On 2016 Sep 10, ROBERT COMBES commented:

Robert Combes and Michael Balls

In a recent exchange of views, in PubMed Commons, with Simon Chapman on the effectiveness and safety of vaping for achieving the cessation of tobacco smoking, provoked by a paper published by Martin McKee [and comments therein], Clive Bates has criticised one of our publications. The paper in question urges caution concerning any further official endorsement of electronic cigarettes (ECs), at least until more safety data (including results from long-term tests) have become available. Bates questions why we should write on such issues, given our long-standing focus on ‘animal rights’, as he puts it, and from this mistaken assumption he makes the remarkably illogical deduction that our paper is without merit. Bates also implies that our views should not be taken seriously, because we published in Alternatives to Laboratory Animals (ATLA), a journal owned by FRAME (Fund for the Replacement of Animals in Medical Experiments), an organisation with which we have been closely associated in the past.<br> We have written a document to correct Bates' misconceptions about who we are, what our experience is, why we decided to write about this topic in the first place, what we actually said, and why we said it. In addition, we have elaborated on our views concerning the regulatory control of e-cigarettes, in which we explain in detail why we believe the current policy being implemented by PHE lacks a credible scientific basis. We make several suggestions to rectify the situation, based on our careers specialising in cellular toxicology: a) the safety of electronic cigarettes should be seen as a problem to be addressed, primarily by applying toxicological principles and methods, to derive relevant risk assessments, based on experimental observations and not opinions and guesswork; b) such assessments should not be confused with arguments in favour of vaping based on how harmful smoking is, and on the results of chemical analysis; c) it would be grossly negligent if the relevant national regulatory authorities were to continue to ignore the increasingly convincing evidence suggesting that exposure to nicotine can lead to serious long-term, as distinct from acute, effects, related to carcinogenicity, mutagenicity (manifested as DNA and chromosomal damage) and reproductive toxicity; and d) only once such information has been analysed, together with the results of other testing, should risks from vaping be weighed against risks from not vaping, to enable properly informed choice.<br> Due to space limitations, the pre-publication version of the complete document has to be downloaded from: https://www.researchgate.net/publication/307958871_Draft_Response_regarding_comments_made_by_Clive_Bates_about_one_of_our_publications_on_the_safety_of_electronic_cigarettes_and_vaping and our original publication is available from: https://www.researchgate.net/publication/289674033_On_the_Safety_of_E-cigarettes_I_can_resist_anything_except_temptation1

We hope that anyone wishing to respond will carefully read these two documents before doing so.

On 2016 Aug 24, Clive Bates commented:

In response to Professor Daube, I am pleased to have the opportunity to explain a different and less authoritarian approach to the public health challenges of smoking.

1. But let me start with a misunderstanding. Professor Daube accuses me of a personal attack on Professor McKee. In fact, I made five specific substantive comments on Professor McKee's short letter, to which Professor Stimson added a further two. These are corrections of fact and understanding, not a 'personal attack'. It is important that academics understand and recognise this distinction.

2. Professor Daube draws the reader's attention to a link to an investor presentation by Imperial Tobacco. I am unsure what point he is trying to make. Nevertheless, the presentation paints a rosy picture of life in Australia for this tobacco company: it is "on track" (p6); it has "continued strong performance in Australia" (p15); in Australia it is "continuing to perform strongly - JPS equity driving share, revenue and profit growth" (p31). It may be a hard pill to swallow, but tobacco companies in Australia are very profitable indeed, in part because the tax regime allows them to raise underlying pre-tax prices easily.

3. It's a common error of activists to believe that harm to tobacco companies is a proxy for success in tobacco control (an idea sometimes known as 'the scream test'). If it that was the case, the burgeoning profitability of tobacco companies would be a sign of utter failure in tobacco control [1]. We should instead focus on what it takes to eliminate smoking-related disease. If that means companies selling products that don't kill the user instead of products that do, then so be it - I consider that is progress. If your alternative is to use coercive policies to stop people using nicotine at all, then you may make progress... but it will be slow and laborious, smoking will persist for longer and many more people will be harmed as a result. These are the unintended consequences of taking more dogmatic positions that seem tougher, but are less effective.

4. In any event, my concerns are not about the welfare of the tobacco industry in Australia or anywhere else. My concern, as I hope I made clear in my response to Professor Chapman, is the welfare of the 2.8 million Australians (16% adults) who continue to smoke despite Australia's tobacco control efforts. For them, the serious health risks of smoking are compounded by some Australian tobacco control policies that are punitive (Australia is not alone in this) while being denied low-risk alternatives. All the harms caused by both smoking and anti-smoking policies can be mitigated and the benefits realised by making very low-risk alternatives to combustible cigarettes (for example, e-cigarettes or smokeless tobacco) available to smokers to purchase with their own money and of their own volition. Professor Daube apparently opposes this simple liberal idea - that the state should not intervene to prevent people improving their own health in a way that works for them and harms no-one else.

5. Professor Daube finishes his contribution with what I can only assume is an attempted smear in pointing out that I sometimes speak at conferences where the tobacco industry is present, as if this is somehow, a priori, an immoral act. I speak at these events because I have an ambitious advocacy agenda about how these firms should evolve from being 'merchants of death' into supplying a competitive low-risk recreational nicotine market, based on products that do not involve combustion of tobacco leaf, which the source of the disease burden. So I, and many others, have a public health agenda - the formation of a market for nicotine that will not kill one billion users in the 21st Century, and that will perhaps avoid hundreds of millions of premature deaths [2]. There is a dispute about how to do this, and no doubt Professor Daube has ideas. However, the policy proposals for the so-called 'tobacco endgame' advanced by tobacco control activists do not withstand even cursory scrutiny [3]. The preferred approach of advocates of 'tobacco harm reduction', among which I include myself, involves a fundamental technology transformation, a disruptive process that has started and is synergistic with well-founded tobacco control policies [4]. If, like me, you wish to see a market change fundamentally, then it makes sense to talk to and understand every significant actor in the market, rather than only those whose convictions you already share.

References & further reading

[1] Bates C. Who or what is the World Health Organisation at war with? The Counterfactual, May 2016 [link].

[2] Bates C. A billion lives? The Counterfactual, November 2015 [link] and Bates C. Are we in the endgame for smoking? The Counterfactual, February 2015 [link]

[3] Bates C. The tobacco endgame: a critique of the policy ideas. The Counterfactual, March 2015 [link]

[4] Bates C. A more credible endgame - creative destruction. The Counterfactual, March 2015 [link].

On 2016 Aug 25, Clive Bates commented:

As I think Professor Daube's comment contains inappropriate innuendo about my motives, let me repeat the disclosure statement from my initial posting:

Competing interests: I am a longstanding advocate for 'harm reduction' approaches to public health. I was director of Action on Smoking and Health UK from 1997-2003. I have no competing interests with respect to any of the relevant industries.

My hope is that prominent academics and veterans of the struggles of the past will adopt an open mind towards the right strategy for reducing the burden of death and disease caused by smoking as we go forward. While he may not like the idea, Professor Daube can surely see that 'tobacco harm reduction' is a concept supported by many of the top scientists and policy thinkers in the field, including the Tobacco Advisory Group of the Royal College of Physicians. It is not the work of the tobacco industry and cannot be dismissed just by claiming it is in their interests.

On 2016 Aug 24, Mike Daube commented:

As part of his lengthy and personalised attacks on Martin McKee, Clive Bates argues that “we certainly should not” look to Australia for policy inspiration.

This view, and some of his other comments, would have strong support from the global tobacco industry, which has ferociously opposed the evidence-based action to reduce smoking taken by successive Australian governments, and reports that we are “the darkest market in the world”. (1)

No doubt Mr Bates will be able to discuss these issues further with tobacco industry leaders at the Global Tobacco & Nicotine Forum (“the annual industry summit”) in Brussels later this year, where as in previous years he is listed as a speaker.(2)

References 1. Brisby D, Pramanik A, Matthews P, Kutz O, Kamaras A. Imperial Brands PLC Investor Day: Jun 8 2016. Transcript – Quality Growth: Returns and Growth – Markets that Matter [p.6] & Presentation Slides – Quality Growth: Returns and Growth – Markets that Matter [slide 16]. http://www.imperialbrandsplc.com/Investors/Results-centre.

1. http://gtnf-2016.com/

On 2016 Aug 22, Clive Bates commented:

Some responses to Professor Simon Chapman:

1. Professor Chapman criticises the Public Health England and Royal College of Physicians consensus on the relative risk of smoking and e-cigarette use by referring to a comment piece Combes RD, 2015 in the journal Alternatives to Laboratory Animals. The piece is written by a commentator whose affiliation is an animal welfare rights campaign (FRAME), for which ATLA is the house journal, and an independent consultant. How these two came to be writing about e-cigarettes at all is not stated, but this is less important than the fact that their commentary provides little of substance to challenge the robust expert-based PHE and RCP analysis, and it provides even less to justify the colourful dismissive pull-out quotes chosen by Professor Chapman. Even though the work can be dismissed on its merits, surely the authors should have disclosed that FRAME has pharmaceutical funders [Our supporters], including companies who make and sell medical smoking cessation products.

2. Professor Chapman confirms my view that the appropriate statistic to use for comparing Australian prevalence of current smoking is 16.0 percent based on the Australian Bureau of Statistics, National Health Survey: First Results, 2014-15 (see table 9.3). This is the latest data on the prevalence of current adult smoking.

3. Unless it's to make the numbers look as low as possible, I am unsure why Professors Chapman and McKee choose to refer to a survey from 2013 or why Professor Chapman didn't disclose in his response that he is citing a survey of drug use, including illicit drug use: [see AIHW, National Drug Strategy Household Survey detailed report 2013]. Surely a neutral investigator would be concerned that a state-run survey asking about illicit drug use might have a low response rate? And further, that non-responders would be more likely to be drug users, and hence also more likely to be smokers - so distorting the prevalence systematically downwards? In fact, the response rate in this survey is just 49.1% [Explanatory notes]. While this might be the best that can be done to understand illicit drug use, it is an unnecessarily unreliable way to gauge legal activity like smoking, especially as a more recent and more reliable survey is available.

4. The figure of 11% given for smoking in Sweden is not 'daily smoking' as asserted by Professor Chapman. With just a little more research before rushing out his reply, Professor Chapman could have checked the source and link I provided. The question used is: "Regarding smoking cigarettes, cigarettes, cigars, cigarillos or a pipe, which of the following applies to you?" 11% of Swedes answer affirmatively to the response: "You currently smoke".

5. If we are comparing national statistics, it is true that measured smoking prevalence in Britain is a little higher than in the Australia - the latest Office for National Statistics data suggests 17.5 percent of adults age 16 and over were current smokers in 2015 (derived from its special survey of e-cigarette use: E-cigarette use in Great Britain 2015). So what? The two countries are very different both today and in where they have come from and many factors explain smoking prevalence - not just tobacco control policy. But if one is to insist on such comparisons, official data from the (until now) vape-friendly United States suggests that American current adult smoking prevalence, at 15.1 percent, is now below that of Australia [source: National Center for Health Statistics, National Health Interview Survey, 1997–2015, Sample Adult Core component. Figure 8.1. Prevalence of current cigarette smoking among adults aged 18 and over: United States, 1997–2015]

6. Regressive taxes are harmful and so is stigmatisation - I shouldn't need to reference that for anyone working in public health. Any thoughtful policy maker will not only try to design policies that achieve a primary objective (reduce the disease attributable to smoking) but also be mindful that the policies themselves can be a source of harm or damaging in some other way. Ignoring the consequences of tobacco policies on wider measures of wellbeing is something best left to fanatics. In public health terms, these consequences may be considered 'a price worth paying' to reduce smoking, but they create real harms for those who continue to smoke, and in my view, those promoting them have an ethical obligation to mitigate these wider harms to the extent possible.

7. The approach, favoured by me and many others, of supporting (or in Australia's case of not actively obstructing) ways in which smokers can more easily move from the most dangerous products to those likely to cause minimal risk has twin advantages:

• (1) it helps to achieve the ultimate goal of reducing cancer, cardiovascular disease, and respiratory illnesses by improving the responsiveness of smokers to conventional tobacco control policy. It does this by removing the significant barrier of having to quit nicotine completely, something many cannot do easily or choose not to do.

• (2) It does this in a way that goes with the grain of consumer preferences and meets people where they are. This is something for public health to rediscover - public health should be about 'enabling', not bullying or nannying, and go about its business with humility and empathy towards those it is trying to help.

On 2016 Aug 22, Clive Bates commented:

As an aside, it's disappointing to see Professor Chapman spreading doubt about e-cigarettes with reference to the filters and 'light and mild' cigarette fiasco (see the 1999 report by Martin Jarvis and me on this fiasco). This 'science-by-analogy' fails because it misunderstands the nicotine-seeking behaviour that underpins both smoking and vaping.

With light and mild cigarettes, health activists were fooled into believing that these cigarettes would much be less risky, even though they are no less risky. It would be wrong to compound this error by implying that e-cigarettes are not much less risky, even though they are sure to be.

The underlying reason for both errors is the same - nicotine users seek a roughly fixed dose of nicotine (a well-understood process, known as titration). If a vaper can obtain their desired nicotine dose without exposure to cigarette smoke toxins, then they will not suffer the smoking-related harms. With light and mild cigarettes, both nicotine and toxins were diluted equally with air to fool smoking machines. However, human smokers adjusted their behaviour to get the desired dose of nicotine and so got almost the same exposures to toxins. This is another well-understood process known as 'compensation'. I am sure a global authority of Professor Chapman's stature would be aware these mechanisms, so it is all the more perplexing that he should draw on this analogy in his campaign against e-cigarettes.

On 2016 Aug 22, Simon Chapman commented:

Clive Bates' efforts to correct points made in Martin McKee’s letter in turn require correction and comment. Bates disputes that there was not a single source for the claim that e-cigarettes are “95% safer” than smoking (in fact Public Health England stated “95% less harmful” [1], a critical difference). Bates cites two references in support of his claim, but both of these are nothing but secondary references, with both citing the same Nutt et al [2] 95% less harmful estimate as their primary source.

Two toxicologists have written an excoriating critique of the provenance of the “95% less harmful” statement, describing its endorsement as “reckless”[3] and nothing but the consensus of the opinions of a carefully hand-picked group. The 95% estimate remains little more than a factoid – a piece of questionable information that is reported and repeated so often that it becomes accepted as fact.

We will not have an evidence-based comparison of harm until we have cohort data in the decades to come comparing mortality and morbidity outcomes from exclusive smokers versus exclusive vapers and dual users. This was how our knowledge eventually emerged of the failure other mass efforts at tobacco harm reduction: cigarette filters and the misleading lights and milds fiasco.

Bates challenges McKee’s statement that Australian smoking prevalence is “below 13%” and cites Australian Bureau of Statistics (ABS) data from 2014-15 derived from a household survey of 14,700 dwellings that shows 16% of those aged 18+ were “current” smokers (14.5% smoking daily). McKee was almost certainly referring to 2013 data from the Australian Institute of Health and Welfare’s (AIHW) ongoing national surveys based on interviews with some 28,000 respondents which showed 12.8% of age 14+ Australians smoked daily, with another 2.2% smoking less than daily[4]. The next AIHW survey will report in 2017 and with the impact of plain packaging, several 12.5% tobacco tax increases, on-going tobacco control campaigning and a downward historical trend away from smoking, there are strong expectations that the 2017 prevalence will be even lower.

Bates cites a 2015 report saying that Sweden has 11% smoking prevalence. This figure is almost certainly daily smoking prevalence data, not total smoking prevalence that Bates insists is the relevant figure that should be cited for Australia. If so, the comparable figure for Sweden should also be used. In 2012 the Swedish Ministry of Health reported to the WHO that 22% of Swedish people aged 16-84 currently smoked (11% daily and 11% less than daily) [5]. It is not credible that Sweden could have halved its smoking prevalence in three years.

Meanwhile, England with current smoking prevalence in 2015 of 18.2% in July 2016 [6 – slide 1] trails Australia, regardless of whether the ABS or AIHW data are used. Also, the proportion of English smokers who smoked in the last year and who tried to stop smoking is currently the lowest recorded in England since 2007 [6 slide 4].

Bates says that the UK and the USA where e-ecigarette use is widespread have seen “recent sharp falls” in smoking prevalence. In fact in smoking prevalence has been falling in both nations for many years prior to the advent of e-cigarettes, as it has in Australia where e-cigarettes are seldom seen. Disturbingly in the USA, the decline in youth smoking has come to a halt after 2014 [7], following continuous falls for at least a decade – well before e-cigarette use became popular. The spectacular increase in e-cigarette use in youth particularly between 2013-2015 (see Figure 1 in reference 7] was either coincident or possibly partly responsible with that halting.

Finally Bates makes gratuitous, unreferenced remarks about “harms” arising from Australia’s tobacco tax policy and “campaigns to denormalise smoking”. There are no policies or campaigns to denormalise smoking in Australian that are not also in place in the UK or the USA, as well as many other nations. When Bates was director at ASH he vigourously campaigned for tobacco taxes to be high and to keep on increasing [8]. His current views make an interesting contrast with even the CEO of British American Tobacco Australia who agrees that tax has had a major impact on reducing smoking, telling an Australian parliamentary committee in 2011 “We understand that the price going up when the excise goes up reduces consumption. We saw that last year very effectively with the increase in excise. There was a 25 per cent increase in the excise and we saw the volumes go down by about 10.2 per cent; there was about a 10.2 per cent reduction in the industry last year in Australia.” [9].

References

1 Public Health England. E-cigarettes: a new foundation for evidence-based policy and practice. Aug 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/454517/Ecigarettes_a_firm_foundation_for_evidence_based_policy_and_practice.pdf

2 Nutt DJ et al. Estimating the harms of nicotine-containing products using the MCDA approach. Eur Addict Res 2014;20:218-25.

3 Combes RD, Balls M. On the safety of e-cigarettes.: “I can resists anything except temptation.” ATLA 2015;42:417-25. https://www.researchgate.net/publication/289674033_On_the_Safety_of_E-cigarettes_I_can_resist_anything_except_temptation1

4 Australian Institute of Health and Welfare. National Drug Household Survey. 2014 data and references. http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129548784

5 Swedish Ministry for Health and Social Affairs. Reporting instrument of the WHO Framework Convention on Tobacco Control 2012 (13 April) http://www.who.int/fctc/reporting/party_reports/sweden_2012_report_final_rev.pdf

6 Smoking in England. Top line findings STS140721 5 Aug 2016 http://www.smokinginengland.info/downloadfile/?type=latest-stats&src=13 (slide 1)

7 Singh T et al. Tobacco use among middle and high school students — United States, 2011–2015. http://www.cdc.gov/mmwr/volumes/65/wr/mm6514a1.htm MMWR April 15, 2016 / 65(14);361–367

8 Bates C Why tobacco taxes should be high and continue to increase. 1999 (February) http://www.ash.org.uk/files/documents/ASH_218.pdf

9 The Treasury. Post-implementation review: 25 per cent tobacco excise increase. Commonwealth of Australia 2013; Feb. http://ris.dpmc.gov.au/files/2013/05/02-25-per-cent-Excise-for-Tobacco.doc p15

On 2016 Aug 21, Gerry Stimson commented:

Clive Bates (below) identifies five assertions by Martin McKee that need correction: there are two more, making seven in McKee's eleven lined letter.

First, McKee states that ‘It is misleading to suggest that there is a consensus on e-cigarettes in England, given that many members of the health community have continuing reservations’ and quotes one short BMA statement that calls for medical regulation of e-cigarettes.

He ignores the ‘public health consensus statement’ from English public health, medical, cancer and tobacco control organisations that supports e-cigarettes for quitting smoking. The consensus statement says that ‘We all agree that e-cigarettes are significantly less harmful than smoking.’ [1, 2]. The first edition of this statement [1] explicitly challenges McKee’s position on the evidence. The consensus statement is endorsed by Public Health England, Action on Smoking and Health, the Association of Directors of Public Health, the British Lung Foundation, Cancer Research UK, the Faculty of Public Health, Fresh North East, Healthier Futures, Public Health Action, the Royal College of Physicians, the Royal Society for Public Health, the UK Centre for Tobacco and Alcohol Studies and the UK Health Forum. McKee and the BMA are minority outliers in England and the UK.

The PHE report on e-cigarettes faced a backlash but this was from a few public health leaders including McKee who organised a behind-the-scenes campaign against the report including a critical editorial and comment in the Lancet, and an editorial in the BMJ backed up by a media campaign hostile to PHE. Emails revealed as a result of a Freedom of Information request show that this backlash was orchestrated by McKee and a handful of public health experts [3, 4].

Second, McKee misrepresents and misunderstands drugs harm reduction. He cites Australia, and it was indeed in Australia (as in the UK) that the public health successes in preventing the spread of HIV infection and other adverse aspects of drug use were driven by harm reduction – including engaging with drug users, outreach to drug users, destigmatisation, provision of sterile needles and syringes, and methadone [5, 6, 7]. Drugs harm reduction was a public health success [4, 6]. The UK and other countries that implemented harm reduction avoided a major epidemic of drug related HIV infection of the sort that has been experienced in many countries. Drugs harm reduction was implemented despite drugs demand and supply and reduction measures, not as McKee asserts because it was part of a combined strategy including supply demand and supply reduction. McKee’s position is out of step with the Open Society Institute, of which he chairs the Global Health Advisory Committee; OSI has resourced drugs harm reduction and campaigns against the criminalisation of drugs ie those demand and supply reduction measures that maximise harm.

1 Public health England (2015) E-cigarettes: a developing public health consensus. https://www.gov.uk/government/news/e-cigarettes-an-emerging-public-health-consensus

2 Public health England (2016) E-cigarettes: a developing public health consensus. https://www.gov.uk/government/publications/e-cigarettes-a-developing-public-health-consensus

3 Puddlecote D, (2016/) Correspondence between McKee and Davies Aug 15 to Oct 15. https://www.scribd.com/doc/296112057/Correspondence-Between-McKee-and-Davies-Aug-15-to-Oct-15. Accessed 07 03 2016

4 Stimson G V (2016) A tale of two epidemics: drugs harm reduction and tobacco harm reduction, Drugs and Alcohol Today, 16, 3 2016, 1-9.

5 Berridge V (1996) AIDS in the UK: The Making of Policy, 1981-1994. Oxford University Press.

6 Stimson G V (1995) AIDS and injecting drug use in the United Kingdom, 1988-1993: the policy response and the prevention of the epidemic. Social Science and Medicine, 41,5, 699-716

7 Wodak A, (2016) Hysteria about drugs and harm minimisation. It's always the same old story. https://www.theguardian.com/commentisfree/2016/aug/11/hysteria-about-drugs-and-harm-minimisation-its-always-the-same-old-story

On 2016 Aug 20, Clive Bates commented:

The author, Martin McKee, makes no less than five assertions in this short letter that demand correction:

First, that there was only one source for the claim that e-cigarettes are "95% safer" than smoking. In fact, this claim does not rely on a single source but is the consensus view of Public Health England's expert reviewers [1] and a close variation on this claim is the consensus view of the Tobacco Advisory Group of the Royal College of Physicians and is endorsed by the College [2]:

Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure. (Section 5.5 page 87)

Second, that PHE's work was in some way compromised by McKee's "concerns about conflicts of interest". To support this largely self-referential claim, he cites a piece of very poor journalism in which every accusation was denied or refuted by all involved. Please see Gornall J, 2015 including my PuBMed Commons critique of this article and a more detailed critique on my blog [3].

Third, that "other evidence, some not quoted in the review, raised serious questions about the safety of these products". The citation for this assertion is Pisinger C, 2014. This review does not, in fact, raise any credible questions about the safety of these products, and suffered numerous basic methodological failings. For this reason, it was reviewed but then ignored in the Royal College of Physicians' assessment of e-cigarette risk [2 - page 79]. Please see the PubMed Commons critiques of this paper [4].

Fourth, that adult smoking prevalence in Australia is "below 13%, without e-cigarettes". Both parts of this claim are wrong. The latest official data shows an adult smoking prevalence of 16.0% in Australia [5]. No citation was provided by the author for his claim. E-cigarettes are widely used in Australia, despite a ban on sales of nicotine liquids. Australians purchase nicotine-based liquids internationally over the internet or buy on a thriving black market that has been created by Australia's wholly unjustified de facto prohibition.

Fifth, that we "should look to Australia" for tobacco policy inspiration. We certainly should not. Australia has a disturbingly unethical policy of allowing cigarettes to be widely available for sale but tries to deny its 2.8 million smokers access to much safer products by banning nicotine-based e-cigarettes. These options have proved extremely popular and beneficial for millions of smokers in Europe and the United States trying to manage their own risks and health outcomes. Further, the author should consider the harms that arise from Australia's anti-smoking policies in their own right, such as high and regressive taxation and stigma that arises from its campaigns to denormalise smoking.

If the author wishes to find a model country, he need not travel as far as Australia. Sweden had a smoking prevalence of 11% in 2015 - an extreme outlier in the European Union, which averages 26% prevalence on the measure used in the only consistent pan-European survey [6]. The primary reason for Sweden's very low smoking prevalence is the use of alternative forms of nicotine (primarily snus, a smokeless tobacco) which pose minimal risks to health and have over time substituted for smoking. This exactly what we might expect from e-cigarettes and, given the recent sharp falls in adult and youth smoking in both the UK and the US, this does seem likely. Going with grain of consumers' preferences represents a more humane way to address the risks of smoking than the battery of punitive and coercive policies favoured in Australia.

Though not specialised in nicotine policy or science, the author is a prolific commentator on the e-cigarette controversy. If he wishes to contribute more effectively, he could start by reading an extensive critique of his own article in the BMJ (McKee M, 2015), which is at once devastating, educational, and entertaining [7].

References

[1] McNeill A. Hajek P. Underpinning evidence for the estimate that e-cigarette use is around 95% safer than smoking: authors’ note, 27 August 2015 [link]

[2] Royal College of Physicians (London) Nicotine without smoke: tobacco harm reduction 28 April 2016 [link]

[3] Bates C. Smears or science? The BMJ attack on Public Health England and its e-cigarettes evidence review, November 2015 [link]

[4] Pisinger C, 2014 Bates C. comment [here] and Zvi Herzig [here]

[5] Australian Bureau of Statistics, National Health Survey: First Results, 2014-15. Table 9.3, 8 December 2015 [link to data]

[6] European Commission, Special Eurobarometer 429, Attitudes of Europeans towards tobacco, May 2015 [link] - see page 11.

[7] Herzig Z. Response to McKee and Capewell, 9 February 2016 [link]

Competing interests: I am a longstanding advocate for 'harm reduction' approaches to public health. I was director of Action on Smoking and Health UK from 1997-2003. I have no competing interests with respect to any of the relevant industries.

On 2016 Aug 20, Clive Bates commented:

The author, Martin McKee, makes no less than five assertions in this short letter that demand correction:

First, that there was only one source for the claim that e-cigarettes are "95% safer" than smoking. In fact, this claim does not rely on a single source but is the consensus view of Public Health England's expert reviewers [1] and a close variation on this claim is the consensus view of the Tobacco Advisory Group of the Royal College of Physicians and is endorsed by the College [2]:

Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure. (Section 5.5 page 87)

Second, that PHE's work was in some way compromised by McKee's "concerns about conflicts of interest". To support this largely self-referential claim, he cites a piece of very poor journalism in which every accusation was denied or refuted by all involved. Please see Gornall J, 2015 including my PuBMed Commons critique of this article and a more detailed critique on my blog [3].

Third, that "other evidence, some not quoted in the review, raised serious questions about the safety of these products". The citation for this assertion is Pisinger C, 2014. This review does not, in fact, raise any credible questions about the safety of these products, and suffered numerous basic methodological failings. For this reason, it was reviewed but then ignored in the Royal College of Physicians' assessment of e-cigarette risk [2 - page 79]. Please see the PubMed Commons critiques of this paper [4].

Fourth, that adult smoking prevalence in Australia is "below 13%, without e-cigarettes". Both parts of this claim are wrong. The latest official data shows an adult smoking prevalence of 16.0% in Australia [5]. No citation was provided by the author for his claim. E-cigarettes are widely used in Australia, despite a ban on sales of nicotine liquids. Australians purchase nicotine-based liquids internationally over the internet or buy on a thriving black market that has been created by Australia's wholly unjustified de facto prohibition.

Fifth, that we "should look to Australia" for tobacco policy inspiration. We certainly should not. Australia has a disturbingly unethical policy of allowing cigarettes to be widely available for sale but tries to deny its 2.8 million smokers access to much safer products by banning nicotine-based e-cigarettes. These options have proved extremely popular and beneficial for millions of smokers in Europe and the United States trying to manage their own risks and health outcomes. Further, the author should consider the harms that arise from Australia's anti-smoking policies in their own right, such as high and regressive taxation and stigma that arises from its campaigns to denormalise smoking.

If the author wishes to find a model country, he need not travel as far as Australia. Sweden had a smoking prevalence of 11% in 2015 - an extreme outlier in the European Union, which averages 26% prevalence on the measure used in the only consistent pan-European survey [6]. The primary reason for Sweden's very low smoking prevalence is the use of alternative forms of nicotine (primarily snus, a smokeless tobacco) which pose minimal risks to health and have over time substituted for smoking. This exactly what we might expect from e-cigarettes and, given the recent sharp falls in adult and youth smoking in both the UK and the US, this does seem likely. Going with grain of consumers' preferences represents a more humane way to address the risks of smoking than the battery of punitive and coercive policies favoured in Australia.

Though not specialised in nicotine policy or science, the author is a prolific commentator on the e-cigarette controversy. If he wishes to contribute more effectively, he could start by reading an extensive critique of his own article in the BMJ (McKee M, 2015), which is at once devastating, educational, and entertaining [7].

References

[1] McNeill A. Hajek P. Underpinning evidence for the estimate that e-cigarette use is around 95% safer than smoking: authors’ note, 27 August 2015 [link]

[2] Royal College of Physicians (London) Nicotine without smoke: tobacco harm reduction 28 April 2016 [link]

[3] Bates C. Smears or science? The BMJ attack on Public Health England and its e-cigarettes evidence review, November 2015 [link]

[4] Pisinger C, 2014 Bates C. comment [here] and Zvi Herzig [here]

[5] Australian Bureau of Statistics, National Health Survey: First Results, 2014-15. Table 9.3, 8 December 2015 [link to data]

[6] European Commission, Special Eurobarometer 429, Attitudes of Europeans towards tobacco, May 2015 [link] - see page 11.

[7] Herzig Z. Response to McKee and Capewell, 9 February 2016 [link]

Competing interests: I am a longstanding advocate for 'harm reduction' approaches to public health. I was director of Action on Smoking and Health UK from 1997-2003. I have no competing interests with respect to any of the relevant industries.

On 2016 Aug 21, Gerry Stimson commented:

Clive Bates (below) identifies five assertions by Martin McKee that need correction: there are two more, making seven in McKee's eleven lined letter.

First, McKee states that ‘It is misleading to suggest that there is a consensus on e-cigarettes in England, given that many members of the health community have continuing reservations’ and quotes one short BMA statement that calls for medical regulation of e-cigarettes.

He ignores the ‘public health consensus statement’ from English public health, medical, cancer and tobacco control organisations that supports e-cigarettes for quitting smoking. The consensus statement says that ‘We all agree that e-cigarettes are significantly less harmful than smoking.’ [1, 2]. The first edition of this statement [1] explicitly challenges McKee’s position on the evidence. The consensus statement is endorsed by Public Health England, Action on Smoking and Health, the Association of Directors of Public Health, the British Lung Foundation, Cancer Research UK, the Faculty of Public Health, Fresh North East, Healthier Futures, Public Health Action, the Royal College of Physicians, the Royal Society for Public Health, the UK Centre for Tobacco and Alcohol Studies and the UK Health Forum. McKee and the BMA are minority outliers in England and the UK.

The PHE report on e-cigarettes faced a backlash but this was from a few public health leaders including McKee who organised a behind-the-scenes campaign against the report including a critical editorial and comment in the Lancet, and an editorial in the BMJ backed up by a media campaign hostile to PHE. Emails revealed as a result of a Freedom of Information request show that this backlash was orchestrated by McKee and a handful of public health experts [3, 4].

Second, McKee misrepresents and misunderstands drugs harm reduction. He cites Australia, and it was indeed in Australia (as in the UK) that the public health successes in preventing the spread of HIV infection and other adverse aspects of drug use were driven by harm reduction – including engaging with drug users, outreach to drug users, destigmatisation, provision of sterile needles and syringes, and methadone [5, 6, 7]. Drugs harm reduction was a public health success [4, 6]. The UK and other countries that implemented harm reduction avoided a major epidemic of drug related HIV infection of the sort that has been experienced in many countries. Drugs harm reduction was implemented despite drugs demand and supply and reduction measures, not as McKee asserts because it was part of a combined strategy including supply demand and supply reduction. McKee’s position is out of step with the Open Society Institute, of which he chairs the Global Health Advisory Committee; OSI has resourced drugs harm reduction and campaigns against the criminalisation of drugs ie those demand and supply reduction measures that maximise harm.

1 Public health England (2015) E-cigarettes: a developing public health consensus. https://www.gov.uk/government/news/e-cigarettes-an-emerging-public-health-consensus

2 Public health England (2016) E-cigarettes: a developing public health consensus. https://www.gov.uk/government/publications/e-cigarettes-a-developing-public-health-consensus

3 Puddlecote D, (2016/) Correspondence between McKee and Davies Aug 15 to Oct 15. https://www.scribd.com/doc/296112057/Correspondence-Between-McKee-and-Davies-Aug-15-to-Oct-15. Accessed 07 03 2016

4 Stimson G V (2016) A tale of two epidemics: drugs harm reduction and tobacco harm reduction, Drugs and Alcohol Today, 16, 3 2016, 1-9.

5 Berridge V (1996) AIDS in the UK: The Making of Policy, 1981-1994. Oxford University Press.

6 Stimson G V (1995) AIDS and injecting drug use in the United Kingdom, 1988-1993: the policy response and the prevention of the epidemic. Social Science and Medicine, 41,5, 699-716

7 Wodak A, (2016) Hysteria about drugs and harm minimisation. It's always the same old story. https://www.theguardian.com/commentisfree/2016/aug/11/hysteria-about-drugs-and-harm-minimisation-its-always-the-same-old-story

On 2016 Aug 22, Simon Chapman commented:

Clive Bates' efforts to correct points made in Martin McKee’s letter in turn require correction and comment. Bates disputes that there was not a single source for the claim that e-cigarettes are “95% safer” than smoking (in fact Public Health England stated “95% less harmful” [1], a critical difference). Bates cites two references in support of his claim, but both of these are nothing but secondary references, with both citing the same Nutt et al [2] 95% less harmful estimate as their primary source.

Two toxicologists have written an excoriating critique of the provenance of the “95% less harmful” statement, describing its endorsement as “reckless”[3] and nothing but the consensus of the opinions of a carefully hand-picked group. The 95% estimate remains little more than a factoid – a piece of questionable information that is reported and repeated so often that it becomes accepted as fact.

We will not have an evidence-based comparison of harm until we have cohort data in the decades to come comparing mortality and morbidity outcomes from exclusive smokers versus exclusive vapers and dual users. This was how our knowledge eventually emerged of the failure other mass efforts at tobacco harm reduction: cigarette filters and the misleading lights and milds fiasco.

Bates challenges McKee’s statement that Australian smoking prevalence is “below 13%” and cites Australian Bureau of Statistics (ABS) data from 2014-15 derived from a household survey of 14,700 dwellings that shows 16% of those aged 18+ were “current” smokers (14.5% smoking daily). McKee was almost certainly referring to 2013 data from the Australian Institute of Health and Welfare’s (AIHW) ongoing national surveys based on interviews with some 28,000 respondents which showed 12.8% of age 14+ Australians smoked daily, with another 2.2% smoking less than daily[4]. The next AIHW survey will report in 2017 and with the impact of plain packaging, several 12.5% tobacco tax increases, on-going tobacco control campaigning and a downward historical trend away from smoking, there are strong expectations that the 2017 prevalence will be even lower.

Bates cites a 2015 report saying that Sweden has 11% smoking prevalence. This figure is almost certainly daily smoking prevalence data, not total smoking prevalence that Bates insists is the relevant figure that should be cited for Australia. If so, the comparable figure for Sweden should also be used. In 2012 the Swedish Ministry of Health reported to the WHO that 22% of Swedish people aged 16-84 currently smoked (11% daily and 11% less than daily) [5]. It is not credible that Sweden could have halved its smoking prevalence in three years.

Meanwhile, England with current smoking prevalence in 2015 of 18.2% in July 2016 [6 – slide 1] trails Australia, regardless of whether the ABS or AIHW data are used. Also, the proportion of English smokers who smoked in the last year and who tried to stop smoking is currently the lowest recorded in England since 2007 [6 slide 4].

Bates says that the UK and the USA where e-ecigarette use is widespread have seen “recent sharp falls” in smoking prevalence. In fact in smoking prevalence has been falling in both nations for many years prior to the advent of e-cigarettes, as it has in Australia where e-cigarettes are seldom seen. Disturbingly in the USA, the decline in youth smoking has come to a halt after 2014 [7], following continuous falls for at least a decade – well before e-cigarette use became popular. The spectacular increase in e-cigarette use in youth particularly between 2013-2015 (see Figure 1 in reference 7] was either coincident or possibly partly responsible with that halting.

Finally Bates makes gratuitous, unreferenced remarks about “harms” arising from Australia’s tobacco tax policy and “campaigns to denormalise smoking”. There are no policies or campaigns to denormalise smoking in Australian that are not also in place in the UK or the USA, as well as many other nations. When Bates was director at ASH he vigourously campaigned for tobacco taxes to be high and to keep on increasing [8]. His current views make an interesting contrast with even the CEO of British American Tobacco Australia who agrees that tax has had a major impact on reducing smoking, telling an Australian parliamentary committee in 2011 “We understand that the price going up when the excise goes up reduces consumption. We saw that last year very effectively with the increase in excise. There was a 25 per cent increase in the excise and we saw the volumes go down by about 10.2 per cent; there was about a 10.2 per cent reduction in the industry last year in Australia.” [9].

References

1 Public Health England. E-cigarettes: a new foundation for evidence-based policy and practice. Aug 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/454517/Ecigarettes_a_firm_foundation_for_evidence_based_policy_and_practice.pdf

2 Nutt DJ et al. Estimating the harms of nicotine-containing products using the MCDA approach. Eur Addict Res 2014;20:218-25.

3 Combes RD, Balls M. On the safety of e-cigarettes.: “I can resists anything except temptation.” ATLA 2015;42:417-25. https://www.researchgate.net/publication/289674033_On_the_Safety_of_E-cigarettes_I_can_resist_anything_except_temptation1

4 Australian Institute of Health and Welfare. National Drug Household Survey. 2014 data and references. http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129548784

5 Swedish Ministry for Health and Social Affairs. Reporting instrument of the WHO Framework Convention on Tobacco Control 2012 (13 April) http://www.who.int/fctc/reporting/party_reports/sweden_2012_report_final_rev.pdf

6 Smoking in England. Top line findings STS140721 5 Aug 2016 http://www.smokinginengland.info/downloadfile/?type=latest-stats&src=13 (slide 1)

7 Singh T et al. Tobacco use among middle and high school students — United States, 2011–2015. http://www.cdc.gov/mmwr/volumes/65/wr/mm6514a1.htm MMWR April 15, 2016 / 65(14);361–367

8 Bates C Why tobacco taxes should be high and continue to increase. 1999 (February) http://www.ash.org.uk/files/documents/ASH_218.pdf

9 The Treasury. Post-implementation review: 25 per cent tobacco excise increase. Commonwealth of Australia 2013; Feb. http://ris.dpmc.gov.au/files/2013/05/02-25-per-cent-Excise-for-Tobacco.doc p15

On 2016 Aug 22, Clive Bates commented:

Some responses to Professor Simon Chapman:

1. Professor Chapman criticises the Public Health England and Royal College of Physicians consensus on the relative risk of smoking and e-cigarette use by referring to a comment piece Combes RD, 2015 in the journal Alternatives to Laboratory Animals. The piece is written by a commentator whose affiliation is an animal welfare rights campaign (FRAME), for which ATLA is the house journal, and an independent consultant. How these two came to be writing about e-cigarettes at all is not stated, but this is less important than the fact that their commentary provides little of substance to challenge the robust expert-based PHE and RCP analysis, and it provides even less to justify the colourful dismissive pull-out quotes chosen by Professor Chapman. Even though the work can be dismissed on its merits, surely the authors should have disclosed that FRAME has pharmaceutical funders [Our supporters], including companies who make and sell medical smoking cessation products.

2. Professor Chapman confirms my view that the appropriate statistic to use for comparing Australian prevalence of current smoking is 16.0 percent based on the Australian Bureau of Statistics, National Health Survey: First Results, 2014-15 (see table 9.3). This is the latest data on the prevalence of current adult smoking.

3. Unless it's to make the numbers look as low as possible, I am unsure why Professors Chapman and McKee choose to refer to a survey from 2013 or why Professor Chapman didn't disclose in his response that he is citing a survey of drug use, including illicit drug use: [see AIHW, National Drug Strategy Household Survey detailed report 2013]. Surely a neutral investigator would be concerned that a state-run survey asking about illicit drug use might have a low response rate? And further, that non-responders would be more likely to be drug users, and hence also more likely to be smokers - so distorting the prevalence systematically downwards? In fact, the response rate in this survey is just 49.1% [Explanatory notes]. While this might be the best that can be done to understand illicit drug use, it is an unnecessarily unreliable way to gauge legal activity like smoking, especially as a more recent and more reliable survey is available.

4. The figure of 11% given for smoking in Sweden is not 'daily smoking' as asserted by Professor Chapman. With just a little more research before rushing out his reply, Professor Chapman could have checked the source and link I provided. The question used is: "Regarding smoking cigarettes, cigarettes, cigars, cigarillos or a pipe, which of the following applies to you?" 11% of Swedes answer affirmatively to the response: "You currently smoke".

5. If we are comparing national statistics, it is true that measured smoking prevalence in Britain is a little higher than in the Australia - the latest Office for National Statistics data suggests 17.5 percent of adults age 16 and over were current smokers in 2015 (derived from its special survey of e-cigarette use: E-cigarette use in Great Britain 2015). So what? The two countries are very different both today and in where they have come from and many factors explain smoking prevalence - not just tobacco control policy. But if one is to insist on such comparisons, official data from the (until now) vape-friendly United States suggests that American current adult smoking prevalence, at 15.1 percent, is now below that of Australia [source: National Center for Health Statistics, National Health Interview Survey, 1997–2015, Sample Adult Core component. Figure 8.1. Prevalence of current cigarette smoking among adults aged 18 and over: United States, 1997–2015]

6. Regressive taxes are harmful and so is stigmatisation - I shouldn't need to reference that for anyone working in public health. Any thoughtful policy maker will not only try to design policies that achieve a primary objective (reduce the disease attributable to smoking) but also be mindful that the policies themselves can be a source of harm or damaging in some other way. Ignoring the consequences of tobacco policies on wider measures of wellbeing is something best left to fanatics. In public health terms, these consequences may be considered 'a price worth paying' to reduce smoking, but they create real harms for those who continue to smoke, and in my view, those promoting them have an ethical obligation to mitigate these wider harms to the extent possible.

7. The approach, favoured by me and many others, of supporting (or in Australia's case of not actively obstructing) ways in which smokers can more easily move from the most dangerous products to those likely to cause minimal risk has twin advantages:

• (1) it helps to achieve the ultimate goal of reducing cancer, cardiovascular disease, and respiratory illnesses by improving the responsiveness of smokers to conventional tobacco control policy. It does this by removing the significant barrier of having to quit nicotine completely, something many cannot do easily or choose not to do.

• (2) It does this in a way that goes with the grain of consumer preferences and meets people where they are. This is something for public health to rediscover - public health should be about 'enabling', not bullying or nannying, and go about its business with humility and empathy towards those it is trying to help.

On 2016 Aug 24, Mike Daube commented:

As part of his lengthy and personalised attacks on Martin McKee, Clive Bates argues that “we certainly should not” look to Australia for policy inspiration.

This view, and some of his other comments, would have strong support from the global tobacco industry, which has ferociously opposed the evidence-based action to reduce smoking taken by successive Australian governments, and reports that we are “the darkest market in the world”. (1)

No doubt Mr Bates will be able to discuss these issues further with tobacco industry leaders at the Global Tobacco & Nicotine Forum (“the annual industry summit”) in Brussels later this year, where as in previous years he is listed as a speaker.(2)

References 1. Brisby D, Pramanik A, Matthews P, Kutz O, Kamaras A. Imperial Brands PLC Investor Day: Jun 8 2016. Transcript – Quality Growth: Returns and Growth – Markets that Matter [p.6] & Presentation Slides – Quality Growth: Returns and Growth – Markets that Matter [slide 16]. http://www.imperialbrandsplc.com/Investors/Results-centre.

1. http://gtnf-2016.com/

On 2016 Aug 24, Clive Bates commented:

In response to Professor Daube, I am pleased to have the opportunity to explain a different and less authoritarian approach to the public health challenges of smoking.

1. But let me start with a misunderstanding. Professor Daube accuses me of a personal attack on Professor McKee. In fact, I made five specific substantive comments on Professor McKee's short letter, to which Professor Stimson added a further two. These are corrections of fact and understanding, not a 'personal attack'. It is important that academics understand and recognise this distinction.

2. Professor Daube draws the reader's attention to a link to an investor presentation by Imperial Tobacco. I am unsure what point he is trying to make. Nevertheless, the presentation paints a rosy picture of life in Australia for this tobacco company: it is "on track" (p6); it has "continued strong performance in Australia" (p15); in Australia it is "continuing to perform strongly - JPS equity driving share, revenue and profit growth" (p31). It may be a hard pill to swallow, but tobacco companies in Australia are very profitable indeed, in part because the tax regime allows them to raise underlying pre-tax prices easily.

3. It's a common error of activists to believe that harm to tobacco companies is a proxy for success in tobacco control (an idea sometimes known as 'the scream test'). If it that was the case, the burgeoning profitability of tobacco companies would be a sign of utter failure in tobacco control [1]. We should instead focus on what it takes to eliminate smoking-related disease. If that means companies selling products that don't kill the user instead of products that do, then so be it - I consider that is progress. If your alternative is to use coercive policies to stop people using nicotine at all, then you may make progress... but it will be slow and laborious, smoking will persist for longer and many more people will be harmed as a result. These are the unintended consequences of taking more dogmatic positions that seem tougher, but are less effective.

4. In any event, my concerns are not about the welfare of the tobacco industry in Australia or anywhere else. My concern, as I hope I made clear in my response to Professor Chapman, is the welfare of the 2.8 million Australians (16% adults) who continue to smoke despite Australia's tobacco control efforts. For them, the serious health risks of smoking are compounded by some Australian tobacco control policies that are punitive (Australia is not alone in this) while being denied low-risk alternatives. All the harms caused by both smoking and anti-smoking policies can be mitigated and the benefits realised by making very low-risk alternatives to combustible cigarettes (for example, e-cigarettes or smokeless tobacco) available to smokers to purchase with their own money and of their own volition. Professor Daube apparently opposes this simple liberal idea - that the state should not intervene to prevent people improving their own health in a way that works for them and harms no-one else.

5. Professor Daube finishes his contribution with what I can only assume is an attempted smear in pointing out that I sometimes speak at conferences where the tobacco industry is present, as if this is somehow, a priori, an immoral act. I speak at these events because I have an ambitious advocacy agenda about how these firms should evolve from being 'merchants of death' into supplying a competitive low-risk recreational nicotine market, based on products that do not involve combustion of tobacco leaf, which the source of the disease burden. So I, and many others, have a public health agenda - the formation of a market for nicotine that will not kill one billion users in the 21st Century, and that will perhaps avoid hundreds of millions of premature deaths [2]. There is a dispute about how to do this, and no doubt Professor Daube has ideas. However, the policy proposals for the so-called 'tobacco endgame' advanced by tobacco control activists do not withstand even cursory scrutiny [3]. The preferred approach of advocates of 'tobacco harm reduction', among which I include myself, involves a fundamental technology transformation, a disruptive process that has started and is synergistic with well-founded tobacco control policies [4]. If, like me, you wish to see a market change fundamentally, then it makes sense to talk to and understand every significant actor in the market, rather than only those whose convictions you already share.

References & further reading

[1] Bates C. Who or what is the World Health Organisation at war with? The Counterfactual, May 2016 [link].

[2] Bates C. A billion lives? The Counterfactual, November 2015 [link] and Bates C. Are we in the endgame for smoking? The Counterfactual, February 2015 [link]

[3] Bates C. The tobacco endgame: a critique of the policy ideas. The Counterfactual, March 2015 [link]

[4] Bates C. A more credible endgame - creative destruction. The Counterfactual, March 2015 [link].

On 2016 Sep 10, ROBERT COMBES commented:

Robert Combes and Michael Balls

In a recent exchange of views, in PubMed Commons, with Simon Chapman on the effectiveness and safety of vaping for achieving the cessation of tobacco smoking, provoked by a paper published by Martin McKee [and comments therein], Clive Bates has criticised one of our publications. The paper in question urges caution concerning any further official endorsement of electronic cigarettes (ECs), at least until more safety data (including results from long-term tests) have become available. Bates questions why we should write on such issues, given our long-standing focus on ‘animal rights’, as he puts it, and from this mistaken assumption he makes the remarkably illogical deduction that our paper is without merit. Bates also implies that our views should not be taken seriously, because we published in Alternatives to Laboratory Animals (ATLA), a journal owned by FRAME (Fund for the Replacement of Animals in Medical Experiments), an organisation with which we have been closely associated in the past.<br> We have written a document to correct Bates' misconceptions about who we are, what our experience is, why we decided to write about this topic in the first place, what we actually said, and why we said it. In addition, we have elaborated on our views concerning the regulatory control of e-cigarettes, in which we explain in detail why we believe the current policy being implemented by PHE lacks a credible scientific basis. We make several suggestions to rectify the situation, based on our careers specialising in cellular toxicology: a) the safety of electronic cigarettes should be seen as a problem to be addressed, primarily by applying toxicological principles and methods, to derive relevant risk assessments, based on experimental observations and not opinions and guesswork; b) such assessments should not be confused with arguments in favour of vaping based on how harmful smoking is, and on the results of chemical analysis; c) it would be grossly negligent if the relevant national regulatory authorities were to continue to ignore the increasingly convincing evidence suggesting that exposure to nicotine can lead to serious long-term, as distinct from acute, effects, related to carcinogenicity, mutagenicity (manifested as DNA and chromosomal damage) and reproductive toxicity; and d) only once such information has been analysed, together with the results of other testing, should risks from vaping be weighed against risks from not vaping, to enable properly informed choice.<br> Due to space limitations, the pre-publication version of the complete document has to be downloaded from: https://www.researchgate.net/publication/307958871_Draft_Response_regarding_comments_made_by_Clive_Bates_about_one_of_our_publications_on_the_safety_of_electronic_cigarettes_and_vaping and our original publication is available from: https://www.researchgate.net/publication/289674033_On_the_Safety_of_E-cigarettes_I_can_resist_anything_except_temptation1

We hope that anyone wishing to respond will carefully read these two documents before doing so.