There is currently a furious back and forth in commentary regarding Tobacco Control, Tobacco Harm Reduction, and Tobacco Companies, following an Op-Ed letter in the NEJM (New England Journal of Medicine)
This series of communications (by no means finished) is hugely important in light of Sweden, without any credible evidence, imposing even harsher regulations on the lifesaving product snus earlier in 2016.
This is quite insane and totally counter to even the most basic notions of evidence based policy. To the best of Swedish knowledge, and using the best currently available statistical methods, 50% of total tobacco sales in Sweden is combustible tobacco and causes >98% of tobacco related disease; whereas the other 50% is sold in food grade non combustible format and accounts for <2% (in all likelihood the real burden is around 0,1%) of total disease and mortality burden in Sweden.
This is a bit of a read, and you need to follow it through, but more than well worth the time it will take, all credits to the NEJM from which these open source communications are taken with gratitude.
This is how it goes: 1st (top) is the article that started the debate. Then come 2 commentaries from McKee and also Myers from Tobacco Free Kids. After that comes the reply to them from the authors of the original article. In support of the original article and in scathing critique of the critique made by McKee there is then a series of comments made on-line in the commentaries section of NEJM, this is where the real fun starts.
This debate is totally unthinkable in Sweden, in Sweden being a scientist and pro “snus” (the food grade smokeless stuff that makes up 50% of total tobacco sales in the entire country) is by definition being a Tobacco Industry lackey and in most cases a total career suicide.
Peer pressure and organized institutional denial is so great in Sweden, to save face, that challenging the current dogma will get you ostracized, your funding will get pulled, career advancement totally out of the question and job severance a quite real likelihood, probably without even putting a dent in the armor of Tobacco Harm Reduction denial dogma.
This of course is not a very attractive option, despite the chance to be a part of saving hundreds of million smokers from an early grave, so there are not many who are willing to pick up the gauntlet.
Why the title choice? Because the only relevant scientific discussion that could be utilized to actually achieve evidence based policy in Sweden, is from outside Sweden, and disqualified in Sweden.
So officially the state of evidence in Sweden is ZERO
First, here is the actual article by Sharon, Green, Bayer and Fairchild (Mailman School of Public Health, Columbia University, New York), and also an audio interview (well worth 10 minutes of your time) with Amy Fairchild on August 4th 2016
Evidence, Policy, and E-Cigarettes — Will England Reframe the Debate?
N Engl J Med 2016; 374:1301-1303April 7, 2016DOI: 10.1056/NEJMp1601154
Tobacco-control advocates have been embroiled in a multiyear controversy over whether electronic cigarettes threaten the goal of further reducing tobacco smoking or offer the possibility of minimizing harm for people who cannot or will not quit smoking conventional cigarettes. England and the United States have now staked out very different positions.
The international landscape was dramatically reshaped in August 2015, when Public Health England (PHE), an agency of England’s Department of Health, released a groundbreaking report, “E-cigarettes: an evidence update.” With its claim that e-cigarettes are 95% less harmful than combustible cigarettes, the report attracted headlines internationally. It recommended that smokers who cannot or will not quit smoking tobacco try e-cigarettes and expressed great concern that the public perceived the two products as posing equal risks. Strikingly, the report underscored e-cigarettes’ potential to address the challenge of health inequalities, a central mission of PHE, stating that these devices “potentially offer a wide reach, low-cost intervention to reduce smoking and improve health in these more deprived groups in society where smoking is elevated.”1
The report — written by tobacco-addiction researcher Ann McNeill of King’s College London — reflected the position on e-cigarettes that had been agreed to by the U.K. public health community. Yet the editors of the Lancet asserted that though PHE claims to protect the nation’s health and well-being, it has failed to do so with this report. Two public health scholars writing in the BMJ also denounced the report, seizing on the methodologic limitations of one of the many studies on which the evidence review had relied, underlining the potential conflicts of interests acknowledged in the paper, and roundly condemning PHE for failing to meet basic evidentiary standards. Invoking the precautionary principle, the authors asserted that e-cigarette proponents bore the burden of proving that these products are not harmful. In contrast, 12 prominent U.K. public health organizations, including Cancer Research U.K. and the British Lung Foundation, defended PHE. Their joint press release underscored a public health responsibility to encourage smokers to switch to e-cigarettes, perhaps with the help of local smoking-cessation programs.
As dramatic as the report’s recommendations appear to be, they built on the United Kingdom’s long-standing commitment to harm reduction. In 1926, the Ministry of Health’s Rolleston Committee concluded that drug addiction was an illness that should be treated by physicians, sometimes with a minimal dose of drugs in order to prevent withdrawal symptoms. When AIDS came to the United Kingdom in the 1980s, the first government report on human immunodeficiency virus (HIV) infection among injection-drug users encouraged safer drug practices. Meanwhile, the United States took a prohibitionist position. Tight narcotic regulation and refusal to provide narcotics to addicts as treatment or maintenance defined the U.S. posture for decades.
Application of harm-reduction principles to tobacco products debuted in England in the 1970s, at the Institute of Psychiatry of the Maudsley Hospital. In 1976, Michael Russell, pioneer of effective nicotine-cessation treatments, famously wrote that “People smoke for nicotine but they die from the tar,”2 suggesting that one could satisfy a nicotine craving without risking the harms caused by smoking. Professional medical bodies in the United Kingdom endorsed a harm-reduction perspective. A 2007 report by the Tobacco Advisory Group of the Royal College of Physicians made the case that strategies to protect smokers were key, since nicotine addiction is difficult to overcome and millions of people fail to quit. That report argued “that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.”3
Even before e-cigarettes became widely available, the venerable and influential antitobacco organization Action on Smoking and Health (ASH) embraced the development of nicotine products that could rival the nicotine-delivery power of combustible cigarettes. Fiercely opposed to the tobacco industry, ASH had for decades called for increasingly stringent policies to reduce the prevalence of tobacco smoking by imposing higher taxes, banning advertisements, and setting strict limits on smoking in enclosed settings. In 2014, an ASH review of the evidence concluded that fears of a “gateway effect” were unsubstantiated and that e-cigarettes were being used largely by current or former cigarette smokers. Because it found little evidence that nonsmoking bystanders could be harmed by the vapor from e-cigarettes, ASH opposed inclusion of e-cigarettes in public smoke-free laws. Reinforcing his organization’s commitment to harm reduction and the primary goal of assisting smokers who could not or would not give up cigarettes, ASH’s chairman, John Moxham, said, “It would be a public health tragedy if smokers were discouraged from switching to electronic cigarettes and vapers were encouraged to go back to smoking because they don’t understand that vaping is a lot less harmful than smoking. That really would cost lives.”4 Not surprisingly, ASH applauded the findings of the PHE report.
The dominant policy perspective in the United States serves as a foil to the one embraced in England. The Campaign for Tobacco-Free Kids — ASH’s U.S. equivalent and a powerful voice in anti-tobacco advocacy — has been unequivocal in its denunciations of e-cigarettes. Similarly, the Centers for Disease Control and Prevention hosted a Public Health Grand Rounds on e-cigarettes in which all five speakers focused on the possible health risks associated with e-cigarette use. None acknowledged a potential role for e-cigarettes in reducing the tobacco burden in marginalized populations or reducing health disparities. Given the tight focus on potential risks to children and nonsmokers, e-cigarettes were out of the question. But one powerful voice for enhanced tobacco control in the United States did support the PHE report. In December 2015, the Truth Initiative (formerly the American Legacy Foundation) declared in an organizational position paper, “If prudently regulated, we believe ENDS [electronic nicotine delivery systems] hold promise as one means to move smokers to a less harmful product and reduce the devastating death and disease burden caused by combustible tobacco products.”5
What distinguishes the harm-reduction approach taken in the PHE report from the more absolutist approach adopted by U.S. policymakers today is a matter of focus. In England, where leading medical organizations regard nicotine alone as relatively benign, the pressing need to reduce the risks for current smokers frames the debate. The overwhelming focus in the United States is abstinence. It is in this broader context that the focus on children and nonsmokers must be viewed.
Will England change the international conversation about e-cigarettes? The answer will depend, in part, on what the evolving evidence suggests, and it may take years before the answers are definitive. In the end, the sorts of policies that are implemented will depend on whether whoever dominates the debate views harm reduction as opportunity or anathema.
Here are the replies to the Editor of NEJM regarding the actual subject matter
Evidence, Policy, and E-Cigarettes
N Engl J Med 2016; 375:e6August 4, 2016DOI: 10.1056/NEJMc1606395
To the Editor:
In their Perspective article in the April 7 issue,1 Green et al. argue that the English approach to e-cigarettes could reframe the debate on these products. They cite our article,2 implying that we were concerned about only one of the many studies in the Public Health England (PHE) review. That study was only one of our concerns, being the only source for the widely cited “95% safer” claim, especially given questions about conflicts of interest.3 We also discussed other evidence, some not quoted in the review, that raised serious questions about the safety of these products.4 Green et al. disregard the fact that harm reduction is only one element of a comprehensive drug strategy that, as in the successful Australian model, also encompasses reduction of demand and supply. 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.5 If we are to reframe the debate, maybe we should instead look to Australia, where adult smoking rates are now under 13%, without e-cigarettes.
Martin McKee, M.D., D.Sc.
London School of Hygiene and Tropical Medicine, London, United Kingdom
Dr. McKee reports that he chaired the Global Health Advisory Committee of the Open Society Foundations, which support and fund narcotics harm reduction. No other potential conflict of interest relevant to this letter was reported.
British Medical Association. E-cigarettes. June 30, 2016 (https://www.bma.org.uk/collective-voice/policy-and-research/public-and-population-health/tobacco/e-cigarettes).
To the Editor:
Green, Bayer, and Fairchild misrepresent the position of the Campaign for Tobacco-Free Kids on e-cigarettes. From the beginning, our organization has called for the Food and Drug Administration (FDA) to regulate e-cigarettes. We have repeatedly stated that it is possible that e-cigarettes could benefit public health if they are properly regulated, shown to be effective at helping smokers quit smoking regular cigarettes completely, and responsibly marketed to smokers who cannot or will not otherwise quit.1,2 However, we have also raised legitimate concerns about the large and rapid increase in the use of e-cigarettes by young people in the United States and the irresponsible marketing of these products with the use of tactics similar to those long used to make regular cigarettes appealing to children.3 It is not by any definition “absolutist” to call for FDA regulation of e-cigarettes. Effective regulation by the FDA is critical to minimizing the risks posed by e-cigarettes and maximizing the potential benefits.
Matthew L. Myers, J.D.
Campaign for Tobacco-Free Kids, Washington, DC
No potential conflict of interest relevant to this letter was reported.
Campaign for Tobacco-Free Kids. Comments submitted to the Food and Drug Administration on Docket No. FDA -2014-N-0189, RIN 0910-AG38, Proposed Rule on Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. August 8, 2014 (http://tfk.org/2014_08_14_deeming_comment).
Campaign for Tobacco-Free Kids. Comments submitted to the Food and Drug Administration on Docket No. FDA-2014-N-1936: Electronic Cigarettes and the Public Health Workshop. July 2, 2015 (http://tfk.org/2015_07_02_cigarette_comments).
Myers ML. Testimony to the Senate Committee on Commerce, Science, and Transportation. June 18, 2014 (https://www.commerce.senate.gov/public/_cache/files/719fb08c-fc96-4d6a-bb29-d5a80898857f/67FF5AFDCED948A4B19BE14ABCF06AFF.senate-commerce-hearing-myers-testimony-6-16-14.pdf).
Author replies to the critique by McKee and Myers
The authors reply: We agree with Myers regarding the need to regulate electronic cigarettes sensibly to protect public health. Rules and policies should encourage smokers to switch to lower-risk tobacco products while also preventing nonsmokers, particularly young people, from picking up these devices. Nevertheless, our intention was to contrast the broad public stances toward e-cigarettes held by major antitobacco organizations in the United Kingdom and the United States. In the United States, many advocacy organizations claim to support tobacco harm reduction but effectively endorse prohibition by regulation. Although Myers and the Campaign for Tobacco-Free Kids may believe in the potential for e-cigarettes to benefit public health if regulated properly, their messaging does not support the use of e-cigarettes for harm reduction in the ways that the U.K. Action on Smoking and Health (ASH) does. The Campaign focuses primarily on the prevention of hypothetical risks to nonsmoking children, whereas ASH’s emphasis is on improving the health of smokers who cannot or will not quit smoking cigarettes, which kill half of all long-term users, who lose more than 20 years of life, on average.
In response to McKee: we did not suggest that harm reduction is the only strategy to combat tobacco. Two of us (Bayer and Fairchild) have written extensively on laws, taxes, and campaigns to reduce the burden of tobacco. The focus in our recent article was on tobacco harm reduction, which should, of course, be implemented as part of a comprehensive drug strategy. McKee is correct in pointing out that there is not complete consensus in the United Kingdom regarding e-cigarettes, as we noted in our article. But what we underscored and what makes the United Kingdom exceptional is that many leading organizations support e-cigarettes for harm reduction. In fact, 12 prominent British organizations signed a press release supporting the PHE report. These organizations included the British Lung Foundation, Cancer Research UK, Faculty of Public Health, and the Royal College of Physicians.1
Sharon H. Green, M.P.H.
Ronald Bayer, Ph.D.
Amy L. Fairchild, Ph.D., M.P.H.
Columbia University Mailman School of Public Health, New York, NY
Since publication of their article, the authors report no further potential conflict of interest.
Public Health England. E-cigarettes: an emerging public health consensus. September 15, 2015 (https://www.gov.uk/government/news/e-cigarettes-an-emerging-public-health-consensus).
Here begins the flurry of online commentary
Here are the teams playing (though playing is not an adequate term since we are quite literally talking about hundreds of millions smoker lives cut short by non availability of effective harm reduction means)
Pro Tobacco Harm Reduction (Bates and Stimson)
Anti Tobacco Harm Reduction (McKee, Chapman, Myers, Daube)
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  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 :
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 .
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 .
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 . 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 . 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 an expert in nicotine policy or science, the author is a prolific commentator on the e-cigarette controversy. If he wishes to raise his game, he should start by reading an extensive critique of his own article in the BMJ (McKee M, 2015), which is at once devastating, educational, and entertaining .
 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]
 Royal College of Physicians (London) Nicotine without smoke: tobacco harm reduction 28 April 2016 [link]
 Bates C. Smears or science? The BMJ attack on Public Health England and its e-cigarettes evidence review, November 2015 [link]
 Australian Bureau of Statistics, National Health Survey: First Results, 2014-15. Table 9.3, 8 December 2015 [link to data]
 European Commission, Special Eurobarometer 429, Attitudes of Europeans towards tobacco, May 2015 [link] – see page 11.
 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.
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” , 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  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” 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. 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) . 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 , 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 . 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.” .
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