NOT PEER REVIEWED The authors point out that rates of adolescent ever use of e-cigarettes are substantial and increasing, but rates of regular use remain low. Yet it is also worth placing these rates of adolescent use in the context of other groups of e-cigarette users. In particular, a recent systematic review colleagues and I published into sociodemographic differences in e-cigarette use gives further salience to Conner et al’s findings. Although the availability of UK evidence for our review was limited, some very clear patterns emerged internationally. For instance, within the 38 studies reporting ever use and the 22 reporting current use, these outcomes were particularly prevalent in older adolescents and younger adults (versus younger children and older adults respectively). This therefore lends further weight to Conner et al’s recommendations around regulating the marketing and sale of e-cigarettes to minors in countries which lack sufficient legislation in this area. Both papers also show the importance of future studies stratifying findings by sociodemographic variables such as age to ensure more subgroup analyses are possible.
1) Hartwell G, Thomas S, Egan M, et al E-cigarettes and equity: a systematic review of differences in awareness and use between sociodemographic groups Tobacco Control Published Online First: 21 December 2016. doi: 10.1136/tobaccocontrol-2016-053222
NOT PEER REVIEWED The United Kingdom government is now recommending e-cigarettes as important tools in helping individuals to quit smoking (http://www.bbc.co.uk/news/health-41339790). It is widely acknowledged that, for many, smoking tobacco is detrimental to health. However, it is perhaps less widely appreciated that we have only a limited understanding of why smoking tobacco is bad for our health. Why, for example, might you be 40 times more likely of succumbing to lung cancer if you are a persistent heavy smoker? What is it in tobacco or in the act of smoking which is damaging to health? These are the enigmas of smoking tobacco which have remained largely unanswered. We are interested in the myriad ways that humans are exposed to aluminium in everyday life (http://pubs.rsc.org/en/content/articlepdf/2013/em/c3em00374d). Intriguingly one such way is smoking tobacco and the main reason for this is the presence of significant amounts of aluminium in tobacco (http://www.amjmed.com/article/S0002-9343(05)00710-2/pdf).When tobacco is smoked its components form an aerosol which is taken down into the lung before it is eventually expired. Anyone who has set up a ‘smoking machine’ to investigate this will no doubt have been impressed by the efficiency with which a surrogate lung fluid transforms th...
NOT PEER REVIEWED The United Kingdom government is now recommending e-cigarettes as important tools in helping individuals to quit smoking (http://www.bbc.co.uk/news/health-41339790). It is widely acknowledged that, for many, smoking tobacco is detrimental to health. However, it is perhaps less widely appreciated that we have only a limited understanding of why smoking tobacco is bad for our health. Why, for example, might you be 40 times more likely of succumbing to lung cancer if you are a persistent heavy smoker? What is it in tobacco or in the act of smoking which is damaging to health? These are the enigmas of smoking tobacco which have remained largely unanswered. We are interested in the myriad ways that humans are exposed to aluminium in everyday life (http://pubs.rsc.org/en/content/articlepdf/2013/em/c3em00374d). Intriguingly one such way is smoking tobacco and the main reason for this is the presence of significant amounts of aluminium in tobacco (http://www.amjmed.com/article/S0002-9343(05)00710-2/pdf).When tobacco is smoked its components form an aerosol which is taken down into the lung before it is eventually expired. Anyone who has set up a ‘smoking machine’ to investigate this will no doubt have been impressed by the efficiency with which a surrogate lung fluid transforms the black smoke coming out of the cigarette into the white wispy vapour which is eventually expired. The surrogate lung fluid, on the other hand, changes from a clear solution to one which is tinged with yellow. We found that a significant amount of aluminium (ca 50(micro)g/L), presumably originating from the tobacco, was retained by the surrogate lung fluid and we speculated that this aluminium could contribute towards tobacco-related illnesses.
The arrival of e-cigarettes encouraged us to repeat our previous experiments. In the first instance we measured the aluminium content of many commercially-available e-liquids. Their aluminium content ranged from 26(micro)g/L for pure propylene glycol (the usual vehicle for e-liquids) to 147(micro)g/L (<0.2ppm) for a Virginian e-liquid with high nicotine content. Nevertheless even the higher figure is considerably lower than the aluminium content of tobacco (ca 2.0ppm) and so we were not expecting e-cigarettes to be a significant source of aluminium to lung fluids. However, we were to be surprised! When a 0.5mL volume of e-liquid was ‘smoked’ to completion through 50mL of a surrogate lung fluid the aluminium content of the lung fluid varied between 2000 and 9000(micro)g/L which equated to between 100 and 500(micro)g of aluminium per 0.5mL of e-liquid. Further experiments where the branded e-liquid was replaced with propylene glycol (which contains only 26(micro)g/L aluminium) produced results up to 13000(micro)g/L aluminium in the surrogate lung fluid, equivalent to approximately 700(micro)g of aluminium per 0.5mL of propylene glycol vehicle.
Smoking e-cigarettes is potentially much more hazardous with respect to potential toxicity due to aluminium than smoking tobacco. The source of the aluminium is the e-cigarette itself and not the e-liquid though the latter may contribute towards the dissolution of aluminium from various components of the e-cigarette.
We do not know if some of the health-related effects of smoking tobacco are attributable to aluminium in tobacco. However, if they are then such will not be addressed by smoking e-cigarettes.
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In the article Potential deaths averted in USA by replacing cigarettes with e-cigarettes (1), a Status Quo model is performed, which suggests that this change will avoid premature deaths of millions. Although the statement is interesting, it´s necessary to mention that, the quantity of cigarettes consumed wasn´t considered. In addition, it´s important to recognize that a controversy still exists about the use of these devices and their toxicity.
Believing that e-cigarettes are an alternative against the use of cigarettes is tempting, but we have to be cautious. One of the major risk factors for cancer is an excessive consumption of cigarettes. In Müezzinler A et al (2), a dose response between the number of cigarettes consumed and mortality of any cause was seen. Therefore, it is not only if you smoke, it is also important how much you smoke. Nevertheless, since this outcome was not assessed, we assume that risk was uniform. In addition, they classify as “never smokers” any persons with less of forty years that smoke cigarettes. Is possible that a person of thirty-eight years who smoke twenty cigarettes per day for twenty years could be classified like a “never smoker”? We doubt it.
Currently, the use of e-cigarettes is controversial. As Chen J et al states in their study (3), we should carefully interpret this idea of a substitution. There is a great quantity of information about the risks of conventional cigarettes in estimation mo...
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In the article Potential deaths averted in USA by replacing cigarettes with e-cigarettes (1), a Status Quo model is performed, which suggests that this change will avoid premature deaths of millions. Although the statement is interesting, it´s necessary to mention that, the quantity of cigarettes consumed wasn´t considered. In addition, it´s important to recognize that a controversy still exists about the use of these devices and their toxicity.
Believing that e-cigarettes are an alternative against the use of cigarettes is tempting, but we have to be cautious. One of the major risk factors for cancer is an excessive consumption of cigarettes. In Müezzinler A et al (2), a dose response between the number of cigarettes consumed and mortality of any cause was seen. Therefore, it is not only if you smoke, it is also important how much you smoke. Nevertheless, since this outcome was not assessed, we assume that risk was uniform. In addition, they classify as “never smokers” any persons with less of forty years that smoke cigarettes. Is possible that a person of thirty-eight years who smoke twenty cigarettes per day for twenty years could be classified like a “never smoker”? We doubt it.
Currently, the use of e-cigarettes is controversial. As Chen J et al states in their study (3), we should carefully interpret this idea of a substitution. There is a great quantity of information about the risks of conventional cigarettes in estimation models like MCDA (Multi Criteria Decision Analysis); in comparison of the e-cigarettes that are “new” products, with less users and long-term information. Therefore, the possible consequences would be less precise and suggest a lower risk. Besides this, the authors found that the use of e-cigarettes expose the users to 9 from the 12 significant hazards identified in the conventional cigarettes, which are more related to neoplastic and respiratory effects. In addition, the virulence increase of the methicillin-resistant Staphylococcus aureus (MRSA) strains exposed to the vapor of e-cigarettes has also been described in rat models of pneumonia (4). Do we want to promote their use, although we don´t truly know the potential hidden risks of these devices?
As noted above, future research about e-cigarettes as an alternative to cigarettes has to consider the known risks about this topic. Therefore, it would provide a valuable conclusion about this global health problem instead of a dangerous illusion.
References:
1. Levy D, Borland R, Lindblom E, Goniewicz M, Meza R, Holford T, et al. Potential deaths averted in USA by replacing cigarettes with e-cigarettes. Tob Control. 2017 Oct 2. pii: tobaccocontrol-2017-053759.
2. Müezzinler A, Mons U, Gellert C, Schöttker B, Jansen E, Kee F, et al. Smoking and All-cause Mortality in Older Adults: Results From the CHANCES Consortium. Am J Prev Med. 2015 Nov;49(5):e53-e63.
3. Chen J, Bullen C, Dirks K. A Comparative Health Risk Assessment of Electronic Cigarettes and Conventional Cigarettes. Int J Environ Res Public Health. 2017 Apr 5;14(4).11.
4. Hwang J, Lyes M, Sladewski K, Enany S, McEachern E, Mathew D, et al. Electronic cigarette inhalation alters innate immunity and airway cytokines while increasing the virulence of colonizing bacteria. J Mol Med (Berl). 2016 Jun;94(6):667-79.
There is also very clear evidence that tobacco industry interference is either delaying or dumbing down implementation of each of the MPOWER policies particularly in LMICs. The TC vaccine is a good concept but the framework needs to include monitoring, exposing and countering industry tactics.
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 authors point out that rates of adolescent ever use of e-cigarettes are substantial and increasing, but rates of regular use remain low. Yet it is also worth placing these rates of adolescent use in the context of other groups of e-cigarette users. In particular, a recent systematic review colleagues and I published into sociodemographic differences in e-cigarette use gives further salience to Conner et al’s findings. Although the availability of UK evidence for our review was limited, some very clear patterns emerged internationally. For instance, within the 38 studies reporting ever use and the 22 reporting current use, these outcomes were particularly prevalent in older adolescents and younger adults (versus younger children and older adults respectively). This therefore lends further weight to Conner et al’s recommendations around regulating the marketing and sale of e-cigarettes to minors in countries which lack sufficient legislation in this area. Both papers also show the importance of future studies stratifying findings by sociodemographic variables such as age to ensure more subgroup analyses are possible.
1) Hartwell G, Thomas S, Egan M, et al E-cigarettes and equity: a systematic review of differences in awareness and use between sociodemographic groups Tobacco Control Published Online First: 21 December 2016. doi: 10.1136/tobaccocontrol-2016-053222
NOT PEER REVIEWED The United Kingdom government is now recommending e-cigarettes as important tools in helping individuals to quit smoking (http://www.bbc.co.uk/news/health-41339790). It is widely acknowledged that, for many, smoking tobacco is detrimental to health. However, it is perhaps less widely appreciated that we have only a limited understanding of why smoking tobacco is bad for our health. Why, for example, might you be 40 times more likely of succumbing to lung cancer if you are a persistent heavy smoker? What is it in tobacco or in the act of smoking which is damaging to health? These are the enigmas of smoking tobacco which have remained largely unanswered. We are interested in the myriad ways that humans are exposed to aluminium in everyday life (http://pubs.rsc.org/en/content/articlepdf/2013/em/c3em00374d). Intriguingly one such way is smoking tobacco and the main reason for this is the presence of significant amounts of aluminium in tobacco (http://www.amjmed.com/article/S0002-9343(05)00710-2/pdf).When tobacco is smoked its components form an aerosol which is taken down into the lung before it is eventually expired. Anyone who has set up a ‘smoking machine’ to investigate this will no doubt have been impressed by the efficiency with which a surrogate lung fluid transforms th...
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In the article Potential deaths averted in USA by replacing cigarettes with e-cigarettes (1), a Status Quo model is performed, which suggests that this change will avoid premature deaths of millions. Although the statement is interesting, it´s necessary to mention that, the quantity of cigarettes consumed wasn´t considered. In addition, it´s important to recognize that a controversy still exists about the use of these devices and their toxicity.
Believing that e-cigarettes are an alternative against the use of cigarettes is tempting, but we have to be cautious. One of the major risk factors for cancer is an excessive consumption of cigarettes. In Müezzinler A et al (2), a dose response between the number of cigarettes consumed and mortality of any cause was seen. Therefore, it is not only if you smoke, it is also important how much you smoke. Nevertheless, since this outcome was not assessed, we assume that risk was uniform. In addition, they classify as “never smokers” any persons with less of forty years that smoke cigarettes. Is possible that a person of thirty-eight years who smoke twenty cigarettes per day for twenty years could be classified like a “never smoker”? We doubt it.
Currently, the use of e-cigarettes is controversial. As Chen J et al states in their study (3), we should carefully interpret this idea of a substitution. There is a great quantity of information about the risks of conventional cigarettes in estimation mo...
Show MoreThere is also very clear evidence that tobacco industry interference is either delaying or dumbing down implementation of each of the MPOWER policies particularly in LMICs. The TC vaccine is a good concept but the framework needs to include monitoring, exposing and countering industry tactics.
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...
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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...
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...
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