September 30th, 2014

Letter to delegates to FCTC COP-6

cop6moscow

Looks lovely…  but is it?

Here’s my first open letter to delegates to the WHO FCTC COP-6 to be held in Moscow 13-18 October.  See also COP-6 resource page on Nicotine Science & Policy site.

Update 3 Oct the United States has pulled out of the meeting (see report). US is a an observer not a party, but outside the health world that will make no difference to the significance of this.  Who will attend now? Narrow minded insular WHO and the FCTC Bureau failed to recognise this political pot-hole. I think the COP6 should go ahead to avoid creating yet more waste – but it will be a tawdry meeting with questionable legitimacy. Update 11 Oct: Canada is out. Australia thinking about walking.

To: Delegates to WHO FCTC COP-6

From: Clive Bates, Counterfactual, London

29 September 2014

Dear delegate

This communication is directed to delegates to the WHO Framework Convention on Tobacco Control, Sixth Conference of the Parties to be held in Moscow, 13-18th October. […]

Please find attached a report on the use of science by WHO regarding electronic nicotine delivery systems (ENDS). This report refers to WHO’s paper on ENDS (FCTC/COP/6/10 Rev.1) prepared for the COP-6 meeting to be held in Moscow 13-18 October.  As this is likely to be controversial at the meeting I thought you would welcome this briefing.

The five main points of the critique:

  • The best available scientific evidence on ENDS, cited with links to original research in the attached report, suggests they are very low risk, and are having the effect of reducing smoking – they are a welcome innovation that will reduce cancer, cardiovascular and lung disease and contribute to success in meeting targets for reducing NCDs by 25% by 2025.
  • There is no evidence to suggest ENDS cause material harm, create gateways, renormalise smoking or are attracting youth who would otherwise be non-smokers.  The use is concentrated in smokers, and this should be expected.
  • WHO acknowledges that these products offer both ‘promise and threats’ but provides a one-sided negative analysis focussed only on threats based on flawed scientific advice. WHO emphasises minor or implausible risks while underplaying potentially large benefits of ENDS.
  • WHO has not developed a coherent framework for discussing relative risk of products like ENDS (around 95-100% less risky than smoking).  The most important function of ENDS is to substitute for smoking and to dramatically reduce risks to people who cannot or choose not to give up nicotine.
  • WHO’s policy recommendations are not based on sound policy-making practice (evidence synthesis, options appraisal, impact assessment and consultation), and ignore many potential unintended negative consequences. These would have the effect of protecting cigarette sales, favouring the tobacco industry and causing more harm to health if implemented uncritically.

The report makes six recommendations:

  1. WHO should restore an objective approach to science and evidence
  2. WHO should take formal independent scientific advice from its specialised TobReg committee, due to report next in January 2015, before proposes policies or draws scientific conclusions
  3. Parties to the FCTC should not bring ENDS into the FCTC – it is both technically and strategically inappropriate.  ENDS are not tobacco products and they are a useful tool for reducing tobacco consumption.
  4. Parties should insist that WHO improve the quality of its policy making and advice – with proper assessment of evidence, options appraisal, impact assessment and consultation
  5. All stakeholders should treat WHO policy recommendations with caution for now – they are built on weak evidential and analytical foundations
  6. WHO should apply much stronger quality control its public risk communications, which have on occasion been highly misleading and potentially dangerous.

Principles for regulation – an input to a COP6 declaration:

The report suggests four principles for the regulation of ENDS, aiming to strike an optimum balance between ‘promise and threat’.  These are proposed as a more constructive alternative to those proposed by WHO at para 36 of its paper.

(a) the public health imperative: secure the optimum health outcomes from ENDS by incentivising smokers to switch, while controlling risks to ENDS users and non-users;

(b) the appropriate target population: ensure ENDS promotion is focussed on adult smokers;

(c) truthful marketing: require any claim made for ENDS to be true and substantiated; and

(d) support for tobacco control:  avoid ENDS regulation that protects cigarette sales or favours the ENDS products of tobacco companies at the expense of independent suppliers.

A COP6 declaration focussed on carefully defining the correct principles for regulation would be a valuable contribution to reducing smoking and tobacco smoke exposure. I hope you will consider the principles set out above as an input to your deliberations in Moscow.

The views of experts

I also attach a copy of a letter sent to WHO Director Dr Margaret Chan in May this year signed by some of the main experts in the field and calling for ENDS to be recognised as ‘part of the solution, not part of the problem’. Further exchanges between experts and campaigners can be viewed on the Nicotine Science and Policy web site.

I hope you find these documents useful background to the COP6. If I can be of further assistance, please let me know. I will not be present in Moscow, but I can be reached by email, phone or Skype.

Clive Bates
Counterfactual Consulting & Advocacy
London
United Kingdom
[contact information]

Disclosure: The author is former Director of Action on Health UK (1997-2003) and a UK and international senior civil servant (2003-2013). He was a founder of the Framework Convention Alliance of NGOs which supports the FCTC. The author now runs a public interest consulting and advocacy practice, Counterfactual.  He has no competing interests, in particular with respect to tobacco, ENDS or pharmaceuticals – this work is undertaken on a pro bono basis.

Writing your own letter

If you want to send a letter like this to your country’s delegation please use your own words and authentic views. If you want to use materials from this web site – including the reports below, please feel free – no permission is required.  But please make the communication your own.  In the report I produced, there are lots of quotable statements – but please cite the original source (I have provided citations and links through out). I do not encourage form letters or mass sign ups – people you are writing to usually value you views (really they do!), but only if they are authentically yours not part of some contrived campaign.  Finding your delegates is not always easy, but here are ways to do it:

  • Write to the health minister in your country – politely, constructively, concisely and drawing on your own experience – and asking for a reply.  It will usually be passed to officials and the delegates attending for action and response.
  • Look at the participants to the last COP in 2012 – here – they are more likely to be the same than not for this one.  Write to them via the health ministry in your country, asking them to forward it on if they have moved on.
  • Find your country’s permanent representation in Geneva and the officials (so called Health Attachés) who shadow WHO here. Look up their Geneva office address and contact details and write to them there, asking to forward to the appropriate government personnel.
  • You may find e-mail addresses with a bit of Googling, but you may need to post it

If you have questions or would like to share what you have written, please use the comments below and I will try to respond.

Talking points – my random thoughts

  • Above all, your own experience and concerns
  • E-cigarettes and vapour products are not tobacco products and do not fit under the Framework Convention on Tobacco Control, which has objectives focussed on tobacco and tobacco smoke
  • E-cigarettes are part of the solution not part of the problem, part of the ‘endgame’ for smoking related disease, a good place for smokers to get to, harm no-one, help many.
  • Products that do not involve burning tobacco (including e-cigarettes, vapour products, smokeless tobacco etc) but provide nicotine in a recreational form have huge potential to contribute to lowering the burden of cancer, heart disease and lung diseases – there are targets to reduce death from ‘non-communicable diseases’ (NCDs) by 25% by 2025 – these products will help meet the tobacco part of that and it can’t be done without them
  • Vapour products are a disruptive technology and a threat to cigarette sales – the tobacco industry’s old business model is under attack from its own customers – WHO and national governments should not get in the way of this
  • The more you restrict and over-regulate them, the more you risk unintended consequences of protecting cigarettes and causing more disease and death, and helping the tobacco industry slow it all down
  • The science so far shows that none of the risks that people worry about are real or occur at any significant scale – however they do appear to support quitting

Other relevant postings

WHO plans e-cigarette offensive

WHO on e-cigarettes – protecting cigarette sales and causing more disease and death

Letter to WHO from 53 scientists and further letter to WHO dismissing anti-scientific response from Glantz, Chapman, McKee, Ashton etc as distorted and misleading

Open letter to COP5 delegates

 

 

32 comments to Letter to delegates to FCTC COP-6

  • […] Intro by Clive Bates. You may remember Louise Ross’s brilliant first outing on this blog: Let there be light!. Louise runs the NHS Stop Smoking Service in Leicester and she was full of optimism for the potential of vaping to help smokers quit smoking.   She has carried on the mission and inspired and enthused many others.  But here, in a new guest blog,  she explains her anger and ‘speechless sadness’ at the damage caused by WHO when it published its report on ‘Electronic Nicotine delivery Systems’ (e-cigarettes) in August – criticised in full in my detailed report and letter to COP6 delegates. […]

  • john

    Clive Phil
    Sorry I have been on the road, typing on Iphones is a bit beyond me.

    A while ago I registered on Alibaba as looking for Chinese made ENDS related products and was a bit startled/delighted? by just how quickly these devices are evolving. There are a extraordinary number of new kinds of and new manufacturers of, ENDS entering the market on a daily basis. A good thing!

    I suppose a regulator could attempt to define what is a ‘regular’ ENDS (and therefore what is not a ENDS) and attempt to restrict innovation and trade to that definition, but that would be a Large Project.

  • Donna

    Hey Clive, well done and thank you. This seems like good news, would be interested in your thoughts. http://www.fctc.org/images/stories/policy_brief.pdf

    [Editor’s note: the link refers to the position on ‘ENDS’ adopted by the ‘Framework Convention Alliance’ of health and tobacco control NGOs that attends and lobbies at the FCTC meetings].

  • Phil Day

    To get back ‘on topic’, looking over the comments for this post underlines just how difficult it will be to arrive at intelligent regulations for e-cigs – and how very important the efforts of Clive (and a few others) are. There must be times when you feel like pulling all your hair out Clive, so a big thanks for persevering.

    The biggest obstacle (as l see it) is that legislators are being unduly influenced by (and are often drawn from) people whose background is in the ‘war on tobacco’ and the (naive imo) belief that all tobacco use can be eliminated in addition, possibly, to groups with other vested interests. These people and groups have nothing to gain from seeing vaping succeed (but many reasons for wanting them to fail) and see nothing wrong with lying or falsifying/misrepresenting research to achieve their aims. Saddest thing of all is that so many of these people just don’t seem to really care whether the harm caused by smoking is reduced by any appreciable amount.

    As you rightly point out, failure to regulate properly is likely to result in many current vapers returning to smoking, of the rest some will quit completely and the remainder will be forced into criminal activity (i.e. using a totally unregulated black market) in order to continue with a healthier lifestyle. This doesn’t even take into account the number of smokers who might have made the switch in the future but would be denied a gateway out of smoking. Of course, in the absence of suitable devices (because bad regs will outlaw them) the temptation to use unsuitable devices, like the ‘herb vapourisers’ John mentions, will increase as well with the inevitable results.

    @John. Of course, the firefly (or any similar device) would be unsuitable for use with e-liquid but l think you may have misunderstood DB’s 30w reference. He actually quotes Dr. Farsalinos’s comments (and cautions) about high power devices. I remember this research and the Dr’s comment was definitely about e-cig specific devices. At the time it was only mechanical mods with low resistance atti’s that reached those power levels but more recently, regulated, variable wattage devices have become available (e.g. DNA30, sigelei 50 etc.) which have enhanced safety features. None of these were ever intended for heating herbs and all use batteries designed for high drain applications e.g. rechargeable torches (not mini ovens). Dr. Farsalinos also emphasised at the time that even with higher acrolein and/or formaldehyde levels these devices were still magnitudes safer than burnt tobacco, something DB ‘conveniently’ forget to mention. The Dr. also didn’t have the benefit of more recent atomisers with their improved air and juice flow for the experiments.

    I can’t speak of the whole world but in the UK there is no segment of the vaping community that l’m aware of using (or advocating the use of) ‘herb vaporisers’ for vaping e-liquid. There is, however, an interest in finding alternative wick and coil materials in order to further reduce the already very low levels of contaminants and indirect heating has been mentioned in this context as it offers a (theoretical) possibility of reducing contaminants by eliminating direct contact between liquid and heat source. ‘Herb vaporisers’ also use indirect heating – maybe this is where you are getting confused John, or maybe you just aren’t aware of the actual devices that are specifically designed for those few vapers who want higher wattage.

    However, if l was a cynic John, l might think you are deliberately trying to mislead people who read Clive’s blog.

  • […] Here's my first open letter to delegates to the WHO FCTC COP-6 to be held in Moscow 13-18 October. Update: 3 Oct the United States has pulled out of the meeting (see report). US is a an observer no…  […]

  • Phil Day

    @ John – To clarify your question, putting more energy into a vaping device does not raise it’s temperature but it does increase the amount and density of the vapour produced. This does assume adequate liquid and air supply, deficiency in either of these will result in the ‘dry hit’ effect which is vile and ‘unvapeable’so not all atomisers are suitable.

    The effect can be seen with a pan of water, once boiling the temperature will remain at approximately 100c regardless of how high the gas is turned up but the rate of boiling will change. At atmospheric pressure, once a liquid is boiling the amount of energy lost by evaporation always equals the amount of energy put in – so no temperature rise.

    Most people will not feel any need to go this route but those who do use higher power devices also often take shorter ‘draws’ which more closely resemble what they would have done if smoking tobacco.

    Also, not sure what high power batteries you refer to, the only reference l could find in DB’s comments link to (sometimes eccentric) 3rd generation mods. The few people l’m aware of who are looking at larger than normal batteries are doing so for duration, consistency and safety reasons not necessarily for absolute power.

    Not happy that l’ve gone off topic Clive, but l was concerned that some of Johns comments might create a false impression of what is happening in the vaping world.

    Phil

  • John

    Clive
    I am on the road , needs be short. The question that has not been asked is: why would anybody want to use so much more power in a ENDS than is needed , to turn a liquid into a vapor? the high power batteries that David references are intended to power mini ‘ovens’ not atomisers .

  • John

    It is important to understand that none of the high power devices , that come with temperature control are suitable or intended for , heating liquids, they are made expressly for heating ‘dry herbs’.

  • Phil Day

    Oh my, l made a schoolboy error in my previous comment. I apologise to both you and your readers for that.

    It seems l got a bit confused (common state for me) in following Dr. Farsalinos’s dealings with David Bareham and credited him with authorship of the report instead of just being a contributor to Stanton Gantz’s blog at the UCSF.

    In trying to understand how l made such a basic error l did find that, while he can be described as respiratory clinician, his position and expertise is not as grand as he tries to portray. He has degrees in pain relief and physiotherapy and practices within the NHS as a ‘specialist respiratory physiotherapist’.

    Given what l now know of him in addition to his connection to S. Glantz l have formed my own opinion as to his motives in posting comments on your site and also Dr. Farsalinos’s (in addition to letters to other authors of the WHO report critique) and leave your readers to draw their own conclusions.

    Once again, my apologies for the error in my previous comment.

    Phil

  • Phil Day

    Quite enjoyed your exchange with David Bareham, for those who are not aware DB was one the authors of the recent WHO commissioned report into e-cigs which was covered at the time by you and critiqued by McNeil, Etter, Farsalinos, Hajek, le Houzec and McRobbie (can be found here: <a href="http://onlinelibrary.wiley.com/doi/10.1111/add.12730/abstract;jsessionid=B4011900417354D3ADCA32B93EE248CA.f02t03&quot; )

    Personally, l'm pleased that you gave him space for his comments and the made time to reply in a civil manner – there are people in the TC world who could learn a lot from this.

    What surprised me was the way he kept quoting Farsalinos as if the good Dr. was supportive of DB's views, anyone familiar with Farsalinos's work will know this is not the case. DB also attempted to troll, sorry, post similar comments to the above on Dr. Farsalinos's site and was given the opportunity to reply to the critique in the form of a guest post. The good Dr's response can be found here: <a href="http://www.ecigarette-research.com/web/index.php/research/2014/183-resp-bareh&quot; (response is at the end, link to his earlier comments at beginning).

    While l do respect his right hold a different opinion to mine l have to wonder why he felt the need to defend it through your (and Dr. Farsalinos's) site? Is he trying to justify a position to your readers knowing they may be adversely affected by his recommendations (and possibly harmed), does he think we will be influenced by his arguments, maybe it's just a manifestation of guilty conscience.

    Whatever the reason l think it is very telling that DB has taken the trouble to do this. Suggests to me that your efforts (and that of Doctor Farsalinos) are having an effect.

    Phil

  • David Bareham

    RESPONSE.

    1. With all due respect, Clive, I am somewhat baffled that, after you stated that you had analysed this paper in depth so recently, and have posted opinion on both yours and other’s blogs, that: you cannot remember if carcinogens were either a primary or a secondary outcome measure. The paper, of course, did not look at carcinogens, if you had read it thoroughly, and I provided the paper for you in my posting. It is a preliminary piece of work to assess for deposition of nicotine: the primary outcome measure in this stage of investigation. However, the precise reason for assessing this was to justify the need, or not, for the potential subsequent step in the correct scientific process. After detecting nicotine, they conclude and clearly state: ““Future research should explore the potential risks of thirdhand exposure to carcinogens formed from nicotine released from e-cigarettes.” This is how science should progress, one step at a time, and I would respectfully state that your suggestion of “I don’t think they measured carcinogens – if they had, it would be a useful discussion” would clearly have introduced a second “primary outcome measure”, which is not “good science”: they, or others, will look at that, next time. The paper is an example of how good science should “build on itself”, progressively (See K. Popper etc). They do give a reason why they think the hypothesis studied is plausible: I quote the key paper and they cite others (if you had read the paper and studied its reference list, you would have seen these, which is also essential critical appraisal). They tried to falsify the hypothesis this time, by testing for the deposition, or not, of nicotine.
    2. So: you agree that Polosa is incorrect, therefore. This is disappointing, I would respectfully suggest, as he had been invited to speak as an expert speaker at this Global Conference: on nicotine. Do you believe that it may call into question other statements that he makes, therefore?
    3. Please give your reference for stating “PG has ‘generally recognised as safe’ status, including for inhalation”: in an electronic cigarette. You state: “but only become significant when the product is used in extreme circumstances, running very hot or dry.” Dr Farsalinos has again pointed out to me that: “There are devices going up to 30 watts now. I consider these extreme, but a lot of people use energy levels up to 10 watts.” (my emphasis, plus also see here http://motherboard.vice.com/read/e-cigarettes-dont-look-anything-like-you-think-they-do ). Please also see Dr Farsalinos’ experiments on temperatures on You Tube, and note that Polosa, in his conclusion in the link provided, confirms that temperatures are a significant issue for concern. All potential users, all populations, should be made aware of this fact, in order that they can make an informed choice about using these devices. As stated: “Since new potentially harmful substances may be produced during heating process, analyses of aerosol are needed to correlate its composition to the chemical components of liquids.” This is why currently, at least, PG is not considered safe as utilised in an electronic cigarette: which IS THE CONTEXT we are discussing.
    4. The discussion that nicotine’s effects are akin to caffeine: I agree that the statements are made in order to encourage current smokers to consider a complete “switch”. This is admirable. However, it clearly has a flip side, as it understates the potential risks to all other potential users/populations: ex-smokers; non-smokers and youth. Youth drink coffee: therefore, listening to this, they will reasonably conclude that vaping is safe. The Times only this last weekend here http://thetim.es/1rxb5Hn stated that, at worst, children “will be driven to harmless vaping” (my emphasis). Please consider Dr Farsalinos’ words here http://www.ecigarette-research.com/web/index.php/research/2014/181-who-resp “Obviously, every non-smoker also deserves to know that the e-cigarette is not a safe new habit for everyone to adopt”. “Experts” expressing, in effect, that they consider nicotine and electronic cigarettes are as safe as caffeine, will clearly not give out this other, essential message, to protect ALL populations of potential users from potential harm. This is what The WHO is endeavoring to do, as well as to reasonably maximize any potential benefits from the devices to smokers.
    5. “The fact that they attributed any risk at all to these products was to anticipate unknowns, because there is nothing at present that suggests any material risk.” Multiple organisations disagree with you, based on the current evidence. Dr Farsalinos states that: “the electronic cigarette is not a safe new habit”, as above. Your statement appears untenable with the current evidence. You clearly understate the risks to all potential users with this statement.
    6. One of the obvious differences between electronic cigarette fluids and washing up liquid is: there are not approaching 8000 different flavours of washing up liquad (http://www.nytimes.com/2014/07/16/business/e-cigarette-makers-are-in-an-arms-race-for-exotic-vapor-flavors.html?_r=2# ). Moreover, we do not consume washing up liquid; children do not observe their parents (hopefully) consuming washing up liquid. These issues, involving any risk assessment and subsequent comparison between the two products, have to be seriously taken into account, whatever we decide about the contrasting toxicity of the fluids concerned. Moreover: you have not answered the question: do you believe that vaping is as safe as washing up, or do you believe the published manufacture’s statement to be misleading to the public? So, when you raise these issues, do please keep in your mind that your extreme understatements, on behalf of others, which I acknowledge is admirable, may be putting other people at risk: currently unknown risks. These devices are out on shelves, next to confectionary: whether placed there as a piece of “aggressive marketing”, or as a “random placement”. The later seems to me far more unlikely than the former.
    7. “Dispute is at the heart of the scientific process.” No Clive . . . . Siegel states: “However, the tone of feedback directed at our team quickly became hostile. Our integrity as researchers was questioned, and criticism quickly shifted from concerns about study methods to personal attacks.” This is clearly unacceptable behaviour, and one that may well do your cause dis-service. This behaviour promotes the junk science that you talk of: but you accept it as normal, and therefore in fact are advocating it. Progressive public health science cannot progress in this environment.
    8. Lastly, I am a clinician, who has already stated here http://tobacco.ucsf.edu/response-mcneill-et-al-criticism-report-we-prepared-who-and-subsequent-review-paper-circulation-ecigs how I practice:
    “I am a respiratory clinician with a great interest in this issue, and I would like to point out that, from the first, I DO refer people to the their local Smoking Cessation Services for support with quitting via use of an electronic cigarette, if: they have had multiple attempts via other evidence-based methods but failed; do not wish to try anymore via those methods; and if THEY raise the topic of quitting via an electronic cigarette. I will discuss the current evidence base with them: that there is some evidence that on an individual level at least, these devices can help. I do point out that, to maximise the health benefits, that they do need to fully quit, and point out that “dual use” will reduce those potential benefits i.e. they need to “switch”. I inform them that, in my opinion, it is inconceivable that an electronic cigarette is either: more harmful, as harmful or, in fact, probably anything like as harmful, as the combustible cigarette. There is no combustion, no tar and no C02.”
    You therefore pre-judge me. The approach I am advocating seeks to maximise any benefits from these devices, while also protecting all other populations from risks: unknown.

    David Bareham

    • Clive Bates

      1. As I said, the paper is about nicotine deposition in artificial circumstances, not carcinogens.
      2. No. Read what I said.
      3. PG is widely used as an excipient in pharmaceuticals. You can check this for yourself.
      4. The comments about caffeine relate to a comparison with nicotine, not vaping.
      5. ‘Multiple organisations’ have multiple agendas, and not always committed to a scientific approach. I am talking about ‘material risk’, not the word ‘safe’, which has little useful meaning. Farsalinos and I agree on most things. If you want to understand the science a little more, look up the reviews of Hajek et al, 2014, Polosa and Farsalinos, 2014 Also, the summary of UK’s most experienced smoking cessation and prevention expert might help you understand why ‘multiple organisations’ can be wrong. West & Brown, 2014. The purpose of these reviews is to give a professional peer reviewed assessment of the available literature, which I would recommend you use in your professional work in the NHS.
      7. I’m not involved in this dispute or answerable for it, but I understand why it happened. I’m not sure why you are asking me about it or why you think it signifies anything.
      8. Just make sure you are upholding proper professional standards when you discuss science and risk with ordinary people using the NHS. The links above will help you take a professional approach to the science of this subject.

      Thank you for your interest in this blog – you have now reached the limit of my willingness to engage in debate with you as I am busy and have other priorities. May I suggest that instead of writing lengthy off-topic comments on my blog that you set up a blog of your own so that you can develop your ideas there? Try: https://www.blogger.com/home. It’s easy to set up, and I’m sure you’d attract a loyal following.

  • john

    sorry typo ” we made importing nicotine for personal use ilegal”

  • john

    Clive trying to regulate something as nebulous as ENDS , in a prescriptive way will run into some serious problems. Some involve serious definitional problems:

    For example: A while ago I came across a article by somebody from a theater background on, how he had ‘hacked’, in a afternoons work, a small theater ultrasonic smoke machine into a multiuser ‘hooka’ for his home. There are so many ways that could be used to create what is effectively a nicotine inhaler. And the web means that ideas spread very quickly and know few borders, these days.

    Others involve problems of ‘proportion’ eg if we made importing nicotine for personal use legal- what sort of penalty would we impose, jail terms large fines. And how much do we want to spend on policing a habit that is basically an issue for the user, inhaling nicotine without significant combustion products is hardly ,’Ice’ from a good social order perspective.
    As an analogy: some US jurisdictions have introduced mandatory drug testing of anybody getting welfare payments (often of as little as $50 a week), these tests cost about $40 a pop, and about %98 of these tests prove to be negative.

    For regulation of ENDS not to become a costly farce, there will need to be a fair degree of self compliance , co-operation and a lot more thought (and less huffing and puffing).

  • It appears some clarification is needed. At no point did our (ECITA’s) press releases surrounding the publication of the bibra report claim that vaping was “safer than washing up”; simply that, according to the classification system for CLP regulation 1272/2008, eliquids up to 2.5% are not classified at all, owing to their lack of toxicity, and that eliquids of between 2.5% and 5% are classified as Category 4, a category which also happens to include some washing up liquid.

    The purpose of our commissioning bibra to undertake this particular analysis was to get a conclusive answer – from recognised qualified experts in toxicology – as to the correct classification of eliquids containing low concentrations of nicotine in accordance with this legislation. bibra carried out the analysis, and reported back; their findings were then assessed by 3 other experts in this field, including a Professor of Toxicology, from around Europe, as well as by the Joint Lead for Product Safety at the Trading Standards Institute. Subsequently, the Health & Safety Executive has confirmed that ECITA took all the correct steps in making this assessment, and ensuring that the industry is informed about this new information so that it can transition to more accurate labelling within an appropriate period of time.

    Science can be a slippery fish sometimes. We can but hope that some common sense can be brought to bear when regulators and policy-makers around the world – including at the WHO – consider the growing body of published papers on this subject. When considering a piece of scientific evidence, there are many factors which need to be taken into account. I agree completely with the frustration expressed by Mr Bareham when the scientists appear to disagree on key issues. However, robust analysis of ALL the available data, taken ‘in the round’, can help enormously in finding the scientifically valid ‘truth’ (a slippery concept all by itself!). This, of course, is the approach taken by toxicologists such as those at bibra, as well as by many reputable researchers. Unfortunately, the ‘yan’ to their ‘yin’ are the junk scientists, the wasps, if you will, who appear to serve no useful purpose other than to make life unpleasant.

    Thank you, Clive, for your continued efforts to expose the junk, swat the wasps, and help lead us all to a more credible ‘truth’!

    Katherine Devlin
    President
    ECITA (EU) Ltd

  • David Bareham

    Dear Clive
    May I respectfully, but strongly suggest, that you have misinterpreted the purpose, results and direction of the very recent Goniewicz and Lee paper here: http://ntr.oxfordjournals.org/content/early/2014/08/28/ntr.ntu152.abstract.html. My reasoning is thus:
    • Goniewicz and Lee initially state clearly in their Abstract: “Nicotine from tobacco smoke has been shown to react with oxidizing chemicals in the air to form secondary pollutants, such as carcinogenic nitrosamines.” And then, in conclusion, state:
    • “Future research should explore the potential risks of thirdhand exposure to carcinogens formed from nicotine released from e-cigarettes.” And then, if you correctly appraise the research:
    • Perhaps the “Key Paper” for their study is: “Formation of carcinogens indoors by surface-mediated reactions of nicotine with nitrous acid, leading to potential thirdhand smoke hazards” Mohamad Sleiman et al, and they state that:

    “This study shows that residual nicotine from tobacco smoke sorbed to indoor surfaces reacts with ambient nitrous acid (HONO) to form carcinogenic tobacco-specific nitrosamines (TSNAs). Substantial levels of TSNAs were measured on surfaces inside a smoker’s vehicle. Laboratory experiments using cellulose as a model indoor material yielded a >10-fold increase of surface-bound TSNAs when sorbed secondhand smoke was exposed to 60 ppbv HONO for 3 hours. In both cases we identified 1-(N-methyl-N-nitrosamino)- 1-(3-pyridinyl)-4-butanal, a TSNA absent in freshly emitted tobacco smoke, as the major product. The potent carcinogens 4-(methylnitrosamino)- 1-(3-pyridinyl)-1-butanone and N-nitroso nornicotine were also detected. Time-course measurements revealed fast TSNA formation, with up to 0.4% conversion of nicotine. Given the rapid sorption and persistence of high levels of nicotine on indoor surfaces— including clothing and human skin—this recently identified process represents an unappreciated health hazard through dermal exposure, dust inhalation, and ingestion. These findings raise concerns about exposures to the tobacco smoke residue that has been recently dubbed “thirdhand smoke.” Our work highlights the importance of reactions at indoor interfaces, particularly those involving amines and NOx/HONO cycling, with potential health impacts.” (my emphasis)
    Therefore:
    1. There are many “surfaces” to be considered here, not just floors, windows etc but vehicles, chairs, beds, clothing, skin . . . . . and
    2. The authors are probably more concerned about exposure to “potent carcinogens”/TSNAs, produced by interactions between nicotine and sources of nitrous acid, rather than nicotine per se, but still concerned about nicotine . . . and
    3. Therefore, what levels of exposures here, to TSNAs, are agreed to be potentially harmful? This is something that you fail to even mention in your “critique”, subsequent to your focus on nicotine.
    4. Some state that there are NO safe levels of exposure to carcinogens, and therefore
    5. The Authors work is far from irrelevant, but in fact a piece of progressive science, building positively on previous work and proposing further development of work in this “unappreciated” area: and therefore needs to be applauded, rather than ridiculed.
    6. I believe that Goniewicz, judging from previous work that you note, wants e-cigarettes “to work”, but, as he is a conscientious scientist, he will not let his schema over-ride the necessity to explore all possible causes of harm to all populations.

    Moreover, please can you explain these following significant incongruities?

    1) At this year’s Global Forum on Nicotine Conference, Riccardo Polosa here http://www.youtube.com/watch?v=CdB-HffpuwM states in slides that nicotine is “a neurostimulant (NOT a poison)” – his emphasis. However, at the same Conference, here http://www.youtube.com/watch?v=oYnyHDG_vq8 Maciej Goniewicz clearly states in slides that nicotine IS a poison. There is clearly a significant difference of opinion here, which needs an explanation. Moreover, if there really is such a difference of opinion about such a central issue, then the only logical and ethical approach to issues surrounding nicotine is: a precautionary one.
    2) Riccardo Polosa states clearly in the above link that he believes that Propylene Glycol (PG) utilised in electronic cigarettes is “Safe”. However, Dr Farsalinos states here http://www.ecigarette-research.com/web/index.php/research/2014/182-lung-detox http://www.ecigarette-research.com/web/index.php/research/2014/182-lung-detox that:
    “It is true, and I have mentioned it repeatedly, that a GRAS substance for ingestion does not necessarily mean that it is safe for inhalation. However, it neither means that it is not safe.”
    There is this data http://www.ncbi.nlm.nih.gov/pubmed/11555686 furthermore which is cited in the recent AHA Statement on electronic cigarettes as you know, but possibly more importantly I believe, Dr Farsalinos has stated to me in email:

    “to tell you the truth i am more worried about the formation of formaldehyde from thermal decomposition of PG rather than PG itself.”

    As these two gentlemen both published together a key paper on a safety evaluation of the chemical composition of electronic cigarettes here http://taw.sagepub.com/content/5/2/67.short, should there not be agreement between them on this key issue?

    3) Furthermore, here http://www.bbc.co.uk/news/health-27161965 and here https://www.youtube.com/watch?v=gm90YJRQcRk Peter Hajek and John Britton respectively both state that the effects of nicotine are akin to caffeine. Here http://www.youtube.com/watch?v=oYnyHDG_vq8 Maciej Goniewicz states that nicotine alone “is generally accepted as a tumor promoter” and that “it’s metabolites can promote tumor growth”. This opinion is supported here: http://www.carcinogenesis.com/article.asp?issn=1477-3163;year=2013;volume=12;issue=1;spage=1;epage=1;aulast=Warren where the authors state that: “Nicotine and its metabolites can promote tumor growth through increased proliferation, angiogenesis, migration, invasion, epithelial to mesenchymal transition, and stimulation of autocrine loops associated with tumor growth. Furthermore, nicotine can decrease the biologic effectiveness of conventional cancer treatments such as chemotherapy and radiotherapy.” Does caffeine, therefore, if Peter and John are correct, also cause these significantly negative effects?
    4) This study by David Nutt et al http://www.karger.com/Article/Pdf/360220, which is also cited by Riccardo Polosa in the GNF link above, was formalised in July 2013 and published in April 2014. This means that it could not consider the data from the Kosmider et al and Hutzler et al data that we have previously discussed. Should therefore the “weighting” for ENDS be adjusted to account for this recognition for increased potential harm? Please note here http://www.ecigarette-research.com/web/index.php/research/2014/181-who-resp that Dr Farsalinos, regarding the Kosmider et al paper, states that: “the levels of carbonyls emitted from e-cigarettes can (under certain conditions) be similar to or higher than smoking”.
    5) I note here http://www.bibra-information.co.uk/e-cigarettes/ from this link http://www.fridays-group.com/2014/07/e-cigarette-risks-grossly-exaggerated-safer-than-washing-up-claim-experts/ that independent services are available for electronic cigarette companies to have their products tested for safety/toxicology. Moreover, I note here http://www.bibra-information.co.uk/portfolio/provision-hazard-risk-assessments-hundreds-flavourings-electronic-cigarettes/ that bibra state that:

    “The toxicological acceptability of such substances has historically been assessed for food and cosmetics applications, and their safety for use in electronic cigarettes (as inhaled flavourings) now needs to be substantiated.”

    It is heartening to see ECITA, therefore, finally testing “hundreds” of flavourings, but ironically, the links are found through the link above: the one claiming that electronic cigarette use is safer than washing up. Would you agree that such current claims about the safety profile of electronic cigarettes are, therefore, both presumptuous and premature? As this http://ntr.oxfordjournals.org/content/early/2014/09/22/ntr.ntu197.abstract very recent review states: “Since new potentially harmful substances may be produced during heating process, analyses of aerosol are needed to correlate its composition to the chemical components of liquids.” This clearly relates to both solvents (e.g. production of carbonyl carcinogens and toxins) and flavourings, as well, possibly, as identified “contaminants” e.g. coumarin (see Hutzler et al).

    6) Finally, I note with interest here http://tobaccoanalysis.blogspot.co.uk/2014/09/discontinuation-of-crowdfunding.html an extraordinary and very recent statement from the ardent pro-harm reduction advocate, Professor Michael Siegel. He states that:

    “Unfortunately, however, we discovered that there is great divisiveness within the e-cigarette community regarding the role of research—including what type of research should be done, who should do it, and who should pay for it. We welcomed feedback and suggestions about creating an optimal study design for BSCiTS, and we sought to be responsive to concerns about study methodology. However, the tone of feedback directed at our team quickly became hostile. Our integrity as researchers was questioned, and criticism quickly shifted from concerns about study methods to personal attacks.”
    Would you agree that such apparent divisiveness from some segments, at least, of the e-cigarette industry about the role of research and the integrity of researchers, is incongruous with the scientific method and with public health?
    Yours sincerely
    David Bareham

    • Clive Bates

      Sorry I don’t have time to leave a lengthy reply.

      0. The paper is focussed on “3rd hand nicotine exposure” – see its title. The exposure to environmental carcinogens from this source would be very low indeed and the pathways highly unlikely to lead to any material risk. I don’t have it here, but I don’t think they measured carcinogens – if they had, it would be a useful discussion. There are several other flaws in this work. As I said in the actual post on this, let them form a hypothesis, give their reason why they think it is plausible, and then devise tests to falsify it. This they have not done.

      1. Nicotine is a poison at high doses, not at low doses.

      2. PG has ‘generally recognised as safe’ status, including for inhalation. Thermal breakdown products are an issue – but only become significant when the product is used in extreme circumstances, running very hot or dry. Polosa and Farsalinos statements are not inconsistent.

      3. The comparison with caffeine used by these experts is to give a scale of risk that makes sense to ordinary people, not to say that the risks are identical. They do this to stop the negative harmful effects of public health representatives overstating risks – implicitly or explicitly – and therefore frightening people back into using cigarettes or not switching You may be doing this yourself. ‘Tumour promoter’ is widely misused or misunderstood and the evidence for it is highly speculative – based on very high doses administered in mice study.

      4. The Kosminder study produced higher level of some toxicants only when the devices were run under unrealistic conditions. It would not change the estimate in the Nutt et al MCDA. The fact that they attributed any risk at all to these products was to anticipate unknowns, because there is nothing at present that suggests any material risk.

      5. ECITA’s claim relates to the safety profile of nicotine liquids at retail concentrations for accidental exposure – their analysis makes that clear, and their conclusion is that it as hazardous as washing up liquid. I see no flaws in their reasoning. I support some testing and regulation to get a better insights into flavours – but the greatest danger is that excessive regulatory reaction to minute risks will compromise the appeal of e-cigarettes to smokers and we end up with more smoking. So when you raise these issues, do please keep in your mind that your extreme risk aversion on behalf of others, may be putting people at far greater risk than those you are keen (or their behalf) for them to avoid.

      6. The disagreement over the proposed crowd sourced research was over: whether it would yield useful results; whether RCTs are the right way to understand this phenomenon; whether it was a realistic ask for crowd-funding; what opportunity costs it would create. Dispute is at the heart of the scientific process. If you want to look at junk science and improper scientific discourse, I would suggest starting with tobacco control science and related spin.

      I’m assuming you aren’t a vaper. I believe you work for the NHS. If I may give you some advice, the approach you are taking here (unquantified emphasis on very small or implausible cherry-picked risks) is a very harmful form of risk communication and the subject of most of my report on WHO. It is likely to discourage people from trying vaping as an alternative to smoking. The result will be more smoking and more death and disease.

      • john

        Clive I think Mr Bareham should have a read of this.
        https://theconversation.com/the-10-stuff-ups-we-all-make-when-interpreting-research-30816
        especially the section on: “Significant doesn’t mean important”

        • Clive Bates

          John – that’s a very cool link, thanks… Haven’t seen that before. Clive

        • john

          Clive
          re Kosminder et al. Has there been any follow up re the liquid (“A6”, from memory )which produced no toxins , even when subject to more than 10 watts, for nearly 3 seconds.

          PEG does look like a better carrier liquid for these devices – it is very stable to about 300+C, on the other hand PG does look like it is not ideal, the irony is that PEG used to be common , until some ‘scientist’ raised some scare about it
          And it turns out that there are some very sophisticated (and expensive ) devices on the market that do give precise control over temperature, unfortunately all of them (so far) are intended for heating… ‘herbs’ and are unsuitable for e liquids

        • Uri

          Re Kosmider et al, there has not been attention given to the fact that metals play a catalytic role in the thermal degradation of PG and/or resulting chemicals:
          http://fire.nist.gov/bfrlpubs/build83/PDF/b83006.pdf
          http://fire.nist.gov/bfrlpubs/build85/PDF/b85009.pdf
          http://fire.nist.gov/bfrlpubs/build85/PDF/b85010.pdf

          I also found he following in an Altria EC patent:

          “In the preferred embodiment, the heater coil is formed from a nickel-chromium alloy that is essentially free of iron content.
          Experience has indicated that heater coils constructed from an iron chromium alloy suffered oxidation of their iron content if the alloys were contacted with water during manufacturing operations, during shelf-life and/or operation of the device.
          It is known that heating glycerin and/or propylene glycol beyond certain temperatures produces carbonyls (which include formaldehydes).
          Iron oxide tends to catalyze these reactions such that carbonyls are produced at lower temperatures. By using alloys essentially free of iron content, such catalyzation is avoided and the possibility of producing carbonyls and other constituents is minimized.”

          Many EC coils have iron (i.e. in widespread kanthal alloy), and copper – another potent catalyst for thermal degradation of PG – has been found in (clinically insignificant levels, but high levels compared with other metals found) EC vapor.

          The Kosmider study didn’t yet address these issues.

  • john

    For any australian readers of this site- The 2012 Australian delegation was headed by the previous (labor) minister for health, the current Australian government minister is Peter Dutton : http://www.health.gov.au/internet/ministers/publishing.nsf/Content/Profile-PD-1

  • Thanks!

    My letters (in German) to the german voice of the WHO / FCTC (Dr. Pötschke-Langer at DKFZ [cancer research]) and relevant ministries:

    https://www.facebook.com/notes/norbert-zillatron/betreff-cop6-an-mpoetschke-langerdkfzde/1507605042814763
    https://www.facebook.com/notes/norbert-zillatron/who-cop6-oktober-2014-in-moskau-bmel-bmjv-bmg/1508448762730391

    No answer yet. And I don’t really expect any. It probably went straight down the drain. Just like my mails to ministries concerning the trialogue massacre.

  • uri

    How can I find out who the delergates of my country are?

    • Clive Bates

      Uri – very good point. I’ve added sections to the post on writing your own letter, finding delegates etc. It was too late and I was too tired to do it last night… I hope this is useful.

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