I am grateful to Bashash et al. for raising some important methodological and policy-related issues. Responding to their specific points:
(1) Very high formaldehyde concentrations may arise in aerosols when atomisers generate excessive heat[1]. Under these circumstances recommended safety limits for formaldehyde may indeed be exceeded and this compound contributes most to the cancer potency summation.
(2) Goodson et al. [2] provide a framework for assessing whether low dose compounds that are not necessarily individual carcinogens may become involved in carcinogenesis when acting in concert. Although discussed under "Strengths and limitations" synergystic phenomena were not accommodated in the cancer potency model as it is not yet possible to predict the mechanism and magnitude of such interactions in tobacco or e-cigarette aerosols. Under the Goodson et al. model adverse effects reflect adventitious synergystic combinations. These may be statistically more likely in tobacco smoke where the number of different compounds greatly exceeds those of simpler aerosols, however this effect is expected to be minor compared with the exceptionally high carcinogenic potencies of some well-established carcinogens in tobacco smoke.
(3) Lifetime cancer risk is linearly dependent on the daily volume of vapour inhaled (equation 7) and the effect on risk of increased consumption after switching to heat not burn (HnB) products is directly related to the chang...
I am grateful to Bashash et al. for raising some important methodological and policy-related issues. Responding to their specific points:
(1) Very high formaldehyde concentrations may arise in aerosols when atomisers generate excessive heat[1]. Under these circumstances recommended safety limits for formaldehyde may indeed be exceeded and this compound contributes most to the cancer potency summation.
(2) Goodson et al. [2] provide a framework for assessing whether low dose compounds that are not necessarily individual carcinogens may become involved in carcinogenesis when acting in concert. Although discussed under "Strengths and limitations" synergystic phenomena were not accommodated in the cancer potency model as it is not yet possible to predict the mechanism and magnitude of such interactions in tobacco or e-cigarette aerosols. Under the Goodson et al. model adverse effects reflect adventitious synergystic combinations. These may be statistically more likely in tobacco smoke where the number of different compounds greatly exceeds those of simpler aerosols, however this effect is expected to be minor compared with the exceptionally high carcinogenic potencies of some well-established carcinogens in tobacco smoke.
(3) Lifetime cancer risk is linearly dependent on the daily volume of vapour inhaled (equation 7) and the effect on risk of increased consumption after switching to heat not burn (HnB) products is directly related to the change in number of sticks. Any implication that HnB products pose acceptable risks was certainly not intended: the adjective 'safe' should never be used to encourage the use of HnB products, nor indeed any VNP with the possible exception of medicinal devices.
(4) Neither emissions nor biomarkers are suitable for accurate determination of absolute risks; long-term clinical evidence is needed for reliable estimates. In the meantime the emissions data used in the paper suggest that the relative lifetime cancer risk from HnB devices may be up to 50 times less than that of combustible cigarettes. The risk is still large - about 10,000 times greater than inhaling an equivalent volume of ambient air. In contrast the modelling suggests that many e-cigarettes pose cancer risks within a factor of 10 of a nicotine inhaler that has been approved for use by the public. E-cigarettes, if used as the manufacturer intended, appear to offer significantly lower risk alternatives to HnB for the smoker intent on using these novel products as aids to quitting to avoid cancer. The relative risks of other diseases are yet to be quantified.
References
[1] Farsalinos KE, Voudris V, Spyrou A, Poulas K. E-cigarettes emit very high formaldehyde levels only in conditions that are aversive to users: A replication study under verified realistic use conditions. Food and Chemical Toxicology. 2017;109:90-4.
[2] Goodson WH, Lowe L, Carpenter DO, Gilbertson M, A. MA, Lopez de Cerain Salsamendi A, 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-S96.
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Without citing any sources or providing any related analysis or explanation, this paper makes several sloppy and misleading statements about the scope and impact of federal preemption relating to state and local restrictions of flavored tobacco products.
We know from the preemption provisions in the federal Tobacco Control Act that state and local governments may not regulate the ingredients or characteristics of a tobacco product if the state or local regulation is “different from, or in addition to” an FDA tobacco product standard. [Sec. 916(a)(2)] But we do not yet know how FDA or the courts will interpret or apply that “different from, or in addition to” phrase. For example, it could mean that state and local governments are free to prohibit or limit the use of certain flavorings in certain types of tobacco products unless or until FDA prohibits or limits flavorings for those same types of tobacco products. To assert and publish a more restrictive interpretation of federal preemption with no qualification or clarification is not only misleading but promotes a more restrictive interpretation than necessary or desirable.
The paper also fails to note that the courts have ruled that the Tobacco Control Act’s preemption provisions leave state and local governments free to restrict the sale of flavored tobacco products within their boundaries. [See, e.g., U.S. Smokeless Tobacco v. City of New York, 708 F.3d 428 (2nd Cir., 2013).] The...
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Without citing any sources or providing any related analysis or explanation, this paper makes several sloppy and misleading statements about the scope and impact of federal preemption relating to state and local restrictions of flavored tobacco products.
We know from the preemption provisions in the federal Tobacco Control Act that state and local governments may not regulate the ingredients or characteristics of a tobacco product if the state or local regulation is “different from, or in addition to” an FDA tobacco product standard. [Sec. 916(a)(2)] But we do not yet know how FDA or the courts will interpret or apply that “different from, or in addition to” phrase. For example, it could mean that state and local governments are free to prohibit or limit the use of certain flavorings in certain types of tobacco products unless or until FDA prohibits or limits flavorings for those same types of tobacco products. To assert and publish a more restrictive interpretation of federal preemption with no qualification or clarification is not only misleading but promotes a more restrictive interpretation than necessary or desirable.
The paper also fails to note that the courts have ruled that the Tobacco Control Act’s preemption provisions leave state and local governments free to restrict the sale of flavored tobacco products within their boundaries. [See, e.g., U.S. Smokeless Tobacco v. City of New York, 708 F.3d 428 (2nd Cir., 2013).] These rulings suggest that state or local laws that restricted the sale of any tobacco products that contained more than a specified amount of certain flavorings would not be preempted (at least if they did not totally prohibit their sale). The tobacco industry would certainly bring legal challenges against any such state or local law and argue for a more restrictive interpretation. But unless the courts actually adopt the tobacco industry’s preferred view of the Tobacco Control Act’s preemption provisions, it is inaccurate and counterproductive for publications in Tobacco Control to present that restrictive view as current law.
Finally, the paper also implies that state and local governments cannot use chemical testing to determine the quantities of added flavorings in specific tobacco products as part of their enforcement efforts to establish violations of their (not preempted) laws restricting the sale of flavored tobacco products. But there is a big difference between directly regulating the amount of flavorings in certain types of tobacco products (possibly subject to preemption) and measuring the amount of flavorings in a tobacco product to develop evidence that it is a flavored tobacco product being sold in violation of a state or local sales restriction (not subject to preemption). For example, federal preemption could not possibly apply to a state or local enforcement agency using chemical analysis to show that a tobacco product has as much or more cherry flavoring than tobacco products previously marketed and sold as cherry flavored in order to establish that the sale of the tobacco product at regular retail outlets violates a (not-preempted) state or local law that allows the sale of tobacco products with a characterizing flavor of cherry only at licensed, adult-only tobacconists.
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.
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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...
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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 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 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 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 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 This ad watch shows an interesting example of illegal marketing
activity of an e-cigarette company in Korea. However, the description of the trend of
e-cigarette prevalence among Korean adolescents is not correct. According
to the national annual surveys that the author quoted (reference 4),
prevalence of current (30-day) e-cigarette use among Korean adolescents was
4.7% in 2011 and 5.0% in 2014. It decre...
NOT PEER REVIEWED This ad watch shows an interesting example of illegal marketing
activity of an e-cigarette company in Korea. However, the description of the trend of
e-cigarette prevalence among Korean adolescents is not correct. According
to the national annual surveys that the author quoted (reference 4),
prevalence of current (30-day) e-cigarette use among Korean adolescents was
4.7% in 2011 and 5.0% in 2014. It decreased continuously after then, and it
was 4.0% in 2015 and 2.5% in 2016. Even though there have been active
marketing activities by e-cigarette companies, strict regulations on e-
cigarettes enacted by the Korean government (i.e. tax levy, ban on sales to minors,
restriction of use in public places, and restriction of advertisement,
promotion and sponsorship) hindered increase of or even reduced e-
cigarette prevalence among Korean adolescents.
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?
I am grateful to Bashash et al. for raising some important methodological and policy-related issues. Responding to their specific points:
(1) Very high formaldehyde concentrations may arise in aerosols when atomisers generate excessive heat[1]. Under these circumstances recommended safety limits for formaldehyde may indeed be exceeded and this compound contributes most to the cancer potency summation.
(2) Goodson et al. [2] provide a framework for assessing whether low dose compounds that are not necessarily individual carcinogens may become involved in carcinogenesis when acting in concert. Although discussed under "Strengths and limitations" synergystic phenomena were not accommodated in the cancer potency model as it is not yet possible to predict the mechanism and magnitude of such interactions in tobacco or e-cigarette aerosols. Under the Goodson et al. model adverse effects reflect adventitious synergystic combinations. These may be statistically more likely in tobacco smoke where the number of different compounds greatly exceeds those of simpler aerosols, however this effect is expected to be minor compared with the exceptionally high carcinogenic potencies of some well-established carcinogens in tobacco smoke.
(3) Lifetime cancer risk is linearly dependent on the daily volume of vapour inhaled (equation 7) and the effect on risk of increased consumption after switching to heat not burn (HnB) products is directly related to the chang...
Show MoreNOT PEER REVIEWED
Without citing any sources or providing any related analysis or explanation, this paper makes several sloppy and misleading statements about the scope and impact of federal preemption relating to state and local restrictions of flavored tobacco products.
We know from the preemption provisions in the federal Tobacco Control Act that state and local governments may not regulate the ingredients or characteristics of a tobacco product if the state or local regulation is “different from, or in addition to” an FDA tobacco product standard. [Sec. 916(a)(2)] But we do not yet know how FDA or the courts will interpret or apply that “different from, or in addition to” phrase. For example, it could mean that state and local governments are free to prohibit or limit the use of certain flavorings in certain types of tobacco products unless or until FDA prohibits or limits flavorings for those same types of tobacco products. To assert and publish a more restrictive interpretation of federal preemption with no qualification or clarification is not only misleading but promotes a more restrictive interpretation than necessary or desirable.
The paper also fails to note that the courts have ruled that the Tobacco Control Act’s preemption provisions leave state and local governments free to restrict the sale of flavored tobacco products within their boundaries. [See, e.g., U.S. Smokeless Tobacco v. City of New York, 708 F.3d 428 (2nd Cir., 2013).] The...
Show MoreNOT 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
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 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 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 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 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 This ad watch shows an interesting example of illegal marketing activity of an e-cigarette company in Korea. However, the description of the trend of e-cigarette prevalence among Korean adolescents is not correct. According to the national annual surveys that the author quoted (reference 4), prevalence of current (30-day) e-cigarette use among Korean adolescents was 4.7% in 2011 and 5.0% in 2014. It decre...
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?
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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