatically ruined the trial from Day 1.

          There are a multitude of parallels with ecig trials here. Such trials don’t work and they can never work. I don’t know if there are other things tested in clinical trials that also cannot possibly provide any meaningful results – but it might apply to many consumer products.

          A clinical trial of ecigs starts with a fallacy: that you are testing one or (perhaps in rare cases) a very few options; but with ecigs you’re testing about a million options upward, many of which require expert advice to operate successfully, so it is never going to work inside a rigid rule structure and where mentoring is banned. Mentoring with ecigs by definition means trial and use of different options, which again then change naturally over time. This is an impossible scenario for clinical trials.

          Clinical trials of ecigs don’t work, have never worked, and will never work – at least as far as providing any meaningful result goes. You might be able to report on the failure rate of providing one option and no mentoring, which is what you are actually testing – you most certainly aren’t testing ecigs.

    • Anthony Billingham

      You will have to excuse me for this comment.
      But I still cannot see how medical regulation of e-cigs, will make them anymore effective, than they already are.
      It appears to me, (I’m only a humble e-cig user and ex 35year smoker)that the main reason for med regs, is for control of something that works well for many.
      Feel free to jump on me for the next bit.
      If the so called “experts” took a proper look, at how smokers start there vaping journey. Which is not the same for everyone. (I for one didn’t do it to quit tobacco completely, just to cut down. My quitting tobacco completely, was more of a side effect.) And then followed through to see how that smoker / vaper, then slowly tailors their e-cig use to suit them. (like many of us do and have done) They might then get the fact, that one size does not fit all. Hence why e-cigs are customizable.
      Apologizes to those “experts”, who have taken a proper look, for that comment.

      • Hi Anthony… That’s exactly the sort of comment experts should listen to. The real life journeys from smoking to vaping is something that should be a subject of careful study.

      • Paul Kendrick

        Exactly, Anthony. The electronic cigarette set-up I currently use barely has a passing resemblance to my initial purchase back in October 2012. I’ve slowly ‘upgraded’ both hardware and e-liquid to suit my needs and taste.
        I can’t say for certain whether or not I would have stuck with vaping if my choice had been limited/removed but I’m certain that if I’d been a subject in a trial of cig-a-likes I would be down as a ‘failure’, I tried cig-a-likes for a few weeks back in 2008 and they just didn’t cut it for me, although they did reduce my smoking.

  • Dodderer

    I think (i.e. evidence-free) that NRT is similar to homeopathy – you need to believe and the SSS reinforces that belief.One problem may be that most smokers will now have tried it and failed and thus lost their belief.

    It also raises the question that the ‘quitting’ population is constantly changing – every success leaves behind a harder core and every failure leaves a more disillusioned smoker.Most of those that could quit with NRT etc have probably done so.

    Curing nicotine addiction with nicotine was always a counter-intuitive sell managed by the power of pharma.The relapse curve shows that the desire to smoke never really goes away – repressing it just gets less difficult the longer you remain abstinent.The difference with ecigs is that you are not repressing anything and so the desire to smoke is not there(at least for me). We’re probably some way off establishing a long-term relapse rate for ecigs but I would guess it will be fairly low.

    The key barriers are that NRT is not a medicine because it is not effective and that nicotine is probably not addictive.Overturning these beliefs will be almost impossible.

  • Clive, do you have a copy of Robert’s research? I’m getting an error from that URL.

    • Clive Bates

      I have notified the journal and they are trying to fix it.

      • Guy Eaton

        Hello Clive

        yes, I new this research was to be published for some time as I know Robert. It is great news. I am getting link errors from the above as well. I think also that the survey goes toward disproving the ‘gateway effect’ also or perhaps this is some other research…will wait till I read it.

        Prior evidence of efficacy in research should not be overlooked either as evidence for efficacy was already mounting. I guess this was a large sample size and from the main man himself!

  • Roger Hall

    Great news and a worthy follow up to the e-cigarette symposium last week. Considering that we have the EU elections this week and the overwhelming e-cigarette evidence that is emerging that highlights just how wrong the TPD legislation is with regard to e-cigs and I might add shamefully with snus too, the key question has to be will or can the UK Government backed up by this evidence do anything now to eradicate the harm that the TPD legislation will undoubtedly create? Or will we be faced with UK Govt an politicians declaring that the TPD is now EU legislation and changes are now impossible. If this is the case it certainly explains why perhaps we should leave the EU as legislative mistakes (such as Snus) seemingly become impossible to rectify and the EU and its legislative process is deeply flawed and open to dangerous big business influence to the detriment of the citizens the EU is meant to serve.

  • Clive – really good stuff and thoughtful, as usual.

    As you might imagine, I would take exception with your slagging off on NRT (and if you want to get some more easy citations to support your assertions I’m sure that John Polito, Stan Glantz, and John Pierce (among others) would be happy to oblige!). Those are fair questions, but relatively easily answered with a “weight of the evidence” approach. Though to be clear, I would certainly agree that there is a real need to get NRT without support to work better, but I for one am not prepared to declare it an “abject failure.”

    Does it advance your cause to pillory NRT?

    • Clive Bates

      Okay it’s one study, and the authors avoided asserting that NRT was pointless in any public statements, but without behavioural support it showed no better effect than using nothing – and in the raw results it was worse than nothing (and there is a plausible mechanism for that). I guess I am just sick of being told that medicine regulation guarantees the efficacy of these products and medicine regulation will make e-cigarettes better products, or that e-cigarettes need to be evaluated scientifically… blah blah… all of that has been done for NRT and what has it led to?

      My view is that the value proposition to smokers of e-cigarettes is so much stronger: most of the ‘benefits’ of smoking and few of the detriments, at a lower cost. The NRT counter offer is withdrawal and cravings made somewhat less unpleasant combined with an enduring sense of loss, that some smokers report never subsides.

      By the way, why would I imagine you would uncritically support NRT regardless of the evidence? I have more respect for you than that.

      • Following up on this point about nrt (and your original q3), I don’t think we can expect the mhra to change course on issues of effectiveness or efficacy based on studies like this (even if they are conducted pretty well, as this one is) – I think they’re just not set up to consider the issue in that way.

        Because their daily fare is regulating pills that act on a particular biological mechanism and tend to work pretty much the same for everyone (well actually many don’t, but that’s another issue…), considering an issue where a strong component of effectiveness is down to many different consumer choice and behaviour factors (product acceptability, attractiveness, other factors that make people more likely to persist with a product) is a big ask.

        I think when you present something like this to them the response will be: ‘but we know these products are effective from systematic reviews of rcts that trump all other forms of evidence. In the real world the products may be less effective because people don’t use them as directed, don’t use them long enough or in high enough doses. Bad people. But we provide copious instructions on correct use, so the people are the problem, not us or the product’.

        • But isn’t that really a proble with:
          1. RCTs
          2. MHRA and its approach.
          3. Public health obsessives who for reasons that remain unexplained wish to regulate these products as medicines.

    • Etchie

      This is just a single study and NRT’s do have a meager bit to bring to the table, but if you’re looking to professor Glantz for help, you’re going to drown. Every time he puts out a paper on e-cigarettes he just further embarrasses himself. It’s one thing to read biased information, but a lot of his material are blatant lies.

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