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NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, taken as a whole, their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control. Current policy, which had its beginnings some 20 years or more later, is painted as being an outgrowth of the low tar programme and as being similarly tainted with industry influence. It reflects no credit on the editorial processes and decision making of Tobacco Control that authors were permitted to get away with such unsupported conclusions in their published paper.
The idea that reduction in tar yield of cigarettes could be an effective way of reducing the health risks of smoking goes back to the 1960s at least. It was supported by many distinguished epidemiologists, including Doll, Peto, and Wynder. See for example this 1979 statement by Ernst Wynder: ““One of the things that has always appealed to me about science is that if I find something that makes biological sense, then I feel reassured. Thirty years ago, when we had a 40mg tar cigarette, if you smoked 30 cigarettes a day you were exposed to about 1200 mg tar a day. Today’s cigarettes have 20 mg tar, so you are exposed to 600 mg daily. If there’s one thing everybody can agree on, it is that all tobacco-related cancers are dose related.” (1)
What was lacking in this formulation was an understanding that the risk from products is not simply determined by their composition, but resides in the interaction between the user and the product – as Michael Russell pointed out, if tar yield was everything, the most dangerous product would be the large Cuban cigar (1).
Russell was an outspoken critic of the ISCSH’s record. In a 1980 comment on the committee’s second report (2) he noted “Most of all it [the report] is remarkable for the stunning naivety of its implicit model of smoking behaviour”. He pointed out that: “Lower risk cigarettes are equated with cigarettes with lower tar and nicotine yields. If people smoked cigarettes in the same way that smoking machines do, this would indeed be the case. But there is much evidence that they do not….The tendency for smokers to regulate their smoke intake has been ignored by the Hunter Committee”.
Russell was not a member of the ISCSH (indeed, the membership of the committee was heavily tilted towards epidemiology and toxicology, and included no behavioural science expertise). It is in Russell’s insights and policy prescriptions that we can see the real intellectual underpinnings of UK policy on harm reduction in recent years.
Russell had a number of key insights, the most fundamental of which is that people smoke for nicotine (3). This coupled with the observation that the harms of smoking come not from the drug people are seeking, but from contaminants of the delivery system used to obtain it, led to his dictum “People smoke for the nicotine, but die from the tar”. As early as the mid-1970s he began to advocate an approach to tobacco harm reduction that was based on an appreciation of nicotine’s role (4, 5). He was the first to expose the fallacy of low tar cigarettes (6) and the first to explore the potential of non-combustible nicotine products for harm reduction (7-9). His 1991 paper in the British Journal of Addiction (10) and editorial in The Lancet (11) set out a vision for a transformed nicotine market: “If a strategy were adopted to sanction and encourage the use of purified nicotine products as substitutes for smoking, and at the same time impose stringent regulations on permissible constituents of cigarette smoke …….. the virtual elimination of smoking could become a more realistic health promotion target” (11). This represents a paradigm shift from the failed approach adopted in the 1970s. How it, or something springing from it, became a part of UK tobacco control policy in recent years, is a story for others to tell. But it did not happen through tobacco industry influence.
References
1. Gori GB, Bock FG. Banbury Report 3: A Safe Cigarette? Cold Spring Harbor Laboratory; 1980.
2. Jarvis MJ, Russell MAH. Comment on the Hunter Committee's second report. British Medical Journal. 1980;5; 280(6219):994-5.
3. Russell MA. Cigarette smoking: natural history of a dependence disorder. Br-J-Med-Psychol. 1971;44(1):1-16.
4. Russell MA. Realistic goals for smoking and health. A case for safer smoking. Lancet. 1974;16; 1(851):254-8.
5. Russell MA. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. Br-Med-J. 1976;12; 1(6023):1430-3.
6. Russell MAH, Jarvis M, Iyer R, Feyerabend C. Relation of nicotine yield of cigarettes to blood nicotine concentrations in smokers. British Medical Journal. 1980;280(6219):972-6.
7. Russell MAH, Jarvis MJ, Feyerabend C. A new age for snuff? Lancet. 1980;1; 1(8166):474-5.
8. Russell MAH, Jarvis MJ, Devitt G, Feyerabend C. Nicotine intake by snuff users. Br Med J. 1981;26; 283(6295):814-7.
9. Russell MAH, Jarvis MJ, West RJ, Feyerabend C. Buccal absorption of nicotine from smokeless tobacco sachets. Lancet. 1985;2(8468):1370.
10. Russell MAH. The future of nicotine replacement. Br-J-Addict. 1991;86(5):653-8.
11. Russell MAH. Nicotine use after the year 2000. The Lancet. 1991;337:1191-2.
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a swi...
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a switch to HNB devices [5]. For non-smokers or occasional smokers to whom HNBs are introduced as a safe product, any additional burden of toxicants increases the risk of cancer.
4) The conclusion concentrates on reduced risk of VNPs compared to the most harmful product (i.e tobacco smoke) and should also calculate elevated risk of using VNPs compared to background concentration.
In summary, smoking imposes exposure to a variety of toxicants with known and/or unknown health effect regardless of name, shape and means of use. These findings suggest that HNB cigarettes should be subject to the same regulations as tobacco cigarettes. The tobacco control community should communicate the absolute risks associated with these products. In particular, there is an urgent need for tobacco control policy actors to understand the potential absolute harms of heat-not-burn (HNB) cigarettes that PMI is pushing as ‘less harmful alternatives to smoking’ in their declared movement toward a smoke-free world (https://www.pmi.com/sustainability).
References:
[1] Stephens WE. Comparing the cancer potencies of emissions from vapourised nicotine products including e-cigarettes with those of tobacco smoke. Tobacco Control 2017.
[2] Auer R, Concha-Lozano N, Jacot-Sadowski I, et al. Heat-not-burn tobacco cigarettes: Smoke by any other name. JAMA Internal Medicine 2017.
[3] Cogliano VJ, Grosse Y, Baan RA, et al. Meeting report: summary of IARC monographs on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol. Environmental health perspectives 2005:1205-1208.
[4] Goodson III WH, Lowe L, Carpenter DO, et al. Assessing the carcinogenic potential of low-dose exposures to chemical mixtures in the environment: the challenge ahead. Carcinogenesis 2015;36(Suppl_1):S254-S296.
[5] Lüdicke F, Baker G, Magnette J, et al. Reduced Exposure to Harmful and Potentially Harmful Smoke Constituents With the Tobacco Heating System 2.1. Nicotine & Tobacco Research 2017;19(2):168-175.
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different the outcome if administered by an organization such as my own where the respondents would likely be more at ease. And while if started from scratch with recruitment it might also attract other-thinking smokers that could skew it the other way (but also then questioning this study's sample at the same time), it need not be necessary in regard to the study limitation present here today.
NOT PEER REVIEWED This paper is part of the ongoing discussion about saving lives from tobacco use. As a practicing oncologist and part-time Hospice physician, I have seen real benefit from "vaping". First, many Hospice patients, who have smoked for decades and are actively dying put themselves at real risk if they smoke real cigarettes while dying. Taking away cigarettes during the terminal illness just causes antagonism and much distress for the patient, their family, and the Hospice staff. Vaping at the end of life does prevent burns, suffering, and psychological distress.
For my oncology patients, I recommend vaping as an alternative to cigarettes for the many cigarette smokers who cannot "quit", despite real effort attempts with nicotine patches, gum, Wellbutrin, or Chantix. I do see lives improving, pulmonary function improving, and less stress in the exam setting, trying to convince the patient to quit yet another time.
We do need more research about cigarette alternatives for the existing nicotine addicts. There is, most definitely a role for these products, but also a need for researching the safety, efficacy, and best application of these products as an alternative for active adult smokers with health issues.
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the mos...
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the most pessimistic possible). Studies support the Royal College that non-combustible nicotine use is substantially less harmful than the smoke from combustion in clinical studies that smokers who switched to e-cigarettes reduced symptoms of pulmonary disease and cancer biomarkers (Shahib et al., Ann. Internal Med 2017; Glasser et al., AJPM, 2017; Benowitz and Fraiman, Nat Rev Cardiol. 2017).
Second, Dr. Peters clearly misunderstands the limitations of the longitudinal youth research. The studies to date cannot rule out confounders based on a shared liability model and, consequently, others suggest that fears of a gateway are overblown (Kozlowski & Warner, Drug & Alc Dep, 2017). These studies were conducted in a period when smoking and vaping rates were going in opposite directions or when smoking rates were continuing to decline more rapidly in the presence of reduced vaping (2013-16), and are based on very low levels of use (ever use or any monthly use, not regular use). The gateway theory is about population level relationships, and it cannot account for the two behaviours, cigarette use and e-cigarette use, going in opposite directions.
Third, Dr. Peters mischaracterizes the use of vaping. Where it is regularly available, vaping is the most used form of smoking cessation help, and, while the current evidence indicates it is at least as effective as nicotine replacement therapy (NRT’s) and possibly more so, as e-cigarettes are used by more smokers in quit attempts than NRT’s (Hartman-Boyce, Cochrane Reviews, 2016), and therefore will be having a larger net population effect. The recent population level analysis of Zhu et al (BMJ, 2017) shows an acceleration of the reduction in smoking prevalence in a period where the rapid uptake of vaping was the most notable change in the tobacco control environment and Levy et al (NTR, 2017) show a strong relationship between vaping, especially when done regularly, and both previous year quit attempts and quit success. A recent review confirms that e-cigarettes help smokers to quit and that studies of negative correlations between e-cigarette use and smoking cessation fail to meet reasonable but rigorous standards of scientific evidence (Villanti et al., Addiction, 2017).
Fourth, Dr. Peters claims that we underestimate the declining prevalence from 2009 to 2015, but does not point out the plausibility of a significant proportion of this change being due to the introduction of vaping. Indeed, this is precisely why we made the starting point for our projections (2012) when we did, at the point when the level of vaping was so small as to not have any appreciable possible impact on smoking rates.
As we indicated in our reply to Dr. Glantz, our goal in this study is not to predict the future, but to suggest a course for reaching an endgame of eliminating cigarettes tobacco use. Our hope is for tobacco control advocates to keep an open mind about the possibilities. Having smokers switch to e-cigarettes may not be the ideal outcome, but do we want to let the perfect continue to be the enemy of the possible?
NOT PEER REVIEWED In his critique, Stan Glantz, PhD interprets and presents our study as doing something we explicitly warned readers it was not intended to do. He argues that “the model is based on a series of assumptions that are inconsistent with empirical evidence.” However, we explicitly state and he reiterates, that the model is not meant to be predictive. In our previous work (Addiction 2017: NTR 2017), we presented a framework to help better understand the effects of e-cigarettes and argued that we need better information before we rush to judgement about the actual impact of e-cigarette use.
Our goal in writing this paper was simply to show that e-cigarettes could help us reach a real smoking and tobacco control endgame. In the US, we have made great progress applying traditional policies, such as tax increases, smoke-free air laws and media campaigns. However, SimSmoke models for the US and other countries indicate that traditional tobacco control policies can only get us partially to the endgame. We think that we can achieve more. Many countries have complied fully or near fully with the FCTC and still have unacceptably high rates of smoking prevalence. The point of our paper is to show that strategies shifting smokers to e-cigarettes can play a role in achieving the endgame.
While Glantz recognizes that we provide a “pessimistic” as well as an “optimistic” scenario, he dwells on the optimistic scenario. Many in the public health community see...
NOT PEER REVIEWED In his critique, Stan Glantz, PhD interprets and presents our study as doing something we explicitly warned readers it was not intended to do. He argues that “the model is based on a series of assumptions that are inconsistent with empirical evidence.” However, we explicitly state and he reiterates, that the model is not meant to be predictive. In our previous work (Addiction 2017: NTR 2017), we presented a framework to help better understand the effects of e-cigarettes and argued that we need better information before we rush to judgement about the actual impact of e-cigarette use.
Our goal in writing this paper was simply to show that e-cigarettes could help us reach a real smoking and tobacco control endgame. In the US, we have made great progress applying traditional policies, such as tax increases, smoke-free air laws and media campaigns. However, SimSmoke models for the US and other countries indicate that traditional tobacco control policies can only get us partially to the endgame. We think that we can achieve more. Many countries have complied fully or near fully with the FCTC and still have unacceptably high rates of smoking prevalence. The point of our paper is to show that strategies shifting smokers to e-cigarettes can play a role in achieving the endgame.
While Glantz recognizes that we provide a “pessimistic” as well as an “optimistic” scenario, he dwells on the optimistic scenario. Many in the public health community seem to think that supporting a thoughtful e-cigarette based harm reduction strategy could have horrible public health consequences. We included a pessimistic scenario with major differences from the optimistic scenario to incorporate the concerns of those most skeptical of e-cigarettes as a harm reduction tool. One of the main findings of this study was to show that even if a strategy that secured large shifts away from smoking sharply increased e-cigarette use among those who would otherwise quit all tobacco use and otherwise nonsmoking youth – and even if e-cigarettes also turned out to be much more harmful than currently available research indicates – an aggressive switching strategy would still secure large net public health benefits. Again, we are not claiming that we know the answer, but we are asking that tobacco control advocates keep an open mind towards strategies encouraging cigarette smokers to switch to e-cigarettes.
Glantz has indicated that he believes that there are alternative ways to achieve endgame goals in regard to smoking without prompting any large shifts from smoking to e-cigarettes. We would encourage Glantz to publish his ideas and estimates of a set of policies that could possibly move us to such an endgame without prompting shifts to e-cigarette use. Cigarette tax increases, graphic health warnings on cigarettes, more aggressive anti-smoking public education campaigns, and even much more novel and aggressive strategies such as minimizing nicotine levels or banning menthol will all directly reduce smoking. But they will also likely move many smokers to e-cigarette use. Among other things, our study shows that securing large smoking declines through such measures will secure large public health gains even if they do so primarily by shifting smokers first to e-cigarettes.
It is interesting that Glantz has ended with a quote from our article, “tobacco industry documents reveal an industry strategy of ‘divide and conquer’ focused primarily on fostering divisions within the tobacco control community regarding modified risk products.” It is important that we in tobacco control do not stray into pointless, divisive stances. We have made great progress in reducing cigarette use, but much more can be done, and we’ll get there faster if we work together.
NOT PEER REVIEWED The data, interpretations and implications of the data modelling exercise conducted by Levy et al(1) should not go unchallenged. Regardless of the number and confidence of the opinions voiced, and the observation of lower levels of selected toxicants in e-cigarette users that are alluded to, there is great uncertainty about the extent to which harm might be reduced by the exclusive use of electronic cigarette rather than combustible tobacco. On this background, to describe one of two models, a 95% harm reduction as optimistic and the second, still a substantial, hopeful estimate of 60% reduction as pessimistic betrays a bias at the outset. The use of this “pessimistic” descriptor would to a casual reader imply that the truth lay, inevitably, somewhere between the two estimates.
Then there is the detail of the model. Firstly, the use of Holford projections(2) overestimated 2015 smoking rates in the US by at least 10% compared to CDC data(3) - underestimating the recent rate of decline in smoking prevalence in men and women between 2005 and 2015 by one-third. A higher base rate and slower rate of decline exaggerate tobacco-related harms in the status quo – naturally favouring each of the modelled scenarios. Starting with lower, more accurate estimates of current smoking and rates of decline would also increase the counterbalancing harms from initiation in non-smokers.
There are other obvious problems. In the status quo, 20% of boys and 14...
NOT PEER REVIEWED The data, interpretations and implications of the data modelling exercise conducted by Levy et al(1) should not go unchallenged. Regardless of the number and confidence of the opinions voiced, and the observation of lower levels of selected toxicants in e-cigarette users that are alluded to, there is great uncertainty about the extent to which harm might be reduced by the exclusive use of electronic cigarette rather than combustible tobacco. On this background, to describe one of two models, a 95% harm reduction as optimistic and the second, still a substantial, hopeful estimate of 60% reduction as pessimistic betrays a bias at the outset. The use of this “pessimistic” descriptor would to a casual reader imply that the truth lay, inevitably, somewhere between the two estimates.
Then there is the detail of the model. Firstly, the use of Holford projections(2) overestimated 2015 smoking rates in the US by at least 10% compared to CDC data(3) - underestimating the recent rate of decline in smoking prevalence in men and women between 2005 and 2015 by one-third. A higher base rate and slower rate of decline exaggerate tobacco-related harms in the status quo – naturally favouring each of the modelled scenarios. Starting with lower, more accurate estimates of current smoking and rates of decline would also increase the counterbalancing harms from initiation in non-smokers.
There are other obvious problems. In the status quo, 20% of boys and 14.8% of girls would commence smoking between ages 15 and 25. To achieve the effects modelled, 83% of the 15 year olds boys who would have commenced smoking and 70% of the pre-destined female smokers would have to be diverted to exclusive e-cigarette use. In the optimistic target, requiring the most complete diversion, there is no allowance for harms of “off target” initiation of e-cigarette use i.e. initiation in a young person otherwise destined not to smoke. This is irrational given that e-cigarette use in young people trebles smoking rates after allowance for predictors of smoking uptake(4). The harder e-cigarette use is pushed the more off-target use is likely unless magic is in operation. This detail is critical. Under the published “pessimistic” model for 15 year old girls, there is already a negative effect in terms of years of life lost; not a benefit.
It goes on. Ten years after the commencement of the model in 15 year olds, no individual appears to have ceased the use of e-cigarettes. In the real world, discontinuation is the norm, rather than the exception. Even in England, with ready availability and a favourable public discourse, a minority of smokers choose e-cigarettes to aid smoking cessation(5) . Assumed smoking cessation rates with e-cigarettes are greatly in excess of what is achieved in clinical trials and standard clinical practice. How an intervention that is rejected longer-term in most smokers and ineffective in short-term use will achieve the 5%/10% smoking rates as modelled is unclear but it does not affect the calculations in the model as under both scenarios the outcome in smoking rates is predetermined. The viability of the steps needed to achieve this outcome are not questioned.
It is not difficult to see where this is heading. The purported benefits could only ever be achieved if electronic cigarettes or other novel products were freely available, including to adolescents at or before the typical age of initiation of combustible tobacco use, and had low pricing/taxation amidst a generally liberal approach to their use in public places. This would need to be supported by strong and effective marketing, attractive packaging and advertising standards that permitted uncertain/unproven claims about long-term safety and health benefits. Products would need to be researched and designed that were more rewarding/addictive than combustible tobacco to prevent switch and interchange with smoking. One wonders what responsible corporate entity would develop such a product, potentially harming many of its consumers whilst removing their easy and free choice to cease its use.
References:
1. Levy DT, Borland R, Lindblom EN, et al. Potential deaths averted in USA by replacing cigarettes with e-cigarettes. Tobacco Control (online first; doi: 10.1136/tobaccocontrol-2017-053759)
2. Holford TR, Levy DT, McKay LA, et al. Patterns of birth cohort-specific smoking histories, 1965-2009. Am J Prev Med 2014;46:e31–7.
3. Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults — United States, 2005–2015. MMWR Morb Mortal Wkly Rep 2016;65:1205–1211.
4. Soneji S, Barrington-Trimis JL, Wills TA et al. Association Between Initial Use of e-Cigarettes and Subsequent Cigarette Smoking Among Adolescents and Young Adults. A Systematic Review and Meta-analysis. JAMA Pediatr 2017; 171:788-797.
NOT PEER REVIEWED
The paper, “Potential deaths averted in USA by replacing cigarettes with e-cigarettes” by David Levy et al. published in Tobacco Control on October 2, 2017, attracted a moderate amount of attention with its conclusion that “Compared with the Status Quo, replacement of cigarette by e-cigarette use over a 10-year period yields 6.6 million fewer premature deaths with 86.7 million fewer life years lost in the Optimistic Scenario. … Our projections show that a strategy of replacing cigarette smoking with vaping would yield substantial life year gains, …”
This is a pretty impressive result until you consider that the Optimistic Scenario is based on a series of assumptions that are of which are inconsistent with empirical evidence to date:
Cigarette smoking prevalence drops from 17% to 5% in 10 years (from 19.3% to 4.6% in men and from $14.1% to 4.6% in women between 2016 and 2026).
The existence of e-cigarettes does not, on average, depress quitting cigarettes.
There is no relapse from e-cigarette use to cigarette smoking.
No youth who initiate with e-cigarettes progress to cigarette use.
No dual use of cigarettes and e-cigarettes.
The evidence free claim that e-cigarettes are 5% as dangerous as cigarettes.
(These assumptions were not clearly stated in the main paper; we figured them out based on the appendix and by examining the Excel spreadsheet of the model that the authors s...
NOT PEER REVIEWED
The paper, “Potential deaths averted in USA by replacing cigarettes with e-cigarettes” by David Levy et al. published in Tobacco Control on October 2, 2017, attracted a moderate amount of attention with its conclusion that “Compared with the Status Quo, replacement of cigarette by e-cigarette use over a 10-year period yields 6.6 million fewer premature deaths with 86.7 million fewer life years lost in the Optimistic Scenario. … Our projections show that a strategy of replacing cigarette smoking with vaping would yield substantial life year gains, …”
This is a pretty impressive result until you consider that the Optimistic Scenario is based on a series of assumptions that are of which are inconsistent with empirical evidence to date:
Cigarette smoking prevalence drops from 17% to 5% in 10 years (from 19.3% to 4.6% in men and from $14.1% to 4.6% in women between 2016 and 2026).
The existence of e-cigarettes does not, on average, depress quitting cigarettes.
There is no relapse from e-cigarette use to cigarette smoking.
No youth who initiate with e-cigarettes progress to cigarette use.
No dual use of cigarettes and e-cigarettes.
The evidence free claim that e-cigarettes are 5% as dangerous as cigarettes.
(These assumptions were not clearly stated in the main paper; we figured them out based on the appendix and by examining the Excel spreadsheet of the model that the authors shared with us in response to an email. Their Pessimistic Scenario is based on similar assumptions, albeit with a higher e-cig risk.)
It is important to recognize that the authors don’t even pretend that their estimates are based on reality. In their Discussion they state: “Unlike previous models of e-cigarette use, our model was not developed to predict future e-cigarette and cigarette use based on past trends. Rather the aim was to examine a hypothetical endgame strategy of reducing cigarette use through switching to e-cigarettes. ”
I used their model to investigate the lives saved if cigarette use dropped along the same trajectory that the authors assumed because of increased smokefree laws, anti-smoking media, higher taxes and achieving smokefree movies without anyone even using an e-cigarette. Doing so (without e-cigarettes) would have saved even more lives – 7.0 million fewer lives lost and 91.4 million fewer life years lost.
The centrality of the first assumption is demonstrated by the fact that, using the Levy et al model (which they provided me as a spreadsheet) requires that e-cigarettes be more dangerous than cigarettes (about 120-130% more dangerous) to end up having a net negative population health impact. This is because they assume huge drops in smoking cigarettes.
In other words, all that this paper shows is that if a lot fewer people smoke, there will be a lot fewer premature deaths from smoking. It contributes absolutely nothing to the discussion of the efficacy of e-cigarettes for harm reduction.
It would be like someone asking what would happen to melting ice sheets if we were to be able to bring greenhouse gasses back to pre-industrial levels in 10 years. The calculation is possible but the results would not contribute anything to public policy because, like the Levy paper, the assumptions are discordant with reality.
Finally, in the Conclusion of their paper Levy et al state that “tobacco industry documents reveal an industry strategy of ‘divide and conquer’ focused primarily on fostering divisions within the tobacco control community regarding modified risk products. Indeed, the tobacco control community has had divided approaches to e-cigarettes, and in the process may have lost focus on cigarettes, the most deadly form of nicotine delivery ... Most important, an e-cigarette substitution strategy provides the justification to redouble efforts to target cigarette use, as called for by the WHO Framework Convention for Tobacco Control.” The authors are, of course, welcome to their opinion. But nothing in this paper provides an empirical support for this argument.
NOT PEER REVIEWED It is disappointing that Robert Proctor’s advocacy for tobacco abolition, so clearly expressed in his magisterial ‘Golden Holocaust’ (2011) and, indeed, in Tobacco Control (1), appears to have been diluted to the same degree that he now seems in favour of diluting the concentration of nicotine in cigarettes. And this in spite of the various potential difficulties he points out in implementing the proposal to reduce nicotine in cigarettes to sub-addictive levels, not least that it could well result in decades-long delays before such cigarettes might eventually replace conventional ones.
I also have argued that the only realistic way to deal with the tobacco problem is through abolition (2). This is easier than it might seem, because, as Robert Proctor himself has said (1):
‘[S]moking is not a recreational drug; most smokers do not like the fact they smoke and wish they could quit.’
Is it not time for tobacco abolition, rather than ‘control’, to become part of the debate?
NOT PEER REVIEWED
Show MoreElias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
1. Britton, J. and Bogdanovica, I. Electronic cigarettes. A report commissioned by Public Health England. Public Health England, 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
Show More2. Bauld, L., Angus, K., and de Andrade, M. E-cigarette uptake and marketing. A report commissioned by Public Health England. Public Health England, 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
3. McNeill, A., Brose, L., Calder, R., Hitchman, S.C., McRobbie, H., and Hajek, P. E-cigarettes: an evidence update. A report commissioned by Public Health England. Public Health England, 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
4. Tobacco Adviso...
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
Show More1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a swi...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
Show MoreNOT PEER REVIEWED This paper is part of the ongoing discussion about saving lives from tobacco use. As a practicing oncologist and part-time Hospice physician, I have seen real benefit from "vaping". First, many Hospice patients, who have smoked for decades and are actively dying put themselves at real risk if they smoke real cigarettes while dying. Taking away cigarettes during the terminal illness just causes antagonism and much distress for the patient, their family, and the Hospice staff. Vaping at the end of life does prevent burns, suffering, and psychological distress.
For my oncology patients, I recommend vaping as an alternative to cigarettes for the many cigarette smokers who cannot "quit", despite real effort attempts with nicotine patches, gum, Wellbutrin, or Chantix. I do see lives improving, pulmonary function improving, and less stress in the exam setting, trying to convince the patient to quit yet another time.
We do need more research about cigarette alternatives for the existing nicotine addicts. There is, most definitely a role for these products, but also a need for researching the safety, efficacy, and best application of these products as an alternative for active adult smokers with health issues.
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
Show MoreFirst, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the mos...
NOT PEER REVIEWED In his critique, Stan Glantz, PhD interprets and presents our study as doing something we explicitly warned readers it was not intended to do. He argues that “the model is based on a series of assumptions that are inconsistent with empirical evidence.” However, we explicitly state and he reiterates, that the model is not meant to be predictive. In our previous work (Addiction 2017: NTR 2017), we presented a framework to help better understand the effects of e-cigarettes and argued that we need better information before we rush to judgement about the actual impact of e-cigarette use.
Our goal in writing this paper was simply to show that e-cigarettes could help us reach a real smoking and tobacco control endgame. In the US, we have made great progress applying traditional policies, such as tax increases, smoke-free air laws and media campaigns. However, SimSmoke models for the US and other countries indicate that traditional tobacco control policies can only get us partially to the endgame. We think that we can achieve more. Many countries have complied fully or near fully with the FCTC and still have unacceptably high rates of smoking prevalence. The point of our paper is to show that strategies shifting smokers to e-cigarettes can play a role in achieving the endgame.
While Glantz recognizes that we provide a “pessimistic” as well as an “optimistic” scenario, he dwells on the optimistic scenario. Many in the public health community see...
Show MoreNOT PEER REVIEWED The data, interpretations and implications of the data modelling exercise conducted by Levy et al(1) should not go unchallenged. Regardless of the number and confidence of the opinions voiced, and the observation of lower levels of selected toxicants in e-cigarette users that are alluded to, there is great uncertainty about the extent to which harm might be reduced by the exclusive use of electronic cigarette rather than combustible tobacco. On this background, to describe one of two models, a 95% harm reduction as optimistic and the second, still a substantial, hopeful estimate of 60% reduction as pessimistic betrays a bias at the outset. The use of this “pessimistic” descriptor would to a casual reader imply that the truth lay, inevitably, somewhere between the two estimates.
Then there is the detail of the model. Firstly, the use of Holford projections(2) overestimated 2015 smoking rates in the US by at least 10% compared to CDC data(3) - underestimating the recent rate of decline in smoking prevalence in men and women between 2005 and 2015 by one-third. A higher base rate and slower rate of decline exaggerate tobacco-related harms in the status quo – naturally favouring each of the modelled scenarios. Starting with lower, more accurate estimates of current smoking and rates of decline would also increase the counterbalancing harms from initiation in non-smokers.
There are other obvious problems. In the status quo, 20% of boys and 14...
Show MoreNOT PEER REVIEWED
The paper, “Potential deaths averted in USA by replacing cigarettes with e-cigarettes” by David Levy et al. published in Tobacco Control on October 2, 2017, attracted a moderate amount of attention with its conclusion that “Compared with the Status Quo, replacement of cigarette by e-cigarette use over a 10-year period yields 6.6 million fewer premature deaths with 86.7 million fewer life years lost in the Optimistic Scenario. … Our projections show that a strategy of replacing cigarette smoking with vaping would yield substantial life year gains, …”
This is a pretty impressive result until you consider that the Optimistic Scenario is based on a series of assumptions that are of which are inconsistent with empirical evidence to date:
Cigarette smoking prevalence drops from 17% to 5% in 10 years (from 19.3% to 4.6% in men and from $14.1% to 4.6% in women between 2016 and 2026).
The existence of e-cigarettes does not, on average, depress quitting cigarettes.
There is no relapse from e-cigarette use to cigarette smoking.
No youth who initiate with e-cigarettes progress to cigarette use.
No dual use of cigarettes and e-cigarettes.
The evidence free claim that e-cigarettes are 5% as dangerous as cigarettes.
(These assumptions were not clearly stated in the main paper; we figured them out based on the appendix and by examining the Excel spreadsheet of the model that the authors s...
Show MoreNOT PEER REVIEWED It is disappointing that Robert Proctor’s advocacy for tobacco abolition, so clearly expressed in his magisterial ‘Golden Holocaust’ (2011) and, indeed, in Tobacco Control (1), appears to have been diluted to the same degree that he now seems in favour of diluting the concentration of nicotine in cigarettes. And this in spite of the various potential difficulties he points out in implementing the proposal to reduce nicotine in cigarettes to sub-addictive levels, not least that it could well result in decades-long delays before such cigarettes might eventually replace conventional ones.
I also have argued that the only realistic way to deal with the tobacco problem is through abolition (2). This is easier than it might seem, because, as Robert Proctor himself has said (1):
‘[S]moking is not a recreational drug; most smokers do not like the fact they smoke and wish they could quit.’
Is it not time for tobacco abolition, rather than ‘control’, to become part of the debate?
symonds@tokyobritishclinic.com
1. Proctor RN. Why ban the sale of cigarettes? The case for abolition. Tobacco Control 2013;22:i27-i30.
2. http://nicotinemonkey.com/?p=1702
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