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.
NOT PEER REVIEWED The Jawad et al systematic review and meta-analysis examining price effects for non-cigarette tobacco and nicotine products appears methodologically sound and was a registered analysis. It provides information that could be used productively by advocates and policymakers seeking to reduce harm. The cross-elasticities reported in this paper can be used to the advantage of public health by increasing the impact of policies that seek to drive down smoking.
However, this work does not take into account the fact that not all tobacco and nicotine products cause the same level of health harms as combustible cigarettes. The paper examines own- and cross-price elasticity across a wide array of products – from combustible tobacco products such as kreteks and little cigars to nicotine-only products such as e-cigarettes and nicotine patches – and then discusses consumption patterns in terms of an undifferentiated aggregate of nicotine use. Jawad and colleagues do not consider the health implications of policies to move nicotine users from more-harmful to less-harmful means of administration (see, for example, Chaloupka, Warner and Sweanor, 2015, recommending differential taxation according to differential risk).
From a public health perspective, any analysis of nicotine-use patterns should consider differential harm levels. A focus on nicotine use as the sole outcome variable can be seriously misleading and detrimental to the goal of reducing smoking....
NOT PEER REVIEWED The Jawad et al systematic review and meta-analysis examining price effects for non-cigarette tobacco and nicotine products appears methodologically sound and was a registered analysis. It provides information that could be used productively by advocates and policymakers seeking to reduce harm. The cross-elasticities reported in this paper can be used to the advantage of public health by increasing the impact of policies that seek to drive down smoking.
However, this work does not take into account the fact that not all tobacco and nicotine products cause the same level of health harms as combustible cigarettes. The paper examines own- and cross-price elasticity across a wide array of products – from combustible tobacco products such as kreteks and little cigars to nicotine-only products such as e-cigarettes and nicotine patches – and then discusses consumption patterns in terms of an undifferentiated aggregate of nicotine use. Jawad and colleagues do not consider the health implications of policies to move nicotine users from more-harmful to less-harmful means of administration (see, for example, Chaloupka, Warner and Sweanor, 2015, recommending differential taxation according to differential risk).
From a public health perspective, any analysis of nicotine-use patterns should consider differential harm levels. A focus on nicotine use as the sole outcome variable can be seriously misleading and detrimental to the goal of reducing smoking.
Cited Reference
Chaloupka, FJ, Sweanor D, Warner KE. Differential taxes for differential risks—toward reduced harm from nicotine-yielding products. N Engl J Med 2015 Aug 13;373(7): 594-7.
NOT PEER REVIEWED
We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises a...
NOT PEER REVIEWED
We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises as the ISCSH. While Russell criticized the ISCSH for its discount of compensation, (which he believed medium- high- nicotine cigarettes could help remedy) the same foundations appear in his recommendations: reduced toxicity is reduced risk, (1) collaboration with the tobacco industry doesn’t influence outcomes, (2) nicotine addiction is inevitable, (3) and products must be popular to curtail use. (4)
We caution that enthusiasm for the tantalizing fantasy of reduced risk products and tobacco industry resources may lead us to readopt the premises promoted by the tobacco industry for decades.
In their response, Drs. Britton and O’Connor implore public health to promote evidence-based tobacco harm reduction. We could not agree more.
1. The Lancet. Nicotine Use After the Year 2000. Lancet. 1991; 337: 1191-2.
2. Russell M. Conversation with Michael AH Russell. Addiction (Abingdon, England). 2004; 99: 9-19.
3. Jarvis M and Russell M. Comment on the Hunter Committee's second report. British medical journal. 1980; 280: 994.
4. Russell M. The future of nicotine replacement. British Journal of Addiction. 1991; 86: 653-8.
NOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by t...
NOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by tobacco companies succeeded in hijacking the tobacco public policy and media agenda, and diverted the government of the day from evidence-based approaches recommended by health authorities to reduce smoking. Elias and Ling have good reason to suggest that there are similarities between then and now.
In passing, Jarvis’s summary that the novel products of the day failed “because consumers rejected them” omits much. One important reason for the failure of tobacco substitutes was that industry rhetoric and hype to the contrary, there was ultimately justifiable concern, with concomitant media coverage, that “all the generally available brands contained 75 per cent tobacco, and were no more than additions to the low and low-to-middle tar range” (1). Indeed, it would have been quite possible for smokers switching to part-substitute brands to find themselves moving to higher tar products.
But before this message hit, there had been a mountain of industry-generated publicity promoting the notion that “safer” and (as inevitably reported) “safe” new brands were on the way. This approach was supported with public relations ploys such as an Imperial Tobacco press conference about part-substitute cigarettes the day after the launch of the 1977 Royal College of Physicians’ “Smoking Or Health” report. Not surprisingly, the tobacco trade press was quick to congratulate the company concerned on its success in diluting the impact of the College report.
1. Daube M. The politics of smoking: thoughts on the Labour record. Community Medicine. 1979; 1, 306-314
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED
Elias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, taken as a whole, their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control. Current policy, which had its beginnings some 20 years or more later, is painted as being an outgrowth of the low tar programme and as being similarly tainted with industry influence. It reflects no credit on the editorial processes and decision making of Tobacco Control that authors were permitted to get away with such unsupported conclusions in their published paper.
The idea that reduction in tar yield of cigarettes could be an effective way of reducing the health risks of smoking goes back to the 1960s at least. It was supported by many distinguished epidemiologists, including Doll, Peto, and Wynder. See for example this 1979 statement by Ernst Wynder: ““One of the things that has always appealed to me about science is that if I find something that makes biological sense, then I feel reassured. Thirty years ago, when we had a 40mg tar cigarette, if you smoked 30 cigarettes a day you were exposed to about 1200 mg tar a day. Today’s cigarettes have 20 mg tar, so you are exposed to 600 mg daily. If there’s one thing everybody can agree on, it is that all tobacco-related cancers are dose related.” (1)
What was lacking in this formulation was an understanding that the risk from products is not simply determined by their composition, but resides in the interaction between the user and the product – as Michael Russell pointed out, if tar yield was everything, the most dangerous product would be the large Cuban cigar (1).
Russell was an outspoken critic of the ISCSH’s record. In a 1980 comment on the committee’s second report (2) he noted “Most of all it [the report] is remarkable for the stunning naivety of its implicit model of smoking behaviour”. He pointed out that: “Lower risk cigarettes are equated with cigarettes with lower tar and nicotine yields. If people smoked cigarettes in the same way that smoking machines do, this would indeed be the case. But there is much evidence that they do not….The tendency for smokers to regulate their smoke intake has been ignored by the Hunter Committee”.
Russell was not a member of the ISCSH (indeed, the membership of the committee was heavily tilted towards epidemiology and toxicology, and included no behavioural science expertise). It is in Russell’s insights and policy prescriptions that we can see the real intellectual underpinnings of UK policy on harm reduction in recent years.
Russell had a number of key insights, the most fundamental of which is that people smoke for nicotine (3). This coupled with the observation that the harms of smoking come not from the drug people are seeking, but from contaminants of the delivery system used to obtain it, led to his dictum “People smoke for the nicotine, but die from the tar”. As early as the mid-1970s he began to advocate an approach to tobacco harm reduction that was based on an appreciation of nicotine’s role (4, 5). He was the first to expose the fallacy of low tar cigarettes (6) and the first to explore the potential of non-combustible nicotine products for harm reduction (7-9). His 1991 paper in the British Journal of Addiction (10) and editorial in The Lancet (11) set out a vision for a transformed nicotine market: “If a strategy were adopted to sanction and encourage the use of purified nicotine products as substitutes for smoking, and at the same time impose stringent regulations on permissible constituents of cigarette smoke …….. the virtual elimination of smoking could become a more realistic health promotion target” (11). This represents a paradigm shift from the failed approach adopted in the 1970s. How it, or something springing from it, became a part of UK tobacco control policy in recent years, is a story for others to tell. But it did not happen through tobacco industry influence.
References
1. Gori GB, Bock FG. Banbury Report 3: A Safe Cigarette? Cold Spring Harbor Laboratory; 1980.
2. Jarvis MJ, Russell MAH. Comment on the Hunter Committee's second report. British Medical Journal. 1980;5; 280(6219):994-5.
3. Russell MA. Cigarette smoking: natural history of a dependence disorder. Br-J-Med-Psychol. 1971;44(1):1-16.
4. Russell MA. Realistic goals for smoking and health. A case for safer smoking. Lancet. 1974;16; 1(851):254-8.
5. Russell MA. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. Br-Med-J. 1976;12; 1(6023):1430-3.
6. Russell MAH, Jarvis M, Iyer R, Feyerabend C. Relation of nicotine yield of cigarettes to blood nicotine concentrations in smokers. British Medical Journal. 1980;280(6219):972-6.
7. Russell MAH, Jarvis MJ, Feyerabend C. A new age for snuff? Lancet. 1980;1; 1(8166):474-5.
8. Russell MAH, Jarvis MJ, Devitt G, Feyerabend C. Nicotine intake by snuff users. Br Med J. 1981;26; 283(6295):814-7.
9. Russell MAH, Jarvis MJ, West RJ, Feyerabend C. Buccal absorption of nicotine from smokeless tobacco sachets. Lancet. 1985;2(8468):1370.
10. Russell MAH. The future of nicotine replacement. Br-J-Addict. 1991;86(5):653-8.
11. Russell MAH. Nicotine use after the year 2000. The Lancet. 1991;337:1191-2.
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a swi...
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a switch to HNB devices [5]. For non-smokers or occasional smokers to whom HNBs are introduced as a safe product, any additional burden of toxicants increases the risk of cancer.
4) The conclusion concentrates on reduced risk of VNPs compared to the most harmful product (i.e tobacco smoke) and should also calculate elevated risk of using VNPs compared to background concentration.
In summary, smoking imposes exposure to a variety of toxicants with known and/or unknown health effect regardless of name, shape and means of use. These findings suggest that HNB cigarettes should be subject to the same regulations as tobacco cigarettes. The tobacco control community should communicate the absolute risks associated with these products. In particular, there is an urgent need for tobacco control policy actors to understand the potential absolute harms of heat-not-burn (HNB) cigarettes that PMI is pushing as ‘less harmful alternatives to smoking’ in their declared movement toward a smoke-free world (https://www.pmi.com/sustainability).
References:
[1] Stephens WE. Comparing the cancer potencies of emissions from vapourised nicotine products including e-cigarettes with those of tobacco smoke. Tobacco Control 2017.
[2] Auer R, Concha-Lozano N, Jacot-Sadowski I, et al. Heat-not-burn tobacco cigarettes: Smoke by any other name. JAMA Internal Medicine 2017.
[3] Cogliano VJ, Grosse Y, Baan RA, et al. Meeting report: summary of IARC monographs on formaldehyde, 2-butoxyethanol, and 1-tert-butoxy-2-propanol. Environmental health perspectives 2005:1205-1208.
[4] Goodson III WH, Lowe L, Carpenter DO, et al. Assessing the carcinogenic potential of low-dose exposures to chemical mixtures in the environment: the challenge ahead. Carcinogenesis 2015;36(Suppl_1):S254-S296.
[5] Lüdicke F, Baker G, Magnette J, et al. Reduced Exposure to Harmful and Potentially Harmful Smoke Constituents With the Tobacco Heating System 2.1. Nicotine & Tobacco Research 2017;19(2):168-175.
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different the outcome if administered by an organization such as my own where the respondents would likely be more at ease. And while if started from scratch with recruitment it might also attract other-thinking smokers that could skew it the other way (but also then questioning this study's sample at the same time), it need not be necessary in regard to the study limitation present here today.
NOT PEER REVIEWED This paper is part of the ongoing discussion about saving lives from tobacco use. As a practicing oncologist and part-time Hospice physician, I have seen real benefit from "vaping". First, many Hospice patients, who have smoked for decades and are actively dying put themselves at real risk if they smoke real cigarettes while dying. Taking away cigarettes during the terminal illness just causes antagonism and much distress for the patient, their family, and the Hospice staff. Vaping at the end of life does prevent burns, suffering, and psychological distress.
For my oncology patients, I recommend vaping as an alternative to cigarettes for the many cigarette smokers who cannot "quit", despite real effort attempts with nicotine patches, gum, Wellbutrin, or Chantix. I do see lives improving, pulmonary function improving, and less stress in the exam setting, trying to convince the patient to quit yet another time.
We do need more research about cigarette alternatives for the existing nicotine addicts. There is, most definitely a role for these products, but also a need for researching the safety, efficacy, and best application of these products as an alternative for active adult smokers with health issues.
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the mos...
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
First, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the most pessimistic possible). Studies support the Royal College that non-combustible nicotine use is substantially less harmful than the smoke from combustion in clinical studies that smokers who switched to e-cigarettes reduced symptoms of pulmonary disease and cancer biomarkers (Shahib et al., Ann. Internal Med 2017; Glasser et al., AJPM, 2017; Benowitz and Fraiman, Nat Rev Cardiol. 2017).
Second, Dr. Peters clearly misunderstands the limitations of the longitudinal youth research. The studies to date cannot rule out confounders based on a shared liability model and, consequently, others suggest that fears of a gateway are overblown (Kozlowski & Warner, Drug & Alc Dep, 2017). These studies were conducted in a period when smoking and vaping rates were going in opposite directions or when smoking rates were continuing to decline more rapidly in the presence of reduced vaping (2013-16), and are based on very low levels of use (ever use or any monthly use, not regular use). The gateway theory is about population level relationships, and it cannot account for the two behaviours, cigarette use and e-cigarette use, going in opposite directions.
Third, Dr. Peters mischaracterizes the use of vaping. Where it is regularly available, vaping is the most used form of smoking cessation help, and, while the current evidence indicates it is at least as effective as nicotine replacement therapy (NRT’s) and possibly more so, as e-cigarettes are used by more smokers in quit attempts than NRT’s (Hartman-Boyce, Cochrane Reviews, 2016), and therefore will be having a larger net population effect. The recent population level analysis of Zhu et al (BMJ, 2017) shows an acceleration of the reduction in smoking prevalence in a period where the rapid uptake of vaping was the most notable change in the tobacco control environment and Levy et al (NTR, 2017) show a strong relationship between vaping, especially when done regularly, and both previous year quit attempts and quit success. A recent review confirms that e-cigarettes help smokers to quit and that studies of negative correlations between e-cigarette use and smoking cessation fail to meet reasonable but rigorous standards of scientific evidence (Villanti et al., Addiction, 2017).
Fourth, Dr. Peters claims that we underestimate the declining prevalence from 2009 to 2015, but does not point out the plausibility of a significant proportion of this change being due to the introduction of vaping. Indeed, this is precisely why we made the starting point for our projections (2012) when we did, at the point when the level of vaping was so small as to not have any appreciable possible impact on smoking rates.
As we indicated in our reply to Dr. Glantz, our goal in this study is not to predict the future, but to suggest a course for reaching an endgame of eliminating cigarettes tobacco use. Our hope is for tobacco control advocates to keep an open mind about the possibilities. Having smokers switch to e-cigarettes may not be the ideal outcome, but do we want to let the perfect continue to be the enemy of the possible?
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 The Jawad et al systematic review and meta-analysis examining price effects for non-cigarette tobacco and nicotine products appears methodologically sound and was a registered analysis. It provides information that could be used productively by advocates and policymakers seeking to reduce harm. The cross-elasticities reported in this paper can be used to the advantage of public health by increasing the impact of policies that seek to drive down smoking.
However, this work does not take into account the fact that not all tobacco and nicotine products cause the same level of health harms as combustible cigarettes. The paper examines own- and cross-price elasticity across a wide array of products – from combustible tobacco products such as kreteks and little cigars to nicotine-only products such as e-cigarettes and nicotine patches – and then discusses consumption patterns in terms of an undifferentiated aggregate of nicotine use. Jawad and colleagues do not consider the health implications of policies to move nicotine users from more-harmful to less-harmful means of administration (see, for example, Chaloupka, Warner and Sweanor, 2015, recommending differential taxation according to differential risk).
From a public health perspective, any analysis of nicotine-use patterns should consider differential harm levels. A focus on nicotine use as the sole outcome variable can be seriously misleading and detrimental to the goal of reducing smoking....
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We thank Dr. Jarvis for his appreciation of our historical scholarship but disagree that our conclusion, “the promotion of tobacco harm reduction may serve the interests of tobacco companies more effectively than the public,” is an attack.
Our paper is about how policy affects ideas and vice versa. The ideas guiding the product modification program led to bad outcomes. That these ideas have been reanimated merits critical assessment. Voluntary agreements led to industry influence over the ISCSH’s recommendations, which in turn undermined public health. We point out that some of the same premises that led the ISCSH astray are popular again. Jarvis claims that current UK harm reduction policy has nothing to do with the product modification program, and everything to do with the influence of the late Michael Russell. Russell’s impressive scholarship – and oft-quoted statement, “people smoke for the nicotine, but die from the tar” – is indeed hugely influential among proponents of tobacco harm reduction. Jarvis posits that Russell’s work serves as a “paradigm shift” on which the UK’s current embrace of long-term nicotine maintenance and tobacco harm reduction actually rests, and which severs any link between the failures of product modification and widespread fears of a redux today.
Yet Russell’s work represents more a variation in theme than it does revolution in content. Russell’s policy recommendations operate from the same premises a...
Show MoreNOT PEER REVIEWED Martin Jarvis is right to describe the Hunter Committee era as “a sorry tale” that by and large is well told by Elias and Ling, but his assertion that “taken as a whole their paper reads more as an attack on current UK policy than as a scholarly contribution to the history of tobacco control” is way over the top, as is his criticism of “the editorial processes and decision-making of Tobacco Control”.
In a paper that runs to a little over five pages of text, there are very brief references to current policies on the first page, then further brief references towards the end, suggesting that there are lessons to be drawn from the earlier episodes.
The paper might indeed have expanded further on the industry-friendly record of the Hunter Committee, noting that after his term as Chairman of the Committee ended, Lord Hunter became a consultant for Imperial Tobacco, while a civil servant who worked on smoking and serviced the Hunter Committee went on to work for Gallahers. It might also have included more emphasis on the way tobacco substitutes dominated public discourse on tobacco policy issues during the 1970s (1), although in fairness to the authors they appear to have been misled by the re-writing of history evident in some of the material they cite, particularly from industry actors.
But this would simply have added more weight to the conclusion that during the 1970s discussion, debate and massive promotion of tobacco substitutes by t...
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Show MoreElias & Ling throw useful light on the slow-motion disaster that was the series of voluntary agreements begun in the 1970s between government and the tobacco industry in the UK, overseen by the Independent Scientific Committee on Smoking and Health (ISCSH). These had as their aim to address the issue of tobacco product modification to reduce the health risks of smoking. Industry produced new smoking materials with the aim of reducing the biological activity of the tar fraction of smoke from cigarettes, and agreed to a programme of gradual tar yield reduction across the years. The novel products failed because consumers rejected them (there were too few users even to recruit for trials to examine their potential benefits), and the reductions in machine-smoked tar yields were achieved largely through increasing filter ventilation. The material cited shows that the low tar programme fiasco was characterized by undue influence from tobacco industry and a complete lack of understanding of the dynamics of smoking behaviour on the part of the scientific experts charged by government with supervision of the programme.
This is a sorry tale from the early days of tobacco control, and Elias & Ling tell it well. So far so good. But in framing and interpreting their material they go well beyond the data they cite, and draw quite unwarranted conclusions about what they see as the deficiencies of the current UK harm reduction policy. Indeed, tak...
NOT PEER REVIEWED Elias and Ling conclude that ‘Regulatory bodies should consider toxin exposure, and new products’ actual use, abuse potential and population health effects before endorsing them as safer’. We agree, and that is exactly what Public Health England and the Royal College of Physicians have done [1-4].
1. Britton, J. and Bogdanovica, I. Electronic cigarettes. A report commissioned by Public Health England. Public Health England, 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
Show More2. Bauld, L., Angus, K., and de Andrade, M. E-cigarette uptake and marketing. A report commissioned by Public Health England. Public Health England, 2014. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
3. McNeill, A., Brose, L., Calder, R., Hitchman, S.C., McRobbie, H., and Hajek, P. E-cigarettes: an evidence update. A report commissioned by Public Health England. Public Health England, 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil...
4. Tobacco Adviso...
NOT PEER REVIEWED The results provided by Stephens [1] may suggest to readers that since the concentrations of carcinogens are lower in vapourised nicotine products (VNPs), the risks of cancer are smaller compared to conventional cigarettes. The article uses the linear non-threshold model for risk assessment (a uniform cancer risk per unit dose from higher to lower doses), which is also used by most regulatory agencies. This model is considered to have a high degree of uncertainty; nevertheless, it implies that any dose of carcinogens increases the risk of cancer. Accordingly, the primary conclusion of Stephens and other’s[2] findings of the presence of carcinogens, particularly in heat-not-burn cigarettes (HNB) is that HNB poses a significant risk of cancer. In addition:
Show More1) The article highlights a summation approach of overall cancer risk for each product, yet the individual concentrations of human carcinogens (for example, formaldehyde [3]) are still at risk level.
2) The assessment of carcinogenesis of low-level exposure to a mixture of chemicals is challenging [4]. Stephens’s summation model assumes that the effect of chemicals is independent. Even if we assume that for an individual chemical a lower concentration lowers carcinogenicity, we cannot rule out the potential effects of interactions among chemicals.
3) The analysis relies on holding consumption constant. However, manufacturer studies have suggested that consumption increases after a swi...
NOT PEER REVIEWED An often overlooked limitation in smoking-related studies based on surveys conducted by health institutions is the pressure on respondents to provide "the right answer." Especially in this area, where this population has been subjected to high intensity tobacco control policies and messages, sample representativeness cannot be established with certainty when those asking the questions are the originators and/or pursuers of these policies and messages and, undeniably, describing the effort as "denormalization" and seeking to form a stigma around smoking and smokers.
Furthering this theory is the strongly implied factor contained in this study's "Limitations" section that the respondents have been plucked from prior tobacco research, thereby affording them even more knowledge about the opinions of the researchers. Those who volunteer for smoking-related studies -- perhaps even receiving incentive payments? -- cannot be dismissed as the type who will lean toward providing expected answers in order to please, are indicative of the type who already agree with the perceived direction of the study, or, as already stated, fear telling the truth to those they know hold a general disapproving attitude toward the subject at hand.
Right now the sample representativeness is skewed because of this. By how much remains the question. But one should not discount wondering what the responses would be and how different...
Show MoreNOT PEER REVIEWED This paper is part of the ongoing discussion about saving lives from tobacco use. As a practicing oncologist and part-time Hospice physician, I have seen real benefit from "vaping". First, many Hospice patients, who have smoked for decades and are actively dying put themselves at real risk if they smoke real cigarettes while dying. Taking away cigarettes during the terminal illness just causes antagonism and much distress for the patient, their family, and the Hospice staff. Vaping at the end of life does prevent burns, suffering, and psychological distress.
For my oncology patients, I recommend vaping as an alternative to cigarettes for the many cigarette smokers who cannot "quit", despite real effort attempts with nicotine patches, gum, Wellbutrin, or Chantix. I do see lives improving, pulmonary function improving, and less stress in the exam setting, trying to convince the patient to quit yet another time.
We do need more research about cigarette alternatives for the existing nicotine addicts. There is, most definitely a role for these products, but also a need for researching the safety, efficacy, and best application of these products as an alternative for active adult smokers with health issues.
NOT PEER REVIEWED The 2014 Surgeon Generals Report (p. 875) stated ““The burden of death and disease from tobacco use in the U.S. is overwhelmingly caused by cigarettes and more must be done to end the deaths from combustible tobacco.” The aim of our study was to show the potential of policies to encourage cigarette smokers to switch to e-cigarettes as a way to reach or at least get closer to that goal. Indeed, FDA Commissioner Gottlieb and Director, Center for Tobacco Products Zeller in a July commentary in NEJM set out a two-pronged approach to the endgame of 1) policies making cigarettes less desirable and 2) policies making e-cigarettes a better substitute for cigarettes. We feel that Dr. Peters misses the point of the article, that the article is an exploratory exercise, and compounds his misunderstanding with unsubstantiated claims.
Show MoreFirst, while Dr. Peters criticizes the 5% excess total mortality risk estimate for e-cigarettes relative to cigarettes and the pessimistic estimate, he does not make a coherent argument as to why we might expect worse outcomes, even though he is a respiratory physician and might be expected to point out specific scientific evidence vaping might approach smoking in harmfulness for respiratory illness at least. Indeed, we have seen no coherent argument for an alternative to the 5% estimate. We note that the UK Royal College of Physicians argued that it was likely to be less, while accepting the 5% as a likely upper bound (not the mos...
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