February 25th, 2014

Unable to take any more, I write to Dr Nathanson of the BMA (updated)

Vinenne Nathanson, BMA

Apex of the public health establishment – but are their views on e-cigarettes coherent and well-informed?

I powered up the iPlayer to listen to Chris Snowdon of IEA (and a vaper) and Vivienne Nathanson of the BMA debate e-cigarettes  on You and Yours 21 February 2014. This was on the occasion of Vype e-cigarettes beginning an advertising campaign on TV.  Vype is made by Nicoventures, the e-cigarette subsidiary of BAT – British American Tobacco – so it is of course controversial.  I was depressed and disappointed by some of the arguments made by Dr Nathanson, though sadly these are all too typical in the public health establishment. 

… unable to take any more, I decided to email Dr Nathanson to ‘pick up on a few points’ made in the interview.

22 February 2014 

Dear Dr Nathanson

I have just listened to your Friday interview on e-cigarettes on You and Yours via BBC iPlayer (from 1′ 25).

I would like to pick up on a few points you made in the interview… I am writing this so that you can consider these arguments and evidence and decide if you wish to continue to make these points in the media.

1. Doubt about whether e-cigarettes are safer than cigarettes. You left an opening for doubt that e-cigarettes may not be safer than smoking: “...almost certainly… but we cannot tell for sure” were the words used. Actually we do know for sure. The reason we are sure is down to basic physics and chemistry.  The primary risk from smoking arises from combustion of organic material, which is then inhaled as smoke particulates and toxic gases into the lungs.  We know with certainty that process is completely absent from all e-cigarettes.  There is no conceivable mechanism in e-cigarettes that could create similar risks and no-one to my knowledge has proposed one.  The more realistic question is whether the reduction in risk is 99% or 99.9%.  Contrived equivocation over what is known beyond dispute is a disreputable tactic – it adds to public confusion and creates baseless concern.

2. Scientific uncertainty. While it may have been acceptable in 2008 to play on how little was known, that really is not credible today.  We know a considerable amount about these products and there is an ever growing body of literature and commentary.  As a general introduction, I recommend this review and all the sources it draws together: A fresh look at tobacco harm reduction: the case for the electronic cigarette.

3. Unknown toxicity. On the specific point you raised about toxicity, this has also been extensively studied. The products are usually a simple mix of nicotine, excipient, water and a flavouring, and these are not subject to high temperature processes that would create products of combustion.  It is possible that there are residual contaminants and some breakdown products, but these have so far been found at an extremely low level. One detailed survey assessed 9000 observations.  It concluded exposure to active e-cigarette users for almost all contaminants was below 1% of the threshold limit values used for involuntary workplace exposure, which is in itself an exacting standard.

There was no evidence of potential for exposures of e-cigarette users to contaminants that are associated with risk to health at a level that would warrant attention if it were an involuntary workplace exposure. The vast majority of predicted exposures are <1% of TLV. Predicted exposures to acrolein and formaldehyde are typically <5% TLV. 
Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks 

This is not to argue for no regulation, but for some basic standards that govern purity of ingredients and operating parameters of devices. Sadly, in the misguided attempt to have these non-medical products regulated as medicines, the public health community has failed to contribute to development of such standards that would actually be useful and proportionate.

4. Cancer causing agents. You raised the spectre of ‘cancer causing agents’ being present in e-cigarettes.  I am sure you know that it is emotive and misleading to imply that the presence of a hazardous substance represents a material risk to health. Risk depends on exposure.  Cancer causing agents are present in pretty well everything, including ambient air.  If you have this approach to e-cigarettes, how would the BMA cope with coffee, for example?  It is literally the case that we do not know what is in each cup – the roasting process is chemically uncontrolled and creates many de novo chemicals, including numerous carcinogens – see this statement from one of the pioneers in the field:

Over a thousand chemicals have been reported in roasted coffee: more than half of those tested (19/28) are rodent carcinogens. There are more rodent carcinogens in a single cup of coffee than potentially carcinogenic pesticide residues in the average American diet in a year, and there are still a thousand chemicals left to test in roasted coffee.
The causes and prevention of cancer: the role of environment (1998).

5. Quit rates. You assert that the quit rate with e-cigarettes is about the same as patches and gum. But that is based on a single RCT (Bullen et al 2013) using old products and with none of the real world advantages of e-cigarettes built in (eg. higher consumer preference, experimentation with different devices, learning over time, and of course the better products that have evolved since the study was conducted etc). Even so, raw data showed higher quit rates for e-cigs than the NRT arm, but the study did not have the power to show these with 95% confidence.   If, instead of relying on the most pessimistic interpretation of one study using technology that is now obsolete, you took all the evidence into account I think you would come to a different conclusion, especially when you consider efficacy in a real world setting rather than in an RCT. You might find this survey from Robert West’s group interesting in that regard:

Conclusion: Among smokers stopping without professional support, those who use e-cigarettes appear more likely to be able to remain abstinent than those who use a licensed NRT product bought over-the-counter or no aid to cessation. 
Real world effectiveness of e-cigarettes – a population study

If you look at the detailed numbers in the abstract, e-cigarettes are substantially more effective in this survey.

6. Gateway effect. You drew on the idea of a gateway effect and ‘renormalisation’ of smoking, or that e-cigarette users would somehow progress from vaping to smoking. This argument was used to justify banning snus in 1992 in the EU (other than Sweden), but the effect never materialised and in fact in both Sweden and Norway, snus acts as an exit gateway from smoking, and diverts young people from smoking onset.  I think everyone who comments on e-cigarettes needs to understand the snus story, and I recommend this letter to Jeremy Hunt from a dozen experts as good starting point. This is important because harmful regulation (a ban) followed from irresponsible population-effect arguments and, as a result, many smokers have been denied access to these much-safer products. There was no scientific, ethical or legal basis for that, and there is a danger that restrictions on e-cigarettes will repeat this lethal error leading to thousands of unnecessary smoking related deaths.  Your assertions about progression from vaping to smoking were quite rightly challenged on the programme: there is no evidence to suggest this pathway exists in reality or is any more than a theoretical construct created for campaigning purposes. If you know of any, please share it. Far more likely is that e-cigarettes will create beneficial pathways out of smoking for existing smokers or divert people who would otherwise have become smokers into vaping.  When the BMA campaigns aggressively, but without evidence of a harmful gateway, it risks diminishing the health benefits that would arise from the beneficial gateways and thereby contributing to more death and disease.  I have written about the gateway effect in some detail here: We need to talk about the children – the gateway effect examined. I would advise much greater care about protecting the health-positive pathways that introduction of a vastly reduced risk product creates.

7. Medicine regulation. You continue to press for these products to be subject to compulsory medical licensing, as if that is the only way that ‘safety’ can be guaranteed.  There are so many objections to this reasoning that I am unable to list them all here, but let me try a few:

  • The products are not medicines – they are not sold or bought as medicines any more than cigarettes are.
  • Six courts in EU member states and the US courts have so far rejected medicines designations for these products, for largely the same reasons. If you would like to understand why this happened, the some of the reasoning is available in this: Are e-cigarettes medicines?
  • Medicine regulation does not give assurance that products are ‘safe’ – it makes a judgement on risks and benefits, and authorises products like Bupropion and Varenicline that are definitely not ‘safe’.
  • It is perfectly possible to regulate these products without classifying them as medicines – there are standards set for many non-medical products under consumer protection regulation. Sadly, the public health establishment ignored this option.
  • Medical regulation is complex, burdensome and restrictive.  It would create high barriers to entry, reduce competition, protect incumbents and favour the industry with the deepest pockets.  It would favour big tobacco – a view shared by many investment analysts.

For more on why regulating these products as medicines is a bad idea, please take a look at this critique of the pro-medicine regulation case as argued by the European Parliament’s rapporteur.   The optimum regulation for these products has to balance control of risks arising from e-cigarettes with realisation of benefits through smokers switching to e-cigarette use.

8. Advertising ban. You want e-cigarette advertising banned. On what basis?  Tobacco advertising is banned in the EU because smoking kills over 500,000 people in Europe annually, and this justification is coded into the tobacco advertising directive 2003/33/EC at recital 3. There is no equivalent justification for banning e-cigarette advertising, and no conceivable reason to protect the cigarette market from challenge by a disruptive entrant that appears to be reducing cigarette sales significantly, at least while it is still allowed to advertise.  If controls beyond the standard advertising code are necessary at all, they can be of the form used to control alcohol advertising in non-broadcast and broadcast media.  Some commentators seem shocked that e-cigarette advertising sometimes looks glamorous or reminds them of vintage cigarette adverts…  they should not be.  This is the important work of appealing to smokers to switch from smoking to vaping, and they will not achieve that with ads that look like ads for athletes foot cream. Again, your preferred approach of a ban assists tobacco companies to two ways: firstly by reducing e-cigarette category competition with cigarettes, secondly because advertising bans favour businesses with established distribution chains and experience of promoting their products without the benefit of advertising – namely tobacco companies.

9. Tobacco industry. I realise the involvement of the tobacco industry is a cause of concern, and I too am cautious. But I am cautiously optimistic. It is actually better if these companies offer their customers options that do not cause death and disease  The idea that they are doing this to protect the cigarette industry falls at the first fence.  The combined tobacco-owned e-cigarette companies have less than 10% of UK market share and there is no conceivable way they could protect cigarette sales in a competitive e-cigarette market. There is no homogenous Big Tobacco in the marketplace: each company will try to sell e-cigarettes as hard as possible.  If they do not produce attractive products that smokers like they will lose out to their competitors – other tobacco companies or non-tobacco e-cigarette companies. Competition will drive innovation that will make e-cigarettes increasingly attractive as an alternative to smoking and will take more of the cigarette market as a result.  The biggest risk to this market place is excessive regulation, not the involvement of tobacco companies per se.

10. Missing empathy.  I wish that the health and medical establishment, of which you are part of the apex, would find time to listen to what the users of these products say and to understand the experience they have had.  There are now thousands of moving and visceral testimonies from people whose lives have been transformed by these products.  These experiences should be what inspires public health professionals – and in rare cases it actually does (see this initiative at an NHS stop smoking clinic). However, the public health establishment has largely responded to the rise of e-cigarettes with an obsessive aversion to minor or implausible risks and casual disregard for the great life-enhancing opportunities.  It is a depressing, prudish, prohibitionist outlook, when there is room to be far more positive. I would like to invite you to contrast the comments from vapers in this posting with the sour and lazy cynicism of public health establishment: Where is the humility? Where is the empathy?

This also starts with a quote from one of the nation’s best loved GPs.  I think this doctor has it right and the doctors’ trade union has it wrong.

For the record: I wholeheartedly support use of E-cigs and think banning them would sound the death knell for smokers everywhere. 
Dr Christian Jensen 

I have tried to provide responses to most of the points you made on the radio in good faith and with good intentions.  I hope you will not just dismiss these comments but consider them seriously and rethink the BMA’s approach to this important public health opportunity. I think the organisation is now out of step with evidence, ethics and experience.

Best regards

Clive Bates

Update: 4 March 2014 reply from Dr Nathanson

From: Vivienne Nathanson
Date: 4 March 2014 15:26
Subject: Re: What we do know about e-cigarettes
To: Clive Bates

Clive

Thank you for your email.

I shall take the points you raise to a future meeting of the Board of Science which writes /defines BMA policy in this area.

Best wishes

Vivienne

Professor Vivienne Nathanson
Director of Professional Activities
British Medical Association

I replied, with hope and exhortation.

From: Clive Bates 
Date: 4 March 2014 16:33
Subject: Re: What we do know about e-cigarettes
To: Vivienne Nathanson

Dear Vivienne – that’s a very welcome move. I hope they approach the issue with open minds. BMA could make a big difference here.

Clive Bates

33 comments to Unable to take any more, I write to Dr Nathanson of the BMA (updated)

  • […] Clive Bates' resounding take-down of a BMA rep's radio interview Or – alternative de-bunking of the standard ANTZ propaganda talking point(??) […]

  • Sue Skillicorn

    Great letter. but is there any evidence that the woman reads the letters, or responds in anything but a standard ‘thank you for your letter, which is receiving attention’ – before it goes in the bin?

    • Clive Bates

      Who knows what effect it has… but if it causes a pause for thought before speaking out it helps. Dr Nathanson has actually replied saying:

      I shall take the points you raise to a future meeting of the Board of Science which writes /defines BMA policy in this area

      I think that is positive and a welcome development – the scientific knowledge is evolving after all. Let’s see what happens.

      Clive

  • I am in two minds about this entire attempt to clasify ecigarettes as medicinal and before I get incoming rounds from my own comrades in the industry let me explain why.

    I not only accept that ecigarettes are not medicinal I have hands on experience creating flavours, producing eliquid and on several occasions even getting my hands dirty fixing a broken bottling machine….so as a manufacturer I know precisly what goes into eliquid and also what does not.

    But there is an opportunnity here to bite the bullet and allow the BMA and MHRA to fall flat on their face and it goes lie this.

    Eliquid in fact cannot be determined as something that has a psysiological effect in the manner in which medicines are decided based on EU law.

    Any attempt to change that law to encompass eliquid would result in other products which also do not have such effects being caught into that regulation. I’m thinking of tobacco, coffee and even honey and other food products.

    So let the MHRA attempt to regulate as a medicine at which point the law would fail on the first challenge in court as happened in the rest of Europe.

    A courtroom is not a blog or forum. Opinions do matter in a courtroom but those opinions must be backed up with evidence, real evidence not just attempts to say there is or is not evidence. The MHRA and BMA have no evidence of harm, no evidence that such a measure is proportional to the risk and no bodies on trollies in hospitals the way they do with tobacco to support their assertions.

    Moreover they also keep insisting there is no science to back up the safety of evigs, which is great news, if they really believe that (and they don’t) then it will come as a great surprise to them in a courtroom when mountains of evidence is presented to their legal team.

    Even such evidence as there is they can wheel out actaully demonstrates the opposite of any social ills or public health issue that might arise.

    For example they whip out the FDA’s 209 report which actaully tells one that
    1. its not repeatable or testable
    2. even if true it actaully demonstrate the low levels of toxins in eliquid.
    3. It also demonstrates that when confronted the company concerned FIXED the problem and have never had antoher product identified with even the unharmful trace amounts recorded.

    That doesn’t look like its something anyone would like to bring up in a courtroom in front of a jusde as a reason to disregard EU and UK existing law.

    The result of losing a court case would be the usual…a round of witch hunting and firings that would make the eyes water. These are civvil servants, they always face the chop when the chips are down and they know it too!

    So, if they really want to lose their jobs becaseu they lost a court case then so be it, they certainly won’t be able to make non existant records of public harm appear from nowhere to suit their agenda uness they start poisoning the population with didgy eliquid manufactured by themselves.

    Even then like any product a recall would b made and addressed. We didn’t ban baby food or seed medical authorisation in the 1980’s during the Cow and Gate scandal.

    Next after losing the right to authorise eliquid as a medicine it would be extremely hard to then do a complete U-Turn and try to regulate it as anything other than a recreational product. Morevore the spotlight of having lost such a battle would weigh heavily on any politician tasked with addressing the issue. They would likely pass the buck for years…in fact so many years it would be impossible to then try to cite any harmful effect EVEN if one emerged.

    Lastly I think that the angle of ‘ohh the children, think of the children’ and ‘what about the gateway effect’ are two things that actauly have bone-fide studies completed and done by a reputable organisation.

    In court it would look incredibly bad for the BMA to be poo-pooing research carried out by ASH UK or frawing invisible potentials that are clearly all going the other way.

    My guess is this is a bluff and it should be called right now before these idiots in the BMA and MHRA actually start believing their own rubbish as can often happen in any institution.

    The bluff can be called easily by informing thme that the day medical authorisation becomes law is the very same day a larghish eliquid compnay will flout the law and initiate a court case calling in the EU directive on what constiutes a medicne and the UK governments acceptence of this by having it almost word for word as UK law too!

    They would back down faster that you can say ’20ml of that stuff there please shopkeep!’

  • Congratulations Clive, you have once again summed-up all the issues in a clear and succinct way. Your letter should be required reading for all those involved in deciding the future of electronic cigarettes.

    It is staggering that so many influencers and decision makers (Vivienne Nathanson being a good example, but sadly not a rare one) are arrogant enough to fall back on tired old rhetoric, rather than to assess the current body of scientific evidence (to which you’ve hopefully now directed them).

    They forget that their influence could determine the fate of around 7 million European smokers who are likely to die over the next decade, unless they have access to this fresh alternative.

    The net result is that we’ll continute to suffer the passive effects of smoking, in much the same way as we’re expected to tolerate the secondary impact of their misguided policy choices.

    • Clive Bates

      What is especially interesting to me is that the public health community doesn’t seem to have any internal challenge, quality control or intolerance of nonsense. It’s as though the tobacco issue, and presence of the tobacco industry, creates such a strong sense of righteousness that it just allows all that to be sidestepped. I think this is why other campaigners want an enemy like Big Tobacco – Big Food, Big Sugar, Big Booze etc – as it makes an awful lot easier.

  • Kurtis Sunday

    An excellent letter.
    I have printed out some of your posts here and sent them to some MEPs.
    The level of ignorance exhibited and spin perpetrated by various individuals in public ond private instituions regarding this issue is appalling. It makes one wonder about what misinformation is being put out there on other issues.

  • Samantha

    What a cogent and wonderfully constructed argument! Thank you so much for your time and effort in campaigning for the vaping community :)

  • Uma

    Bravo!! Great fact filled letter, calm, cool, & sensible.
    I wish someone would correct Slantzz letter to WHO . http://dropproxy.com/f/661
    He’s also sent letters to city councils, etc.. Grrr

  • Viv Nathanson is a proven liar: exposed on radio as a blatant liar when she vigorously and forcefully defended her claim that the famous ’23 times’ measurement came from a peer-reviewed study, when it subsequently turned out to be an April Fool joke perpetrated in a comic or some such. That episode is probably the least significant of her lies.

    It’s very hard to tell whether she is a just a barking mad crackpot or one of the usual murderously corrupt scum found floating at the top of the tobacco control industry pond. Her lies and propaganda come straight out of the pharma playbook so it would be easy to dismiss her as just another pharma whore; but someone as crazy as she seems can’t just do it as a job.

    They say that doctors put up with the mad Marxist malpractice of the BMA management because their negotiating skill with the NHS has made every GP a potential millionaire. I don’t begrudge them the money at all, but I do wish they would not employ vicious sociopaths as spokespersons.

    • Dodderer

      On Radio 4s Today programme Vivienne Nathanson of the BMA was questioned about her evidence:

      Nathanson: Well, the evidence is, in fact, that the levels of toxins that can build up in a car do reach 23 times the levels in a smoky bar…

      Interviewer: And that is—sorry to interrupt you—but that is peer-reviewed?

      Nathanson: Yes, absolutely.

      Interviewer: Everyone in the scientific community accepts that it’s true?

      Nathanson: Absolutely.

      The BMA has since issued a major correction and apology with the explanation that the mistake was caused by human error. These things happen but as Head of Science and Ethics, Nathanson has a duty to check. I find her glib assertions regarding peer review and scientific consensus indefensible. It is hard to see how they could be made in error.

      http://www.liberal-vision.org/tag/deborah-arnott/

  • […] I powered up the iPlayer to listen to Chris Snowdon of IEA (and a vaper) and Vivienne Nathanson of the BMA debate e-cigarettes on You and Yours 21 February 2014. This was on the occasion of Vype e-cigarettes beginning an advertising campaign on TV. Vype is made by Nicoventures, the e-cigarette subsidiary of BAT – British American Tobacco – so it is of course controversial. I was depressed and disappointed by some of the arguments made by Dr Nathanson, though sadly these are all too typical in the public health establishment. … unable to take any more, I decided to email Dr Nathanson to ‘pick up on a few points’ made in the interview.  […]

  • Jon Holland

    A first class letter although I suspect the BMA will as usual just ignore it. I don’t remember ‘Sense about science’ getting a reply to their letter challenging the BMA’s stance on Ecigs.

  • vapingpoint

    Thank you Clive for your support of vaping. Is it not really the fact that, clearly, vaping is a pleasing substitute for smoking – and thus cannot be supported – ever? It cannot be, because of the deliberate previous demonisation of smokers and smoking, who are killing themselves with their filthy nicotine “habit”. Vaping gives smokers something nice to do instead of quitting. All the efforts of the anti smoking industries and health charity industries around the world who have made money off the back of these poor, helpless, dying smokers, would find that the new vaping substitute would render them obsolete. These are people hanging onto their jobs! You cannot expect anything other than obfuscation, lies and bloody mindedness. They need someone to persecute in order to put food on their tables. Its about work and keeping jobs or the future. As I have said before here, it’s the anti smoking ideology that is the problem for electronic cigarettes.

  • Simon

    I purchased my first ‘look alike’ from my local garage 3 weeks ago, and my last rolling tobacco 4 days ago. A good vaping device purchased 3 days ago from a local shop (open a week) and I am now tobacco free.

    The last of the tobacco I have rolled and will mount in a glass fronted box with the words ‘Break in the event of Regulation’

  • Jonathan Bagley

    A the end of the programme, Nathanson defined the purpose of ecigs as an aid to quitting smoking. That is what most annoys me – the Public Health Industry telling me why I am vaping.

  • Medicinal product, medicinal regulation, MHRA… apart from her logical fallacies, factual errors, and unevidenced assertations… she’s still of the view that the UK should and will take this route. I’m certain that she’s not alone and that the ‘medicine by function’ boulevard is getting ever closer for the UK.

  • […] This letter from Clive Bates to Dr Vivienne Nathanson of the BMA makes good reading. It follows a debate with Dr Nathanson and Chris Snowden on a BBC radio programme. Reply With Quote […]

  • […] This is definitely going in my list of must reads […]

  • lizzie

    I was very disappointed that the BBC gave her the first word and the last word. It seems so difficult to get across all the facts to the general public. They go away with the idea that e cigs are not regulated and therefore not safe.

    I never ever knew what I was smoking, but what I do know, like other vapers, what is in the e cigs I use.

  • […] I powered up the iPlayer to listen to Chris Snowdon of IEA (and a vaper) and Vivienne Nathanson of the BMA debate e-cigarettes on You and Yours 21 February 2014. This was on the occasion of Vype e…  […]

  • Rhidders

    On her BMA biography it says:

    “Dr Nathanson has a particular interest in public health, ethics, weapons control and human rights.”

    Ethics and human rights…hmm…I would seem that these things have completely been ignored by her and other health bodies. How Article 18 has been made in its rushed way by skipping over key aspects of legislation making within the EU is, in my opinion, unethical. Also, a ban or restriction through over-regulation is in essence taking away the freedom to choose. Surely freedom to choose is a human right. I think so! I have the freedom to choose to post this reply and I (currently) have the freedom to choose to use my e-cigarette.

  • Lynne James

    Yet again you have so eloquently challenged the propaganda we hear over and over again. Thank you Clive for your sustained efforts. We Vapers write letters and help keep up the pressure but your command of the arguments is phenomenal. to read letters like this helps calm me down after screaming at the radio.

  • Tom Jasper

    Chris,

    Just wanted to say that you’re amazing and to thank you.

    May I be so bold as to write to the You and Yours editorial team with a copy of this text.

    They can be contacted by
    http://www.bbc.co.uk/radio4/features/contact-forms/you-and-yours/
    email [email protected]

    or through post (more effective)
    We can also be contacted by post

    You & Yours
    BBC Radio 4
    Dock House
    Salford
    M50 2BH
    U.K

    Never give up.

  • Dodderer

    The RPS announced its ecig policy yesterday and,of course,the BMA has a similar one.In theory,these policies will have been decided based on a careful review of all available evidence and due consideration given to weighting this evidence.

    I believe Dr Farsalinos identified 97 relevant studies – could someone ‘with clout’ respectfully ask the RPS and the BMA for further details of their assessments of the evidence?

  • Alan Depauw

    It is weird to see legislation being passed that is so clearly liberticidal and contrary to what should be the objective of a decent public health policy: to reduce the risk to the health of millions of smokers and not to seek to eradicate a perceived behavioural trait.

    It is deeply saddening to see public institutions, at national and at European level, wilfully disseminating disinformation and following legally flawed and opaque decision-making processes the likely outcome of which will certainly be challenged in the Courts.

    Shame on MEPs who will have allowed this to happen, bowing to powerful lobbies and deaf to the heartfelt plea of millions of their voters!

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