October 9th, 2014

Review of the FCA COP-6 position on e-cigarettes

FCA position on ENDS

Not bad. But good enough?

On 7 October 2014, the Framework Convention Alliance, the largest alliance of NGOs that attend and lobby in the WHO FCTC meetings, published its COP-6 policy brief on ENDS (e-cigarettes).  Its policy briefing sets out a position that reflects a careful navigation through the middle ground between the pro- and anti- harm reduction factions in that alliance, while basically not saying too much that is wrong or likely to cause harm. It is a real achievement that they reached agreement at all, given how polarising this issue is within that community.  The paper is a positive contribution to the negotiations and important corrective to the stance taken by WHO. Some more thoughts:

  • Their position is in sharp contrast to WHO, which failed to achieve similar balance itself in its own paper and communications.  The maturity of the NGO approach should put WHO to shame and on notice that it must do better in future.
  • The argument that it is ‘not feasible or advisable’ for COP to come to a regulatory position is right and constructive given the developing evidence and poor understanding of what is already known – especially in that world. It contrasts favourably with the hubris of WHO in simply listing measures without analysis, justification or assessment and expecting Parties to adopt them.
  • The idea of agreeing on direction-setting principles is a good one: I recommend this as a prior requirement for any policy making. Their FCA principles are not bad, and much better than the one sided loss-averse principles proposed by WHO. The FCA principles listed below and discussed in more detail in the next section.
  1. The global burden of death and disease from tobacco is primarily caused by smoking.
  2. While quitting tobacco use is paramount, quitting nicotine use altogether is the best option.
  3. For those unable to quit tobacco, switching to alternative sources of nicotine that are less harmful can reduce, often very substantially, the harm smoking causes to the individual.
  4. The benefits of such an approach would be maximised if uptake were limited to existing smokers who are unable to quit.
  5. The risks of such an approach would be minimised by taking measures to limit uptake by never-smokers, in particular amongst young people, to protect non-users, and to discourage long-term dual use.
  6. There could be negative unintended consequences from over-regulation just as there could be from under-regulation.
  7. The involvement of tobacco companies in the production and marketing of e-cigarettes is a matter of particular concern as there is an irreconcilable conflict of interest between those profiting from the sale of tobacco and public health.
  • They are right in their analysis that different weight is placed on the different principles in their list by the various factions in the debate, but that is partly where the problem lies with this alliance.
  • The idea of setting up an expert body is good, providing that the membership is not stitched up to give pre-ordained answers. In other words, WHO or the FCTC secretariat shouldn’t be allowed to do what it does with science and hand-pick extremists to give it the answers that best support its prejudices.
  • They wish to include civil society in their expert body.  In that world, the definition of ‘civil society’ usually means: “that’s us, we the FCA are civil society“. In fact, they are not – but it’s a longer discussion about who they are, what they represent and to whom they owe their involvement. But as a minimum, they should have representatives of the users of these products involved – not only for the knowledge and experience they would bring but also on the ‘nothing about us, without us’ principle that is routinely and complacently ignored in this forum.
  • The habit of excluding representatives of producers is a bad one – and partly responsible for NGOs promoting very burdensome regulatory regimes, thus unwittingly supporting the tobacco industry’s preferred approach. A risk that is mercifully recognised at principle 6.

Comments on the FCA’s principles

1. The global burden of death and disease from tobacco is primarily caused by smoking

Comment: Yes, the burden of disease is primarily caused by smoking.  The FCA should adopt similar open-minded principles with respect to other non-combustible recreational nicotine products that provide orders of magnitude lower risk – that would include smokeless tobacco products (appropriately regulated) and vapourising ‘heat not burn’ tobacco products.  It is time to acknowledge that bans on products like snus have no scientific or ethical basis and cause harm.  Targets for reducing tobacco consumption should be focussed on smoking, or at least be weighted by disease risk. We should stop conflating the harms caused by betel, areca and lime in South Asian products with smokeless tobacco.

2. While quitting tobacco use is paramount, quitting nicotine use altogether is the best option

Comment: From a health point of view, quitting smoking is paramount (see principle 1) not tobacco use. Quitting nicotine is not necessarily the best option if it leaves permanent craving, a sense of loss and risk of relapse back to smoking.  The big step is taken when someone quits smoking – at that point, their job is done.  Even if you agree the quitting nicotine is the ‘best option’ it is important to be clear how far you would go to cause it to happen – for example, would it be friendly advice, or would you try to back that preference with an element of coercion – for example by taxing nicotine? I do not think the latter is justified.

3. For those unable to quit tobacco, switching to alternative sources of nicotine that are less harmful can reduce, often very substantially, the harm smoking causes to the individual

Comment: This is the key point – only it should say unable or unwilling – people are, surely at least partly, autonomous agents who take their own decisions about risk.  There is a strong ethical justification for allowing and encouraging people to make these choices for themselves.  Much of conventional tobacco control creates pressure and motivation to quit smoking, but conventional tobacco control has been poor at recognising transitional pathways that appeal to smokers, rather than the preferred course of the medical profession or regulators.

4. The benefits of such an approach would be maximised if uptake were limited to existing smokers who are unable to quit

Comment: This sounds reasonable but is not true.  Alternative sources of nicotine also have the prospect of substituting for smoking initiation in current non-smokers. One of the reasons for very low rates of smoking in parts of Scandinavia is that snus initiation has displaced smoking.  It is possible alternative nicotine sources them to have a ‘protective’ effect by diverting young people away from smoking into something that does little harm and is less likely to form dependence. While this pathway is not as desirable as remaining as a permanent non-smoker, it is better than smoking initiation.  It is also possible that uptake by ex-smokers works as a protective effect against relapse to smoking.

5. The risks of such an approach would be minimised by taking measures to limit uptake by never-smokers, in particular amongst young people, to protect non-users, and to discourage long-term dual use

Comment: The question, acknowledged but not addressed in the briefing, is how to strike the trade-offs between measures that limit uptake, protect bystanders, and discourage long-term dual use (if this is an alternative to quitting) and encouraging smokers to switch to alternative nicotine products. What if a measure designed to reduce unintended consequences (e.g. banning certain flavours or types of advertising has the effect of reducing the number of smokers who quit).  In other words, the third principle is in tension with the fourth and fifth.  Some subsidiary principles might help:

a. Take a realistic evidence based view of the scale of these unintended consequences (extremely low at present) and the harm they would cause to individuals (extremely low unless they progress to smoking).  Further, recognise that some ENDS use is an alternative to smoking in never smokers and young people: that it may be protecting non-users from smoke (especially in the home); and that long-term dual use only adds to the problem if it is alternative to quitting in the dual user.

b. Take an evidence-based view of the harms avoided if people switch or cut down substantially (these are very large – both to the individual and to bystanders)

c. Weigh the avoided harms against the unintended consequences, but also apply a ‘tolerability of risk’ lens and recognise that zero risk is not and never has been an aim for adults or adolescents.

6.There could be negative unintended consequences from over-regulation just as there could be from under-regulation

Comment: Possibly the most important insight of the paper and discussed here: Turning the tables on public health – let’s talk about the risks they create.  A double negative is at work – ‘tough on alternatives to smoking’ can mean ‘easy on smoking’.  The trick is to find a ‘sweet spot’ for regulation that builds consumer confidence, gets rid of cowboys, protects against most of the risk, but allows sustains the appeal of the product, pace of innovation and cost advantages.   I think it is becoming clear to the more thoughtful people in tobacco control that pressing for very strong regulation leaves them in an unholy (if unwitting) alliance with the more cynical tobacco companies, who wish to use regulatory barriers to entry to destroy competitors, limit the potential of ENDS category and shape the market to suit the commoditised, high volume, low diversity products that best suit their business model.

7. The involvement of tobacco companies in the production and marketing of e-cigarettes is a matter of particular concern as there is an irreconcilable conflict of interest between those profiting from the sale of tobacco and public health.

Comment: This is not really a useful principle in its current form – though it is a bit of a mantra and to be expected from this alliance.  If it turns out that ‘harm reduction’ is good for health, as the preceding six principles suggest it may well be, then there it is problematic to deny this as a matter of principle if the products happen to be made by tobacco companies or their subsidiaries.  It should be problematic only if their involvement results in more smoking.    It is very far from clear that the companies have incentives to protect smoking (a longer discussion, but competition for market share will tend to prevent this and excessive regulation will encourage it).  I would prefer:

Regulation of the market for e-cigarettes should not have the aim or effect of either: protecting cigarette sales; or favouring the e-cigarette products of tobacco manufacturers relative to independent or smaller scale producers.

Overall – good, but good enough?

This paper is good and a welcome and constructive development – and the architects of it should take credit where credit is due.  But is it good enough? I don’t want to be churlish, but…

…this alliance really should be the pre-eminent civil society forum in the world for addressing the harms arising from tobacco use. Alliance members should not be cheerleading populist prohibitionist stances (as some do), but leading with real insight and helping to make the political headroom for measures that may seem counter-intuitive or difficult, but deliver major health dividends – tobacco harm reduction falls into this category. It should be taking an evidence-based and ethically-principled view of the issues, and not allowing the instinctive preferences and prejudices of some of its members to cloud its collective judgement and fudge its positions  My concern is that that this paper looks like a middle ground between a more-or-less rigorous approach and the fears and fictions that are generated in the tobacco control community more broadly.

Rather than be grateful that the position is not far worse (which of course I am) perhaps we should lament that it is not far better?   Think what could be achieved if this alliance embraced the concept of tobacco harm reduction, and ran hard with it – becoming the experts and authorities on managing the risks and unintended consequences in their own countries and, if appropriate, in the FCTC.  The only conceivable way I can see to meet the extremely ambitious commitment to reduce tobacco consumption* by the 30% by 2025 is to find alternatives that make it easier for smokers to quit smoking. There are 10 years of innovation in ENDS/harm reduction technologies to come before 2025, how can the benefits be harnessed, especially in developing countries, and the risks are properly placed in proportion and managed?  If the lives of FCA members depended on hitting that 30% goal, would any of them take a hostile approach to e-cigarettes? I doubt it. But many millions of people’s health, wellbeing and life expectancy will actually depend on it.

* the target should be smoking or tobacco consumption weighted by disease risk.  It is counter-productive to have an undifferentiated target that includes both smokeless tobacco and smoking when the former is an alternative to the latter but at greatly reduced disease risk.

Debate

If you disagree with this or think I have misunderstood, especially if you are in the FCA, I would really welcome a debate. Use the comments or, if you would like to do it privately, use email or the contact page .

11 comments to Review of the FCA COP-6 position on e-cigarettes

  • festus

    I agree with mark on this,the executioner will eventually become redundant as time goes.

  • […] were reported in the daily brief here. Our dear friend in arms, Clive Bates, produced a cogent analysis of the talking points and concludes as well that it isn’t bad, but isn’t yet good […]

  • Thank you Clive, for the cogent review. Great minds think alike. I was pleased that the position paper made some strong progress from the abysmal document we all tore apart some months previous. (See my take here: http://goo.gl/xBkR5l)

    I am also concerned that the position paper is not only not definitive enough but calls for further study and recommendations which are likely the province of our favorite personna non grata in the THR world Mr. Stanton Glanz, whose earlier work seems to be the de facto foundation for the prior work mentioned.

    It is going to take some serious effort to be heard at this point. Given that the current modus operandi appears to place the effort of research and proof of concept upon an industry which is vilified and barred from participation. That erects a nearly insurmountable barrier to further progress unless, and until, a way over the wall is found.

    So the question becomes, how to get appropriate information into the hands of sufficient parties to support the momentum of change that we see beginning with this publication. THR advocates have, so far, been relegated to the wastelands of Big Tobacco allies it would seem. So how do we differentiate them and promote the goals you so eloquently put forward. Is repetition enough? Does public demonstration have a role yet? Are there allies we have not reached out to or considered?

    Thanks for your time and effort.

  • Mark Magenis

    Time has been, and probably always will be, our biggest ally in this struggle. The rapid spread of understanding, evidence and growth of users
    will eventually (hopefully) turn the whole issue into a non argument.
    The best outcome in any of the current battles is in gaining a stay of execution. The executioner will eventually become redundant.

  • Jon Fell

    Thanks Clive, very useful, as always. A further problem with principle 7 as currently worded (“sale of tobacco”) is that it ignores snus and also other novel tobacco products (eg ‘heat-not-burn’) which might turn out to carry similar levels of risk to e-cigs / vapour. This definitional problem is only likely to get more complex as the market for reduced-risk products develops further. As for the expert group, I agree that it’s a bad habit – and fundamentally unscientific – to exclude producers, but the FCTC seems to have dug itself a hole on this matter. The wish to include members of the tobacco control community with “a good understanding of the tobacco industry” is laudable but if intepreted literally might leave them with rather a limited field of candidates (this blog’s author obviously excepted) given that mastery of this discipline too often seems to be predicated on advocacy and spin rather than genuine understanding.

  • Mark Magenis

    Its significance is in showing a willingness to return to an objective starting point before the stone tablets get written.

    • Clive Bates

      Mark – I agree… and think there is a deep lesson in there for any policy makers or legislators willing to learn it. The EU made its decisions based on junk inputs from fake experts hyping up risks and ignoring benefits. They got away with this because they could say: “we just don’t know enough”. Time, and the increasing evidence, awareness, understanding and allies that come with it, is the key factor in getting this right.

      Prohibitionists in Europe managed to shut down snus because it had hardly appeared in most countries, so they were able to strangle it at birth based on completely fatuous reasoning that was never adequately scrutinised.

  • […] On 7 October 2014, the Framework Convention Alliance, the largest alliance of NGOs that attend and lobby in the WHO FCTC meetings, published its COP-6 policy brief on ENDS (e-cigarettes). Its poli…  […]

  • Irish Lass

    Another good post, Clive. So the FCA report card should have the comment “Encouraging work, but could do better.”
    I have similar feelings about the e-cig position paper agreed between the chairs of the All Party Parliamentary Groups on Smoking and Health and on Pharmacy, following a meeting in June this year that, apparently, has been copied to MPs. Have you seen this paper? (It was sent to my MP at the end of August.)
    The meeting of the APPGs in June was apparently informed by a “number of national experts”, including Prof David Walker (Deputy Chief Medical Officer) and Prof Robert West. What other experts were involved neither the covering letter nor the position paper tells us.
    The position paper is not – in my view – too bad; and it may help inform those MPs who have previously relied on the daily newspapers for their information about e-cigs, or otherwise been influenced by sensationalist claims.
    The paper includes the points that e-cigs “deliver nicotine in vapour form without the deadly tar or carbon monoxide inhaled from cigarettes”; that “very few people who have never smoked have used e-cigs”; that “around one third of current users have quit smoking entirely”; and that “there is growing evidence that the devices can help smokers quit”. Importantly, it also makes the point that although a small number of children have experimented with e-cigs almost all of these are current or ex-smokers.”
    The paper states as potential risks “concerns that [the rapid growth in the numbers of people using e-cigs] will encourage uptake amongst the young and be a gateway into smoking” (that’s not a risk, its a statement that some people have expressed this concern!) and that the vapour “may sometimes contain toxic substances and we don’t know what their long term impact may be” (same old, same old, and Burstyn’s report not referenced – why??). But the paper then goes on to put forward the potential benefits of e-cigs (“a new route to quitting for smokers and even if used long-term any harm is negligible compared to smoking cigarettes”), and a statement on their potential to save many lives. Also, the APPGs state their support for an approach to implementing the EU TPD regulations in “such a way so as to maximise the benefits and minimise the risks”.
    Overall, quite a balanced view, I thought, and encouraging (a bit). I hope that this paper may help develop support amongst our politicians for a sensible implementation of the TPD. Well, one can always hope!

    • Clive Bates

      I agree that it is encouraging, and quite a relief given the harm to health this alliance is capable of doing if it mishandles issues like this.

  • Alan Fletcher

    As a vaper I can underline everything you have said Clive. An extremely good analysis and recommendation paper. Vaping is currently the only really effective way of getting smokers who do not want to or simply cannot quit, off the dreaded burnt weed. I was one of these smokers myself over two years ago and am now enjoying the health benefits of vaping only.

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